chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Acute sinusitis, Aphonia, Nasopharyngeal swab, Oropharyngeal pain
Clinical narrative: Contracted a severe acute sinusitis; Was losing voice; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 at 16:00 as dose 2, single (Lot number: FK9896) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing), notes: Herpes, asthma, migraines; "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Tomatoes, Eggs" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Known allergies: naproxen", notes: Sulfa, Naproxen, Tomatoes, Eggs. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FL3198, Location of injection: Arm Right, Vaccine Administration date: 12Jan2022, Vaccine Administration Time: 02:30 PM), administration date: 12Jan2022, when the patient was 43-year-old, for Covid-19 immunization.  The following information was reported: ACUTE SINUSITIS (medically significant) with onset 14Feb2022 at 12:00, outcome "recovered" (2022), described as "Contracted a severe acute sinusitis"; APHONIA (non-serious) with onset 14Feb2022 at 12:00, outcome "recovered" (2022), described as "Was losing voice"; OROPHARYNGEAL PAIN (non-serious) with onset 14Feb2022 at 12:00, outcome "recovered" (2022), described as "sore throat". The events "contracted a severe acute sinusitis", "was losing voice" and "sore throat" required physician office visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (14Feb2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of acute sinusitis, aphonia, oropharyngeal pain. The patient AE treatment included: Antibiotics, allergy medicine and steroid shots. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient had no fever.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; 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 female patient received BNT162b2 (BNT162B2), 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, Unknown manufacturer, Primary Immunization completed), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer, Primary Immunization completed), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster), Unknown manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  Additional information: Patient received the Pfizer Covid19 2nd booster this morning at 10:45 (Unspecified date), she wants to know if she can take Tylenol for injection site pain and she also wants to know if she can continue to take her muscle relaxer. Patient and her husband both got their second COVID booster at (withheld) hospital drive through. She just wanted to know if it is okay for them to take Tylenol for mild injection site pain. It is nothing serious. She doesn't want to do a report. She stated she is a doctor but not a medical doctor. She had success with both COVID vaccines and both boosters. She will get another in the fall if needed. 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-202200966945 same reporter/drug, different patient, similar event;
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Exercise electrocardiogram, Gait disturbance
Clinical narrative: having a heart attack and went to the hospital; gained 80 pounds; some chest pain; had a walking stress echo a week later and was only able to walk 3 of the 5 minutes required; 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 male 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: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization.  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2022, outcome "unknown", described as "had a walking stress echo a week later and was only able to walk 3 of the 5 minutes required"; MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "having a heart attack and went to the hospital"; CHEST PAIN (non-serious) with onset 2022, outcome "unknown", described as "some chest pain"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "gained 80 pounds". The events "having a heart attack and went to the hospital" required physician office visit.  The patient underwent the following laboratory tests and procedures: Chest X-ray: (2022) Negative, notes: all results came back negative they couldn't find anything; Electrocardiogram: (2022) Negative, notes: all results came back negative they couldn't find anything; Exercise electrocardiogram: (2022) Unknown result, notes: test was inconclusive; another test: (2022) Negative, notes: all results came back negative they couldn't find anything; (2022) Unknown result; Weight: (unspecified date) 80 lbs, notes: gained 80 lbs.  Clinical course: It was reported that patient received the first and then the second a month later of the Pfizer Covid 19 Vaccine while in the nursing home. He received the booster a year later. Caller reported that he has gained 80 pounds. He has been getting pains in his chest and like a heart attack and 3 weeks ago he went to the hospital and they gave him a chest X-ray and EKG and another test and they couldn't find anything. A week later he went back and had a stress echo test and he did not finish and he is not in great shape and he did test on the treadmill and he was supposed to walk for 5 minutes and his legs starting hurting and he did 3 minutes and the test was inconclusive. Asking if taking the injection could have damaged his chest? Caller said he would provide contact information if it didn't take too long.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Myocardial infarction, Weight, Weight increased
