chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Fever; I feel very bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (COMIRNATY), on 14Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 15Apr2022 at 03:00, outcome "unknown", described as "Fever"; FEELING ABNORMAL (non-serious) with onset 15Apr2022 at 03:00, outcome "unknown", described as "I feel very bad".  Additional information: Consumer stated she got Comirnaty vaccine yesterday and at 3 AM she woke up with a fever and felt very bad so she just wanted to report it in 24 hours.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Developed a blood clot in left lung; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD in bottom lung Diagnosed with a long time ago" (ongoing), notes: The caller has a preexisting condition in the lungs.; "Had Pneumonia 5 times in bottom left lung" (unspecified if ongoing), notes: Had Pneumonia 5 times in bottom left lung and the left lung doesn't work; "the left lung doesn't work" (unspecified if ongoing), notes: Had Pneumonia 5 times in bottom left lung and the left lung doesn't work. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose: 26Mar2021 , lot: ER8730, NDC: Unknown, expiration: Unknown , Route of administration: left arm), administration date: 26Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "couldn't breathe"; BNT162b2 (First dose: 26Mar2021 , lot: ER8730, NDC: Unknown, expiration: Unknown , Route of administration: left arm), administration date: 26Mar2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "Dry drowning in lung", "got worse in lungs", "except for taste and smell"; BNT162b2 (First dose: 26Mar2021 , lot: ER8730, NDC: Unknown, expiration: Unknown , Route of administration: left arm), administration date: 26Mar2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "except for taste and smell"; BNT162b2 (Second dose: 16Apr2021 , lot: EW0170, NDC: unknown , expiration: unknown , Route of adminstration: left arm, the caller had no reaction to the second dose), administration date: 16Apr2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "had no reaction to the second dose". The following information was reported: THROMBOSIS (medically significant) with onset Feb2022, outcome "unknown", described as "Developed a blood clot in left lung".  Clinical course: Caller states prior to receiving the first dose Unknown Pfizer Vaccine, the caller had no lung issue and no cold, did not have Pneumonia or bronchitis, nothing. Developed a blood clot in left lung: The caller developed a blood clot in the left lung.never had a blood clot before. The blood clot was found in Feb2022 but doesn't know when the blood clot occurred. The caller had never had blood clots before. Eventually, later down the road the caller was in the hospital five times. Caller not able to provide dates for hospitalization.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site; low grade fever; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 , Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site necrosis
Clinical narrative: Narcosis tissue injection site; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 3 (booster), single (Lot number: 9895) at the age of 48 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Patient had no known allergies. Facility type vaccine was reported as Pharmacy or Drug Store. There were no concomitant medications, reported as no other medications in two weeks. No other vaccine in four weeks. No covid prior vaccination and reported as patient tested for covid post vaccination. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0177, Location of injection: Arm Left), administration date: 06Jun2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0196, Location of injection: Arm Right), administration date: 27Jun2021, when the patient was 47-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE NECROSIS (medically significant), outcome "not recovered", described as "Narcosis tissue injection site". The event "narcosis tissue injection site" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Negative. Therapeutic measures were taken as a result of vaccination site necrosis included Surgery.; Sender's Comments: Based on information provided in narrative , there is reasonable possibility of causal association between the event Vaccination site necrosis and the suspect vaccine 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Fatigue, Nausea, Pain
Clinical narrative: Body aches and joint aches; Fatigue; Severe chills; Nausea; Backache; Shivering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization , Unknown manufacturer), for Covid-19 Immunization.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "Body aches and joint aches"; FATIGUE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown", described as "Severe chills"; NAUSEA (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "Backache"; CHILLS (non-serious), outcome "unknown", described as "Shivering".  Additional information: Concern, reporter stated, she was just calling to ask a question. We got our 3rd COVID-19 Booster shot on Monday afternoon late and my friend (consumer) like 2 days later started having the normal things like just like body aches, fatigue while in the next day severe chills, nausea, joint aches and then yesterday she felt pretty fine last night and then today I mean severe chills, nausea and her backache. Should we go to the Doctor or are these normal things? I mean is it like severe chills and shivering.  When paraphrased the concern, reporter stated, "Yes, the 3rd one she had done Moderna Booster (COVID-19 Vaccine) and the first time she had for the Pfizer (COVID-19 Vaccine) at (name withheld)Pharmacy."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Migraine, SARS-CoV-2 test
