chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 22 of 40 adult patients described by the reporter.  No concomitant product was reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Pharmacy intern reported that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 7th of 40 adult patients described by the reporter.  No concomitant product was reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Pharmacy intern reported that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  This is patient number 23th of 40.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medication was reported.  No treatment medication was reported.  This case pertains to patient number 8 out of 40.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  This case pertains to patient number 24 out of 40.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:master case
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: I have a friend that facial swelling on 1 side of her face.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SWELLING FACE (I have a friend that facial swelling on 1 side of her face.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (I have a friend that facial swelling on 1 side of her face.). At the time of the report, SWELLING FACE (I have a friend that facial swelling on 1 side of her face.) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that, patient had facial swelling on 1 side of her face, after her shot too. Patient didn't get the booster either. No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 9 out of 40 adult patients described by the reporter. No concomitant information was reported. Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023; No adverse event; Dose administered 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 (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023) 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 (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023).    Concomitant products were not reported.  It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial size was reported as 10 dose vial, it was initially stored in the refrigerator on 14-Dec-2022. The vial did not undergo any temperature excursion.   Treatment medications were not reported.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: Previous neuropathy worsened; Previous neuropathy worsened; Slight sore throat; Feeling horrible; Hard to walk; Blood pressure is high; Swollen gland (on my right side); Skin is itchy; Arm skin is breaking out; Severely fatigued; Muscle aches; Joints are aching; This serious initial spontaneous safety report was received by Novavax on 17-JAN-2023 from a consumer via a contact center.   A female of 82 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 21-NOV-2022 on the left side, intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 2 on 22-DEC-2022 on the right side at a pharmacy.  Medical history was reported as Renal cancer (kidney lymphoma in 2010, been in remission for 2 years) Gluten sensitivity (Wheat sensitive, individual does not have celiac disease but avoids gluten and sugar) and Hypertension.  Concomitant medications were reported as losartan (25 mg) and levothyroxine (25 mg).   On an unspecified day in DEC-2022, after second dose of the vaccination the individual experienced feeling horrible (PT: Feeling abnormal), severely fatigued (PT: Fatigue), swollen gland (on my right side) (PT: Lymphadenopathy), a slight sore throat (PT: Oropharyngeal pain) and can barely get out of bed. With these symptoms coming after the vaccine, the individual was very disturbed. The individual called their PCP (primary care physician) already and let them know. The individual experienced skin was itchy (PT: Pruritus), arm skin was breaking out (PT: Rash), muscle aches (PT: Myalgia), hard to walk (PT: Gait disturbance), blood pressure high (PT: Hypertension), joints aching (PT: Arthralgia) and the individual experienced previous neuropathy associate with their lymphoma that seemed to worsen (PT: Neuropathy peripheral) (Serious: Medically Significant) (PT: Condition aggravated).  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 09-FEB-2022).  At the time of reporting, the event outcomes of Fatigue, Lymphadenopathy, Oropharyngeal pain, Pruritus, Rash , Myalgia, Gait disturbance, Hypertension, Arthralgia, Neuropathy peripheral and Feeling abnormal were unknown.; Sender's Comments: This 82 year-old female experienced: Condition aggravated, Neuropathy peripheral, Arthralgia, Fatigue, Feeling abnormal, Gait disturbance, Hypertension, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pruritus and Rash after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The events Condition aggravated and Neuropathy peripheral were assessed as serious. The events Arthralgia, Fatigue, Feeling abnormal, Gait disturbance, Hypertension, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pruritus and Rash were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Hypertension, Lymphadenopathy, Myalgia, Neuropathy peripheral, Oropharyngeal pain
