chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Get really sick from them; muscle aches; fever; Immune system is down; couldn't get out of bed I was too weak; couldn't get out of bed I was too weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162B2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years for COVID-19 immunisation. The patient's relevant medical history included: "Factor V" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (Dose:2), administration date: Mar2021, for COVID-19 Immunization, reaction(s): "couldn't get out of bed I was too weak", "get really, really sick from them", "my immune system is down", "muscle aches", "fever"; BNT162B2 (Dose:1), administration date: Feb2021, for COVID-19 Immunization, reaction(s): "couldn't get out of bed I was too weak", "get really, really sick from them", "my immune system is down", "muscle aches", "fever". The following information was reported: ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "Get really sick from them"; IMMUNE SYSTEM DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "Immune system is down"; ASTHENIA (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset Oct2021, outcome "unknown" and all described as "couldn't get out of bed I was too weak"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "fever"; MYALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "muscle aches".  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-202201233151 same patient/drug, different dose and event;US-PFIZER INC-202201233152 same patient/drug/AE, different dose;
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Joint range of motion decreased, Magnetic resonance imaging, Neck pain
Clinical narrative: adhesive capsulitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 24Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of the Pfizer Covid vaccine she had wrist pain, but it resolved on it's own), for COVID-19 immunization, reaction(s): "wrist pain". The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "adhesive capsulitis". The event "adhesive capsulitis" required physician office visit. Therapeutic measures were taken as a result of periarthritis.  Addition information: Patient stated she was getting better with steroids and physical therapy she was getting a lot better but still not completely normal. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nervous system disorder, Pain in extremity, Paraesthesia, Periarthritis, Radial nerve palsy
Clinical narrative: adhesive capsulitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 24Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of the Pfizer Covid vaccine she had wrist pain, but it resolved on it's own), for COVID-19 immunization, reaction(s): "wrist pain". The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "adhesive capsulitis". The event "adhesive capsulitis" required physician office visit. Therapeutic measures were taken as a result of periarthritis.  Addition information: Patient stated she was getting better with steroids and physical therapy she was getting a lot better but still not completely normal. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Spondylitis, Vaccination complication, Vaccination site pain, X-ray, X-ray limb
Clinical narrative: adhesive capsulitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 24Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of the Pfizer Covid vaccine she had wrist pain, but it resolved on it's own), for COVID-19 immunization, reaction(s): "wrist pain". The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "adhesive capsulitis". The event "adhesive capsulitis" required physician office visit. Therapeutic measures were taken as a result of periarthritis.  Addition information: Patient stated she was getting better with steroids and physical therapy she was getting a lot better but still not completely normal. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Electromyogram, Injected limb mobility decreased, Magnetic resonance imaging
Clinical narrative: adhesive capsulitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 24Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of the Pfizer Covid vaccine she had wrist pain, but it resolved on it's own), for COVID-19 immunization, reaction(s): "wrist pain". The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "adhesive capsulitis". The event "adhesive capsulitis" required physician office visit. Therapeutic measures were taken as a result of periarthritis.  Addition information: Patient stated she was getting better with steroids and physical therapy she was getting a lot better but still not completely normal. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: adhesive capsulitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 24Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of the Pfizer Covid vaccine she had wrist pain, but it resolved on it's own), for COVID-19 immunization, reaction(s): "wrist pain". The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "adhesive capsulitis". The event "adhesive capsulitis" required physician office visit. Therapeutic measures were taken as a result of periarthritis.  Addition information: Patient stated she was getting better with steroids and physical therapy she was getting a lot better but still not completely normal. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Periarthritis
