chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Throat irritation
Clinical narrative: swollen left hand; itchy throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 at 15:45 as dose 1, single (Lot number: fj4989) at the age of 22 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: Other medical history: depression. Concomitant medication(s) included: WELLBUTRIN. Past drug history included: Novocain, reaction(s): "Known allergies: Novocain", notes: Known allergies: Novocain.  The following information was reported: THROAT IRRITATION (non-serious) with onset 27Apr2022 at 15:45, outcome "recovering", described as "itchy throat"; PERIPHERAL SWELLING (non-serious) with onset 27Apr2022 at 15:45, outcome "recovering", described as "swollen left hand". Therapeutic measures were taken as a result of peripheral swelling, throat irritation.
Sex: F
Vaccine: PNC13, PPV, PNC13, PPV
Symptoms: Chest X-ray abnormal, Drug ineffective, Pneumonia
Clinical narrative: developed pneumonia twice; developed pneumonia twice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal polysaccharide vaccine, 23-valent (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing), notes: It is not related (She does have a history of Colitis, but that is not related). The patient's concomitant medications were not reported. She has no history of these vaccines. She has never had pneumonia before.  The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "developed pneumonia twice". The patient underwent the following laboratory tests and procedures: Chest X-ray: Pneumonia.  Clinical course: The patient received both Prevnar-13 and PPPSV23 in 2015 and 2016. She developed pneumonia twice this year. She wanted to know if it would be recommended that she get the PCV-20 and also questioned if it would it be harmful to receive Prevnar-20 after having the PCV-13 and the PPSV23. She had no history of these vaccines. She has never had pneumonia before. She can't remember if she got Pneumonia the first time in Jan or Feb2022 or in Nov2021, but then a few months after she got it again. She got it twice in a few months. She went to urgent care, and they did an x-ray to find out.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC13, PPV, PNC13, PPV
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: developed pneumonia twice; developed pneumonia twice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal polysaccharide vaccine, 23-valent (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing), notes: It is not related (She does have a history of Colitis, but that is not related). The patient's concomitant medications were not reported. She has no history of these vaccines. She has never had pneumonia before.  The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "developed pneumonia twice". The patient underwent the following laboratory tests and procedures: Chest X-ray: Pneumonia.  Clinical course: The patient received both Prevnar-13 and PPPSV23 in 2015 and 2016. She developed pneumonia twice this year. She wanted to know if it would be recommended that she get the PCV-20 and also questioned if it would it be harmful to receive Prevnar-20 after having the PCV-13 and the PPSV23. She had no history of these vaccines. She has never had pneumonia before. She can't remember if she got Pneumonia the first time in Jan or Feb2022 or in Nov2021, but then a few months after she got it again. She got it twice in a few months. She went to urgent care, and they did an x-ray to find out.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac function test, Drug ineffective, Palpitations, Rheumatoid arthritis, Suspected COVID-19
Clinical narrative: Rheumatoid arthritis flaring up; Possible COVID; COVID; Heart Palpitations; MARKETING PROGRAM NAME NOT AVALIBLE  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-163-4369758-00 (Company).  A 66-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1155990) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flaring up"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Possible COVID"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart Palpitations". The patient underwent the following laboratory tests and procedures: Cardiac function test: Unknown results. The action taken for adalimumab was dosage not changed.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab):The reporter's causality for the event (s) of heart palpitations and rheumatoid arthritis started flaring up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of possible COVID was not provided.Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) :The reporter's causality for the event (s) of heart palpitations and rheumatoid arthritis started flaring up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of possible COVID was Possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of 9 LOE ,    palpitations ,rheumatoid arthritis flare up  cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Off label use, Product use issue
Clinical narrative: I had a recurrence of covid symptoms and positive test results five days after completing paxlovid therapy; I had a recurrence of covid symptoms and positive test results five days after completing paxlovid therapy; Moderna full dose/Moderna booster dose; Moderna full dose/Moderna booster dose; 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 male patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 08Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN, start date: 01Dec2020, stop date: 27Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had a recurrence of covid symptoms and positive test results five days after completing paxlovid therapy"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Moderna full dose/Moderna booster dose".  Adverse event: I had a recurrence of Covid symptoms and positive test results five days after Completing paxlovid therapy and ten days after my first covid symptoms had resolved.  Follow-up (28Apr2022): This is a follow-up report from product quality group providing investigation results. This report included that:  Additional Information: This is a notification generated from the system. New/updated information pertaining to an AE was reported to PQC. You are receiving this notification because you have been identified as a Recipient for this record. A brief summary of this Agency/ Complaint Contact is listed below: Pfizer Receipt Date (PRD): 28Apr2022 Responsible Person: (name withheld) AE Reference Number: 202200633715; 202200635294 Status: Initial Processing Please use the following link to log into the system and view the full details of this Agency/ Complaint Contact:   Reporter Information: Is Reporter Anonymous? No Please use the following link to log into the system and view the full details of the Reporter:  Addit'l Information: 28Apr2022 02:17 PM (GMT-4:00) added by Agent: Duplicate received, attached supporting document. Added AER#  Product Description: Paxlovid co-package tablets 100 mg 5 blister cards EA with 4 x pf07321332 + 2 x RTV Product Description: compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinus disorder, Vaccination failure
