chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; High Fever; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 24Aug2022 as dose number unknown, single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 25Aug2022, outcome "unknown"; PYREXIA (non-serious) with onset 25Aug2022, outcome "unknown", described as "High Fever"; HEADACHE (non-serious), outcome "unknown". Therapeutic measures were taken as a result of pyrexia, chills, headache.  Additional Information: It was reported that, Transferring agent stated, I have a caller on the other. She was a consumer. The caller got the Pfizer COVID 19 vaccine yesterday and today she experience high fever and chills. She was asking if she can take Tylenol and I tried to give her the number of our Pfizer Medical Information department but she refused. You can transfer her later with the Pfizer Medical Information Department for her question. When paraphrased the concern, consumer stated, Yes, I am also having headache. Is report related to a study or programme was Yes. Product Name as Reported by the Primary Source: Tylenol.      No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; COVID-19; Covid obviously cold symptoms, headache, temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 was not reported. Concomitant medication(s) included: CALCIUM; VITAMIN C [ASCORBIC ACID]; MAGNESIUM; ZINC; ZOLOFT. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 22Aug2022, outcome "not recovered", described as "Covid obviously cold symptoms, headache, temperature"; 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 antibody test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical Course: Patient received treatment for Covid-19 with Paxlovid from 15Aug2022 to 20Aug2022. Patient received other medication in 2 weeks that also included multi, probiotic and Life extension.  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
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) (Physician).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 03May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea" (unspecified if ongoing). 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: He tested negative; (23Aug2022) Positive, notes: and then positive again after finishing drug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:anti viral details: product: COVID 19 Treatment, treatment start date:16Aug2022, treatment stop date: 22Aug2022. Patient experienced COVID rebound after completing Paxlovid. He tested negative and then positive again after finishing drug.  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 provide and plausible temporal association, the causality between BNT162B2 and events (DRUG INEFFECTIVE,  COVID 19 Treatment) cannot be completely excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: My left arm has had pain and numbness since the injection in November; My left arm has had pain and numbness since the injection in November; 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 BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: FH2087) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Lot No: EN6208, Location of injection: Arm Left), administration date: 17Mar2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Lot No: EN6200, Location of injection: Arm Left), administration date: 24Feb2021, when the patient was 39-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (disability), HYPOAESTHESIA (disability) all with onset 13Nov2021, outcome "not recovered" and all described as "My left arm has had pain and numbness since the injection in November". The events "my left arm has had pain and numbness since the injection in november" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, hypoaesthesia. Clinical Course:No other vaccine in four weeks. Patient reported that My left arm has had pain and numbness since the injection in November. I have tried different pain killers and physical therapy. Nothing has improved the symptoms. Any idea's?. if treatment ae Yes. ae treatment Cream/medicine/Physical Therapy. if covid prior vaccination was No. if covid tested post vaccination was No.
Age: 61.0
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 17:00 as dose 1, single (Lot number: ER8727), in left arm, on 13Apr2021 as dose 2, single (Lot number: Ew0158), in left arm and on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "weight" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Known allergies: Cantaloupe" (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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received COVID-19 treatment as anti-viral from 19Aug2022 to 24Aug2022. Patient received other medication in 2 weeks product were Mucinex extended release, Flonase, Tylenol extra strength, Zicam swabs as treatment from 16Aug2022.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysarthria, Pyrexia, SARS-CoV-2 test
Clinical narrative: very high fever 104 degrees/low grade fever (99/100 degrees); speech has been slurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 4-year-old male patient received BNT162b2 (BNT162B2), on 22Aug2022 at 17:00 as dose 2, single (Lot number: FT9142) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: yes. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FT9142, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 01Aug2022, when the patient was 4-year-old, for Covid-19 immunization. The following information was reported: DYSARTHRIA (non-serious) with onset 23Aug2022 at 16:30, outcome "recovering", described as "speech has been slurred"; PYREXIA (non-serious) with onset 23Aug2022 at 16:30, outcome "recovering", described as "very high fever 104 degrees/low grade fever (99/100 degrees)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: It was reported that, almost exactly 24 hours after the shot his son had a very high fever 104 degrees and fever reducers (tylenol & advil) at times only brought it down to 103 so they had to use ice packs to lower his fever in addition to the fever reducers. His fever lasted 32 hours and he then had a low grade fever (99/100 degrees). they noticed the day after his fever that his speech had been slurred. Patient recieved treatment fever reducers. Patient had covid prior vaccination. Patient did not test covid positive post vaccination no. Patient has no known allergies. Patient had no other vaccine in four weeks. Patient had no other medications in two weeks.