chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Negative; (30Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was not taking any other medications/ products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Rebound positive test on day 11 after testing negative after 5 days prior. The patient received COVID-19 Treatment of Paxlovid from 21Jul2022 to 26Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red swollen area that itched a lot/it was speckled; red swollen area that itched a lot/it was speckled; red swollen area that itched a lot/it was speckled; tiredness; felt really lousy/ feeling bad/ felt like a bad flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL8982) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lost two inches/loosing inches" (unspecified if ongoing), notes: She has lost two inches. Caller clarified that loosing inches was prior to receiving the Covid19 vaccines.; "blood pressure" (unspecified if ongoing), notes: she takes regular medicines for blood pressure and thyroid for years.; "thyroid" (unspecified if ongoing), notes: she takes regular medicines for blood pressure and thyroid for years. Concomitant medication(s) included: AMLODIPINE;OLMESARTAN taken for blood pressure abnormal; LEVOTHYROXIN taken for thyroid disorder; ECOTRIN; BAYER ASPIRIN. Past drug history included: Flu shot, notes: she gets that every years. Vaccination history included: Pneumonia shot (had the life long pneumonia shot that she got several years back). The following information was reported: FEELING ABNORMAL (non-serious) with onset Jan2021, outcome "recovered", described as "felt really lousy/ feeling bad/ felt like a bad flu"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset Jan2021, outcome "recovered" and all described as "red swollen area that itched a lot/it was speckled"; FATIGUE (non-serious) with onset Jan2021, outcome "recovered", described as "tiredness". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pruritus, fatigue, feeling abnormal.  Additional information: Ecotrin is a coated Aspirin. Patient takes it daily and has been on it for years. If patient can't find it, she uses Bayer coated aspirin. patient does one or the other. The red swollen area and the tiredness appeared the next day or that night, patient can't remember. It was a two-day process where she felt really lousy. It probably showed up the next day. Patient remembers feeling bad but not enough to go to the doctor. It felt like a bad flu. With the second one her arm was worse. Ache in her arm: Patient never had the continual achiness until the second booster. She had achiness right after the shot, tiredness, and feeling bad with all the shots but she never had the heaviness or continual achiness until the second booster. She got the shots in her left arm because she is right-handed. This morning she can hardly move her arm. Patient doesn't take any pain medication ever no matter how sick even if it is prescribed, she won't get it filled. Patient doesn't believe in that. She only takes Aspirin.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red swollen area that itched a lot/it was speckled; red swollen area that itched a lot/it was speckled; red swollen area that itched a lot/it was speckled; tiredness; feeling bad/felt like a bad flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement; LEVOTHYROXIN taken for thyroid disorder; ECOTRIN. Vaccination history included: BNT162b2, administration date: 30Jan2021, for COVID-19 immunization, reaction(s): "she had red swollen area that itched a lot. It was speckled", "she had red swollen area that itched a lot. It was speckled", "she had red swollen area that itched a lot. It was speckled", "Tiredness", "feeling bad/felt like bad flu"; flu shot, administration date: 01Oct2021, for Immunization; Pneumonia shot, for Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "red swollen area that itched a lot/it was speckled"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling bad/felt like a bad flu".  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, SARS-CoV-2 test
Clinical narrative: In Jun2022, the patient experienced COVID; In Jun2022, the patient experienced COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4449823-00.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as 40 mg (citrate free (1 in 2 wk) (Batch/Lot number: unknown) subcutaneous for colitis ulcerative. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "In Jun2022, the patient experienced COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for adalimumab was unknown. 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.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), on 29Jul2022 at 11:30 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 30Jul2022, outcome "unknown", described as "Fever".  Additional Information: The reporter son was given COVID vaccine on 29Jul2022 morning and did not have any symptoms of fever and cold on that day. On 30Jul2022, in the evening he was having fever. The reporter asked if any medicine needs to be given for reducing temperature or not.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
