chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram, Cystocele, Uterine prolapse, X-ray
Clinical narrative: prolapsed bladder or uterus; prolapsed bladder or uterus; This is a spontaneous report received from a 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 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "covid-19". The following information was reported: CYSTOCELE (non-serious), UTERINE PROLAPSE (non-serious), outcome "unknown" and all described as "prolapsed bladder or uterus". Relevant laboratory tests and procedures are available in the appropriate section.  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: Asthenia, Decreased immune responsiveness, Movement disorder
Clinical narrative: my body just keeps getting weaker and weaker; It's like I have no immune system anymore; couldn't get out of bed; 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), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, I received the first round of your double Covid vaccine back in Jan2021), administration date: Jan2021, for COVID-19 immunization, reaction(s): "I had a reaction to it in my left arm & that night my right hand started trembling", "I had a reaction to it in my left arm & that night my right hand started trembling"; Bnt162b2 (DOSE 2, SINGLE, I received the first round of your double Covid vaccine back in Jan2021, Anatomical location: right arm), administration date: Jan2021, for COVID-19 immunization. The following information was reported: MOVEMENT DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "couldn't get out of bed"; ASTHENIA (non-serious), outcome "unknown", described as "my body just keeps getting weaker and weaker"; DECREASED IMMUNE RESPONSIVENESS (non-serious), outcome "unknown", described as "It's like I have no immune system anymore". Additional information: In August I had the Delta variant couldn't get out of bed, 2022 covid, 2023 covid. It's like I have no immune system anymore thanks to your vaccine and my body just keeps getting weaker and weaker. Doctors are no help. Long Covid is killing me.  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-PV202300167477 Same patient and reporter; different vaccine dose and event;US-PFIZER INC-202300321704 Same patient and reporter; different vaccine dose and event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 23Sep2023 to 29Sep2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320744 same patient, different suspect drug/AE;
Age: 60.0
Sex: F
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(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30May2022 as dose 5 (booster), single (Lot number: FH8027) at the age of 60 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "severe gastroparesis" (unspecified if ongoing); "Known allergies Erythromycin" (unspecified if ongoing); "Known allergies reglan" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Weak positive, notes: previous test on Day 8 was weak positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 24Sep2023 to 28Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320767 same patient, different event/ drug (Paxlovid case);
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, COVID-19, Computerised tomogram, Drug ineffective, X-ray
Clinical narrative: I had COVID; I had COVID; This is a spontaneous report received from a 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 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had COVID". The patient underwent the following laboratory tests and procedures: Angiogram: Unknown Results; Computerised tomogram: Unknown Results, notes: I told I went to ER and they said it was be going to take X-rays, CTs, Bladder or uterus,; X-ray: Unknown Results, notes: I told I went to ER and they said it was be going to take X-rays, CTs, Bladder or uterus,.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID 19 Treatment from 21Sep2023 to 26Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), on 15Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years 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), 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. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was treated with PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Off label use, Vaccination site pain
Clinical narrative: DOSE 4 (BOOSTER); DOSE 4 (BOOSTER); sore arm-no big deal; violent chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An 81-year-old female patient received bnt162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "violent chills", "sore arm-no big deal"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "violent chills", "sore arm-no big deal"; Bnt162b2 (DOSE 3, SINGLE), for COVID-19 Immunization, reaction(s): "violent chills", "sore arm-no big deal". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "DOSE 4 (BOOSTER)"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm-no big deal"; CHILLS (non-serious), outcome "unknown", described as "violent chills".  Additional information: With the previous Pfizer Covid vaccinations, she felt all of them go into her arm muscle. Patient reported that she felt it go into her muscle and she got a bit of a sore arm-no big deal. Then about twelve hours later on the money every time, she has gotten violent chills that last about another 12 hours or so.   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-202300322049 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322023 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322046 Same reporter, Patient / Different AE, Vaccine Dose;
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pain in extremity
Clinical narrative: bit of a sore arm; DOSE 5 (BOOSTER); DOSE 5 (BOOSTER); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An 81-year-old female patient received bnt162b2 (COMIRNATY), as dose 5 (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: Bnt162b2 (DOSE: 1st), for Covid-19 immunization, reaction(s): "sore arm-no big deal"; Bnt162b2 (DOSE: 2nd), for Covid-19 immunization, reaction(s): "sore arm-no big deal"; Bnt162b2 (DOSE: 3rd), for Covid-19 immunization, reaction(s): "sore arm-no big deal"; Bnt162b2 (DOSE: 4th), for Covid-19 immunization, reaction(s): "DOSE 4 (BOOSTER)", "DOSE 4 (BOOSTER)", "sore arm-no big deal". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "bit of a sore arm"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "DOSE 5 (BOOSTER)".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 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: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". Additional information: Concern, consumer stated, I get the vaccine yesterday, the  (Comirnaty) and I feel dizzy, is that because of it, I read this is some of the side effects."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pain in extremity
