chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Malaise, Pruritus, Sensitive skin
Clinical narrative: Face is puffy; One single red splash in the left leg, it was about an 1 1/2 inch in diameter and it was sensitive; One single red splash in the left leg and it was sensitive; Little bit itchy; Felt a little funny; Little shaky; Unwell; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is puffy), PRURITUS (Little bit itchy), FEELING ABNORMAL (Felt a little funny), TREMOR (Little shaky) and MALAISE (Unwell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clot blood (taking blood thinner). Concurrent medical conditions included Immunocompromised (taking immunosuppressant medication). Concomitant products included PREDNISONE for an unknown indication.    On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced PRURITUS (Little bit itchy), FEELING ABNORMAL (Felt a little funny), TREMOR (Little shaky) and MALAISE (Unwell). On 28-Dec-2021, the patient experienced ERYTHEMA (One single red splash in the left leg, it was about an 1 1/2 inch in diameter and it was sensitive) and SENSITIVE SKIN (One single red splash in the left leg and it was sensitive). On 29-Dec-2021, the patient experienced SWELLING FACE (Face is puffy). In December 2021, PRURITUS (Little bit itchy), FEELING ABNORMAL (Felt a little funny), TREMOR (Little shaky) and MALAISE (Unwell) had resolved. On 29-Dec-2021, ERYTHEMA (One single red splash in the left leg, it was about an 1 1/2 inch in diameter and it was sensitive) and SENSITIVE SKIN (One single red splash in the left leg and it was sensitive) had resolved. At the time of the report, SWELLING FACE (Face is puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she was unaware of her biological date of birth. However, she provided her documented date of birth.  The patient was taking medications, which were not reported  She also had one single red splash in the left leg.  It was about an 1 1/2 inch in diameter. It was sensitive and lasted a day ad was taking antihistamine. She was schedule to receive the second dose.  Treatment medication was not provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tremor
Clinical narrative: Face is puffy; One single red splash in the left leg, it was about an 1 1/2 inch in diameter and it was sensitive; One single red splash in the left leg and it was sensitive; Little bit itchy; Felt a little funny; Little shaky; Unwell; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is puffy), PRURITUS (Little bit itchy), FEELING ABNORMAL (Felt a little funny), TREMOR (Little shaky) and MALAISE (Unwell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clot blood (taking blood thinner). Concurrent medical conditions included Immunocompromised (taking immunosuppressant medication). Concomitant products included PREDNISONE for an unknown indication.    On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced PRURITUS (Little bit itchy), FEELING ABNORMAL (Felt a little funny), TREMOR (Little shaky) and MALAISE (Unwell). On 28-Dec-2021, the patient experienced ERYTHEMA (One single red splash in the left leg, it was about an 1 1/2 inch in diameter and it was sensitive) and SENSITIVE SKIN (One single red splash in the left leg and it was sensitive). On 29-Dec-2021, the patient experienced SWELLING FACE (Face is puffy). In December 2021, PRURITUS (Little bit itchy), FEELING ABNORMAL (Felt a little funny), TREMOR (Little shaky) and MALAISE (Unwell) had resolved. On 29-Dec-2021, ERYTHEMA (One single red splash in the left leg, it was about an 1 1/2 inch in diameter and it was sensitive) and SENSITIVE SKIN (One single red splash in the left leg and it was sensitive) had resolved. At the time of the report, SWELLING FACE (Face is puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she was unaware of her biological date of birth. However, she provided her documented date of birth.  The patient was taking medications, which were not reported  She also had one single red splash in the left leg.  It was about an 1 1/2 inch in diameter. It was sensitive and lasted a day ad was taking antihistamine. She was schedule to receive the second dose.  Treatment medication was not provided by the reporter.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Headache
Clinical narrative: blood in urine; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (blood in urine) and HEADACHE (headache) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose) in May 2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 27-Dec-2021 at 2:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced HEADACHE (headache). On 28-Dec-2021, the patient experienced BLOOD URINE PRESENT (blood in urine). At the time of the report, BLOOD URINE PRESENT (blood in urine) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Blood urine present: blood in urine (abnormal) blood in urine.         No treatment medication was reported. No Concomitant medication was reported. Patient did not take any medications for symptom relief. Adverse events were still persisting. Patient had blood in urine and it was his first time experiencing this. Patient  still has a trace of it.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster vaccine >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021 at 3:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021 at 3:18 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture). On 16-Dec-2021 at 3:18 PM, EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that administered an expired Moderna COVID-19 booster vaccine  to a patient. The patient's first 2 doses were Moderna brand COVID-19 vaccine as well. On 14 Dec 2021, the vial was initially stored in the refrigerator. First punctured was done on 15 Dec 2021 at 10:48 AM.