chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: She also had aches and pains; Hands were swollen; Knees were swollen/knee replacements were so swelled up that she couldn't bend them; Lymph nodes were swollen; Fever that went up to 104° F and it went down to 101° F.; knee replacements hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She also had aches and pains), PERIPHERAL SWELLING (Hands were swollen), JOINT SWELLING (Knees were swollen/knee replacements were so swelled up that she couldn't bend them), LYMPHADENOPATHY (Lymph nodes were swollen) and PYREXIA (Fever that went up to 104° F and it went down to 101° F.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (Had two knee replacement.). Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), CARVEDILOL and CANDESARTAN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (She also had aches and pains), PERIPHERAL SWELLING (Hands were swollen), JOINT SWELLING (Knees were swollen/knee replacements were so swelled up that she couldn't bend them), LYMPHADENOPATHY (Lymph nodes were swollen), PYREXIA (Fever that went up to 104° F and it went down to 101° F.) and ARTHRALGIA (knee replacements hurt). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (She also had aches and pains), PERIPHERAL SWELLING (Hands were swollen), LYMPHADENOPATHY (Lymph nodes were swollen) and PYREXIA (Fever that went up to 104° F and it went down to 101° F.) outcome was unknown and JOINT SWELLING (Knees were swollen/knee replacements were so swelled up that she couldn't bend them) and ARTHRALGIA (knee replacements hurt) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104° F and 101 (High) 101° F.         Treatment provided also included cold shower.  Patient reported that she had a pretty violent reaction on  12-Feb-2021,after receiving the vaccine. Patient also reported that it took a couple of days to loosen up the knees.   This case was linked to MOD-2021-362373 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021 at 11:06 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021 at 11:06 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 18-Oct-2021 at 11:06 AM, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.  It was reported that the Moderna vial with expiry date on 15-Oct-2021 (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 11-Oct-2021 without any temperature variations in the transfer from the freezer. And the solution was off white in color, no variation in color from all the other previously used vials. At the time of this report, no adverse reactions have been reported.   This case was linked to MOD-2021-355973 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 20 plus patients were administered vaccine that was expired on 22Sep2021; vaccine was initially in frozen storage condition and placed in the refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 plus patients were administered vaccine that was expired on 22Sep2021) and PRODUCT STORAGE ERROR (vaccine was initially in frozen storage condition and placed in the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 plus patients were administered vaccine that was expired on 22Sep2021) and PRODUCT STORAGE ERROR (vaccine was initially in frozen storage condition and placed in the refrigerator). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (20 plus patients were administered vaccine that was expired on 22Sep2021) and PRODUCT STORAGE ERROR (vaccine was initially in frozen storage condition and placed in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Dose administered after a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 044B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller stated that they had a temperature excursion of about 20 doses of Moderna, it got down to 32°F, went up to 34°F, then up to 36°F, then up to 37°F over the course of an hour.The doses were put in a portable transport unit and left at 32°F, the transport unit wasn't prepared for enough time to maintain the temperature. Patient is immunocompromised. No concomitant medications were reported. No treatment medications were reported.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-355973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-355973:Cross linked case/ Original Cluster Case
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in my ears) 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 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced TINNITUS (Ringing in my ears). At the time of the report, TINNITUS (Ringing in my ears) had not resolved. Not Provided    No relevant concomitant medications was reported. Treatment information was not provided.    This case was linked to MOD-2021-350843 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic, Hypersensitivity, Inappropriate schedule of product administration
Clinical narrative: Allergic rash in lower back/n both legs; Allergic reaction in right wrist; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic rash in lower back/n both legs), HYPERSENSITIVITY (Allergic reaction in right wrist) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL and METOPROLOL for Blood pressure.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Oct-2021, the patient experienced DERMATITIS ALLERGIC (Allergic rash in lower back/n both legs), HYPERSENSITIVITY (Allergic reaction in right wrist) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. On 10-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, DERMATITIS ALLERGIC (Allergic rash in lower back/n both legs) and HYPERSENSITIVITY (Allergic reaction in right wrist) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Terrible headache; Few chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache) and CHILLS (Few chills) 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 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced HEADACHE (Terrible headache) and CHILLS (Few chills). At the time of the report, HEADACHE (Terrible headache) and CHILLS (Few chills) outcome was unknown.            