chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Investigation, Iron binding capacity total
Clinical narrative: Iron Overload; This is a literature report for the following literature source(s).  A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IRON OVERLOAD (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 20; 19; 16; 25; 25; 24; Aspartate aminotransferase: 24; 23; 20; 19; 23; 19; Blood alkaline phosphatase: 53; 52; 51; 49; 47; 53; Hereditary hemochromatosis genetic panels (BMP2): unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; Iron binding capacity total: 155; 161; 162; 145; 139; 170; Magnetic resonance elastography: Normal; Magnetic resonance imaging heart: normal; Serum ferritin: 541; 519; 548; 530; 506; 457; Transferrin saturation: 66; 56; 47; 55; 45; 33; Ultrasound abdomen: normal liver morphology. This is a case series of identical twins with elevated ferritin levels and biopsy-proven iron deposition in hepatocytes, proposed to be triggered by the COVID-19 vaccine.; Sender's Comments: Based on current available information, event Iron overload  is more likely due to the patient's underlying or intercurrent condition is unrelated to suspect drug The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Sex: M
Vaccine: COVID19
Symptoms: Iron overload, Magnetic resonance elastography, Magnetic resonance imaging heart, Serum ferritin, Transferrin saturation
Clinical narrative: Iron Overload; This is a literature report for the following literature source(s).  A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IRON OVERLOAD (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 20; 19; 16; 25; 25; 24; Aspartate aminotransferase: 24; 23; 20; 19; 23; 19; Blood alkaline phosphatase: 53; 52; 51; 49; 47; 53; Hereditary hemochromatosis genetic panels (BMP2): unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; Iron binding capacity total: 155; 161; 162; 145; 139; 170; Magnetic resonance elastography: Normal; Magnetic resonance imaging heart: normal; Serum ferritin: 541; 519; 548; 530; 506; 457; Transferrin saturation: 66; 56; 47; 55; 45; 33; Ultrasound abdomen: normal liver morphology. This is a case series of identical twins with elevated ferritin levels and biopsy-proven iron deposition in hepatocytes, proposed to be triggered by the COVID-19 vaccine.; Sender's Comments: Based on current available information, event Iron overload  is more likely due to the patient's underlying or intercurrent condition is unrelated to suspect drug The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: Iron Overload; This is a literature report for the following literature source(s).  A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IRON OVERLOAD (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 20; 19; 16; 25; 25; 24; Aspartate aminotransferase: 24; 23; 20; 19; 23; 19; Blood alkaline phosphatase: 53; 52; 51; 49; 47; 53; Hereditary hemochromatosis genetic panels (BMP2): unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; Iron binding capacity total: 155; 161; 162; 145; 139; 170; Magnetic resonance elastography: Normal; Magnetic resonance imaging heart: normal; Serum ferritin: 541; 519; 548; 530; 506; 457; Transferrin saturation: 66; 56; 47; 55; 45; 33; Ultrasound abdomen: normal liver morphology. This is a case series of identical twins with elevated ferritin levels and biopsy-proven iron deposition in hepatocytes, proposed to be triggered by the COVID-19 vaccine.; Sender's Comments: Based on current available information, event Iron overload  is more likely due to the patient's underlying or intercurrent condition is unrelated to suspect drug The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: still have a sore, aching; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Dec2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Dec2024, outcome "not recovered", described as "still have a sore, aching".  Additional information: Patient had not yet received a bill for the office visit the morning after the vaccination received on 02Dec2024. When patient do, and patient assume patient would. It was asked would patient be able to be reimbursed. Also asked to keep in mind that as of this writing (report), patient still have a sore, aching.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia, Vaccination site pain
Clinical narrative: got seriously sick; fever; chills; pain at the injection site; This is a spontaneous report received from an Other HCP, Program ID.  A 46-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got seriously sick"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: she experienced a red rash at the injection site that was about the size of a grapefruit; This is a spontaneous report received from an Other HCP, Program ID.  A 41-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE RASH (non-serious) with onset Nov2023, outcome "unknown", described as "she experienced a red rash at the injection site that was about the size of a grapefruit".  Additional information: The patient reported that when they received the vaccine last year, they had a really bad reaction. The patient stated she experienced a red rash at the injection site that was about the size of a grapefruit. No further information was provided.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: high fever; This is a spontaneous report received from an Other HCP, Program ID.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jul2023 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) at the age of 65 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2023, outcome "unknown", described as "high fever".  Additional information: Patient reported that whenever she gets the vaccine, she runs a high fever.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough
Clinical narrative: chest pain; bad cough; This is a spontaneous report received from an Other HCP, Program ID.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "bad cough".  Additional information: Patients wife reported that the last time the patient received a vaccine he had chest pain and a bad cough that lasted for two months.  The information on the batch/lot number for BNT162b2 omi xbb.1.5, pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: arm hurt a lot afterwards; This is a spontaneous report received from an Other HCP, Program ID.  A 55-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2024 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2024, outcome "unknown", described as "arm hurt a lot afterwards".  Additional information: Patient reported the last time they received a vaccine their arm hurt a lot afterwards.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: getting really sick; This is a spontaneous report received from an Other HCP, Program ID.  A 75-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 74 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "getting really sick".  Additional information: Patient reported that when they got the vaccine last year they ended up getting really sick.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feel bad afterwards; This is a spontaneous report received from an Other HCP, Program ID.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 20 (strength: 0.5ML, Dose: 0.5ml, Frequency: once,Route: intramuscularly), administration date: May2023, for immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2023, outcome "unknown", described as "feel bad afterwards".  Additional information: patient reported that when she gets the covid vaccine they make her feel bad afterwards.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe pain in his arm; This is a spontaneous report received from an Other HCP, Program ID.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2024, outcome "unknown", described as "severe pain in his arm".  Additional information: The patient reported experiencing severe pain in his arm after receiving the last vaccine. He stated that the pain didn't start right away; it took about six months for the symptoms to appear, but they lasted for a very long time.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nasopharyngitis
Clinical narrative: cold; flu like symptoms; This is a spontaneous report received from an Other HCP, Program ID.  A 72-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2023, outcome "unknown", described as "flu like symptoms"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information: Patient reports that she was currently experiencing a cold and would like to wait until after new year's before getting the next covid shot. unknown when cold first started. patient also states that for 24 hours after receiving the vaccine she experiences flu like symptoms.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Fever; Chills; Feeling sick; This is a spontaneous report received from an Other HCP, Program ID: .  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2023 as dose number unknown, 0.5 ml, single (Batch/Lot number: unknown) intramuscular for pneumococcal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Jun2023, 2 days after the suspect product(s) administration, outcome "unknown"; MALAISE (non-serious) with onset Jun2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Feeling sick"; PYREXIA (non-serious) with onset Jun2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Fever".  Additional Information: The ent reports after getting the vaccine for approximately 2 days after getting a fever, chills, and feeling sick.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: bad headaches; This is a spontaneous report received from an Other HCP, Program ID.  A 41-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 41 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2023, outcome "unknown", described as "bad headaches".  Additional information: Patient reported that he always has a reaction when he gets a covid-19 vaccine. Patient stated he gets really bad headaches when he gets the vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Cough
Clinical narrative: cough; This is a spontaneous report received from an Other HCP, Program ID.  A 70-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2023 as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) at the age of 70 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of cough.  Additional information: Patient reported the last time they got a vaccine they had a really bad reaction. They ended up going to an urgent care and obtained a prescription for a Medrol dose pack and Tessalon pearls to help with their cough that lasted for almost a month. No further information provided. Lot number and expiration date was unknown.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biopsy liver, Blood alkaline phosphatase, Blood iron
