chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Sweating; spiked a fever, 102.5 F and 103.2 F; Headache; Fatigue; Achy Joints; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PYREXIA (spiked a fever, 102.5 F and 103.2 F), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Achy Joints) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect products included non-company products ABALOPARATIDE (TYMLOS) for Senile osteoporosis and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 07-Jan-2024 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient started ABALOPARATIDE (TYMLOS) (Subcutaneous use) 80 microgram once a day. On 07-Jan-2024, the patient experienced HYPERHIDROSIS (Sweating), PYREXIA (spiked a fever, 102.5 F and 103.2 F), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Achy Joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Jan-2024, HYPERHIDROSIS (Sweating), PYREXIA (spiked a fever, 102.5 F and 103.2 F), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Achy Joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2024, Body temperature: 102.5 F. On 08-Jan-2024, Body temperature: 103.2 F. On an unknown date, Body temperature: no fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The action taken with Tymlos treatment was not reported. Treatment included tylenol which was reported as effective.
Age: 58.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pyrexia
Clinical narrative: Sweating; spiked a fever, 102.5 F and 103.2 F; Headache; Fatigue; Achy Joints; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PYREXIA (spiked a fever, 102.5 F and 103.2 F), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Achy Joints) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect products included non-company products ABALOPARATIDE (TYMLOS) for Senile osteoporosis and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 07-Jan-2024 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient started ABALOPARATIDE (TYMLOS) (Subcutaneous use) 80 microgram once a day. On 07-Jan-2024, the patient experienced HYPERHIDROSIS (Sweating), PYREXIA (spiked a fever, 102.5 F and 103.2 F), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Achy Joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Jan-2024, HYPERHIDROSIS (Sweating), PYREXIA (spiked a fever, 102.5 F and 103.2 F), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Achy Joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2024, Body temperature: 102.5 F. On 08-Jan-2024, Body temperature: 103.2 F. On an unknown date, Body temperature: no fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The action taken with Tymlos treatment was not reported. Treatment included tylenol which was reported as effective.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site pain/ Mild injection site tenderness; Mild fever; Mild injection site swelling; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain/ Mild injection site tenderness), PYREXIA (Mild fever), VACCINATION SITE SWELLING (Mild injection site swelling) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain/ Mild injection site tenderness), PYREXIA (Mild fever), VACCINATION SITE SWELLING (Mild injection site swelling) and HEADACHE (Headache and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain/ Mild injection site tenderness), PYREXIA (Mild fever), VACCINATION SITE SWELLING (Mild injection site swelling) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2024, Body temperature: 100.4 to 101.2 °F.         (Privacy) Subject ID was reported. (Privacy) Subject ID was reported.  Concomitant medication was not provided. The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on 25-Jan-2024 and 26-Jan-2024. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-759564, US-MODERNATX, INC.-MOD-2024-759567, US-MODERNATX, INC.-MOD-2024-759568, US-MODERNATX, INC.-MOD-2024-759569, US-MODERNATX, INC.-MOD-2024-759562 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759567:Same reporter case US-MODERNATX, INC.-MOD-2024-759568:Same reporter case US-MODERNATX, INC.-MOD-2024-759564:Same reporter case US-MODERNATX, INC.-MOD-2024-759569:Same reporter case US-MODERNATX, INC.-MOD-2024-759562:Same reporter case
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site pain/ Mild injection site tenderness; Mild fever; Mild injection site swelling; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain/ Mild injection site tenderness), PYREXIA (Mild fever), VACCINATION SITE SWELLING (Mild injection site swelling) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain/ Mild injection site tenderness), PYREXIA (Mild fever), VACCINATION SITE SWELLING (Mild injection site swelling) and HEADACHE (Headache and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain/ Mild injection site tenderness), PYREXIA (Mild fever), VACCINATION SITE SWELLING (Mild injection site swelling) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2024, Body temperature: 100.4 to 101.2 °F.         (Privacy) Subject ID was reported. (Privacy) Subject ID was reported.  Concomitant medication was not provided. The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on 25-Jan-2024 and 26-Jan-2024. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-759564, US-MODERNATX, INC.-MOD-2024-759567, US-MODERNATX, INC.-MOD-2024-759568, US-MODERNATX, INC.-MOD-2024-759569, US-MODERNATX, INC.-MOD-2024-759562 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759567:Same reporter case US-MODERNATX, INC.-MOD-2024-759568:Same reporter case US-MODERNATX, INC.-MOD-2024-759564:Same reporter case US-MODERNATX, INC.-MOD-2024-759569:Same reporter case US-MODERNATX, INC.-MOD-2024-759562:Same reporter case