No Concomitant medications were provided No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; This spontaneous case was reported by a nurse and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Cardiac disorder NOS (20 years ago).    On 21-Jan-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 ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information were reported.  No concomitant medication was reported.  Patent did not have COVID-19 and she has no history of myocarditis or pericarditis.  Treatment for atrial fibrillation, cardiac ablation was placement of pacemaker.  Company comment: This case concerns a female patient of an unknown age, with previous relevant medical history of cardiac disorder, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since it is unknown the outcome of the event. The medical history cardiac disorder remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-026566 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age, with previous relevant medical history of cardiac disorder, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since it is unknown the outcome of the event. The medical history cardiac disorder remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pain
Clinical narrative: cold symptoms; Stuffy nose; Achy body; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (Stuffy nose) and PAIN (Achy body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (Stuffy nose) and PAIN (Achy body). At the time of the report, NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (Stuffy nose) and PAIN (Achy body) outcome was unknown.            No Concomitant and Treatment medication were reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Dose administered after a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 025J20-2A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021 at 11:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported.   19 doses of Moderna was administered to 19 patients. The Moderna vial (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 11 Oct 2021 without any temperature variations in the transfer from the freezer.The solution was off white in color.  No variation in color from all the other previously used vials.16 patients received 0.25 ml booster dose and 3 patients received 0.5 ml full dose. All patients tolerated vaccine administration well, without any complications in the office after observed for 15 minutes per protocol. As of 18 Oct 2021, no adverse reactions have been reported to our office staff or medical staff. No concomitants were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: HCP administered expired vials but she doesn´t remember how many; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered expired vials but she doesn´t remember how many) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered expired vials but she doesn´t remember how many). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (HCP administered expired vials but she doesn´t remember how many) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter  Treatment information was not provided
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: With the first two, I had similar symptoms that were common to the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.) in an 85-year-old 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.). At the time of the report, VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient post first dose had similar symptoms that were common to the vaccine.   This case was linked to MOD-2021-362728, MOD-2021-341009 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with vaccine on 23-oct-2021,which was punctured on 22-oct-2021.It was stored in refrigerator on 14Oct2021 at 44 F. Concomitant medications were not provided. Treatment information was not provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: With the first two, I had similar symptoms that were common to the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.) in an 85-year-old 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.). At the time of the report, VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.) outcome was unknown. Not Provided    mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant medication information was provided.  No treatment medication information was provided.   This case was linked to MOD-2021-341009 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: arm was sore for a couple days; We got a full dose (100 mcg shot) as opposed to a half dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for a couple days) and INCORRECT DOSE ADMINISTERED (We got a full dose (100 mcg shot) as opposed to a half dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 006B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 15-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (We got a full dose (100 mcg shot) as opposed to a half dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for a couple days). On 15-Oct-2021, INCORRECT DOSE ADMINISTERED (We got a full dose (100 mcg shot) as opposed to a half dose) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore for a couple days) had resolved.      No treatment and concomitant medications were provided.   This case was linked to MOD-2021-363657 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: follow up received contains, Patient information, Dose information, event and reporter contact details updated.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Breakthrough COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough COVID-19). At the time of the report, COVID-19 (Breakthrough COVID-19) outcome was unknown.            Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case concerns a female patient of unknown age with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred at an unknown date after the second dose of Spikevax. No further information was provided. The rechallenge is not applicable, since the only reported event was COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Drug ineffective was not capture since there is lack of information regarding the schedule of vaccination and temporal association with COVID-19.   This case was linked to MOD-2021-362733 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred at an unknown date after the second dose of Spikevax. No further information was provided. The rechallenge is not applicable, since the only reported event was COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Drug ineffective was not capture since there is lack of information regarding the schedule of vaccination and temporal association with COVID-19.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Vaccination site pain
