chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Lack of drug effect) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 020B21A-1) for COVID-19 vaccination.     Patient had no allergies to medications, food, and other product.  It was unknown patient had acute illnesses at the time of vaccination and up to one month before.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19) and VACCINATION FAILURE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Company comment-This Spontaneous case concerns a 30-year-old, female patient with no medical history reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), approximately 6 months 28 days after receiving the second dose of mRNA-1273 Vaccine. The patient received both the doses of mRNA-1273 Vaccine 34 days apart. Hence vaccination failure is considered in the case. No further details on clinical course, lab test results and treatment received were reported.  At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19 could be confounding factor for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-538933 (Patient Link). Sender's Comments: This Spontaneous case concerns a 30-year-old, female patient with no medical history reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), approximately 6 months 28 days after receiving the second dose of mRNA-1273 Vaccine. The patient received both the doses of mRNA-1273 Vaccine 34 days apart. Hence vaccination failure is considered in the case. No further details on clinical course, lab test results and treatment received were reported.  At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19 could be confounding factor for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered >12 /24(CA) hours post puncture; 7 patients were administered booster doses from a vial that had been open for 24 h; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients were administered booster doses from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Dose administered >12(US)/24(CA) hours post puncture) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022 at 8:02 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients were administered booster doses from a vial that had been open for 24 h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered >12(US)/24(CA) hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients were administered booster doses from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Dose administered >12(US)/24(CA) hours post puncture) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was initially stored in the refrigerator on 12-Apr-2022 and the vial was first punctured on 13-Apr-2022 at 8:00 am.  The vial was stored in refrigerator at 4-5 °C post puncture.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 30 min or less  The vial did not undergo any temperature excursions.  The patient did not experienced any symptoms.  No treatment medications were reported.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was open for more than 12 hours post puncture; Patient was administered booster dose from a vial that had been open for 24 h; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022 at 8:02 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. The patient received the booster dose of Moderna COVID-19 Vaccine.  On 12-Apr-2022, the vial was initially stored in the refrigerator.  On 13-Apr-2022 at 8:00 am, the vial was first punctured and was administered on 14-Apr-2022 8:02 am. Post puncture the vial was stored in refrigerator at 4-5 °C. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8  to 25 degree Celsius = 46 to 77 F) was 30 min or less.  No symptoms were experienced by the patient.  No treatment medications were provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was administered booster dose from a vial that had been open for 24 h; Vial was open for more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022 at 8:02 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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 at 12-Apr-2022. The date and time vial was first punctured on 13-Apr-2022 at 8:00 AM. The vial was stored in refrigerator at 4-5 °C post puncture. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 30 min or less. The patient did not experience any symptoms. No treatment medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was open for more than 12 hours post puncture; Patient was administered booster dose from a vial that had been open for 24 h; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022 at 8:02 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered booster dose from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (Vial was open for more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the booster dose of Moderna COVID-19 Vaccine.  No concomitant medications information was reported.  On 12-Apr-2022, the vial was initially stored in the refrigerator.  On 13-Apr-2022 at 8:00 am, the vial was first punctured and was administered on 14-Apr-2022 8:02 am. Post puncture the vial was stored in refrigerator at 4-5 °C. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8  to 25 degree Celsius = 46 to 77 F) was 30 min or less.  No symptoms were experienced by the patient.  No treatment medications were provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered >12/24 hours post puncture/vial was kept in the refrigerator at normal room temperature; Patient was administered booster doses from a vial that had been open for 24 hour; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered booster doses from a vial that had been open for 24 hour) and PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture/vial was kept in the refrigerator at normal room temperature) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022 at 8:02 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered booster doses from a vial that had been open for 24 hour). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture/vial was kept in the refrigerator at normal room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered booster doses from a vial that had been open for 24 hour) and PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture/vial was kept in the refrigerator at normal room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reported stated that patient were administered booster dose from a vial that had been open for 24 hr. The vial was kept in the refrigerator at normal room temperature. The vial was initially stored in the refrigerator on 12-Apr-2022. The vial was first punctured on 13-Apr-2022 at 8:00 am. Post puncture the vials were refrigerated at 4-5 degree Celsius.The vials did not undergo any temperature excursion. Total amount of time the vial exposed to room temperature range (8° to 25°C= 46° to 77°F) was 30 min or less. The patient did not have any symptoms.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore left arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore left arm for a couple of days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation (cardiac issues) since 2018, Latex allergy (sensitive to latex.) and Drug allergy (sensitive to morphine.). Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, AMIODARONE, ZINC and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced MYALGIA (sore left arm for a couple of days). On 02-Jan-2021, MYALGIA (sore left arm for a couple of days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2022-542338, MOD-2022-542339 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Hyperhidrosis, Illness, Inappropriate schedule of product administration
Clinical narrative: patient felt sick; sweating; Had cold; experienced chills; 1st dose: 01Jan2021/ 2nd dose: 08Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient felt sick), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (Had cold), CHILLS (experienced chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021/ 2nd dose: 08Feb2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Atrial fibrillation since 2018, Drug allergy (sensitive to morphine) and Latex allergy (sensitive to latex). Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, AMIODARONE, ZINC and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced ILLNESS (patient felt sick), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (Had cold), CHILLS (experienced chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021/ 2nd dose: 08Feb2021). On 09-Feb-2021, ILLNESS (patient felt sick), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (Had cold) and CHILLS (experienced chills) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021/ 2nd dose: 08Feb2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Antibody test: 250 (High) 250 units per mL greater than the normal range.         Amiodarone was started instead of metoprolol since 2 weeks ago. Patient did not seek medical care for the events. Patient got an antibody test on the same day previous to get 1st booster shot. No treatment had been given to the patient.   This case was linked to MOD-2022-542337, MOD-2022-542339 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: patient felt sick; sweating; Had cold; experienced chills; 1st dose: 01Jan2021/ 2nd dose: 08Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient felt sick), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (Had cold), CHILLS (experienced chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021/ 2nd dose: 08Feb2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Atrial fibrillation since 2018, Drug allergy (sensitive to morphine) and Latex allergy (sensitive to latex). Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, AMIODARONE, ZINC and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced ILLNESS (patient felt sick), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (Had cold), CHILLS (experienced chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021/ 2nd dose: 08Feb2021). On 09-Feb-2021, ILLNESS (patient felt sick), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (Had cold) and CHILLS (experienced chills) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021/ 2nd dose: 08Feb2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Antibody test: 250 (High) 250 units per mL greater than the normal range.         Amiodarone was started instead of metoprolol since 2 weeks ago. Patient did not seek medical care for the events. Patient got an antibody test on the same day previous to get 1st booster shot. No treatment had been given to the patient.   This case was linked to MOD-2022-542337, MOD-2022-542339 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19, PPV
Symptoms: Cough, Nasal congestion, Pain
Clinical narrative: Congestion; Cough; Few pains in body; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), COUGH (Cough) and PAIN (Few pains in body) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 026D21A, 029K20A and 039K20A) for COVID-19 vaccination.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for an unknown indication.    Concurrent medical conditions included Atrial fibrillation (Patient has A-fib but it fairly healthy). Concomitant products included WARFARIN SODIUM (JANTOVEN) for Atrial fibrillation.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-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 received dose of PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) (unknown route) 1 dosage form. In April 2022, the patient experienced NASAL CONGESTION (Congestion), COUGH (Cough) and PAIN (Few pains in body). At the time of the report, NASAL CONGESTION (Congestion), COUGH (Cough) and PAIN (Few pains in body) outcome was unknown.            