Clinical narrative: adhesive capsulitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 24Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of the Pfizer Covid vaccine she had wrist pain, but it resolved on it's own), for COVID-19 immunization, reaction(s): "wrist pain". The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "adhesive capsulitis". The event "adhesive capsulitis" required physician office visit. Therapeutic measures were taken as a result of periarthritis.  Addition information: Patient stated she was getting better with steroids and physical therapy she was getting a lot better but still not completely normal. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: adhesive capsulitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 24Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of the Pfizer Covid vaccine she had wrist pain, but it resolved on it's own), for COVID-19 immunization, reaction(s): "wrist pain". The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "adhesive capsulitis". The event "adhesive capsulitis" required physician office visit. Therapeutic measures were taken as a result of periarthritis.  Addition information: Patient stated she was getting better with steroids and physical therapy she was getting a lot better but still not completely normal. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Pain in extremity, Pelvic venous thrombosis, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: Covid booster caused a blood clot in my left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jul2022 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "May and Thurer Syndrom" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19 , prev dose brand=phizer , is bivalent=False  , prev dose administration date=25Mar2021 , prev dose administration time=10:00 AM, prev dose dose number=2 , prev dose vaccine location=Right arm), administration date: 25Mar2021, when the patient was 51-year-old, for COVID-19 Immunization; BNT162b2 (prev dose product=COVID 19, prev dose brand=phizer , is bivalent=False , prev dose administration date=03Mar2021 , prev dose administration time=11:00 AM , prev dose dose number=1, prev dose vaccine location=Right arm), administration date: 03Mar2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 11Jul2022, outcome "recovered with sequelae", described as "Covid booster caused a blood clot in my left leg". The patient was hospitalized for thrombosis (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of thrombosis.   Clinical course: Adverse event treatment was surgery.The patient had no allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive Other medications in two weeks. prior vaccination, the patient had no covid. The patient has not been tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Covid booster caused a blood clot in my left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jul2022 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "May and Thurer Syndrom" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19 , prev dose brand=phizer , is bivalent=False  , prev dose administration date=25Mar2021 , prev dose administration time=10:00 AM, prev dose dose number=2 , prev dose vaccine location=Right arm), administration date: 25Mar2021, when the patient was 51-year-old, for COVID-19 Immunization; BNT162b2 (prev dose product=COVID 19, prev dose brand=phizer , is bivalent=False , prev dose administration date=03Mar2021 , prev dose administration time=11:00 AM , prev dose dose number=1, prev dose vaccine location=Right arm), administration date: 03Mar2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 11Jul2022, outcome "recovered with sequelae", described as "Covid booster caused a blood clot in my left leg". The patient was hospitalized for thrombosis (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of thrombosis.   Clinical course: Adverse event treatment was surgery.The patient had no allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive Other medications in two weeks. prior vaccination, the patient had no covid. The patient has not been tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 4.0
Sex: F
Vaccine: COVID19, HEP, HIBV, MMRV, PNC13, COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: On 10/19/2022 was noted that patient had Pfizer Ped dose 5-11 instead of 6months to 4 year dose. Patients parent was aware, stated the nurse called him to explain in August.   States no adverse reaction.  CDC called to see what dose to give the patient for 2nd vaccine. CDC replyIf the administration error resulted in a higher-than-authorized vaccine dose, in general a subsequent dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile), lead to serious adverse reactions, or are ongoing at the time of the subsequent dose, this dose might be delayed, but this decision should be as
Age: 4.0
Sex: F
Vaccine: COVID19, HEP, HIBV, MMRV, PNC13, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: On 10/19/2022 was noted that patient had Pfizer Ped dose 5-11 instead of 6months to 4 year dose. Patients parent was aware, stated the nurse called him to explain in August.   States no adverse reaction.  CDC called to see what dose to give the patient for 2nd vaccine. CDC replyIf the administration error resulted in a higher-than-authorized vaccine dose, in general a subsequent dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile), lead to serious adverse reactions, or are ongoing at the time of the subsequent dose, this dose might be delayed, but this decision should be as
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Arrhythmia, Chest pain, Echocardiogram abnormal, Electrocardiogram, Pericardial fibrosis