Clinical narrative: sore arm; stomach ache; headache; 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.  An adolescent male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes:  prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacture), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Oct2023, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 08Oct2023, outcome "recovering", described as "sore arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 08Oct2023, outcome "recovering", described as "stomach ache". Therapeutic measures were not taken as a result of pain in extremity, abdominal pain upper, headache.  Additional information: The patient was not COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, RSV
Symptoms: Body height, Vaccination site bruising
Clinical narrative: Developed black and blue over about 6 square inches of skin and that seemed a little unusual; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-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) intramuscular, in left arm for covid-19 immunisation; respiratory syncytial virus vaccine (RESPIRATORY SYNCYTIAL VIRUS VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing); "Cholesterol" (ongoing); "blood sugar" (ongoing). Concomitant medication(s) included: OLMESARTAN taken for blood pressure measurement (ongoing); CRESTOR taken for blood cholesterol (ongoing); TRAJENTA taken for blood glucose abnormal (ongoing); JARDIANCE taken for blood glucose abnormal (ongoing). Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 Immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious), outcome "unknown", described as "Developed black and blue over about 6 square inches of skin and that seemed a little unusual". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site bruising.  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: COVID-19, Drug ineffective
Clinical narrative: having COVID; having COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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), COVID-19 (medically significant), outcome "unknown" and all described as "having COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 65 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 26Mar2021 as dose 2, single (Lot number: EP6955), in right arm, on 04Sep2021 as dose 3 (booster), single (Lot number: FC3183), in right arm and on 15Jun2022 as dose 4 (booster), single (Lot number: FM7553), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Cancer", start date: 2017 (unspecified if ongoing); "sensory hearing loss" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "tinnitus" (unspecified if ongoing), notes: 20000. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; terrible aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "terrible aches and pains".  Additional information: Reporter mentioned that two other people that had very similar side effects just like herself. Two friends of reporter mentioned the same thing and they never had the same response like this before. So, reporter don't know whether the patient is supposed to take Tylenol afterwards.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, 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 (Consumer or other non HCP) from medical information team. 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; 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 included: "COVID-19" (unspecified if ongoing), notes: before the vaccines came out. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) She had COVID-19. Additional information: The patient called as she wanted to know how effective the vaccine was. She had her 5th vaccine in Apr2023 and was asking how long it will last. She had COVID-19 before the vaccines came out and got all the Pfizer COVID-19 vaccines and she still had COVID-19 every year. Her husband got all Moderna vaccines and he never got COVID-19. The patient stated that Moderna vaccines are better than Pfizer vaccines. The last time she had COVID-19 was in Jan2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising immediately or right after receiving the new 2023-2024 formulation of the COVID-19 vaccine, and that gets worse with time / She's worried about her arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "Bruising immediately or right after receiving the new 2023-2024 formulation of the COVID-19 vaccine, and that gets worse with time / She's worried about her arm". Additional information: The patient would like to know if there's any report of bruising immediately or right after receiving the new 2023-2024 formulation of the COVID-19 vaccine, and that gets worse with time. She's worried about her arm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm pain; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 30Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Oct2023, outcome "recovered", described as "Arm pain"; FATIGUE (non-serious) with onset 07Oct2023, outcome "recovered" (08Oct2023), described as "tired". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: Arm pain, she stated it felt like the shot went up her neck and also into her heart. She panicked a bit but then calmed down. She went home and took an hour nap. She was tired for the rest of the day. Recovered except for sore arm today (next day). Covid not tested post vaccination. The patient had no known allergies.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache, sore left arm; Headache, sore left arm; 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 female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE], on 30Sep2023 as dose number unknown, single; MONTELUKAST SODIUM; XYZAL. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 05, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 06, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 07Oct2023 at 21:00, outcome "recovered" (Oct2023) and all described as "Headache, sore left arm". Therapeutic measures were not taken as a result of headache, pain in extremity.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 60 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: after completing Paxlovid and testing  negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid administered from 27Sep2023 to 01Oct2023.
