chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: sick; night sweats; fever; chills; It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach; bowel problem/ Something is going on with her gastrointestinal; not feeling well down there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; NIGHT SWEATS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "bowel problem/ Something is going on with her gastrointestinal"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well down there".  Additional information: The patient got the new pfizer 2nd vaccine which is the bivalent. She had been sick for almost 3 weeks getting worse each day. It is pain in left side and stomach fever chills break out in night sweats. Something is going on with her gastrointestinal. The patient was 68 and had no ovaries. It was a stomachs and bowel problem. Please let her know if anyone else has side effects like these and when woukld it go away. Caller had not received the Bivalent vaccine before. Caller has been feeling sick since she received the vaccine. The caller had experienced fever, breaking into sweat at night, stomach pain which she described as soreness in the stomach, trouble with bowels, and not feeling well down there. Caller did not wanted to be transferred. The caller wanted to get more information.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Blood test, Condition aggravated, Diverticulitis, Illness
Clinical narrative: sick; night sweats; fever; chills; It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach; bowel problem/ Something is going on with her gastrointestinal; not feeling well down there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; NIGHT SWEATS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "bowel problem/ Something is going on with her gastrointestinal"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well down there".  Additional information: The patient got the new pfizer 2nd vaccine which is the bivalent. She had been sick for almost 3 weeks getting worse each day. It is pain in left side and stomach fever chills break out in night sweats. Something is going on with her gastrointestinal. The patient was 68 and had no ovaries. It was a stomachs and bowel problem. Please let her know if anyone else has side effects like these and when woukld it go away. Caller had not received the Bivalent vaccine before. Caller has been feeling sick since she received the vaccine. The caller had experienced fever, breaking into sweat at night, stomach pain which she described as soreness in the stomach, trouble with bowels, and not feeling well down there. Caller did not wanted to be transferred. The caller wanted to get more information.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pain, Pyrexia, Vomiting, Weight
Clinical narrative: sick; night sweats; fever; chills; It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach; bowel problem/ Something is going on with her gastrointestinal; not feeling well down there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; NIGHT SWEATS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "bowel problem/ Something is going on with her gastrointestinal"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well down there".  Additional information: The patient got the new pfizer 2nd vaccine which is the bivalent. She had been sick for almost 3 weeks getting worse each day. It is pain in left side and stomach fever chills break out in night sweats. Something is going on with her gastrointestinal. The patient was 68 and had no ovaries. It was a stomachs and bowel problem. Please let her know if anyone else has side effects like these and when woukld it go away. Caller had not received the Bivalent vaccine before. Caller has been feeling sick since she received the vaccine. The caller had experienced fever, breaking into sweat at night, stomach pain which she described as soreness in the stomach, trouble with bowels, and not feeling well down there. Caller did not wanted to be transferred. The caller wanted to get more information.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased, Wrong product administered
Clinical narrative: sick; night sweats; fever; chills; It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach; bowel problem/ Something is going on with her gastrointestinal; not feeling well down there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; NIGHT SWEATS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "It is pain in left side and stomach/ Something is going on with her gastrointestinal/ soreness in the stomach"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "bowel problem/ Something is going on with her gastrointestinal"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well down there".  Additional information: The patient got the new pfizer 2nd vaccine which is the bivalent. She had been sick for almost 3 weeks getting worse each day. It is pain in left side and stomach fever chills break out in night sweats. Something is going on with her gastrointestinal. The patient was 68 and had no ovaries. It was a stomachs and bowel problem. Please let her know if anyone else has side effects like these and when woukld it go away. Caller had not received the Bivalent vaccine before. Caller has been feeling sick since she received the vaccine. The caller had experienced fever, breaking into sweat at night, stomach pain which she described as soreness in the stomach, trouble with bowels, and not feeling well down there. Caller did not wanted to be transferred. The caller wanted to get more information.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing), notes: Other medical history: Afib. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300199012 Same patient, different product/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 20May2023, outcome "recovering"; DRUG INEFFECTIVE (medically significant) with onset 20May2023, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The individual tested positive for COVID (first time) on 20May2023, and noted sore throat, head and joint pain, and flu-like symptoms The individual has taken NSAIDs (eg: Aleve) for pain, but not Paxlovid. Patient did not had covid prior vaccination.  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-202300199240 same patient/drug, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Hip surgery
