chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur
Clinical narrative: heart murmur; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart problems" (unspecified if ongoing), notes: in the past. The patient took concomitant medications. The following information was reported: CARDIAC MURMUR (non-serious), outcome "unknown", described as "heart murmur". Additional information: Caller mentioned she saw an advertisements of the new Moderna COVID-19 vaccine for new variants, but the advertisements mentioned that it could cause heart inflammation and inflammation lining of the heart. She wanted to know if the Pfizer 2023-2024 formulation also had this side effect. She mentioned she wanted to know because in the past she already experienced heart problems and wants to know whether or not to get the vaccine. Upon learning that the Pfizer COVID-19 Vaccine does have reports of myocarditis and pericarditis, she mentioned she did experienced a heart murmur after having 3 previous Pfizer COVID-19 Vaccine doses last year and the year before. She mentioned she experienced this murmur after previous doses, but she never thought it could be related to the vaccine as she changed her treating physician. However, she never had any problem and the only thing she's done different was getting the vaccine. She mentioned she does take a low dose of blood pressure medication, but she had been taking it before and didn't change anything in what she does, and she has the same diet. She didn't report it because she never thought it could be related. Caller mentioned she was scared of the side effects and had to balance what is worse if the side effects or COVID-19, mentioning she was specially  scared of the blood clots and the heart inflammation. She stated she was concerned on this information as she has a holiday dinner next week and doesn't want to risk it, as many of her friends have used Moderna and have gotten very sick. She mentioned she still wears a mask and people look ugly at her and proceeded to mention that she lives in where people are ignorant and many didn't even get the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300392535 same patient/product/events.;
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: loses sense of smell again; 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 elderly male patient received bnt162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: EW0181) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NOVOLIN 70/30 (ongoing); PRESERVISION AREDS 2 (ongoing). Vaccination history included: comirnaty (DOSE 1; Lot number: EN6198 in the left upper arm), administration date: 20Feb2021, when the patient was 83-year-old, for COVID-19 immunisation, reaction(s): "affected my sense of smell"; comirnaty (Lot number: ER2613; in left arm), administration date: 31Mar2021, when the patient was 83-year-old, for COVID-19 immunisation, reaction(s): "affected my sense of smell". The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "loses sense of smell again".  Additional information: The patient received Pfizer's COVID-19 vaccine for each of the injections made available to the public. The first injection, and each of the following, thereafter affected sense of smell. The patient states that if this continues, he will never smell again. This is frustrating for him as most foods have no flavor except for the taste on his tongue. The pleasure of eating a good meal is lost. Every vaccine he has received, he has a loss of smell and gets a little better and gets next dose or booster vaccine and loses sense of smell again. Just got latest Pfizer Covid vaccine and it happened again. He cannot identify any smells and can tell difference between some foods but not what they are; it makes a big difference on what he enjoys. The first time noticed the loss of smell was after the first two initial vaccinations he got a month apart. He remembers it was after the 2nd dose is when he realized what was going on. It has stayed about the same, it got a little better and when he got the next booster shot it went back. That happens each time he gets booster shot. He doesn't know how to explain improvement, he can tell a little difference between fruit or maple syrup but not the flavors for example. If he has a hot cup coffee in front of him, he can't smell it. But it tastes different, something there but doesn't know what it is. they only mentioned to primary care doctor and see him end of this month and will mention again. States when they see doctor on 29th this month and will talk to him about this again. Going to ask once again for recommendation or referral to ENT. Prior Vaccinations (within 4 weeks): no.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384676 same patient, same product/event, different doses;US-PFIZER INC-202300367705 same patient, same product/event, different doses;
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: as if caller was hit by a truck; 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 number unknown, single (Lot number: Not Provided) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "as if caller was hit by a truck". No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Fever; Strong headache; Rash all over her body; going up to her face now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose number unknown), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; HEADACHE (non-serious), outcome "unknown", described as "Strong headache"; RASH (non-serious), outcome "unknown", described as "Rash all over her body; going up to her face now".  Additional information: The patient had the Pfizer, the latest vaccine, the third one (Clarified as Pfizer COVID-19 Vaccine) and they were wondering that maybe what she have are the side effects of that one but it almost a week now, in the past she always had the Moderna and the patient had no reactions. The reporter just called the pharmacy and they said no, this time they gave her the Pfizer. So, the reporter  was wondering because the side effects that she is getting, rash all over her body, fever, strong headache and she has been having almost for a week for now with that and the rash is all over her body and it's going up to her face now. The reporter was wondering if that probably 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.
