chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: By the evening on 22Apr, symptoms had returned and I tested positive again; By the evening on 22Apr, symptoms had returned and I tested positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PHENYLEPHRINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "recovering" and all described as "By the evening on 22Apr, symptoms had returned and I tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2022) positive, notes: evening on 22Apr, symptoms had returned and I tested positive again; (12Apr2022) positive, notes: tested positive with symptoms on a rapid test on the evening of 12Apr; (20Apr2022) negative, notes: tested negative (rapid) on 20Apr; (28Apr2022) positive, notes: positive rapid test result on 28Apr. 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.  Clinical course: Patient had no known allergy. He experienced a COVID rebound. He tested positive with symptoms on a rapid test on the evening of 12Apr. He began Paxlovid on 13Apr and completed all 30 pills. Treatment stop date was 17Apr2022.  He had no further symptoms and tested negative (rapid) on 20Apr. By the evening on 22Apr, symptoms had returned, and he tested positive again. He main with symptoms and a positive rapid test result on 28Apr with outcome resolving.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: By the evening on 22Apr, symptoms had returned and I tested positive again; By the evening on 22Apr, symptoms had returned and I tested positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PHENYLEPHRINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "recovering" and all described as "By the evening on 22Apr, symptoms had returned and I tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2022) positive, notes: evening on 22Apr, symptoms had returned and I tested positive again; (12Apr2022) positive, notes: tested positive with symptoms on a rapid test on the evening of 12Apr; (20Apr2022) negative, notes: tested negative (rapid) on 20Apr; (28Apr2022) positive, notes: positive rapid test result on 28Apr. 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.  Clinical course: Patient had no known allergy. He experienced a COVID rebound. He tested positive with symptoms on a rapid test on the evening of 12Apr. He began Paxlovid on 13Apr and completed all 30 pills. Treatment stop date was 17Apr2022.  He had no further symptoms and tested negative (rapid) on 20Apr. By the evening on 22Apr, symptoms had returned, and he tested positive again. He main with symptoms and a positive rapid test result on 28Apr with outcome resolving.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 15:30 as dose 1, single (Lot number: EL9265), in left arm, on 01Mar2021 at 15:30 as dose 2, single (Lot number: EN6200), in left arm and on 11Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Symptoms started all over again with low fever, body aches, sneezing, coughing, extremely congested and a dull headache. Anti viral details: [{product=COVID 19 Treatment, brand=Paxlovid, treatment start date=18Apr2022, treatment stop date=22Apr2022, indication=Treatment of COVID-19}]
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My initial dx of covid was 4/16/22; My initial dx of covid was 16Apr2022; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 30Apr2021 as dose 2, single (Lot number: EL3246), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 35 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications, reported as no other medication in 2weeks. The following information was reported: COVID-19 (medically significant) with onset 16Apr2022, outcome "unknown", described as "My initial dx of covid was 16Apr2022"; DRUG INEFFECTIVE (medically significant) with onset 16Apr2022, outcome "unknown", described as "My initial dx of covid was 4/16/22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) COVID-19. Therapeutic measures were taken as a result of drug ineffective and covid-19 included Anti viral: Paxlovid (brand=Pfizer) from 18Apr2022 to 22Apr2022. Clinical course was reported as, Paxlovid Medication helped with covid tremendously after patient ended the course of tx (Treatment), but 5 days later, on 27Apr2022, he started noticing fatigue, runny nose, headache, similar covid sx (Symptoms) but milder, rebound of Symptoms started 27Apr2022. Patient initial Diagnosis of covid was 16Apr2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Incorrect dose administered, Lymphadenitis, Nodule, Pain in jaw