Clinical narrative: Iron Overload; This is a literature report for the following literature source(s).  A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IRON OVERLOAD (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 26; 24; 18; 16; 23; 26; Aspartate aminotransferase: 21; 22; 17; 17; 22; 22; Biopsy liver: 30 %, notes: hepatocyte iron deposition without significant fibrosis or Kupffer cell involvement; Blood alkaline phosphatase: 65; 64; 55; 59; 75; 73; Blood iron (normal high range 2): 2.3 mg/g; Hepatic enzyme: normal; Hereditary hemochromatosis genetic panels (BMP2): unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; Iron binding capacity total: 145; 173; 156; 177; 157; 141; Serum ferritin: elevated; 572.8; 528; 479; 502; 618; 662; Transferrin saturation: elevated; 55 %; 33 %; 21 %; 20 %; 21 %; 43 %; Ultrasound abdomen: normal liver morphology. This is a case series of identical twins with elevated ferritin levels and biopsy-proven iron deposition in hepatocytes, proposed to be triggered by the COVID-19 vaccine.; Sender's Comments: Reported event Iron overload  is assessed as unrelated to suspect drug but most likely due to intercurrent condition or illness. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme, Investigation, Iron binding capacity total, Iron overload, Serum ferritin
Clinical narrative: Iron Overload; This is a literature report for the following literature source(s).  A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IRON OVERLOAD (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 26; 24; 18; 16; 23; 26; Aspartate aminotransferase: 21; 22; 17; 17; 22; 22; Biopsy liver: 30 %, notes: hepatocyte iron deposition without significant fibrosis or Kupffer cell involvement; Blood alkaline phosphatase: 65; 64; 55; 59; 75; 73; Blood iron (normal high range 2): 2.3 mg/g; Hepatic enzyme: normal; Hereditary hemochromatosis genetic panels (BMP2): unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; Iron binding capacity total: 145; 173; 156; 177; 157; 141; Serum ferritin: elevated; 572.8; 528; 479; 502; 618; 662; Transferrin saturation: elevated; 55 %; 33 %; 21 %; 20 %; 21 %; 43 %; Ultrasound abdomen: normal liver morphology. This is a case series of identical twins with elevated ferritin levels and biopsy-proven iron deposition in hepatocytes, proposed to be triggered by the COVID-19 vaccine.; Sender's Comments: Reported event Iron overload  is assessed as unrelated to suspect drug but most likely due to intercurrent condition or illness. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Sex: M
Vaccine: COVID19
Symptoms: Transferrin saturation, Ultrasound abdomen
Clinical narrative: Iron Overload; This is a literature report for the following literature source(s).  A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IRON OVERLOAD (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 26; 24; 18; 16; 23; 26; Aspartate aminotransferase: 21; 22; 17; 17; 22; 22; Biopsy liver: 30 %, notes: hepatocyte iron deposition without significant fibrosis or Kupffer cell involvement; Blood alkaline phosphatase: 65; 64; 55; 59; 75; 73; Blood iron (normal high range 2): 2.3 mg/g; Hepatic enzyme: normal; Hereditary hemochromatosis genetic panels (BMP2): unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; unremarkable; Iron binding capacity total: 145; 173; 156; 177; 157; 141; Serum ferritin: elevated; 572.8; 528; 479; 502; 618; 662; Transferrin saturation: elevated; 55 %; 33 %; 21 %; 20 %; 21 %; 43 %; Ultrasound abdomen: normal liver morphology. This is a case series of identical twins with elevated ferritin levels and biopsy-proven iron deposition in hepatocytes, proposed to be triggered by the COVID-19 vaccine.; Sender's Comments: Reported event Iron overload  is assessed as unrelated to suspect drug but most likely due to intercurrent condition or illness. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms such as chills; This is a spontaneous report received from an Other HCP, Program ID.  An 85-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1 (toppac), 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms such as chills".  Additional Information: The patient reports that they get sick with the vaccine sometimes. She reports that she experienced flu-like symptoms such as chills.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia
Clinical narrative: weakness; This is a spontaneous report received from an Other HCP, Program ID.  A 63-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2024 as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) at the age of 63 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2024, outcome "unknown", described as "weakness".  Additional information: Patient reported that the last time she received the vaccine she had a horrible reaction. Patient reported weakness to the point to where all she can do was lay in bed. No further information provided. Lot number and expiration date was unknown.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: body aches; a low grade fever; just in general did not feel good; This is a spontaneous report received from an Other HCP, Program ID.  A 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "a low grade fever"; MALAISE (non-serious), outcome "unknown", described as "just in general did not feel good". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: FLUX
Symptoms: Cough
Clinical narrative: coughing my head off for over a week; Initial information received on 27-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves Adult female patient who experienced coughing her head off for over a week after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination  (Immunization).   On an unknown date the patient developed coughing my head off for over a week (cough) (unknown latency) following the administration of influenza vaccine.  Reportedly, patient had the flu shot, but it wasn't any good.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (coughing my head off for over a week).  At time of reporting, the outcome was Unknown for the event coughing my head off for over a week.