Age: 40.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Vaccination site pain
Clinical narrative: sore arm at injection site. I also got Flucelvax in the same left arm at the same time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 08Oct2023 at 10:30 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 immunization; Flucelvax (Dose: 01, Manufacturer: Unknown), for immunisation; Flucelvax (Dose: 02, Manufacturer: Unknown), for immunisation; Flucelvax (Dose: 03, Manufacturer: Unknown), for immunisation; Flucelvax (Dose: 04, Manufacturer: Unknown), for immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Oct2023, outcome "recovering", described as "sore arm at injection site. I also got Flucelvax in the same left arm at the same time.". Therapeutic measures were not taken as a result of vaccination site pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pain of skin
Clinical narrative: Skin pain; Sore arm; Hip pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: the patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 08Oct2023, outcome "recovering", described as "Hip pain"; PAIN OF SKIN (non-serious) with onset 08Oct2023, outcome "recovering", described as "Skin pain"; PAIN IN EXTREMITY (non-serious) with onset 08Oct2023, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of pain of skin, pain in extremity, arthralgia.  Additional information: The patient has not been tested for COVID-19 Since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 6 (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), 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 included: "Penicillin" (unspecified if ongoing); "wasp bites" (unspecified if ongoing); "Metastatic sweat gland carcinoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received COVID 19 anti viral treatment with Paxlovid form 01Oct2023 to 05Oct2023. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: felt lousy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Lot number: HG4680) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt lousy". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient got the Covid19 Vaccine and mentioned that after getting it felt lousy so did a test for Covid and it was negative.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose 1: Pfizer, Dose 2: Pfizer, Dose 3: Moderna; COVID 19 Treatment.; COVID 19 Treatment.; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Product Quality Group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Mar2021 at 15:00 as DOSE 1, SINGLE (lot number: ER 873c), administered in the left arm and on 13Apr2021 at 15:00 as DOSE 2, SINGLE (lot number: Er8735) at the age of 39 years, administered in the left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 09Dec2021 as DOSE 3 (BOOSTER), SINGLE (lot number: 031h21a), administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "ezcema" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Nickel allergy" (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 28Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment."; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" described as "Dose 1: Pfizer, Dose 2: Pfizer, Dose 3: Moderna." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2023) Positive, notes: Initial day of Covid/ Treatment of COVID-19. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Colon cancer stage II, Intestinal obstruction
Clinical narrative: recurrent bowel obstructions; stage 2 colon cancer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received bnt162b2 (BNT162B2), on 16Apr2021 as dose 2, single (Lot number: EW0164) at the age of 53 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Depression/Anxiety" (ongoing); "Depression/Anxiety" (ongoing); "Hypothyroidism" (ongoing); "Restless leg syndrome" (ongoing). Concomitant medication(s) included: SYNTHROID oral taken for hypothyroidism (ongoing); MIRAPEX oral taken for restless legs syndrome (ongoing); ZOLOFT oral taken for depression, anxiety (ongoing). Vaccination history included: bnt162b2 (Anatomical site of injection: Arm (deltoid), Route of administration: Intramuscular, Batch/Lot Number: FR8733), administration date: 26Mar2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: COLON CANCER STAGE II (medically significant) with onset 02Jun2021, outcome "recovered" (16Jun2021), described as "stage 2 colon cancer"; INTESTINAL OBSTRUCTION (medically significant) with onset 25Jun2021, outcome "not recovered", described as "recurrent bowel obstructions". Therapeutic measures were taken as a result of colon cancer stage ii.  Clinical information: Illness/AE: Stage 2 colon cancer, Onset Date: 02Jun2021, Stop Date: 16Jun2021, Pertinent Details: Partial colectomy 16Jun2021. no chemo or radiation. Illness/AE: Recurrent bowel obstructions, Onset Date: 25Jun2021, Stop Date: ongoing, Pertinent Details: Have had 6 obstructions since colectomy. Began after cancer surgery. Received full vaccination course and two boosters, all from Pfizer. Due to cancer history and vulnerable family members, patient hoped my vaccination would help protect her better. Dated: 26Sep2023. The product was prescribed by a healthcare professional and was taken as prescribed. Only taking ongoing maintenance meds. Specific relevant tests for thromboembolic events with thrombocytopenia were none. Pfizer/BioNTech COVID-19 Vaccine Details 3rd dose: Date: 11May2021, Anatomical Site of injection: Arm (deltoid), Route of administration: Intramuscular, Batch/Lot number: Pfizer 301308A (Booster). 