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 16:00 as dose 1, single (Lot number: EN6203), in left arm, on 21Mar2021 at 16:00 as dose 2, single (Lot number: ER8730), in left arm, on 02Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 01May2022 at 16:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer- total thyroidectomy" (unspecified if ongoing); "Thyroid cancer- total thyroidectomy" (unspecified if ongoing); "Breast cancer lumpectomy and radiation" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Feb2002; BUPROPION HCL XL, start date: 01Mar2021; PRAVASTATIN SODIUM, start date: 01Jan2015, stop date: 15Aug2022; ANASTROZOLE, start date: 01Jun2019; VITAMIN D3, start date: 01Oct2016; CALCIUM, start date: 01May2011; VITAMIN C [ASCORBIC ACID], start date: 01Feb2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (24Aug2022) Negative; (25Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course information: Patient received other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Rebound of symptoms; 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 01Apr2021 as dose 1, single (Lot number: ER8737), in right arm, on 22Apr2021 as dose 2, single (Lot number: EW0172), in right arm and on 22Nov2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "post herpetic neuralgia" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA; MONTELUKAST, reported as patient also received other medication in 2weeks. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 2022, outcome "not recovered", described as "Rebound of symptoms"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (lot number: 2815225) started on 15Aug2022 and stopped on 19Aug2022. Clinical course was reported as, Rebound of symptoms included severe cough, phlem, shortness of breath, right kidney pain, fever.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 at 18:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid removed" (unspecified if ongoing), notes: Thyroid removed; "breast cancer" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "cholesterol" (unspecified if ongoing), notes: cholesterol; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient took anti viral product: COVID-19 treatment, start date: 16Aug2022, stop date: 21Aug2022, lot number: Unknown, indication: Treatment of Covid-19. Yes the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment and the patient previously receive a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Covid rebound 6 days after completing Paxlovid; 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), as dose 2, single (Batch/Lot number: unknown), in left arm 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 included: "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Covid rebound 6 days after completing Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (25Aug2022) Negative, notes: Covid rebound 6 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if therapeutic measures were taken as a result of disease recurrence.  Clinical course: Anti-viral details: Product: COVID 19 Treatment Brand: Paxlovid, Treatment received from 15Aug2022 to 19Aug2022, No Known allergies reported.  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: Full blood count, Gingival swelling, Psoriasis
Clinical narrative: swelling gums; Psoriasis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), 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: "Acidity" (ongoing). Concomitant medication(s) included: FOLIC ACID; PEPCID [FAMOTIDINE] taken for acidosis. The following information was reported: GINGIVAL SWELLING (non-serious), outcome "unknown", described as "swelling gums"; PSORIASIS (non-serious), outcome "unknown". The events "swelling gums" and "psoriasis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gingival swelling, psoriasis.  Additional information: The patient reported she received the Pfizer Covid 19 vaccine and she mention that she had a Psoriasis and also gums were little bit swollen and she would like to know if she could take booster. When paraphrased the concern: reporter stated, Yes her gum was swollen, well she went to dentist she did know about that, they told her swelling was due to denture that she had so, they adjusted it. She had Psoriasis and she take Methotrexate (Treatment). Expiration Date: reporter stated, she didn't know it was injected in January so the first injection was 29Jan. They didn't indicate here. NDC#, UPC#: reporter stated, she didn't know. LOT# (Methotrexte): reporter stated, she can't see it on her prescription. Expiration date (Methotrexate): reporter stated,  They also did not mention the expiration date. NDC#, UPC#: reporter stated, The only thing she had here was prescription. Dose (Methotrexate): 10 mg, once a week tablet. Lab test: reporter stated, Well she think January of this year. Yes, the only test she had CBC and that was done on January this year. Treatment: reporter stated, No Nothing. Anatomical site of administration: reporter stated, The first two on her right arm.   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: Pain
Clinical narrative: really hurting this time; This is a spontaneous report received from a non-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 number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "really hurting this time".  Additional information: The patient was an older lady who was taking lot of other medications. The patient was on second booster and had event. The patient asked if she would be recommended Tylenol or Ibuprofen.