chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Abdominal rigidity, Blood test, Computerised tomogram, Feeling abnormal
Clinical narrative: EVER SINCE PATIENT GOT THE SHOT AND HAD NOT BEEN THE SAME; STOMACH PAIN; STOMACH SPASM; WOKE UP MANY TIMES DURING NIGHT IN PAIN; EXTREMITIES FELT LIKE SKIN BADLY BURNED; HORRIBLE ARM PAIN; NAUSEA; LEFT SIDE FACE NUMB AND TORSO NUMB; PAIN; DEATHLY ILL; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was actively played sports. The patient had not overweight and had no underlining ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced pain. On AUG-2021, the patient experienced deathly ill. On AUG-2021, the patient experienced stomach pain. On AUG-2021, the patient experienced stomach spasm. On AUG-2021, the patient experienced woke up many times during night in pain. On AUG-2021, the patient experienced extremities felt like skin badly burned. On AUG-2021, the patient experienced horrible arm pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced left side face numb and torso numb. On 13-AUG-2021, the patient experienced ever since patient got the shot and had not been the same. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported, and CT scan (NR: not provided) negative. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deathly ill, and ever since patient got the shot and had not been the same, stomach pain, stomach spasm, waken up many times during night in pain, extremities felt like skin badly burned, horrible arm pain, and nausea on OCT-2021, was recovering from left side face numb and torso numb, and the outcome of pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Illness, Middle insomnia, Nausea, Pain
Clinical narrative: EVER SINCE PATIENT GOT THE SHOT AND HAD NOT BEEN THE SAME; STOMACH PAIN; STOMACH SPASM; WOKE UP MANY TIMES DURING NIGHT IN PAIN; EXTREMITIES FELT LIKE SKIN BADLY BURNED; HORRIBLE ARM PAIN; NAUSEA; LEFT SIDE FACE NUMB AND TORSO NUMB; PAIN; DEATHLY ILL; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was actively played sports. The patient had not overweight and had no underlining ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced pain. On AUG-2021, the patient experienced deathly ill. On AUG-2021, the patient experienced stomach pain. On AUG-2021, the patient experienced stomach spasm. On AUG-2021, the patient experienced woke up many times during night in pain. On AUG-2021, the patient experienced extremities felt like skin badly burned. On AUG-2021, the patient experienced horrible arm pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced left side face numb and torso numb. On 13-AUG-2021, the patient experienced ever since patient got the shot and had not been the same. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported, and CT scan (NR: not provided) negative. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deathly ill, and ever since patient got the shot and had not been the same, stomach pain, stomach spasm, waken up many times during night in pain, extremities felt like skin badly burned, horrible arm pain, and nausea on OCT-2021, was recovering from left side face numb and torso numb, and the outcome of pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Skin burning sensation
Clinical narrative: EVER SINCE PATIENT GOT THE SHOT AND HAD NOT BEEN THE SAME; STOMACH PAIN; STOMACH SPASM; WOKE UP MANY TIMES DURING NIGHT IN PAIN; EXTREMITIES FELT LIKE SKIN BADLY BURNED; HORRIBLE ARM PAIN; NAUSEA; LEFT SIDE FACE NUMB AND TORSO NUMB; PAIN; DEATHLY ILL; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was actively played sports. The patient had not overweight and had no underlining ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced pain. On AUG-2021, the patient experienced deathly ill. On AUG-2021, the patient experienced stomach pain. On AUG-2021, the patient experienced stomach spasm. On AUG-2021, the patient experienced woke up many times during night in pain. On AUG-2021, the patient experienced extremities felt like skin badly burned. On AUG-2021, the patient experienced horrible arm pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced left side face numb and torso numb. On 13-AUG-2021, the patient experienced ever since patient got the shot and had not been the same. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported, and CT scan (NR: not provided) negative. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deathly ill, and ever since patient got the shot and had not been the same, stomach pain, stomach spasm, waken up many times during night in pain, extremities felt like skin badly burned, horrible arm pain, and nausea on OCT-2021, was recovering from left side face numb and torso numb, and the outcome of pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Adrenal insufficiency, Angiogram pulmonary normal, Anion gap increased, Anxiety
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine normal, Blood culture negative, Blood glucose increased, Blood lactic acid decreased, Blood sodium decreased
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urea normal, Chest X-ray normal, Chest pain, Chills, Computerised tomogram abdomen normal
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram spine, Diabetic ketoacidosis, Dyspnoea, Electrocardiogram normal
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematocrit increased, Haemoglobin decreased, Hypotension, Hypovolaemic shock, Influenza A virus test negative
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza B virus test, Lipase normal, Liver function test normal, Mean cell volume normal, Metabolic acidosis