Clinical narrative: inflamed lymph nodes; jaw hurting bad/jaw pain; knot in wrist; Ear infection; second dose 02Mar2022/Booster dose 19Mar2022; 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-163-4277625-00 (Company).  A 44-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years intramuscular for covid-19 immunization. The patient's relevant medical history included: "Difficulty in opening jars" (unspecified if ongoing); "Knee pain" (unspecified if ongoing); "Difficulty in yard work" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Daily dose: 1)first dose (1 in 1 once), Route of admin: 1)intramuscular, Indications for use: 2) covid-19 vaccination), administration date: 09Feb2022, when the patient was 44-year-old, for Covid-19 immunization, reaction(s): "Mobility decreased", "Lymph node inflammation", "Jaw pain", "Nodule", "Ear infection", "Psoriatic arthritis aggravated"; BNT162b2 (Daily dose: 2)second dose (1 in 1 once), Route of admin: 2)intramuscular, Indications for use: 2) covid-19 vaccination), administration date: 02Mar2022, when the patient was 44-year-old, for Covid-19 immunization, reaction(s): "Lymph node inflammation", "Jaw pain", "Nodule", "Ear infection". The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 19Mar2022, outcome "unknown", described as "second dose 02Mar2022/Booster dose 19Mar2022"; LYMPHADENITIS (non-serious), outcome "not recovered", described as "inflamed lymph nodes"; PAIN IN JAW (non-serious), outcome "not recovered", described as "jaw hurting bad/jaw pain"; NODULE (non-serious), outcome "recovering", described as "knot in wrist"; EAR INFECTION (non-serious), outcome "not recovered".  Additional information: The reporter's causality for the event(s) of difficulty getting in and out of bed/tub, difficulty climbing flight of stairs, inflamed lymph nodes, jaw hurting bad/jaw pain, ear infection and flare up of psoriatic arthritis was not provided. The reporter's causality for the event(s) of knot in wrist with Humira (Adalimumab) was a reasonable possibility. It was unknown if patient was enrolled in a covid-19 vaccine trial.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Product: COVID 19 Treatment; Product: 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 37-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; manufacturer unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Apr2022) Positive; (19Apr2022) Negative. Therapeutic measures were taken as a result of covid-19. Tested negative three days after paxlovid regimen and then tested positive again. Patient had other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness".  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: Basophil count, COVID-19, Eosinophil count, Full blood count, Haemoglobin
Clinical narrative: RVP resulted positive for COVID- 19 and rhinovirus; RVP resulted positive for COVID-19 and rhinovirus; This is a spontaneous report received from contactable reporter(s) (Physician).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 20Mar2021 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: COVID-19 (hospitalization, medically significant) with onset 21Feb2022, outcome "unknown", described as "RVP resulted positive for COVID- 19 and rhinovirus"; VACCINATION FAILURE (hospitalization, medically significant) with onset 21Feb2022, outcome "unknown", described as "RVP resulted positive for COVID-19 and rhinovirus". The patient was hospitalized for covid-19, vaccination failure (start date: 2022). The patient underwent the following laboratory tests and procedures: Basophil count: (21Feb2022) 0.0, notes: k/mcl; Eosinophil count: (21Feb2022) 0.0, notes: k/mcl; Full blood count: (21Feb2022) 5.0, notes: K/mcL; Haemoglobin: (21Feb2022) 12.0 g/dl; Lymphocyte count: (21Feb2022) 0.2, notes: k/mcl; Monocyte count: (21Feb2022) 1.2, notes: k/mcl; Neutrophil count: (21Feb2022) 3.02, notes: k/mcl; Platelet count: (21Feb2022) 181, notes: k/mcl; Red blood cell count: (21Feb2022) 4.37, notes: M/mcL; Respiratory viral panel: (21Feb2022) positive for COVID- 19 and rhinovirus. Therapeutic measures were taken as a result of covid-19, vaccination failure. On 21Feb2022, RVP (Respiratory Viral Panel) resulted positive for COVID- 19 and rhinovirus. Patient was treated for COVID-19 with remdesivir for 5 days and dexamethasone 6 mg, daily, for 10 days. Patient maintained on 2-3L nasal cannula. On 01Mar2022, dexamethasone was changed to prednisone 40 mg, orally, for 5 days. On 01Mar2022, patient remained stable on room air for 48 hours and was discharged to home.   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 limited information in the case , a possible causal association between  all the reported  events covid 19, vaccination failure and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Monocyte count, Neutrophil count, Platelet count, Red blood cell count