Clinical narrative: having a heart attack and went to the hospital; gained 80 pounds; some chest pain; had a walking stress echo a week later and was only able to walk 3 of the 5 minutes required; 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 male 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: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization.  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2022, outcome "unknown", described as "had a walking stress echo a week later and was only able to walk 3 of the 5 minutes required"; MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "having a heart attack and went to the hospital"; CHEST PAIN (non-serious) with onset 2022, outcome "unknown", described as "some chest pain"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "gained 80 pounds". The events "having a heart attack and went to the hospital" required physician office visit.  The patient underwent the following laboratory tests and procedures: Chest X-ray: (2022) Negative, notes: all results came back negative they couldn't find anything; Electrocardiogram: (2022) Negative, notes: all results came back negative they couldn't find anything; Exercise electrocardiogram: (2022) Unknown result, notes: test was inconclusive; another test: (2022) Negative, notes: all results came back negative they couldn't find anything; (2022) Unknown result; Weight: (unspecified date) 80 lbs, notes: gained 80 lbs.  Clinical course: It was reported that patient received the first and then the second a month later of the Pfizer Covid 19 Vaccine while in the nursing home. He received the booster a year later. Caller reported that he has gained 80 pounds. He has been getting pains in his chest and like a heart attack and 3 weeks ago he went to the hospital and they gave him a chest X-ray and EKG and another test and they couldn't find anything. A week later he went back and had a stress echo test and he did not finish and he is not in great shape and he did test on the treadmill and he was supposed to walk for 5 minutes and his legs starting hurting and he did 3 minutes and the test was inconclusive. Asking if taking the injection could have damaged his chest? Caller said he would provide contact information if it didn't take too long.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Covid test date=26Dec2021/Covid test result=Positive; Covid test date=26Dec2021/Covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Aug2021 at 15:45 as dose 1, single (Lot number: FA7485) at the age of 20 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHE" (unspecified if ongoing), notes: Other medical history: ADHD; "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: VYVANSE; SYEDA. Past drug history included: Sodium laurel sulfate, reaction(s): "Known allergies: sodium laurel sulfate", notes: Known allergies: sodium laurel sulfate. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 26Dec2021, outcome "recovered" (30May2022) and all described as "Covid test date=26Dec2021/Covid test result=Positive". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) high heart rate of 200bpm; SARS-CoV-2 test: (26Dec2021) Positive, notes: Covid test type post vaccination=Nasal Swab; (30May2022) Negative, notes: Covid test type post vaccination=Nasal Swab.  Clinical information: No other vaccine was received in four weeks. Other medications received in two weeks included Vyvanse, generic allergy, Syeda. Adverse event included as from a college athlete to being very fatigued, sleeping 15 hr a day high heart rate of 200bpm, even when watching Netflix, dizzy, lightheaded, difficulty thinking, and breathing, and unable to walk to the bathroom on her own or care for herself, became very weak developed air trapping in her lungs confirmed, and possibly pulmonary hypertension, in and out of the ER for 6 months and mostly on bed rest during that time. Patient was tested Covid prior and post vaccination.  No follow-up attempts possible. No further information expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Hypersomnia, Investigation, Lung disorder
