chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Insomnia, Malaise, Pain
Clinical narrative: Not feeling well; Ache; I could not sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; rsv vaccine (RSV VACCINE), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "mechanical valves" (unspecified if ongoing), notes: Coumadin which is a blood thinner because I have a mechanical valves; "anxiety" (unspecified if ongoing), notes: I took a Lorazepam which is 0.5 milligrams. It just helps you to relax that's all. It is an anxiety pill, Lorazepam 0.5 milligrams. Concomitant medication(s) included: COUMADIN taken for thrombosis. Vaccination history included: bnt162b2 (Dose: 1), administration date: 09Feb2021, when the patient was 78-year-old, for Covid-19 Immunization; bnt162b2 (Dose: 2), administration date: 03Mar2021, when the patient was 79-year-old, for Covid-19 Immunization; bnt162b2 (Dose: 3 Booster), administration date: 09Oct2021, when the patient was 79-year-old, for Covid-19 Immunization; bnt162b2 (Dose: 4 Booster), administration date: 02May2022, when the patient was 80-year-old, for Covid-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose: 5 Booster), administration date: Dec2022, when the patient was 80 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 2023, outcome "unknown", described as "Ache"; INSOMNIA (non-serious) with onset 2023, outcome "unknown", described as "I could not sleep"; MALAISE (non-serious) with onset 2023, outcome "unknown", described as "Not feeling well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, pain, insomnia.  Additional information: The patient was not feeling well and wanted to ask if she can take Tylenol with it. She also had pain, not pain but like an ache and could not sleep, so she took a Lorazepam which is 0.5 milligrams. It just helps you to relax that's all.  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: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand: Pfizer/BioNTech; Vaccine lot unknown: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92-year-old male patient received bnt162b2 (BNT162B2 NOS), on 26Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 91 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disorder" (unspecified if ongoing); "Lung disorder" (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 Sep2023, outcome "recovered" (Sep2023) and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "vaccine brand: Pfizer/BioNTech; Vaccine lot unknown: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: I was ok tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 21Sep2023 to 25Sep2023. Clinical course: No known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317336 same reporter/patient, different drug/event;
Age: 59.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 10:00 as dose 5 (booster), single (Lot number: GJ6738) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 16Sep2023 to 20Sep2023. Clinical course: No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317526 same reporter/patient, different drug/event;
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) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) 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 3 (BOOSTER), Single, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series completed, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given from 23Sep2023 tp 27Sep2023.  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: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective, covid-19 and suspect product.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 7 (booster) single (Batch/Lot number: unknown) at the age of 76 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number:1), for COVID-19 immunization; Moderna (Dose Number:2), for COVID-19 immunization; Moderna (Dose Number:3), for COVID-19 immunization; Moderna (Dose Number:4), for COVID-19 immunization; Moderna (Dose Number:5), for COVID-19 immunization; Moderna (Dose Number:6), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "Fever". Additional information:  She reported experiencing fever on and off couple of times this week.   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: M
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: Patient reported 4 weeks after second dose, was hospitalized for heart failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), on 24Mar2021 as dose 2, 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 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 03Mar2021, for Covid-19 Immunization. The following information was reported: CARDIAC FAILURE (hospitalization, medically significant) with onset 2021, outcome "recovered with sequelae", described as "Patient reported 4 weeks after second dose, was hospitalized for heart failure". The patient was hospitalized for cardiac failure (start date: 2021). It was unknown if therapeutic measures were taken as a result of cardiac failure.  Clinical Course: It was unknown if patient received other vaccine in four weeks. Patient reported 4 weeks after second dose, was hospitalized for heart failure. Physician would not link symptoms to COVID shot. It was reported that patient recovered with lasting effects. It was unknown if patient had covid prior vaccination, also unknown if tested for covid post vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300318717 same patient/reporter/vaccine, different dose, events;
Sex: U
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An adult patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 30Sep2023 as dose number unknown, 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: SARS-COV-2 TEST POSITIVE (non-serious), outcome "unknown", described as "Patient tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2023) Positive, notes: Patient tested positive for Covid. Therapeutic measures were taken as a result of sars-cov-2 test positive.  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: COVID-19, Drug ineffective