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) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6207), on 09Apr2021 as dose 2, single (Lot number: ER8733), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 29 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Generalized Anxiety Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Patient has no known allergies. Concomitant medication(s) included: ISIBLOOM 0.15-0.03, start date: 01Jan2019; ESCITALOPRAM OXALATE 20mg, start date: 01Jan2021; ADDERALL XR 20 mg, start date: 01Jan2020, stop date: 19Jun2022; IPRATROPIUM 0.03% Nasal Spray 21mcg, start date: 01Jun2021 (Other medication in 2weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) positive, notes: I took an at-home antigen COVID test on 29Jun and it was positive; (24Jun2022) Negative, notes: I tested negative on a PCR on Day 5 (24Jun). Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included paxlovid from 20Jun2022 to 24Jun2022. Clinical course: It was reported as patient tested negative on a PCR on Day 5 (24Jun) of taking the Paxlovid series and all of her symptoms were gone, other than fatigue. On 28Jun, patient noticed that she was having a slightly stuffy nose and scratchy throat. (Notably, she did not have a stuffy nose during round 1 of symptoms.) she took an at-home antigen COVID test on 29Jun and it was positive. Overall, however, her symptoms were much less severe the second time around.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weak for over a year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weak for over a year".  Additional information: The caller stated that she was wondering if anyone else has commented that it made them weak. Caller states that she has been weak for over a year. States she took the vaccine in Feb2021 and it still just as weak as can be. Caller states that she thought it was her thyroid, but it isn't. Caller states that she has a beep and needs to go. Asks if she can call back before no longer responding to call handler.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 10:00 as dose 1, single (Lot number: EN6204), in left arm and on 27Mar2021 at 10:00 as dose 2, single (Lot number: ER2613) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Nov2021 at 09:45 as dose 3 (booster), single (Lot number: 012H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate aplastic anemia" (unspecified if ongoing), notes: Moderate aplastic anemia; "minor PNH clone" (unspecified if ongoing), notes: minor PNH clone; "low WBC" (unspecified if ongoing), notes: low WBC; "known allergies: bee stings" (unspecified if ongoing), notes: known allergies: bee stings. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim"; Codeine, reaction(s): "known allergies: codeine". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Positive; (28Jul2022) negative; (30Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Prescribed Paxlovid on 21Jul2022, first day of positive test (exposed by husband who was also put on Paxlovid two days prior). Symptoms were fever 100.4, cough in upper chest, chills, body aches, headache. Symptoms improved 2 hours in to the 2nd dose. Finished all 10 doses, symptoms greatly improved. Tested negative on 28Jul2022. Only symptoms at that time were slight cough and exhaustion. 3 am on 30Jul2022 woke up with swollen glands and sore throat. Tested positive by 9 am and symptoms worsened to heavy sinus congestion, very raw throat, coughing, sneezing, swollen glands. Started maximum doses of Tylenol and Motrin (alternating), Sudafed, Mucinex with little to no relief. Temperature 96.6. No doctor appointments available until 02Aug so continuing with over the counter medications for now. Still extremely congested in sinuses, clogged ears, dry and unproductive cough, bad headache, swollen glands, very sore throat on Day 3 after second positive test. the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.
Age: 46.0
Sex: F
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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 included: "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "latex" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA; FLUOXETINE. Past drug history included: Keflex, reaction(s): "Drug Allergy: keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment start date: 22Jul2022, treatment stop date: 26Jul2022.  Clinical course: Patient got COVID symptoms worse than before. Week 1 was sore throat, congestion, cough, took Paxlovid and immediately felt better during week 2, week 3 got severe fatigue and congestion returned and headache. Unable to work. Worked first 2 weeks.  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 information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,vcovid-19.