Age: 38.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Fatigue, Vaccination site pain, Wrong product administered
Clinical narrative: Pfizer Bivalent; Drug start date: 18Nov2023; Pain at injection site, minor chills and fatigue; Pain at injection site, minor chills and fatigue; Pain at injection site, minor chills and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2023 as dose number unknown, single (Lot number: Unknown) at the age of 38 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 18Nov2023 as unk unk, single (Batch/Lot number: unknown), in left arm for immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Nov2023 at 03:00, outcome "recovering", CHILLS (non-serious), FATIGUE (non-serious) all with onset 19Nov2023 at 03:00, outcome "unknown" and all described as "Pain at injection site, minor chills and fatigue"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Pfizer Bivalent; Drug start date: 18Nov2023". Therapeutic measures were not taken as a result of vaccination site pain. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, Inflammation, Joint swelling
Clinical narrative: painful joint inflammation and swelling above right big toe area; painful joint inflammation and swelling above right big toe area; painful joint inflammation and swelling above right big toe area; Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present; Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present; Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing). Concomitant medication(s) included: LYSINOPRIL taken for hypertension. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Bnt162b2 (Dose number unknown), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious), PERIPHERAL SWELLING (non-serious), INFLAMMATION (non-serious) all with onset 11Nov2023 at 06:00, outcome "not recovered" and all described as "Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present"; ARTHRALGIA (non-serious), ARTHRITIS (non-serious), JOINT SWELLING (non-serious) all with onset 11Nov2023 at 06:00, outcome "not recovered" and all described as "painful joint inflammation and swelling above right big toe area". Therapeutic measures were not taken as a result of arthralgia, arthritis, joint swelling, back pain, peripheral swelling, inflammation. 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: Peripheral swelling
Clinical narrative: painful joint inflammation and swelling above right big toe area; painful joint inflammation and swelling above right big toe area; painful joint inflammation and swelling above right big toe area; Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present; Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present; Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing). Concomitant medication(s) included: LYSINOPRIL taken for hypertension. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Bnt162b2 (Dose number unknown), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious), PERIPHERAL SWELLING (non-serious), INFLAMMATION (non-serious) all with onset 11Nov2023 at 06:00, outcome "not recovered" and all described as "Progressing to include ioint inflammation both hands and achy lower back and toes swelling and inflammation still present"; ARTHRALGIA (non-serious), ARTHRITIS (non-serious), JOINT SWELLING (non-serious) all with onset 11Nov2023 at 06:00, outcome "not recovered" and all described as "painful joint inflammation and swelling above right big toe area". Therapeutic measures were not taken as a result of arthralgia, arthritis, joint swelling, back pain, peripheral swelling, inflammation. 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, FLUA4
Symptoms: Arthralgia
Clinical narrative: Sever pain in both shoulders and knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), in Nov2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "avascular necrois" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (3rd dose, MANUFACTURER UNKOWN ), for COVID-19 immunisation; Covid-19 vaccine (2nd dose, MANUFACTURER UNKOWN ), for COVID-19 immunisation; Covid-19 vaccine (1st dose, MANUFACTURER UNKOWN ), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 18Nov2023 at 12:00, outcome "not recovered", described as "Sever pain in both shoulders and knees". Therapeutic measures were taken as a result of arthralgia. Additional information: treatment received VOLTAREN
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur
Clinical narrative: heart murmur; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart problems" (unspecified if ongoing), notes: in the past. The patient took concomitant medications. The following information was reported: CARDIAC MURMUR (non-serious), outcome "unknown", described as "heart murmur". Additional information: Caller mentioned she saw an advertisements of the new Moderna COVID-19 vaccine for new variants, but the advertisements mentioned that it could cause heart inflammation and inflammation lining of the heart. She wanted to know if the Pfizer 2023-2024 formulation also had this side effect. She mentioned she wanted to know because in the past she already experienced heart problems and wants to know whether or not to get the vaccine. Upon learning that the Pfizer COVID-19 Vaccine does have reports of myocarditis and pericarditis, she mentioned she did experienced a heart murmur after having 3 previous Pfizer COVID-19 Vaccine doses last year and the year before. She mentioned she experienced this murmur after previous doses, but she never thought it could be related to the vaccine as she changed her treating physician. However, she never had any problem and the only thing she's done different was getting the vaccine. She mentioned she does take a low dose of blood pressure medication, but she had been taking it before and didn't change anything in what she does, and she has the same diet. She didn't report it because she never thought it could be related. Caller mentioned she was scared of the side effects and had to balance what is worse if the side effects or COVID-19, mentioning she was specially  scared of the blood clots and the heart inflammation. She stated she was concerned on this information as she has a Thanksgiving dinner next week and doesn't want to risk it, as many of her friends have used Moderna and have gotten very sick. She mentioned she still wears a mask and people look ugly at her and proceeded to mention that she lives in where people are ignorant and many didn't even get the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300382095 same patient/product/events;
