chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She already received the 2 doses and 3 boosters of the Pfizer Covid-19 vaccine. She tested positive for Covid; She already received the 2 doses and 3 boosters of the Pfizer Covid-19 vaccine. She tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A female patient received BNT162b2 (BNT162B2), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), 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), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "She already received the 2 doses and 3 boosters of the Pfizer Covid-19 vaccine. She tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive.  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-202201173405 same patient/vaccine, different dose/event;
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 08Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (unspecified if ongoing), notes: been taking Flovent, singular, Zyrtec and sertraline. Symptoms moderate and improving slowly as of 19Sep2022.; "Depression" (unspecified if ongoing); "obesity" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flovent for asthma; Zyrtec for asthma; Sertraline for asthma. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2022) Negative, notes: I had negative COVID antigen tests on 11Sep2022 and 14Sep2022; (14Sep2022) Negative, notes: I had negative COVID antigen tests on 11Sep2022 and 14Sep2022; (17Sep2022) positive, notes: . I retested on 17Sep2022 when my son got a fever (previously negative as I had isolated from him) and the antigen test was positive; (08Sep2022) positive, notes: First positive PCR was on 08Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid as COVID 19 Treatment from 08Sep2022 to "06Sep2022" (as reported).; Sender's Comments: Based on the available information in the case, the causal association between the event Covid-19 and vaccination failure  and the suspect drug BNT162B2 cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 14Jan2022 at 12:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 38 years, in left arm for covid-19 immunisation; covid-19 vaccine, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Eggs and egg-derived products allergies" (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 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: got a dose of the Pfizer Covid 19 orange cap formulation instead of the recommended maroon cap formulation; got a dose of the Pfizer Covid 19 orange cap formulation instead of the recommended maroon cap formulation; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 4-year-old patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) at the age of 4 years 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), for COVID-19 immunisation. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "got a dose of the Pfizer Covid 19 orange cap formulation instead of the recommended maroon cap formulation".  Additional information: Caller was a physician reporting that a patient just turned 4 years old. Caller stated, that was the patient's second dose so she asked if she could still get the 3rd dose of the maroon cap 8 weeks later.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient had 4 Pfizer COVID vaccines and tested positive for COVID virus; Patient had 4 Pfizer COVID vaccines and tested positive for COVID virus; 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 73-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 11Feb2021 as dose 2, single (Lot number: EM9809), in right arm, on 14Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 19May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Stated she is fat" (unspecified if ongoing), notes: Onset Date: 20-25 years. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Sep2022, outcome "recovered" and all described as "Patient had 4 Pfizer COVID vaccines and tested positive for COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Sep2022) Negative; (05Sep2022) Negative; (07Sep2022) Positive; (Sep2022) Negative, notes: Just negative COVID Test since she has taken Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: She always wore a mask and had been for 2 years. She took it off 10 minutes to eat a sandwich. She thought that was where she got COVID. She was exposed on 03Sep2022. Patient took Paxlovid from 07Sep2022 to 12Sep2022 and was still pretty tired and the hoarseness was weird. Patient had a couple of rough days last week, around 07Sep2022 through 09Sep2022, but otherwise, pretty good. She was not completely recovered even though she had tested negative 3-4 times.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173786 same patient/drug, different doses/events;
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Headache, Lip swelling, SARS-CoV-2 test, Swelling face
Clinical narrative: Patient had 4 Pfizer COVID vaccines and tested positive for COVID virus; Patient had 4 Pfizer COVID vaccines and tested positive for COVID virus; 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 73-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 11Feb2021 as dose 2, single (Lot number: EM9809), in right arm, on 14Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 19May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Stated she is fat" (unspecified if ongoing), notes: Onset Date: 20-25 years. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Sep2022, outcome "recovered" and all described as "Patient had 4 Pfizer COVID vaccines and tested positive for COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Sep2022) Negative; (05Sep2022) Negative; (07Sep2022) Positive; (Sep2022) Negative, notes: Just negative COVID Test since she has taken Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: She always wore a mask and had been for 2 years. She took it off 10 minutes to eat a sandwich. She thought that was where she got COVID. She was exposed on 03Sep2022. Patient took Paxlovid from 07Sep2022 to 12Sep2022 and was still pretty tired and the hoarseness was weird. Patient had a couple of rough days last week, around 07Sep2022 through 09Sep2022, but otherwise, pretty good. She was not completely recovered even though she had tested negative 3-4 times.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173786 same patient/drug, different doses/events;
