chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Pain, Pain in extremity, Peripheral swelling, Therapeutic response unexpected
Clinical narrative: swelling in my arm; soreness; Patient is calling to report side effects she incurred during Pfizer vaccination went away after receiving Spikevax 2023-2024; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling in my arm), PAIN (soreness) and THERAPEUTIC RESPONSE UNEXPECTED (Patient is calling to report side effects she incurred during Pfizer vaccination went away after receiving Spikevax 2023-2024) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 pneumonia (hospitalized with COVID Pneumonia. And while in the hospital, patient woke up screaming in pain.), Bursitis (Muscle tissues and Bursitis going through my arms and down my Chest and stuff .), Musculoskeletal pain (Patient was inflamed. Skeletomuscular Pain.) and Chills. Previously administered products included for Product used for unknown indication: Pfizer monovalent (First Primary Pfizer monovalent dose) on 21-Feb-2021, Pfizer monovalent (2nd Primary Pfizer monovalent dose) on 11-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3, First Pfizer t Booster dose) on 23-Aug-2021, Pfizer (Dose 4, 2nd Pfizer Monovalent Booster dose) on 14-Apr-2022 and Pfizer (Dose 5 Pfizer Booster) on 15-Nov-2022; for Shoulder pain: lidocaine (They placed lidocaine patches on shoulders.). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, Pfizer, Pfizer, Pfizer monovalent, Pfizer monovalent and lidocaine. Concurrent medical conditions included Costochondral separation (Patient kept having pain in arms and shoulder and went to see cardiologist. And He said patient had Costochondral-separation.).    On 18-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Oct-2023, the patient experienced PERIPHERAL SWELLING (swelling in my arm), PAIN (soreness) and THERAPEUTIC RESPONSE UNEXPECTED (Patient is calling to report side effects she incurred during Pfizer vaccination went away after receiving Spikevax 2023-2024). At the time of the report, PERIPHERAL SWELLING (swelling in my arm) and PAIN (soreness) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (Patient is calling to report side effects she incurred during Pfizer vaccination went away after receiving Spikevax 2023-2024) outcome was unknown.            Patient past medications included steroids. Patient took oral steroids, then steroid shots. Patient had therapeutic massages. She went through a lot and could not even lift her arms up. It hurt so badly. The evening of 18-OCT-2023, patient had a little swelling in her arm and soreness. Since having the Spikevax vaccine on 18-OCT-2023, those issues have gone away. They all went away. Patient could move her arm now. It was not hurting. No treatment medication reported.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Muscle fatigue, Pain
Clinical narrative: Muscle fatigue; Aches and pains; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), PAIN (Aches and pains) and FATIGUE (Tiredness) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7163B, 065F22A, 046B21A and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune thyroiditis, Drug allergy and Allergy.   On 09-Apr-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1. On 07-May-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (Muscle fatigue), PAIN (Aches and pains) and FATIGUE (Tiredness). At the time of the report, MUSCLE FATIGUE (Muscle fatigue), PAIN (Aches and pains) and FATIGUE (Tiredness) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   This case was linked to MOD-2023-746812 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid 19) in a 78-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication not reported.  Patient was on IV cancer medication. He was tested positive for COVID in APR or MAY 2022, about 6 months after receiving the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-746863, US-MODERNATX, INC.-MOD-2023-746968 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746863:grandson case US-MODERNATX, INC.-MOD-2023-746968:Wife case
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: Caller states that she has spoken with the patient's physician regarding her daughter's symptoms and he told her that he has heard this a lot with the new Spikevax vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Caller states that she has spoken with the patient's physician regarding her daughter's symptoms and he told her that he has heard this a lot with the new Spikevax vaccine) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     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. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller states that she has spoken with the patient's physician regarding her daughter's symptoms and he told her that he has heard this a lot with the new Spikevax vaccine). At the time of the report, IMMUNISATION REACTION (Caller states that she has spoken with the patient's physician regarding her daughter's symptoms and he told her that he has heard this a lot with the new Spikevax vaccine) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746812.   Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2023: Live follow-up received contains non-significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746812:same reporter
Age: 13.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Malaise, Pyrexia, SARS-CoV-2 antibody test positive
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 13-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination.     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. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient came to visit their grandparents in Aug-2022, and while he was visiting, he developed a fever and just very sick. Both. The grandmother was not sure if patient had received Moderna Covid-19 vaccine, or he had Pfizer. The grandmother would check with her daughter.   This case was linked to US-MODERNATX, INC.-MOD-2023-746856.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746856:Grandfather case
