chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paraesthesia, Pyrexia
Clinical narrative: Anxiety; Depression; Patient was unable to work because of the symptoms; Horrible fever; Chills; Neuropathy; Pins and needles/paresthesia; Not being able to walk; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020f21a and 052e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles/paresthesia), GAIT INABILITY (Not being able to walk), PYREXIA (Horrible fever) and CHILLS (Chills). On an unknown date, the patient experienced ANXIETY (Anxiety), DEPRESSION (Depression) and IMPAIRED WORK ABILITY (Patient was unable to work because of the symptoms). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), ANXIETY (Anxiety), DEPRESSION (Depression), PARAESTHESIA (Pins and needles/paresthesia), GAIT INABILITY (Not being able to walk), IMPAIRED WORK ABILITY (Patient was unable to work because of the symptoms), PYREXIA (Horrible fever) and CHILLS (Chills) had not resolved.            Concomitant product not reported  Treatment medications also included unspecified depression and anxiety medications  Noted discrepancy in Date of Birth (19-AUG-1997) and Age at time of onset of reaction/event - 34  Company comment: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected events of Neuropathy peripheral, Paraesthesia, Gait Inability and the expected events Pyrexia and Chills approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The events Anxiety, Depression and Impaired wor ability occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected events of Neuropathy peripheral, Paraesthesia, Gait Inability and the expected events Pyrexia and Chills approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The events Anxiety, Depression and Impaired wor ability occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after each dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm after each dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Cancer and RA.    On 25-Sep-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 PAIN IN EXTREMITY (Sore arm after each dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after each dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-350729, MOD-2021-350755 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Testing positive after the first dose)) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Testing positive after the first dose)) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet). At the time of the report, COVID-19 (Testing positive after the first dose)) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.; Sender's Comments: This is a case of product dose omission issue and concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the  unexpected non-serious event of SARS-CoV-2 test positive. The event occurred unknown number of days after the dose of mRNA 1273 vaccine. It is not clear from the source document whether this was a first or second dose.  Re-challenge was not applicable as the dose number was not reported. The benefit-risk relationship of vaccine in not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 39 doses administered past the 30 day use by date; 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 (39 doses administered past the 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047821A) 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) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (39 doses administered past the 30 day use by date). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (39 doses administered past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Dose was administered after 30-day Use . Vials were initially stored in refrigerated on 13-APR-2021 from which 10 doses were administrated on 17-APR-2021 , 10 were  administrated on 19-MAY-2021 and 39 doses were administrated on 24-SEP-2021. Concomitant medications were not provided. Treatment information was not provided. Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia
Clinical narrative: Diarrhea; Pain everywhere in her body; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and MYALGIA (Pain everywhere in her body) in a 42-year-old female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and MYALGIA (Pain everywhere in her body) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and MYALGIA (Pain everywhere in her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.  Company comment: This case concerns a 42 year-old female patient with no reported medical history who experienced the unexpected serious events of diarrhea and myalgia.The events occurred on an unknown date relative to the first dose of mRNA-1273. The rechallenge was unknown as the dates of the vaccine administration and of the events are not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. The events' seriousness is assessed as per Regulatory Authority report.   This case was linked to MOD-2021-350957 (Patient Link).; Sender's Comments: This case concerns a 42 year-old female patient with no reported medical history who experienced the unexpected serious events of diarrhea and myalgia.The events occurred on an unknown date relative to the first dose of mRNA-1273. The rechallenge was unknown as the dates of the vaccine administration and of the events are not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. The events' seriousness is assessed as per Regulatory Authority report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from expired vial; 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 (Received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) 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 information was provided.  The patients were told to hold on to this vaccine because of the potential extension. Date the vial was initially stored in the refrigerator: 16-Sep-2021. It was stated that the vial did not undergo any temperature excursions, and the box has an expiration date of FEB 2022.