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Mild injection site redness; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Mild injection site redness) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced VACCINATION SITE ERYTHEMA (Mild injection site redness). At the time of the report, VACCINATION SITE ERYTHEMA (Mild injection site redness) outcome was unknown.          Concomitant medications were not reported.   Patient experienced mild injection site redness anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, 24-Jan-2024 and Thursday, 25-Jan-2024.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-759560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759560:Same reporter, Master case (patient 1)
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Joint pain and no interference with activity; Moderate muscle pain with some interference with activity; Moderate fatigue with some interference with activity; Headache and no interference with activity; Moderate injection site swelling; Mild injection site redness; Moderate injection site tenderness (tenderness with movement)/Mild injection site pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), FATIGUE (Moderate fatigue with some interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), FATIGUE (Moderate fatigue with some interference with activity), HEADACHE (Headache and no interference with activity), VACCINATION SITE SWELLING (Moderate injection site swelling), VACCINATION SITE ERYTHEMA (Mild injection site redness) and VACCINATION SITE PAIN (Moderate injection site tenderness (tenderness with movement)/Mild injection site pain and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), FATIGUE (Moderate fatigue with some interference with activity), HEADACHE (Headache and no interference with activity), VACCINATION SITE SWELLING (Moderate injection site swelling), VACCINATION SITE ERYTHEMA (Mild injection site redness) and VACCINATION SITE PAIN (Moderate injection site tenderness (tenderness with movement)/Mild injection site pain and no interference with activity) outcome was unknown.            (Privacy) Subject ID was reported.  (Privacy) Subject ID was reported.  Concomitant medication was not provided.  The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on 24-Jan-2024 and 25-Jan-2024. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-759560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759560:Same reporter, Master case
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Joint pain and no interference with activity; Moderate muscle pain with some interference with activity; Moderate fatigue with some interference with activity; Headache and no interference with activity; Moderate injection site swelling; Mild injection site redness; Moderate injection site tenderness (tenderness with movement)/Mild injection site pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), FATIGUE (Moderate fatigue with some interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), FATIGUE (Moderate fatigue with some interference with activity), HEADACHE (Headache and no interference with activity), VACCINATION SITE SWELLING (Moderate injection site swelling), VACCINATION SITE ERYTHEMA (Mild injection site redness) and VACCINATION SITE PAIN (Moderate injection site tenderness (tenderness with movement)/Mild injection site pain and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), FATIGUE (Moderate fatigue with some interference with activity), HEADACHE (Headache and no interference with activity), VACCINATION SITE SWELLING (Moderate injection site swelling), VACCINATION SITE ERYTHEMA (Mild injection site redness) and VACCINATION SITE PAIN (Moderate injection site tenderness (tenderness with movement)/Mild injection site pain and no interference with activity) outcome was unknown.            (Privacy) Subject ID was reported.  (Privacy) Subject ID was reported.  Concomitant medication was not provided.  The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on 24-Jan-2024 and 25-Jan-2024. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-759560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759560:Same reporter, Master case
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Mild muscle pain and no interference with activity; Mild injection site pain and no interference with activity /Moderate injection site tenderness (tenderness with movement); This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (Mild muscle pain and no interference with activity) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity /Moderate injection site tenderness (tenderness with movement)) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MYALGIA (Mild muscle pain and no interference with activity) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity /Moderate injection site tenderness (tenderness with movement)). At the time of the report, MYALGIA (Mild muscle pain and no interference with activity) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity /Moderate injection site tenderness (tenderness with movement)) outcome was unknown.            (Privacy) Subject ID was reported.  (Privacy) Subject ID was reported.  Concomitant medication was not provided.  The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on 26-Jan-2024 and 27-Jan-2024.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-759560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759560:Same reporter, Master case
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Dyspnoea, Fatigue, Malaise