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Lip swelling, Swelling face
Clinical narrative: Half her face swollen from all of these vaccines/ It was her left side; her lip and face were a little swollen; flushing/ just right cheek would flush real red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL1283), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: SWELLING FACE (non-serious), outcome "recovered", described as "Half her face swollen from all of these vaccines/ It was her left side"; LIP SWELLING (non-serious), outcome "recovered", described as "her lip and face were a little swollen"; FLUSHING (non-serious), outcome "recovered", described as "flushing/ just right cheek would flush real red". Therapeutic measures were taken as a result of swelling face, lip swelling, flushing.  Additional information: Patient stated she is fat as medical history (no height, weight, or BMI reported) for 20-25 years. First COVID-19 vaccine dose was administered either on 21Jan2021 or 20Jan2021, it was a zero with a line going through it. Patient received four doses of Pfizer vaccines. Half her face was swollen from all of these vaccines. It was her left side. She recovered completely. It took a long time for the face to be normal. It was not swollen real big, but her lip and face were a little swollen. The first one she had, the doctor onsite said to take diphenhydramine hydrochloride  (BENADRYL) and she told him she already takes allergy pills. She took diphenhydramine hydrochloride  when she got home. She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3; she could have had for the last one. Patient stated she takes her normal medications (not further specified).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 69-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6202), in right arm, on 16Mar2021 as dose 2, single (Lot number: ER8727), in right arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF884), in left arm and on 23May2022 at 11:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), 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. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Pfizer COVID 19 Treatment from 03Sep2022 to 07Sep2022.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" 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. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Interchange of vaccine products, Oral herpes, Oral mucosal eruption
Clinical narrative: Rash on mouth; looks like cold sores; Rash on mouth; looks like cold sores; Dose1: Janssen; dose 2: Moderna; dose 3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2022 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 16Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: janssen (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 10Mar2022, for COVID-19 Immunization; moderna coviD-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 25May2022, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 16Sep2022 at 09:00, outcome "unknown", described as "Dose1: Janssen; dose 2: Moderna; dose 3: Pfizer"; ORAL MUCOSAL ERUPTION (non-serious), ORAL HERPES (non-serious) all with onset 17Sep2022, outcome "not recovered" and all described as "Rash on mouth; looks like cold sores". Therapeutic measures were not taken as a result of oral mucosal eruption, oral herpes.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.  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: Cerebrovascular accident, Visual field defect
Clinical narrative: Doctor said bilateral stroke causing loss of peripheral vision on right; Doctor said bilateral stroke causing loss of peripheral vision on right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EK9231), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID; VITAMIN D [COLECALCIFEROL]; FOLIC ACID. Vaccination history included: BNT162b2 (at 10:00, dose 1, in left arm, Lot number: EK9231), administration date: 06Jan2021, for COVID-19 immunisation. The patient had no known allergies. The following information was reported: CEREBROVASCULAR ACCIDENT (disability), VISUAL FIELD DEFECT (disability) all with onset 21Feb2021 at 12:00, outcome "recovered with sequelae" and all described as "Doctor said bilateral stroke causing loss of peripheral vision on right". The event "doctor said bilateral stroke causing loss of peripheral vision on right" required physician office visit.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had chills this morning and was cold and tested positive for COVID; she received the Pfizer Covid19 booster vaccine months ago and has tested positive for Covid today; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 19Sep2022, outcome "unknown", described as "Had chills this morning and was cold and tested positive for COVID"; DRUG INEFFECTIVE (medically significant) with onset 19Sep2022, outcome "unknown", described as "she received the Pfizer Covid19 booster vaccine months ago and has tested positive for Covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Positive, notes: has tested positive for COVID today.  Clinical course as follows: patient received the Pfizer COVID19 booster vaccine months ago and has tested positive for COVID today. Caller states she is driving in the car on the way to pick up her grandson from school and is asking "am I still contagious if I wear a N95 mask". Serious was reported as No. Got booster of Pfizer COVID vaccine months ago. Had chills this morning and was cold and tested positive for COVID. Called before last year regarding her vaccines. Now this morning when she had this problem her daughter and son-in-law don't have anyone to pick up her grandson. Called Pfizer to see if ok to pick him up. Caller mentioned that she already completed her primary series and booster shots for Pfizer COVID 19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; 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 received BNT162b2 (BNT162B2), 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive; (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid 5 days treatment and last on 06Sep.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19: Yes; result: positive; Since the vaccination, has the patient been tested for COVID-19: Yes; result: positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 at 10:00 as dose 1, single (Lot number: EK9231), in left arm, as dose 2, single (Lot number: EK9231), in left arm, on 01Sep2021 at 12:00 as dose 3 (booster), single (Lot number: EC3180), in left arm and on 23Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID; VITAMIN D [COLECALCIFEROL]; FOLIC ACID. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19: Yes; result: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Dose 1 and 2: Moderna, Dose 3: Pfizer; 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 (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: FJ8762) at the age of 39 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Lot number: 046A21A), in left arm and on 22Apr2021 as dose 2, single (Lot number: 038B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Jan2022, outcome "unknown", described as "Dose 1 and 2: Moderna, Dose 3: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid from 06Sep2022 to 11Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 27Feb2021 as dose 2, single (Lot number: EN5318), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 30558A) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Cervical Myelopathy" (unspecified if ongoing); "known allergies: Raw egg" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing); "known allergies: dust" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment for Covid-19 Test; (17Sep2022) Positive, notes: Rebound Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid anti-viral COVID 19 Treatment which start date was 07Sep2022 and stop date was 12Sep2022 (lot numberGC0490).  No follow-up attempts are possible. No further information is expected
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: off label use; Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: EW0173) at the age of 67 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Aug2022 as dose 4 (booster), single (Lot number: 044C22A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DOXYCYCLINE; CETIRIZINE. The following information was reported: OFF LABEL USE (medically significant), outcome "not recovered"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), 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: rapid test. Therapeutic measures were taken as a result of off label use, interchange of vaccine products, drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173813 Same patient, different product and event;
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Sep2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (Sep2022) Negative, notes: Tested negative days 5-10; (Sep2022) Positive, notes: Tested positive again on Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid from 10Sep2022 to 15Sep2022 used for the treatment of covid-19.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID on 07Aug; got COVID on 07Aug; 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), on 02May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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) all with onset 07Aug2022, outcome "unknown" and all described as "got COVID on 07Aug".  Clinical course: Patient reported that she has an appointment today at 5:20 pm for the new variant of Pfizer COVID-19 Vaccine Bivalent and was just concerned because she just had COVID about 40 days ago. She was confirming if she was able to get it or not because she got her last Booster Pfizer COVID-19 Vaccine on 02May and then got COVID on 07Aug. So, she wants to know if she can still get the Pfizer COVID-19 Vaccine Bivalent or not and don't want to get transferred to multiple people to get an answer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cough
Clinical narrative: My infant developed a cough after getting vaccinated. I have 2 other children in my home who are not sick. Only symptom for my newborn is a cough after vaccination.  In 1993 I developed pertussis as an infant after vaccination and the cough my newborn has is the same cough sound according to my mother. My infant now has a doctor appointment for Friday and will be speaking with his doctor and he will no longer receive tdap , he will only receive TD vaccine. I do not trust tdap vaccines any longer.
Sex: F
Vaccine: COVID19
Symptoms: Neuromyelitis optica spectrum disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), 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: NEUROMYELITIS OPTICA SPECTRUM DISORDER (medically significant), outcome "unknown", described as "neuromyelitis optica". Additional information: a woman suspects she has developed neuromyelitis optica as an adverse effect of the Pfizer booster. She developed the symptoms less than a month after vaccination, and has no underlying health conditions, NMO (neuromyelitis optica) usually needs to be preceded by infection, the vaccination was the only major event preceding her symptoms. 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: Fatigue, Headache
Clinical narrative: Fatigue; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-023809 (Moderna).  A 35-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Trimethoprim for Drug allergy. The following information was reported: FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown".  Additional information: She had very mild side effects with Pfizer doses. She might have had fatigue and headache, but no side effects from the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My mom had a adverse reaction and died; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female 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: DEATH (death, medically significant), outcome "fatal", described as "My mom had a adverse reaction and died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Open-ended question: Please describe below all you remember about the Pfizer-BioNTech/Comirnaty advertisement you saw. Please include what you saw, what was said about Pfizer-BioNTech/Comirnaty, and what ideas about Pfizer-BioNTech/Comirnaty were brought out in the advertisement. That it is preferred by over one hundred people. I don't agree with this vaccination. My mom had a adverse reaction and died.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: My mom had a adverse reaction and died