Clinical narrative: Retested positive for Covid on 25Apr2022 after experiencing sinus symptoms; Retested positive for Covid on 25Apr2022 after experiencing sinus symptoms; sinus symptoms; 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203), in right arm, on 22Mar2021 as dose 2, single (Lot number: ER8727), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "recovering" and all described as "Retested positive for Covid on 25Apr2022 after experiencing sinus symptoms"; SINUS DISORDER (medically significant) with onset 25Apr2022, outcome "recovering", described as "sinus symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Had a rebound effect of Covid symptoms 9-10 days after finishing the Paxlovid and texting negative; (25Apr2022) positive, notes: Retested positive for Covid on 25Apr2022 after experiencing sinus symptoms. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of sinus disorder.  Clinical course: Serious: No Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid rebound; covid rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 at 11:00 as dose 3 [booster], single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lung infections/inflammation" (unspecified if ongoing), notes: Frequent (multiple times per year) lung infections/inflammation for ~2 decades. The patient's concomitant medications were not reported. Past drug history included: None, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccination (Primary immunization series complete, manufacturer unknown.), for Covid-19 immunization.  The following information was reported: COVID-19 (medically significant) with onset 15Apr2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 15Apr2022, outcome "unknown" and all described as "covid rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (14Apr2022) Negative; (15Apr2022) positive, notes: strong positive antigen test. Therapeutic measures were taken as a result of covid-19.  Clinical course: covid rebound. The patient reported that on 14Apr2022 he had a negative antigen test. On 15Apr2022 he had a strong positive antigen test and became symptomatic with moderate nasal congestion, chest congestion, fatigue, and the beginning of fluid in lungs. Symptoms worsened rapidly over the course of the day. He started taking paxlovid that day and took the full course of medication. By the next day, symptoms stabilized and the following he was much improved. The only initial side effect was a strong bad/metallic taste. After finishing the full course, he still had a weak positive band by antigen test on Day 5. On day 7, he tested negative and again 2 days later he tested negative, with all symptoms resolved. On day 10, he returned to work. On day 12 (yesterday) he began to feel unwell again, with severe nasal congestion and mild chest congestion, GI symptoms, and fatigue. Last night, he took another antigen test and it was very strongly positive, higher even than the first time around. The patient received Anti-viral therapy for COVID 19. Treatment start date was on 15Apr2022 and treatment stop date on 19Apr2022.  This is a follow-up spontaneous report from a Product Quality Group providing investigation results: Updated information included: Product note 'Batch and lot tested and found within specifications' checked. This is a notification generated from the system. New/updated information pertaining to an AE was reported to PQC.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: Em9810), in left arm, on 08Mar2021 as dose 2, single (Lot number: En6202), in left arm and on 18Aug2021 as dose 3 (booster), single (Lot number: Ew0181) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Feb2022 as dose 4 (booster), single (Lot number: Dd7j21-2a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive; (Apr2022) Negative; (Apr2022) Positive, notes: retested positive in a rapid test again (day 14).Therapeutic measures were taken as a result of covid-19 with Anti-viral. Details of the treatment are as followed. Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 10Apr2022, Treatment stop date: 15Apr2022, Indication: Treatment of COVID-19.  Clinical course: Adverse event: Patient is also on Humira, got covid and started Pax and delayed my Humira until symptoms subsided. Patient took the Humira on day 4 of Pax, finished Pax, She felt a lot better, my tests went to negative. I continued to feel tired, though. But then she developed cold like symptoms and retested positive in a rapid test again (day 14). Adverse event country: Adverse event start date: 21Apr2022.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "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), all with latency 11 days after the suspect product(s) administration, 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Lot number: Ew0181) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Feb2022 as dose 4 (booster), single (Lot number: Dd7j21-2a), in left arm. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Past drug history included: Known allergy: cipro, reaction(s): "Allergy"; Known allergy: flagyl, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Manufacture by- Pfizer, Vaccine lot number- Em9810, Vaccine dose number- 1, Vaccine location- Left arm), administration date: 15Feb2021, when the patient was 37-year-old, for COVID-19 immunization, reaction(s): "Drug ineffective", "covid-19"; BNT162b2 (Manufacture by- Pfizer, Vaccine lot number- En6202, Vaccine dose number- 2, Vaccine location- Left arm), administration date: 08Mar2021, when the patient was 37-year-old, for Covid-19 immunization, reaction(s): "covid-19", "covid-19"; BNT162b2 (Manufacture by- Pfizer, Vaccine lot number- En6202, Vaccine dose number- 2, Vaccine location- Left arm), administration date: 08Mar2021, when the patient was 37-year-old, for Covid-19 Immunization, reaction(s): "Drug ineffective". The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "tired". Additional information: Patient also on Humira. got covid and started Pax and delayed Humira until symptoms subsided. took the Humira on day 4 of Pax.  finished Pax,  felt a lot better,  tests went to negative. continued to feel tired, though. But then I developed cold like symptoms and retested positive in a rapid test again (day 14). .