Clinical narrative: arrhythmia; chest pain; tachycardia; thickening of the pericardium; Pericarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 17:00 as dose 4 (booster), single (Lot number: G-5 5342) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing); "muscle tension" (unspecified if ongoing); "dysphonia" (unspecified if ongoing); "hyperactive larynx" (unspecified if ongoing); "Cogan's dystrophy" (unspecified if ongoing); "inverse psoriasis" (unspecified if ongoing). Concomitant medication(s) included: PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED; MAGNESIUM CARBONATE]; VITAMIN D [VITAMIN D NOS]; ACIDOPHILUS; VALIUM. Vaccination history included: Covid-19 vaccine (Primary series of Immunization complete. Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 3, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PERICARDITIS (disability, medically significant) with onset 2022, outcome "not recovered"; PERICARDIAL FIBROSIS (disability, medically significant) with onset 2022, outcome "not recovered", described as "thickening of the pericardium"; ARRHYTHMIA (medically significant) with onset 21Sep2022 at 09:00, outcome "not recovered"; CHEST PAIN (non-serious) with onset 21Sep2022 at 09:00, outcome "not recovered"; TACHYCARDIA (non-serious) with onset 21Sep2022 at 09:00, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown result, notes: diagnosed with pericarditis with thickening of the pericardium after echocardiogram; Heart rate: Unknown result, notes: tachycardia, and arrhythmia. Therapeutic measures were not taken as a result of pericardial fibrosis, pericarditis, arrhythmia, chest pain, tachycardia.  Clinical information: Patient was not pregnant at the time of vaccination. Patient had not received any other vaccines within 4 weeks. Patient was not tested with covid-19 to post vaccination.  Follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pericarditis, Tachycardia
Clinical narrative: arrhythmia; chest pain; tachycardia; thickening of the pericardium; Pericarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 17:00 as dose 4 (booster), single (Lot number: G-5 5342) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing); "muscle tension" (unspecified if ongoing); "dysphonia" (unspecified if ongoing); "hyperactive larynx" (unspecified if ongoing); "Cogan's dystrophy" (unspecified if ongoing); "inverse psoriasis" (unspecified if ongoing). Concomitant medication(s) included: PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED; MAGNESIUM CARBONATE]; VITAMIN D [VITAMIN D NOS]; ACIDOPHILUS; VALIUM. Vaccination history included: Covid-19 vaccine (Primary series of Immunization complete. Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 3, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PERICARDITIS (disability, medically significant) with onset 2022, outcome "not recovered"; PERICARDIAL FIBROSIS (disability, medically significant) with onset 2022, outcome "not recovered", described as "thickening of the pericardium"; ARRHYTHMIA (medically significant) with onset 21Sep2022 at 09:00, outcome "not recovered"; CHEST PAIN (non-serious) with onset 21Sep2022 at 09:00, outcome "not recovered"; TACHYCARDIA (non-serious) with onset 21Sep2022 at 09:00, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown result, notes: diagnosed with pericarditis with thickening of the pericardium after echocardiogram; Heart rate: Unknown result, notes: tachycardia, and arrhythmia. Therapeutic measures were not taken as a result of pericardial fibrosis, pericarditis, arrhythmia, chest pain, tachycardia.  Clinical information: Patient was not pregnant at the time of vaccination. Patient had not received any other vaccines within 4 weeks. Patient was not tested with covid-19 to post vaccination.  Follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Arrhythmia, Chest pain, Echocardiogram, Heart rate, Pericardial fibrosis
Clinical narrative: arrhythmia; chest pain; tachycardia; thickening of the pericardium; Pericarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 17:00 as dose 4 (booster), single (Lot number: G-5 5342) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing); "muscle tension" (unspecified if ongoing); "dysphonia" (unspecified if ongoing); "hyperactive larynx" (unspecified if ongoing); "Cogan's dystrophy" (unspecified if ongoing); "inverse psoriasis" (unspecified if ongoing). Concomitant medication(s) included: PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED; MAGNESIUM CARBONATE]; VITAMIN D [VITAMIN D NOS]; ACIDOPHILUS; VALIUM. Vaccination history included: Covid-19 vaccine (Primary series of Immunization complete. Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 3, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PERICARDITIS (disability, medically significant) with onset 2022, outcome "not recovered"; PERICARDIAL FIBROSIS (disability, medically significant) with onset 2022, outcome "not recovered", described as "thickening of the pericardium"; ARRHYTHMIA (medically significant) with onset 21Sep2022 at 09:00, outcome "not recovered"; CHEST PAIN (non-serious) with onset 21Sep2022 at 09:00, outcome "not recovered"; TACHYCARDIA (non-serious) with onset 21Sep2022 at 09:00, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown result, notes: diagnosed with pericarditis with thickening of the pericardium after echocardiogram; Heart rate: Unknown result, notes: tachycardia, and arrhythmia. Therapeutic measures were not taken as a result of pericardial fibrosis, pericarditis, arrhythmia, chest pain, tachycardia.  Clinical information: Patient was not pregnant at the time of vaccination. Patient had not received any other vaccines within 4 weeks. Patient was not tested with covid-19 to post vaccination.  Follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Investigation, Pain in extremity, X-ray