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: jump in liver enzymes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001481.  A female patient received bnt162b2 (BNT162B2 NOS), in 2022 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. The following information was reported: HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "jump in liver enzymes".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300190704 Same patient, different dose, different event;US-PFIZER INC-PV202300190704 Same patient, different dose, different event;
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: side effects (sore backs) one week after shots/ back muscle pain one week later; The initial case was missing the following minimum criteria: [Unspecified product]. Upon receipt of follow-up information on [15-NOV-2023], this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 88-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 as dose 1, single (Lot number: HG4633) at the age of 88 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious) with onset 22Oct2023, outcome "unknown", described as "side effects (sore backs) one week after shots/ back muscle pain one week later". Therapeutic measures were not taken as a result of back pain.  Additional information: Patient's doctor said that he had patients with similar problems of pain after COVID Pfizer shot. Patient have had multiple Pfizer shots (COVID) with no aftereffects.
Age: 80.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain
Clinical narrative: Received her flu and coronavirus disease (COVID) vaccines, so was having some aches and pains; This is a spontaneous report received from non-contactable reporter(s) (Other HCP and Consumer or other non HCP).  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Nov2023 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "secondary pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: ASPIRIN EC; PULMICORT; LIPITOR; CRANBERRY; OFEV; PROAIR DIGIHALER; IPRATROPIUM BROMIDE. The following information was reported: PAIN (non-serious) with onset Nov2023, outcome "unknown", described as "Received her flu and coronavirus disease (COVID) vaccines, so was having some aches and pains".  Additional Information: On 06Nov2023, the patient received her flu and coronavirus disease [COVID] vaccines so she was having some aches and pains (pain). Concomitant medications Multivitamins (Ascorbic acid, Ergocalciferol, Folic acid, Nicotinamide, Panthenol, Retinol, Riboflavin, Thiamine hydrochloride) Tablet, Omega-3 (Docosahexaenoic acid, Eicosapentaenoic acid) and Oxygen (Oxygen) were also taken.The reporter's causality for the event of pain with influenza vaccine and COVID-19 vaccine was considered to be possibly related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; 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 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), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "got COVID". Clinical course: Patient mentioned that he started getting the Pfizer COVID vaccine the very first month that it came out but he got COVID and he wanted to know what Pfizer claim that the vaccine did.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: she got the RSV vaccine last 10Nov and yesterday it started itching and red on the site of the injection; she got the RSV vaccine last 10Nov and yesterday it started itching and red on the site of the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 14Nov2023, outcome "unknown" and all described as "she got the RSV vaccine last 10Nov and yesterday it started itching and red on the site of the injection". Additional information: Caller calling in because she got the RSV vaccine last 10Nov2023 and yesterday it started itching and red on the site of the injection, she wanted to know what to expect regarding the reaction  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: if you get the Covid shot you wouldn't get Covid or spread it; if you get the Covid shot you wouldn't get Covid or spread it; 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 62-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "if you get the Covid shot you wouldn't get Covid or spread it". Clinical Course: Reporter considered event was as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: Interchange of vaccine products; I had to go to the emergency room after getting COVID shot while I had COVID; I had to go to the emergency room after getting COVID shot while I had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 57-year-old 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. Vaccination history included: Janssen covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "I had to go to the emergency room after getting COVID shot while I had COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2023, outcome "unknown". The event "i had to go to the emergency room after getting covid shot while i had covid" required emergency room visit. Clinical course: He had to go to the emergency room after getting COVID shot while he had COVID and he does not want another COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Transient ischaemic attack