Clinical narrative: RVP resulted positive for COVID- 19 and rhinovirus; RVP resulted positive for COVID-19 and rhinovirus; This is a spontaneous report received from contactable reporter(s) (Physician).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 20Mar2021 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: COVID-19 (hospitalization, medically significant) with onset 21Feb2022, outcome "unknown", described as "RVP resulted positive for COVID- 19 and rhinovirus"; VACCINATION FAILURE (hospitalization, medically significant) with onset 21Feb2022, outcome "unknown", described as "RVP resulted positive for COVID-19 and rhinovirus". The patient was hospitalized for covid-19, vaccination failure (start date: 2022). The patient underwent the following laboratory tests and procedures: Basophil count: (21Feb2022) 0.0, notes: k/mcl; Eosinophil count: (21Feb2022) 0.0, notes: k/mcl; Full blood count: (21Feb2022) 5.0, notes: K/mcL; Haemoglobin: (21Feb2022) 12.0 g/dl; Lymphocyte count: (21Feb2022) 0.2, notes: k/mcl; Monocyte count: (21Feb2022) 1.2, notes: k/mcl; Neutrophil count: (21Feb2022) 3.02, notes: k/mcl; Platelet count: (21Feb2022) 181, notes: k/mcl; Red blood cell count: (21Feb2022) 4.37, notes: M/mcL; Respiratory viral panel: (21Feb2022) positive for COVID- 19 and rhinovirus. Therapeutic measures were taken as a result of covid-19, vaccination failure. On 21Feb2022, RVP (Respiratory Viral Panel) resulted positive for COVID- 19 and rhinovirus. Patient was treated for COVID-19 with remdesivir for 5 days and dexamethasone 6 mg, daily, for 10 days. Patient maintained on 2-3L nasal cannula. On 01Mar2022, dexamethasone was changed to prednisone 40 mg, orally, for 5 days. On 01Mar2022, patient remained stable on room air for 48 hours and was discharged to home.   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 limited information in the case , a possible causal association between  all the reported  events covid 19, vaccination failure and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory viral panel, Vaccination failure
Clinical narrative: RVP resulted positive for COVID- 19 and rhinovirus; RVP resulted positive for COVID-19 and rhinovirus; This is a spontaneous report received from contactable reporter(s) (Physician).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 20Mar2021 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: COVID-19 (hospitalization, medically significant) with onset 21Feb2022, outcome "unknown", described as "RVP resulted positive for COVID- 19 and rhinovirus"; VACCINATION FAILURE (hospitalization, medically significant) with onset 21Feb2022, outcome "unknown", described as "RVP resulted positive for COVID-19 and rhinovirus". The patient was hospitalized for covid-19, vaccination failure (start date: 2022). The patient underwent the following laboratory tests and procedures: Basophil count: (21Feb2022) 0.0, notes: k/mcl; Eosinophil count: (21Feb2022) 0.0, notes: k/mcl; Full blood count: (21Feb2022) 5.0, notes: K/mcL; Haemoglobin: (21Feb2022) 12.0 g/dl; Lymphocyte count: (21Feb2022) 0.2, notes: k/mcl; Monocyte count: (21Feb2022) 1.2, notes: k/mcl; Neutrophil count: (21Feb2022) 3.02, notes: k/mcl; Platelet count: (21Feb2022) 181, notes: k/mcl; Red blood cell count: (21Feb2022) 4.37, notes: M/mcL; Respiratory viral panel: (21Feb2022) positive for COVID- 19 and rhinovirus. Therapeutic measures were taken as a result of covid-19, vaccination failure. On 21Feb2022, RVP (Respiratory Viral Panel) resulted positive for COVID- 19 and rhinovirus. Patient was treated for COVID-19 with remdesivir for 5 days and dexamethasone 6 mg, daily, for 10 days. Patient maintained on 2-3L nasal cannula. On 01Mar2022, dexamethasone was changed to prednisone 40 mg, orally, for 5 days. On 01Mar2022, patient remained stable on room air for 48 hours and was discharged to home.   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 limited information in the case , a possible causal association between  all the reported  events covid 19, vaccination failure and the suspect drug BNT162B2 cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "adrenal hyperplasia" (unspecified if ongoing); "Known allergy:Fish" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Paxlovid, start date: 15Apr2022, for Covid 19 infection, reaction(s): "nausea", notes: on 15Apr for moderate symptoms with Covid 19 infection.; Paxlovid, start date: 15Apr2022, for Covid 19 infection, reaction(s): "vertigo", notes: on 15Apr for moderate symptoms with Covid 19 infection. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: On 26Apr I became symptomatic again and tested positive.  Clinical Course: The patient was prescribed Paxlovid on 15Apr for moderate symptoms with Covid 19 infection. Patient stopped taking the medication after 2 full and one-half days of the 5-day regimen. It was stopped due to nausea and vertigo and a significant decrease in Covid symptoms. On 26Apr the patient became symptomatic again and tested positive. The symptoms are stronger than previous ones and 2 rapid test results within seconds revealed very dark test line before control line. The patient wanted to know that is there any info regarding taking a new full 5 day regimen after a partial dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "adrenal hyperplasia" (unspecified if ongoing); "Known allergy:Fish" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Paxlovid, start date: 15Apr2022, for Covid 19 infection, reaction(s): "nausea", notes: on 15Apr for moderate symptoms with Covid 19 infection.; Paxlovid, start date: 15Apr2022, for Covid 19 infection, reaction(s): "vertigo", notes: on 15Apr for moderate symptoms with Covid 19 infection. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: On 26Apr I became symptomatic again and tested positive.  Clinical Course: The patient was prescribed Paxlovid on 15Apr for moderate symptoms with Covid 19 infection. Patient stopped taking the medication after 2 full and one-half days of the 5-day regimen. It was stopped due to nausea and vertigo and a significant decrease in Covid symptoms. On 26Apr the patient became symptomatic again and tested positive. The symptoms are stronger than previous ones and 2 rapid test results within seconds revealed very dark test line before control line. The patient wanted to know that is there any info regarding taking a new full 5 day regimen after a partial dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid 19 infection/On 26Apr I became symptomatic again and tested positive; Covid 19 infection/On 26Apr I became symptomatic again and tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 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 included: "hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypothyroidism, adrenal hyperplasia; "adrenal hyperplasia" (unspecified if ongoing), notes: Other medical history: hypothyroidism, adrenal hyperplasia; "Known allergies: fish" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "Covid 19 infection/On 26Apr I became symptomatic again and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was received other medication in 2 weeks. Treatment start date: 15Apr2022. Treatment stop date: 18Apr2022. Patient was prescribed Paxlovid on 15Apr for moderate symptoms with Covid 19 infection. Patient stopped taking the medication after 2 full and one-half days of the 5-day regimen. Patient stopped due to nausea and vertigo and a significant decrease in Covid symptoms. On 26Apr patient became symptomatic again and tested positive. The symptoms were stronger than previous ones and 2 rapid test results within seconds revealed very dark test line before control line.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19 infection/On 26Apr I became symptomatic again and tested positive; Covid 19 infection/On 26Apr I became symptomatic again and tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 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 included: "hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypothyroidism, adrenal hyperplasia; "adrenal hyperplasia" (unspecified if ongoing), notes: Other medical history: hypothyroidism, adrenal hyperplasia; "Known allergies: fish" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "Covid 19 infection/On 26Apr I became symptomatic again and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was received other medication in 2 weeks. Treatment start date: 15Apr2022. Treatment stop date: 18Apr2022. Patient was prescribed Paxlovid on 15Apr for moderate symptoms with Covid 19 infection. Patient stopped taking the medication after 2 full and one-half days of the 5-day regimen. Patient stopped due to nausea and vertigo and a significant decrease in Covid symptoms. On 26Apr patient became symptomatic again and tested positive. The symptoms were stronger than previous ones and 2 rapid test results within seconds revealed very dark test line before control line.