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: developed a red and itchy rash in left arm at injection site that moved down arm; developed a red and itchy rash in left arm at injection site that moved down arm; developed a red and itchy rash in left arm at injection site that moved down arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (developed a red and itchy rash in left arm at injection site that moved down arm), VACCINATION SITE ERYTHEMA (developed a red and itchy rash in left arm at injection site that moved down arm) and VACCINATION SITE PRURITUS (developed a red and itchy rash in left arm at injection site that moved down arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced VACCINATION SITE RASH (developed a red and itchy rash in left arm at injection site that moved down arm), VACCINATION SITE ERYTHEMA (developed a red and itchy rash in left arm at injection site that moved down arm) and VACCINATION SITE PRURITUS (developed a red and itchy rash in left arm at injection site that moved down arm). At the time of the report, VACCINATION SITE RASH (developed a red and itchy rash in left arm at injection site that moved down arm), VACCINATION SITE ERYTHEMA (developed a red and itchy rash in left arm at injection site that moved down arm) and VACCINATION SITE PRURITUS (developed a red and itchy rash in left arm at injection site that moved down arm) outcome was unknown.            No concomitant medication were provided.   Steroid cream was used twice daily for rash.   This case was linked to MOD-2021-350950 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.  Date the vial was initially stored in the refrigerator - 07-Oct-2021
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Peripheral swelling, Swelling
Clinical narrative: swelling in my left arm /  / arm is very swollen; whole  upper body on the left side only is swollen; seems to be getting worse / this morning it is a lot worse; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in my left arm /  / arm is very swollen), SWELLING (whole  upper body on the left side only is swollen) and CONDITION AGGRAVATED (seems to be getting worse / this morning it is a lot worse) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCORTISONE for an unknown indication.    On 26-Aug-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 PERIPHERAL SWELLING (swelling in my left arm /  / arm is very swollen), SWELLING (whole  upper body on the left side only is swollen) and CONDITION AGGRAVATED (seems to be getting worse / this morning it is a lot worse). At the time of the report, PERIPHERAL SWELLING (swelling in my left arm /  / arm is very swollen), SWELLING (whole  upper body on the left side only is swollen) and CONDITION AGGRAVATED (seems to be getting worse / this morning it is a lot worse) outcome was unknown.            Patient were taking chemo drugs as concomitant. No treatment drugs were reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Lack of efficacy; Covid test turned out to be positive; initially a few rashes on which progressed; felt a little weird/; Exposed to a patient with Covid-19; brief/occasional chills; cough; sneezing; Strangely enough she had more energy than usual; Nasal congestion/She is still feeling stuffy; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion/She is still feeling stuffy), FEELING ABNORMAL (felt a little weird/), COUGH (cough), SNEEZING (sneezing) and DRUG INEFFECTIVE (Lack of efficacy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012l20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to a patient with Covid-19). On 04-Oct-2021, the patient experienced FEELING ABNORMAL (felt a little weird/) and RASH (initially a few rashes on which progressed). On 06-Oct-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (Covid test turned out to be positive). In October 2021, the patient experienced NASAL CONGESTION (Nasal congestion/She is still feeling stuffy), COUGH (cough), SNEEZING (sneezing), ENERGY INCREASED (Strangely enough she had more energy than usual) and CHILLS (brief/occasional chills). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Nasal congestion/She is still feeling stuffy) and RASH (initially a few rashes on which progressed) had not resolved and FEELING ABNORMAL (felt a little weird/), COUGH (cough), SNEEZING (sneezing), DRUG INEFFECTIVE (Lack of efficacy), ENERGY INCREASED (Strangely enough she had more energy than usual), COVID-19 (Covid test turned out to be positive), EXPOSURE TO SARS-COV-2 (Exposed to a patient with Covid-19) and CHILLS (brief/occasional chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided.; Sender's Comments: This case concerns a 67-year-old, female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19 together with other non-serious unexpected and expected events. Drug ineffective was considered also an additional event. The event of COVID-19 occurred approximately 8 months and 24 days after the second dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Dose administered after 12 hours of vial puncture; Dose administered after being more than 24 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021 at 12:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021 at 12:27 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature). On 13-Oct-2021 at 12:27 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. This case is a report of the adverse events of patient 3. The vial was reported to be in the freezer prior to 11-Oct-2021. On 11-Oct-2021, the vial was stored in the refrigerator. On 12-Oct-2021 at 8:00 AM around 30 hours, they were taken out of the fridge to the room temperature. On 12-Oct-2021 at 10:00 AM, the vial was punctured. After puncture, the vial was stored at room temperature. Total amount of time the vial was exposed to temperature range (8 to 25 degree Celsius ( 46 to 77 degree Fahrenheit).   