chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EN6202), in left arm and on 25Mar2021 at 10:00 as dose 2, single (Lot number: EN62555) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "polycystic liver disease" (unspecified if ongoing); "known Allergy: Strawberries" (unspecified if ongoing); "known Allergy: melons" (unspecified if ongoing); "known Allergy:Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid disorder
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EN6202), in left arm and on 25Mar2021 at 10:00 as dose 2, single (Lot number: EN62555) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "polycystic liver disease" (unspecified if ongoing); "known Allergy: Strawberries" (unspecified if ongoing); "known Allergy: melons" (unspecified if ongoing); "known Allergy:Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: my thyroid stopped working for almost a year; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EN6202), in left arm and on 25Mar2021 at 10:00 as dose 2, single (Lot number: EN62555) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "polycystic liver disease" (unspecified if ongoing); "known allergies: Strawberries" (unspecified if ongoing); "known allergies: melons" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: THYROID DISORDER (non-serious), outcome "recovered", described as "my thyroid stopped working for almost a year". Therapeutic measures were taken as a result of thyroid disorder.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid disorder
Clinical narrative: my thyroid stopped working for almost a year; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EN6202), in left arm and on 25Mar2021 at 10:00 as dose 2, single (Lot number: EN62555) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "polycystic liver disease" (unspecified if ongoing); "known allergies: Strawberries" (unspecified if ongoing); "known allergies: melons" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: THYROID DISORDER (non-serious), outcome "recovered", described as "my thyroid stopped working for almost a year". Therapeutic measures were taken as a result of thyroid disorder.
Age: 63.0
Sex: M
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 63-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 12:00 as dose 1, single (Lot number: ER8732), in left arm, on 14Apr2021 at 14:00 as dose 2, single (Lot number: ER8729), in right arm, on 13Nov2021 at 10:00 as dose 3 (booster), single (Lot number: EN0173), in left arm and on 25May2022 at 14:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Ulcerative Colitis" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing), notes: Known allergies: Allergic to shrimp; "Known allergies: Lobster" (unspecified if ongoing), notes: Known allergies: Allergic lobster. Concomitant medication(s) included: ADVAIR, start date: 01Aug2020; LIALDA, start date: 01Aug2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I tested positive for COVID; (04Jul2022) Negative, notes: tested negative on day 8; (05Jul2022) Positive, notes: On day 9 I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid Rebound - I tested positive for COVID and began taking a 5-day course of PAXLOVID that day. I continued to experience mild symptoms for several days then started improving and tested negative on day 8. On day 9 I tested positive again and began experiencing rebound symptoms that were worse than what I initially experienced.  No follow-up attempts are possible, no information is necessary.
Age: 58.0
Sex: M
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 59-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 16Apr2021 as dose 2, single (Lot number: ER8729) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Nov2021 as dose 3 (booster), single (Lot number: 012h21B), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. the patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. Patient received brand Pfizer Anti viral product from 30Jun2022 to 04Jul2022 as COVID 19 Treatment. Patient experienced reinfection about 5 days after stopped treatment. Patient had tested negative and felt fine for a couple days then on 09Jul2022 started sneezing and got watery eyes and light congestion. It was not as bad as initial sickness. No treatment received. Patient was not recovered. Case was considered non-serious.