Clinical narrative: Mini stroke after Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female 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 included: "Diabetes" (ongoing); "Thyroid condition" (ongoing); "High blood pressure" (ongoing); "Overweight" (unspecified if ongoing). The patient's family history included: "Stroke" (unspecified if ongoing), notes: Grandmother had stroke, that was years ago. The patient took concomitant medications. Vaccination history included: Moderna vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna vaccine (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 2023, outcome "unknown", described as "Mini stroke after Covid vaccine". The event "mini stroke after Covid vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical course: Patient had to hospital but clarified it was just to emergency room, was not admitted to hospital.  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-202300371824 same patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Mini stroke after Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female 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 included: "Diabetes" (ongoing); "Thyroid condition" (ongoing); "High blood pressure" (ongoing); "Overweight" (unspecified if ongoing). The patient's family history included: "Stroke" (unspecified if ongoing), notes: Grandmother had stroke, that was years ago. The patient took concomitant medications. Vaccination history included: Moderna vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna vaccine (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 2023, outcome "unknown", described as "Mini stroke after Covid vaccine". The event "mini stroke after Covid vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical course: Patient had to hospital but clarified it was just to emergency room, was not admitted to hospital.  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-202300371824 same patient, different drug/event;
Sex: M
Vaccine: COVID19
Symptoms: Terminal state
Clinical narrative: He took 2 doses of the Pfizer and now he is dying.; 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 male 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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: TERMINAL STATE (medically significant, life threatening), outcome "unknown", described as "He took 2 doses of the Pfizer and now he is dying.". Clinical course: Patient mentioned that he took 2 doses of the Pfizer and now he was dying. He was asking why. He said that it was the vaccines that he have gotten. He said his doctor said that he was dying. He said that his doctor said a lot about it. He said why Pfizer want to kill people.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK9231) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Therapeutic measures were taken as a result of headache.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152033 same patient and reporter, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: covid 19 vaccinations and how sick it made me; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly 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: ILLNESS (non-serious), outcome "unknown", described as "covid 19 vaccinations and how sick it made me".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 60-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "very sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Feeling abnormal, Illness, Muscle tightness, Palpitations
Clinical narrative: had pain in my sternum; my body to lock up from neck, down arms, and thoracic area of back; sick; feel heart palpitations; muscles tightening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious), outcome "unknown", described as "had pain in my sternum"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "my body to lock up from neck, down arms, and thoracic area of back"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PALPITATIONS (non-serious), outcome "unknown", described as "feel heart palpitations"; MUSCLE TIGHTNESS (non-serious), outcome "unknown", described as "muscles tightening". Additional information: Reporter stated, "Your Pfizer vaccines and Omicron booster caused my body to lock up from neck, down arms, and thoracic area of back. My husband could feel my muscles tightening and I could feel heart palpitations and had pain in my sternum. I endured one month of Medrol treatments, plus a trigger point injection in thoracic and epidural for Lumbar. People with autoimmune conditions shouldn't get this. I've been sick since my first vaccine FEBRUARY 2021 and everyone after."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300385262 same reporter and product, different dose and event .;US-PFIZER INC-202300385261 same reporter/product, different dose/ event.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Muscle tightness, Palpitations
Clinical narrative: had pain in my sternum; my body to lock up from neck, down arms, and thoracic area of back; sick; feel heart palpitations; muscles tightening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious), outcome "unknown", described as "had pain in my sternum"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "my body to lock up from neck, down arms, and thoracic area of back"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PALPITATIONS (non-serious), outcome "unknown", described as "feel heart palpitations"; MUSCLE TIGHTNESS (non-serious), outcome "unknown", described as "muscles tightening". Additional information: Reporter stated, "Your Pfizer vaccines and Omicron booster caused my body to lock up from neck, down arms, and thoracic area of back. My husband could feel my muscles tightening and I could feel heart palpitations and had pain in my sternum. I endured one month of Medrol treatments, plus a trigger point injection in thoracic and epidural for Lumbar. People with autoimmune conditions shouldn't get this. I've been sick since my first vaccine FEBRUARY 2021 and everyone after."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300385262 same reporter and product, different dose and event .;US-PFIZER INC-202300385261 same reporter/product, different dose/ event.;