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 14:00 as dose 4 (booster), single (Lot number: fp4554) at the age of 65 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 was not reported. The patient took concomitant medications. Other medication in 2 weeks: Product: Cough medicine, Other medication in 2 weeks, Brand: , Other medication in 2 weeks, Start date: 09Apr2022, Other medication in 2 weeks, Stop date: 16Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 10Apr2022, Treatment stop date: 15Apr2022, Lot number: FX2740, Indication: Treatment of COVID-19. Adverse event: I had a relapse 4 days after taking Paxlovid. Adverse event start date: 18Apr2022, Adverse event start time: 05:00 PM, If patient recovered: Not recovered, If treatment ae: No. Known allergies: NKA (No known allergies). Covid vaccine details. Vaccine brand unknown: False. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (15Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: fully vaccinated, had both Pfizer Covid Vaccines/tested positive for COVID; fully vaccinated, had both Pfizer Covid Vaccines/tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2, Solution for injection), as dose 1, single (Batch/Lot number: unknown, Expiration date: Unknown) and as dose 2, single (Batch/Lot number: unknown, Expiration date: Unknown) at the age of 65 years for COVID-19 immunization; COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown, Expiration date: Unknown) for COVID-19 immunization. Doses 1 and 2: Lots/NDCs/Expiries: Unknown, caller did not have CDC vaccine record card with her at time of call. Moderna Covid Vaccine: Booster: Lot/NDC/Expiry: Unknown, caller did not have CDC vaccine record card with her at time of call. The patient had no relevant medical history. There were no concomitant medications.   The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "fully vaccinated, had both Pfizer Covid Vaccines/tested positive for COVID". It was reported that the patient was fully vaccinated, had both Pfizer Covid Vaccines and then a Moderna Covid Vaccine booster. She did not expect to be very sick with COVID if got it. When tested positive for COVID just came on like whoa, felt really sick and scared. She called her doctor and the doctor prescribed her Paxlovid for COVID, and patient got Paxlovid within 2 hours of the phone call she placed to her doctor. The Paxlovid seemed to really work, she started feeling better, her COVID symptoms weren't worsening at the same time that she noticed the metallic taste onset. So initial onset of both of those events were when she woke up from a nap and thought she didn't feel so bad, but that's also when she noticed the metallic taste. Now the strictly sour taste in her mouth seems to be getting worse, more pronounced at the same time that her COVID symptoms continue to improve. It was reported that the patient was taking Paxlovid for Covid. She is feeling way better, Paxlovid has alleviated her COVID symptoms. That was also the same time that she noticed Paxlovid started working because her COVID symptoms weren't getting any worse, she felt a little better. she's feeling way better regarding COVID, it feels like a cold instead of a really bad flu. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient had no other investigations. Therapeutic measures were taken as a result of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: fully vaccinated, had both Pfizer Covid Vaccines/tested positive for COVID; fully vaccinated, had both Pfizer Covid Vaccines/tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2, Solution for injection), as dose 1, single (Batch/Lot number: unknown, Expiration date: Unknown) and as dose 2, single (Batch/Lot number: unknown, Expiration date: Unknown) at the age of 65 years for COVID-19 immunization; COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown, Expiration date: Unknown) for COVID-19 immunization. Doses 1 and 2: Lots/NDCs/Expiries: Unknown, caller did not have CDC vaccine record card with her at time of call. Moderna Covid Vaccine: Booster: Lot/NDC/Expiry: Unknown, caller did not have CDC vaccine record card with her at time of call. The patient had no relevant medical history. There were no concomitant medications.   