Age: 50.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jun2022 at 12:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Other medical history: Anxiety and depression; "depression" (unspecified if ongoing), notes: Other medical history: Anxiety and depression; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin and ibuprofen. There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: ibuprofen", notes: Known allergies: Penicillin and ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There was no other medication in 2weeks.Anti viral details product for COVID 19 Treatment included Paxlovid Treatment start date: 15Jul2022 and Treatment stop date: 21Jul2022.Known allergies include penicillin and ibuprofen and Other medical history included Anxiety and depression.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 (not pregnant) received BNT162b2 (BNT162B2, Vaccine brand unknown, Vaccine lot unknown, Vaccine dose number unknown-False), on 07Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK2587) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing); "Penicillin and derivatives" (unspecified if ongoing), notes: Known allergies: Penicillin and derivatives. Concomitant medication(s) included: AMLODIPINE, start date: Apr2018. Past drug history included: Valacyclovir, reaction(s): "Known allergies: Valacyclovir". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 17Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (17Jul2022) Positive, notes: Tested positive for COVID on 17Jul2022; (24Jul2022) Negative, notes: Tested negative on 24Jul2022 and 28Jul2022; (28Jul2022) Negative, notes: Tested negative on 24Jul2022 and 28Jul2022; (31Jul2022) Positive, notes: Retested positive on the Antigen Rapid Test at home test on 31Jul2022; (01Aug2022) Positive, notes: tested positive again on 01Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: Product-COVID 19 Treatment, Brand-Paxlovid, Treatment start date-17Jul2022, Treatment stop date-22Jul2022, Lot number-28156213, Indication-Treatment of COVID-19 (Adverse event: Tested positive for COVID on 17Jul2022 with cold-like symptoms and started Paxlovid that evening. Completed Paxlovid on 22Jul2022 with symptoms completely resolved. Tested negative on 24Jul2022 and 28Jul2022 using iHealth COVID-19 Antigen Rapid Test at home. On 31Jul2022 experienced severe lethargy, but no fever or other symptoms, and suspected COVID on the rebound. Retested positive on the Antigen Rapid Test at home test on 31Jul2022. Though asymptomatic at that point, tested positive again on 01Aug2022. Returned to isolation. Other medication details: Other medication in 2 weeks product-Amlodipine 5mg, Other medication in 2 weeks brand-Generic, Other medication in 2 weeks start date-Apr2018).  No follow-up attempts are possible. No further information is expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment with paxlovid from 13Jul2022 to 20Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Breast neoplasm
Clinical narrative: tumor in right breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 17 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (prev dose product-COVID 19,, prev dose brand unknown-True,, prev dose dose number1), for Covid-19 immunization; Covid-19 vaccine (prev dose product-COVID 19,, prev dose brand unknown-True,, dose number-2,), for Covid-19 immunization. The following information was reported: BREAST NEOPLASM (hospitalization, life threatening) with onset Feb2022, outcome "recovering", described as "tumor in right breast". The patient was hospitalized for breast neoplasm (hospitalization duration: 3 day(s)). The event "tumor in right breast" required physician office visit. Therapeutic measures were taken as a result of breast neoplasm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2022 at 15:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "PCOS" (unspecified if ongoing), notes: Other medical history: PCOS; "Thyroid cancer" (unspecified if ongoing), notes: Other medical history: Thyroid cancer; "IDA" (unspecified if ongoing), notes: Other medical history: IDA; "seasonal allergies" (unspecified if ongoing), notes: Other medical history: seasonal allergies; "known allergies: strawberries" (unspecified if ongoing), notes: known allergies: strawberries. Concomitant medication(s) included: NYQUIL, start date: 20Jul2022, stop date: 27Jul2022; MUCINEX, start date: 20Jul2022, stop date: 27Jul2022. Past drug history included: Ceftin, reaction(s): "known allergies: Ceftin", notes: known allergies: Ceftin; Aldactone, reaction(s): "known allergies: Aldactone", notes: known allergies: Aldactone.  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". Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that the patient received treatment Paxlovid for the treatment of COVID-19 from 21Jul2022 to 25Jul2022.   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 known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Age: 61.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 61 years, in left 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; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: 005M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ra" (unspecified if ongoing); "psoriatic" (unspecified if ongoing); "meniere" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "GERD" (unspecified if ongoing) and menierries. Concomitant medication(s) included/Other medication in 2 weeks: CIMZIA; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; CRESTOR; FUROSIMIDE; AMITRIPTYLINE; WELLBUTRIN; VITAMIN D [COLECALCIFEROL]; MAGNESIUM; CALCIUM; COQ10 + D3. Past drug history included: Sulphate drugs, reaction(s): "drug allergy"; Ceclor, reaction(s): "drug allergy"; Steroidz, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknon results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: brand=Paxlovid, Treatment start date=11Jun2022, treatment stop date=12Jun2022.  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: Feeling abnormal, Tremor
Clinical narrative: there was some weird feeling from my elbow to my wrist; kind of felt light; arm started shaking a little; it was kind of shaking like I couldn't control it just shook; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Lot number: EN6205) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN, LOT UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, MANUFACTURER UNKNOWN, LOT UNKNOWN), for Covid-19 Immunization. The following information was reported: TREMOR (non-serious) with onset 30Jul2022, outcome "unknown", described as "arm started shaking a little; it was kind of shaking like I couldn't control it just shook"; FEELING ABNORMAL (non-serious) with onset 30Jul2022, outcome "unknown", described as "there was some weird feeling from my elbow to my wrist; kind of felt light".  Additional information: It was reported that, the patient was just wondering, after second booster shot last Saturday a week ago and then yesterday noticed there was some weird feeling from elbow to wrist and thought well, that was weird. It kind of felt light and everything else well then, last night it was like arm started shaking a little if that make sense, it kind of like where patient had the shot and stuff, it was kind of shaking like and could not control it just shook. So, did not know if that was a common, if that has happened before with the shot, it was not even a shot it may just be a coincidence but have never had anything like that before. Expiry Date of COVID-19 Vaccine was Unknown. Reason for no lot number of COVID-19 Vaccine: Other: It was stated, it looks like, it says EN6205. Yes, not the 5 patient think, hard to read the writing but yes think that was. Product details, Pharmacy details and other details could not be probed as consumer was unwilling to complete the report. Hence further probing could not be done. Limited information available over the call.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6200), in right arm, on 12Mar2021 as dose 2, single (Lot number: EN6205), in right arm, on 16Nov2021 as dose 3 (booster), single (Lot number: FH8030), in right arm and on 11May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 18Jul2022 to 22Jul2022.