Clinical narrative: Patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer Biontech Covid-19 vaccine.; Patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer Biontech Covid-19 vaccine.; Patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer Biontech Covid-19 vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine headaches" (unspecified if ongoing), notes: Other medical history: Migraine headaches. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single, Lot number- UNKNOWN), for Covid-19 immunization, reaction(s): "Condition worsened", "Headache", "Migraine"; Bnt162b2 (Dose 1, Single, Lot number- UNKNOWN), for Covid-19 immunization, reaction(s): "Condition worsened", "Headache", "Migraine". The following information was reported: MIGRAINE (non-serious), CONDITION AGGRAVATED (non-serious), HEADACHE (non-serious), outcome "recovered with sequelae" and all described as "Patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer Biontech Covid-19 vaccine.". The events "patient reports that her chronic migraine headaches worsened and were more severe after receiving each dose of the pfizer biontech covid-19 vaccine." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of migraine, condition aggravated, headache. Additional information: Patient was not pregnant at the time of vaccination. Patient medical history included Migraine headaches. It was unknown if patient had any known allergies. It was unknown if patient received any other vaccines in four weeks. It was unknown if patient received any other medications in two weeks. Patient reported that her chronic migraine headaches worsened and were more severe after receiving each dose of the Pfizer BioNTech Covid-19 vaccine. As a result, she is hesitant to receive a second booster/fourth dose but she also suspected there may be other factors affecting her migraine(s) and planned to discuss with her doctor. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for the adverse events. Patient did not have COVID-19 prior to vaccination. Patient was tested with COVID-19 post vaccination with results as unknown.   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: Abortion spontaneous
Clinical narrative: While sitting in a pub, the bar tender told me his ex-wife had a Pfizer vaccine then miscarried her child.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 16Apr2022, outcome "unknown", described as "While sitting in a pub, the bar tender told me his ex-wife had a Pfizer vaccine then miscarried her child.". It was unknown if therapeutic measures were taken as a result of abortion spontaneous. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Limb discomfort
Clinical narrative: Felt severe pressure on chest, abdomen, & legs; Felt severe pressure on chest, abdomen, & legs; Felt severe pressure on chest, abdomen, & legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 33026BD) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "kidney disease" (unspecified if ongoing); "Multi cystic liver" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL; ATENOLOL; ATORVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 03Feb2021, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 13Jan2021, for COVID-19 immunization. The following information was reported: CHEST DISCOMFORT (non-serious), ABDOMINAL DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious) all with onset 28Oct2021 at 04:00, outcome "recovered" and all described as "Felt severe pressure on chest, abdomen, & legs". Therapeutic measures were not taken as a result of chest discomfort, abdominal discomfort, limb discomfort.  Additional information: The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. No known allergies reported for the patient.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy that won't go away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: EW 0164) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER 8732), administration date: 03Apr2021, when the patient was 50-year-old, for Covid-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 01May2021, outcome "not recovered", described as "Bell's Palsy that won't go away.". It was unknown if therapeutic measures were taken as a result of bell's palsy.  Clinical information:The patient was not tested with Covid19 prior and post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Dysmenorrhoea, Gait disturbance, Inflammation
Clinical narrative: I felt weak and at times could barely walk; I felt weak and at times could barely walk; After my first vaccination my first period was a week late, but I received bad cramps the whole week; After my first vaccination my first period was a week late, but I received bad cramps the whole week; I felt inflammation in my uterus, chest and all over my body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 13:00 as dose 1, single (Lot number: EW0191) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "surgery" (unspecified if ongoing), notes: I've spent 50-60% of this past year being bed ridden and unable to live my life. It's been awful. The specialist found a fibroid and I had surgery to remove it, but fibroids have nothing to do with my symptoms(which I knew going into it). The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (disability, medically significant), DYSMENORRHOEA (disability, medically significant) all with onset 03May2021 at 12:00, outcome "not recovered" and all described as "After my first vaccination my first period was a week late, but I received bad cramps the whole week"; INFLAMMATION (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", described as "I felt inflammation in my uterus, chest and all over my body"; GAIT DISTURBANCE (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", ASTHENIA (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered" and all described as "I felt weak and at times could barely walk". The events "i felt weak and at times could barely walk", "after my first vaccination my first period was a week late, but i received bad cramps the whole week" and "i felt inflammation in my uterus, chest and all over my body" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (03May2021) looks fine; SARS-CoV-2 test: (05Jan2022) Positive, notes: Other. Therapeutic measures were not taken as a result of gait disturbance, asthenia, menstrual disorder, dysmenorrhoea, inflammation.