chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive covid home test 5-7-22 with mild symptoms; Positive covid home test 5-7-22 with mild symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 at 12:00 as dose 2 , single (Batch/Lot number: unknown) at the age of 70 years, 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: COVID-19 (medically significant) with onset 17May2022 at 06:00, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Positive covid home test 5-7-22 with mild symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: Positive covid home test 07May22 with mild symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: the patient had no Other medication in 2weeks. Anti viral details included product=COVID 19 Treatment and the treatment start date from 09May2022, to 13May2022, for Treatment of COVID-19. Adverse event: Positive covid home test 07May22 with mild symptoms. Prescribed and took 5 day course of Paxlovit. Cold like symptoms mitigated to day 10 after test positive day 0 but same symptoms recurred and persist to day 14. I am athletic male, no medication or health conditions the patient did not received any treatment  and does not have any Known allergies and the patient had no medical history  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive; testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 24 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 had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "recovering" and all described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12May2022 to 16May2022. Clinical course: No other medication were received in 2weeks. Patient started having symptoms of COVID the night of Wednesday 11May2022. And started taking Paxlovid on Thursday 12May2022 after testing positive that morning. By Tuesday 17May2022 felt pretty much good as new. On Thursday 19May2022 began feeling a little congested, and symptoms got worse over the next two days. Patient was writing this on Saturday 21May2022 and feel congested and tired. No Known allergies.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 18:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 at 18:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Nov2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hereditary hemochromatosis" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; SYMBICORT. Past drug history included: Known allergies:dioxicyclin, reaction(s): "Drug Allergy". 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 suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose1, single (Lot number: EL9261), in right arm, on 15Feb2021 as dose2, single (Lot number: EL3246), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 30158BA) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure treated with medication. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive; (11May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Adverse event: Consumer tested positive for Covid on 04May2022. Consumer began Paxlovid on May 05May2022. Her primary symptoms were extreme fatigue, chills, a slight cough, and some nasal drainage. By 09May2022 she was symptom free and tested negative on 11May2022. On 15May2022, she developed nasal stuffiness which she thought might be a new allergy to pollen. She spoke with the Pharmacist on May 18, 2022 about her nasal stuffiness. She did not feel it was an allergy because she did not have any other allergy symptoms. She advised me to take Mucinex which she did. We were to visit her son and his family to help with the new baby this coming 22May2022. Yesterday she decided to take a Covid test, never dreaming it would be positive. She called her primary care physician and he advised her not to go because of the newborn. This morning she was researching rebound cases of Covid after taking Paxlovid and found that this can occur. She was hoping her information can further the Knowledge of a virus that was constantly mutating.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: States that she and her husband both have Covid and the doctor put them on Paxlovid; States that she and her husband both have Covid and the doctor put them on Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EL9267), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "States that she and her husband both have Covid and the doctor put them on Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Result: Positive;  Unit: Not Provided She took a test on Wednesday and it was positive. Caller states that she started Paxlovid last night. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Reporter states that they both had IV Therapy yesterday that really helped them.  States it was called a Covid Cocktail and consisted of Lactated Ringers, Vitamin C, Glucagon, Vitamin B12, and others are unknown. Reporter mentions that for herself, her pulse was a little high yesterday and her pulse ox was a little low; she thinks she was dehydrated.  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 in the case report, a possible causal relationship between the reported events: "Vaccination failure", "COVID-19" and the suspect drug BNT162B2 cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: taking positive/COVID-19; taking positive/COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 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: "Ulcerative Colitis" (unspecified if ongoing). Date of last menstrual period: 01Dec2021. The patient was 17 weeks pregnant at the time of exposure to BNT162b2. The patient is expected to deliver a baby(s) on 07Sep2022. Concomitant medication(s) included: HUMIRA; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; LEVOTHYROXINE; NASACORT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "taking positive/COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested negative 6 days after taking positive; Negative, notes: Tested negative 6 days after taking positive; Positive, notes: tested positive on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19 dated from 08May2022 to 12May2022 with Anti-viral.  