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 07Sep2021 as dose 1, single (Lot number: 30135BA), in left arm and on 28Sep2021 as dose 2, single (Lot number: 30135BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Vitiligo"; "IBS", notes: nausea for IBS; when she was 18-19 years old; "Hashimoto's"; "Anxiety"; "Restless leg"; "Bipolar 1"; "chronic fatigue syndrome"; "endometriosis"; "Amenorrhoea"; "ablation", notes: it was about 12-13 years ago and saved her life; "laparoscopy"; "car accident", notes: 10 years ago; "muscle pain"; "joint swelling"; "allergic to black mold"; "urticaria"; "numb skin". Concomitant medication(s) included: LIOTHYRONINE taken for autoimmune thyroiditis; LEVOTHYROXINE taken for autoimmune thyroiditis; TIZANIDINE taken for myalgia, joint swelling; ONDANSETRON taken for irritable bowel syndrome; PHENTERMINE; QUETIAPINE taken for bipolar i disorder; CLONAZEPAM taken for anxiety, restless legs syndrome; HYDROXYZINE taken for mycotic allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) unknown result.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201222423 same patient/drug, different dose/event;US-PFIZER INC-202201222794 same patient/drug, different dose/event;
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 07Sep2021 as dose 1, single (Lot number: 30135BA), in left arm and on 28Sep2021 as dose 2, single (Lot number: 30135BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Vitiligo"; "IBS", notes: nausea for IBS; when she was 18-19 years old; "Hashimoto's"; "Anxiety"; "Restless leg"; "Bipolar 1"; "chronic fatigue syndrome"; "endometriosis"; "Amenorrhoea"; "ablation", notes: it was about 12-13 years ago and saved her life; "laparoscopy"; "car accident", notes: 10 years ago; "muscle pain"; "joint swelling"; "allergic to black mold"; "urticaria"; "numb skin". Concomitant medication(s) included: LIOTHYRONINE taken for autoimmune thyroiditis; LEVOTHYROXINE taken for autoimmune thyroiditis; TIZANIDINE taken for myalgia, joint swelling; ONDANSETRON taken for irritable bowel syndrome; PHENTERMINE; QUETIAPINE taken for bipolar i disorder; CLONAZEPAM taken for anxiety, restless legs syndrome; HYDROXYZINE taken for mycotic allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) unknown result.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201222423 same patient/drug, different dose/event;US-PFIZER INC-202201222794 same patient/drug, different dose/event;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: lot of pain in her injection site arm and shoulder.; lot of pain in her injection site arm and shoulder.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (lot of pain in her injection site arm and shoulder.) and ARTHRALGIA (lot of pain in her injection site arm and shoulder.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 043L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (lot of pain in her injection site arm and shoulder.) and ARTHRALGIA (lot of pain in her injection site arm and shoulder.). At the time of the report, VACCINATION SITE PAIN (lot of pain in her injection site arm and shoulder.) and ARTHRALGIA (lot of pain in her injection site arm and shoulder.) outcome was unknown.      No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-658750, MOD-2022-658756.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: lot of pain in her injection site arm and shoulder.; lot of pain in her injection site arm and shoulder.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (lot of pain in her injection site arm and shoulder.) and ARTHRALGIA (lot of pain in her injection site arm and shoulder.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 043L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (lot of pain in her injection site arm and shoulder.) and ARTHRALGIA (lot of pain in her injection site arm and shoulder.). At the time of the report, VACCINATION SITE PAIN (lot of pain in her injection site arm and shoulder.) and ARTHRALGIA (lot of pain in her injection site arm and shoulder.) outcome was unknown.      No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-658750, MOD-2022-658756.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2, COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: lot of pain in her injection site arm and shoulder.; lot of pain in her injection site arm and shoulder.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (lot of pain in her injection site arm and shoulder.) and ARTHRALGIA (lot of pain in her injection site arm and shoulder.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 043L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (lot of pain in her injection site arm and shoulder.) and ARTHRALGIA (lot of pain in her injection site arm and shoulder.). At the time of the report, VACCINATION SITE PAIN (lot of pain in her injection site arm and shoulder.) and ARTHRALGIA (lot of pain in her injection site arm and shoulder.) outcome was unknown.      No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-658750, MOD-2022-658756.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered the monovalent vaccine instead of the bivalent booster vaccine.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine stored outside of recommended storage temperatures for greater than 2 weeks and administered to patient. Manufacturer contacted. Patient did not experience signs or symptoms of adverse outcome.