Clinical narrative: COVID-19; Trouble breathing; I really don't feel good. I don't feel good at all; I am getting so tired/I am having a little, just feeling really tired; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), DYSPNOEA (Trouble breathing), MALAISE (I really don't feel good. I don't feel good at all) and FATIGUE (I am getting so tired/I am having a little, just feeling really tired) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) 1 dosage form. On 25-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) dosage was changed to 1 dosage form. On 27-Jan-2022, received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) dosage was changed to 1 dosage form. On 08-Jul-2022, received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) dosage was changed to 1 dosage form. In June 2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), DYSPNOEA (Trouble breathing), MALAISE (I really don't feel good. I don't feel good at all) and FATIGUE (I am getting so tired/I am having a little, just feeling really tired). At the time of the report, COVID-19 (COVID-19) outcome was unknown, DYSPNOEA (Trouble breathing) had resolved and MALAISE (I really don't feel good. I don't feel good at all) and FATIGUE (I am getting so tired/I am having a little, just feeling really tired) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments.   Patient has unspecified concomitant medications.   Patient had Pfizer vaccine on 27-Jan-22 (consumer was unsure about the date of vaccination). Looking at original card, patient thought maybe its January instead of September.  Patient had all vaccines Intramuscular via Intramuscular and it did not feel good.   Treatment information was not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pharyngeal swelling
Clinical narrative: Pain; Swollen glands; I can't even touch my throat because of the pain/swollen throat; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (I can't even touch my throat because of the pain/swollen throat), PAIN (Pain) and LYMPHADENOPATHY (Swollen glands) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 036B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (I can't even touch my throat because of the pain/swollen throat). On an unknown date, the patient experienced PAIN (Pain) and LYMPHADENOPATHY (Swollen glands). At the time of the report, PHARYNGEAL SWELLING (I can't even touch my throat because of the pain/swollen throat), PAIN (Pain) and LYMPHADENOPATHY (Swollen glands) had not resolved.            Concomitant medications were not reported.  It was reported that events goes away and comes back.   Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-758905 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-758905:Same Patient Different Product
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Death, Electrocardiogram
Clinical narrative: Caused early death; Atrial fibrillation; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 05Feb2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), on 18Aug2021 at 09:30 as dose 2, single (Lot number: FD8448) at the age of 93 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol abnormal" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medications included: ATORVASTATIN oral taken for blood cholesterol abnormal (ongoing); AMLODIPINE BESYLATE oral taken for hypertension (ongoing).  Vaccination history included: BNT162b2 (Dose 1, single , Time: 09:30 AM, Anatomical Site of injection: arm, Route of administration: Intramuscualr , Batch/Lot number: FA7485), administration date: 28Jul2021, for COVID-19 immunization.  The following information was reported: DEATH (death), outcome "fatal", described as "Caused early death"; ATRIAL FIBRILLATION (medically significant), outcome "unknown. Patient had heart issues after getting these Vaccines. He developed Atrial fibrillation which he never had before. Those could Vaccines are no good for anyone. He had Abnormal EKG (electrocardiogram). The date and cause of death for the patient were unknown. No autopsy was performed. Patient's child (reporter) believe these vaccines caused early death.; Reported Cause(s) of Death: Caused early death
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have ringing in my right ear that started about 32 hours after having received the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies. The patient received Paxlovid from 24Jan2024 to 28Jan2024 as treatment.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
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 Consumer or other non HCP.  An elderly male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 13:00 as dose 1, single (Lot number: HD9876), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hydrocodone allergy/tramadol allergy " (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 6 (BOOSTER); SINGLE, administration time: 13:00, Batch/lot number: AS7184B, Anatomical location: right arm), administration date: 18May2023, for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, Covid-19 with Paxlovid from 25Jan2024 to 30Jan2024 .  No follow-up attempts are possible.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 01May2021 as dose 1, single (Lot number: EW0158), in right arm, on 22May2021 as dose 2, single (Lot number: EW0172), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 37 years, in right arm 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) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included: Paxlovid from 23Jan2024 to 28Jan2024.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Blood alkaline phosphatase
