chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EW0167) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing); "Anemic" (ongoing); "glaucoma" (ongoing); "allergy" (ongoing). Concomitant medication(s) included: FLUTICASONE PROPIONATE (GLUCOCORTICOID) nasal taken for hypersensitivity (ongoing); AMLODIPINE [AMLODIPINE BESILATE] taken for blood pressure measurement (ongoing); FEXOFENADINE HCL taken for hypersensitivity (ongoing); FERROUS SULFATE taken for anaemia, start date: 2022 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0161; anatomical location: left arm), administration date: 15Apr2021, when the patient was 70-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Nov2022, outcome "not recovered", described as "All of those doses were administered into her left arm. She noticed a knot on her left arm where she had been administered those doses a couple of weeks ago, around beginning of Nov2022". Therapeutic measures were not taken as a result of vaccination site mass.  Additional information: It was reported that there was a knot on her left arm where the patient had been getting Pfizer Covid-19 Vaccines and booster doses. Caller clarified that the patient had received 3 doses of Pfizer Covid-19 Vaccine in total including the first two doses, and then the third dose which was her booster. All of those doses were administered into her left arm. The patient noticed a knot on her left arm where the patient had been administered those doses a couple of weeks ago, around beginning of Nov2022.The patient was going to go get the updated version of the vaccine booster, whatever it is, but then noticed this knot on her left arm so thought the patient should find out if its ok to get another dose with her having the knot on her left arm before doing that. She got all her doses in the left arm because she gets a sinus shot in her right arm for allergies. The patient was taking concomitant medication One-A-Day Vitamin 1 daily as Multivitamin multimineral supplement.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Site has not healed in 6 weeks, it looks like a mosquito bite as it itches all the time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 61 years, in right arm for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Moderna COVID-19 vaccine (Dose: 01, Batch/Lot number: 016B21A), administration date: 05Mar2021, when the patient was 59-year-old, for COVID-19 Immunization; Moderna COVID-19 vaccine (Dose: 02, Batch/Lot number: 006C21A), administration date: 22Apr2021, when the patient was 59-year-old, for COVID-19 Immunization; BNT162b2 (Dose:03, Batch/Lot number: FL3197), administration date: 27Dec2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Interchange of vaccine products"; BNT162b2 (Dose: 04, Batch/Lot number: FM9992), administration date: 27Apr2022, when the patient was 60-year-old, for COVID-19 Immunization.  The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 03Oct2022, outcome "not recovered", described as "Site has not healed in 6 weeks, it looks like a mosquito bite as it itches all the time".
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Accident, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 09:00 as dose 4 (booster), single (Lot number: GJ6/42) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; SYNTHROID; CETIRIZINE; DAPSONE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), FATIGUE (non-serious) all with onset 17Nov2022 at 06:30, outcome "not recovered" and all described as "Extreme dizziness and tired"; ACCIDENT (non-serious) with onset 17Nov2022 at 06:30, outcome "not recovered", described as "Had an accident on the way to work".  Additional information: The patient had no known allergies and had not been tested for COVID-19 since vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Skin irritation, Tenderness
Clinical narrative: a little redness/red skin; tenderness; irritation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004045.  A male patient received BNT162b2 (BNT162B2), on 20Mar2022 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: 01), administration date: 26Feb2022, for COVID-19 Immunization, reaction(s): "irritation", "a little redness", "tenderness". The following information was reported: ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "a little redness/red skin"; SKIN IRRITATION (non-serious) with onset 2022, outcome "unknown", described as "irritation"; TENDERNESS (non-serious) with onset 2022, outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Neuralgia