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Weakness in legs; Pain beneath my toes on both feets; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in legs), PAIN IN EXTREMITY (Pain beneath my toes on both feets) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced MUSCULAR WEAKNESS (Weakness in legs), PAIN IN EXTREMITY (Pain beneath my toes on both feets) and MYALGIA (Muscle pain). At the time of the report, MUSCULAR WEAKNESS (Weakness in legs), PAIN IN EXTREMITY (Pain beneath my toes on both feets) and MYALGIA (Muscle pain) outcome was unknown.            No concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-293640 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received their booster of the Moderna COVID-19 vaccine 3 months after their second dose instead of 6 months; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received their booster of the Moderna COVID-19 vaccine 3 months after their second dose instead of 6 months) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received their booster of the Moderna COVID-19 vaccine 3 months after their second dose instead of 6 months). On 22-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received their booster of the Moderna COVID-19 vaccine 3 months after their second dose instead of 6 months) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication
Clinical narrative: booster she had a reaction a week after the shot; Both of her arms have a rash.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (booster she had a reaction a week after the shot) and RASH (Both of her arms have a rash.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 007C21A and 028A21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LOSARTAN and BUPROPION HYDROCHLORIDE (BUP) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (booster she had a reaction a week after the shot) and RASH (Both of her arms have a rash.). At the time of the report, VACCINATION COMPLICATION (booster she had a reaction a week after the shot) and RASH (Both of her arms have a rash.) outcome was unknown.            No treatment drug information was provided   This case was linked to MOD-2021-433312, MOD-2021-433166 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt pretty lousy/not as bad as the second dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt pretty lousy/not as bad as the second dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEELING ABNORMAL (felt pretty lousy/not as bad as the second dose). At the time of the report, FEELING ABNORMAL (felt pretty lousy/not as bad as the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drug information was provided.   This case was linked to (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: pain all over her stomach; nausea; Patient threw up for 2 days in a row.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (pain all over her stomach), NAUSEA (nausea) and VOMITING (Patient threw up for 2 days in a row.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (pain all over her stomach), NAUSEA (nausea) and VOMITING (Patient threw up for 2 days in a row.). At the time of the report, ABDOMINAL PAIN UPPER (pain all over her stomach), NAUSEA (nausea) and VOMITING (Patient threw up for 2 days in a row.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitants medications was reported.  No treatments medications was reported.   This case was linked to (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with the vaccine from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which has been punctured for more than 12 hours) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which has been punctured for more than 12 hours). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: so cold that I was sleeping with coat on and covers piled; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (so cold that I was sleeping with coat on and covers piled), CHILLS (chills) and PYREXIA (fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 025B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure management, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Reflux esophagitis, ROPINIROLE HYDROCHLORIDE (REQUIP) for Restless legs.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FEELING COLD (so cold that I was sleeping with coat on and covers piled), CHILLS (chills) and PYREXIA (fever). On 08-Apr-2021, FEELING COLD (so cold that I was sleeping with coat on and covers piled), CHILLS (chills) and PYREXIA (fever) had resolved.            Treatment medications was not provided. Medical history included current condition of blood pressure.  The symptoms lasted for about one or one and half days. Patient scheduled to receive booster dose on 29 Dec 2021.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: HCP said she was giving her 0.25mcg for the booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP said she was giving her 0.25mcg for the booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 microgram. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (HCP said she was giving her 0.25mcg for the booster). At the time of the report, ACCIDENTAL UNDERDOSE (HCP said she was giving her 0.25mcg for the booster) had resolved.            No concomitant products were reported. No treatment information was reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Arm pain; J & J vaccine dose 1 and Moderna vaccine dose 2; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and INCORRECT DOSE ADMINISTERED (J & J vaccine dose 1 and Moderna vaccine dose 2) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and INCORRECT DOSE ADMINISTERED (J & J vaccine dose 1 and Moderna vaccine dose 2). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown and INCORRECT DOSE ADMINISTERED (J & J vaccine dose 1 and Moderna vaccine dose 2) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster shot; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A, 040A21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster shot). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient   This case was linked to MOD-2021-433646 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Illness, Respiration abnormal