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event as of yet; pt was supposed to receive Fluzone Quad for her age
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered the monovalent vaccine instead of the bivalent booster vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received a booster instead of a bivalent
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside of recommended storage temperatures for greater than 2 weeks and administered to patient. Manufacturer contacted. Patient did not experience signs or symptoms of adverse outcome.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received a booster instead of a bivalent
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Blood sodium increased, Blood test, Headache, Laboratory test
Clinical narrative: Blood Labs reading -High Sodium and increased blood pressure . Readings prior to High Dose Flu Shot were normal and blood labs Normal.  My mother has allergies listed with pharmacy and last year she received a Flu Shot with no side effects the pharmacy tech giving the Flu Vaccine did not explain to my elderly parents they were giving her a different vaccine the strongest dose Flu shot and my mother was not given any medical information of side effects of the Vaccine for Flu she is elderly above age 65 with known allergies especially to eggs. No one in my family is in medical profession so we have no knowledge about the various flu vaccines but my mother was told she was receiving the low dose Flu vaccine she had last year with no medical issues. She  started having mild headaches with raise blood pressure readings soon after injection of vaccine and has had two emergency room visits at local hospital telling the Emergency Room medical personnel attending her that the Flu shot caused her several side effects and she was told her blood pressure may remain elevated due to this High Dose Flu Vaccine and she had absolutely normal blood pressure readings every morning but since this shot was given to her she has elevated blood pressure readings. Nothing has changed in her plant food diet and she is not taking any new medications. I am writing you because the person that gave her the vaccine pharmacy is on video camera never explaining nothing to my parents and no one told my mother they were giving her a vaccine with higher dose from the previous year she had no complications with the Flu shot. Both my parents were not even given the name of the Flu shot. I went with both parents received a flu shot with them and was not told about it being a high dose vaccine but have had no Emergency room visits to local hospital had mild headache and muscle soreness where injection was given. I did notice a swollen arm and bump on my mothers arm where injection was given my father whom is a year older than my mother had a sore arm as well but not a bump like my mother had on site of injection. She is average weight and pharmacy is aware of her allergies as well as the complaint about this store employee that did not explain anything about the Flu Vaccine that was given this year to my mother harmed by the higher dose vaccine. I have no medical knowledge and am not a healthcare worker but I wanted to write to you about this shot that was given to my mother without her knowledge. Nobody at the pharmacy explained to us about how many flu vaccines are available or the side effects of the flu vaccine. I am hoping that me reporting this that may explain to people how many vaccines are out there for flu and the side effects at least some information to help someone unknowing in medical information.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: Blood Labs reading -High Sodium and increased blood pressure . Readings prior to High Dose Flu Shot were normal and blood labs Normal.  