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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years 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. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: became symptomatic after having previously testing negative post-Paxlovid; (unspecified date) Positive, notes: Treatment of COVID-19; (18May2022) Positive, notes: Relapse 10 days after Paxlovid, tested positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Patient took Paxlovid on 08May2022 and stopped on 12May2022 for the treatment of COVID-19.   Clinical course: There were no known allergies. The patient had no other medications in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I finally tested COVID-Negative on Day 8 and am now testing Positive again; I finally tested COVID-Negative on Day 8 and am now testing Positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at dose 1, single and second regimen (Batch/Lot number: unknown) at dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis (immunocompromised)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 20May2022, outcome "not recovered" and all described as "I finally tested COVID-Negative on Day 8 and am now testing Positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive.  Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Clinical significance: Reported about covid treatment.: Received vaccine, No other medication in 2weeks. Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=12May2022, treatment stop date=17May2022, indication=Treatment of COVID-19, Covid vaccine details: vaccine brand=Pfizer / BioNTech, Vaccine brand unknown=False, Vaccine administration date=21Oct2021, vaccine lot number=EW0187, vaccine lot unknown=False, vaccine dose number=3, vaccine dose number unknown=False, vaccine location=Left arm. Adverse event: Rebound infection on Day 10. I finally tested COVID-Negative on Day 8 and am now testing Positive again. Likewise, runny nose (only symptom) has returned. Event started on  20May2022, The event was not recovered, no treatment was received.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: prescribed paxlovid after vaccination; prescribed paxlovid after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE taken for migraine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "prescribed paxlovid after vaccination". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Narrative case summary and further information: Reason for no lot number: of Paxlovid: Other: LOT#: Consumer stated, "PAA183750 or may be not. Sorry, I see GA5765. I see that's 5, hold on. So, the GA5765 or 6765. I can not count (Not confirmed hence not captured in tab). Expiry Date of Paxlovid: Jan2023. Other Products: Yes. Additional Context: Consumer stated, So, I have been taking Paxlovid and I was on a hold with my doctor this morning and I had a side effect and they wanted me to call and let you know what it was. When asked for the side effect: Consumer stated, "I am actually having pain, where I got my vaccine shot in my left arm. Name of the medication: Paxlovid. When paraphrased the concern: Consumer stated, That is correct, at the injection site where I had my vaccine, I had 3 shots in the same arm for my covid vaccine and I am experiencing pain in the arm, at the site of the injection. Consumer was informed about the role of Pfizer Drug Safety. When asked if consumer is HCP: Consumer stated, Doctor. Oh! no. Me? I am a patient. Product details: (LOT#, NDC#, UPC#, Expiration date) LOT#: Consumer stated, PAA183750 or may be not. Sorry, I see GA5765. I see that's 5, hold on. So, the GA5765 or 6765. I cannot count(Not confirmed hence not captured in tab). Expiration date: Consumer stated, I do have expiration Jan2023 (Confirmed as Jan2023). Pharmacy details: Name: Consumer stated, (pharmacy name) in (city, state name). Dose: Consumer stated, Repeat that one more time. So, Thursday I took the morning and the night dose, and then Friday I took morning and night dose and this morning I took morning dose. So, I guess 5 doses. Treatment for adverse events: Consumer stated, I took Tylenol for cover my covid symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Fatigue, Psoriasis, SARS-CoV-2 test
Clinical narrative: drug ineffective; COVID-19; SORE ARM AFTER COVID VACCINE; Psoriasis flare-up; Fatigue; 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-163-4398413-00 (FACILITATED COLLECT).  A 27-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 1, single (Batch/Lot number: unknown) and in Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 26 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "SORE ARM AFTER COVID VACCINE"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis flare-up"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "drug ineffective", "covid-19" and "psoriasis flare-up" 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 reporter considered "sore arm after covid vaccine" and "fatigue" related to BNT162b2.  Additional information: Solicited report from a consumer of an adult male with events of non-serious Sore arm after Covid vaccine, Fatigue, Occasional Plaque Psoriasis flare and Covid with Humira (Adalimumab). There was no reported medical history. On unknown date, the patient experienced Sore arm after Covid vaccine, Fatigue, Occasional Plaque Psoriasis flare and Covid. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if Patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Sore Arm After Covid Vaccine, Fatigue, Occasional Plaque, Psoriasis Flares And Covid was not provided. Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran):  The reporter's causality for the event(s) of Sore Arm After Covid Vaccine, Fatigue was reported as Possible whereas for Flares And Covid was Not Reported.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19  and psoriasis flare-up,pain in arm,fatigue.