Clinical narrative: fell ill; has been on medications for breathing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (fell ill) and RESPIRATION ABNORMAL (has been on medications for breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (fell ill) and RESPIRATION ABNORMAL (has been on medications for breathing). At the time of the report, ILLNESS (fell ill) and RESPIRATION ABNORMAL (has been on medications for breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Reporter states that reporter friend fell ill just 2 weeks after the exposure to these experimental chemicals and has been on medications for breathing since. Patient received the poke in the fall of 2021.   This case was linked to MOD-2021-434221 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Immunisation
Clinical narrative: Angioedema in my lips the next day; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Dec2021 10:00 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER2613, Vaccine Administration Time: 11:00 AM), administration date: 01Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Vaccine Administration Time: 11:00 AM), administration date: 11Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021 10:00, outcome "unknown", described as "Booster"; ANGIOEDEMA (medically significant) with onset 16Dec2021 18:00, outcome "recovering", described as "Angioedema in my lips the next day". The event "angioedema in my lips the next day" was evaluated at the physician office visit. Therapeutic measures were taken as a result of angioedema  Patient had no receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no any other medications the patient received within 2 weeks of vaccination. Patient received Solumedrol shot and medrol dose pack for the adverse event. Patient had no diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Patient had no known allergies.  No follow up attempts needed no further information expected..; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Immunisation, Angioedema and 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Loss of consciousness
Clinical narrative: Nearly passed out the following morning; headache; muscle aches; chills; fatigue; swollen and painful lymph nodes under left arm and collar bone; swollen and painful lymph nodes under left arm and collar bone; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 12:45 (Lot number: FL3197) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "anxiety disorder" (unspecified if ongoing); "Acid reflux (oesophageal)" (unspecified if ongoing). Patient did not have known allergies. Concomitant medication(s) included: PROZAC; DEXILANT; CLARITINE, unspecified  birth control and unspecified vitamines. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EP6955, in arm left), administration date: 12Apr2021, when the patient was 45 years old, for COVID-19 immunisation; Bnt162b2 (Dose 1, Batch/Lot No: EP6955, in arm left), administration date: 22Mar2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 17Dec2021, outcome "recovering", described as "Nearly passed out the following morning"; HEADACHE (medically significant) with onset 17Dec2021, outcome "recovering", described as "headache"; MYALGIA (medically significant) with onset 17Dec2021, outcome "recovering", described as "muscle aches"; CHILLS (medically significant) with onset 17Dec2021, outcome "recovering", described as "chills"; FATIGUE (medically significant) with onset 17Dec2021, outcome "recovering", described as "fatigue"; LYMPH NODE PAIN (medically significant), LYMPHADENOPATHY (medically significant) all with onset 17Dec2021, outcome "recovering" and all described as "swollen and painful lymph nodes under left arm and collar bone"; IMMUNISATION (non-serious) with onset 16Dec2021 12:45, outcome "unknown", described as "booster". Therapeutic measures were not taken as a result of loss of consciousness, headache, myalgia, chills, fatigue, lymph node pain, lymphadenopathy. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient has not been diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Nearly passed out the following morning; headache; muscle aches; chills; fatigue; swollen and painful lymph nodes under left arm and collar bone; swollen and painful lymph nodes under left arm and collar bone; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 12:45 (Lot number: FL3197) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "anxiety disorder" (unspecified if ongoing); "Acid reflux (oesophageal)" (unspecified if ongoing). Patient did not have known allergies. Concomitant medication(s) included: PROZAC; DEXILANT; CLARITINE, unspecified  birth control and unspecified vitamines. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EP6955, in arm left), administration date: 12Apr2021, when the patient was 45 years old, for COVID-19 immunisation; Bnt162b2 (Dose 1, Batch/Lot No: EP6955, in arm left), administration date: 22Mar2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 17Dec2021, outcome "recovering", described as "Nearly passed out the following morning"; HEADACHE (medically significant) with onset 17Dec2021, outcome "recovering", described as "headache"; MYALGIA (medically significant) with onset 17Dec2021, outcome "recovering", described as "muscle aches"; CHILLS (medically significant) with onset 17Dec2021, outcome "recovering", described as "chills"; FATIGUE (medically significant) with onset 17Dec2021, outcome "recovering", described as "fatigue"; LYMPH NODE PAIN (medically significant), LYMPHADENOPATHY (medically significant) all with onset 17Dec2021, outcome "recovering" and all described as "swollen and painful lymph nodes under left arm and collar bone"; IMMUNISATION (non-serious) with onset 16Dec2021 12:45, outcome "unknown", described as "booster". Therapeutic measures were not taken as a result of loss of consciousness, headache, myalgia, chills, fatigue, lymph node pain, lymphadenopathy. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient has not been diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site haemorrhage