Clinical narrative: Previous neuropathy worsened; Previous neuropathy worsened; Slight sore throat; Feeling horrible; Hard to walk; Blood pressure is high; Swollen gland (on my right side); Skin is itchy; Arm skin is breaking out; Severely fatigued; Muscle aches; Joints are aching; This serious initial spontaneous safety report was received by Novavax on 17-JAN-2023 from a consumer via a contact center.   A female of 82 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 21-NOV-2022 on the left side, intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 2 on 22-DEC-2022 on the right side at a pharmacy.  Medical history was reported as Renal cancer (kidney lymphoma in 2010, been in remission for 2 years) Gluten sensitivity (Wheat sensitive, individual does not have celiac disease but avoids gluten and sugar) and Hypertension.  Concomitant medications were reported as losartan (25 mg) and levothyroxine (25 mg).   On an unspecified day in DEC-2022, after second dose of the vaccination the individual experienced feeling horrible (PT: Feeling abnormal), severely fatigued (PT: Fatigue), swollen gland (on my right side) (PT: Lymphadenopathy), a slight sore throat (PT: Oropharyngeal pain) and can barely get out of bed. With these symptoms coming after the vaccine, the individual was very disturbed. The individual called their PCP (primary care physician) already and let them know. The individual experienced skin was itchy (PT: Pruritus), arm skin was breaking out (PT: Rash), muscle aches (PT: Myalgia), hard to walk (PT: Gait disturbance), blood pressure high (PT: Hypertension), joints aching (PT: Arthralgia) and the individual experienced previous neuropathy associate with their lymphoma that seemed to worsen (PT: Neuropathy peripheral) (Serious: Medically Significant) (PT: Condition aggravated).  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 09-FEB-2022).  At the time of reporting, the event outcomes of Fatigue, Lymphadenopathy, Oropharyngeal pain, Pruritus, Rash , Myalgia, Gait disturbance, Hypertension, Arthralgia, Neuropathy peripheral and Feeling abnormal were unknown.; Sender's Comments: This 82 year-old female experienced: Condition aggravated, Neuropathy peripheral, Arthralgia, Fatigue, Feeling abnormal, Gait disturbance, Hypertension, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pruritus and Rash after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The events Condition aggravated and Neuropathy peripheral were assessed as serious. The events Arthralgia, Fatigue, Feeling abnormal, Gait disturbance, Hypertension, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pruritus and Rash were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: Previous neuropathy worsened; Previous neuropathy worsened; Slight sore throat; Feeling horrible; Hard to walk; Blood pressure is high; Swollen gland (on my right side); Skin is itchy; Arm skin is breaking out; Severely fatigued; Muscle aches; Joints are aching; This serious initial spontaneous safety report was received by Novavax on 17-JAN-2023 from a consumer via a contact center.   A female of 82 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 21-NOV-2022 on the left side, intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 2 on 22-DEC-2022 on the right side at a pharmacy.  Medical history was reported as Renal cancer (kidney lymphoma in 2010, been in remission for 2 years) Gluten sensitivity (Wheat sensitive, individual does not have celiac disease but avoids gluten and sugar) and Hypertension.  Concomitant medications were reported as losartan (25 mg) and levothyroxine (25 mg).   On an unspecified day in DEC-2022, after second dose of the vaccination the individual experienced feeling horrible (PT: Feeling abnormal), severely fatigued (PT: Fatigue), swollen gland (on my right side) (PT: Lymphadenopathy), a slight sore throat (PT: Oropharyngeal pain) and can barely get out of bed. With these symptoms coming after the vaccine, the individual was very disturbed. The individual called their PCP (primary care physician) already and let them know. The individual experienced skin was itchy (PT: Pruritus), arm skin was breaking out (PT: Rash), muscle aches (PT: Myalgia), hard to walk (PT: Gait disturbance), blood pressure high (PT: Hypertension), joints aching (PT: Arthralgia) and the individual experienced previous neuropathy associate with their lymphoma that seemed to worsen (PT: Neuropathy peripheral) (Serious: Medically Significant) (PT: Condition aggravated).  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 09-FEB-2022).  At the time of reporting, the event outcomes of Fatigue, Lymphadenopathy, Oropharyngeal pain, Pruritus, Rash , Myalgia, Gait disturbance, Hypertension, Arthralgia, Neuropathy peripheral and Feeling abnormal were unknown.; Sender's Comments: This 82 year-old female experienced: Condition aggravated, Neuropathy peripheral, Arthralgia, Fatigue, Feeling abnormal, Gait disturbance, Hypertension, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pruritus and Rash after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The events Condition aggravated and Neuropathy peripheral were assessed as serious. The events Arthralgia, Fatigue, Feeling abnormal, Gait disturbance, Hypertension, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pruritus and Rash were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Tachycardia (HR of 120 - 140 bpm for 12 hours); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, 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: TACHYCARDIA (non-serious), outcome "recovered", described as "Tachycardia (HR of 120 - 140 bpm for 12 hours)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia.   