The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "fully vaccinated, had both Pfizer Covid Vaccines/tested positive for COVID". It was reported that the patient was fully vaccinated, had both Pfizer Covid Vaccines and then a Moderna Covid Vaccine booster. She did not expect to be very sick with COVID if got it. When tested positive for COVID just came on like whoa, felt really sick and scared. She called her doctor and the doctor prescribed her Paxlovid for COVID, and patient got Paxlovid within 2 hours of the phone call she placed to her doctor. The Paxlovid seemed to really work, she started feeling better, her COVID symptoms weren't worsening at the same time that she noticed the metallic taste onset. So initial onset of both of those events were when she woke up from a nap and thought she didn't feel so bad, but that's also when she noticed the metallic taste. Now the strictly sour taste in her mouth seems to be getting worse, more pronounced at the same time that her COVID symptoms continue to improve. It was reported that the patient was taking Paxlovid for Covid. She is feeling way better, Paxlovid has alleviated her COVID symptoms. That was also the same time that she noticed Paxlovid started working because her COVID symptoms weren't getting any worse, she felt a little better. she's feeling way better regarding COVID, it feels like a cold instead of a really bad flu. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient had no other investigations. Therapeutic measures were taken as a result of COVID-19.  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: Alanine aminotransferase, Antibody test, Antinuclear antibody, Antinuclear antibody negative, Aspartate aminotransferase
Clinical narrative: diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine; This is a literature report.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATOMYOSITIS (medically significant), 5 days after the suspect product(s) administration, outcome "recovered", described as "diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (0-55): 154 IU/l, notes: elevated; Antibody test: remarkably elevated; Antinuclear antibody: No antibodies detected; Antinuclear antibody negative: No antibodies detected, notes: Jo-1; Aspartate aminotransferase (5-34): 256 IU/l, notes: elevated; Biopsy: revealed features of interface dermatitis with, notes: superficial perivascular mononuclear inflammation and dermal edema; revealed overexpression of major, notes: histocompatibility complex class I, inflammatory cells, necrotic fibers, and atrophic fibers organized in a perimysial pattern, suggesting an immune-mediated myopathy of a dermatomyositis type; Blood creatine phosphokinase (29-168): 2804 IU/l, notes: first day of presentation; 4476 IU/l, notes: 3 days; 1135 IU/l, notes: decreased significantly; Normalized, notes: 12 weeks after initial presentation; Computerised tomogram abdomen: No internal malignancy; Computerised tomogram pelvis: No internal malignancy; Computerised tomogram thorax: No internal malignancy; Enzyme level test: Normalized, notes: liver enzymes normalized twelve weeks after initial presentation; Flow cytometry: lymphoma disorder unremarkable; Hepatitis B: negative; Hepatitis C: negative; Additional cutaneous findings: included multiple vesicles and erythematous, notes: papules on the right upper extremity and reticulated, erythematous patches on both of her thigh; remarkably elevated; unknown results; showed basal vacuolar alteration with foci of, notes: necrotic keratinocytes; Mi2-a: No antibodies detected, notes: Mi2-alpha; No antibodies were detected, notes: Mi2-beta; No antibodies were detected, notes: PL-12; No antibodies were detected, notes: PL-7; physical examination: violaceous, poikilodermatous scaly plaques were, notes: observed on the anterior aspect of the neck and chest; Tuberculosis: negative. Therapeutic measures were taken as a result of dermatomyositis. She had received an initial dose of the COVID-19 vaccine 5 days before the onset of the symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event dermatomyositis and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood creatine phosphokinase, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine; This is a literature report.