Clinical narrative: got booster this past week.; a lot of blood came out of the shot spot once the shot was administered; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "got booster this past week."; VACCINATION SITE HAEMORRHAGE (non-serious) with onset Dec2021, outcome "unknown", described as "a lot of blood came out of the shot spot once the shot was administered".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Near death experience
Clinical narrative: complex with potential life threatening condition which was monitored closely in the office with frequent re-evaluation for over an hour.; Life threatening illness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 15:45 (Lot number: FF2590) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: NEAR DEATH EXPERIENCE (life threatening) with onset 03Nov2021 16:15, outcome "recovered" (2021), described as "complex with potential life threatening condition which was monitored closely in the office with frequent re-evaluation for over an hour."; ILLNESS (life threatening) with onset 03Nov2021 16:15, outcome "recovered" (2021), described as "Life threatening illness". Immediate risk of death from the event. Since the vaccination, patient had not been tested for COVID-19. The events "complex with potential life threatening condition which was monitored closely in the office with frequent re-evaluation for over an hour." and "life threatening illness" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of near death experience, illness with Antihistamines and Steriods.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Heart rate, Heart rate abnormal, Illness
Clinical narrative: But the third is really unusual, I am sicker. I am on my 6th day and I am still sick; My heart, my blood pressure went out of control; My heart, my blood pressure went out of control; I still have infection; it is the third one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FE3594) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Note: was sick on the first one for two days), when the patient was 60 years old, for COVID-19 immunization, reaction(s): "sick"; Bnt162b2 (Dose: 2, Note: was sicker on the second one for 3 days), when the patient was 60 years old, for COVID-19 immunization, reaction(s): "sicker". The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "it is the third one"; ILLNESS (hospitalization), outcome "not recovered", described as "But the third is really unusual, I am sicker. I am on my 6th day and I am still sick"; BLOOD PRESSURE ABNORMAL (non-serious), HEART RATE ABNORMAL (non-serious), outcome "unknown" and all described as "My heart, my blood pressure went out of control"; INFECTION (non-serious), outcome "not recovered", described as "I still have infection". The event "my heart, my blood pressure went out of control" and "my heart, my blood pressure went out of control" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: went out of control, notes: my blood pressure went out of control; sars-cov-2 test: negative, notes: Have I gotten Covid? I was negative I did not get Covid and so; heart rate: went out of control.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Infection, SARS-CoV-2 test
Clinical narrative: But the third is really unusual, I am sicker. I am on my 6th day and I am still sick; My heart, my blood pressure went out of control; My heart, my blood pressure went out of control; I still have infection; it is the third one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FE3594) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Note: was sick on the first one for two days), when the patient was 60 years old, for COVID-19 immunization, reaction(s): "sick"; Bnt162b2 (Dose: 2, Note: was sicker on the second one for 3 days), when the patient was 60 years old, for COVID-19 immunization, reaction(s): "sicker". The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "it is the third one"; ILLNESS (hospitalization), outcome "not recovered", described as "But the third is really unusual, I am sicker. I am on my 6th day and I am still sick"; BLOOD PRESSURE ABNORMAL (non-serious), HEART RATE ABNORMAL (non-serious), outcome "unknown" and all described as "My heart, my blood pressure went out of control"; INFECTION (non-serious), outcome "not recovered", described as "I still have infection". The event "my heart, my blood pressure went out of control" and "my heart, my blood pressure went out of control" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: went out of control, notes: my blood pressure went out of control; sars-cov-2 test: negative, notes: Have I gotten Covid? I was negative I did not get Covid and so; heart rate: went out of control.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: COVID vaccine booster; fever; Arm pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID vaccine booster"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiac disorder, Cardiac monitoring, Fibrin D dimer