Clinical narrative: had recent hip surgery (Apr2023); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: HIP SURGERY (medically significant) with onset Apr2023, outcome "unknown", described as "had recent hip surgery (Apr2023)".  Clinical course: It was unknown whether patient has other vaccines in 4 weeks.   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-202300199220 same patient/drug, different dose/event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PCR result: Positive; PCR result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Aug2021 as dose 1, single (Lot number: FA7485), in left arm and on 26Aug2021 as dose 2, single (Lot number: FA7485) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Cancer" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SIMVASTATIN; FARXIGA nasal. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Sep2022, outcome "unknown" and all described as "PCR result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199410 Same Patient/drug, different dose/AE;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Deafness unilateral, Tinnitus
Clinical narrative: Bird chirping noise in right ear only and could hear heart beat right ear only; Hair lost; Still having the bird chirpingIn the right ear; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Aug2021 as dose 2, single (Lot number: FA7485) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Cancer" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SIMVASTATIN; FARXIGA nasal. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Batch/lot number: FA7485; Anatomical location: Left arm), administration date: 02Aug2021, for COVID-19 immunisation. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 28Aug2021, outcome "unknown", described as "Bird chirping noise in right ear only and could hear heart beat right ear only"; ALOPECIA (non-serious) with onset 28Aug2021, outcome "unknown", described as "Hair lost"; TINNITUS (non-serious) with onset 28Aug2021, outcome "unknown", described as "Still having the bird chirpingIn the right ear". The events "bird chirping noise in right ear only and could hear heart beat right ear only", "hair lost" and "still having the bird chirpingin the right ear" required physician office visit. Therapeutic measures were not taken as a result of deafness unilateral, alopecia, tinnitus.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199394 Same patient/vaccine, different dose/events (LOE);
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 at 15:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Aortic valve stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 10May2023, outcome "not recovered", described as "COVID 19 Treatment". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199663 Same patient, different product, different event (Paxlovid);
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: recovering from COVID; recovering from COVID; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 90-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, 0.3 ml single (Batch/Lot number: unknown) and on 04Mar2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) at the age of 88 years for covid-19 immunisation. The patient's relevant medical history included: "CKD 4/5" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "recovering from COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject product , BNT162B2 vaccine, cannot be excluded for suspected LOE.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300199917 same patient and suspect drug/different AE;US-PFIZER INC-PV202300091944 sam epatient/different suspect drug and AE;
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 at 13:00 as dose 1, single (Lot number: ER2613), in left arm and on 14Apr2021 at 13:00 as dose 2, single (Lot number: ER8729) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 at 15:00 as dose 3 (booster), single (Lot number: 012H21B), in left arm and on 10Oct2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "not recovered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient took Paxlovid, felt better, tested negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199926 same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective/got COVID; Suspected COVID-19/got COVID; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Clumsy" (unspecified if ongoing); "Double vision" (unspecified if ongoing); "Limp" (unspecified if ongoing); "Trouble walking" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; RITUXAN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective/got COVID"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Suspected COVID-19/got COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300091292 Same patient/same product, different dose/event;
Age: 1.0
Sex: U
Vaccine: PNC13
Symptoms: Illness, Immunodeficiency, Malaise
Clinical narrative: immunocompromised; sickly; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 1-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 19Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 12 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: prevnar (DOSE 1, SINGLE), administration date: 13Oct2021, for Immunization; prevnar (DOSE 2, SINGLE), administration date: 13Dec2021, for Immunization; prevnar (DOSE 3 (BOOSTER), SINGLE), administration date: 14Feb2022, for Immunization. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised"; ILLNESS (non-serious), outcome "unknown", described as "sickly". The health care professional reported an adverse event for Prevnar 13. Explained that a patient received Prevnar 13 vaccinations on 13Oct2021, 13Dec2021, 14Feb2022, and 19Aug2022. Reported that the patient is sickly, immunocompromised, and at high risk for developing pneumonia.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The association between the event "immunocompromised" with PREVNAR 13 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: PNC13