4th dose: Date: 30Sep2022, Anatomical Site of injection: Arm (deltoid), Route of administration: Intramuscular, Batch/Lot number: Pfizer Bivalent GN9693. 1st and 2nd dose was at Public Health Clinic/Facility and Vaccine was not administered at Military Facility. 3rd and 4th dose was at Pharmacy or Drug Store and Vaccine not Administered at Military Facility. Booster dose due to a weakened immune system: Current or recent cancer (including blood cancers such as Hodgkin's disease, leukemias, and myelomas). Prior vaccinations (within 4 weeks) were none.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Aug2023 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received paxlovid from 29Sep2023 to 03Oct2023.   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: Dermatomyositis
Clinical narrative: Dermatomyositis flare-up following the SARS-CoV-2 vaccine; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATOMYOSITIS (medically significant), outcome "unknown", described as "Dermatomyositis flare-up following the SARS-CoV-2 vaccine".; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Dermatomyositis and the suspect drug cannot be completely excluded. 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.
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria
Clinical narrative: Chronic Spontaneous Urticaria; This is a literature report.  A 35-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto disease" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "Ehlers-Danlos syndrome" (unspecified if ongoing). The patient had no previous COVID-19 infection diagnosed.  The patient's concomitant medications were not reported. The following information was reported: CHRONIC SPONTANEOUS URTICARIA (medically significant), 7 hrs after the suspect product(s) administration, outcome "recovering". Resolution reported as symptom control but no resolution. Therapeutic measures were taken as a result of chronic spontaneous urticaria, included Anti-H1, sCS.; Sender's Comments: Based on the known the information available the Causal relation between the event CHRONIC SPONTANEOUS URTICARIA  and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug 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-PV202300166685 Same article/ drug/patient/ different event;
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash on her arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: RASH (non-serious), outcome "unknown", described as "a rash on her arm".  Additional information: An unknown consumer wanted to know why is there a reaction and a rash on her arm after she took the new COVID-19 vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: migraines not a day has passed that I have not had one; Pain; 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.  An adult patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "migraines not a day has passed that I have not had one"; PAIN (non-serious), outcome "not recovered".  Additional Information: Reporter said when the COVID shot come out, had gotten it. Since then patient have had migraines not a day has passed that he/she have not had one. Patient was unable to find a medication that will relieve the pain. Patient was interested for a "Dui an". No one here seems to know where to turn or what to give the patient to relieve the pain. Patient was hoping that someone there at Pfizer could take some time to reply back to patient with the names of medication he/she could use to become somewhat "Normal" again. Then he/she could take the letter and show it to the Drs. where patient was located and change things around.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Syncope
Clinical narrative: fainting; asthma; 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), in Dec2022 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 immunisation. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "fainting"; ASTHMA (non-serious), outcome "unknown". Clinical course: The caller said that she was trying to got the Pfizer booster shot, and her last booster was in Dec2022. The caller said that she really needed to got the vaccine. The caller said that she was getting her vaccine in her doctor's office, but they don't had it. The caller wanted to know when her doctor's office would have the vaccine and also their local health department. The caller said the pharmacy in her area that carries the vaccine didn't had a bed to lie down on because she was fainted if she got the vaccine without lying down in the bed. Reporter created the manual AE form because the caller already took the vaccine and had asthma, and she was fainted upon receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.