This case was linked to MOD-2021-351075, MOD-2021-351200  , MOD-2021-352001  , MOD-2021-352549 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients got a dose of the Moderna vaccine from a vial that was used through multiple days, once punctured; exposed to room temperature range (8° to 25°C= 46° to 77°F); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients got a dose of the Moderna vaccine from a vial that was used through multiple days, once punctured) and PRODUCT STORAGE ERROR (exposed to room temperature range (8° to 25°C= 46° to 77°F)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients got a dose of the Moderna vaccine from a vial that was used through multiple days, once punctured) and PRODUCT STORAGE ERROR (exposed to room temperature range (8° to 25°C= 46° to 77°F)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients got a dose of the Moderna vaccine from a vial that was used through multiple days, once punctured) and PRODUCT STORAGE ERROR (exposed to room temperature range (8° to 25°C= 46° to 77°F)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No additional patient identifiers are available. Concomitant medication details were not reported by the reporter.  There are no patient identifiers and state doses were administered from 11-Oct-2021 till 13-Oct-2021, probably.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): HCP  was not sure, but probably less that 2 hours, the vial was only out of the fridge to draw up the doses to be administered.  Treatment details was not reported by the reporter.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrillation
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Eye swelling, Mouth swelling
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient reported arm pain and tingling
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Palpitations, Tachycardia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Systemic: Weakness-Mild, Additional Details: pt reported numbness in hand right after administration. monitored bp and hr after pt reported heart felt like it was racing. measured bp 127/98, hr 66. pt seemed nervous prior to administration
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder
Clinical narrative: Systemic: oral lesions on the right top and bottom inner lips-Mild.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: I have not gotten my period since I was vaccinated, it was scheduled to come two days later and I still have not received it and I am not pregnant, and my period has never been more than a day late, it is now 7 days late.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Pharyngeal paraesthesia, Swollen tongue
Clinical narrative: Tingling in throat, lip and tongue swelling and tingling.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Provided patient with gatorade and oreos. Adverse effects subsided within 10-15 min.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Provided patient with gatorade and oreos. Adverse effects subsided within 10-15 min.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sodium pentothal).  On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine given beyond 30 days of refrigeration period; Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Sulfa), Drug allergy (Ultram), Allergy to antibiotic (Bactrim.) and Allergy to antibiotic (Augmentine.).   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine given beyond 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyond 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included TROSPIUM and HYDROCHLOROTHIAZIDE for an unknown indication.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) on deltoid.  No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient received 1st dose of vaccine in deltoid region  Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was 267 pounds.  No concomitant medication were reported No treatment medication were reported   This case was linked to MOD-2021-313106 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache; joint and body aches; joint and body aches; fever; fatigue; This is a spontaneous report from a non-contactable other HCP(patient). A 25-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Er8737) via an unspecified route of administration, administered in Arm Left on 03Apr2021 as DOSE 2, SINGLE for COVID-19 immunization (age at vaccination 25 years). The patient medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6203) via an unspecified route of administration, administered in Arm Left on 13Mar2021 at 08:30 AM as DOSE 1, SINGLE for COVID-19 immunization and the events occurred are Headache, arm soreness, fatigue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.On 03Apr2021 16:15 the patient experienced headache, joint and body aches, fever, fatigue. No treatment was received for the events. The outcome of the event was reported as recovering.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Urinary tract infection
Clinical narrative: Two days after second shot frequent urination as if I had a UTI, did not have a UTI symptoms were often on for the last two months. Had frequent Jaren before but not as bad after second shot.; Two days after second shot frequent urination as if I had a UTI, did not have a UTI symptoms were often on for the last two months. Had frequent Jaren before but not as bad after second shot.; This is a spontaneous report from a contactable consumer or other non-health care professional reported for herself. A 21-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0217, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 16Jun2021 at 15:00 (age at vaccination was 21 years) as dose 2, single for COVID-19 immunization. Medical history included ongoing anxiety, ongoing depression, food allergy, ongoing obsessive-compulsive disorder, Wisdom teeth removal on 02Jul2016. Concomitant medication included sertraline hydrochloride (ZOLOFT) within 2 weeks. The patient previously took amoxicillin and experienced hypersensitivity, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0185, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 26May2021 at 15:00 (age at vaccination was 21 years) as dose 1, single for COVID-19 immunization. On 20Jun2021 at 12:00, the patient experienced two days after second shot frequent urination as if he had a urinary tract infection, did not have urinary tract infection symptoms were often on for the last two months had frequent Jaren before but not as bad after second shot. Treatment was received in response to adverse events with Cather for urine test. No other vaccine was received