chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). 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 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 01Dec2023 to 05Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: 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 contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Nov2023 at 10:30 as dose 1, single (Lot number: HG4675) at the age of 63 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 immunization. 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 Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid given as   COVID 19 Treatment start date= 02Dec2023, treatment stop date=06Dec2023)  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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Laboratory test
Clinical narrative: blood on 1 side of nostril, and it was dripping/bloody nose; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Dec2023 at 14:00 as dose 1, single (batch/lot number: HM7010) at the age of 66 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "celiac disease" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medications included: BREO ELLIPTA resp inhalation. Vaccination history included: flu vaccine (vaccine prior past 4 weeks), administration date: 19Oct2023, for immunization; Bnt162b2 (dose 1, batch/lot number unknown), for COVID-19 immunization; Bnt162b2 (dose 2, batch/lot number unknown), for COVID-19 immunization; Bnt162b2 (dose 3 (booster), batch/lot number unknown), for COVID-19 immunization; Bnt162b2 (dose 4 (booster), batch/lot number unknown), for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 13Dec2023 at 07:00, outcome "recovered", described as "blood on 1 side of nostril, and it was dripping/bloody nose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of epistaxis.  Additional information: The patient was calling regarding the Pfizer Covid-19 vaccine yesterday, stated that this was the 5th one she received over the years. The route of administration was stated as "It is an injection". The patient informed that today (also reported "this morning") she woke up to blood on 1 side of nostril, and it was dripping. The patient informed that she never had a bloody nose before. The patient wanted to know if it was something she should be worried about.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: Vaccine that I had 4 days ago caused me to have COVID 19 now; the minute I get this shot I get sick; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Dec2023 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: ILLNESS (non-serious) with onset 08Dec2023, outcome "unknown", described as "the minute I get this shot I get sick"; COVID-19 (non-serious) with onset 12Dec2023, outcome "unknown", described as "Vaccine that I had 4 days ago caused me to have COVID 19 now". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Vaccine that patient had 4 days ago caused him to have COVID 19 now. The patient on the other line he was reporting an Adverse event. The member stated that he had a COVID vaccine (Clarified as Pfizer COVID vaccine) 4 days ago, initially when he called, he was trying to get assistance with getting the Paxlovid medication at the Pharmacy. He did not get that far but then when he mentioned that he had the COVID vaccine 4 days ago transferring agent thought let him report this. He had the COVID vaccine at the PRIVACY, 4 days ago. Patient had COVID again but he was not taking Paxlovid because the cost was such, he could not purchase it. he was trying to get Paxlovid. The doctor diagnosed and the test showed that he had COVID. This was so irregular, vaccine that he had 4 days ago caused him to have COVID 19 now. For 6 months, patient went to 3 skilled nursing homes, one unlicensed hospice, 3 hospitals every day for his friend who passed away on the 28Nov2023, this from 25May2023 until 28Nov and nobody wore a mask. Patient never got sick and the minute he got this shot he got sick. Consumer further stated, because the vaccine was a cause of agent. if he was an Anti-vaxxer, he would not have even taken it.  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: Menstruation delayed
Clinical narrative: Caller states they haven't gotten their period in a couple of months now and has taken lots of pregnancy test and is not pregnant.; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bottom surgery" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "Caller states they haven't gotten their period in a couple of months now and has taken lots of pregnancy test and is not pregnant.".  Additional information: The patient is a transgender female. The patient was concerned if it was something to do with their bottom surgery maybe. Patient wanted to find out if not seeing period and getting pregnant was a side effect of the COVID-19 vaccine. Caller stated they hadn't gotten their period in a couple of months now and had taken lots of pregnancy test and was not pregnant. They thought the vaccine was the only thing that has changed. Patient had no additional information to share. The caller inquired about whether the inability to menstruate or conceive was a potential side effect of the COVID-19 vaccine he received.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness; swelling; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An elderly 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. Vaccination history included: Smallpox vaccine (as a child), for immunization, reaction: "small keloid scar all my upper arm from when I got a smallpox shot". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling. Additional information: The caller received the Pfizer booster vaccine last Friday. They have always received Pfizer vaccine boosters, so it was not a new vaccine for them. However, they mentioned that when they asked the vaccinator to inject the vaccine in a specific region, the vaccinator mistakenly injected it between their shoulder and elbow area. The caller has never received a vaccine in that region before. They experienced redness and swelling, similar to their previous vaccinations, but this time, the swelling continued to grow and became a large round circle about 3 to 3 1/2 inches in size. They visited a pharmacy, where the pharmacist was not concerned about the redness and swelling but was more concerned about the injection site.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300445550 same patient/drug, different dose/event;US-PFIZER INC-202300444314 same patient/drug, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness; swelling; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Smallpox vaccine, for immunization, reaction: "small keloid scar all my upper arm from when I got a smallpox shot"; Bnt162b2 (dose number and lot number unknown), for covid-19 immunization, reactions: "redness", "swelling". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling. Additional information: The caller received the Pfizer booster vaccine last Friday. They have always received Pfizer vaccine boosters, so it was not a new vaccine for them. However, they mentioned that when they asked the vaccinator to inject the vaccine in a specific region, the vaccinator mistakenly injected it between their shoulder and elbow area. The caller has never received a vaccine in that region before. They experienced redness and swelling, similar to their previous vaccinations, but this time, the swelling continued to grow and became a large round circle about 3 to 3 1/2 inches in size. They visited a pharmacy, where the pharmacist was not concerned about the redness and swelling but was more concerned about the injection site.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300445540 same patient/drug, different dose/event;US-PFIZER INC-202300444314 same patient/drug, different dose/event;
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 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; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 04Dec2023 to 08Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 16:00 as dose 1, single (Lot number: Hg2649) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 01Dec2023 to 06Dec2023. Clinical course: Patient had no known allergies.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 54-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Neuroendocrine tumor of the small intestine" (unspecified if ongoing), notes: Neuroendocrine tumor of the small intestine; "known allergies: contact allergies to metals" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL, start date: 01Jan2023; SERTRALINE, start date: 01Jan2023; BUPROPION, start date: 01Jan2023; VITAMIN D [COLECALCIFEROL], start date: 01Jan2023; SANDOSTATIN, start date: 01Jan2023. Past drug history included: Neosporin, reaction(s): "known allergies: Neosporin". Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE, Time: 10:00 AM, Batch/lot number: GH9702, Anatomical location: Arm left), administration date: 12Sep2022, when the patient was 52-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from Dec2023 to Dec2023.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Swelling face
Clinical narrative: she had sensitivity and mild reaction to previous Pfizer COVID-19 Vaccines including swelling in the face; she had sensitivity and mild reaction to previous Pfizer COVID-19 Vaccines including swelling in the face; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2 NOS), 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), for Covid-19 immunization, reaction(s): "drug hypersensitivity", "swelling face"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "drug hypersensitivity", "swelling face". The following information was reported: DRUG HYPERSENSITIVITY (non-serious), SWELLING FACE (non-serious), outcome "unknown" and all described as "she had sensitivity and mild reaction to previous Pfizer COVID-19 Vaccines including swelling in the face".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300445621 same reporter, event and patient , different dose;US-PFIZER INC-PV202300202893 same reporter, event and patient , different dose;US-PFIZER INC-202300444268 same reporter, event and patient , different dose;
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 55-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Hazelnuts" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2022. Vaccination history included: bnt162b2 (DOSE 1, SINGLE at 08:45 AM, Anatomical location: Arm Left), administration date: 16Apr2021, when the patient was 52-year-old, for COVID-19 Immunisation; bnt162b2 (DOSE 2, SINGLE at 08:30 AM, Anatomical location: Arm Left), administration date: 31Oct2021, when the patient was 53-year-old, for COVID-19 Immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE at 01:00 PM, Anatomical location: Arm Left), administration date: 22Jul2022, when the patient was 54-year-old, for COVID-19 Immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE at 04:30 PM, Anatomical location: Arm Left), administration date: 28Oct2022, when the patient was 54-year-old, for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 29Nov2023 to 05Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
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 Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 12:00 as dose 1, single (Lot number: HG4680) at the age of 60 years, in left arm for covid-19 immunisation, Device Lot Number: HG4680. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE, start date: Jan2020. 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 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 29Nov2023 to 04Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5  will be requested and submitted if and when received.