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Moderna Covid-19 vaccine (lot number 013L20A and expiration date is not known (right arm).) on 21-Jan-2021, Moderna Covid-19 vaccine (lot number 016M20A expiration date is not known (right arm).) on 20-Feb-2021, Moderna Covid-19 vaccine (lot number 035C21A expiration date is not known (right arm).) on 29-Oct-2021, Moderna Covid-19 vaccine (lot number 056M21A expiration date is not known (right arm).) on 22-Apr-2022 and Moderna Covid-19 vaccine (lot number A57144B expiration date is not known (right arm).) on 12-Sep-2022. Past adverse reactions to the above products included No adverse reaction with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient had not yet had the most recent Moderna Covid-19 Spikevax vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-746555 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746555:wife case
Sex: M
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: Her husband is experiencing some of the same stuff he did, but not as bad.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Her husband is experiencing some of the same stuff he did, but not as bad.) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced IMMUNISATION REACTION (Her husband is experiencing some of the same stuff he did, but not as bad.). At the time of the report, IMMUNISATION REACTION (Her husband is experiencing some of the same stuff he did, but not as bad.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746763 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746763:Same reporter Wife case
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Eye haemorrhage
Clinical narrative: he had bleeding in his eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (he had bleeding in his eye) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced EYE HAEMORRHAGE (he had bleeding in his eye) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (he had bleeding in his eye) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: 5.6 within the normal range.     mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was withdrawn on an unknown date.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatments were reported.  Patient went for eye doctor checkup on 19 OCT 2023. Doctor looked in her husband's eye and he had bleeding in his eye. This was not in his field of vision. This occurred after his 5th covid shot on 20 SEP 2023. The Optometrist thinks that the COVID-19 vaccine and this symptom might be related. He recommended that this individual not receive any additional covid-19 vaccines.  Company Comment This spontaneous case concerns a male patient of an unknown age with no medical history reported who experienced the unexpected seriousness criterion medically significant event of eye haemorrhage unknown days after a dose of mRNA-1273.815 vaccine. Approximately 1 month after vaccination the patient went to optometrist and he looked bleeding in his eye. At the time of the report, the event had not resolved. Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
Sex: U
Vaccine: UNK
Symptoms: Diarrhoea, Fatigue, Headache, Pain in extremity
Clinical narrative: Patient had a sore arm and was tired; Patient had a sore arm and was tired; diarrhea; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Patient had a sore arm and was tired), DIARRHOEA (diarrhea), HEADACHE (severe headache) and PAIN IN EXTREMITY (Patient had a sore arm and was tired) in an elderly patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030536) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Moderna (As a booster dose lot number 034F21A and expiration date is not known) on 09-Nov-2021, Moderna (As a booster dose lot number 034F21A and expiration date is not known) on 09-Nov-2021 and Pfizer. Past adverse reactions to the above products included Diarrhea with Moderna; No adverse event with Pfizer; and Tiredness with Moderna.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 15-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced HEADACHE (severe headache). On 21-Oct-2023, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced FATIGUE (Patient had a sore arm and was tired) and PAIN IN EXTREMITY (Patient had a sore arm and was tired). At the time of the report, FATIGUE (Patient had a sore arm and was tired), DIARRHOEA (diarrhea), HEADACHE (severe headache) and PAIN IN EXTREMITY (Patient had a sore arm and was tired) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   This case was linked to MOD-2023-746827 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Aching all over; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Aching all over), PYREXIA (fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 015M20A, 088D21A and 048L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine. Concomitant products included RIMEGEPANT SULFATE (NURTEC ODT) for Migraine, BUDESONIDE and PANTOPRAZOLE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aching all over), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (Aching all over), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient does not remember which arm she received the vaccine in. The patient had fever, chills, and aching all over after first, second, third and fourth dose of Moderna. The patient received their fifth Moderna vaccine as the bivalelnt vaccine on 11-Oct-2022 lot number 050o22A. The patient received her Spikevax 2023 2024 vaccine on 18-Oct-2023. No treatment medication reported.   This case was linked to MOD-2023-746962, MOD-2023-747032.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Exposure to communicable disease, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: malaise; fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced MALAISE (malaise) and PYREXIA (fever). At the time of the report, MALAISE (malaise) and PYREXIA (fever) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  Patient had reasonable exposure to individuals who seemed sick. She took a card test regularly to determine if she has covid. The card test she took today was positive. The test she took expired in July. She was unsure if the card test is for antibodies or some other indicator.  Dosage text was reported as unknown. No treatment information was reported.
