chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac disorder, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received a Pfizer covid-19 booster dose on Thursday and Sunday she tested positive for Covid; received a Pfizer covid-19 booster dose on Thursday and Sunday she tested positive for Covid; She only has part of a heart that works; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 26May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine  (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious) with onset May2022, outcome "unknown", described as "She only has part of a heart that works"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 29May2022, outcome "unknown" and all described as "received a Pfizer covid-19 booster dose on Thursday and Sunday she tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Negative; (29May2022) Positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective, cardiac disorder. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Caller received a Pfizer COVID-19 booster dose on Thursday and Sunday she tested positive for COVID. She tested negative on Saturday. She only has part of a heart that works, so her treating HCP prescribed her Paxlovid. She wants to know how she knows if it's safe for her to take. She has not started Paxlovid yet. Caller stated they just prescribed Paxlovid for her and didn't even check to see if it would interact with any of the other medications she was taking.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17May2022, outcome "unknown", COVID-19 (medically significant) with onset 17May2022, outcome "not recovered" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive; (22May2022) Negative, notes: Testing negative each day during this time frame; (23May2022) Negative, notes: Testing negative each day during this time frame; (24May2022) Negative, notes: Testing negative each day during this time frame; (25May2022) Negative, notes: Testing negative each day during this time frame; (26May2022) Negative, notes: Testing negative each day during this time frame; (27May2022) Negative, notes: Testing negative each day during this time frame; (28May2022) Positive, notes: Day 12 - Day 14 - Started testing positive again; (29May2022) Positive, notes: Day 12 - Day 14 - Started testing positive again; (30May2022) Positive, notes: Day 12 - Day 14 - Started testing positive again. Therapeutic measures were taken as a result of covid-19. Patient did not received other medication in 2 weeks. Patient received anti-viral treatment from 18May2022 to 23May2022 for COVID-19. Patient had no known allergies. Patient experienced a rebound infection. Timeline: Day 1: Tuesday 17May2022 - Onset of symptoms - tested positive, Day 2: Wednesday 18May2022- Started Paxlovid, Day 5: Saturday 21May2022- Symptoms went away 23May2022- Finished complete dose of Paxlovid. Day 6 - Day 11: Sunday 22May2022- Friday 27May2022- Testing negative each day during this time frame. Day 12 - Day 14 - Started testing positive again on the rapid antigen tests and symptoms came back as well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
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) (Nurse) from Regulatory Authority.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose number unknown, single (Lot number: FJ4991) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flovent diskus, reaction(s): "Reaction: Allergy", notes: known allergies: Flovent Diskus. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Tested positive on 17May2022; (24May2022) Positive, notes: Retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient previously receive COVID-19 Vaccine. There was list of other medications the patient received within 2 weeks of vaccination  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anaphylactic reaction, Haemorrhoids, Inflammation
Clinical narrative: hemorrhoid; inflammation; anaphylaxis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4409243-00 (Agency).  A 63-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset Mar2021, outcome "recovered", described as "anaphylaxis"; HAEMORRHOIDS (medically significant), outcome "unknown", described as "hemorrhoid"; INFLAMMATION (medically significant), outcome "recovering". The action taken for adalimumab was unknown.  The reporter considered "anaphylaxis" related to BNT162b2. The reporter's assessment of the causal relationship of "hemorrhoid" and "inflammation" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 14Apr2021 as dose 2, 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 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "not recovered" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: I tested positive for covid on a friday; (28May2022) negative, notes: I tested negative Saturday, Monday (at home antigen); (29May2022) negative, notes: I tested negative Saturday, Monday (at home antigen); (30May2022) negative, notes: I tested negative Saturday, Monday (at home antigen); (31May2022) Positive, notes: on Tuesday symptoms returned and I tested positive (at home antigen). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient did not take other medications in two weeks, Patient received Anti-viral treatment for Covid-19 Treatment start date 22May2022 and stop date 27May2022. Covid rebound after taking full course of paxlovid. Patient was tested positive for covid on a friday. Started paxlovid on sunday and tested negative Saturday, Monday (at home antigen). Around lunch time on Tuesday symptoms returned and tested positive (at home antigen). 