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, N-terminal prohormone brain natriuretic peptide normal, Presyncope, SARS-CoV-2 test negative, Shock
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stress, Tremor, Troponin, Urine analysis, Urine ketone body present
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Computerised tomogram, Echocardiogram, Electrocardiogram, Fibrin D dimer
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Intensive care, Laboratory test, Shock, Troponin
Clinical narrative: "Unspecified" Shock In an intensive care unit on life-saving IV medication (Levophed). Multiple appointments since discharge to ensure wellbeing.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood albumin decreased, Blood calcium decreased, Blood loss anaemia, Blood urea increased, COVID-19
Clinical narrative: hospitalized due to COVID
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Dyspnoea, Gastrointestinal haemorrhage, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: hospitalized due to COVID
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lung opacity, N-terminal prohormone brain natriuretic peptide increased, Occult blood positive, Platelet count decreased, Red blood cell count decreased
Clinical narrative: hospitalized due to COVID
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Troponin increased, White blood cell count increased
Clinical narrative: hospitalized due to COVID
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized due to COVID
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac normal, Chest discomfort, Dyspnoea, Metabolic function test
Clinical narrative: 10/07/2021 Fever and body aches - Following by Fatigue - @ One week later short of breath followed by chest tightness - All symptoms continued to increased - 11/1/2021 Covid screen negative - PCP tele-med - Prednisone Daily, Flovent PRN and Albuterol PRN. 11/05/2021 PCP in office EKG then immediately to Hospital admitted 11/05/2021 to 11/14/2021 - Myocarditis - Home on Cardiac meds wearing LifeVest with continued symptoms SOB, Chest pain, Lightheadedness/dizziness, and Fatigue
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac assistance device user, Cardiac stress test, Catheterisation cardiac, Chest X-ray, Chest discomfort
Clinical narrative: 10/07/2021 Fever and body aches - Following by Fatigue - @ One week later short of breath followed by chest tightness - All symptoms continued to increased - 11/1/2021 Covid screen negative - PCP tele-med - Prednisone Daily, Flovent PRN and Albuterol PRN. 11/05/2021 PCP in office EKG then immediately to Hospital admitted 11/05/2021 to 11/14/2021 - Myocarditis - Home on Cardiac meds wearing LifeVest with continued symptoms SOB, Chest pain, Lightheadedness/dizziness, and Fatigue
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: 10/07/2021 Fever and body aches - Following by Fatigue - @ One week later short of breath followed by chest tightness - All symptoms continued to increased - 11/1/2021 Covid screen negative - PCP tele-med - Prednisone Daily, Flovent PRN and Albuterol PRN. 11/05/2021 PCP in office EKG then immediately to Hospital admitted 11/05/2021 to 11/14/2021 - Myocarditis - Home on Cardiac meds wearing LifeVest with continued symptoms SOB, Chest pain, Lightheadedness/dizziness, and Fatigue
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Laboratory test, Magnetic resonance imaging, Myocarditis, Pain
Clinical narrative: 10/07/2021 Fever and body aches - Following by Fatigue - @ One week later short of breath followed by chest tightness - All symptoms continued to increased - 11/1/2021 Covid screen negative - PCP tele-med - Prednisone Daily, Flovent PRN and Albuterol PRN. 11/05/2021 PCP in office EKG then immediately to Hospital admitted 11/05/2021 to 11/14/2021 - Myocarditis - Home on Cardiac meds wearing LifeVest with continued symptoms SOB, Chest pain, Lightheadedness/dizziness, and Fatigue
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 10/07/2021 Fever and body aches - Following by Fatigue - @ One week later short of breath followed by chest tightness - All symptoms continued to increased - 11/1/2021 Covid screen negative - PCP tele-med - Prednisone Daily, Flovent PRN and Albuterol PRN. 11/05/2021 PCP in office EKG then immediately to Hospital admitted 11/05/2021 to 11/14/2021 - Myocarditis - Home on Cardiac meds wearing LifeVest with continued symptoms SOB, Chest pain, Lightheadedness/dizziness, and Fatigue
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac monitoring abnormal, Fatigue, Loss of consciousness, Palpitations
Clinical narrative: Client reports at 1000 on 6/25/21, the day following the receipt of his second dose, that he experienced an episode where he passed/blacked out. Client reports ever since this episode he has been experiencing extreme fatigue and heart palpitations on several occasions. Client reports being seen by his provider for these symptoms and has since been diagnosed with sinus tachycardia. Client reports that his provider recommended he take an oral beta blocker, but client reports he declined to "take a medication daily for something that is intermittent."  Client reports that he is still experiencing the fatigue and heart palpitations and that his provider told him he can or cannot say whether this condition is related to receipt of the vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia
Clinical narrative: Client reports at 1000 on 6/25/21, the day following the receipt of his second dose, that he experienced an episode where he passed/blacked out. Client reports ever since this episode he has been experiencing extreme fatigue and heart palpitations on several occasions. Client reports being seen by his provider for these symptoms and has since been diagnosed with sinus tachycardia. Client reports that his provider recommended he take an oral beta blocker, but client reports he declined to "take a medication daily for something that is intermittent."  Client reports that he is still experiencing the fatigue and heart palpitations and that his provider told him he can or cannot say whether this condition is related to receipt of the vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Fatigue, Loss of consciousness, Palpitations, Sinus tachycardia
Clinical narrative: Client reports at 1000 on 6/25/21, the day following the receipt of his second dose, that he experienced an episode where he passed/blacked out. Client reports ever since this episode he has been experiencing extreme fatigue and heart palpitations on several occasions. Client reports being seen by his provider for these symptoms and has since been diagnosed with sinus tachycardia. Client reports that his provider recommended he take an oral beta blocker, but client reports he declined to "take a medication daily for something that is intermittent."  Client reports that he is still experiencing the fatigue and heart palpitations and that his provider told him he can or cannot say whether this condition is related to receipt of the vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate decreased, Nausea
Clinical narrative: heart rate dropped into the 40's; nausea; This is a spontaneous report received from a contactable reporter(s) (Physician) via COVAES.  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FK5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not received any other vaccines in 4 weeks. The following information was reported: BRADYCARDIA (medically significant) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "heart rate dropped into the 40's"; NAUSEA (non-serious) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "nausea". The patient underwent the following laboratory tests and procedures: heart rate: (18Nov2021) 40. Therapeutic measures were not taken as a result of bradycardia, nausea. After waiting 15 minutes, as the patient was leaving, he had nausea and heart rate dropped into the 40s for 10-plus minutes. Since vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Heart rate, Nausea
Clinical narrative: heart rate dropped into the 40's; nausea; This is a spontaneous report received from a contactable reporter(s) (Physician) via COVAES.  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: FK5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not received any other vaccines in 4 weeks. The following information was reported: BRADYCARDIA (medically significant) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "heart rate dropped into the 40's"; NAUSEA (non-serious) with onset 18Nov2021, outcome "recovered" (Nov2021), described as "nausea". The patient underwent the following laboratory tests and procedures: heart rate: (18Nov2021) 40. Therapeutic measures were not taken as a result of bradycardia, nausea. After waiting 15 minutes, as the patient was leaving, he had nausea and heart rate dropped into the 40s for 10-plus minutes. Since vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Exposure during pregnancy, Heavy menstrual bleeding
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 19:00 (Lot number: FG3527) at the age of 38 years as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "Alopecia areata" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, start date: 09Oct2021, stop date: 09Oct2021. Past drug history included: Sulfamethoxazole, reaction(s): "known allergies:Sulfamethoxazole"; Fluconazole, reaction(s): "known allergies: fluconazole". Vaccination history included: Janssen/j&j (Dose Number: 1, Batch/Lot No: 1805025, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 25Mar2021, when the patient was 37 years old, for Covid-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 06Nov2021 15:00, outcome "unknown", described as "Unexpected postpartum resumption of menstrual cycle with heavy bleeding"; BACK PAIN (non-serious) with onset 06Nov2021 15:00, outcome "unknown", described as "back pain"; OFF LABEL USE (non-serious) with onset 05Nov2021, outcome "unknown", described as "prev_dose_brand=Janssen/J&J/prev_dose_administration_date=25Mar2021/Exclusively breastfed all 3 babies"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 05Nov2021, outcome "unknown" and all described as "prev_dose_brand=Janssen/J&J/prev_dose_administration_date=25Mar2021"; PRODUCT USE ISSUE (non-serious) with onset 05Nov2021, outcome "unknown", described as "Exclusively breastfed all 3 babies". Therapeutic measures were not taken as a result of heavy menstrual bleeding, back pain, off label use, interchange of vaccine products, inappropriate schedule of product administration, product use issue.  Additional information: For event: she had no breakthrough bleeding since week 8 postpartum (now at month 6) and in previous post-partum (x2) menstrual cycle began after 11 months with breakthrough bleeding prior to a full cycle. Exclusively breastfed all 3 babies. The patient had other vaccine within four weeks included flu shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 07Nov2021.  Follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101540118 Baby case