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATOMYOSITIS (medically significant), 5 days after the suspect product(s) administration, outcome "recovered", described as "diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (0-55): 154 IU/l, notes: elevated; Antibody test: remarkably elevated; Antinuclear antibody: No antibodies detected; Antinuclear antibody negative: No antibodies detected, notes: Jo-1; Aspartate aminotransferase (5-34): 256 IU/l, notes: elevated; Biopsy: revealed features of interface dermatitis with, notes: superficial perivascular mononuclear inflammation and dermal edema; revealed overexpression of major, notes: histocompatibility complex class I, inflammatory cells, necrotic fibers, and atrophic fibers organized in a perimysial pattern, suggesting an immune-mediated myopathy of a dermatomyositis type; Blood creatine phosphokinase (29-168): 2804 IU/l, notes: first day of presentation; 4476 IU/l, notes: 3 days; 1135 IU/l, notes: decreased significantly; Normalized, notes: 12 weeks after initial presentation; Computerised tomogram abdomen: No internal malignancy; Computerised tomogram pelvis: No internal malignancy; Computerised tomogram thorax: No internal malignancy; Enzyme level test: Normalized, notes: liver enzymes normalized twelve weeks after initial presentation; Flow cytometry: lymphoma disorder unremarkable; Hepatitis B: negative; Hepatitis C: negative; Additional cutaneous findings: included multiple vesicles and erythematous, notes: papules on the right upper extremity and reticulated, erythematous patches on both of her thigh; remarkably elevated; unknown results; showed basal vacuolar alteration with foci of, notes: necrotic keratinocytes; Mi2-a: No antibodies detected, notes: Mi2-alpha; No antibodies were detected, notes: Mi2-beta; No antibodies were detected, notes: PL-12; No antibodies were detected, notes: PL-7; physical examination: violaceous, poikilodermatous scaly plaques were, notes: observed on the anterior aspect of the neck and chest; Tuberculosis: negative. Therapeutic measures were taken as a result of dermatomyositis. She had received an initial dose of the COVID-19 vaccine 5 days before the onset of the symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event dermatomyositis and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dermatomyositis, Enzyme level test, Flow cytometry, Hepatitis B, Hepatitis C
Clinical narrative: diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine; This is a literature report.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATOMYOSITIS (medically significant), 5 days after the suspect product(s) administration, outcome "recovered", described as "diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (0-55): 154 IU/l, notes: elevated; Antibody test: remarkably elevated; Antinuclear antibody: No antibodies detected; Antinuclear antibody negative: No antibodies detected, notes: Jo-1; Aspartate aminotransferase (5-34): 256 IU/l, notes: elevated; Biopsy: revealed features of interface dermatitis with, notes: superficial perivascular mononuclear inflammation and dermal edema; revealed overexpression of major, notes: histocompatibility complex class I, inflammatory cells, necrotic fibers, and atrophic fibers organized in a perimysial pattern, suggesting an immune-mediated myopathy of a dermatomyositis type; Blood creatine phosphokinase (29-168): 2804 IU/l, notes: first day of presentation; 4476 IU/l, notes: 3 days; 1135 IU/l, notes: decreased significantly; Normalized, notes: 12 weeks after initial presentation; Computerised tomogram abdomen: No internal malignancy; Computerised tomogram pelvis: No internal malignancy; Computerised tomogram thorax: No internal malignancy; Enzyme level test: Normalized, notes: liver enzymes normalized twelve weeks after initial presentation; Flow cytometry: lymphoma disorder unremarkable; Hepatitis B: negative; Hepatitis C: negative; Additional cutaneous findings: included multiple vesicles and erythematous, notes: papules on the right upper extremity and reticulated, erythematous patches on both of her thigh; remarkably elevated; unknown results; showed basal vacuolar alteration with foci of, notes: necrotic keratinocytes; Mi2-a: No antibodies detected, notes: Mi2-alpha; No antibodies were detected, notes: Mi2-beta; No antibodies were detected, notes: PL-12; No antibodies were detected, notes: PL-7; physical examination: violaceous, poikilodermatous scaly plaques were, notes: observed on the anterior aspect of the neck and chest; Tuberculosis: negative. Therapeutic measures were taken as a result of dermatomyositis. She had received an initial dose of the COVID-19 vaccine 5 days before the onset of the symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event dermatomyositis and the suspect drug BNT162B2 cannot be excluded.