Clinical narrative: AST in the two hundreds; ALT in two hundreds; my alkaline phosphatase was in the nine hundreds; My liver enzymes became very elevated; This is a spontaneous report received from a Consumer or other non HCP from medical information team. Other Case identifier(s): MOD-2024-759367 (Moderna).  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, 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 (Primary Immunization series complete), for COVID-19 immunisation. The following information was reported: ASPARTATE AMINOTRANSFERASE INCREASED (medically significant), outcome "unknown", described as "AST in the two hundreds"; ALANINE AMINOTRANSFERASE INCREASED (medically significant), outcome "unknown", described as "ALT in two hundreds"; BLOOD ALKALINE PHOSPHATASE INCREASED (medically significant), outcome "unknown", described as "my alkaline phosphatase was in the nine hundreds"; HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "My liver enzymes became very elevated". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 200, notes: ALT in two hundreds; Aspartate aminotransferase: 200, notes: AST in the two hundreds; Blood alkaline phosphatase: 900, notes: alkaline phosphatase went into the nine hundreds; Hepatic enzyme: Elevated. Clinical course: Patient had a couple of questions about the Pfizer vaccine. Patient had all Pfizer shots vaccines and then got the Pfizer booster September 22nd 23 and recently had an episode of elevated liver enzymes where alkaline phosphatase went into the nine hundreds, liver enzymes became very elevated, alkaline phosphatase was in the nine hundreds, AST in the two hundreds, ALT in two hundreds. Question was does the booster have anything to do with liver disease.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase increased, Hepatic enzyme, Hepatic enzyme increased
Clinical narrative: AST in the two hundreds; ALT in two hundreds; my alkaline phosphatase was in the nine hundreds; My liver enzymes became very elevated; This is a spontaneous report received from a Consumer or other non HCP from medical information team. Other Case identifier(s): MOD-2024-759367 (Moderna).  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, 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 (Primary Immunization series complete), for COVID-19 immunisation. The following information was reported: ASPARTATE AMINOTRANSFERASE INCREASED (medically significant), outcome "unknown", described as "AST in the two hundreds"; ALANINE AMINOTRANSFERASE INCREASED (medically significant), outcome "unknown", described as "ALT in two hundreds"; BLOOD ALKALINE PHOSPHATASE INCREASED (medically significant), outcome "unknown", described as "my alkaline phosphatase was in the nine hundreds"; HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "My liver enzymes became very elevated". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 200, notes: ALT in two hundreds; Aspartate aminotransferase: 200, notes: AST in the two hundreds; Blood alkaline phosphatase: 900, notes: alkaline phosphatase went into the nine hundreds; Hepatic enzyme: Elevated. Clinical course: Patient had a couple of questions about the Pfizer vaccine. Patient had all Pfizer shots vaccines and then got the Pfizer booster September 22nd 23 and recently had an episode of elevated liver enzymes where alkaline phosphatase went into the nine hundreds, liver enzymes became very elevated, alkaline phosphatase was in the nine hundreds, AST in the two hundreds, ALT in two hundreds. Question was does the booster have anything to do with liver disease.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "allergies: Penicillin" (unspecified if ongoing); "allergies / sulfa" (unspecified if ongoing); "allergies / gluten" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "grave's disease" (unspecified if ongoing); "hashimoto's disease" (unspecified if ongoing); "thyroid eye disease" (unspecified if ongoing); "metabolic syndrome" (unspecified if ongoing); "histamine intolerance" (unspecified if ongoing); "chronic urticaria" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 26Jan2016. Past drug history included: Doxycycline, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2024) negative; (01Feb2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID-19 treatment from 24Jan2024 to 29Jan2024. Also, the patient received TYLENOL EXTRA STRENGTH since 24Jan2024.  The lot number for BNT162b2, BNT162b2 omi ba.4-5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400032439 Same reporter and patient, different product and event;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1 (toppac); single (Lot number: Hg4629) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE, Batch/Lot No: 013L20A), administration date: 11Jan2021, when the patient was 63-year-old, for COVID-19 immunisation; moderna (DOSE 2, SINGLE, Batch/Lot No: 031M20A), administration date: 08Feb2021, when the patient was 63-year-old, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 939905, Location of injection: Arm Left), administration date: 02Nov2021, when the patient was 64-year-old, for COVID-19 immunisation; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: 055A22A, Location of injection: Arm Left), administration date: 21Jul2022, when the patient was 65-year-old, for COVID-19 immunisation; moderna (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: 049D22A, Location of injection: Arm Left), administration date: 17Oct2022, when the patient was 65-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jan2024, outcome "recovered" (Jan2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: Tested negative on day 5 and day 7; (26Jan2024) Positive, notes: Took Paxlovid Starting on the day first tested positive; (2024) Negative, notes: Tested negative on day 5 and day 7. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 26Jan2024 to 29Jan2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Dec2023 at 12:00 as dose 1, single (Lot number: HS7224), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Negative, notes: for 2.5 days. Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19 from 26Jan2024 to 31Jan2024.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 (BNT162B2 NOS), on 27Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "prediabetic" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL+HCTZ, start date: May2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 27Jan2024 to 31Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 22Jan2024 to 26Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: F