My mother has allergies listed with pharmacy and last year she received a Flu Shot with no side effects the pharmacy tech giving the Flu Vaccine did not explain to my elderly parents they were giving her a different vaccine the strongest dose Flu shot and my mother was not given any medical information of side effects of the Vaccine for Flu she is elderly above age 65 with known allergies especially to eggs. No one in my family is in medical profession so we have no knowledge about the various flu vaccines but my mother was told she was receiving the low dose Flu vaccine she had last year with no medical issues. She  started having mild headaches with raise blood pressure readings soon after injection of vaccine and has had two emergency room visits at local hospital telling the Emergency Room medical personnel attending her that the Flu shot caused her several side effects and she was told her blood pressure may remain elevated due to this High Dose Flu Vaccine and she had absolutely normal blood pressure readings every morning but since this shot was given to her she has elevated blood pressure readings. Nothing has changed in her plant food diet and she is not taking any new medications. I am writing you because the person that gave her the vaccine pharmacy is on video camera never explaining nothing to my parents and no one told my mother they were giving her a vaccine with higher dose from the previous year she had no complications with the Flu shot. Both my parents were not even given the name of the Flu shot. I went with both parents received a flu shot with them and was not told about it being a high dose vaccine but have had no Emergency room visits to local hospital had mild headache and muscle soreness where injection was given. I did notice a swollen arm and bump on my mothers arm where injection was given my father whom is a year older than my mother had a sore arm as well but not a bump like my mother had on site of injection. She is average weight and pharmacy is aware of her allergies as well as the complaint about this store employee that did not explain anything about the Flu Vaccine that was given this year to my mother harmed by the higher dose vaccine. I have no medical knowledge and am not a healthcare worker but I wanted to write to you about this shot that was given to my mother without her knowledge. Nobody at the pharmacy explained to us about how many flu vaccines are available or the side effects of the flu vaccine. I am hoping that me reporting this that may explain to people how many vaccines are out there for flu and the side effects at least some information to help someone unknowing in medical information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received a booster instead of a bivalent
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine stored outside of recommended storage temperatures for greater than 2 weeks and administered to patient. Manufacturer contacted. Patient did not experience signs or symptoms of adverse outcome.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received a booster instead of a bivalent
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: received a booster instead of a bivalent
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received a booster dose instead of a bivalent
Age: 27.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Urticaria
Clinical narrative: 5 days later I started breaking out in hives. I think I'm having an allergic reaction
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Herpes zoster, Pain
Clinical narrative: Aches and chills the next day   Shingles attack nearly 1 year later
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye disorder, Eye irritation, Vision blurred
Clinical narrative: Woke up at 7am day after vaccine injection. Right eye was burning and felt like it had a film on it. Tried eye drops but did not relieve burning.  Early afternoon when I left home and drove to run errands noticed both my eyes were blurry and right eye felt swollen. No appearance of swelling however. Was advised by primary care dr. To go to urgent care to have it checked. Was given prescription for prednisolone acetate drops. Also had flu shot the same day in left arm.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast pain, Oedema peripheral, Pain, Tenderness
Clinical narrative: Third dose of COVID vaccine, first bivalent. Significant left under arm edema, with tenderness and radiating pain to left breast.
Age: 49.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Chills, Eye pain, Laboratory test normal, Magnetic resonance imaging head normal, Muscle fatigue
Clinical narrative: pt developed muscle fatigue (felt like he worked out), recurring paresthesias persisting for at least 2 months.   In addition, had difficulty focusing his vision with a dull pain in his left eye.  He also had intermittent chills and funny sensation of his tongue. Symptoms worsened following 2nd and 3rd vaccine in the series.