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid /he has mild cold-like symptoms; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Her son (17) tested positive for COVID on 30May respectively. They are both vaccinated with Pfizer COVID vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30May2022, outcome "unknown", described as "tested positive for Covid"; COVID-19 (medically significant) with onset 30May2022, outcome "unknown", described as "tested positive for Covid /he has mild cold-like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 11Mar2021 as dose 2, single (Lot number: EN6208), in right arm, on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Isaacs Syndrome" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "Known allergies: Contrast Dye" (unspecified if ongoing). Concomitant medication(s) included: IMMUNOGLOBULIN [IMMUNOGLOBULIN HUMAN NORMAL], start date: 17May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. It was reported that patient had taken other medication in 2 weeks. Patient had taken Paxlovid for COVID 19 Treatment. Treatment start date was 29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Syringomyelia" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing), notes: Known allergies: Iodine. The patient's concomitant medications were not reported. 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: (unspecified date) Unknown results, notes: Treatment of COVID-19; (15Jan2022) Positive, notes: on day 3, I started coughing, choking and retest positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral details: The patient has received treatment for COVID-19 with Paxlovid from 13Jan2022 to 17May2022. Adverse event: I took paxlovid and on day 1 and day 2 I saw good improvement, breathing and coughing improve but on day 3, I started coughing, choking and retest positive for COViD , then after completing day five I lost all abilities to swallow. I required a pick line, for nutrition and several hospitalizations including ICU. They diagnosed me with Guillian Barre. AE resulted in: Hospitalization, Prolongation of existing hospitalization (treatment received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid 19 on 19May2022 after receiving 4 Doses of the Pfizer Covid 19 Vaccine; Tested Positive for Covid 19 on 19May2022 after receiving 4 Doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), on 03Sep2021 as dose 2, single (Lot number: EW0173), on 01Feb2022 as dose 3 (booster), single (Lot number: FJ6369) and on 18Mar2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immune Compromised Multiple Sclerosis" (ongoing), notes: Comments: Immune Compromised Multiple Sclerosis. Concomitant medication(s) included: OCREVUS taken for multiple sclerosis.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "Tested Positive for Covid 19 on 19May2022 after receiving 4 Doses of the Pfizer Covid 19 Vaccine". The event "tested positive for covid 19 on 19may2022 after receiving 4 doses of the pfizer covid 19 vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: she initially tested positive for Covid 19 on 19May2022; (24May2022) Negative, notes: Unit: Not Provided; (28May2022) Positive, notes: Unit: Not Provided; (01Jun2022) Positive, notes: on day 14, she is still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Vitamin D and Evosheld.  Clinical course: Reporter on the line to report an Adverse Event with Paxlovid for rebound effect and stated that she tested Positive for Covid on day 1 and she started Paxlovid that same day. Reporter stated on Day 6, she tested negative for Covid and then on day 10, she tested positive again and on day 14, she was still testing positive. Confirmed reporter details and above information with the caller. Reporter stated she initially tested positive for Covid 19 on 19May2022 and she started Paxlovid that day. Reporter stated she tested negative for Covid on 24May2022. Reporter stated on 28May2022, she started feeling sick again and tested positive for Covid and she was still testing positive. Reporter stated that when she very first tested positive was lighter and now it was a lot darker and she feels worse.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound Covid; Rebound Covid; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: ELO140), on 26Jan2021 as dose 2, single (Lot number: EL3249) and on 17Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: HTN, RA, Hyperlipidemia; "Rheumatoid arthritis" (unspecified if ongoing), notes: Other medical history: HTN, RA, Hyperlipidemia; "Hyperlipidemia" (unspecified if ongoing), notes: Other medical history: HTN, RA, Hyperlipidemia. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "unknown" and all described as "Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) positive; (25May2022) negative; (31May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had taken antiviral COVID 19 Treatment of paxlovid from 18May2022 to 23May2022. Patient had no known allergies.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccine brand: Pfizer/BioNTech, product: COVID 19 Treatment; Vaccine brand: Pfizer/BioNTech, 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 66-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 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: "allergy" (unspecified if ongoing). Concomitant medication(s) included: THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "not recovered" and all described as "Vaccine brand: Pfizer/BioNTech, 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 drug ineffective, covid-19. Clinical information: Other medication product the patient took in 2 weeks was Thyroid and allergy. The patient took COVID 19 treatment with Paxlovid (Treatment start date: 20May2022, Treatment stop date: 24May2022). The patient experienced Paxlovid rebound symptoms day 10, rapid antigen test positive on 29May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Pollen" (unspecified if ongoing), notes: known allergies: Pollen. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19I tested positive again; (May2022) Negative, notes: I tested negative a few days later; (31May2022) Positive, notes: I tested positive again (31May. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medications received in 2 weeks. Treatment for covid-19 started on 16May2022 and stop on 21May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 at 11:00 as dose 3 (booster), single (Lot number: 301558A) at the age of 70 years, in right arm for covid-19 immunization; 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 immunization. The patient had no relevant medical history. Patient had no Known allergies. There were no concomitant medications, also reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 27Apr2022, outcome "not recovered" and all described as "tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) positive; (05May2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 27Apr2022 to 02May2022. Clinical course was reported as, Patient took a full course of paxlovid when she tested positive for Covid with active symptoms. 3 days after finishing 10 doses of paxlovid, she tested negative. 5.5 days after finishing the paxlovid on 07May2022 at 06:00, Patient developed fever & full symptoms once again. Her physician treated her with another 10 doses of Paxlovid (2nd course of paxlovid). Patient recovered from symptoms on 10May2022.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT C, start date: Apr2022, stop date: May2022; VIT D [COLECALCIFEROL], start date: Apr2022, stop date: May2022; BABY ASPIRIN, start date: Apr2022, stop date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: Still testing pos 10 days after treatment. Therapeutic measures were taken as a result of covid-19 with Paxlovid. Patient also received MULTIVITAMINS as concomitant medication, start date: Apr2022, stop date: May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: 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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 14May2022, outcome "unknown", COVID-19 (medically significant) with onset 14May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive, notes: Paxlovid started 16May2022 (2 days after symptoms and testing positive); (25May2022) Positive, notes: Tested positive day 5 after completing treatment; (31May2022) Positive, notes: 11days after final dose-still testing positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient started paxlovid two days after the symptoms and testing positive. The patient completed medications on 20May2022. The symptoms subsided by day 3 of treatment. Four days after completion of treatment symptoms returned. The patient tested positive on day 5 after completing treatment. 11 days after final dose, the patient was still testing positive. The patient still had head congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in left arm, on 24Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fish allergy" (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 "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive; (24May2022) Negative; (31May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: F
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) from product quality group. The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 29 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 was not reported. Concomitant medication(s) included: TYLENOL, start date: 19May2022, stop date: 25May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took paxlovid for the treatment of COVID 19. Treatment start date 19May2022, Treatment stop date 24May2022.Patient had Adverse events foul, bitter/metallic taste for entire course of Paxlovid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for Covid-19 from 21May2022 to 25May2022. The patient received some herbal medicine in 2 weeks product from 20May2022 to 21May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6203), in right arm, on 22Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 08Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Positive, notes: The patient tested himself again on the 11th day and COVID was back. Therapeutic measures were taken as a result of vaccination failure, covid-19. This report about COVID-19 treatment. Patient had no known allergies. Other medical history included asthma. Patient received the vaccine. Patient did not receive other medications in two weeks. Patient received treatment for the event as COVID-19 treatment was paxlovid from 22May2022 to 27May2022. He tested himself again on the eleventh day and COVID-19, he was still feeling sick, it was like the pills extended the timeline of mess being sick with COVID-19.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid; had Covid; 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 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: had Covid, notes: her husband had Covid.  Clinical information: Caller was prescribed with Paxlovid. Caller states before she realizes, she and her husband had Covid, they got their second booster dose on Sunday. Caller states that she was getting her first dose of Paxlovid. Caller wants to know any information if it (Paxlovid) will reduce the effect of the Pfizer Covid-19 booster.  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-202200784485 Same reporter/product/event, different patient
Age: 40.0
Sex: F