Age: 50.0
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 Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". 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 with paxlovid from 05Dec2023 to 10Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Vision blurred
Clinical narrative: Blurred vision; chills; body aches; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Dec2023 at 11:30 as dose 1, single (Lot number: HD9876) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MULTIVITAMINS [VITAMINS NOS]; FISH OIL. Past drug history included: Metachlopramide, reaction(s): "Allergy". The following information was reported: VISION BLURRED (non-serious) with onset 10Dec2023, outcome "not recovered", described as "Blurred vision"; PAIN (non-serious) with onset 10Dec2023, outcome "recovered" (10Dec2023), described as "body aches"; CHILLS (non-serious) with onset 10Dec2023, outcome "recovered" (10Dec2023). Therapeutic measures were not taken as a result of vision blurred, chills, pain.  Additional Information: The patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination nor COVID test post vaccination. The patient had blurred vision on the day after receiving the vaccine in addition to chills and body aches. Chills and body aches only lasted for one day, but blurred vision is still there.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lactose intolerance" (unspecified if ongoing); "Allergies: Sulfa, Bactrim Trimethoprim, Penicillin, Antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 13Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Headaches; body aches; fatigue; dizziness; nausea; brain fog; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 02Oct2023 at 15:00 as dose 1, single (Lot number: Unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TERAZOSIN. The following information was reported: HEADACHE (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered", described as "Headaches"; PAIN (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered", described as "body aches"; BRAIN FOG (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered"; DIZZINESS (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered"; FATIGUE (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered"; NAUSEA (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered". The events "headaches", "body aches", "fatigue", "dizziness", "nausea" and "brain fog" required physician office visit. Therapeutic measures were taken as a result of headache, pain, fatigue, dizziness, nausea, brain fog.  Additional information: The patient received Meloxicam, Terrozin within 2 weeks of vaccination. The patient informed that within 24 hours of receiving the COVID booster shot, he began experiencing side effects- Headaches, body aches, fatigue, dizziness, nausea, and brain fog (general spaciness). These symptoms have continued now for almost 2 1/2 months with no sign of relief. Sometimes they are mild. Some days he have only one of the symptoms. Some days he have them all and have been to his Doctor and they have not been able to pinpoint the reason. They believe it may be directly related to the shot but cannot be sure. On 16Oct2023, the patient had test (Health as reported) and had a negative swab result. No known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headaches; body aches; fatigue; dizziness; nausea; brain fog; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 02Oct2023 at 15:00 as dose 1, single (Lot number: Unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TERAZOSIN. The following information was reported: HEADACHE (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered", described as "Headaches"; PAIN (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered", described as "body aches"; BRAIN FOG (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered"; DIZZINESS (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered"; FATIGUE (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered"; NAUSEA (non-serious) with onset 03Oct2023 at 15:00, outcome "not recovered". The events "headaches", "body aches", "fatigue", "dizziness", "nausea" and "brain fog" required physician office visit. Therapeutic measures were taken as a result of headache, pain, fatigue, dizziness, nausea, brain fog.  Additional information: The patient received Meloxicam, Terrozin within 2 weeks of vaccination. The patient informed that within 24 hours of receiving the COVID booster shot, he began experiencing side effects- Headaches, body aches, fatigue, dizziness, nausea, and brain fog (general spaciness). These symptoms have continued now for almost 2 1/2 months with no sign of relief. Sometimes they are mild. Some days he have only one of the symptoms. Some days he have them all and have been to his Doctor and they have not been able to pinpoint the reason. They believe it may be directly related to the shot but cannot be sure. On 16Oct2023, the patient had test (Health as reported) and had a negative swab result. No known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus in both ears is getting louder; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus in both ears is getting louder". The action taken for BNT162b2 omi xbb.1.5 was unknown. Additional information: He wanted to inform that the tinnitus in both ears is getting louder. States the first shot didn't do anything. This is the fourth call he has made. The ear ringing is much worse and goes loud and low, in both ears. He went to specialist. He wants a call back from someone above this department. He spoke to someone that could pull up his old report and he asks this call handler to pull up his prior reports. Informed did not have the ability to do so.  His case has been sent to the federal CDC level and states there are 25,000 of us in state. He does not have his vaccine card, he already provided all that.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Cardiac disorder, Dizziness, Electrocardiogram, Malaise, Pain