Clinical narrative: Covid test date=26Dec2021/Covid test result=Positive; Covid test date=26Dec2021/Covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Aug2021 at 15:45 as dose 1, single (Lot number: FA7485) at the age of 20 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHE" (unspecified if ongoing), notes: Other medical history: ADHD; "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: VYVANSE; SYEDA. Past drug history included: Sodium laurel sulfate, reaction(s): "Known allergies: sodium laurel sulfate", notes: Known allergies: sodium laurel sulfate. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 26Dec2021, outcome "recovered" (30May2022) and all described as "Covid test date=26Dec2021/Covid test result=Positive". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) high heart rate of 200bpm; SARS-CoV-2 test: (26Dec2021) Positive, notes: Covid test type post vaccination=Nasal Swab; (30May2022) Negative, notes: Covid test type post vaccination=Nasal Swab.  Clinical information: No other vaccine was received in four weeks. Other medications received in two weeks included Vyvanse, generic allergy, Syeda. Adverse event included as from a college athlete to being very fatigued, sleeping 15 hr a day high heart rate of 200bpm, even when watching Netflix, dizzy, lightheaded, difficulty thinking, and breathing, and unable to walk to the bathroom on her own or care for herself, became very weak developed air trapping in her lungs confirmed, and possibly pulmonary hypertension, in and out of the ER for 6 months and mostly on bed rest during that time. Patient was tested Covid prior and post vaccination.  No follow-up attempts possible. No further information expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental impairment, Pulmonary hypertension, SARS-CoV-2 test
Clinical narrative: Covid test date=26Dec2021/Covid test result=Positive; Covid test date=26Dec2021/Covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Aug2021 at 15:45 as dose 1, single (Lot number: FA7485) at the age of 20 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHE" (unspecified if ongoing), notes: Other medical history: ADHD; "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: VYVANSE; SYEDA. Past drug history included: Sodium laurel sulfate, reaction(s): "Known allergies: sodium laurel sulfate", notes: Known allergies: sodium laurel sulfate. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 26Dec2021, outcome "recovered" (30May2022) and all described as "Covid test date=26Dec2021/Covid test result=Positive". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) high heart rate of 200bpm; SARS-CoV-2 test: (26Dec2021) Positive, notes: Covid test type post vaccination=Nasal Swab; (30May2022) Negative, notes: Covid test type post vaccination=Nasal Swab.  Clinical information: No other vaccine was received in four weeks. Other medications received in two weeks included Vyvanse, generic allergy, Syeda. Adverse event included as from a college athlete to being very fatigued, sleeping 15 hr a day high heart rate of 200bpm, even when watching Netflix, dizzy, lightheaded, difficulty thinking, and breathing, and unable to walk to the bathroom on her own or care for herself, became very weak developed air trapping in her lungs confirmed, and possibly pulmonary hypertension, in and out of the ER for 6 months and mostly on bed rest during that time. Patient was tested Covid prior and post vaccination.  No follow-up attempts possible. No further information expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Heart rate, SARS-CoV-2 test
Clinical narrative: Covid test date=26Dec2021/Covid test result=Positive; Covid test date=26Dec2021/Covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Aug2021 at 15:45 as dose 1, single (Lot number: FA7485) at the age of 20 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHE" (unspecified if ongoing), notes: Other medical history: ADHD; "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: VYVANSE; SYEDA. Past drug history included: Sodium laurel sulfate, reaction(s): "Known allergies: sodium laurel sulfate", notes: Known allergies: sodium laurel sulfate. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 26Dec2021, outcome "recovered" (30May2022) and all described as "Covid test date=26Dec2021/Covid test result=Positive". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) high heart rate of 200bpm; SARS-CoV-2 test: (26Dec2021) Positive, notes: Covid test type post vaccination=Nasal Swab; (30May2022) Negative, notes: Covid test type post vaccination=Nasal Swab.  Clinical information: No other vaccine was received in four weeks. Other medications received in two weeks included Vyvanse, generic allergy, Syeda. Adverse event included as from a college athlete to being very fatigued, sleeping 15 hr a day high heart rate of 200bpm, even when watching Netflix, dizzy, lightheaded, difficulty thinking, and breathing, and unable to walk to the bathroom on her own or care for herself, became very weak developed air trapping in her lungs confirmed, and possibly pulmonary hypertension, in and out of the ER for 6 months and mostly on bed rest during that time. Patient was tested Covid prior and post vaccination.  No follow-up attempts possible. No further information expected.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Severe nose bleed after both doses; approximately 12-15 hours after injection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 3-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 3 years, in left leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious) with onset 2022, outcome "unknown", described as "Severe nose bleed after both doses; approximately 12-15 hours after injection.". Therapeutic measures were taken as a result of epistaxis.  Additional information: Patient did not receive other vaccine in four weeks. Patient doesn't have Covid-19 prior to vaccination and not been tested for Covid post vaccination. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Insomnia, Nasopharyngitis