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: I felt weak and at times could barely walk; I felt weak and at times could barely walk; After my first vaccination my first period was a week late, but I received bad cramps the whole week; After my first vaccination my first period was a week late, but I received bad cramps the whole week; I felt inflammation in my uterus, chest and all over my body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 13:00 as dose 1, single (Lot number: EW0191) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "surgery" (unspecified if ongoing), notes: I've spent 50-60% of this past year being bed ridden and unable to live my life. It's been awful. The specialist found a fibroid and I had surgery to remove it, but fibroids have nothing to do with my symptoms(which I knew going into it). The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (disability, medically significant), DYSMENORRHOEA (disability, medically significant) all with onset 03May2021 at 12:00, outcome "not recovered" and all described as "After my first vaccination my first period was a week late, but I received bad cramps the whole week"; INFLAMMATION (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", described as "I felt inflammation in my uterus, chest and all over my body"; GAIT DISTURBANCE (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", ASTHENIA (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered" and all described as "I felt weak and at times could barely walk". The events "i felt weak and at times could barely walk", "after my first vaccination my first period was a week late, but i received bad cramps the whole week" and "i felt inflammation in my uterus, chest and all over my body" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (03May2021) looks fine; SARS-CoV-2 test: (05Jan2022) Positive, notes: Other. Therapeutic measures were not taken as a result of gait disturbance, asthenia, menstrual disorder, dysmenorrhoea, inflammation.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, COVID-19, Dysmenorrhoea, Loss of personal independence in daily activities, Menstrual disorder
Clinical narrative: I felt weak and at times could barely walk; I felt weak and at times could barely walk; After my first vaccination my first period was a week late, but I received bad cramps the whole week; After my first vaccination my first period was a week late, but I received bad cramps the whole week; I felt inflammation in my uterus, chest and all over my body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 13:00 as dose 1, single (Lot number: EW0191) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "surgery" (unspecified if ongoing), notes: I've spent 50-60% of this past year being bed ridden and unable to live my life. It's been awful. The specialist found a fibroid and I had surgery to remove it, but fibroids have nothing to do with my symptoms(which I knew going into it). The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (disability, medically significant), DYSMENORRHOEA (disability, medically significant) all with onset 03May2021 at 12:00, outcome "not recovered" and all described as "After my first vaccination my first period was a week late, but I received bad cramps the whole week"; INFLAMMATION (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", described as "I felt inflammation in my uterus, chest and all over my body"; GAIT DISTURBANCE (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", ASTHENIA (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered" and all described as "I felt weak and at times could barely walk". The events "i felt weak and at times could barely walk", "after my first vaccination my first period was a week late, but i received bad cramps the whole week" and "i felt inflammation in my uterus, chest and all over my body" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (03May2021) looks fine; SARS-CoV-2 test: (05Jan2022) Positive, notes: Other. Therapeutic measures were not taken as a result of gait disturbance, asthenia, menstrual disorder, dysmenorrhoea, inflammation.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myomectomy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I felt weak and at times could barely walk; I felt weak and at times could barely walk; After my first vaccination my first period was a week late, but I received bad cramps the whole week; After my first vaccination my first period was a week late, but I received bad cramps the whole week; I felt inflammation in my uterus, chest and all over my body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 13:00 as dose 1, single (Lot number: EW0191) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "surgery" (unspecified if ongoing), notes: I've spent 50-60% of this past year being bed ridden and unable to live my life. It's been awful. The specialist found a fibroid and I had surgery to remove it, but fibroids have nothing to do with my symptoms(which I knew going into it). The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (disability, medically significant), DYSMENORRHOEA (disability, medically significant) all with onset 03May2021 at 12:00, outcome "not recovered" and all described as "After my first vaccination my first period was a week late, but I received bad cramps the whole week"; INFLAMMATION (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", described as "I felt inflammation in my uterus, chest and all over my body"; GAIT DISTURBANCE (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered", ASTHENIA (disability, medically significant) with onset 03May2021 at 12:00, outcome "not recovered" and all described as "I felt weak and at times could barely walk". The events "i felt weak and at times could barely walk", "after my first vaccination my first period was a week late, but i received bad cramps the whole week" and "i felt inflammation in my uterus, chest and all over my body" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (03May2021) looks fine; SARS-CoV-2 test: (05Jan2022) Positive, notes: Other. Therapeutic measures were not taken as a result of gait disturbance, asthenia, menstrual disorder, dysmenorrhoea, inflammation.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Dysmenorrhoea, Gait disturbance, Inflammation