Additional Information: Covid prior vaccination: No. covid tested post vaccination: No. Tachycardia (HR of 120 - 140 bpm for 12 hours) the day after all 4 doses of the Pfizer covid-19 vaccine, which was worse after doses 3 and 4. I had the flu shot on the same day as dose 3 in Nov2021. I had the flu shot 01Sep2022, 16 days before I had dose 4 of the Pfizer covid vaccine (17Sep2022) and had tachycardia that was worse (more rapid HR and lasted longer) than after dose 3.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 49 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pemphigus Vulgaris" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Hard of Hearing" (unspecified if ongoing); "Mastoidectomy" (unspecified if ongoing); "Eustachian Tube Dysfunction" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL], start date: 02Jan2017, stop date: 02Jan2023; CYMBALTA, start date: 01Apr2022, stop date: 15Jan2023; CELEBREX, start date: 01Apr2022, stop date: 15Jan2023. Past drug history included: Neomycin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, COVID-19, Drug ineffective, Full blood count, Metabolic function test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 16:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "sickle cell trait, not disease" (unspecified if ongoing), notes: Other medical history: sickle cell trait, not disease. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Activated partial thromboplastin time prolonged: (16Jan2023) Normal; Full blood count: (16Jan2023) Normal; Metabolic function test: (16Jan2023) Normal; Prothrombin time: (16Jan2023) Normal. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Yes, patient received vaccine. From 04Jan2023 to 08Jan2023 paxlovid was taken as treatment for COVID-19 via oral route.   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: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective and COVID-19 cannot be ruled out.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 16:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "sickle cell trait, not disease" (unspecified if ongoing), notes: Other medical history: sickle cell trait, not disease. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Activated partial thromboplastin time prolonged: (16Jan2023) Normal; Full blood count: (16Jan2023) Normal; Metabolic function test: (16Jan2023) Normal; Prothrombin time: (16Jan2023) Normal. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Yes, patient received vaccine. From 04Jan2023 to 08Jan2023 paxlovid was taken as treatment for COVID-19 via oral route.   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: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: Dose 1,2,3 are Moderna vaccine and Dose 4 is Pfizer vaccine; he now has COVID; he now has COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 037A21B), on 22Apr2021 as dose 2, single (Lot number: 043B21A) and on 29Dec2021 as dose 3 (booster), single (Lot number: 033H21A), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "blood pressure high" (unspecified if ongoing), notes: blood pressure is high. Concomitant medication(s) included: AMLODIPINE taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 17Jan2023 at 07:30, outcome "unknown" and all described as "he now has COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1,2,3 are Moderna vaccine and Dose 4 is Pfizer vaccine".  Clinical course: Patient developed COVID at 7:30 am this morning, 17Jan2023. When his blood pressure is high and has taken the pill twice in the last 2 weeks. Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent Dose/Dosage Form: Gray cap, Original (Monovalent), greater than or equal to 12 years - 30 mcg/dose, Do not dilute.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Poor quality product administered, Product physical issue
Clinical narrative: received prevnar 20 and it has white flakes and is cloudy; received prevnar 20 and it has white flakes and is cloudy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT PHYSICAL ISSUE (non-serious) and all described as "received prevnar 20 and it has white flakes and is cloudy".  The reporter considered "received prevnar 20 and it has white flakes and is cloudy" associated to pneumococcal 20-val conj vac (dipht CRM197 protein).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arteriosclerosis, Carotid artery disease, Cerebrovascular accident
Clinical narrative: stroke; blocked artery in his neck to the brain; his artery is totally blocked; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A male patient received BNT162b2 (BNT162B2), as dose 1, 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; CAROTID ARTERY DISEASE (medically significant), outcome "unknown", described as "blocked artery in his neck to the brain"; ARTERIOSCLEROSIS (non-serious), outcome "unknown", described as "his artery is totally blocked".  Clinical course: Reporter mentioned that she and her husband already got the 3 shots of Pfizer COVID-19 Vaccine and she mentioned that her husband experienced a stroke, and they want to know the if the Pfizer shot instigated some of it and they are calling to ask, what was the legal status on this. If the vaccine instigated this situation and must find out what was the legal status. She also mentioned that they have 3 authorities in their family and there was so much to get into the legal history right now. So, they are just reporting this stroke that her husband experienced, and also mentioned that he got block, his artery is totally blocked, blocked artery in his neck to the brain that was why he experienced stroke." Appropriate response could not be provided as the Reporter hung up the call abruptly. Call back was done; however, reporter did not respond over the call. Thus, further probing could not be done  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024699 same patient/drug/AE, different dose;US-PFIZER INC-202300024827 same patient/drug/AE, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Just had some tiredness; 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 62-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 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, reaction(s): "Just had some tiredness". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Just had some tiredness".  Additional information: The caller states he took the Pfizer-BioNTech COVID-19 Vaccine primary series 1 and 2. He states he just had some tiredness and then received his first Pfizer booster dose and "got a headache for 4-5 days, 2nd booster had no side effects. The caller just got my 3rd Pfizer booster dose last week on 05Jan2023, I felt very bad after 3 hours my shoulders, arms ached and I had headaches and at night I got a fever and woke up at night with chills and fever and took Tylenol and and then I was sweating. caller states he Got up in morning. Just tired and had a little pain over my left chest and 3rd or 4th day my heart was beating very fast and then went away. Yesterday, the chest pain came back and lasted all day and my BP (Blood pressure) was 179/96 and last night the pain went away at 12:00 and at 3am I went to (Withheld) and for an hour or so I had chest pain. I just wanted to call and see if anyone else had these symptoms, then I wouldn't worry so much. His wife just a little tired and sore after the Pfizer booster vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024481 same patient and reporter, different dose and event;
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: got sick; fever; chills; swollen lymph nodes under left arm pits; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 at 10:30 as dose 4 (booster), single (Lot number: GH9697) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TRADJENTA; LISINOPRIL; VIT D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL1284, Location of injection: Arm Left; Vaccine Administration Time: 08:30 AM), administration date: 28Dec2020, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL8982, Location of injection: Arm Left; Vaccine Administration Time: 08:00 AM), administration date: 15Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: EW0196, Location of injection: Arm Left; Vaccine Administration Time: 08:00 AM), administration date: 15Oct2021, when the patient was 55-year-old, for Covid-19 immunization, reaction(s): "chills", "got sick", "swollen lymph nodes under left arm pits", "fever". The following information was reported: CHILLS (non-serious) with onset 04Jan2023 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 04Jan2023 at 21:00, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 04Jan2023 at 21:00, outcome "recovering", described as "got sick"; LYMPHADENOPATHY (non-serious) with onset 04Jan2023 at 21:00, outcome "recovering", described as "swollen lymph nodes under left arm pits". The events "got sick", "fever", "chills" and "swollen lymph nodes under left arm pits" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300025237 same reporter/patient/AE, different dose.;
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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).  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid treatment. treatment start date=04Jan2023, treatment stop date=08Jan2023. Patient had no Known allergies.  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: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 59 years, in left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received COVID-19 treatment with Paxlovid start date: 08Jan2023 and stop date: 13Jan2023.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngeal swab, Thrombosis
Clinical narrative: Received updated covid booster and a week and a half later a clot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Jan2023 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor five" (unspecified if ongoing). Concomitant medication(s) included: PRADAXA (ongoing). Vaccination history included: Covid-19 vaccine (Dose: 01, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, 1st Booster; UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: THROMBOSIS (prolonged hospitalization, medically significant) with onset 12Jan2023, outcome "recovered with sequelae", described as "Received updated covid booster and a week and a half later a clot.". The events "received updated covid booster and a week and a half later a clot." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (21Oct2022) Negative, notes: At home. Therapeutic measures were taken as a result of thrombosis.  Clinical course: Prior to the vaccination, the patient was not diagnosed with COVID. The patient had been taking Pradaxa for 6 years. Received updated covid booster and a week and a half later a clot. He had factor five, so he was prone to developing clots. Treatment received as Heprin to dissolve the clot and heightened dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 38 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8729), on 27Apr2021 as dose 2, single (Lot number: EW0167) and on 02Dec2021 as dose 3 (booster), single (Lot number: 301558H) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID given on 05Jan2023 to 09Jan2023.  No follow-up attempts are possible. No further information is expected.