Age: 26.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: drug ineffective; COVID-19; SORE ARM AFTER COVID VACCINE; Psoriasis flare-up; Fatigue; 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-163-4398413-00 (FACILITATED COLLECT).  A 27-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 1, single (Batch/Lot number: unknown) and in Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 26 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "SORE ARM AFTER COVID VACCINE"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis flare-up"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "drug ineffective", "covid-19" and "psoriasis flare-up" 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 reporter considered "sore arm after covid vaccine" and "fatigue" related to BNT162b2.  Additional information: Solicited report from a consumer of an adult male with events of non-serious Sore arm after Covid vaccine, Fatigue, Occasional Plaque Psoriasis flare and Covid with Humira (Adalimumab). There was no reported medical history. On unknown date, the patient experienced Sore arm after Covid vaccine, Fatigue, Occasional Plaque Psoriasis flare and Covid. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if Patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Sore Arm After Covid Vaccine, Fatigue, Occasional Plaque, Psoriasis Flares And Covid was not provided. Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran):  The reporter's causality for the event(s) of Sore Arm After Covid Vaccine, Fatigue was reported as Possible whereas for Flares And Covid was Not Reported.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19  and psoriasis flare-up,pain in arm,fatigue.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I recently have covid after I had a two doses of Pfizer; I recently have covid after I had a two doses of Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; acetylsalicylic acid (ALKA-SELTZER), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I recently have covid after I had a two doses of Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for acetylsalicylic acid was unknown. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included 2 weeks. COVID-19 treatment of Paxlovid from 05May2022 to 09May2022. 9 days after onset of COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Pfizer / BioNTech dose number=4; Pfizer / BioNTech dose number=4; 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 19Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Psoriatic Arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: COSENTYX; AIMOVIG. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Pfizer / BioNTech dose number=4"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  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: Fatigue, Lymphadenopathy, Migraine, Night sweats, Pain in extremity
Clinical narrative: Lt axillary swollen lymph nodes; lt (left) arm pain; Night sweats; Fatigue; Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 at 10:30 as dose 4 (booster), single (Lot number: FL3179), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EW0217, prev dose lot unknown=False, prev dose administration date=08Oct2021, prev dose dose number=3, prev dose vaccine location=Left arm), administration date: 08Oct2021, for Covid-19 immunization; BNT162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EP6955, prev dose lot unknown=False, prev dose administration date=02Apr2021, prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 02Apr2021, for COVID-19 immunization; BNT162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EL3247, prev dose lot unknown=False, prev dose administration date=12Mar2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 12Mar2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022); LYMPHADENOPATHY (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022), described as "Lt axillary swollen lymph nodes"; MIGRAINE (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022); NIGHT SWEATS (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022); PAIN IN EXTREMITY (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022), described as "lt (left) arm pain". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity, night sweats, fatigue, migraine.  Additional information: Patient did not receive any other vaccines within four weeks and did not receive any other medications within 2 weeks. Patient did not have covid prior vaccination and patient did not tested post vaccination. Known allergies and Other medical history reported as No.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested negative after 5 days on treatment. Now testing positive a week later; Tested negative after 5 days on treatment. Now testing positive a week later; 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 male patient received BNT162b2 (BNT162B2), on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "not recovered" and all described as "Tested negative after 5 days on treatment. Now testing positive a week later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were not taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
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). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2021 at 02:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, 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: "High blood pressure" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE; BYSTOLIC. 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 covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: could also be due to Covid 19, but much worse after started paxlovid; could also be due to Covid 19, but much worse after started paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 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: "Fibromyalgia" (unspecified if ongoing), notes: Other medical history: Fibromyalgia, depression; "depression" (unspecified if ongoing), notes: Other medical history: Fibromyalgia, depression. Concomitant medication(s) included: VYVANSE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; WELLBUTRIN. 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 "could also be due to Covid 19, but much worse after started paxlovid". 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.  