Age: 86.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Immune system disorder, Injection site pain, Malaise, Nasopharyngitis
Clinical narrative: no energy; patient felt that his immune system was "shocked" one sneeze after another; mild sore injection site arm; cold; malaise; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold), MALAISE (malaise), ASTHENIA (no energy ), IMMUNE SYSTEM DISORDER (patient felt that his immune system was "shocked" one sneeze after another) and VACCINATION SITE PAIN (mild sore injection site arm) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3032229) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    On 23-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023, the patient experienced NASOPHARYNGITIS (cold), MALAISE (malaise), IMMUNE SYSTEM DISORDER (patient felt that his immune system was "shocked" one sneeze after another) and VACCINATION SITE PAIN (mild sore injection site arm). On 24-Oct-2023, the patient experienced ASTHENIA (no energy ). At the time of the report, NASOPHARYNGITIS (cold), MALAISE (malaise) and VACCINATION SITE PAIN (mild sore injection site arm) was resolving and ASTHENIA (no energy ) and IMMUNE SYSTEM DISORDER (patient felt that his immune system was "shocked" one sneeze after another) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. 12 hours later the patient reports a sharply runny nose and sneezing. The patient felt that his immune system was "shocked" one sneeze after another. The patient does not feel that this was a food allergy. Patient used a box of tissues. This morning the patient reports less sneezing and his nose is slightly stuffy. The patient does not report any trouble breathing. It feels to the patient that he has a cold. The patient does feel washed and feels malaise. The patient has no energy today. The patient also reports a mild sore injection site arm.   This case was linked to US-MODERNATX, INC.-MOD-2023-747010, US-MODERNATX, INC.-MOD-2023-747013 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747013:Bivalent Case US-MODERNATX, INC.-MOD-2023-747010:Monovalent case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: headache; tired; general feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0164) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: before any of the Pfizer shots; "Osteoporosis" (ongoing); "Breathing issue" (unspecified if ongoing), notes: 4 days in hospital breathing issue on oxygen supply for 3month; "Thyroid" (ongoing); "high cholesterol" (ongoing); "Stomach ache" (ongoing), notes: Protect stomachache from prednisone. Concomitant medication(s) included: ALENDRONATE SODIUM taken for osteoporosis (ongoing); PREDNISONE taken for polymyalgia rheumatica (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); PRAVASTATIN taken for blood cholesterol increased (ongoing); OMEPRAZOLE taken for abdominal pain upper (ongoing). The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell".
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: headache; tired; general feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 06May2021 as dose 2, single (Lot number: EW0172) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots" (unspecified if ongoing), notes: She also had covid before any of the Pfizer shots; "Breathing issue" (unspecified if ongoing), notes: 4 days in hospital breathing issue on oxygen supply for 3month; "Osteoporosis" (ongoing); "Thyroid" (ongoing); "high cholesterol" (ongoing); "Stomach ache" (unspecified if ongoing), notes: Protect stomachache from prednisone. Concomitant medication(s) included: ALENDRONATE SODIUM taken for osteoporosis (ongoing); PREDNISONE taken for polymyalgia rheumatica (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); PRAVASTATIN taken for blood cholesterol increased (ongoing); OMEPRAZOLE taken for abdominal pain upper (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE lot no. EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for Covid-19 Immunization, reaction(s): "headache", "tiredness", "general feeling unwell". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell".