Sex: M
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: had covid twice in last 40 days after the vaccine; Initial information received on 30-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves Adult male patient who had covid twice in last 40 days after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization).   On an unknown date the patient had covid twice in last 40 days after the vaccine (covid-19) (unknown latency) following the administration of influenza vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: CELLULITIS
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called the pharmacy today (1/2/25) to report that the flu shot they were given on 10/01/24 was still sore and giving her issues raising her arm in the air at times. Patient reported that they went to see their NP who told them the shot might have hit the muscle. Informed the patient that since this is an intramuscular shot it is supposed to hit the muscle, but that we would report the reaction accordingly. Encouraged patient to follow up with us and inform of us any changed or possible improvements but that we would report the reaction to VAERs.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy test, Asthenia, Cold sweat, Nausea, Pruritus
Clinical narrative: After having the vaccine, had hives over the whole body, hands and feet were extremely itchy, nausea, burning in throat, weakness, cold sweats, rash around eyes. Took Benadryl seemed to make it better.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Throat irritation, Urticaria
Clinical narrative: After having the vaccine, had hives over the whole body, hands and feet were extremely itchy, nausea, burning in throat, weakness, cold sweats, rash around eyes. Took Benadryl seemed to make it better.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was in Clinic for a Well child check, pt was offered to received 1st dose of Covid vaccine series, Parent of child approved. Pt received vaccine and took well, no adverse reactions.  This writer then found out vaccine was non-viable per Pfizer recommendations. Vaccine was viable until 12/05/2024., vaccine was given 12/13/24.  Vial of vaccine expired on 12/2025.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Malaise, Nausea
Clinical narrative: I ate dinner with my family at 6:15 and was the only person in my family who suddenly became extremely nauseous around 7:05 and was getting sick by 7:10. Prior to that I was burning up and now I?m freezing.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt came in for a Well child check, pt was offered first covid vaccine, pt took vaccine well and had no adverse reactions.  Vaccine was given on a non-viable date per Pfizer recommendations.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received Prevnar 20 Vaccine last year. Patient did not disclose this information to me at the time of today's visit. I called the patient and discussed this information and patient is aware that she does not need to get Prevnar 20 vaccine annually.
Age: 18.0
Sex: M
Vaccine: COVID19, FLU3, IPV, TDAP
Symptoms: Blood glucose decreased, Head injury, Hypotension, Syncope
Clinical narrative: Patient received 4 vaccines : Polio, Afluria, Comirnaty, Boostrix . After receiving all 4, he got up and stand up while waiting for his brother to get his. About a few minutes after, he fainted and hit his head against the wall . We called EMS but his mom said he should be fine. We still stayed on the phone with the medical dispatcher to wait for advice and help. The paramedics came to check him out and gave him NaCl fluids since his blood pressure and blood sugar were low. He was taken to the hospital to get medical attention by the paramedics.
Age: 0.25
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse affects. This was found upon inventory of vaccines.
Age: 81.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Extra dose administered
Clinical narrative: Received second dose of arexvy. First dose was 01/2024
Age: 70.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received Prevnar 20 Vaccine last year in 2023. Patient did not disclose this information to me at the time of today's visit. Patient came to the visit wanting pneumonia and influenza vaccine. I called the patient and discussed this information and patient is aware that she does not need to get Prevnar 20 vaccine annually. Patient verbalized understanding.
Age: 82.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Extra dose administered
Clinical narrative: Received 2nd dose of Arexvy. First dose was 01/2024
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Covid age 5-11 years given to patient instead of the adult dose by, FNP-C
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Covid 5-11 years given to patient instead of adult dose by, FNP-C.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Heart rate increased, Interstitial lung disease
Clinical narrative: Shortness of breath, inability to move without blood oxygen saturation dropping drastically & causing heart rate to spike
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Oxygen saturation decreased, X-ray
Clinical narrative: Shortness of breath, inability to move without blood oxygen saturation dropping drastically & causing heart rate to spike
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Benign fasciculation syndrome
Clinical narrative: Benign Fasciculation Syndrome
Age: 8.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Pain in extremity
Clinical narrative: Report pulled from State Profile did not show a hx of vaccination. Patient received an additional dose of Varicella, MMR, IPV and TDAP. No adverse reaction found after waiting 15 min post vaccination.  Parented reported complaints leg pain to Provider during follow up phone call on 1/02/2025. No other symptoms reported, red flag and return precautions provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus?I?ve gone to clinic to see if they can help and they gave me hearing aids. But it does nothing to stop the constant ringing in both ears.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: pt developed BLE weakness approximately 6 days after receiving flu vaccine.  Diagnosed w/ Guillain Barre Syndrome 10/30/24. No other abnormal findings during hospital admission (acute). Received electronic disease notification report of Guillain Barre, reported by Dr. Neurologist.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: AMLODIPINE taken for hypertension. The following information was reported: URTICARIA (non-serious) with onset 2024, outcome "unknown", described as "hives". The event "hives" required physician office visit. Additional information: After taking the Covid vaccine Sep2024, patient has broken out with hives. After seeing an allergist, was informed that it's because of the vaccine and unfortunately the hives will last for 6 months. Also possible that vaccine and amlodopine (high blood pressure medicine) don't agree with each other. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: booster, dose at 7-months old, which is earlier than the recommended age for the booster; no adverse event; This spontaneous report was received from a consumer and refers to a 15-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date at 2 months old, the patient received the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (dose, strength, lot #, expiry date, and route of administration were not provided). On an unspecified date at 4 months old received the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (dose, strength, lot #, expiry date, and route of administration were not provided). On an unspecified date at 7 months old, the patient received the booster and third haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), this was earlier than the recommended age for booster dose (inappropriate schedule of product administration). No additional adverse event was reported.
Age: 59.0
Sex: F
Vaccine: COVID19, PNC21, UNK
Symptoms: Injection site cellulitis, Injection site inflammation
Clinical narrative: Injection site cellulitis; Injection site inflammation; Initial information received on 26-Dec-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-hcp (non-healthcare professional).  This case involves 59 years old female patient who experienced injection site cellulitis and injection site inflammation after receiving Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) and Covid-19 Vaccine Prot. Subunit (Nvx Cov 2373) (Novavax Covid-19 Vaccine) and Influenza Trivalent Recombinant Vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants used/reported.  On 06-Nov-2024, the patient received a dose 1 of suspect novavax covid-19 vaccine not produced by Sanofi Pasteur Injection with strength 0.5 ml (lot 6024MF016A) for COVID-19 immunization; received a dose 1 of suspect Capvaxive not produced by Sanofi Pasteur injection (lot Y011819) for prophylactic vaccination (Immunisation) and received a dose 1 of suspect influenza trivalent recombinant vaccine Solution for injection(lot TFAA2437) for prophylactic vaccination (Immunisation), all via intramuscular route in unknown administration site.  On 07-NOV-2024 the patient developed injection site cellulitis and injection site inflammation (latency- 1 day) following the administration of influenza trivalent recombinant vaccine, novavax covid-19 vaccine and Capvaxive.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.  The CDC's (Centers for Disease Control and Prevention) adverse event description (narrative) was provided as follows: lnflamation/cellulitus below injection site approximately 6 inches wide and 8 inches long
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Stress fracture
Clinical narrative: I am not aware of worsening bone mineral density or an increase in fracture risk as a result of the covid vaccines, but there is a correlation in timing with her and She raises concerns regarding COVID-19 vaccine and stress fractures of her feet.  First foot stress fracture was in July 2021 And now has had 5 foot/stress fractures in total,.  Her Moderna COVID-19 vaccines were: 3/29/21 and 4/26/21 She wonders / thinks these vaccines might have caused some changes that led to her stress/foot fracture  More details July 2021: Right foot fracture Oct 2021: Left foot fracture, fracture of fifth metatarsal Nov 2022: possible right foot stress fracture Jan 2023: fracture fifth metarsal bone on my left foot again July 2024: left foot fracture (4th metatarsal)  Per patient Dec'24: That makes FIVE factures of my feet (two on the right and three on the left).
