chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 032F21A, 017C21A/083J21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-560262, MOD-2022-561458, MOD-2022-561464 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Use of COVID-19 vaccines from more than one manufacturer in the 2-dose primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Use of COVID-19 vaccines from more than one manufacturer in the 2-dose primary series) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (first dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Use of COVID-19 vaccines from more than one manufacturer in the 2-dose primary series). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Use of COVID-19 vaccines from more than one manufacturer in the 2-dose primary series) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No medical history information was reported.  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Live follow-up information included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period; 1 Expired Dose Administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: terrible ringing in her ear for a year; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (terrible ringing in her ear for a year) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (terrible ringing in her ear for a year). At the time of the report, TINNITUS (terrible ringing in her ear for a year) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. It was reported that patient was immunized with Moderna last year and mentioned that she was being glad she didn't take the booster. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired on 23Mar2022, Continuously stored in stable FREEZER environment/Only stored in fridge on date of administration for thaw period, date of administration on 15Apr2022; 1 Expired Doses Administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered) and PRODUCT STORAGE ERROR (expired on 23Mar2022, Continuously stored in stable FREEZER environment/Only stored in fridge on date of administration for thaw period, date of administration on 15Apr2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired on 23Mar2022, Continuously stored in stable FREEZER environment/Only stored in fridge on date of administration for thaw period, date of administration on 15Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered) and PRODUCT STORAGE ERROR (expired on 23Mar2022, Continuously stored in stable FREEZER environment/Only stored in fridge on date of administration for thaw period, date of administration on 15Apr2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vaccine was administered past expiry date. The vaccine was continuously stored in stable freezer environment and only stored in fridge on the date of administration for thaw period.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient administered expired vaccine on date 03-Feb-2022 which was continuously stored in stable freezer environment. Only stored in fridge on date of administration for thaw period; 1 Expired Dose administered on 03-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Dose administered on 03-Feb-2022) and PRODUCT STORAGE ERROR (Patient administered expired vaccine on date 03-Feb-2022 which was continuously stored in stable freezer environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Dose administered on 03-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient administered expired vaccine on date 03-Feb-2022 which was continuously stored in stable freezer environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Dose administered on 03-Feb-2022) and PRODUCT STORAGE ERROR (Patient administered expired vaccine on date 03-Feb-2022 which was continuously stored in stable freezer environment. Only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period; 1 Expired Doses Administered - date of administration on 11-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered - date of administration on 11-Feb-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered - date of administration on 11-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered - date of administration on 11-Feb-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period; vaccine administered past expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered past expiration date) and PRODUCT STORAGE ERROR (Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered past expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered past expiration date) and PRODUCT STORAGE ERROR (Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment information was provided.  The reporter was asking for the stability information of the vaccine administered past its expiry date.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period; Patient received expired dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine continuously stored in stable freezer environment, only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever/Low-grade fever about 99.8 to 101.2; Chills; A little sore in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever/Low-grade fever about 99.8 to 101.2), CHILLS (Chills) and PAIN IN EXTREMITY (A little sore in the arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     The patient had no food allergies.  The patient's past medical history included COVID-19 (tested COVID positive) on 01-Apr-2022. Previously administered products included for COVID-19 vaccination: Pfizer (First dose) on 23-Feb-2021, Pfizer (Second dose) on 16-Mar-2021 and Pfizer (Third dose/1st booster dose) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Hypertension (high blood pressure started at age 55) and Drug allergy (Patient has allergies with high doses of Advil 800mg).    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced PYREXIA (Fever/Low-grade fever about 99.8 to 101.2), CHILLS (Chills) and PAIN IN EXTREMITY (A little sore in the arm). At the time of the report, PYREXIA (Fever/Low-grade fever about 99.8 to 101.2) and PAIN IN EXTREMITY (A little sore in the arm) had not resolved and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 06-May-2022, Body temperature: 99.8 to 101.2 (High) 99.8 to 101.2 (low grade fever).         No concomitant medication information was provided.  On 06-May-2022, the patient received the second booster dose of Moderna COVID-19 Vaccine.  The reporter (patient's husband) wanted to know if the patient was contagious and if it was fine to have a COVID-19 test even if they got the vaccine.  On the previous night of 06-May-2022, the patient developed fever and chills which the reporter read as being the general side effects of the Moderna vaccine.  The patient also mentioned that the pharmacist had told the patient that the patient could get the vaccine after 2 weeks of testing positive with COVID-19.  The patient had not received any medical care yet.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting, Vomiting projectile