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: have sensitivity in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), 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 complete; Manufacturer unknown.), for COVID-19 Immunization. The following information was reported: SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "have sensitivity in the arm".  Additional information: Patient received one Booster months ago by Pfizer and had sensitivity in the arm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: too many people I know have come down with covid even after being fully vaccinated, including myself; too many people I know have come down with covid even after being fully vaccinated, including myself; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), 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 "too many people I know have come down with covid even after being fully vaccinated, including myself".  Clinical Course: Reported that the patient was thinking of the advertising he just saw saying, 'please enter anything you felt, thought, or were reminded of while viewing it. Everything was acceptable. There are no right or wrong answers, no silly or dumb feelings. Don't worry about spelling, punctuation, or grammar'. He understood the idea of getting vaccinated, since he was fully vaccinated and had the additional booster. When it was said that, it fully protects from covid, he disagree, too many people he knew had come down with covid even after being fully vaccinated, including himself. Inquired if it was not better just to say it minimizes the effects of covid. Patient had no side effects from the Pfizer/BioNTech vaccine, while with moderna he did. This way he thought Pfizer-BioNTech COVID-19 vaccine unique and different from other COVID-19 vaccines.  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-202201174283 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental exposure to product, Underdose, Vaccination site pain
Clinical narrative: When it was administered it hurt a lot; some vaccine spewed out on my arm; some vaccine spewed out on my arm; 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 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 PAIN (non-serious), outcome "unknown", described as "When it was administered it hurt a lot"; UNDERDOSE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown" and all described as "some vaccine spewed out on my arm".  Additional Information: The patient (reporter) received the newest booster and had terrible side effects and when it was administered it hurt a LOT. When the young man pulled the shot out some vaccine spewed out on my arm.  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.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered powder reconstituting it with non-GSK diluent; administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   Concurrent medical conditions included allergic rhinitis (on 24th December 2016) and constipation (on 18th July 2018).   On 24th August 2022, the patient received the 1st dose of Menveo (intramuscular). On 24th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The registered nurse reported that the patient received Menveo in that administered powder reconstituting it with non-GSK diluent. The patient was revaccinated on 1st September 2022. All five potential patients were recalled for revaccination. No adverse reactions known. The reporter stated that the system was utilized from 6th September 2022. Diluent would be dispensed with the powder in this machine. Nurses to check all vials for vaccines prior to administration. The reporter did not consent to follow up. Additional supportive information: Menveo reconstituted with non-GSK diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR131247:Same reporter US-GSK-US2022AMR131228:Same reporter US-GSK-US2022AMR131200:Same reporter US-GSK-US2022124956:Same reporter/ original report
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via a social media and by a company representative concerned a male of an unspecified age race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s (second shot), the patient experienced stroke (Dose number in series: 2). It was reported that "One of my brothers (I have 3) after he took the second COVID shot he had a stroke, he is doing better now, but not like he used. To be". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220939883-covid-19 vaccine ad26.cov2.s-Stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, SARS-CoV-2 test
Clinical narrative: MIld soreness in shoulder; COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and ARTHRALGIA (MIld soreness in shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D [VITAMIN D NOS] and ATORVASTATIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced ARTHRALGIA (MIld soreness in shoulder). At the time of the report, COVID-19 (COVID) and ARTHRALGIA (MIld soreness in shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Diagnosed with Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported.  Company comment: This case concerns a 68 Y/O M with an unexpected event of COVID-19 and expected event of arthralgia. Event onset 14 days after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Upon internal review on 20-Sep-2022, non-significant correction was performed to update case level seriousness.; Sender's Comments: This case concerns a 68 Y/O M with an unexpected event of COVID-19 and expected event of arthralgia. Event onset 14 days after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient received a positive result on a COVID test on Sep 18 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient received a positive result on a COVID test on Sep 18 2022) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs).   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2022, the patient experienced COVID-19 (Patient received a positive result on a COVID test on Sep 18 2022). At the time of the report, COVID-19 (Patient received a positive result on a COVID test on Sep 18 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, SARS-CoV-2 test: (Positive) Positive.   Concomitant products included Thyroid pill. No treatment details were reported. Patient had experienced after vaccination the following symptoms: Scratchy throat and a runny nose and sneezing, so patient took COVID-19 test and it came out positive. Patient had not seek medical care. Patient had not experienced the similar events in the past.   Reporter did not allow further contact