Clinical narrative: could not sleep on injection site arm; injection site arm was sore for several days after both shots; I had a headache after one of the vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep on injection site arm), VACCINATION SITE PAIN (injection site arm was sore for several days after both shots) and HEADACHE (I had a headache after one of the vaccinations) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INSOMNIA (could not sleep on injection site arm), VACCINATION SITE PAIN (injection site arm was sore for several days after both shots) and HEADACHE (I had a headache after one of the vaccinations). In 2021, VACCINATION SITE PAIN (injection site arm was sore for several days after both shots) had resolved. At the time of the report, INSOMNIA (could not sleep on injection site arm) and HEADACHE (I had a headache after one of the vaccinations) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment  medication were provided.   This case was linked to MOD-2021-362812 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second shot in the other arm at six weeks apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second shot in the other arm at six weeks apart) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second shot in the other arm at six weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second shot in the other arm at six weeks apart) had resolved.            No concomitant medication was provided. No treatment information was provided.  The patient had no problems after receiving the second dose.   This case was linked to MOD-2021-306141 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: injection site arm was sore for several days after both shots/could not sleep on injection site arm; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site arm was sore for several days after both shots/could not sleep on injection site arm) and HEADACHE (headaches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 01A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (injection site arm was sore for several days after both shots/could not sleep on injection site arm) and HEADACHE (headaches). At the time of the report, VACCINATION SITE PAIN (injection site arm was sore for several days after both shots/could not sleep on injection site arm) had resolved and HEADACHE (headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-362790 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Headache, Vaccination site pain
Clinical narrative: Sore arm at the injection site; Little bit tiredness; Mild headache; Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site), FATIGUE (Little bit tiredness), HEADACHE (Mild headache) and EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site), FATIGUE (Little bit tiredness) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse reaction, at an unspecified dose and frequency. On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site), FATIGUE (Little bit tiredness) and HEADACHE (Mild headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient do not take any concomitant medicine since they do not have any comorbidities. Expiry date of vaccine was  16 Oct 2021.Dose quantity was 1/2 dose.   This case was linked to MOD-2021-361496 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: is very sick; She was throwing up constantly; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (is very sick) and VOMITING (She was throwing up constantly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 045A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (is very sick) and VOMITING (She was throwing up constantly). At the time of the report, ILLNESS (is very sick) and VOMITING (She was throwing up constantly) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. The patient called to report that himself and his wife received the booster dose, and wife is very sick and constantly vomiting up every few minutes. Patient callback and informed that his wife is very sick and gave details such as batch lot number for the booster dose, and information about first dose and second dose was provided.   This case was linked to MOD-2021-066503 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up received contain Batch lot number for booster dose and information of dose1 and dose 2 is added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Extra dose administered, Palpitations