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Electrocardiogram, Fatigue, Headache, Malaise
Clinical narrative: headache; tired; general feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 13Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: Before any of the Pfizer shots.; "breathing issue on", start date: 06Jan2021 (unspecified if ongoing), notes: 4 days in hospital breathing issue on oxygen supply for 3month; "osteoporosis" (ongoing); "thyroid (low)" (ongoing); "cholesterol (high)" (ongoing); "Protect stomachache from prednisone" (ongoing), notes: Reason for use: Protect stomachache from prednisone. Concomitant medication(s) included: ALENDRONATE SODIUM taken for osteoporosis (ongoing); PREDNISONE taken for polymyalgia rheumatica (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); PRAVASTATIN taken for blood cholesterol increased (ongoing); OMEPRAZOLE taken for abdominal pain upper (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired", "headache", "feeling unwell"; bnt162b2 (DOSE 2, SINGLE Lot: EW0172 on left Arm, Intramuscular), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired", "headache", "feeling unwell"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE Lot: FE3590 on left arm, intramuscular), administration date: 12Nov2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired", "headache", "feeling unwell". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: headache; tired; general feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 13Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: Before any of the Pfizer shots.; "breathing issue on", start date: 06Jan2021 (unspecified if ongoing), notes: 4 days in hospital breathing issue on oxygen supply for 3month; "osteoporosis" (ongoing); "thyroid (low)" (ongoing); "cholesterol (high)" (ongoing); "Protect stomachache from prednisone" (ongoing), notes: Reason for use: Protect stomachache from prednisone. Concomitant medication(s) included: ALENDRONATE SODIUM taken for osteoporosis (ongoing); PREDNISONE taken for polymyalgia rheumatica (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); PRAVASTATIN taken for blood cholesterol increased (ongoing); OMEPRAZOLE taken for abdominal pain upper (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired", "headache", "feeling unwell"; bnt162b2 (DOSE 2, SINGLE Lot: EW0172 on left Arm, Intramuscular), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired", "headache", "feeling unwell"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE Lot: FE3590 on left arm, intramuscular), administration date: 12Nov2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "tired", "headache", "feeling unwell". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: Two of the five vaccines, it kind of like exploded when we were mixing them; The initial case was missing the following minimum criteria: [No adverse effect]. Upon receipt of follow-up information on (16Oct2023), this case now contains all required information to be considered valid. This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5023, Expiration Date: Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Two of the five vaccines, it kind of like exploded when we were mixing them".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pruritus, Rash
Clinical narrative: Interchange of vaccine products; small red raised rash on left forearm, back and left side of torso; Itching; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 at 10:00 as dose 1, single (Lot number: HG4680) at the age of 61 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Drug Allergies: sulfa" (unspecified if ongoing); "Drug Allergies: Penicillin" (unspecified if ongoing); "Drug Allergies: DYE IV" (unspecified if ongoing); "IVP" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for influenza immunisation, on 07Oct2023 as dose number unknown, single, on 07Oct2023 as dose number unknown, single. Past drug history included: Codeine, reaction(s): "Drug Allergies: Codeine"; Compazine, reaction(s): "Drug Allergies: Compazine". Vaccination history included: moderna (COVID 19, Moderna dose 1, lot number: 012L20A, administration time: 10:00 AM, vaccine location: Left arm), administration date: 10Jan2021, when the patient was 59-year-old, for COVID-19 Immunization; moderna (COVID 19, Moderna dose 2, lot number: 012L20A, administration time: 10:00 AM, vaccine location: Left arm), administration date: 03Feb2021, when the patient was 59-year-old, for COVID-19 Immunization; bnt162b2 (COVID 19, Pfizer; dose 3 (booster), single; lot number: 33030BD, vaccine location: Left arm), administration date: 27Nov2021, when the patient was 59-year-old, for COVID-19 Immunization; bnt162b2 (COVID 19, Pfizer; dose 4 (booster), single; lot number: FM0173, administration time: 10:00 AM, vaccine location: Left arm), administration date: 18Jun2022, when the patient was 60-year-old, for COVID-19 Immunization; bnt162b2 (COVID 19, Pfizer; dose 5 (booster), single; lot number: GH9693, administration time: 10:00 AM, vaccine location: Left arm), administration date: 30Oct2022, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 17Oct2023, outcome "recovering", described as "Itching"; RASH (non-serious) with onset 17Oct2023, outcome "recovering", described as "small red raised rash on left forearm, back and left side of torso"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of rash, pruritus.  Additional information: On 17Oct2023 noted small red raised rash on left forearm, back and left side of torso. Itching. Rash is closed with no drainage. Facility type vaccine was reported as Pharmacy or Drug Store. Patient received other vaccine in four weeks included Influenza Sanofi.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Anaphylactic reaction, Confusional state, Gait disturbance