Clinical narrative: nerve pain and could not move her arm; nerve pain and could not move her arm; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 55-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years intramuscular for covid-19 immunisation.  The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing), notes: Relevant Medical History and Concurrent Conditions (not including reaction / event): Hyperthyroid.  Concomitant medication included: METHIMAZOLE taken for thyroid disorder. The following information was reported: NEURALGIA (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown" and all described as "nerve pain and could not move her arm".  Additional information: 1st vaccine, the vaccine was put in her shoulder capsule and had nerve pain and couldnt move her arm. She did make sure she has padding on her shoulder and not feeling like that. She couldnt tell she couldnt move her left arm till the next morning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site reaction
Clinical narrative: Arm was sore; Had a site reaction; 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, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), for COVID-19 immunization; Comirnaty (Dose 2, single. Patient contracted covid-19 after initial Comirnaty vaccine series.), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm was sore"; VACCINATION SITE REACTION (non-serious), outcome "recovered", described as "Had a site reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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 female patient in her 80's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic to Polyethylene glycol (PEG)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (Dose 2, Single), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Reported as, She was allergic to Polyethylene glycol (PEG) and remembers that when she called, someone told her that it contains 53 mg. However, she stated that she never had an adverse event when she received her first doses of the Pfizer-BioNTech COVID 19 Vaccine. Later she mentioned that she only had a sore arm but that's all. She said she was allergic to PEG on quantities greater than 1000mg. She waited between 4 to 5 months to receive her next dose of the COVID Vaccine. Patient who was in her 80's took three shots of the COVID-19 vaccine and would like to know more regarding the new booster vaccine because she had an allergic reaction with one of the ingredients in it. She also mentioned she was allergic to high doses.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201304036 Same reporter/patient/vaccine/events, different dose;US-PFIZER INC-202201304677 Same reporter/patient/vaccine/events, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction, Magnetic resonance imaging, Myopericarditis
Clinical narrative: Post-COVID-19 Vaccine Associated Myopericarditis; This is a literature report.  A 17-year-old male patient received BNT162b2 (BNT162B2), 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: MYOPERICARDITIS (hospitalization, medically significant), 36 hrs after the suspect product(s) administration, outcome "recovered", described as "Post-COVID-19 Vaccine Associated Myopericarditis". Symptoms at admission: Fever, chills, fatigue, myalgias, pericarditic substernal chest pain. The patient underwent the following laboratory tests and procedures: Ejection fraction: 61 %, notes: at Admission; 57 %, notes: at Follow-Up; 59 %, notes: at Admission; 53 %, notes: at Follow-Up; Magnetic resonance imaging: No edema. Focal midmyocardial and epicardial, notes: delayed enhancement. No pericardial changes.  (at Admission); no edema; mild improvement in enhancement; notes: hyperintense pericardial signal and thickened pericardium; trivial pericardial effusion (4 months). Symptoms at follow-up (4 month): asymptomatic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Post-COVID-19 Vaccine Associated Myopericarditis and the use of suspect product  BNT162b2 cannot be fully excluded.The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/drug/event and different patient.;
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: headache; body aches; chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown".  Clinical course: patient with no additional health conditions had COVID-like symptoms within 24 hours of receiving the COVID bivalent booster dose. Symptoms included headache, body aches and chills. These AEs were not experienced after administration of either initial series doses or the first booster dose. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: injection site soreness; Fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness"; FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown".  Additional information: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Leukaemia