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). The reporter is the patient.  A 39-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic CD4 lymphocytopenia" (unspecified if ongoing). There were no concomitant medications. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient given Paxlovid as treatment on 21Sep2023 to 26Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: Vaccination site haemorrhage, Vaccination site swelling, Wrong technique in product usage process
Clinical narrative: when the technician administered the vaccine there was a bleeding and some swelling and she thought that she hit the vein; when the technician administered the vaccine there was a bleeding and some swelling and she thought that she hit the vein; when the technician administered the vaccine there was a bleeding and some swelling and she thought that she hit the vein; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, 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: VACCINATION SITE HAEMORRHAGE (non-serious), VACCINATION SITE SWELLING (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown" and all described as "when the technician administered the vaccine there was a bleeding and some swelling and she thought that she hit the vein". Additional information: Adult patient with question regarding new Pfizer covid 19 vaccine (2023-2024): would it still work if it would go into a vein? Should she get another? (refer to HCP). Per caller: when the technician administered the vaccine, there was a bleeding and some swelling and she thought that she hit the vein, caller was wondering if the vaccine hit the vein and if any of the vaccine came out with a bleeding because there was a decent amount of bleeding. Asked will her vaccine still work, or should she get another one.  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: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm 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), outcome "recovering", described as "Pain in arm". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional information: It was unknown if the any other vaccine was received in four weeks and other medications in two weeks. Prior vaccination, it was unknown if patient had COVID-19 and post-vaccination, it was unknown if COVID-19 was tested.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose 1: Janssen/ Dose 2: Moderna/ Dose 3: Pfizer; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 3 (booster), single (Lot number: UT7751KA) at the age of 61 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14May2022 as dose 2 (booster), single (Lot number: 071F21A) for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 30Oct2021 as dose 1, single (Lot number: 1805020) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "diabetes insipidus", start date: 2015 (ongoing), notes: my comorbidity is diabetes insipidus since 2015; "hypothyroidism" (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 2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1: Janssen/ Dose 2: Moderna/ Dose 3: Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 02Oct2023 to 03Oct2023. Clinical course: The patient had no 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: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300318207 Same reporter/patient, different drug, different event.;
Sex: M
Vaccine: PNC20
Symptoms: Chronic obstructive pulmonary disease, Expired product administered
Clinical narrative: vaccine was 30 days expired; COPD; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 95-year-old male patient received pneumococcal 20-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 20), on 03Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "vaccine was 30 days expired"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". Additional information: The reporter stated she is a nurse calling on behalf of her 95 years old dad. The reporter received a call from the pharmacist stating they did not realize the vaccine was 30 days expired. The reporter stated this is frustrating how a pharmacy can keep a 30 day expired medicine on the shelf. Her dad (patient) has COPD.   The information on the batch/lot number for pneumococcal 20-valent conjugated vaccine (diphtheria crm197 protein), pneumococcal 20-valent conjugated vaccine (diphtheria crm197 protein)  has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: Flushing, Headache, Pyrexia, Urticaria
Clinical narrative: Patient described breaking out with hives all over her body. She also reports having headache, fever, flushing. She reports all symptoms have persisted for around 5 days
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: THE PATIENT REQUESTED FOR COMINARTY (PFIZER COVID VACCINES), BUT RECEIVED PEDIATRIC DOSING OF PFIZER COVID VACCINE.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 13:15 as dose 4 (booster), single (Lot number: GJ6738), in right arm and on 03Mar2023 at 13:15 as dose 5 (booster), single (Lot number: fm0689) at the age of 67 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (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 25Sep2023, outcome "recovered" (30Sep2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (25Sep2023) Positive; (27Sep2023) Positive; (30Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not have known allergies. Tested positive on 25Sep and began course of treatment that evening. Took doses through Saturday morning 30Sep. Tested positive on Wednesday (27Sep), negative on Saturday (30Sep). Only mild symptoms during week of (30Sep). Only mild symptoms during week of sore throat - somewhat severe Sunday (24Sep) during the night and next morning leading to testing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300318294 same patient, different drug/AE;