Clinical narrative: covid test result= Positive; covid test result= Positive; bed ridden; unable to live my life; The specialist found a fibroid and I had surgery to remove it; My periods are still not normal; I constantly have cramps but my blood work looks fine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 13:00 as dose 1, single (Lot number: EW0191), in left arm and on 26May2021 at 13:00 as dose 2, single (Lot number: 7534) at the age of 33 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSMENORRHOEA (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "I constantly have cramps but my blood work looks fine"; MENSTRUAL DISORDER (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "My periods are still not normal"; MYOMECTOMY (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "The specialist found a fibroid and I had surgery to remove it"; BEDRIDDEN (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "bed ridden"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "unable to live my life"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "covid test result= Positive". The events "covid test result= positive", "bed ridden", "unable to live my life", "the specialist found a fibroid and i had surgery to remove it", "my periods are still not normal" and "i constantly have cramps but my blood work looks fine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2022) Positive, notes: At home rapid test. Therapeutic measures were not taken as a result of covid-19, vaccination failure, bedridden, loss of personal independence in daily activities, menstrual disorder, dysmenorrhoea. Therapeutic measures were taken as a result of myomectomy.  Clinical information: Patient called her doctor and saw him multiple times and he kept telling her there was no way to know if it was related to the vaccination. He was truly unhelpful and finally sent me to a women's specialist.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: covid test result= Positive; covid test result= Positive; bed ridden; unable to live my life; The specialist found a fibroid and I had surgery to remove it; My periods are still not normal; I constantly have cramps but my blood work looks fine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 13:00 as dose 1, single (Lot number: EW0191), in left arm and on 26May2021 at 13:00 as dose 2, single (Lot number: 7534) at the age of 33 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSMENORRHOEA (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "I constantly have cramps but my blood work looks fine"; MENSTRUAL DISORDER (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "My periods are still not normal"; MYOMECTOMY (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "The specialist found a fibroid and I had surgery to remove it"; BEDRIDDEN (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "bed ridden"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "unable to live my life"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "covid test result= Positive". The events "covid test result= positive", "bed ridden", "unable to live my life", "the specialist found a fibroid and i had surgery to remove it", "my periods are still not normal" and "i constantly have cramps but my blood work looks fine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2022) Positive, notes: At home rapid test. Therapeutic measures were not taken as a result of covid-19, vaccination failure, bedridden, loss of personal independence in daily activities, menstrual disorder, dysmenorrhoea. Therapeutic measures were taken as a result of myomectomy.  Clinical information: Patient called her doctor and saw him multiple times and he kept telling her there was no way to know if it was related to the vaccination. He was truly unhelpful and finally sent me to a women's specialist.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, COVID-19, Dysmenorrhoea, Loss of personal independence in daily activities, Menstrual disorder
Clinical narrative: covid test result= Positive; covid test result= Positive; bed ridden; unable to live my life; The specialist found a fibroid and I had surgery to remove it; My periods are still not normal; I constantly have cramps but my blood work looks fine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 13:00 as dose 1, single (Lot number: EW0191), in left arm and on 26May2021 at 13:00 as dose 2, single (Lot number: 7534) at the age of 33 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSMENORRHOEA (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "I constantly have cramps but my blood work looks fine"; MENSTRUAL DISORDER (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "My periods are still not normal"; MYOMECTOMY (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "The specialist found a fibroid and I had surgery to remove it"; BEDRIDDEN (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "bed ridden"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "unable to live my life"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "covid test result= Positive". The events "covid test result= positive", "bed ridden", "unable to live my life", "the specialist found a fibroid and i had surgery to remove it", "my periods are still not normal" and "i constantly have cramps but my blood work looks fine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2022) Positive, notes: At home rapid test. Therapeutic measures were not taken as a result of covid-19, vaccination failure, bedridden, loss of personal independence in daily activities, menstrual disorder, dysmenorrhoea. Therapeutic measures were taken as a result of myomectomy.  Clinical information: Patient called her doctor and saw him multiple times and he kept telling her there was no way to know if it was related to the vaccination. He was truly unhelpful and finally sent me to a women's specialist.