Clinical narrative: Heart complications/have inflammation around my heart; Heart complications/have inflammation around my heart; D-dimer levels were high; I feel weak; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 12:15 (Lot number: 33130BA) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Covid prior vaccination: no. There were no concomitant medications. Other medications in two weeks: no. Other vaccine in four weeks: no. Past drug history included: Ibuprofen, reaction(s): "Allergy". Other medical history: nothing. The following information was reported: MYOCARDITIS (medically significant), CARDIAC DISORDER (non-serious) all with onset 16Dec2021, outcome "not recovered" and all described as "Heart complications/have inflammation around my heart"; FIBRIN D DIMER INCREASED (non-serious) with onset 16Dec2021, outcome "not recovered", described as "D-dimer levels were high"; ASTHENIA (non-serious) with onset 16Dec2021, outcome "not recovered", described as "I feel weak". Ever since the shot she had experienced heart complications. The patient was taken to the hospital, completed blood work, urine specimen, iodine test because D-dimer levels were high, no blood clot but had inflammation around her heart and she felt weak and on a heart monitor now. The events "heart complications/have inflammation around my heart", "heart complications/have inflammation around my heart", "d-dimer levels were high" and "i feel weak" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (16Dec2021) unknown results; cardiac monitoring: (16Dec2021) unknown results; fibrin d dimer: (16Dec2021) high, notes: No blood clot; investigation: (16Dec2021) unknown results; urine analysis: (16Dec2021) unknown results. Covid tested post vaccination: No. Therapeutic measures were not taken as a result of myocarditis, cardiac disorder, fibrin d dimer increased, asthenia.; Sender's Comments: Based on the information available, the causal relationship between the reported events and 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Investigation, Myocarditis, Urine analysis
Clinical narrative: Heart complications/have inflammation around my heart; Heart complications/have inflammation around my heart; D-dimer levels were high; I feel weak; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 12:15 (Lot number: 33130BA) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Covid prior vaccination: no. There were no concomitant medications. Other medications in two weeks: no. Other vaccine in four weeks: no. Past drug history included: Ibuprofen, reaction(s): "Allergy". Other medical history: nothing. The following information was reported: MYOCARDITIS (medically significant), CARDIAC DISORDER (non-serious) all with onset 16Dec2021, outcome "not recovered" and all described as "Heart complications/have inflammation around my heart"; FIBRIN D DIMER INCREASED (non-serious) with onset 16Dec2021, outcome "not recovered", described as "D-dimer levels were high"; ASTHENIA (non-serious) with onset 16Dec2021, outcome "not recovered", described as "I feel weak". Ever since the shot she had experienced heart complications. The patient was taken to the hospital, completed blood work, urine specimen, iodine test because D-dimer levels were high, no blood clot but had inflammation around her heart and she felt weak and on a heart monitor now. The events "heart complications/have inflammation around my heart", "heart complications/have inflammation around my heart", "d-dimer levels were high" and "i feel weak" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (16Dec2021) unknown results; cardiac monitoring: (16Dec2021) unknown results; fibrin d dimer: (16Dec2021) high, notes: No blood clot; investigation: (16Dec2021) unknown results; urine analysis: (16Dec2021) unknown results. Covid tested post vaccination: No. Therapeutic measures were not taken as a result of myocarditis, cardiac disorder, fibrin d dimer increased, asthenia.; Sender's Comments: Based on the information available, the causal relationship between the reported events and 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: 12.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive PCR COVID test on 16Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Dec2021 19:00 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. List of any other medications the patient received within 2 weeks of vaccination: daily multi-vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The following information was reported: COVID-19 (medically significant) with onset 16Dec2021 16:00, outcome "recovering", described as "Positive PCR COVID test on 16Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive, notes: Post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she was so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FE3594) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (hospitalization, medically significant), outcome "unknown", described as "she was so sick". The event "she was so sick" was evaluated at the emergency room visit.  Clinical Course: Patient was 113 Pounds. Consumer reported that she was sick for first 2 days after her first dose and she was sick for 6 days after her third dose.Consumer stated, that she was in emergency room for 6 hours because of blood pressure which was out of control.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Immunisation, Investigation
Clinical narrative: 3rd covid19 booster; thought I was having a stroke but kind of neurologist said, it's Bell's palsy as a result of getting my third Covid vaccine; This is a spontaneous report received from a contactable reporter, Consumer. The reporter is the patient.  A 60-year-old patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administration date 12Dec2021 (Lot number: ER2613) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: Hypertension (unspecified if ongoing); Diabetes mellitus (unspecified if ongoing). Concomitant medications included: metoprolol taken for hypertension; empagliflozin (JARDIANCE); linagliptin (TRAJENTA). Vaccination history included: Covid-19 vaccine (Dose:1st, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:2nd, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: immunisation (medically significant) with onset 12Dec2021, outcome unknown; bell's palsy (medically significant) with onset Dec2021, outcome unknown, described as "thought I was having a stroke but kind of neurologist said, it's Bell's palsy as a result of getting my third Covid vaccine". The event was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (18Dec2021) unknown results, notes: I had it yesterday, I do not know, there was several test that they perform.  No follow-up attempts are possible. No further information is expected.