Clinical narrative: projectile vomiting; nausea; headache; Vomiting,unable to keep anything solid down; This spontaneous case was reported by an other health care professional and describes the occurrence of VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea), HEADACHE (headache) and VOMITING (Vomiting,unable to keep anything solid down) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea), HEADACHE (headache) and VOMITING (Vomiting,unable to keep anything solid down). The patient was treated with METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) in April 2022 at a dose of 1 dosage form. At the time of the report, VOMITING PROJECTILE (projectile vomiting), NAUSEA (nausea), HEADACHE (headache) and VOMITING (Vomiting,unable to keep anything solid down) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient was okay for the first 2 days and then was unable to keep anything down, nausea, vomiting and headache. Patient was okay if she had electrolyte water and protein shakes.   On Friday, the patient visited ER where she was given fluids and Reglan.   This case was linked to MOD-2022-561892, MOD-2022-561891 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Somnolence
Clinical narrative: Fells asleep just like he passed out; tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Fells asleep just like he passed out) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced SOMNOLENCE (Fells asleep just like he passed out) and FATIGUE (tired). At the time of the report, SOMNOLENCE (Fells asleep just like he passed out) outcome was unknown and FATIGUE (tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Reporter mentioned that ever since they have the shot on October, her husband was so tired and it was not normal. The caller also mentioned that the had Covid in March last year. After her husband had a shot on October, felt asleep still just like he passed out. The side-effect was ongoing for more than a year. The caller wants to know the side-effects of the vaccine after receiving it for a year. The reporter refused to provide anymore information. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow-up received contains no new information
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: I felt really crummy all around/ just not myself; Was achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt really crummy all around/ just not myself) and PAIN (Was achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (I felt really crummy all around/ just not myself) and PAIN (Was achy). At the time of the report, FEELING ABNORMAL (I felt really crummy all around/ just not myself) and PAIN (Was achy) had resolved.            Patient did not want to have 2nd booster as the patient had reaction with booster and 2nd dose.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Reactions did not cause patient to seek medical care or emergency room visit or hospitalized.   This case was linked to MOD-2022-561889, MOD-2022-561912 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow-up was received and included no new information
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 antibody test
Clinical narrative: I felt really crummy all around/ just not myself; Was achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt really crummy all around/ just not myself) and PAIN (Was achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (I felt really crummy all around/ just not myself) and PAIN (Was achy). At the time of the report, FEELING ABNORMAL (I felt really crummy all around/ just not myself) and PAIN (Was achy) had resolved.            Patient did not want to have 2nd booster as the patient had reaction with booster and 2nd dose.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Reactions did not cause patient to seek medical care or emergency room visit or hospitalized.   This case was linked to MOD-2022-561889, MOD-2022-561912 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow-up was received and included no new information
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Vision blurred
Clinical narrative: blurring of vision/blurredness; 1st dose of the vaccine - 26Apr2021; 2nd dose - 04May2022; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurring of vision/blurredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the vaccine - 26Apr2021; 2nd dose - 04May2022) in a 25-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 056A22A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the vaccine - 26Apr2021; 2nd dose - 04May2022). On 05-May-2022, the patient experienced VISION BLURRED (blurring of vision/blurredness). At the time of the report, VISION BLURRED (blurring of vision/blurredness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the vaccine - 26Apr2021; 2nd dose - 04May2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication reported. Patient had an appointment on 10-may-2022 No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was first moved to refrigeration was on 08-Apr-2022, date of administration was on 09-May-2022 (booster's fridge shelf life of 30 days ran out on 08-May-2022); Administered a booster dose, the booster's fridge shelf life of 30 days ran out on 08-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a booster dose, the booster's fridge shelf life of 30 days ran out on 08-May-2022) and PRODUCT STORAGE ERROR (The vial was first moved to refrigeration was on 08-Apr-2022, date of administration was on 09-May-2022 (booster's fridge shelf life of 30 days ran out on 08-May-2022)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a booster dose, the booster's fridge shelf life of 30 days ran out on 08-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first moved to refrigeration was on 08-Apr-2022, date of administration was on 09-May-2022 (booster's fridge shelf life of 30 days ran out on 08-May-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a booster dose, the booster's fridge shelf life of 30 days ran out on 08-May-2022) and PRODUCT STORAGE ERROR (The vial was first moved to refrigeration was on 08-Apr-2022, date of administration was on 09-May-2022 (booster's fridge shelf life of 30 days ran out on 08-May-2022)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Upon live follow-up, date of administration and lot number of suspect product as well when the vial was first moved to refrigeration were added.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: I have a horr ble metallic taste in my mouth, it's truly awful.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (I have a horr ble metallic taste in my mouth, it's truly awful.) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Patient had no known allergy.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced DYSGEUSIA (I have a horr ble metallic taste in my mouth, it's truly awful.). At the time of the report, DYSGEUSIA (I have a horr ble metallic taste in my mouth, it's truly awful.) had not resolved.            No concomitant medication were reported. No treatment information were provided. Device Date is 07-May-2022
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: After the last shot I started losing my hearing,With hearing loss, Patient now disabled and unable to work.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: DEAFNESS (disability, medically significant), outcome "unknown", described as "After the last shot I started losing my hearing,With hearing loss, Patient now disabled and unable to work.".  Clinical course includes, customer Verbatim: Patient had three shots of Pfizer vaccine to prevent coronavirus. After the last shot patient started losing hearing. Patient then had a fourth shot and hearing got worse. Patient wrote please do more research on vaccine. With hearing loss, Patient now disabled and unable to work. It is a big loss and before it happens to someone else hoping the issue gets resolved.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: I tested positive again on 29Apr2022; I tested positive again on 29Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: Jan2019 (unspecified if ongoing); "Known allergy: Sulfas" (unspecified if ongoing), notes: Known allergies: Sulfas. Concomitant medication(s) included: EXEMESTANE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "not recovered" and all described as "I tested positive again on 29Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (23Apr2022) Negative; (29Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diarrhoea haemorrhagic, Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; COVID-19; Bloody diarrhea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4377284-00 (AbbVie).  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for 1 day at the age of 76 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at unk, citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; Suspected COVID-19 (medically significant), outcome "recovering"; DIARRHOEA HAEMORRHAGIC (medically significant), outcome "recovering", described as "Bloody diarrhea". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "drug ineffective" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "Suspected covid-19" and "bloody diarrhea" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the information in the case provided and known drug temporal relationship, the causal association between the reported events with the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack".  Clinical course: This is first case out of two cases. Reporter Name: (Name withheld) (Name not clarified over the call, hence not captured in tab) Reporter stated, "May I ask you a question? I have two, have some friend, two of our friends, one was 51 the other one 72, post night after they had the COVID shot, one had a heart attack and the other one, she was told totally healthy, she run five miles a day, only walk five miles a day, never had nothing wrong with her, she died reactions from the COVID Shot(Pfizer was not checked as the manufacturer was not clear over the call). Now, I never had a COVID shot. Now, I might to get one but what (incomplete sentence). How do I know it's compatible because I take other kind of medication? I take shots every day. Every day I take Forteo. Somebody told me right plus I take other kind of medication. I take shots earlier shots every three months in my eye balls, then I take cholesterol pills. I take pills for the tummy and I take high cholesterol, no, cholesterol pills, 'Lisinopril' blood pressure medication and the one for the tummy (History). This W2022407365 is cross linked with W2022407370.   QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: muscle ache; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): (Janssen).  A 52-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 52 years intramuscular for covid-19 immunization; Janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 29Oct2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; FATIGUE (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: cold-like symptoms; stuffy nose/Nasal congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): (Janssen).  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (covid-19 vaccine ad26.cov2.s), administration date: Apr2021, for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 25Apr2022, outcome "unknown", described as "stuffy nose/Nasal congestion"; NASOPHARYNGITIS (non-serious) with onset 26Apr2022, outcome "unknown", described as "cold-like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 at 09:00 as dose 1, single (Lot number: ER8734), in right arm and on 22Apr2021 at 15:00 as dose 2, single (Lot number: ER8731) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 17Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 091D21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing), notes: Other medical history: No. Concomitant medication(s) included: ADDERALL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Had a very faint positive line at-home test yesterday and a much more prominent positive line at-home test today; Positive, notes: Had a very faint positive line at-home test yesterday and a much more prominent positive line at-home test today. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: product: COVID 19 Treatment Paxlovid, Treatment start date: 27Apr2022, Treatment stop date: 01May2022, Indication: Treatment of COVID-19. Other medication details: other medication in 2weeks product: Adderall. Adverse event: patient started the Paxlovid Wed evening and finished the 5 day course. My symptoms got much better over the next two days and were fully resolved by Sunday. They came back last night, basically exactly the same ones patient had when patient first got sick. Had a very faint positive line at-home test yesterday and a much more prominent positive line at-home test today.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Increased upper airway secretion, Pain
Clinical narrative: COVID Positive self test; COVID Positive self test; Chill; body aches; running nose; coughing; mucus build up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL3247), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. No known allergies. The patient was not tested positive for covid 19 prior to vaccination and had been tested positive post vaccination. Facility type vaccine reported as workplace clinic. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04May2022 at 18:00, outcome "unknown", COVID-19 (medically significant) with onset 04May2022 at 18:00, outcome "not recovered" and all described as "COVID Positive self test"; CHILLS (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "Chill"; PAIN (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "body aches"; COUGH (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "coughing"; INCREASED UPPER AIRWAY SECRETION (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "mucus build up"; RHINORRHOEA (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "running nose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2021) Negative, notes: Nasal Swab; (04May2022) Positive. Therapeutic measures were not taken as a result of covid-19, chills, pain, rhinorrhoea, cough, increased upper airway secretion.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID Positive self test; COVID Positive self test; Chill; body aches; running nose; coughing; mucus build up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL3247), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. No known allergies. The patient was not tested positive for covid 19 prior to vaccination and had been tested positive post vaccination. Facility type vaccine reported as workplace clinic. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04May2022 at 18:00, outcome "unknown", COVID-19 (medically significant) with onset 04May2022 at 18:00, outcome "not recovered" and all described as "COVID Positive self test"; CHILLS (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "Chill"; PAIN (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "body aches"; COUGH (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "coughing"; INCREASED UPPER AIRWAY SECRETION (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "mucus build up"; RHINORRHOEA (non-serious) with onset 04May2022 at 18:00, outcome "not recovered", described as "running nose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2021) Negative, notes: Nasal Swab; (04May2022) Positive. Therapeutic measures were not taken as a result of covid-19, chills, pain, rhinorrhoea, cough, increased upper airway secretion.
Sex: F
Vaccine: COVID19
Symptoms: Immunoglobulins, Product administered at inappropriate site, Rash macular
Clinical narrative: have blotch where I received the shot, that got large, and knot under my arm; I don't think it was in Deltoid, it looks like it was lower.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: immunocompromised because I have low immunoglobulin level. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Manufacturer Unknown, Dose 1), for COVID-19 immunization; Bnt162b2 (Manufacturer Unknown, Dose 2), for COVID-19 immunization; Bnt162b2 (1st booster manufacturer unknown), for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious), outcome "recovering", described as "have blotch where I received the shot, that got large, and knot under my arm"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "I don't think it was in Deltoid, it looks like it was lower.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient stated, "I am losing you. It went out a little bit. I can hear you now. So first I am immunocompromised because I have low immunoglobulin level, I am not treated for it but I do have low immunoglobulin level (Intent: Medical History). I went to get my second booster on Sunday and I use to give shot because I use to do medical assisting many many years ago (Further reporter type not clarified hence captured as consumer) and after I received the shot in my shoulder she have put band aid. I have realized it was not in the deltoid muscle it was a little bit it was lower the deltoid muscle and apparently I had a big reaction, I had a blotch on my arm yet since Sunday each day it has gotten larger but it has, it is gotten larger but the color but the coloring is subsided like it is fading away now at this point and it was swollen underneath but that seems to be getting 'flexes' well. Her concern is if this shot was administered in the wrong spot lower then the deltoid do I , my cells can get its efficiency?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.