Clinical narrative: leukemia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2017 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: LEUKAEMIA (medically significant), outcome "unknown", described as "leukemia". Additional information: patient had the Prevnar 13 5 years ago (2017) and mentioned that he has a form of leukemia. He wanted to know if he could get Prevnar 20. Patient had a leukemia after getting prevnar13.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Arm sore; Arm sore and "heavy" after bivalent booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm sore"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "Arm sore and "heavy" after bivalent booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown".  Additional information: Patient experienced nausea and headache after receiving booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Chills; Fever; Diarrhea; Coughing which kept me from lying down to sleep; Fatigue; Coughing which kept me from lying down to sleep; Feeling faint; My upper arm was completely black & blue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  An 82-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immunosuppressed" (unspecified if ongoing), notes: I am 82, immunosuppressed. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (1st booster; unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 14Nov2022, outcome "not recovered"; COUGH (non-serious), INSOMNIA (non-serious) all with onset 14Nov2022, outcome "not recovered" and all described as "Coughing which kept me from lying down to sleep"; DIARRHOEA (non-serious) with onset 14Nov2022, outcome "not recovered", described as "Diarrhea"; FATIGUE (non-serious) with onset 14Nov2022, outcome "not recovered"; DIZZINESS (non-serious) with onset 14Nov2022, outcome "not recovered", described as "Feeling faint"; PYREXIA (non-serious) with onset 14Nov2022, outcome "not recovered", described as "Fever"; VACCINATION SITE BRUISING (non-serious) with onset Nov2022, outcome "not recovered", described as "My upper arm was completely black & blue". Additional information: The patient received the 2nd Pfizer booster on Saturday, 12Nov2022. The patient is 82, immunosuppressed, a retired nuclear engineer. The upper arm was completely black & blue. Starting the following Monday, had chills, fever, diarrhea, coughing which kept him/her from lying down to sleep, fatigue, feeling faint. As of today, 17Nov2022, the symptoms have not receded. The patient was sending this email just to advise Pfizer of the outcome of this booster for him/her. Had he/she been aware of the reaction, he/she would not have received it.  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.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia, Vaccination site bruising
Clinical narrative: Chills; Fever; Diarrhea; Coughing which kept me from lying down to sleep; Fatigue; Coughing which kept me from lying down to sleep; Feeling faint; My upper arm was completely black & blue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  An 82-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immunosuppressed" (unspecified if ongoing), notes: I am 82, immunosuppressed. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (1st booster; unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 14Nov2022, outcome "not recovered"; COUGH (non-serious), INSOMNIA (non-serious) all with onset 14Nov2022, outcome "not recovered" and all described as "Coughing which kept me from lying down to sleep"; DIARRHOEA (non-serious) with onset 14Nov2022, outcome "not recovered", described as "Diarrhea"; FATIGUE (non-serious) with onset 14Nov2022, outcome "not recovered"; DIZZINESS (non-serious) with onset 14Nov2022, outcome "not recovered", described as "Feeling faint"; PYREXIA (non-serious) with onset 14Nov2022, outcome "not recovered", described as "Fever"; VACCINATION SITE BRUISING (non-serious) with onset Nov2022, outcome "not recovered", described as "My upper arm was completely black & blue". Additional information: The patient received the 2nd Pfizer booster on Saturday, 12Nov2022. The patient is 82, immunosuppressed, a retired nuclear engineer. The upper arm was completely black & blue. Starting the following Monday, had chills, fever, diarrhea, coughing which kept him/her from lying down to sleep, fatigue, feeling faint. As of today, 17Nov2022, the symptoms have not receded. The patient was sending this email just to advise Pfizer of the outcome of this booster for him/her. Had he/she been aware of the reaction, he/she would not have received it.  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.