Clinical narrative: chills; shivers; feel very cold on the inside; No sleep at all; feel very warm on the outside; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate Cancer" (unspecified if ongoing), notes: Other medical history: Prostate Cancer. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization. The following information was reported: FEELING HOT (non-serious) with onset 16Jul2022 at 21:15, outcome "recovering", described as "feel very warm on the outside"; INSOMNIA (non-serious) with onset 16Jul2022 at 21:30, outcome "recovering", described as "No sleep at all"; CHILLS (non-serious) with onset 16Jul2022 at 21:30, outcome "recovering"; NASOPHARYNGITIS (non-serious) with onset 16Jul2022 at 21:30, outcome "recovering", described as "feel very cold on the inside"; CHILLS (non-serious) with onset 16Jul2022 at 21:30, outcome "recovering", described as "shivers". Therapeutic measures were not taken as a result of feeling hot, chills, chills, nasopharyngitis, insomnia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II" (unspecified if ongoing); "HBP" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing); "Gout" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "bladder carcinoma in Situ" (unspecified if ongoing), notes: bladder carcinoma in Situ. The patient's concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "known allergies: iodine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01Jul2022 to 06Jul2022.  Clinical summery: The event did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per available information the causality of the event Covid-19 and Drug ineffective with the suspect product BNT162B2 can not be ruled out.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Patient received COVID 19 Treatment with Paxlovid from 03Jul2022 to 07Jul2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. After testing negative from 9-11Jul, (finishing Paxlovid on 07Jul) testing positive again on 15Jul, and cough/runny nose is the symptom. New symptoms started on 13Jul (cough/runny nose). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Negative; (10Jul2022) Negative; (11Jul2022) Negative; (15Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body height, Body height decreased, Dyspnoea, Fatigue
Clinical narrative: feeling very fatigued all the time; out of breath easily; she has shrunk; She screamed when she got her Covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 73 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: She had knee replacement years ago; "Covid" (unspecified if ongoing), notes: She got Covid before getting the Covid vaccine, She had Covid about a year and a half ago; "thyroid" (unspecified if ongoing), notes: pill for her thyroid; "UTI" (unspecified if ongoing), notes: UTI's were before the Covid vaccine. Concomitant medication(s) included: EXTRA C; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE ;Lot number: Unknown), for Covid-19 immunization, reaction(s): "screamed when she got her Covid shot"; Flu (It was for flu and the one that makes you burn and itchy body), for immunization, reaction(s): "burn and itchy body", "burn and itchy body". The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "feeling very fatigued all the time"; DYSPNOEA (non-serious), outcome "not recovered", described as "out of breath easily"; BODY HEIGHT DECREASED (non-serious), outcome "unknown", described as "she has shrunk"; SCREAMING (non-serious), outcome "unknown", described as "She screamed when she got her Covid shot". The event "feeling very fatigued all the time" required physician office visit. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Screaming
Clinical narrative: feeling very fatigued all the time; out of breath easily; she has shrunk; She screamed when she got her Covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 73 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: She had knee replacement years ago; "Covid" (unspecified if ongoing), notes: She got Covid before getting the Covid vaccine, She had Covid about a year and a half ago; "thyroid" (unspecified if ongoing), notes: pill for her thyroid; "UTI" (unspecified if ongoing), notes: UTI's were before the Covid vaccine. Concomitant medication(s) included: EXTRA C; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE ;Lot number: Unknown), for Covid-19 immunization, reaction(s): "screamed when she got her Covid shot"; Flu (It was for flu and the one that makes you burn and itchy body), for immunization, reaction(s): "burn and itchy body", "burn and itchy body". The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "feeling very fatigued all the time"; DYSPNOEA (non-serious), outcome "not recovered", described as "out of breath easily"; BODY HEIGHT DECREASED (non-serious), outcome "unknown", described as "she has shrunk"; SCREAMING (non-serious), outcome "unknown", described as "She screamed when she got her Covid shot". The event "feeling very fatigued all the time" required physician office visit. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 at 13:00 as dose 1, single (Lot number: EN-5318), in left arm, on 06Mar2021 at 15:00 as dose 2, single (Lot number: EL-3246), in left arm and on 30Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FNI7553) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 032F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pneumothorax" (unspecified if ongoing), notes: History of recurring pneumothorax and pleurodesis; "pleurodesis" (unspecified if ongoing), notes: History of recurring pneumothorax and pleurodesis. The patient had no known allergies. Concomitant medication(s) included: VIVELLE DOT. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 19-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EP6955) and on 21Apr2021 as dose 2, single (Batch/Lot number: unknown, Expiration Date: 30Jun2021) at the age of 18 years for Covid-19 immunisation; CoviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Lot number: 068H21A) for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Person that had COVID Vaccination; first two vaccination from Pfizer and the third booster was from Moderna and she have now got the COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for COVID. (within two weeks). Therapeutic measures were not taken as a result of Covid-19. Clinical course: The Pfizer employee stated that he/she was reporting on behalf of someone, the patient name (daughter) (Initial captured as withheld in the tab). Employee stated that the reason for missing lot numbers of COVID-19 Vaccine Pfizer was that it looked like the first dose is EP6955 and second looked like, it is the same lot (further not clarified hence, not captured in tab). The employee had some details of the patient. The reporter stated that the patient had medical condition in past, but now she had recovered. The patient did not receive any other vaccines within four weeks prior to the vaccination. Regarding the treatment that the patient did not take medication. The reporter did not had the expiration date for the second dose. The reporter stated that the mailing address was withheld. This report was a product complaint report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body height, Screaming
Clinical narrative: She screamed when she got her Covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in arm (shoulder) for covid-19 immunisation. The patient's relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: She had knee replacement years ago; "Covid" (unspecified if ongoing), notes: She got Covid before getting the Covid vaccine; "thyroid" (ongoing), notes: pill for her thyroid; "UTI" (unspecified if ongoing), notes: UTI's were before the Covid vaccine. Concomitant medication(s) included: EXTRA C. Vaccination history included: Flu (It was for flu and the one that makes you burn and itchy body), for INFLUENZA Immunization, reaction(s): "burn and itchy body", "burn and itchy body".  The following information was reported: SCREAMING (non-serious), outcome "unknown", described as "She screamed when she got her Covid shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Suspect Product: Pfizer Covid vaccine, 2 doses. Got them in her shoulder. She screamed when she got her Covid shot, they must have hit a muscle or something. Other concomitant medications included pill for her thyroid, Multivitamin, Extra D, and one that was for her getting UTI frequently, it comes in liquid that you drink but she takes the pill form. No prior vaccinations. No family medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN. Concomitant medication(s) included: LOSARTAN/HCTZ, start date: Jan2010; AMLODIPINE BESYLATE 10, start date: Jan2006; VITAMIN D [ERGOCALCIFEROL], start date: Oct2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". 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. The patient received treatment of Paxlovid from 28Jun2022 till 03Jul2022 for treatment of COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198) and on 17Mar2021 as dose 2, single (Lot number: EN6207) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Nov2021 as dose 3 (booster), single (Lot number: 939909) and on 02Jun2022 as dose 4 (booster), single (Lot number: 054142219) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Other medication in 2weeks product=Anti-anxiety; "Oral Contraceptive" (unspecified if ongoing), notes: Other medication in 2weeks product=Oral Contraceptive; "Antihistamine" (unspecified if ongoing), notes: Other medication in 2weeks product=Antihistamine; "Antiviral" (unspecified if ongoing), notes: Other medication in 2weeks product=Antiviral. Concomitant medication(s) included: SERTRALINE taken for anxiety; ALLEGRA-D 24 HOUR taken for antiallergic therapy; MUCINEX DM; LO LOESTRIN FE taken for oral contraception; BABY ASPIRIN; AZELASTINE; FLONASE [FLUTICASONE PROPIONATE]; VALACYCLOVIR [VALACICLOVIR] taken for antiviral treatment.