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myomectomy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result= Positive; covid test result= Positive; bed ridden; unable to live my life; The specialist found a fibroid and I had surgery to remove it; My periods are still not normal; I constantly have cramps but my blood work looks fine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 13:00 as dose 1, single (Lot number: EW0191), in left arm and on 26May2021 at 13:00 as dose 2, single (Lot number: 7534) at the age of 33 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSMENORRHOEA (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "I constantly have cramps but my blood work looks fine"; MENSTRUAL DISORDER (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "My periods are still not normal"; MYOMECTOMY (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "The specialist found a fibroid and I had surgery to remove it"; BEDRIDDEN (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "bed ridden"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) with onset 03May2021 at 12:00, outcome "not recovered", described as "unable to live my life"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "covid test result= Positive". The events "covid test result= positive", "bed ridden", "unable to live my life", "the specialist found a fibroid and i had surgery to remove it", "my periods are still not normal" and "i constantly have cramps but my blood work looks fine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2022) Positive, notes: At home rapid test. Therapeutic measures were not taken as a result of covid-19, vaccination failure, bedridden, loss of personal independence in daily activities, menstrual disorder, dysmenorrhoea. Therapeutic measures were taken as a result of myomectomy.  Clinical information: Patient called her doctor and saw him multiple times and he kept telling her there was no way to know if it was related to the vaccination. He was truly unhelpful and finally sent me to a women's specialist.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Drug ineffective, Suspected COVID-19
Clinical narrative: lost taste and smell; lost taste and smell; I got covid; I got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 20Sep2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 13Apr2022, outcome "unknown" and all described as "I got covid"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 16Apr2022, outcome "unknown" and all described as "lost taste and smell".  Clinical Course: Forwarded as an Adverse Event by the team on 18Apr2022. Reporter provided verification of contact address on 16Apr2022. Customer Verbatim: Just wanted to let you know she got Covid on 13Apr2022. Her booster was 20Sep2021. She had symptoms and just lost taste and smell today. She think she need to let people know they need to get 2nd booster. It was a shame that the 2nd booster decision didn't come out earlier.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: administered a Covid vaccine that was for age range 12 and up to an 11 year old; patient had a sore arm after this vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team.  An 11-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2022 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 11 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 20Jan2022, outcome "unknown", described as "administered a Covid vaccine that was for age range 12 and up to an 11 year old"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "patient had a sore arm after this vaccine".  Additional information: In January they administered a Covid vaccine that was for age range 12 and up to an 11 year old that was 3 months shy of 12. Wanted to know if there was anything that they needed to worry about and what to do. The patient was on the scheduled for second dose on 14Apr2022 and that is when it was noticed that she was 11 years old when she got the first one. The patient was a couple days shy of 12. This was the patient's first dose. It should have been 0.3ml intramuscular injection in deltoid. Prior Vaccinations (within 4 weeks) If applicable, AE(s) following prior vaccinations, patient's medical history and relevant tests reported as none at the time of report and family medical history relevant to AE(s) reported as n/a. Product Details: It is the Gray top.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: positive for Covid; positive for Covid; 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 77-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. 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: Systemic lupus erythematosus
Clinical narrative: lupus; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received BNT162b2 (COMIRNATY), 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, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus". Therapeutic measures were taken as a result of systemic lupus erythematosus.  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 the current available limited information in the case provided, the causal association between the event lupus and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: she did all the Pfizer shots and boosters/ tested positive for COVID; she did all the Pfizer shots and boosters/ tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she did all the Pfizer shots and boosters/ tested positive for COVID". The patient underwent the following laboratory tests and procedures: Oxygen saturation: 98, notes: my little finger in the air thing is 98; SARS-CoV-2 test: positive.  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
Symptoms: Limb injury, SARS-CoV-2 test
Clinical narrative: she did all the Pfizer shots and boosters/ tested positive for COVID; she did all the Pfizer shots and boosters/ tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she did all the Pfizer shots and boosters/ tested positive for COVID". The patient underwent the following laboratory tests and procedures: Oxygen saturation: 98, notes: my little finger in the air thing is 98; SARS-CoV-2 test: positive.  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
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: little finger in the air thing is 98; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number- unknown), for Covid-19 Immunization; Bnt162b2 (Dose 2, single, Lot number- unknown), for Covid-19 Immunization. The following information was reported: LIMB INJURY (non-serious), outcome "unknown", described as "little finger in the air thing is 98". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient called in to ask if she needed PAXLOVID since she tested positive for COVID. Patient symptoms were minimal. Patient stated her little finger in the air thing is 98 and feels fine. patient was with somebody that had COVID a few days ago. Patient was in excellent health and physically at 77 years old. Patient walks the golf course, carries her golf clubs, runs and does everything. patient stated she had been around a lot and her husband, daughter, and son are doctors and did all the Pfizer shots and boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.