Symptoms: Antibody test abnormal, Drug ineffective, Illness, Malaise, Viral titre decreased
Clinical narrative: Lack of vaccine effect; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered", described as "Lack of vaccine effect"; ILLNESS (non-serious), outcome "recovered", described as "sick". The patient underwent the following laboratory tests and procedures: Antibody test: titer levels were very low, notes: the mother found a doctor who would do antibody testing, and the doctor saw that the child's titer levels were very low. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac tamponade, Microscopic polyangiitis
Clinical narrative: Cardiac Tamponade as a Complication of Microscopic Polyangiitis; Cardiac Tamponade as a Complication of Microscopic Polyangiitis; This is a literature report for the following literature source(s): "Cardiac Tamponade as a Complication of Microscopic Polyangiitis: A Case Associated With a COVID-19 mRNA Vaccine".  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC TAMPONADE (medically significant), MICROSCOPIC POLYANGIITIS (non-serious), outcome "unknown" and all described as "Cardiac Tamponade as a Complication of Microscopic Polyangiitis".; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported event cardiac tamponade and BNT162B2 is considered possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Brain fog, Rash macular
Clinical narrative: brain fog; Rash macular; skeletal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 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: Covid-19 vaccine (DOSE: 1; single UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset Apr2021, outcome "not recovered"; BRAIN FOG (non-serious) with onset Apr2021, outcome "not recovered"; BONE PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "skeletal pain".   Additional Information; Patient reported that he received the vaccine in Apr2021 the following day after that dose the second shot my health has been in decline brain fog rash muscular skeletal pain that continues to this day I have been working with a myraid of doctors ever since I have say this has destroyed my life I can no longer work and I am financially destroyed as well your vaccine poisoned me my life has been turned upside down I have not had any income my last pay check was 15Mar2022 it is a struggle for me each day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: pt couldn't walk at all; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4901136.  A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Clumsy" (unspecified if ongoing); "Double vision" (unspecified if ongoing); "Limp" (unspecified if ongoing); "Trouble walkig" (unspecified if ongoing); "COVID" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; RITUXAN. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE; Lot number: unknown), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (medically significant), outcome "unknown", described as "pt couldn't walk at all".  Clinical course: On unknown date, patient started therapy with Pfizer COVID vaccine for unknown indication. On unknown date, it was reported that patient experienced: got COVID, waited a month, got her second Pfizer and then patient had a very bad reaction to it where patient couldn't walk at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  BNT162B2 is under agreement with Agency.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood bilirubin, Enzyme level test, Hepatitis
Clinical narrative: Autoimmune Hepatitis Flare; This is a literature report for the following literature source(s): A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Mycophenolate mofetil for autoimmune hepatitis. The following information was reported: HEPATITIS (hospitalization, medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "Autoimmune Hepatitis Flare". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1450; Aspartate aminotransferase: 830; Blood bilirubin: 7.6; Enzyme level test: elevated; normalized within a month.; lab: autoimmune hepatitis. Therapeutic measures were taken as a result of hepatitis.  Clinical course: A 62-year-old male presented to the clinic with right upper quadrant pain associated with elevated liver enzymes. This patient's lab and liver biopsy results were consistent with autoimmune hepatitis. He remained stable on mycophenolate mofetil (MMF) for nine years without any acute flares. However, two weeks after receiving the first COVID Pfizer vaccine, the patient presented with jaundice and severely elevated liver enzymes - AST: 830, ALT: 1,450, and total bilirubin: 7.6. He was subsequently hospitalized and required IV solumedrol for seven days. The patient was transitioned to oral steroids and his liver enzymes normalized within a month. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (Autoimmune Hepatitis) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300199136 Same article/ drug/event and different patient;US-PFIZER INC-202300199135 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: Autoimmune Hepatitis Flare; This is a literature report for the following literature source(s): A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Mycophenolate mofetil for autoimmune hepatitis. The following information was reported: HEPATITIS (hospitalization, medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "Autoimmune Hepatitis Flare". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1450; Aspartate aminotransferase: 830; Blood bilirubin: 7.6; Enzyme level test: elevated; normalized within a month.; lab: autoimmune hepatitis. Therapeutic measures were taken as a result of hepatitis.  Clinical course: A 62-year-old male presented to the clinic with right upper quadrant pain associated with elevated liver enzymes. This patient's lab and liver biopsy results were consistent with autoimmune hepatitis. He remained stable on mycophenolate mofetil (MMF) for nine years without any acute flares. However, two weeks after receiving the first COVID Pfizer vaccine, the patient presented with jaundice and severely elevated liver enzymes - AST: 830, ALT: 1,450, and total bilirubin: 7.6. He was subsequently hospitalized and required IV solumedrol for seven days. The patient was transitioned to oral steroids and his liver enzymes normalized within a month. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (Autoimmune Hepatitis) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300199136 Same article/ drug/event and different patient;US-PFIZER INC-202300199135 Same article/ drug/event and different patient;