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Heavy menstrual bleeding, Inappropriate schedule of product administration, Interchange of vaccine products, Off label use
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 19:00 (Lot number: FG3527) at the age of 38 years as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "Alopecia areata" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, start date: 09Oct2021, stop date: 09Oct2021. Past drug history included: Sulfamethoxazole, reaction(s): "known allergies:Sulfamethoxazole"; Fluconazole, reaction(s): "known allergies: fluconazole". Vaccination history included: Janssen/j&j (Dose Number: 1, Batch/Lot No: 1805025, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 25Mar2021, when the patient was 37 years old, for Covid-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 06Nov2021 15:00, outcome "unknown", described as "Unexpected postpartum resumption of menstrual cycle with heavy bleeding"; BACK PAIN (non-serious) with onset 06Nov2021 15:00, outcome "unknown", described as "back pain"; OFF LABEL USE (non-serious) with onset 05Nov2021, outcome "unknown", described as "prev_dose_brand=Janssen/J&J/prev_dose_administration_date=25Mar2021/Exclusively breastfed all 3 babies"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 05Nov2021, outcome "unknown" and all described as "prev_dose_brand=Janssen/J&J/prev_dose_administration_date=25Mar2021"; PRODUCT USE ISSUE (non-serious) with onset 05Nov2021, outcome "unknown", described as "Exclusively breastfed all 3 babies". Therapeutic measures were not taken as a result of heavy menstrual bleeding, back pain, off label use, interchange of vaccine products, inappropriate schedule of product administration, product use issue.  Additional information: For event: she had no breakthrough bleeding since week 8 postpartum (now at month 6) and in previous post-partum (x2) menstrual cycle began after 11 months with breakthrough bleeding prior to a full cycle. Exclusively breastfed all 3 babies. The patient had other vaccine within four weeks included flu shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 07Nov2021.  Follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101540118 Baby case
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product use issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 19:00 (Lot number: FG3527) at the age of 38 years as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "Alopecia areata" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, start date: 09Oct2021, stop date: 09Oct2021. Past drug history included: Sulfamethoxazole, reaction(s): "known allergies:Sulfamethoxazole"; Fluconazole, reaction(s): "known allergies: fluconazole". Vaccination history included: Janssen/j&j (Dose Number: 1, Batch/Lot No: 1805025, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 25Mar2021, when the patient was 37 years old, for Covid-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 06Nov2021 15:00, outcome "unknown", described as "Unexpected postpartum resumption of menstrual cycle with heavy bleeding"; BACK PAIN (non-serious) with onset 06Nov2021 15:00, outcome "unknown", described as "back pain"; OFF LABEL USE (non-serious) with onset 05Nov2021, outcome "unknown", described as "prev_dose_brand=Janssen/J&J/prev_dose_administration_date=25Mar2021/Exclusively breastfed all 3 babies"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 05Nov2021, outcome "unknown" and all described as "prev_dose_brand=Janssen/J&J/prev_dose_administration_date=25Mar2021"; PRODUCT USE ISSUE (non-serious) with onset 05Nov2021, outcome "unknown", described as "Exclusively breastfed all 3 babies". Therapeutic measures were not taken as a result of heavy menstrual bleeding, back pain, off label use, interchange of vaccine products, inappropriate schedule of product administration, product use issue.  Additional information: For event: she had no breakthrough bleeding since week 8 postpartum (now at month 6) and in previous post-partum (x2) menstrual cycle began after 11 months with breakthrough bleeding prior to a full cycle. Exclusively breastfed all 3 babies. The patient had other vaccine within four weeks included flu shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 07Nov2021.  Follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101540118 Baby case
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Fever of 102, chills, body aches
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever of 102, chills, body aches
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19.  Unable to f/u with pt after several attempts.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19.  Unable to f/u with pt after several attempts.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: 12/2/21 3rd COVID 19 booster Vaccine dose administered to patient at Thibodaux regional facility. 12/3/21 Patient reported developed symptoms of: Severe headache, dizziness, fatigue, chills, decreased appetite, arm soreness at injection site. No fever.  Evaluated by MD 12/4/21 in clinic. Symptoms had improved and resolved except for mild headache complaint. Reported feeling about 75% better.  Neurologic physical exam normal. Orthostatic blood pressure and vitals normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: 12/2/21 3rd COVID 19 booster Vaccine dose administered to patient at Thibodaux regional facility. 12/3/21 Patient reported developed symptoms of: Severe headache, dizziness, fatigue, chills, decreased appetite, arm soreness at injection site. No fever.  Evaluated by MD 12/4/21 in clinic. Symptoms had improved and resolved except for mild headache complaint. Reported feeling about 75% better.  Neurologic physical exam normal. Orthostatic blood pressure and vitals normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: 12/2/21 3rd COVID 19 booster Vaccine dose administered to patient at Thibodaux regional facility. 12/3/21 Patient reported developed symptoms of: Severe headache, dizziness, fatigue, chills, decreased appetite, arm soreness at injection site. No fever.  Evaluated by MD 12/4/21 in clinic. Symptoms had improved and resolved except for mild headache complaint. Reported feeling about 75% better.  Neurologic physical exam normal. Orthostatic blood pressure and vitals normal.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza B virus test positive, Injection site pain, Neurological examination normal, SARS-CoV-2 test