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood culture, Brain natriuretic peptide normal, COVID-19, Chest X-ray abnormal, Cough
Clinical narrative: no vaccination adverse event, but patient presented to the ED on 9/11/2023 with shortness of breath and non-productive cough.  Tested positive for COVID.  Admitted to the Adult Care Unit the same day due to concern for multifocal lung infiltrates in the setting of pulmonary fibrosis.  Received antibiotics (ceftriaxone/azithromycin) and a course of remdesivir/steroids during admission.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Full blood count abnormal, Leukocytosis, Lung infiltration, Metabolic function test normal
Clinical narrative: no vaccination adverse event, but patient presented to the ED on 9/11/2023 with shortness of breath and non-productive cough.  Tested positive for COVID.  Admitted to the Adult Care Unit the same day due to concern for multifocal lung infiltrates in the setting of pulmonary fibrosis.  Received antibiotics (ceftriaxone/azithromycin) and a course of remdesivir/steroids during admission.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary fibrosis, SARS-CoV-2 test positive, Tachycardia, Tachypnoea, Troponin normal
Clinical narrative: no vaccination adverse event, but patient presented to the ED on 9/11/2023 with shortness of breath and non-productive cough.  Tested positive for COVID.  Admitted to the Adult Care Unit the same day due to concern for multifocal lung infiltrates in the setting of pulmonary fibrosis.  Received antibiotics (ceftriaxone/azithromycin) and a course of remdesivir/steroids during admission.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Underdose
Clinical narrative: I was administering the vaccine and at the last moment right before the needle was about to retract the patient jerked and the needle came out of her arm. She received most of the medication. But she didn't receive the last amount right before the needle retracts.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Patient has local redness and rash at injection sites as well as rash on back of the neck. Patient's nurse said she can take benadryl if needed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: at 2am fever, aches, soreness, headache
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Diarrhoea, Frequent bowel movements, Haemorrhoidal haemorrhage
Clinical narrative: Stomach upset 6 hours after COVID-19 vaccination, followed by severe diarrhea (watery). More than 6 bowel movements a day for 2 days, causing hemorrhoidal bleeding. Completely resolved on October 5, 2023. No sequelae.
Age: 100.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site rash, Pain
Clinical narrative: Patient site of injection got extremely red and the rash spread her entire upper arm from site of injection to her elbow. Contacted primacy care physician who prescribed amoxicillin and recommended benadryl. This started after receiving vaccine, got worse and the patient complained of pain.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Discomfort, Electrocardiogram normal, Full blood count abnormal
Clinical narrative: no adverse reaction to the vaccine, but who presented to the ED on 9/1/23 with a chief complaint of generalized weakness.  He also noticed a little swellling in left lower extremity.  He was admitted to the Adult Care Unit for further evaluation due to patient not feeling comfortable returning to home (~50 miles away), and due to hypoxia on exertion (down to sat on room air of 89%), weakness, and inability to ambulate as he normally does.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gait inability, Haematocrit decreased, Haemoglobin decreased, Hypoxia, Peripheral swelling
Clinical narrative: no adverse reaction to the vaccine, but who presented to the ED on 9/1/23 with a chief complaint of generalized weakness.  He also noticed a little swellling in left lower extremity.  He was admitted to the Adult Care Unit for further evaluation due to patient not feeling comfortable returning to home (~50 miles away), and due to hypoxia on exertion (down to sat on room air of 89%), weakness, and inability to ambulate as he normally does.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Red blood cell sedimentation rate normal, SARS-CoV-2 test positive, Ultrasound Doppler, Ultrasound Doppler normal, Urine analysis normal
Clinical narrative: no adverse reaction to the vaccine, but who presented to the ED on 9/1/23 with a chief complaint of generalized weakness.  He also noticed a little swellling in left lower extremity.  He was admitted to the Adult Care Unit for further evaluation due to patient not feeling comfortable returning to home (~50 miles away), and due to hypoxia on exertion (down to sat on room air of 89%), weakness, and inability to ambulate as he normally does.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Haematoma, Vaccination site swelling
Clinical narrative: Developed swelling of the left arm at vaccination site after receiving Meningococcal AND HPV vaccines both in left arm on 9/26/23.  Diagnosed with left arm hematoma and cellulitis 9/29/23. Treated with clindamycin, tylenol, and ibuprofen with improvement.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site pain, Pyrexia
Clinical narrative: A third dose of Shingrix was given on accident. When speaking to the patient, the day after her vaccination, she reports a fever of 100.5 through the evening and night. Fever was gone by morning. She also reports pain at injection sight, starting a couple of hours after receiving vaccine and still has arm pain the day after. She has taken ibuprofen to help with the pain.
Age: 67.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Severe skin reaction/rash/pain at and around injection site, approximately 6?x4?, intensely itchy and warm to the touch. Urgent Care provider suggested high dose antihistamines. Pain continued for 10 days, rash for 9 days.