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 OMI BA.4-5, as dose number unknown (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: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives". The event "hives" required physician office visit. Therapeutic measures were taken as a result of urticaria.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Skin irritation, Tenderness
Clinical narrative: A little redness / red skin; Tenderness; Irritation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004045 (Novavax).  A male patient received BNT162b2 (BNT162B2), on 26Feb2022 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: ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "A little redness / red skin"; SKIN IRRITATION (non-serious) with onset 2022, outcome "unknown", described as "Irritation"; TENDERNESS (non-serious) with onset 2022, outcome "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: Drug ineffective, Suspected COVID-19
Clinical narrative: Contracted COVID-19; Contracted 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 female patient received BNT162b2 (COMIRNATY), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID-19".  Additional information: Patient contracted COVID-19 after initial Comirnaty vaccine series. Patient contracted COVID-19 after receiving the Comirnaty vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Reaction to excipient
Clinical narrative: Experienced an allergic reaction to one of the preservatives; Experienced an allergic reaction to one of the preservatives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004043 (Novavax).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: REACTION TO EXCIPIENT (non-serious), HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "Experienced an allergic reaction to one of the preservatives". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: arm is a little sore and starting to hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162B2 OMI BA.4-5, on 17Nov2022 as dose number unknown (booster), single (Lot number: Gh9694) for covid-19 immunisation. 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: PAIN IN EXTREMITY (non-serious) with onset 17Nov2022, outcome "unknown", described as "arm is a little sore and starting to hurt".  Additional information: Patient reported that the nurse came in about an hour ago and gave her the booster shot that was supposed to help prevent the new variant. She said she can't read what the nurse wrote. She got a code but doesn't know which one is the Pfizer bivalent booster. She provided 2 lot numbers, fj5682 she got in June and Gh9694 the one she received today. She wanted to know if the booster she got today was the bivalent. She also mentioned that her arm was a little sore and starting to hurt.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site mass, Vaccination site pruritus
Clinical narrative: has a little bump on the injection site and it's been itchy for the last six weeks; has a little bump on the injection site and it's been itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 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: Covid-19 vaccine (Primary immunization completed, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "has a little bump on the injection site and it's been itchy for the last six weeks"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "has a little bump on the injection site and it's been itchy". 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.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: sick; flu-like symptoms; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Nov2022, outcome "unknown", described as "flu-like symptoms"; ILLNESS (non-serious) with onset Nov2022, outcome "unknown", described as "sick".  Additional information: The patient received one of the most recent bivalent booster on tuesday 15Nov and it made the patient very sick for days with flu-like symptoms. The patient attempted to report this to the (name withheld) at (address withheld) where he/she received the booster and they said that they have no means of reporting side effects. This was unacceptable. Patient said that If there were no means of reporting and recording side effects then you are essentially running blind and using them as guinea pigs.  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.
Sex: U
Vaccine: COVID19-2
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fall" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed (Manufacturer Unknown)), for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious), outcome "unknown".  Additional information: The patient was not sure where this should go, but patient had migraine aura several times over the week or two after the latest covid booster. The patient rarely had that (once or twice in a number of years) and after a few days patient thought back and realized it may have been related to the booster. At first patient thought it may have been related to a fall patient would had a few weeks before, but later patient thought it was much closer to the booster. In any case, patient thought someone keeping track of reactions, side effects, might need to know.  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.
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction, Magnetic resonance imaging heart, Myopericarditis
Clinical narrative: Myopericarditis; This is a literature report for the following literature source(s):   A 19-year-old male patient received BNT162b2 (BNT162B2), 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: MYOPERICARDITIS (hospitalization, medically significant, life threatening), 72 hrs after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Ejection fraction: 59 %, notes: (At admission); 56 %, notes: (at follow-up); 54 %, notes: (At admission); 58 %, notes: (at follow-up); Magnetic resonance imaging heart: No edema.Focal mid myocardial and, notes: near transmural delayed enhancement. No pericardial changes. Hyperintense pericardial signal and thickened pericardium (at admission); no edema,mild focal improvement in, notes: enhancement; hyperintense pericardial signal and thickened pericardium; trivial pericardial effusion (at Follow up 4 Months).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event MYOPERICARDITIS  and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/drug/event and different patient;
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: flu vaccine is more painful; Initial information was received on 11-Nov-2022 regarding an unsolicited valid non-serious case received from a patient.  This case involves Adult female patient who reported flu vaccine is more painful while receiving vaccine 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 a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for Prophylactic vaccination.  On an unknown date the patient reported flu vaccine is more painful (Vaccination site pain) (unknown latency) following the administration of Influenza vaccine.  It was reported that: Consumer states the pain with injection is from alcohol wipe and needle going in skin. She states by the time she removes the needle there is no more pain. She states the flu vaccine is more painful. She is not going to respond to paperwork she received.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered
Clinical narrative: received 2 high dose flu shots within 2 weeks; Initial information was received on 11-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who received 2 high dose flu shots wthin 2 weeks while receiving vaccine 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 2 high dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, form, route, administration site, lot number and expiration date) for Prophylactic vaccination within 2 weeks (extra dose administered).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  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: Influenza
Clinical narrative: Flu; Initial information received on 10-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included COVID-19 vaccine.  On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Reportedly, Got mine the 26th Oct n last Covid vac been sick since then with flu.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Malaise, Nasopharyngitis
Clinical narrative: got a flu shot around that time and was wondering if that caused him to feel sick; since last fill caught a cold; cough; Initial information received on 10-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult male patient who since last fill caught a cold, cough  and got a flu shot around that time and was wondering if that caused him to feel sick while receiving vaccine influenza vaccine and while treated with dupilumab [Dupixent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2022, the patient started taking dupilumab at a dose of 600 mg TOTAL once via subcutaneous route (strength: 150 mg/mL, lot - Unknown) for Atopic dermatitis. On an unknown date, dupilumab dosage was changed to 300 mg QOW for Atopic dermatitis.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious events of got a flu shot around that time and was wondering if that caused him to feel sick (malaise), since last fill caught a cold (nasopharyngitis) and cough (unknown latency) following the first dose intake of dupilumab and (unknown latency) following the administration of influenza vaccine.  It was reported, since last fill, "caught a cold." pt not sure if was a side effect. he believed he started feeling sick about 3 weeks ago, but last dose of dupixent was about a week after that, so doesn't think it was from the shot. he also says he got a flu shot around that time and was wondering if that caused him to feel sick he slates that only the cough remains, but it is bothering him he will speak to and about it and see if he can get something for the cough.   Action taken with DUPILUMAB (DUPIXENT) was unknown. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (since last fill caught a cold, got a flu shot around that time and was wondering if that caused him to feel sick, cough).  At time of reporting, the outcome was Unknown for all the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu now; Initial information received on 13-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who got the flu now while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, route: unknown) lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient got the flu now (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Regulatory authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu now).  At time of reporting, the outcome was Unknown for the event
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: inadvertently administered tenivac instead of daptacel; missed dose with no reported adverse event.; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 01358211.  This case involves a 4 years old female patient who was inadvertently administered Tenivac instead of Diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] missed dose with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Nov-2022 the patient inadvertently administered Tenivac instead of Daptacel (with unknown strength, dose, lot number and expiration date) with no reported adverse event (product dose omission issue) (unknown latency).  Action taken: Not applicable.  Outcome: Unknown.   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.
Age: 0.42
Sex: F
Vaccine: UNK
Symptoms: Incorrect product formulation administered, Medication error, No adverse event
Clinical narrative: only received the liquid portion with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old female patient who only received the liquid portion with no reported adverse event. (DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 01-Nov-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ684AA and Expiration Date :16-Sep-2023)Strength: standard at a dose of 0.5 ml Total via intramuscular route in the left vastus lateralis for Immunization.  On an unknown date the patient only received the liquid portion with no reported adverse event (incorrect product formulation administered)(unknown latency).  Reportedly, stated 2 patients received PENTACEL. One patient received the full dose, the other only received the liquid portion. HCP isn't sure which patient received the full dose. Caller states that she has two patients that received Pentacel and realized that they had an extra Hib dose and only one was given. Caller states that she realized as she was providing the lot and expiation information that the second patients Pentacel were from the state vaccine and he received his full dose. Caller states that another patient did not receive a full dose of Pentacel because last month she 5 doses and now she has 3 and half.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient received Fluzone High-Dose Quadrivalent twice this season 14SEP2022 and 7NOV2022, with no reported adverse event; Initial information received on 10-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 65-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] twice this season 14sep2022 and 7nov2022, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2022, on the same day the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE twice this season (strength, formulation, dose: unknown) in unknown administration site and on 07-Nov-2022 at 0.7ml total dose (lot number: UJ924AC and expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization, with no reported adverse event (extra dose administered).  It was reported, reporter was requesting safety information. This situation is reported as a medication error due to two FLUZONE HIGH-DOSE QUADRIVALENT administrations in this flu season.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was unknown.  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.