Clinical narrative: Issues with my heart; Pain; Dizziness; Not feeling good; This is a spontaneous report received from a Consumer or other non HCP.  A 95-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5342), in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Lot number: Unknown) for immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing), notes: CLL; "thyroid tested low function" (unspecified if ongoing), notes: they boosting it up a little with this. Concomitant medication(s) included: ASPIRIN (E.C.); CITALOPRAM; FUROSEMIDE; FERROUS SULFATE; IMBRUVICA taken for chronic lymphocytic leukaemia; LASIX [FUROSEMIDE]; LEVOTHYROXINE taken for thyroid disorder; POTASSIUM CHLORIDE; TRAMADOL taken for spinal stenosis. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Issues with my heart"; PAIN (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "Not feeling good". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Context: Concern: Consumer stated, "she was going to report the side effect that she got after her Pfizer Booster shot (Pfizer COVID 19 Booster shot) last October, it was the last of Sep2022. I had issues with her heart, the pain and the dizziness and just not feeling good for about five months after she had the Booster shot and then gradually it went away. How that happened she will never know but she was relieved. Height and Weight: Consumer stated, "4(feet) 11(inches) now, she has lost 5 inches. Her weight about 138 pounds. "Consumer stated, "she got that on 30Sep2022. She doesn't see anything like that. "Consumer stated, "she just needed a booster shot for COVID and she got the Flu shot (Unspecified Flu Shot) at the same time.  She was in the hospital, they did some EKG and stuff like that. They didn't check for any heart function except, and they did do a lab on that long time ago. Consumer stated, "The incident occurred 10 days after the booster shot. The first vaccination she had no problem with it at all, no."
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Sore arm; chills; muscle aches; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Dec2023 as dose 1, single (Lot number: HM7010) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Dec2023 at 20:00, outcome "recovered", described as "Sore arm"; CHILLS (non-serious) with onset 13Dec2023 at 20:00, outcome "recovered"; MYALGIA (non-serious) with onset 13Dec2023 at 20:00, outcome "recovered", described as "muscle aches".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received sertraline within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: 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 an Other HCP.  A 38-year-old female patient (pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Dust mites - anaphylactic reaction" (unspecified if ongoing); "Dust mites - anaphylactic reaction" (unspecified if ongoing). Date of last menstrual period: 20Apr2023. The patient is expected to deliver a baby(s) on 25Jan2024. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication details: (other medication in 2weeks product: OTC cough remedies), Anti-viral details: Product Paxlovid: COVID 19 Treatment, indication: Treatment of COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Drug ineffective and COVID 19 cannot be ruled out.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 43 years intramuscular, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "afib" (unspecified if ongoing); "slightly overweight" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; DILTIAZEM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Dec2023 at 19:00, outcome "not recovered" and all described as "tested positive for covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2023) Positive, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Pfizer employee reported no other vaccine in four weeks. On 13Dec2023, (name) tested positive for Covid. He should have gotten a booster this year. No covid-19 prior to vaccination. No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "paroxysmal tachycarida" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID, start date: Jan2012. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from from 17Nov2023 to 22Nov2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: vaccinated and still got covid19; vaccinated and still got covid19; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "vaccinated and still got covid19". Clinical course: Caller was a consumer asking regarding the components of Pfizer covid19 vaccine and asked why were they still got covid19 after vaccinated.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300203774 Same patient, dame product, different event;
Age: 68.0
Sex: M
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 Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 01Dec2023 to 06Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 22Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: EL0182) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (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 Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Dec2023 to 09Dec2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible.; Sender's Comments: A causal relationship to the suspect drug BNT162b2 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19 from 05Dec2023 to 10Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 14:00 as dose 1, single (Lot number: HD9876) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: Pravastatin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 29Jan2021, when the patient was 78-year-old, for COVID-19 immunisation; BNT162b2 (Dose 2, single, Batch/Lot No: EN6201, Anatomical location: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 19Feb2021, when the patient was 78-year-old, for COVID-19 immunisation; BNT162b2 (Dose 3 (booster), single, Batch/Lot No: EW0217, Anatomical location: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 19Aug2021, when the patient was 79-year-old, for COVID-19 immunisation; BNT162b2 (Dose 4 (booster), single, Batch/Lot No: FJ5682, Anatomical location: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 05Apr2022, when the patient was 79-year-old, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (Dose 5 (booster), single, Batch/Lot No: GJ5342, Anatomical location: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 14Sep2022, when the patient was 80-year-old, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (Dose 6 (booster), single, Batch/Lot No: GJ3268, Anatomical location: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 07Jul2023, when the patient was 81-year-old, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 02Dec2023 to 06Dec2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300447579 same patient, different vaccine dose/events;