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Productive cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 77 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: BNT162b2 (Dose 2, Batch/Lot No: EN6198, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 27Feb2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Batch/Lot No: EL9269, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 06Feb2021, when the patient was 77-year-old, for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Coughing"; PRODUCTIVE COUGH (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Flem in throat"; NASOPHARYNGITIS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "I have Cold Symptoms but have no Cold"; RHINORRHOEA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Runnie Nose"; SNEEZING (non-serious) with onset 01Dec2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasopharyngitis, rhinorrhea, cough, productive cough, sneezing. Additional information: The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. The patient had received other medications Lisinopril 20 mg TAB within 2 weeks of vaccination. Reporter stated, I have Cold Symptoms but have no Cold. Runny Nose, coughing, flem in throat and sneezing. This has been going on sense my last shot on 05Nov2021. I have tested negative for Covid, Sep2021. Still have Symptoms but feel fine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. Patient had no known allergies. No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 77 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: BNT162b2 (Dose 2, Batch/Lot No: EN6198, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 27Feb2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Batch/Lot No: EL9269, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 06Feb2021, when the patient was 77-year-old, for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Coughing"; PRODUCTIVE COUGH (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Flem in throat"; NASOPHARYNGITIS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "I have Cold Symptoms but have no Cold"; RHINORRHOEA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Runnie Nose"; SNEEZING (non-serious) with onset 01Dec2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasopharyngitis, rhinorrhea, cough, productive cough, sneezing. Additional information: The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. The patient had received other medications Lisinopril 20 mg TAB within 2 weeks of vaccination. Reporter stated, I have Cold Symptoms but have no Cold. Runny Nose, coughing, flem in throat and sneezing. This has been going on sense my last shot on 05Nov2021. I have tested negative for Covid, Sep2021. Still have Symptoms but feel fine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. Patient had no known allergies. No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal discomfort
Clinical narrative: This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: 22K-163-4510288-00. A 53-year-old female patient received BNT162b2 (BNT162B2), on 04May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years intramuscular for COVID-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, single, Route of administration: Intramuscular), administration date: 29Mar2021, when the patient was 52-year-old, for COVID-19 immunisation; BNT162b2 (dose 2, single, Route of administration: Intramuscular), administration date: 19Apr2021, when the patient was 52-year-old, for COVID-19 immunisation. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "Shoulder discomfort". The action taken for adalimumab was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-PV202200050135 same patient/drug, different dose/event;
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body mass index, COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound COVID; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 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: "Overweight BMI 31" (unspecified if ongoing), notes: Overweight BMI 31; "Penicillin Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "unknown", described as "Rebound COVID". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 31, notes: Overweight BMI 31; SARS-CoV-2 test: (21Aug2022) Negative, notes: Tested negative antigen on 21Aug to return to work developed congestion the night of 26Aug; (27Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical information: Anti viral details: Product: COVID 19 Treatment, brand: Paxlovid , Treatment start date was 17Aug2022, Treatment stop date was 22Aug2022. Patient took Acetaminophen in 2 weeks product. Rebound COVID 19 after last Paxlovid dose on 22Aug, tested negative antigen on 21Aug to return to work developed congestion the night of 26Aug and tested antigen positive on 27Aug.   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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound of symptoms and positive antigen test; Treatment of COVID-19; Treatment of 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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), on 20Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety/ADHD" (unspecified if ongoing); "Anxiety/ADHD" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "not recovered", described as "Rebound of symptoms and positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2022) Positive, notes: Positive antigen test; (Aug2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical information: The patient had no known allergies. The patient received vaccine and other medication were received in 2 weeks. Anti-viral details included; Product was COVID 19 Treatment. Brand was Pfizer. Treatment start date was 17Aug2022 and treatment stop date was 22Aug2022. Indication was for Treatment of COVID-19.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; On the sixth day I tested positive again and symptoms began.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "On the sixth day I tested positive again and symptoms began.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 include Paxlovid from 18Aug2022 to 21Aug2022. After finishing the Paxlovid, patient tested negative four days in a row, then on the fifth day patient tested positive with no symptoms. On the sixth day he tested positive again and symptoms began.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 4 (booster), single (Lot number: FJ4989) 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: "COPD" (unspecified if ongoing); "Lung cancer" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "Known allergies: iodine in contrast media" (unspecified if ongoing), notes: Known allergies: iodine in contrast media. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2012, stop date: 08Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, 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 drug ineffective, covid-19.  Clinical Course: Patient received COVID-19 Treatment as Paxlovid from 08Aug2022 to 12Aug2022. Patient also reported that he had a recurrence of COVID symptoms and resumption of positive home antigen test.