prior to vaccination within 4 weeks. The patient stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; Sick; Really big bump on her arm; Twitch in her right eye; Soreness and lump under skin at shot point; Soreness and lump under skin at shot point; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 08Aug2021 15:15 (at the age of 57 years) (Batch/Lot Number: PAA165969) as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergy to drug Codeine. Prior to the vaccination, the 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 other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left Right on 18Jul2021 03:00 PM (Batch/Lot Number: EW0178) as DOSE 1, SINGLE for covid-19 immunisation and experienced sore arm. Patient was a 57-year-old consumer who stated that she filled out a safety report about adverse effects she had but was wondering if Pfizer could tell her how long they might last. She stated that she got really sick for three days after the shot and about an hour after getting the shot she had a really big bump on her arm. She stated that the bump was there for 2.5 weeks. She stated that during those times she developed a twitch in her right eye and was still having the twitch. She stated that her arm was really sore and that you couldn't touch it, it was so sore. She stated that the only had the soreness and the bump for 2.5 weeks after the second dose. She stated that after the first shot she had a sore arm but there was no bump like there was after the second shot, she had the shots in two different arms. The 1st shot was in the left arm and the 2nd shot was in her right arm and it was really painful. She stated that after the second shot she developed a twitch in her right eye and wanted to know if anyone else had reported it and how long it last for? After 2nd shot got very ill for 3 days. Continued to had soreness and lump under skin at shot point and had developed a consistent twitch in right eye, did not have more than sore arm after first shot. She had an elderly mother that lives with her and she did not really want to go to a doctor's office and be exposed to anything. The treatment received for the adverse events was unknown. The clinical outcome of the events soreness and lump under skin at shot point, Soreness and lump under skin at shot point was not recovered and remaining all other events was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vomiting
Clinical narrative: Arm- red and swollen with a knot around injection site; Vomiting-every morning since receiving the vaccine.; swollen with a knot around injection site.; Arm- red; This is a spontaneous report from a non-contactable other hcp (patient). A 27-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation (age at vaccination: 27-years-old). Medical history included food allergy (Pumpkin and mushroom), covid-19 (If Covid prior vaccination: Yes). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced arm- red and swollen with a knot around injection site, vomiting-every morning since receiving the vaccine, swollen with a knot around injection site and arm- red on 27Aug2021 at 08:30. Outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Vaccination site mass, Vaccination site pain
Clinical narrative: I have fibromyalgia and it has made my pain worse; On injection site I feel like I have a knot and it is very painful; On injection site I feel like I have a knot and it is very painful; have numbness on my arms, hands and fingers; This is a spontaneous report from a contactable consumer.   This 42-year-old (non-pregnant) female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration into the left arm on 30Aug2021 at 14:45/02:45 PM (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included fibromyalgia from an unknown date and unknown if ongoing (I have fibromyalgia; Other medical history: Fibromyalgia). Concomitant medications included zingiber officinale root (GINGER ROOT [ZINGIBER OFFICINALE ROOT]); fenugreek [trigonella foenum-graecum] (FENUGREEK [TRIGONELLA FOENUM-GRAECUM]); cinnamomum verum (CINNAMON) and curcuma longa (TURMERIC [CURCUMA LONGA]) all taken for unspecified indications, start and stop dates were not reported and milk t. No other vaccine in four weeks. No treatments, no Covid prior vaccination nor Covid tested post vaccination. On 30Aug2021, the patient experienced she has fibromyalgia and it has made her pain worse, on injection site she feels like she has a knot and it was very painful and have numbness on her arms, hands and fingers if she was on one side for too long. Outcome was resolved on an unspecified date for all the events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (11Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeling hot, Pruritus, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Mild, Additional Details: Patient complained of getting warm and itchy and thought she was having an allergic reaction. Gave patient 2 diphenhydramine 25mg and pt said she felt better after waiting 15 minutes. Counseled to call us if anything more serious happens. Employee to check in on pt at 5:40pm
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Mild
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Malaise, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient got the vaccine around 12:17pm by RN. After 3 mins, patient called the nurse and states he wasn't feeling well and passed out for about 1 min. Woke up sweting and dizzy. he drank a full bottle of water. Blood pressure was taken @12:24pm 147/125, P=105. Patient remained seated for observation. @12:40pm BP=135/84, P=65. Follow up with the patient 10/20/21 and stated he is ok.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient got the vaccine around 12:17pm by RN. After 3 mins, patient called the nurse and states he wasn't feeling well and passed out for about 1 min. Woke up sweting and dizzy. he drank a full bottle of water. Blood pressure was taken @12:24pm 147/125, P=105. Patient remained seated for observation. @12:40pm BP=135/84, P=65. Follow up with the patient 10/20/21 and stated he is ok.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild