chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported; No adverse event; Received Expired Monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported).    Concomitant medication was not reported.  Patient received Monovalent vaccine on 06-Apr-2022 Lot 046L21A which was shipped on 02-MAR-2022 and thawed in a cooler while being transported. Vial did not undergo any temperature excursions. Vial size 5.5 ml red cap. Reporter stated that, since they did not notice the vaccine was expired, some of these patients received another Monovalent dose after the expired dose within recommended time. They are still investigating and does not have any patient identifiers at this point.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live Significant Follow-up received: Reporter added and narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported; No adverse event; Received Expired Monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-May-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported).    Concomitant medication was not reported.  Patient received Monovalent vaccine on 06-May-2022 Lot 046L21A which was shipped on 02-MAR-2022 and thawed in a cooler while being transported. Vial did not undergo any temperature excursions. Vial size 5.5 ml red cap. Reporter stated that, since they did not notice the vaccine was expired, some of these patients received another Monovalent dose after the expired dose within recommended time. They are still investigating and does not have any patient identifiers at this point. Treatment medication was not reported.   This case was linked to MODERNATX, INC.-MOD-2022-682174, MODERNATX, INC.-MOD-2022-682176, MODERNATX, INC.-MOD-2022-682038 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live follow up added. Reporter added and narrative updated.; Sender's Comments:  MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter) MODERNATX, INC.-MOD-2022-682038:Same reporter case/master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported; No adverse event; Received expired monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (2 Adult patients received Monovalent shots on 13MAY2022 from vial shipped in 02MAR2022 and thawed in a cooler while being transported).    Concomitant medication was not reported.  Patient received Monovalent vaccine on 13-May-2022 Lot 046L21A which was shipped on 02-MAR-2022 and thawed in a cooler while being transported. Vial did not undergo any temperature excursions.   Treatment medication was not reported.  This case is for patient 1 from 2 adult patients who received vaccine on 13-May-2022 from vial shipped in 02-Mar-2022.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176, US-MODERNATX, INC.-MOD-2022-682173 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live follow up received. Contain no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682173:Patient 2 from 2 Adult patients received Monovalent shots on 13MAY2022, master case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over the body that lasted for 2 to 3 weeks; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (hives all over the body that lasted for 2 to 3 weeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives all over the body that lasted for 2 to 3 weeks). At the time of the report, URTICARIA (hives all over the body that lasted for 2 to 3 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. It was reported that the patient had hives all over the body that lasted for 2 to 3 weeks and eventually completely went away.  No treatment medication information was reported.   Novavax Reference ID was 2022NVX-US-000004257.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient has reacted poorly to all COVID vaccines to date, with each reaction being different in symptoms.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient has reacted poorly to all COVID vaccines to date, with each reaction being different in symptoms.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no comorbidities and was currently not taking any medication.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included Vaccination adverse reaction with Pfizer and Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient has reacted poorly to all COVID vaccines to date, with each reaction being different in symptoms.). At the time of the report, IMMUNISATION REACTION (Patient has reacted poorly to all COVID vaccines to date, with each reaction being different in symptoms.) outcome was unknown.            Concomitant medication was not provided. Patient experienced negative side effects following the fourth COVID booster vaccine (bi-valent) with Pfizer. These side effects included muscle aches, headache and chills for one day as well as a red, swollen, itchy, and warm injection site (commonly known as COVID arm) for approximately three days. Treatment information was not reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator and administered after its beyond use by date of 30-Nov-2022; No adverse event; Patient received an expired first primary dose after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired first primary dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator and administered after its beyond use by date of 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired first primary dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator and administered after its beyond use by date of 30-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired first primary dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator and administered after its beyond use by date of 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired first primary dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator and administered after its beyond use by date of 30-Nov-2022).    No concomitant medication information was reported.  The vial size was 2.5 mL.     The date on which the vial was initially stored in the refrigerator was unknown but beyond use by date was on 30-Nov-2022.  The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pyrexia
Clinical narrative: a bit weak; temperature over 100; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (a bit weak) and PYREXIA (temperature over 100) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 010A21A, 010M20A and 013L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2022, the patient experienced ASTHENIA (a bit weak) and PYREXIA (temperature over 100). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 19-Oct-2022 at an unspecified dose and frequency. On 20-Oct-2022, ASTHENIA (a bit weak) and PYREXIA (temperature over 100) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2022, Body temperature: temperature was over 100.         No concomitant medications were reported. The patient took an Advil, went to bed and woke up fine. No symptoms with the first 3 doses   This case was linked to MOD-2022-682333 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Urticaria
Clinical narrative: experienced a reaction; hives/not truly noticeable; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (experienced a reaction) and URTICARIA (hives/not truly noticeable) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient was on no medications prior to getting the vaccines and has no past medical history other than seasonal allergies.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (experienced a reaction) and URTICARIA (hives/not truly noticeable). At the time of the report, IMMUNISATION REACTION (experienced a reaction) and URTICARIA (hives/not truly noticeable) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-682537 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose).    No concomitant medications were reported. At least 5 adult patients received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose. These administrations occurred over the course of approximately 1 month.No symptoms were reported. No treatment medications were reported. This case pertains to Adult patient no.4.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022) and NO ADVERSE EVENT (no adverse event) in a 59-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Clinic staff administered vaccine one day beyond expiration date/ the medication expired on 11/28/2022).    Concomitant product use was not provided by the reporter.   Medication expired on 28-Nov-2022. Physician and patient notified on 30-Nov-2022 as soon as the staff become aware of administration error. Patient did not experienced any symptoms at that time, and it was unknown that the patient experienced any additional symptoms/events.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Live follow-up received: additional reporter, date of birth, suspect product name, dose, case narrative were updated.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dermatitis acneiform, Fatigue
Clinical narrative: Pimple like eruptions/different than normal eruptions; Fatigue with Moderna covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ACNEIFORM (Pimple like eruptions/different than normal eruptions) and FATIGUE (Fatigue with Moderna covid vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On an unknown date, the patient experienced DERMATITIS ACNEIFORM (Pimple like eruptions/different than normal eruptions) and FATIGUE (Fatigue with Moderna covid vaccine). At the time of the report, DERMATITIS ACNEIFORM (Pimple like eruptions/different than normal eruptions) and FATIGUE (Fatigue with Moderna covid vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  The reporter's causality for the events of fatigue with Moderna covid vaccine and pimple like eruptions/different than normal eruptions with Adalimumab Solution for Injection was not Provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Never been so sick; This serious initial spontaneous safety report was received by Novavax on 03-DEC-2022 from a consumer via social media monitoring.  An 85 year-old individual of an unspecified race and sex was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual had never been so sick (PT: Illness) (Serious: Hospitalization). The individual was hospitalized for 10 days.  At the time of reporting, the event outcome of Illness was unknown.  Lot number was not provided in the report.; Sender's Comments: This 85 year-old individual of an unspecified sex experienced: Illness after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Illness was reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event is considered Possible.
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: particles in some of the syringes; This is a spontaneous report received from a contactable reporter (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2602) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "particles in some of the syringes".  Additional information: Reportability Determination: This is Medical Device Related. Reportability Determination: This complaint for Prevnar 20v PFS suspension 0.5mlx10 for Particles in two Prevnar 20 syringes that are different lot numbers. is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury. Product used for treatment. This is a 30-day review 15Nov2022  Amendment: this report is being submitted because case validity has been reassessed.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Computerised tomogram, Drug ineffective, Electrocardiogram
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure", start date: 2022 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided; Computerised tomogram: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided; Electrocardiogram: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided; SARS-CoV-2 test: (24Nov2022) positive, notes: Treatment of COVID-19; Scan brain: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: She took the Pfizer Vaccine and was diagnosed with COVID on 24Nov2022 and was then prescribed Paxlovid. Pfizer Vaccine: Clarification of product name/Lot/NDC/Expiry: Not provided, caller chose to end the call abruptly. When she went to emergency room at (Hospital name withheld) on 28Nov2022 they did an EKG, Chest X-Ray, CAT Scan and Brain scan because they thought she was having a heart attack, but all of those test results were negative.  The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Scan brain
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure", start date: 2022 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided; Computerised tomogram: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided; Electrocardiogram: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided; SARS-CoV-2 test: (24Nov2022) positive, notes: Treatment of COVID-19; Scan brain: (28Nov2022) Negative, notes: Result: Negative; Unit: Not Provided. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: She took the Pfizer Vaccine and was diagnosed with COVID on 24Nov2022 and was then prescribed Paxlovid. Pfizer Vaccine: Clarification of product name/Lot/NDC/Expiry: Not provided, caller chose to end the call abruptly. When she went to emergency room at (Hospital name withheld) on 28Nov2022 they did an EKG, Chest X-Ray, CAT Scan and Brain scan because they thought she was having a heart attack, but all of those test results were negative.  The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 included: "Asthma" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: ADVAIR, start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19  (Paxlovid - Treatment start date: 16Nov2022, Treatment stop date: 20Nov2022).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
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 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteopenia" (unspecified if ongoing); "slightly elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VALTREX, start date: 01Feb2013; NATURES WAY COD LIVER OIL; NATURE'S WAY VITAMIN D3; VITAMIN C + ZINC; CALCIUM; NATURES WAY COZYME Q10. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Nov2022, outcome "recovered" (27Nov2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2022) Positive; (27Nov2022) Negative, notes: tested negative on that day. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient developed covid on 22Nov2022. She tested positive. She was prescribed Paxlovid that day and took all doses, ending on Sunday 27Nov2022 (five full days later). She tested negative on that day. The patient had no known allergies. Other medication of patient in 2weeks was Red Bean and Yeast.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: got her 2nd dose and then experienced atrial fibrillation, cardio version; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "She had had ablation for the tachycardia in the past" (unspecified if ongoing); "She had had Afib treated in the past" (unspecified if ongoing); "She had had ablation for the tachycardia in the past" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "abdominal pain", "lightheadedness", "tachycardia". The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 29Jan2021, outcome "unknown", described as "got her 2nd dose and then experienced atrial fibrillation, cardio version". Therapeutic measures were taken as a result of atrial fibrillation including cardioversion and unspecified medications. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded.  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.
Age: 68.0
Sex: F
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 (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EJ1685), on 30Jan2021 as dose 2, single (Lot number: EL1283), on 01Oct2021 as dose 3 (booster), single (Lot number: FF8841) and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Patient received Paxlovid as Covid-19 treatment from 21Nov2022 to 26Nov2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: After 4 days of negative tests; (01Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: developed Guillan-Barre; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "developed Guillan-Barre".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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.,Linked Report(s) : US-PFIZER INC-202201348576 same reporter/product/AE, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: developed Guillan-Barre; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer.), for covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "developed Guillan-Barre".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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.,Linked Report(s) : US-PFIZER INC-202201348518 same reporter/product/AE, different patient;
Sex: U
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Vaccination site cellulitis
Clinical narrative: Cellulitis reported by patient who is also a nurse; Redness and swelling that spread under arm from injection site; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM 197 protein) (PREVNAR 20) as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE CELLULITIS (medically significant), outcome "unknown," described as "Cellulitis reported by patient who is also a nurse; Redness and swelling that spread under arm from injection site." The event took place after use of the product.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM 197 protein) has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of PCV 20 in triggering the onset of VACCINATION SITE CELLULITIS cannot be fully excluded, considering the temporal relationship. 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: F
Vaccine: COVID19
Symptoms: Blood thromboplastin, Cerebral venous sinus thrombosis, Computerised tomogram venography head, Full blood count, International normalised ratio
Clinical narrative: Cerebral venous sinus thrombosis following third dose (booster shot) of BNT162B2 vaccine; This is a literature report for the following literature source(s):    A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ER" (unspecified if ongoing); "Headache" (unspecified if ongoing), notes: Pressure like headache; "ear/sinus infection" (unspecified if ongoing), notes: Initially treated with NSAIDs and antibiotics.; "ear/sinus infection" (unspecified if ongoing), notes: Initially treated with NSAIDs and antibiotics. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed,, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: CEREBRAL VENOUS SINUS THROMBOSIS (medically significant), 7 weeks after the suspect product(s) administration, outcome "recovering", described as "Cerebral venous sinus thrombosis following third dose (booster shot) of BNT162B2 vaccine". The patient underwent the following laboratory tests and procedures: Blood thromboplastin: Normal; Computerised tomogram venography head: abnormal signal in the, notes: superior sagittal, left transverse and sigmoid sinus-concern for CVST; Full blood count: Normal; International normalised ratio: Normal; Thombophilia: Negative; Magnetic resonance imaging: improving recanalization, notes: of the sinus and patient  3 months later; Magnetic resonance imaging head: which showed no stroke or, notes: parenchymal abnormality but raised concern for abnormal signal in the superior sagittal, left transverse and sigmoid sinus-concern for CVST; Metabolic function test: Normal; Prothrombin time: Normal. Therapeutic measures were taken as a result of cerebral venous sinus thrombosis.; Sender's Comments: Based on the available information in the case, the causal association between the event  Cerebral venous sinus thrombosis and the suspect drug BNT162B2 cannot be excluded.  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: F
Vaccine: COVID19
Symptoms: Investigation, Magnetic resonance imaging, Magnetic resonance imaging head, Metabolic function test, Prothrombin time
Clinical narrative: Cerebral venous sinus thrombosis following third dose (booster shot) of BNT162B2 vaccine; This is a literature report for the following literature source(s):    A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ER" (unspecified if ongoing); "Headache" (unspecified if ongoing), notes: Pressure like headache; "ear/sinus infection" (unspecified if ongoing), notes: Initially treated with NSAIDs and antibiotics.; "ear/sinus infection" (unspecified if ongoing), notes: Initially treated with NSAIDs and antibiotics. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed,, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: CEREBRAL VENOUS SINUS THROMBOSIS (medically significant), 7 weeks after the suspect product(s) administration, outcome "recovering", described as "Cerebral venous sinus thrombosis following third dose (booster shot) of BNT162B2 vaccine". The patient underwent the following laboratory tests and procedures: Blood thromboplastin: Normal; Computerised tomogram venography head: abnormal signal in the, notes: superior sagittal, left transverse and sigmoid sinus-concern for CVST; Full blood count: Normal; International normalised ratio: Normal; Thombophilia: Negative; Magnetic resonance imaging: improving recanalization, notes: of the sinus and patient  3 months later; Magnetic resonance imaging head: which showed no stroke or, notes: parenchymal abnormality but raised concern for abnormal signal in the superior sagittal, left transverse and sigmoid sinus-concern for CVST; Metabolic function test: Normal; Prothrombin time: Normal. Therapeutic measures were taken as a result of cerebral venous sinus thrombosis.; Sender's Comments: Based on the available information in the case, the causal association between the event  Cerebral venous sinus thrombosis and the suspect drug BNT162B2 cannot be excluded.  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: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: partial paralysis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male 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: PARALYSIS (medically significant), outcome "unknown", described as "partial paralysis". Clinical course: Shortly after vaccinations, and otherwise healthy male patient experienced partial paralysis, and is now wheelchair bound. No other medical explanation except for neurological vaccine side effect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported Event Paralysis and 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 drug 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.