It mentioned that according to patient history patient is eligible to receive two of the Pneumonia vaccines.  Patient got the 2nd booster and Pneumovax in different arms but couldn't remember which arm for which vaccine. Patient stated that patient never had any of these events from other vaccines.  Patient didn't taken any medications for adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Non significant follow up received.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Room's turning, it's been three days now/I had vertigo) and DIZZINESS (getting very dizzy, it's been three days now) 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced VERTIGO (Room's turning, it's been three days now/I had vertigo) and DIZZINESS (getting very dizzy, it's been three days now). At the time of the report, VERTIGO (Room's turning, it's  been three days now/I had vertigo) and DIZZINESS (getting very dizzy, it's been three days now) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow up contains Significant information: Event added.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: just a headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE ( just a headache) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Previously administered products included for Pneumonia: Pneumonia vaccine (had hives on arm and hand after receiving the second dose of the pneumonia vaccine). Past adverse reactions to the above products included Hives with Pneumonia vaccine. Concurrent medical conditions included Cardiac disorder NOS, Rheumatoid arthritis, Egg allergy, Fruit allergy, Fish allergy and Allergy to nuts. Concomitant products included FLECAINIDE ACETATE for Cardiac disorder NOS.    On 09-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 HEADACHE ( just a headache) and PYREXIA (fever). At the time of the report, HEADACHE ( just a headache) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2022-542349, MOD-2022-542350, MOD-2022-542351 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) in a female 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu symptoms). At the time of the report, INFLUENZA (Flu symptoms) had resolved.  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. no concomitant medications were provided. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: She had this cold; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (She had this cold), HEADACHE (headache) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 036A21A and 015M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pneumonia vaccine (Patient had hives on arm and hand after receiving the second dose of the pneumonia vaccine). Past adverse reactions to the above products included Hives with pneumonia vaccine. Concurrent medical conditions included Rheumatoid arthritis, Cardiac disorder NOS (Cardiac medication), Egg allergy (egg yolk allergy), Fruit allergy (papaya allergy), Fruit allergy (banana allergy), Allergy to nuts and Fish allergy. Concomitant products included FLECAINIDE ACETATE for Cardiac disorder NOS.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, 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 NASOPHARYNGITIS (She had this cold), HEADACHE (headache) and PYREXIA (fever). At the time of the report, NASOPHARYNGITIS (She had this cold), HEADACHE (headache) and PYREXIA (fever) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19 after receiving the first two vaccines.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter   It was reported that the patient does not t have any actual allergy but some sensitivities.She stated it was 2 weeks before the  variant hit the city and about one month ago there was a very bad cold going around her city. She had this cold and states the symptoms were pretty similar.   This case was linked to MOD-2022-542346, MOD-2022-542349, MOD-2022-542351 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine kept in refrigerator on 15-Mar-2022/administered on 18-Apr-2022; administer vaccine to one patient three days after the use by date expired; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer vaccine to one patient three days after the use by date expired) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 15-Mar-2022/administered on 18-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer vaccine to one patient three days after the use by date expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 15-Mar-2022/administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer vaccine to one patient three days after the use by date expired) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 15-Mar-2022/administered on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The frequency of Spikevax reported was times per. HCP called because they left box of Moderna vaccine in the refrigerator, and the use by date was on the 15-Apr-2022.  On 18-Apr-2022 vaccine was administered to one patient, three days after the use by date was expired. HCP could not provide patient information.The vial was initially stored on refrigerator on 15-Mar-2022 and the vial did not undergo any temperature excursions. The healthcare professional stated that, total 150 vials were expired but only one expired dose administered to one patient. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow-up document received includes: I-narrative updated. On 18-Apr-2022: Follow-up document received includes: contact details updated