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine product" (unspecified if ongoing). The patient's concomitant medications were not reported. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information :Patient received vaccine in 2 weeks of vaccination. Also received other medication in 2 weeks of vaccination.  Anti-viral details: Product- COVID 19 Treatment, Brand- Paxlovid, Treatment start date- 20Mar2022, Treatment stop date- 24Mar2022, Lot number- GA8204, Indication- Treatment of COVID-19  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right leg 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: "Allergy" (unspecified if ongoing), notes: Other medical history: Yes, Known allergies: Yes. The patient took concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient had known allergies. She received antiviral 5 day treatment for COVID-19, from 03May2022 to 08May2022. AE treatment: Many see doctors notes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I also began to test positive again; Negative, notes: 5 successive days of negative tests; Negative, notes: 5 successive days of negative tests; Negative, notes: 5 successive days of negative tests; Negative, notes: 5 successive days of negative tests; Negative, notes: 5 successive days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Gait disturbance, Off label use
Clinical narrative: got my second booster shot, got it on Saturday; Monday I could not walk; my knees were in so much pain that could not walk; got my second booster shot, got it on Saturday; Monday I could not walk; my knees were in so much pain that could not walk; I have actual bone and bone pain which I haven't had before; booster in some way reduced the inflamation that protects me from having bone and bone pain; got my second booster shot, got it on Saturday; Monday I could not walk; my knees were in so much pain that could not walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 28May2022 as dose number unknown, (second booster) single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Arthritis in my knees" (unspecified if ongoing), notes: I have Arthritis in my knees. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (First booster. , unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 28May2022, outcome "unknown", ARTHRALGIA (non-serious), GAIT DISTURBANCE (non-serious) all with onset 30May2022, outcome "unknown" and all described as "got my second booster shot, got it on Saturday; Monday I could not walk; my knees were in so much pain that could not walk"; BONE PAIN (non-serious) with onset 30May2022, outcome "unknown", described as "I have actual bone and bone pain which I haven't had before; booster in some way reduced the inflamation that protects me from having bone and bone pain". Therapeutic measures were taken as a result of arthralgia, gait disturbance, bone pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID infection - tested positive for COVID-19 on 14Apr2022.; COVID infection - tested positive for COVID-19 on 14Apr2022.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3247), on 02Mar2021 as dose 2, single (Lot number: EL3247) and on 09Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 24 years for COVID-19 immunization. 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 09Apr2022, outcome "recovered" and all described as "COVID infection - tested positive for COVID-19 on 14Apr2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Apr2022) Positive, notes: Nasal Swab, OTC test; (15Apr2022) Positive, notes: Nasal Swab, PCR test. Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included OTC medication-NYQUIL. No other vaccine in four weeks, no other medications in two weeks. Adverse event: COVID infection - tested positive for COVID-19 on 14Apr2022. Adverse event start date was on 09Apr2022. Patient had not experienced covid prior vaccination. Covid tested post vaccination. Patient had no known allergies.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the COVID recently with severe symptoms; got the COVID recently with severe symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sefexim, reaction(s): "known allergies Sefexim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "unknown" and all described as "got the COVID recently with severe symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: post vaccination. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: He reported getting covid in Apr2022; He reported getting covid in Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 09Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 47 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There were no other vaccines received within four weeks. The patient did not have COVID prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovered" and all described as "He reported getting covid in Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She was positive for covid; She was positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Nov2021 as dose 1, single (Lot number: FK5618), in left arm and on 28Nov2021 as dose 2, single (Lot number: FK5127) at the age of 10 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. The patient did not have COVID prior to vaccination. The patient was positive for COVID on 11May2022. The patient underwent a nasal swab on 11May2022: positive result. The patient did not receive treatment for the event. The outcome of the event was recovered.
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) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: 30May2022 she tested positive for Covid.  The lot number for [BNT162b2], was not provided and will be requested during follow up.