Age: 32.0
Sex: F
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 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 12Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 32 years, in left 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2 weeks. Paxlovid Treatment start date: 19Jul2022, and Treatment stop date: 23Jul2022.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Magnetic resonance imaging, Tendonitis
Clinical narrative: Right shoulder tendonitis/used arm but difficult Dec 2021; Right shoulder tendonitis/used arm but difficult Dec 2021; The initial case was missing the following minimum criteria: Unspecified product and Unspecified AE. Upon receipt of follow-up information on (01Aug2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Lot number: FF8844) at the age of 71 years, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: coviD-19 biontech (Dose 1, Single, Lot/Batch Number: EL9267), administration date: 10Feb2021, for Covid-19 Immunization, reaction(s): "Covid-19"; coviD-19 biontech (Dose 2, Single, Lot/Batch Number: EN6204), administration date: 03Mar2021, for Covid-19 Immunization, reaction(s): "Covid-19".  The following information was reported: LIMB DISCOMFORT (non-serious), TENDONITIS (non-serious), outcome "recovered" and all described as "Right shoulder tendonitis/used arm but difficult Dec 2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of limb discomfort, tendonitis.  Additional Information: I Did Have an MRI Which Showed Some Stenosis L4/L5/S1 Levels. Where I Saw Neurologist in Withheld and In Withheld, Larch Advised Name Withheld Not Currently Candidate of Surgery. So Tried Nerve Lost Black Injections and Found Only Temporary (24 Hrs). Relief. Hip Pain Continues as Well as Burning Sensation- Attributed to Stenosis but Not Experienced Prior To Vaccine Injections. My Belief Is That Vaccinations Contributed to Tendmitis and Neuropathy Symptoms At Least Stirred Things Upto the Point Where I Noticed Changes in How I Walk and Move in General-Hip Pain Is Intermittent but Burning Sensation Is 24/7 For Past 16 Months
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Stenosis, Tendonitis
Clinical narrative: Right shoulder tendonitis/used arm but difficult Dec 2021; Right shoulder tendonitis/used arm but difficult Dec 2021; The initial case was missing the following minimum criteria: Unspecified product and Unspecified AE. Upon receipt of follow-up information on (01Aug2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Lot number: FF8844) at the age of 71 years, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: coviD-19 biontech (Dose 1, Single, Lot/Batch Number: EL9267), administration date: 10Feb2021, for Covid-19 Immunization, reaction(s): "Covid-19"; coviD-19 biontech (Dose 2, Single, Lot/Batch Number: EN6204), administration date: 03Mar2021, for Covid-19 Immunization, reaction(s): "Covid-19".  The following information was reported: LIMB DISCOMFORT (non-serious), TENDONITIS (non-serious), outcome "recovered" and all described as "Right shoulder tendonitis/used arm but difficult Dec 2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of limb discomfort, tendonitis.  Additional Information: I Did Have an MRI Which Showed Some Stenosis L4/L5/S1 Levels. Where I Saw Neurologist in Withheld and In Withheld, Larch Advised Name Withheld Not Currently Candidate of Surgery. So Tried Nerve Lost Black Injections and Found Only Temporary (24 Hrs). Relief. Hip Pain Continues as Well as Burning Sensation- Attributed to Stenosis but Not Experienced Prior To Vaccine Injections. My Belief Is That Vaccinations Contributed to Tendmitis and Neuropathy Symptoms At Least Stirred Things Upto the Point Where I Noticed Changes in How I Walk and Move in General-Hip Pain Is Intermittent but Burning Sensation Is 24/7 For Past 16 Months
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Magnetic resonance imaging, Tendonitis
Clinical narrative: Left shoulder tendonitis sever to point of non-use/still experience; MRI which showed some Stenosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EL9267), on 03Mar2021 as dose 2, single (Lot number: EN6204) and on 11Nov2021 as dose 3 (booster), single (Lot number: FF8844) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TENDONITIS (non-serious) with onset Apr2021, outcome "not recovered", described as "Left shoulder tendonitis sever to point of non-use/still experience"; STENOSIS (non-serious) with onset 2021, outcome "unknown", described as "MRI which showed some Stenosis". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tendonitis.  Additional information: I did have an MRI which showed some stenosis L4/L5/S1 levels. I am not currently candidate for surgery. So tried nerve root block injections and found only temporary (24hrs) relief. Hip pain continues as well as burning sensation-attributed to stenosis but not experienced prior to vaccine injections. My belief is that vaccinations contributed to tendonitis and neuropathy symptoms at least stirred things up to the point where I noticed changes in how I wash and move in general-Hip pain is intermittent but burning sensation is 24/7 for past 16 months.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Stenosis, Tendonitis