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient received the Pfizer vaccine as first dose and Moderna as second dose; Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Pfizer vaccine as first dose and moderna as second dose) and EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (first primary series vaccine dose) on 12-Feb-2022. Past adverse reactions to the above products included No adverse event with Pfizer vaccine. On 18-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Pfizer vaccine as first dose and Moderna as second dose) and EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Pfizer vaccine as first dose and moderna as second dose) and EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter No other adverse reactions or side effects were reported on 18 APR 2022. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza, Malaise, Pain in extremity
Clinical narrative: did not feel well; bit of a flu; run down; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), INFLUENZA (bit of a flu), FEELING ABNORMAL (run down) and PAIN IN EXTREMITY (Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 1.5 years ago).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced MALAISE (did not feel well), INFLUENZA (bit of a flu), FEELING ABNORMAL (run down) and PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 30-Aug-2021, MALAISE (did not feel well), INFLUENZA (bit of a flu) and FEELING ABNORMAL (run down) had resolved. On 02-Sep-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            No concomitant medication was reported. After the first booster dose of the vaccine the patient had a sore arm the day after and did not feel well. For 1 day the patient felt run down and had a bit of a flu. The patients sore arm lasted 3 days before resolving.   This case was linked to MOD-2022-542616 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chilly; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chilly) and HEADACHE (mild headache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient has unknown allergies (medications, food and other products). Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of Vaccination reported as unknown.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced CHILLS (chilly) and HEADACHE (mild headache). At the time of the report, CHILLS (chilly) and HEADACHE (mild headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   The patient has no ever had COVID + test or diagnosis.  Recent change in status such as improvement or worsening was unknown.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose) reported as was unknown.  Manufacturer and dose of all COVID-19 vaccinations received (Complete for each COVID-19 vaccine received). It was unknown that the adverse events cause patient to seek medical care such as (office visit, Urgent care, ER, hospitalized). It was unknown that the patient has experienced a similar event in the past.  The patient's symptoms improved.  Treatment medications were not reported.   This case was linked to MOD-2022-542609, MOD-2022-542613, MOD-2022-542615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow-up received contains no new information
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: I got chilly; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I got chilly) and HEADACHE (mild headache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024821A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (I got chilly) and HEADACHE (mild headache). At the time of the report, CHILLS (I got chilly) and HEADACHE (mild headache) had resolved.            Concomitant and treatment information was not reported.   This case was linked to MOD-2022-542607, MOD-2022-542613, MOD-2022-542615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow up received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: I got chilly; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I got chilly) and HEADACHE (mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 024821A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced CHILLS (I got chilly) and HEADACHE (mild headache). At the time of the report, CHILLS (I got chilly) and HEADACHE (mild headache) had resolved.            No concomitant medication were reported.   No treatment drug were reported.   This case was linked to MOD-2022-542607, MOD-2022-542609, MOD-2022-542615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow up document contain non significant information.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: I got chilly; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I got chilly) and HEADACHE (mild headache) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 039F21A, 024821A and 031L20A) for COVID-19 vaccination.     The patient allergies were unknown.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, the patient experienced CHILLS (I got chilly) and HEADACHE (mild headache). At the time of the report, CHILLS (I got chilly) and HEADACHE (mild headache) had resolved.            No concomitant medication was reported. The treatment information was not reported.   This case was linked to MOD-2022-542607, MOD-2022-542609, MOD-2022-542613 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow up received contains no new information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Tremor
Clinical narrative: Could not sleep; Tremendous amount of shaking; Her joints namely her hands, legs, body, back, fingers, feet and neck were extremely sore/Could not get up and walk; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), TREMOR (Tremendous amount of shaking) and ARTHRALGIA (Her joints namely her hands, legs, body, back, fingers, feet and neck were extremely sore/Could not get up and walk) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 013L20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Previous experience with COVID-19 1.5 years ago, before receiving the vaccine) in 2020.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced INSOMNIA (Could not sleep), TREMOR (Tremendous amount of shaking) and ARTHRALGIA (Her joints namely her hands, legs, body, back, fingers, feet and neck were extremely sore/Could not get up and walk). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK, qd. At the time of the report, INSOMNIA (Could not sleep), TREMOR (Tremendous amount of shaking) and ARTHRALGIA (Her joints namely her hands, legs, body, back, fingers, feet and neck were extremely sore/Could not get up and walk) was resolving.            The patient had received two primary series doses and two booster doses of the Moderna COVID-19 vaccine by intramuscular injection. No concomitant medications were reported. It was reported that following the most recent dose, the patient came home and could not slept. The patient had a tremendous amount of shaking and could not got up and walk the day after getting the vaccine. The patient felt this like previous experience with COVID-19. The patient symptoms were still ongoing today although 99.9 percent resolved.  Treatment medication information included the patient had been taking Advil daily for her symptoms.   This case was linked to MOD-2022-542606 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Maternal exposure during pregnancy, Pain, Pain in extremity, Pruritus
Clinical narrative: Hives on chest, neck, arms; Red/itchy chest/neck; Body aches; Itchy neck/chest; Pregnant at the time of vaccination? Yes; Sore arm; This is a spontaneous report from a contactable consumer (patient). This is a maternal report. A 33-years-old pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, in the left arm on 25Feb2021 at 16:00 (at the age of 33-year-old) as single dose for COVID-19 immunisation. Medical history included chronic hypertension and pregnant both from an unknown date and unknown if ongoing. Known allergies not reported. Concomitant medications included labetalol, loratadine (CLARITIN), low dose aspirin [acetylsalicylic acid] and prenatals all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration, in the left arm on 04Feb2021 at 16:00 as single dose for COVID-19 immunisation. Facility type vaccine reported workplace clinic. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 25Feb2021 at 04:00, the patient experienced pregnant at the time of vaccination, vaccine on Thursday on 25Feb2021 afternoon sore arm, on 26Feb2021, Friday morning had tchy neck/chest, body aches progressed through the day, on 27Feb2021, Saturday experienced red/itchy chest/neck and on 28Feb2021, Sunday experienced hives on chest, neck, arms. Patient had received treatment for event was Benadryl. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was pregnant at the onset of the event. The mother was due to deliver on 21Apr2021. Gestational period reported 32. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on chest, neck, arms; Red/itchy chest/neck; Body aches; Itchy neck/chest; Pregnant at the time of vaccination? Yes; Sore arm; This is a spontaneous report from a contactable consumer (patient). This is a maternal report. A 33-years-old pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, in the left arm on 25Feb2021 at 16:00 (at the age of 33-year-old) as single dose for COVID-19 immunisation. Medical history included chronic hypertension and pregnant both from an unknown date and unknown if ongoing. Known allergies not reported. Concomitant medications included labetalol, loratadine (CLARITIN), low dose aspirin [acetylsalicylic acid] and prenatals all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration, in the left arm on 04Feb2021 at 16:00 as single dose for COVID-19 immunisation. Facility type vaccine reported workplace clinic. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 25Feb2021 at 04:00, the patient experienced pregnant at the time of vaccination, vaccine on Thursday on 25Feb2021 afternoon sore arm, on 26Feb2021, Friday morning had tchy neck/chest, body aches progressed through the day, on 27Feb2021, Saturday experienced red/itchy chest/neck and on 28Feb2021, Sunday experienced hives on chest, neck, arms. Patient had received treatment for event was Benadryl. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was pregnant at the onset of the event. The mother was due to deliver on 21Apr2021. Gestational period reported 32. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Throat irritation
Clinical narrative: Itchy throat; mother reported she became pregnant while taking bnt162b2; This is a spontaneous report from a contactable consumer. A 41-year-old pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EN6202), via an unspecified route of administration in the left arm on 09Mar2021 at a single dose for covid-19 immunisation. The patient received the vaccine in the pharmacy or drug store. The medical history was not reported. Concomitant medications included lansoprazole (PREVACID); calcium carbonate (TUMS [CALCIUM CARBONATE]) and unspecified vitamin, all two weeks before vaccination. There were no vaccines in previous 4 weeks. On 09Mar2021 at 18:00, the patient experienced itchy throat. The mother reported she became pregnant while taking bnt162b2 on 09Mar2021. The mother was pregnant at the onset of the event. The mother was due to deliver on 01Jul2021. Last menstrual date: Oct2020; Pregnancy Due date: Jul2021; Gestational period: 20. There was no treatment given. There was no immunization given post vaccination. The clinical outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Nasal septum deviation
Clinical narrative: try to attach the needle, the cap keeps on spinning on the vial; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: DEVICE ISSUE (non-serious), outcome "unknown", described as "try to attach the needle, the cap keeps on spinning on the vial".  Additional information: The clinical course was reported as the reporter mentioned due to a malfunction 2 vials of the prevnar 13 could not be used. The reporter also mentioned the top cap does not let you tighten the needle. When they try to attach the needle, the cap keeps on spinning on the vial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.