Clinical narrative: Patient received her Moderna third dose; Arrhythmia; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 001B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received her Moderna third dose). In July 2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations). On 10-Jul-2021, EXTRA DOSE ADMINISTERED (Patient received her Moderna third dose) had resolved. At the time of the report, ARRHYTHMIA (Arrhythmia) and PALPITATIONS (Heart palpitations) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. It is stated that patient experienced heart palpitations and arrhythmias a few weeks after her third vaccination.  It is stated that patient was lied and told the pharmacy that it was her first dose when she went for her third dose.  Company comment: This case concerns a  65-year-old, female patient with no relevant medical history, who experienced the unexpected event of Arrhythmia. The event occurred within a month after she received an Extra Dose (third dose) of mRNA-1273 (Moderna Covid-19 vaccine) under a pretense of first dose at the pharmacy. The rechallenge was not applicable as event occurred after the third dose. However, the extra dose administered remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: updated reporter details, updated patient demographics, added dose details.; Sender's Comments: This case concerns a  65-year-old, female patient with no relevant medical history, who experienced the unexpected event of Arrhythmia. The event occurred within a month after she received an Extra Dose (third dose) of mRNA-1273 (Moderna Covid-19 vaccine) under a pretense of first dose at the pharmacy. The rechallenge was not applicable as event occurred after the third dose. However, the extra dose administered remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Pain in heart; Pain in right & left Lungs; Permanent running Nose; overall health is weakend; Facial cyst got infected; Hand cellulitis (no cuts / no bites); This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Hand cellulitis (no cuts / no bites)) and INFECTED CYST (Facial cyst got infected) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 0S0CHA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Allergic reaction to antibiotics, Drug allergy, Fruit allergy, Gluten sensitivity (Gluten sensitivity (Autoimmune disorder) (7 years ago approximately)) and Psoriasis ((7 years ago approximately)). Concomitant products included COLECALCIFEROL (VIT D3), VITAMIN B12 NOS and ECHINACEA ADVANCED IMMUNE for an unknown indication.   On 07-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced CELLULITIS (Hand cellulitis (no cuts / no bites)) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced INFECTED CYST (Facial cyst got infected) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Pain in heart), PULMONARY PAIN (Pain in right & left Lungs), RHINORRHOEA (Permanent running Nose) and ASTHENIA (overall health is weakend). At the time of the report, CELLULITIS (Hand cellulitis (no cuts / no bites)), INFECTED CYST (Facial cyst got infected), RHINORRHOEA (Permanent running Nose) and ASTHENIA (overall health is weakend) outcome was unknown and CHEST PAIN (Pain in heart) and PULMONARY PAIN (Pain in right & left Lungs) had not resolved.            Patient administered unknown antibiotics on 19 Aug 2021 for hand cellulitis On 27 Aug 2021 patient got injected for Face cyst and administered unknown antibiotics. She mentioned she didn't had any of the symptoms before vaccination. Patient mentioned that adverse event pain in heart and lungs would come and go. Company Comment :  This case concerns a 46-year-old female patient with no relevant medical history, who experienced the unexpected event of Cellulitis. The event occurred approximately 3 monthsh after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-300087 (Patient Link).; Sender's Comments: This case concerns a 46-year-old female patient with no relevant medical history, who experienced the unexpected event of Cellulitis. The event occurred approximately 3 monthsh after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 to 5 patients received shot past 30-day use by date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. Expiration date was 1/20/22. Number of doses/vials was 15-dose vial. Date the vial was initially stored in the refrigerator was 08 Sep 2021. Patient had no side effects.   This case was linked to MOD-2021-351064, MOD-2021-363707, MOD-2021-363708, MOD-2021-363703, MOD-2021-363708, MOD-2021-351064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up information contains NNI.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia, Swelling
Clinical narrative: Swollen/blowing up again; Had temp; Didn't feel good; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (Didn't feel good), SWELLING (Swollen/blowing up again) and PYREXIA (Had temp) 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 08-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced FEELING ABNORMAL (Didn't feel good) and PYREXIA (Had temp). On 17-Oct-2021, the patient experienced SWELLING (Swollen/blowing up again). At the time of the report, FEELING ABNORMAL (Didn't feel good) and SWELLING (Swollen/blowing up again) had not resolved and PYREXIA (Had temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: high (High) Had temperature.         Patient was taking more water pills and stated that he was having and had a reaction from vaccine.  No concomitant medications information was not reported
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 22-Oct-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. It was stated that the date of refrigeration was 07 May 2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oestradiol, Oestradiol increased
Clinical narrative: Heavy menses April, May, July 2021; increase in estradiol levels per blood lab results.; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533), via an unspecified route of administration in Arm Left on 30Mar2021 at 16:45 (at 55 years) for covid-19 immunisation. Medical history included hypothyroidism, breast cancer and asthma. No known allergy.No covid prior vaccination and no covid tested post vaccination. Concomitant medications included thyroid (ARMOUR THYROID), tamoxifen and montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported.  Previously the patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6208), via an unspecified route of administration in Arm Left for covid-19 immunisation . The patient had heavy menses on 05Apr2021 (also reported as Apr2021), May2021 and Jul2021 with increase in estradiol levels per blood lab results. No treatment given and outcome of the events was unknown.