Vaccine: PNC20
Symptoms: Eczema, Urticaria
Clinical narrative: finding something that was causing her to have hives/she have it on her upper chest, arms, face and head/hard bumps in the hives on her arms, forehead and chest; broke out and had eczema on her arms and hand; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 79-year-old female patient received pneumococcal 20-val conj vac (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: URTICARIA (non-serious), outcome "unknown", described as "finding something that was causing her to have hives/she have it on her upper chest, arms, face and head/hard bumps in the hives on her arms, forehead and chest"; ECZEMA (non-serious), outcome "unknown", described as "broke out and had eczema on her arms and hand". Additional information: Patient stated that she got a Prevnar pneumonia shot in Jun (year not specified) and have been finding something that was causing her to have hives and she is just checking to see if the pneumonia shot is causing the hives. She would like to know some of the adverse side effects of the product. Stated she have it on her upper chest, arms, face and head, she also broke out and had eczema on her arms and hand and have hard bumps in the hives on her arms, forehead and chest.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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 Consumer or other non HCP.  An elderly male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Peripheral Neuropathy" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "high Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Pfizer / biontech (DOSE 2, SINGLE, ), for COVID-19 immunisation. Patient had no known allergies The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 18Jan2024 to 23Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Bronchitis, Injection site cellulitis, Nasopharyngitis
Clinical narrative: Cellulitis at the site of the injection; bronchitis; bad colds; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) for pneumococcal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis at the site of the injection"; BRONCHITIS (non-serious), outcome "unknown"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "bad colds".  Additional information: Patient received Prevnar 10 (actually, She don't remember if it was the 8 or the 10, but it was one of the first versions of the vaccine) and she developed cellulitis. So, she didn't take the second dose of the vaccine. Patient mentioned it was one of the early forms of pneumonia vaccines but doesn't remember which one. Patient have had a reaction to the Prevenar10, 1st Shot: resulted in Cellulitis at the site of the injection. She did not take the second shot. She have not taken any more Prevenar shots. Her need was to know what ingredients in RSV vaccine may be the same as those in the pneumonia shots, Patient had the Pfizer Covid boosters with no problems. Would there be any chemicals that would counter act with the RSV vaccine. Patient have developed bronchitis after bad colds.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oral steroids, reaction(s): "Known allergies: Oral steroids". Vaccination history included: Covid-19 vaccine (DOSE 5, SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE , UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid as event treatment from 26Jan2024 to 30Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Gluten allergy" (unspecified if ongoing); "known allergies: Celiac" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE XR, start date: 01Oct2023. Vaccination history included: moderna (vaccine brand=Other, vaccine brand other=Moderna, vaccine brand unknown=False, vaccine lot number=055F2213, vaccine lot unknown=False, vaccine dose number=4, vaccine dose number unknown=False), administration date: 28Sep2022, when the patient was 34-year-old, for Covid-19 Immunization; moderna (vaccine brand=Other, vaccine brand other=Moderna, vaccine brand unknown=False, vaccine lot number=012F21A, vaccine lot unknown=False, vaccine dose number=3, vaccine dose number unknown=False), administration date: 28Oct2021, when the patient was 33-year-old, for Covid-19 Immunization; BNT162b2 (vaccine brand=Pfizer / BioNTech, vaccine brand unknown=False, vaccine lot number=ER8735, vaccine lot unknown=False, vaccine dose number=2, vaccine dose number unknown=False), administration date: 25Apr2021, when the patient was 32-year-old, for Covid-19 Immunization; BNT162b2 (vaccine brand=Pfizer / BioNTech, vaccine brand unknown=False, vaccine lot number=EW0150, vaccine lot unknown=False, vaccine dose number=1, vaccine lot unknown=False, vaccine dose number=1, vaccine dose number unknown=False), administration date: 04Apr2021, when the patient was 32-year-old, for Covid-19 Immunization.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19,Paxlovid treatment from 28Jan2024 to 02Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.