Clinical narrative: Anaphalatic response; Mental confusion; Unsteady gait; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 84-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09Oct2023 at 08:00 as dose 1, single (Lot number: HF5020) at the age of 84 years intramuscular, in arm for immunisation; for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 02Oct2023 as dose 1, single; HCTZ; LOSARTAN; MELOXICAM; OMEPRAZOLE; ROSUVASTATIN. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen; Lisinopril, reaction(s): "Known allergies: lisinopril", notes: Known allergies: lisinopril. The following information was reported: ANAPHYLACTIC REACTION (hospitalization) with onset 09Oct2023 at 08:15, outcome "recovered" (09Oct2023), described as "Anaphalatic response"; CONFUSIONAL STATE (hospitalization) with onset 09Oct2023 at 08:15, outcome "recovered" (09Oct2023), described as "Mental confusion"; GAIT DISTURBANCE (hospitalization) with onset 09Oct2023 at 08:15, outcome "recovered" (09Oct2023), described as "Unsteady gait". Therapeutic measures were not taken as a result of anaphylactic reaction, confusional state, gait disturbance. Additional information: Abrysvo vaccine location was deltoid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the temporal association  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: 47.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Vaccination site reaction
Clinical narrative: Muscle twitching at injection site for Covid vaccine (left arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 20Oct2023 as dose 1, single (Lot number: 70461032303), in right arm for influenza immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing). The patient took concomitant medications. 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; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 21Oct2023 at 10:30, outcome "not recovered", described as "Muscle twitching at injection site for Covid vaccine (left arm)". Therapeutic measures were not taken as a result of vaccination site reaction.  Additional information: The patient had no known allergies. Patient did not tested COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: Continues Twitching of right eye lower lid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 03:45 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BLEPHAROSPASM (non-serious) with onset 02Oct2023, outcome "not recovered", described as "Continues Twitching of right eye lower lid".  Additional information: Patient had no Known allergies. Patient had no covid prior or post vaccination  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Urticarial vasculitis
Clinical narrative: Urticaria vasculitis lasting over a year; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 39-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: Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: URTICARIAL VASCULITIS (disability), outcome "recovered", described as "Urticaria vasculitis lasting over a year". The event "urticaria vasculitis lasting over a year" required physician office visit. Therapeutic measures were taken as a result of urticarial vasculitis which included Steroid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors  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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: Pain at injection site; myalgias; arthralgias; fatigue; low grade temp 100.2; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 10:30 as dose 1, single (Lot number: HG2282) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "migraine" (unspecified if ongoing); "IBS" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "SVT" (unspecified if ongoing). Concomitant medications included: OTEZLA; ESOMEPRAZOLE; CENTRUM SILVER MULTIVITAMIN MULTIMINERAL PLUS LUTEIN & LYCOPENE. Past drug history included: Bactrim and amoxicillin, reaction: "Drug Allergies: Bactrim"; Bactrim and amoxicillin, reaction: "Drug Allergies: Amoxicillin"; Acetaminophen, reaction: "Known allergies: Acetaminophen". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered", described as "Pain at injection site"; ARTHRALGIA (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered", described as "arthralgias"; FATIGUE (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered"; PYREXIA (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered", described as "low grade temp 100.2"; MYALGIA (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered", described as "myalgias". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, myalgia, arthralgia, fatigue, pyrexia.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; myalgias; arthralgias; fatigue; low grade temp 100.2; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 10:30 as dose 1, single (Lot number: HG2282) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "migraine" (unspecified if ongoing); "IBS" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "SVT" (unspecified if ongoing). Concomitant medications included: OTEZLA; ESOMEPRAZOLE; CENTRUM SILVER MULTIVITAMIN MULTIMINERAL PLUS LUTEIN & LYCOPENE. Past drug history included: Bactrim and amoxicillin, reaction: "Drug Allergies: Bactrim"; Bactrim and amoxicillin, reaction: "Drug Allergies: Amoxicillin"; Acetaminophen, reaction: "Known allergies: Acetaminophen". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered", described as "Pain at injection site"; ARTHRALGIA (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered", described as "arthralgias"; FATIGUE (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered"; PYREXIA (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered", described as "low grade temp 100.2"; MYALGIA (non-serious) with onset 21Oct2023 at 19:30, outcome "not recovered", described as "myalgias". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, myalgia, arthralgia, fatigue, pyrexia.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Sep2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme disease" (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; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 11oct2023 to 15Oct2023. Clinical course: The patient did not had any Known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335740 same patient, different product, different event;
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (16Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 09Oct2023 to 14Oct2023.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335978 same reporter/patient with different drug/AE;