Age: 49.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pain, Paraesthesia, Paraesthesia oral, Vision blurred
Clinical narrative: pt developed muscle fatigue (felt like he worked out), recurring paresthesias persisting for at least 2 months.   In addition, had difficulty focusing his vision with a dull pain in his left eye.  He also had intermittent chills and funny sensation of his tongue. Symptoms worsened following 2nd and 3rd vaccine in the series.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood calcium, Blood creatine phosphokinase, Blood magnesium
Clinical narrative: Rapid heartrate, pounding heartbeat for 2+ hours, shortness of breath, tongue swelling and severe muscle cramps in legs on Sunday, October 9, 2022.  Admitted to local Emergency Room on Sunday, Oct. 9th and diagnosed with pericarditis.  Treatment is rest and colchicine 0.6 mg 2x daily.   Adverse event occured 4 days after Pfizer-Bivalent vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood phosphorus, Blood thyroid stimulating hormone, Brain natriuretic peptide, Differential white blood cell count, Dyspnoea
Clinical narrative: Rapid heartrate, pounding heartbeat for 2+ hours, shortness of breath, tongue swelling and severe muscle cramps in legs on Sunday, October 9, 2022.  Admitted to local Emergency Room on Sunday, Oct. 9th and diagnosed with pericarditis.  Treatment is rest and colchicine 0.6 mg 2x daily.   Adverse event occured 4 days after Pfizer-Bivalent vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Full blood count, Heart rate increased, Laboratory test, Lipase
Clinical narrative: Rapid heartrate, pounding heartbeat for 2+ hours, shortness of breath, tongue swelling and severe muscle cramps in legs on Sunday, October 9, 2022.  Admitted to local Emergency Room on Sunday, Oct. 9th and diagnosed with pericarditis.  Treatment is rest and colchicine 0.6 mg 2x daily.   Adverse event occured 4 days after Pfizer-Bivalent vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle spasms, Palpitations, Pericarditis, Prothrombin time, SARS-CoV-2 test negative
Clinical narrative: Rapid heartrate, pounding heartbeat for 2+ hours, shortness of breath, tongue swelling and severe muscle cramps in legs on Sunday, October 9, 2022.  Admitted to local Emergency Room on Sunday, Oct. 9th and diagnosed with pericarditis.  Treatment is rest and colchicine 0.6 mg 2x daily.   Adverse event occured 4 days after Pfizer-Bivalent vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swollen tongue, Troponin, Ultrasound scan
Clinical narrative: Rapid heartrate, pounding heartbeat for 2+ hours, shortness of breath, tongue swelling and severe muscle cramps in legs on Sunday, October 9, 2022.  Admitted to local Emergency Room on Sunday, Oct. 9th and diagnosed with pericarditis.  Treatment is rest and colchicine 0.6 mg 2x daily.   Adverse event occured 4 days after Pfizer-Bivalent vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: LARGE HIVE that got bigger as the day progresses. I had a large hive that went down my arm near my elbow. The injection site was hot, ichi, and painful to touch. This lasted for about 3 weeks and when I was mandated to take the second dose I had inform about mu reaction and was told that I should be fine... well when I received the second some hours about 3 hours later I began to have pain in my check and felt like I had a heavy baby laying on my chest and I had pain in my chest, I also had pain in my back and... I was also experiencing odd heart beats... injection site was very painful and hot, but what was scary wa the amount of visit to the er I had because of this vaccine... I never had any heart problems and now I am dealing with this because of this shot
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear, Heart rate increased, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: LARGE HIVE that got bigger as the day progresses. I had a large hive that went down my arm near my elbow. The injection site was hot, ichi, and painful to touch. This lasted for about 3 weeks and when I was mandated to take the second dose I had inform about mu reaction and was told that I should be fine... well when I received the second some hours about 3 hours later I began to have pain in my check and felt like I had a heavy baby laying on my chest and I had pain in my chest, I also had pain in my back and... I was also experiencing odd heart beats... injection site was very painful and hot, but what was scary wa the amount of visit to the er I had because of this vaccine... I never had any heart problems and now I am dealing with this because of this shot
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pain, Urticaria
Clinical narrative: LARGE HIVE that got bigger as the day progresses. I had a large hive that went down my arm near my elbow. The injection site was hot, ichi, and painful to touch. This lasted for about 3 weeks and when I was mandated to take the second dose I had inform about mu reaction and was told that I should be fine... well when I received the second some hours about 3 hours later I began to have pain in my check and felt like I had a heavy baby laying on my chest and I had pain in my chest, I also had pain in my back and... I was also experiencing odd heart beats... injection site was very painful and hot, but what was scary wa the amount of visit to the er I had because of this vaccine... I never had any heart problems and now I am dealing with this because of this shot
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Child had pityriasis rosea shortly after second dose
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Dyskinesia, Electromyogram, Impaired work ability
Clinical narrative: In 2 weeks after the second shot I felt muscle twitching (mostly in my calves), vibration in different parts of my body, painful pins and needles, severe insomnia, jerk movements while falling asleep, internal tremor, burning in legs and arms. I visited 8 neurologists, 2 immunologists, took Lyrica, Gabapentin, Medrol, Miaser, Magnesium, VitB complex and many other supplements. All my symptoms did not change, I am straggling every day, can not work and live normal live. Desperately need help.