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Pain, Vaccination site pain, Wrong product administered
Clinical narrative: moderate pain at injection site; mild fatigue; mild body aches; BNT162B2 on 09Oct2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023SA310727.  A 45-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), on 09Oct2023 as dose number unknown, single (Lot number: FJ1611) at the age of 45 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), on 09Oct2023 (Lot number: UT8155JA) intramuscular, in left arm for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 09Oct2023, outcome "unknown", described as "BNT162B2 on 09Oct2023"; PAIN (non-serious) with onset 09Oct2023, outcome "recovering", described as "mild body aches"; FATIGUE (non-serious) with onset 09Oct2023, outcome "recovering", described as "mild fatigue"; VACCINATION SITE PAIN (non-serious) with onset 09Oct2023, outcome "recovering", described as "moderate pain at injection site". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, pain, wrong product administered.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost all sense of taste and smell after the second shot; lost all sense of taste and smell after the second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2021 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 (first dose), for covid-19 immunization. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "lost all sense of taste and smell after the second shot".  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: Asthma
Clinical narrative: significant asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 immunization, reaction(s): "inflammation"; Covid-19 vaccine (booster dose # unknown, manufacturer unknown), for COVID-19 immunization, reaction(s): "inflammation". The following information was reported: ASTHMA (non-serious) with onset Nov2023, outcome "not recovered", described as "significant asthma". Therapeutic measures were taken as a result of asthma.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my arm at site was painful & sore for a week; 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)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 5, manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "my arm at site was painful & sore for a week".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Vertigo
Clinical narrative: vertigo; extreme lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Nov2023 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: LETHARGY (non-serious) with onset Nov2023, outcome "unknown", described as "extreme lethargy"; VERTIGO (non-serious) with onset Nov2023, outcome "unknown".  Additional information: "my husband and I both received all vaccines and the booster on the first round. We both contracted Covid twice. This time, we went for the new booster on November 18, 2023 and I had vertigo and extreme lethargy for 4 days".  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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: It was reported the patient experienced tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001492 (Novavax).  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Nov2023, outcome "unknown", described as "It was reported the patient experienced tiredness".
Sex: F
Vaccine: COVID19
Symptoms: Non-alcoholic fatty liver
Clinical narrative: It was reported the patient had NAFLD; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001481 (Novavax).  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 included: "underlying liver condition" (ongoing); "acute liver injury" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (booster), administration date: 2022, for COVID-19 immunisation, reaction(s): "jump in liver enzymes"; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: NON-ALCOHOLIC FATTY LIVER (non-serious), outcome "unknown", described as "It was reported the patient had NAFLD". 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-202300392929 Same patient, different dose, different event;US-PFIZER INC-202300392929 Same patient, different dose, different event;
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Pain, Pruritus
Clinical narrative: body aches; mild itching; fatigue; coughing; Initial information received on 14-Nov-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case is linked to case 2023SA357652(Same Patient).  This case involves a 73 years old male patient who experienced body aches, mild itching, fatigue and coughing after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On 08-Oct-2023 the patient developed body aches (pain), mild itching (pruritus), fatigue and coughing (cough) (latency- 7 days) following the administration of influenza vaccine.  Action taken- not applicable.  The patient was treated with dexamethasone for Pruritus.  At time of reporting, the outcome was Unknown for all the events.
Age: 80.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain
Clinical narrative: some aches and pains; Initial information was received on 14-Nov-2023 regarding an unsolicited valid, courtesy case non-serious case received from a consumer/non-hcp.  This case involves a 80 years old female patient (76.4 kg) who experienced some aches and pains while receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient received a  dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for Covid-19 immunization.  On an unknown date the patient developed a non-serious some aches and pains (pain) (unknown latency)   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (some aches and pains).  At time of reporting, the outcome was Unknown for the event some aches and pains.