Age: 56.0
Sex: M
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 56-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Nov2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Mar2022 as dose 3, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Positive, notes: Tested positive; (08Jul2022) Negative, notes: tested negative home test; (11Jul2022) Positive, notes: tested positive on home test.  Additional information: adverse event: Tested positive 01Jul2022 completed 5 days Paxlovid on 8Jul2022 tested negative home test. No longer with symptoms. On 11Jul2022 symptoms returned and tested positive on home test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 at 12:00 as dose 1, single (Lot number: EN6201), in right arm, on 13Mar2021 at 12:00 as dose 2, single (Lot number: EN6204), in right arm, on 09Sep2021 at 13:00 as dose 3 (booster), single (Lot number: fc3182), in right arm and on 25Mar2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Presumed allergy to Penicillin" (unspecified if ongoing), notes: Known allergies: Presumed allergy to Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (04Jul2022) Negative, notes: I tested negative on the 4th, the 5th and the 6th; (05Jul2022) Negative, notes: I tested negative on the 4th, the 5th and the 6th; (06Jul2022) Negative, notes: I tested negative on the 4th, the 5th and the 6th; (10Jul2022) Positive, notes: 10th, we both tested and were both positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks.  Anti-viral details: Product: COVID 19 Treatment, start date: 02Jul2022, Stop date: 06Jul2022, Lot: FX3874 for treatment of COVID-19). Patient waited until three days after she finished the Paxlovid 5-day course. (4Jul), and She was tested negative on the 4th, the 5th and the 6th. Then on the 9th, my husband started to cough and had a fever and in general looked like heck. SO, on the a.m. of the 10th, we both were tested and were both positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
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) (Physician) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), on 11Jan2021 as dose 2, single (Lot number: ER9231) and on 26Sep2021 as dose 3 (booster), single (Lot number: 301458a) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Allergic rhinitis (seasonal and animal)" (unspecified if ongoing). Concomitant medication(s) included: CETRIZINE; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Unknown Result; (05Jul2022) Negative; (06Jul2022) Negative; (07Jul2022) Negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: F63527) at the age of 33 years, as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRYSELLE. Past drug history included: Penicillin, reaction(s): "Allergy".  The following information was reported: DISEASE RECURRENCE (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: I never tested negative but the positive line was very faint at this point.  Additional information: I finished my final dose of Paxlovid on Sunday, 03Jul, and my symptoms had mostly cleared up by Wednesday 06Jul. I never tested negative, but the positive line was very faint at this point. However, on Friday 08Jul I started to feel fatigued again, and on 09Jul I was coughing a lot again, was very fatigued, and congested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Sore throat, slight temp, malaise for two days, positive home test, took Paxlovid 5 days; Sore throat, slight temp, malaise for two days, positive home test, took Paxlovid 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9263), in left arm and on 19Feb2021 as dose 2, single (Lot number: EL9269) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Lot number: 013121A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "controlled high blood pressure" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Sore throat, slight temp, malaise for two days, positive home test, took Paxlovid 5 days". 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.   Clinical course: Sore throat, slight temp, malaise for two days, positive home test, took Paxlovid 5 days, felt good, then two days later developed cough, tested two days later when cough was worse, positive home test. The patient received medication Paxlovid (lot number: 1917017A) from 02Jul2022 to 07Jul2022 for COVID 19 Treatment.
Age: 35.0
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) (Other HCP).  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "Bladder cancer surveillance" (unspecified if ongoing), notes: Bladder cancer surveillance; "Allergic rhinitis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: COVID-19 (medically significant) with onset 29Jun2022, outcome "not recovered", DRUG INEFFECTIVE (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; (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She tested positive for covid-19 on 29Jun2022 and started treatment that day with paxlovid. she had rebound covid symptoms on 7Jul2022 and tested positive again 08Jul2022 with a covid antigen test (turned positive before control line).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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.  An 81-year-old patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: 9264), in left arm, on 02Mar2021 as dose 2, single (Lot number: En6202) and on 12Oct2021 as dose 3 (booster), single (Lot number: 30155ba) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "apnea" (unspecified if ongoing); "obese" (unspecified if ongoing); "had tnductile cancer" (unspecified if ongoing), notes: had tnductile cancer w treatment through Nov 2021 through; "Sensitive to milk" (unspecified if ongoing); "gluten" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL AND HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Covid-19 treatment was done with paxlovir.  Clinical course : it was reported that on 07Jul2022, covid rebound 6 days after done with paxlovir.