Age: 75.0
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) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Aug2021 as dose 3 (booster), single (Lot number: fc3182) and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 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: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC, start date: Jan2010; LOSARTIN, start date: Jan2010; SPIRONOLACTON, start date: Jan2017; AMLODIPINE, start date: Aug2021; SIMVASTATIN, start date: Jan2007, stop date: 22Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". 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 course: Patient received antiviral treatment of Paxlovid. Treatment start date: 22Aug2022, Treatment stop date: 26Aug2022, Lot number: ge1577,Indication: Treatment of COVID-19. Adverse event Severe stomach discomfort. Inability to eat or drink for 36 hours. Adverse event start date 25Aug2022. If patient recovered Recovering. Known allergies no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; COVID Rebound; 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 76-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Lot number: 026L20A), on 24Feb2021 as dose 2, single (Lot number: 011M20A) and on 26Oct2021 as dose 3 (booster), single (Lot number: 014F21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 25Aug2022, outcome "recovering", described as "COVID Rebound"; 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: (25Aug2022) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: COVID 19 Treatment, brand=Paxlovid, treatment start date=15Aug2022, treatment stop date=20Aug2022. No known allergies.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Took Paxlovid from 20Aug-24Aug. Tested negative on 26Aug. Rebound symptoms began on 28Aug and tested positive.; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 at 09:00 as dose 1, single (Lot number: EL3247), in right arm, on 10Mar2021 at 09:00 as dose 2, single (Lot number: EL3248), in right arm, on 21Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 04Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FL3197) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR, start date: 07Aug2022, stop date: 13Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 28Aug2022 at 08:00, outcome "recovering", described as "Took Paxlovid from 20Aug-24Aug. Tested negative on 26Aug. Rebound symptoms began on 28Aug and tested positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Negative, notes: Took Paxlovid from 20Aug - 24Aug. Tested negative on 26Aug; (28Aug2022) Positive, notes: Rebound symptoms began on 28Aug and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: The patient was treated with Paxlovid from 20Aug2022 to 24Aug2022 for COVID-19.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 at 13:00 as dose 3 (booster), single (Lot number: Fk9893) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 30Mar2021 at 13:00 as dose 1, single (Lot number: 1808980), in left arm and on 26Nov2021 at 10:00 as dose 2 (booster), single (Lot number: 1822811), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Apr2022 at 13:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 19Aug2022 to 23Aug2022 for Treatment of COVID-19. Clinical Course: There were no other medication in 2weeks. After paxlovid therapy, rebounded with flu like symptoms. Congestion, sniffles, low grade fever and chills.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound case of covid 19 after completing 5 day course of Paxlovid treatment/testing positive again on rapid antigen test.; 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 41-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "not recovered", described as "Rebound case of covid 19 after completing 5 day course of Paxlovid treatment/testing positive again on rapid antigen test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative, notes: after completing 5 day  course of paxlovid treatment; (Aug2022) Positive, notes: 3 days after completing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Paxlovid was started on 17Aug2022 to 22Aug2022 for the treatment of COVID-19. Rebound case of covid 19 after completing 5 day course of Paxlovid treatment and testing negative. 3 days after completing Paxlovid sore throat began followed by congestion and now testing positive again on rapid antigen test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 6 days after completing the Paxlovid meds I tested positive for COVID again; Treatment of COVID-19; Treatment of 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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "unknown", described as "6 days after completing the Paxlovid meds I tested positive for COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative; (27Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence..  Clinical information: The patient was reporting about COVID treatment. The patient did not receive other medication within 2 weeks. Patient administered Paxlovid started on 16Aug2022 and stopped on 20Aug2022 for Covid-19 treatment. Patient reported that he took Paxlovid and it helped right away and was tested negative, according to a home test kit, 7 days after starting the meds. But now, 6 days after completing the Paxlovid meds, patient was tested positive for COVID again on 27Aug. it was unknown that patient was recovered. No treatment was reported for AE and there were no known allergies.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: FC3184) 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: "Hypertension" (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 drug ineffective, covid-19.  Clinical course: Patient was given anti-viral Paxlovid 25Aug2022 to 28Aug2022 for treatment of COVID-19 (Lot numbe GE0257). No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN-6207) and on 02Apr2021 as dose 2, single (Lot number: ER-8734) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Dec2021 as dose 3 (booster), single (Lot number: 030H216) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "Known allergies: Only narcotics" (unspecified if ongoing), notes: Known allergies: Only narcotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received COVID 19 Treatment with Paxlovid, started on 11Aug2022.