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Dizziness, Fatigue, Injection site swelling, Rash
Clinical narrative: Rash started within 12 hours.  Extreme fatigue, dizziness, lightheadedness upon awaking the next day. Rash appeared to look like a chemical burn after 36hours and turned to hives after 48hours .which lasted a week. Diarrhea persisted throughout. There is still a bump at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Rash started within 12 hours.  Extreme fatigue, dizziness, lightheadedness upon awaking the next day. Rash appeared to look like a chemical burn after 36hours and turned to hives after 48hours .which lasted a week. Diarrhea persisted throughout. There is still a bump at injection site.
Sex: F
Vaccine: FLU3, HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Accidently administered Fluzone instead of the intended vaccine hepatitis B with no reported adverse event.; Accidently administered Fluzone instead of the intended vaccine hepatitis B with no reported adverse event.; This spontaneous report was received from a health care professional and refers to a 15-day-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-NOV-2024, the patient was accidentally vaccinated with influenza vaccine (FLUZONE [INFLUENZA VACCINE]) suspension for injection, 0.5 milligram, administered for prophylactic vaccination (strength, lot #, expiry date, route and anatomical site of administration were not provided) instead of the intended hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (Wrong product administered) with no reported adverse event (No adverse event).  The reported inquired about any potential concerns they should be aware of when the patient was transferred to them, including possible side effects or any they could do regarding this situation. She reiterated that this did not happen in their facility.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Large red spot (about the size of a 50 cent coin) with some swelling below injection site. Headache.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Pain in extremity
Clinical narrative: arm soreness; fatigue; pain in the ophthalmic; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had in her 30s).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm soreness), fatigue (Verbatim: fatigue) and eye pain (Verbatim: pain in the ophthalmic). The outcome of the pain in arm, fatigue and eye pain were not resolved.   It was unknown if the reporter considered the pain in arm, fatigue and eye pain to be related to Shingrix.     It was unknown if the company considered the pain in arm, fatigue and eye pain to be related to Shingrix.   Additional Information: GSK receipt date: 06-DEC-2024 This case was reported by a patient via interactive digital media. The patient reported that she had shingles in her 30s and got vaccinated at 51 and interestingly the first shot had a more robust reaction in terms of arm soreness and fatigue. The reporter reported that she even developed return of a bit of pain in the ophthalmic region where her earlier shingles attack happened.
Age: 10.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was too old to recveive the Kinrix Vaccine.
Age: 7.0
Sex: F
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was too old to receive the Kinrix vaccine.
Age: 11.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Drooling, Ear discomfort, Posture abnormal
Clinical narrative: Pt to clinic with mother for immunizations. Mother states NKA. Pt is needing Tdap, IPV, and MMR for school. Pt given vaccines around 1400 and as soon as last vaccine administered patient slumps forward on clinical bed. Pt leaned back and laid down on clinical bed where she is fully responsive with little drool on face and complaining of her "ears feel clogged." Pt was only out for about 5 seconds. Mother states pt has not eaten all day and stated last time she had her blood drawn she had done the same thing.  Pt was given juice and a snack as she laid back. Pt then sat up for a few minutes before having pt stand. Pt states felt good before she left the clinic.
Age: 1.75
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: This pt received 0.5 mL Afluria 2024-2025 formula on 3 Jan 25. The on call provider was notified, PSR and VAERS form have been placed.  The child received a higher dose than is recommended for his age group. Afluria is approved for his age group at a dose of 0.25ml.