Age: 58.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single, in Apr2021 as dose 2, single and in Nov2021 as dose 3 (booster), single at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
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) (Physician). The reporter is the patient.  A 37-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Jul2022 as dose 4 (booster), single (Lot number: 058a22-2a), 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 had no relevant medical history. The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 17Aug2022. The patient took concomitant medications. 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: Negetive, notes: Home test neg on day 7; Positive, notes: took another test which was positive; Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information incided that rebound Covid. Home test neg on day 7, then got sniffles on day 9 so took another test which was positive. Paxlovid was used for tretament of COVID 19 from 03Jul2022 to 07Jul2022.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Gotten covid on 21Jun2022; Gotten covid on 21Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "copd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Jun2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 21Jun2022, outcome "not recovered" and all described as "Gotten covid on 21Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) positive, notes: Gotten covid on 21Jun2022 was told to take Paxlovid; (07Jul2022) Unknown results, notes: Unknown results. Therapeutic measures were taken as a result of suspected covid-19.  Clinical information: Gotten covid on 21Jun2022 was told to take Paxlovid due to underline health Cond and rebound of covid started on 07Jul2022. Patient started treatment with Paxlovid on 22Jun2022 and stopped treatment on 27Jun2022. Patient did not received other vaccination with 2 weeks of vaccination. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested Positive for COVID; tested Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 39-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (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 25May2022, outcome "unknown" and all described as "tested Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive; (02Jun2022) Negative; (07Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: The patient tested positive for COVID on 25May2022. The patient received treatment with Paxlovid on 26May2022 to 30May2022. The patient tested negative on 02Jun2022. The symptoms recurred on 06Jun2022 and on 07Jun2022, the patient tested positive for COVID. No drug or alcohol abuse. The patient had no family history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events Drug ineffective and COVID-19 cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Lot number: EL9261), in right arm, on 04Mar2021 at 10:00 as dose 2, single (Lot number: EL9267), in right arm and on 25Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "borderline high cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN MEDOXOMIL, start date: Oct2017; ROSUVASTATIN, start date: Jun2018; HYDROCHLOROTHIAZIDE, start date: Jun2001. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin", notes: Known allergies: amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Covid-19 treatment. Paxlovid. Treatment start date: 29Jun2022. Treatment stop date: 03Jul2022 Lot number: GC9431. Indication: Treatment of Covid-19  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Fatigue, Pain in extremity
Clinical narrative: arm soreness; some fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "borderline high cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: Jun2001; OLMESARTAN MEDOXOMIL, start date: Oct2017; ROSUVASTATIN, start date: Jun2018. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". Vaccination history included: BNT162b2 (vaccine brand=Pfizer/BioNTech, vaccine brand unknown=False, vaccine administration date=04Mar2021, vaccine administration time=10:00 AM, vaccine lot number=EL9267, vaccine lot unknown=False, vaccine dose number=2, vaccine dose number unknown=False, vaccine location=Right arm), administration date: 04Mar2021, when the patient was 69-year-old, for Covid-19 Immunization, reaction(s): "arm soreness", "some fatigue"; BNT162b2 (vaccine brand=Pfizer/BioNTech, vaccine brand unknown=False, vaccine administration date=11Feb2021, vaccine administration time=10:00 AM, vaccine lot number=EL9261, vaccine lot unknown=False, vaccine dose number=1, vaccine dose number unknown=False, vaccine location=Right arm), administration date: 11Feb2021, when the patient was 69-year-old, for Covid-19 Immunization, reaction(s): "arm soreness", "some fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown", described as "some fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