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive, notes: I tested positive for Covid-19 on 06Jul2022; (12Jul2022) Negative, notes: I tested negative for Covid-19 on 12Jul2022; (15Jul2022) Positive, notes: I tested positive for Covid-19 on 15Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Covid-19 rebound after Paxlovid. Patient tested positive for Covid-19 on 06Jul2022. Patient initiated Paxlovid that night, 06Jul2022 and continued through the morning of 11Jul2022, completing the therapy. Patient tested negative for Covid-19 on 12Jul2022. Patient started having symptoms on 14Jul2022. Patient tested positive for Covid-19 on 15Jul2022.The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Dyspnoea, Headache, Pain
Clinical narrative: Having heartaches; Really bad headaches; It's hard to breathe at times without feeling a sharp clenching pain; It's hard to breathe at times without feeling a sharp clenching pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jun2022 at 11:00 as dose 1, single (Lot number: FM7553) at the age of 26 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Dilaudid, reaction(s): "Allergies: Dilaudid". The following information was reported: ANGINA PECTORIS (medically significant) with onset 17Jun2022, outcome "not recovered", described as "Having heartaches"; DYSPNOEA (non-serious), PAIN (non-serious) all with onset 17Jun2022, outcome "not recovered" and all described as "It's hard to breathe at times without feeling a sharp clenching pain"; HEADACHE (non-serious) with onset 17Jun2022, outcome "not recovered", described as "Really bad headaches". Therapeutic measures were not taken as a result of angina pectoris, headache, dyspnoea, pain.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) 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) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Rebound COVID after testing negative for 3 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old patient received BNT162b2 (BNT162B2), on 25Sep2021 as dose 1, single (Lot number: FF8839), in left arm, on 25Feb2022 as dose 2, single (Lot number: EM9809), in left arm, on 17Mar2022 as dose 3 (booster), single (Lot number: EN6207), in left arm and on 01Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FL3198) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild Htn" (unspecified if ongoing), notes: Mild Htn; "cataracts" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE, start date: 01Sep2016, stop date: 05Jul2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive; (08Jul2022) Positive; (10Jul2022) Positive; (12Jul2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient received other medication in 2weeks: Yes. Patient tested positive for COVID on 05Jul2022 took 5 day course of Paxlovid and completed it on 10Jul2022. Sx rapidly disappeared but on Day 9 post initial dx I began to experience mild congestion runny nose and sneezing. I have tested on Days 05Jul2022, 08Jul2022, 10Jul2022 and 12Jul2022 with all positive results. Patient was recovering and no treatment and patient had no known drug allergies. Device timestamp on 17Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Negative; (14Jul2022) Negative; (16Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 08Jul2022 to 12Jul2022.   Clinical Course: No Other medication in 2 weeks. COVID symptoms returned following completion of 5-day Paxlovid course. Tested positive again on 16Jul, 4 days after completing treatment testing negative on 13Jul and 14Jul.  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: COVID-19, Drug ineffective, Oxygen saturation, Vital capacity
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 at 15:00 as dose 1, single (Lot number: 33030BD), in right arm, on 03Mar2022 at 15:00 as dose 2, single (Lot number: EN6205), in right arm and on 24Mar2022 at 17:45 as dose 3 (booster), single (Lot number: FR2613) in right arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Oxygen saturation: 95; Vital capacity: 104/62/99, notes: 104/62/99. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks included Ezetimibe, Lisinopril , Metoprolol ER and Spironolactone. Paxlovid pills started throwing up on morning dose and now have diarrhea with anything eat in or drank just like slim and uncontrollable stop taking pills B4 the evening just taking Tylenol and cold medicine 3D days now no control still and cough tighter and in chest but no trouble breathing with meds im on is there a interaction to cause the diarrhea vitals 104/62/99.  No follow-up attempts are needed. No further information is expected.