Clinical narrative: 12/2/21 3rd COVID 19 booster Vaccine dose administered to patient at Thibodaux regional facility. 12/3/21 Patient reported developed symptoms of: Severe headache, dizziness, fatigue, chills, decreased appetite, arm soreness at injection site. No fever.  Evaluated by MD 12/4/21 in clinic. Symptoms had improved and resolved except for mild headache complaint. Reported feeling about 75% better.  Neurologic physical exam normal. Orthostatic blood pressure and vitals normal.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received dose of second covid pfizer too early. Original dose was given 9/28/2021 and second dose given 10/14/2021. This is 1 day prior to the 4 day grace period so this vaccine is invalid and will need to be repeated.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received dose of second covid pfizer too early. Original dose was given 9/28/2021 and second dose given 10/14/2021. This is 1 day prior to the 4 day grace period so this vaccine is invalid and will need to be repeated.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given second dose of the vaccine on 10/14/21. Initial vaccine was given on 9/28/21 so the second dose was invalid as it was a day prior to the 4 day grace period. Patient will need to get second dose again as this is not vaild.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid-19
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid-19
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid +
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid +
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy
Clinical narrative: Expired vaccine given; pregnant patient administered expired booster shot; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient administered expired booster shot) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039021A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Feb-2022. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient administered expired booster shot). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant patient administered expired booster shot) outcome was unknown.        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  Nurse informed that the vial was actually already punctured since 23-Nov-2021
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications. On 08-NOV-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T017179 was confirmed to be valid, expiration date 26-OCT-2021 for prophylaxis (exact dose, dose #, route and anatomical location were not provided).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthacre business professional and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. On 05-OCT-2021, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # U020244, expiration date 28-JUN-2023 or lot# U010395; expiration date: 01-APR-2023 (reporter was unable to clarify which lot# was administered to the patient at event time; both lot# were verified to be valid) for prophylaxis (dose, route of administration, and anatomical location were not reported). Administered dose of vaccine has been stored in the temperature of 1.45 degrees Celsius (°C) for 6 hours. There were previous temperature excursions reported. No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure via blood, Occupational exposure to product, Syringe issue
Clinical narrative: as a result of the broken finger glange the medical assistant cut her finger / the cut was deep enoguth to bleed and need a Band-Aid; Was the product administered or exposed to patient's bodily fluids? Yes, the medical assistant was cut by the broken finger flange; Was the product administered or exposed to patient's bodily fluids? Yes, the medical assistant was cut by the broken finger flange; medical assistant removed the GARDASIL 9 syringe from the tray and discovered the finger flange was broken; This spontaneous report was received from an administrator and refers to a female patient of unknown age, who was also a medical assistant. There was no information regarding her medical history, concurrent condition nor concomitant therapies provided.  On 24-NOV-2021, the medical assistant removed HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # U008897, expiration date 16-MAY-2021) syringe from the tray and discovered the finger flange was broken; 3 pieces of the broken finger flange were found in the tray (discrepant information, also reported as the syringe was broken into less than 2 pieces) (syringe issue). The syringe tray was intact and undamaged on receipt and the syringe carton was not damaged prior to use. The product did not come with a cellophane cover. There was no crack noticed on the syringe. The tip of the syringe and Luer lock adaptor were not loose or broken off of the syringe tip. It was unknown whether there was difficulty trying to attach the syringe needle to the syringe as the medical assistant did not attempt.  