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.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6202), in right arm, on 17Mar2021 as dose 2, single (Lot number: ER2613), in right arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 30130BA), in right arm and on 18Jun2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Mitrol valve replacement" (unspecified if ongoing); "Gluten Allergy" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE, start date: Jun2018; LOSARTAN [LOSARTAN POTASSIUM], start date: Jun2018; FUROSEMIDE, start date: Jun2018; SYMBICORT "ASTRAZENECA", start date: Dec2019; SPIRIVA RESPIMAT, start date: Dec2019; ALBUTEROL HFA, start date: Dec2019; MONTELUKAST SODIUM, start date: Feb2021; LEFLUNOMIDE, start date: Apr2021; CELECOXIB, start date: Apr2022; SAMBUCUS NIGRA;ZINC, start date: Feb2021; ONE A DAY [MINERALS NOS;VITAMINS NOS], start date: Jan2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive; (29Jun2022) Negative; (30Jun2022) Positive; (01Jul2022) Positive, notes: Tested positive both Antigen & PCR; (11Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient received other medication in 2 weeks. Patient was prescribed with Paxlovid after positive test for Covid-19 on 23Jun2022. Medication completed in full on 27Jun2022. Tested Negative on 29Jun2022. Tested positive on 30Jun2022. Tested positive both Antigen & PCR on 01Jul2022. Continue to test positive on 11Jul2022. Symptoms returned stronger on 01Jul2022 - more sweats, more phlem nose & throat, loss of smell, body pain. Symptoms began to lessen 09Jul2022.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm soreness; some fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 2, single (Lot number: EL9267) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "BPH" (unspecified if ongoing); "borderline high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN MEDOXOMIL, start date: Oct2017; ROSUVASTATIN GLENMARK, start date: Jun2018; HYDROCHLOROTHIAZIDE, start date: Jun2001. Past drug history included: Amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: amoxicillin. Vaccination history included: BNT162b2 (Vaccine administration date=11Feb2021,, Vaccine administration time=10:00 AM, vaccine lot number=EL9261,, Vaccine dose number=1,, Vaccine location=Right arm, Adverse event: , Mild reactions after each injection. Arm soreness, some fatigue.), administration date: 11Feb2021, for COVID-19 Immunization, reaction(s): "Arm soreness", "some fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Jul2022, outcome "recovering", described as "arm soreness"; FATIGUE (non-serious) with onset 09Jul2022, outcome "recovering", described as "some fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm soreness; some fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Lot number: EL9261) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "borderline high cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN MEDOXOMIL, start date: Oct2017; ROSUVASTATIN, start date: Jun2018; HYDROCHLOROTHIAZIDE, start date: Jun2001. Past drug history included: Amoxicillin, reaction(s): "Allergy".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm soreness"; FATIGUE (non-serious), outcome "recovering", described as "some fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional Information: Patient administered other medications in 2 weeks.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted COVID-19; contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient had 3 doses of the vaccine designed to lessen severe illness from a COVID-19 infection. The patient contracted COVID-19, likely 03Jul2022. The patient was vaccinated and boosted with Covid-19 vaccines and had contracted the virus.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200021017 Same reporter/vaccine/event, different patient.;
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted COVID-19; contracted COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 1, single (Lot number: FK5127, Expiration Date: 03Dec2021), on 17Dec2021 as dose 2, single (Lot number: FK5127, Expiration Date: 21Jan2022) and on 23May2022 as dose 3 (booster), single (Lot number: FL0007) at the age of 5 years for covid-19 immunisation. The patient had no relevant medical history. No family medical history. There were no concomitant medications. No additional Vaccines Administered on Same Date, no prior vaccinations within 4 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "contracted COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: Vaccinated still tested positive for Covid-19 afterwards. tested positive on 05Jul2022; (unspecified date) Positive. Additional information: the reporter (patient's mother) reported that patient had 3 doses of the vaccine designed to lessen severe illness from a COVID-19 infection. Patient contracted COVID-19, likely 03Jul2022. Reporter's family all got vaccinated and still tested positive for covid19 afterwards on 05Jul2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200021017 Same reporter/vaccine/event, different patient.;