Clinical course: Other medication in 2weeks brand Vyvanse, Wellbutrin, Zyrtec. COVID 19 Treatment, Paxlovid, Treatment start date: 19May2022, Lot number: GA5120. Adverse event: Terrible, bitter taste in my mouth after starting Paxlovid. Very bad headache on left side of head (could also be due to Covid 19, but much worse after started paxlovid. Adverse event start date: 19May2022. Ae resulted in: None of the above. If patient recovered: Not recovered. If treatment ae: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He has received the Pfizer double dose first, he has been double boosted with Pfizer (Confirmed as Pfizer covid 19 vaccine). He tested positive on 12May; He has received the Pfizer double dose first, he has been double boosted with Pfizer (Confirmed as Pfizer covid 19 vaccine). He tested positive on 12May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 12May2022, outcome "unknown", COVID-19 (medically significant) with onset 12May2022, outcome "not recovered" and all described as "He has received the Pfizer double dose first, he has been double boosted with Pfizer (Confirmed as Pfizer covid 19 vaccine). He tested positive on 12May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive; (17May2022) Negative; (22May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical Course: Reporter stated, "husband tested positive with covid last Thursday, 12May. He has received the Pfizer double dose first, he has been double boosted with Pfizer (Confirmed as Pfizer covid 19 vaccine). He tested positive (PC filed) on 12May, our doctor prescribed paxovid which he took for 5 days. He finished paxlovid on Monday, 16May and he tested negative on Tuesday 17May Now this morning which is 22May, he woke up with slight cold symptoms and tested positive again."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Had the Pfizer shot (COVID shot), I have got COVID; I took the Pfizer vaccine both booster, I got COVID now; Had the Pfizer shot (COVID shot), I have got COVID; I took the Pfizer vaccine both booster, I got COVID now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing), notes: she has an autoimmune. 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 "Had the Pfizer shot (COVID shot), I have got COVID; I took the Pfizer vaccine both booster, I got COVID now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient was treated with Paxlovid.The NDC number of COVID Shot and UPC number of covid shot was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; LEVOCETRIZINE HYDROCHLORIDE; BREZTRI AEROSPHERE; VENTOLINE [SALBUTAMOL]; VITAMIN D NOS; ELDERBERRY [RUBUS IDAEUS LEAF;SAMBUCUS NIGRA FLOWER;SAMBUCUS NIGRA FRUIT]; IBUPROFEN; FLONASE SENSIMIST ALLERGY RELIEF; ZINC. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13May2022) Negative, notes: I tested negative and felt well by day 7; (20May2022) Positive, notes: Tested positive on day 14 and felt very I'll with breathing difficulties, body wide pain, nasal congestion the days before, headache, and facial/sinus pain. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: My wife and I both contracted, we both had all the Pfizer boosters (Unspecified booster) and everything else, booster twice and we both ended up with COVID; My wife and I both contracted, we both had all the Pfizer boosters (Unspecified booster) and everything else, booster twice and we both ended up with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My wife and I both contracted, we both had all the Pfizer boosters (Unspecified booster) and everything else, booster twice and we both ended up with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment with paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Investigation, Vomiting
Clinical narrative: her son received the Pfizer COVID-19 vaccine last Friday and yesterday her son started vomiting; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional), Program ID: (159558). The reporter is the parent.   A male patient received BNT162b2 (BNT162B2), on 20May2022 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: HEADACHE (non-serious) with onset 21May2022, outcome "unknown"; VOMITING (non-serious) with onset 21May2022, outcome "unknown", described as "her son received the Pfizer COVID-19 vaccine last Friday and yesterday her son started vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting, headache.   Additional information: Reason for no lot number: of Covid-19 vaccine: Complainant hung up abruptly/transfer incomplete. Expiry Date of Covid-19 vaccine: Unknown. NDC number of Covid-19 vaccine: Unknown. UPC number of Covid-19 vaccine: Unknown. Call was transferred by (withheld) (not clarified) from Customer Service Center for the Pfizer-BioNTech COVID-19 vaccine (CEP ID: 159558) (cep details were not clarified appropriately). Transferring agent stated, had a (withheld) interpreter on the other line. They had a caller on hold and she was a (withheld) and actually what happened was her son received the Pfizer COVID-19 vaccine last Friday and yesterday her son started vomiting and had a headache and she already gave Tylenol (treatment) and now she was really concerned about the condition of her son and she was concerned with the heart, she was concerned with the reading of her son's heart, she said.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 at 12:00 as dose 3 (booster), single (Lot number: ff8839), in left arm and on 20Apr2022 at 10:00 as dose 4 (booster), single (Lot number: fm9992) at the age of 69 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: "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN, start date: 01Jan2017; ROSUVASTATIN, start date: Jan2017, stop date: 01May2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of covid-19.   Clinical information: The patient received vaccine and other medications in two weeks. and Paxlovid form 01May2022 to 05May2022 as a Treatment of Covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (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 "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 covid-19. Clinical course: On 19May2022, started anti-viral covid-19 treatment (paxlovid), (lot number: FY8932) and treatment stop on 22May2022, for treatment of covid-19. On 18May2022, patient had other medication in 2 weeks with day quilt night quil (lot number: 2ak1093) and product stop on 20May2022. The patient experienced metallic taste starting day 3 Diarrhea for first 2 days with onset 19May2022 at 01:00 PM, outcome "not recovered" and had not adverse event treatment. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200743797 Same pt, diff event/drug