On 24-NOV-2021, as a result of the broken syringe, the medical assistant cut her finger; the cut was deep enough to bleed and a Band-Aid was needed. It was reported, that exposure to the vaccine via body fluid occurred (occupational exposure to product, exposure via blood). No additional medical attention was needed for the cut. At the time of the report, the medical assistant was recovering from the finger cut.  The reporter confirmed the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not administered to a patient.  The causal relationship between the event and the suspect vaccine was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided. On 19-OCT-2021, the patient was vaccinated with an improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T042012, expiration date 22-JUL-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 34.8 degree Fahrenheit (F) for 192 hours. No previous temperature excursion occurred. No adverse effect was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2112USA000788: US-009507513-2112USA000789: US-009507513-2112USA000790: US-009507513-2112USA000791: US-009507513-2112USA000792.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided. On 26-OCT-2021, the patient was vaccinated with an improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T042012, expiration date 22-JUL-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 34.8 degree Fahrenheit (F) for 192 hours. No previous temperature excursion occurred. No adverse effect was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2112USA000790: US-009507513-2112USA000791: US-009507513-2112USA000792: US-009507513-2112USA000785: US-009507513-2112USA000789.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided. On 29-OCT-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1741275, expiration date 07-MAR-2022 (exact dose was not provided) for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 34.8 degree Fahrenheit (F) for 192 hours. No previous temperature excursion occurred. No adverse effect was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2112USA000785: US-009507513-2112USA000788: US-009507513-2112USA000790: US-009507513-2112USA000789: US-009507513-2112USA000791: US-009507513-2112USA000789: US-009507513-2112USA000792.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided. On 28-OCT-2021, the patient was vaccinated with an improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T042012, expiration date 22-JUL-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 34.8 degree Fahrenheit (F) for 192 hours. No previous temperature excursion occurred. No adverse effect was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2112USA000788: US-009507513-2112USA000785: US-009507513-2112USA000789: US-009507513-2112USA000792: US-009507513-2112USA000791.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; temperature excursion / temperature 34.8 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 19-OCT-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # U007652, expiration date 14-APR-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 34.8 degree Fahrenheit (F) for 192 hours. No previous temperature excursion occurred. No adverse effect was reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2112USA000788: US-009507513-2112USA000785: US-009507513-2112USA000790: US-009507513-2112USA000789: US-009507513-2112USA000792:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; temperature excursion / temperature 34.8 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 26-OCT-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # U007652, expiration date 14-APR-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 34.8 degree Fahrenheit (F) for 192 hours. No previous temperature excursion occurred. No adverse effect was reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2112USA000788: US-009507513-2112USA000785: US-009507513-2112USA000790: US-009507513-2112USA000791: US-009507513-2112USA000789:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an "other" reporter referring to a patient of unreported age and gender. The patient's relevant medical history, drug reactions or allergies, and concomitant medications were not provided. On 01-NOV-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliters (ml) for prophylaxis after a temperature excursion (lot number U002529, expiration date 24-AUG-2022). The vaccine underwent a temperature excursion of minus 10 (-10) degrees Celsius (C) for 7 hours. There was no previous temperature excursion. No additional adverse events (AE) were reported (no adverse event).
Age: 1.25
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event, Product use issue
Clinical narrative: The spontaneous report was received from a licensed practical nurse concerning to 15-month-old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, drug reactions or allergies and concomitant medications was provided. On 24-NOV-2021, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707496, expiration date: 29-MAR-2022) (dose and vaccination site were not provided) as prophylaxis. 15 month old received a dose of ROTATEQ in error on 24-NOV-2021 (product use issue). Caller reported that patient previously completed series appropriately (extra dose administered). Caller did not provide detailed information regarding previously completed series. No further information provided. No additional adverse events reported (no adverse event).