Sex: U
Vaccine: DTP
Symptoms: Hypersensitivity
Clinical narrative: Allergy; Initial information was received on 19-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and gender patient who experienced allergy after receiving DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number was requested.  On an unknown date the patient had allergy (hypersensitivity) (unknown latency) following the administration of DIPHTHERIA and TETANUS and not otherwise specified PERTUSSIS VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: vaccine exposure during 6.5 months of pregnancy with no reported adverse event; Initial information received on 17-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves female patient of an unknown age and who was 6.5 months pregnant and was exposed to INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine exposure during 6.5 months of pregnancy.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE (dosage, strength, expiry date and lot number: not reported) via unknown route in unknown administration site for Immunization and was exposed to vaccine  during 6.5 months of pregnancy (exposure during pregnancy) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 18.0
Sex: U
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: MENQUADFI underwent temperature excursion was administered to patient with no reported adverse event; Menquadfi reached a low temperature of 32.9F with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 18 years old patient of unknown gender who was administered the Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] that underwent temperature excursion and reached a low temperature of 32.9 F with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-May-2023, the patient received dose 2 dose 0.5 ml of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7576AB and expiry: 28-Feb-2025 via intramuscular route in the left arm for prophylactic vaccination (immunization).  On an unknown date, it was reported that Meningococcal A-C-Y-W135 (T CONJ) vaccine reached a low temperature of 32.9 F with no reported adverse event (product storage error) (unknown latency).  On 01-May-2023, the patient was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine that underwent temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).   No lab data was reported.   Action taken was not applicable.   At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: MENQUADFI underwent temperature excursion with low temperature of 0.5 degrees C with no reported AE; MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse).  This case is linked to cases 2023SA157204 and 2023SA157696.  This case involves a 18 years old and unknown gender patient who was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] which underwent temperature excursion with low temperature of 0.5 degrees c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-May-2023, the Meningococcal A-C-Y-W135 (T CONJ) vaccine underwent temperature excursion with low temperature of 0.5 degrees C (product storage error) and patient received a dose of 0.5 ml dose 1 of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection (lot: U7576AB; expiry date: 28-Feb-2025) with unknown strength via intramuscular route in the left arm for Immunization with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: nurse who reported MENQUADFI underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; nurse who reported MENQUADFI underwent temperature excursion with low temperature of 0.5 degrees C and was administered with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old and unknown gender patient who had nurse who reported menquadfi underwent temperature excursion with low temperature of 0.5 degrees c and was administered with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-May-2023, the patient received a dose 2, 0.5 ml of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot U7576AB, 28-FEB-2025 via intramuscular route in the left arm for Immunization.  On 15-May-2023 the patient developed a non-serious event nurse who reported menquadfi underwent temperature excursion with low temperature of 0.5 degrees c and was administered with no reported adverse event (poor quality product administered) (latency: same day). On an unknown date the patient developed a non-serious nurse who reported menquadfi underwent temperature excursion with low temperature of 0.5 degrees c with no reported adverse event (product storage error) (unknown latency).  Action taken was not applicable.  Outcome: Unknown for both the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: U
Vaccine: MEN
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: MENQUADFI underwent temperature excursion was administered to patient with no reported adverse event; Menquadfi reached a low temperature of 32.9F with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 13 years old patient of unknown gender who was administered the Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] that underwent temperature excursion and reached a low temperature of 32.9 F with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus vaccine Toxoid (TDAP) for Immunisation.  On 15-May-2023, the patient received an unknown dose (series 1) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7576AB and expiry: 28-Feb-2025 via intramuscular route in the left arm for immunization.  On an unknown date, it was reported that Meningococcal A-C-Y-W135 (T CONJ) vaccine reached a low temperature of 32.9 F with no reported adverse event (product storage error) (unknown latency).   On 15-May-2023, the patient was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine that underwent temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).   No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.