Age: 43.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Anxiety, Dyspnoea, Hypoaesthesia, Palpitations, Pharyngeal hypoaesthesia
Clinical narrative: Pt reported heart palpitations, shortness of breath, anxiousness and a numb prickly feeling in nose and left side of throat. No swelling or wheezing. Pt was instructed to take Benadryl or equivalent which she did.  Symptoms subsided within a couple of hours.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product use in unapproved indication
Clinical narrative: RN gave an MMR to a client that was immune. No adverse reactions.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: 4 weeks after 3rd dose couldn't breathe and was diagnosed with heart failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), 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 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 24Mar2021, for COVID-19 immunization, reaction(s): "heart failure"; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 03Mar2021, for COVID-19 immunization. The following information was reported: CARDIAC FAILURE (hospitalization, medically significant) with onset Dec2021, outcome "recovered with sequelae", described as "4 weeks after 3rd dose couldn't breathe and was diagnosed with heart failure". It was unknown if therapeutic measures were taken as a result of cardiac failure.  Clinical Course: It was unknown if patient received other vaccine in four weeks. Patient reported 4 weeks after second dose, was hospitalized for heart failure and after 3rd dose couldn't breathe and was diagnosed with heart failure. Physician would not link symptoms to COVID shot. It was reported that patient recovered with lasting effects. It was unknown if patient had covid prior vaccination, also unknown if tested for covid post vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300318099 same patient/reporter/vaccine, different dose, events;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric age 5-11 yrs old given to this adult patient. NDC given to this patient is 59267-4331-02. We discovered the error on 10/06/23  the morning following the dose. I've called patient twice and left voicemail. No adverse reaction reported by patient.
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Swollen tongue
Clinical narrative: tongue was swollen/swollen tongue; not able to swallow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose number unknown, 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: DYSPHAGIA (hospitalization) with onset 04Oct2023, outcome "unknown", described as "not able to swallow"; SWOLLEN TONGUE (hospitalization) with onset 04Oct2023, outcome "unknown", described as "tongue was swollen/swollen tongue". The events "tongue was swollen/swollen tongue" and "not able to swallow" required emergency room visit. The clinical course was reported as follows: "04Oct2023, my husband woke up not able to swallow because his tongue was swollen and we had to go to the ER and they admitted him".   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: U
Vaccine: COVID19
Symptoms: Bone marrow disorder
Clinical narrative: There are graphene oxide nanoparticles in your vaccine which lay dormant in bone marrow for years and are toxic to the body.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, 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: BONE MARROW DISORDER (non-serious), outcome "unknown", described as "There are graphene oxide nanoparticles in your vaccine which lay dormant in bone marrow for years and are toxic to the body".  Additional information: The reporter stated that the Pfizer Covid vaccine had caused endless suffering to him/her and many others. There were graphene oxide nanoparticles in the vaccine which laid dormant in bone marrow for years and are toxic to the body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected  Follow-up (01Oct2023): This is a spontaneous follow-up report received from the same contactable Consumer. Updated information included: Reporter information (email address and other) updated; Follow-up activities possible updated.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Feeding disorder, Feeling abnormal, Insomnia, Lethargy
Clinical narrative: Felt yucky; 101 fever; Cannot sleep; In so much pain as her hands are sore; Couldn't eat; Extremely lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2023, outcome "unknown", described as "101 fever"; INSOMNIA (non-serious) with onset 2023, outcome "unknown", described as "Cannot sleep"; FEEDING DISORDER (non-serious) with onset 2023, outcome "unknown", described as "Couldn't eat"; LETHARGY (non-serious) with onset 2023, outcome "unknown", described as "Extremely lethargic"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "In so much pain as her hands are sore"; FEELING ABNORMAL (non-serious) with onset 29Sep2023 at 18:00, outcome "unknown", described as "Felt yucky". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient stated that she had the flu vaccine RVP and COVID vaccine last Friday at 3pm and between 6pm-8pm, she felt yucky, and she is 65 years old. She also mentioned that she had a 101 fever, cannot sleep, and in so much pain as her hands are sore, she has aching fever and she couldn't eat. She was extremely lethargic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Felt yucky; 101 fever; Cannot sleep; In so much pain as her hands are sore; Couldn't eat; Extremely lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2023, outcome "unknown", described as "101 fever"; INSOMNIA (non-serious) with onset 2023, outcome "unknown", described as "Cannot sleep"; FEEDING DISORDER (non-serious) with onset 2023, outcome "unknown", described as "Couldn't eat"; LETHARGY (non-serious) with onset 2023, outcome "unknown", described as "Extremely lethargic"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "In so much pain as her hands are sore"; FEELING ABNORMAL (non-serious) with onset 29Sep2023 at 18:00, outcome "unknown", described as "Felt yucky". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient stated that she had the flu vaccine RVP and COVID vaccine last Friday at 3pm and between 6pm-8pm, she felt yucky, and she is 65 years old. She also mentioned that she had a 101 fever, cannot sleep, and in so much pain as her hands are sore, she has aching fever and she couldn't eat. She was extremely lethargic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: Fatigue