Clinical narrative: Left shoulder tendonitis sever to point of non-use/still experience; MRI which showed some Stenosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EL9267), on 03Mar2021 as dose 2, single (Lot number: EN6204) and on 11Nov2021 as dose 3 (booster), single (Lot number: FF8844) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TENDONITIS (non-serious) with onset Apr2021, outcome "not recovered", described as "Left shoulder tendonitis sever to point of non-use/still experience"; STENOSIS (non-serious) with onset 2021, outcome "unknown", described as "MRI which showed some Stenosis". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tendonitis.  Additional information: I did have an MRI which showed some stenosis L4/L5/S1 levels. I am not currently candidate for surgery. So tried nerve root block injections and found only temporary (24hrs) relief. Hip pain continues as well as burning sensation-attributed to stenosis but not experienced prior to vaccine injections. My belief is that vaccinations contributed to tendonitis and neuropathy symptoms at least stirred things up to the point where I noticed changes in how I wash and move in general-Hip pain is intermittent but burning sensation is 24/7 for past 16 months.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Patient was given a shot at 0930 stayed for 15 mins experiencing no signs or symptoms of an allergic reaction. Patient then went to Dunkin Donuts and MOP notice red spots on the Patient's Arm and Leg. MOP of Patient then brought Patient back to the immunization treatment and was assessed by a provider. Provider continued to monitor for 15 more minutes and prescribed oral diphenhydramine for current reaction. MOP was educated if reactions gets worse to go to the closer emergency room.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: test for Covid was positive and I already had my three shots (Pfizer COVID-19 Vaccine); test for Covid was positive and I already had my three shots (Pfizer COVID-19 Vaccine); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and on 26Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.Consumer stated, "No, I am not taking any medication." The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "test for Covid was positive and I already had my three shots (Pfizer COVID-19 Vaccine)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: test for Covid was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from unspecified date to an unspecified date. Clinical course includes consumer stated, "My test for Covid was positive and I already had my three shots (Pfizer COVID-19 Vaccine), my vaccination since my test was positive two days ago". She was prescribed with Paxlovid and she was getting 3 medication in the morning and 3 in the afternoon   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: Fatigue, Myalgia
Clinical narrative: muscle pain; tired; 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 68-year-old 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 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 1,SINGLE), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: I noticed the arm pain like you know I cannot use them; it got little bit swollen; I noticed the arm pain like you know I cannot use them; it got little bit swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 (Primary immunization completed., MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), single), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "I noticed the arm pain like you know I cannot use them; it got little bit swollen".  Additional information: Consumer stated that "The reason I am calling is I had fourth booster shot Friday and I have arm pain. Can I take Aspirin". Consumer stated, "I noticed the arm pain like you know I cannot use them and I have pain but not severe pain and it got little bit swollen and I want to know if I can ice it. Can I put ice on it". When confirm the shot as Pfizer COVID-19 shot: Consumer stated, "Yes. that is with, that was Pfizer."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.