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted COVID-19/got vaccinated still tested positive for covid19 afterwards; contracted COVID-19/got vaccinated still tested positive for covid19 afterwards; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 1, single (Lot number: FK5127), on 23Nov2021 as dose 2, single (Lot number: FK5127, Expiration Date: 03Dec2021) and on 23May2022 as dose 3 (booster), single (Lot number: FL0007) at the age of 9 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "contracted COVID-19/got vaccinated still tested positive for covid19 afterwards". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: got vaccinated still tested positive for covid19 afterwards. Clinical course: the reporter was a vaccinated and twice boosted mother of 4 and part time HCP. Reporter's husband and four children (Ages 5, 5, 7, and 9) have each had 3 doses of the vaccine designed to lessen severe illness from a COVID-19 infection. They contracted COVID-19, likely 03Jul2022. Only one of the five year olds has remained negative via at home antigen testing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200021017 Same reporter/vaccine/event, different patient.;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EJ1685), in arm, on 01Jan2021 as dose 2, single (Lot number: EL3246), in arm and on 08Oct2021 as dose 3 (booster), single (Lot number: EW0196), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Former smoker" (unspecified if ongoing); "HIV" (unspecified if ongoing). Concomitant medications included: BIKTARVY; ATORVASTATIN; TAMSULOSIN and others. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: Quidel Antigen Test positive; SARS-CoV-2 test: (26Dec2021) positive, notes: Antigen Test positive nasopharyngeal; (05Jan2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19, includes: Bamlanivimab did not help vs omicron from 27Dec2021 to 27Dec2021. The patient received coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Apr2022 as dose 4 (booster), single (Lot number: 068H21A), in arm for covid-19 immunisation.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of suspect cannot be excluded for the reported events.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown (booster), single (Lot number: FK9894) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bouts of vertigo" (unspecified if ongoing), notes: other medical history: bouts of vertigo; "known allergies: Pollen" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Epinephrine, reaction(s): "known allergies: Epinephrine, Tramadol", notes: known allergies: epinephrine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Patient had no medications in two weeks. And received Paxlovid for Covid-19 treatment.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed by PCR with Covid 19 /sore throat, nasal congestion, fever, myalgias, fatigue and cough; diagnosed by PCR with Covid 19 /sore throat, nasal congestion, fever, myalgias, fatigue and cough; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 13Jan2021 as dose 2, single (Lot number: EL3249), in right arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 01Jun2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "menopause syndrome" (unspecified if ongoing); "seasonal affective disorder" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; DIVIGEL; DULOXETINE; VITAMIN D [VITAMIN D NOS]; DOCUSATE SODIUM. Past drug history included: Voltaren, reaction(s): "Voltaren causes rash", notes: Voltaren causes rash; other NSAIDS are fine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "not recovered" and all described as "diagnosed by PCR with Covid 19 /sore throat, nasal congestion, fever, myalgias, fatigue and cough". Clinical course: Patient was diagnosed by PCR with Covid 19 on 28Jun2022 after one day of sore throat, nasal congestion, fever, myalgias, fatigue and cough. Her covid symptoms improved noticeably after 5 days of PAXLOVID treatment with no further symptom beyond mild fatigue, but starting on 08Jul2022, patient had a recurrence of sore throat, nasal congestion, dry cough, myalgias and fatigue. Patient was still symptomatic on 11Jul2022, but slowly improving again without further treatment. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) positive, notes: A home Covid antigen test was positive on day 11; (28Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included PAXLOVID.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Age: 50.0
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 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 12Aug2021 as dose 1, single (Lot number: EW0171), in left arm, on 01Sep2021 as dose 2, single (Lot number: EW0172), in left arm and on 02Mar2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid disease" (unspecified if ongoing); "sulpha drugs" (unspecified if ongoing), notes: Known allergies: sulpha drugs. Concomitant medication(s) included: LEVOTHYROXIN; SINGULAIR. Past drug history included: Wellbutrin, reaction(s): "Known allergies: wellbutrin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (05Jul2022) Negative; (06Jul2022) Negative; (07Jul2022) Negative; (08Jul2022) Negative; (10Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient started taking Paxlovid 29Jun and took it twice daily for 5 days as prescribed.