Clinical narrative: severe fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Lot number and batch number not provided.), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number and batch number not provided.), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "severe fatigue".  Additional information: Caller reported that she just got her booster of the Biontech Pfizer Covid 19 Vaccine and was actually in one of the Pfizer trials on 2020. She was just wondering if she had come up with any other tips for major side effects. In the trial, it only came after the second shot. With the booster, it had come each time. She had severe fatigue the next day after the shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316840 Same patient, different dose/event;
Sex: U
Vaccine: RSV
Symptoms: Chills, Decreased appetite, Pyrexia
Clinical narrative: chills; fever; loss of appetite; This is a spontaneous report received from a contactable reporter (consumer), Program ID. The reporter is the patient. A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Sep2023 as dose number unknown, single (lot number unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2023, outcome "unknown"; PYREXIA (non-serious) with onset 2023, outcome "unknown", described as "fever"; DECREASED APPETITE (non-serious) with onset 2023, outcome "unknown", described as "loss of appetite".  Additional Information: The patient received the RSV vaccine on 23Sep2023 and experienced chills, fever, and loss of appetite. The patient asked how long symptoms subside from these adverse side effects.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The reporter stated that her husband got a Pfizer covid-19 vaccine shot however he tested positive. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: terrible diarrhea; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown (booster), single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete (unknown manufacturer) for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown" described as "terrible diarrhea."  Additional information: The consumer, got a Pfizer Covid-19 booster shot on Thursday and she got terrible diarrhea. She wanted to report this and wanted to know if this is the side effects of the booster shot. There is an administration.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: feeling ill after receiving a flu vaccine; Initial information received on 24-Sep-2023 (processed as a non-case) and follow up information received on  24-Sep-2023 regarding an unsolicited valid non-serious case received from a patient via specialty pharmacy.   This case involves a 68 years old male patient who experienced feeling ill after receiving a flu vaccine (INFLUENZA VACCINE) and while treated with DUPILUMAB [DUPIXENT] via dupixent single dose pre-filled pen.  The patient's past medical history, medical treatment(s), concomitant disease, risk factor and family history were not provided.   On an unknown date, the patient started taking DUPILUMAB Solution for injection at a dose of 300 mg subcutaneously (strength: 300 mg/2mL, frequency: other, with an unknown batch number, indication and expiry date). On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  Information on batch numbers was requested.  Patient reports missing one dose of Dupixent due to feeling ill after receiving a flu vaccine (malaise) (onset: 24-Sep-2023,  unknown latency)   It is unknown if there were lab data/results available.  Action taken with DUPILUMAB was drug withdrwn.   Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (feeling ill after receiving a flu vaccine).  At time of reporting, the outcome was Unknown for the event feeling ill after receiving a flu vaccine.  Additional information was received on 24-Sep-2023 from patient: Case was updated from non case to valid case. Text amended accordingly.
Sex: U
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Menquadfi Vaccine administered with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient with unknown demographics who received expired meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] vaccine administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Sep-2023, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection expiry date: 24-sep-2023 Lot u7449ab via unknown route in unknown administration site for prophylactic vaccination (immunization).  On 28-SEP-2023 the patient received expired menquadfi vaccine administered with no reported adverse event (expired product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired menquadfi vaccine administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got very sick for a week; Initial information was received on 01-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got very sick for a week after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination  (Immunization). The information on the batch number will not be available.  On an unknown date the patient got very sick for a week (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got very sick for a week).  At time of reporting, the outcome was Unknown for the event got very sick for a week.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu/Worst case of it I ever had; Initial information received on 01-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who reported still got the flu/worst case of it i ever had after receiving vaccine Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, expiry date, dose and form not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization).  On an unknown date the patient reported still got the flu/worst case of it i ever had (influenza) (unknown latency) following the administration of Influenza Vaccine.  It was reported "Dude...I got the flu shot last year and my wife and I both still got the flu. My wife was hospitalized and I should have been."  Action taken: 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.