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FT5407) at the age of 48 years, in right arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, 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: "Mitralvalve Prolapse" (unspecified if ongoing); "Mitralvalve Regurgitation" (unspecified if ongoing); "First Degree Heart Block" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: 03Jan2022, stop date: 20Apr2022; DAYQUIL, start date: 18Apr2022, stop date: 20Apr2022; SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 18Apr2022, stop date: 20Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: The patient had chest pain and upper abdominal pain started within 30 minutes of first dose. Still happening 9 hours later. Nasty taste in her mouth. She had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: product COVID 19 Treatment, brand Paxlovid , indication Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient has no reported allergies. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included with in two weeks LOSARTAN; MONTELUKAST; DYMISTA. The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", described as "product COVID 19 Treatment, brand Paxlovid , indication Treatment of COVID-19"; COVID-19 (medically significant) with onset Apr2022, outcome "unknown", described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: after a positive diagnosis via PCR. Therapeutic measures were taken as a result of covid-19. Clinical course: : I took Paxlovid after a positive diagnosis via PCR. By day 5 of the prescription I had a very faint line on the antigen test and was feeling fine. It has been a I took Paxlovid after a positive diagnosis via PCR. By day 5 of the prescription I had a very faint line on the antigen test and was feeling fine. It has been a week since I finished the Paxlovid and today is day 11 since I first tested positive. My congestion is back and other symptoms, and the line on the antigen test is dark again. (I recognize the antigen test wasn't intended to measure viral load but it's hard not to notice the difference).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: developing COVID symptoms; developing COVID symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 33026BD) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Feb2017, stop date: 13Apr2022; ESCITALOPRAM, start date: 30Apr2020.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Apr2022, outcome "unknown" and all described as "developing COVID symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: rapid at-home test, which was positive again. I still have symptoms 4 days later, and continue to test positive; (14Apr2022) Positive; (19Apr2022) Negative, notes: at-home rapid test; (20Apr2022) Positive; (23Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had no known allergies. Patient had received other medications within two weeks. Adverse event- Started taking Paxlovid after developing COVID symptoms of a scratchy throat and cough, and after testing positive. Took the pills as prescribed twice a day, for the full five days of the course. Felt better within 3 days of taking Paxlovid, and tested negative on an at-home rapid test on days 5 and 6 after first testing positive and starting Paxlovid. 4 days later (day 9 after testing positive and starting Paxlovid), patient started developing a sore throat, cough, and congestion again, and took another rapid at home test, which was positive again. Patient still have symptoms 4 days later, and continue to test positive.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Relapse of covid after taking paxlovid. I tested positive for covid on 12Apr.; Relapse of covid after taking paxlovid. I tested positive for covid on 12Apr.; 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 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: None. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "Relapse of covid after taking paxlovid. I tested positive for covid on 12Apr.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient did not received Other medication in 2 weeks. Treatment start date: 13Apr2022 Treatment stop date: 18Apr2022. Relapse of covid after taking paxlovid. Patient tested positive for covid on 12Apr. (Name) taking Paxlovid on 13Apr and took full five day course. Tested positive for covid on 17Apr and the negative on 18Apr. Felt fine except for vague lingering congestion from 18Apr-27Apr. On the morning of 27Apr tested positive for covid and evening of 27Apr covid symptoms returned.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "non hodgkins lymphoma follicular" (unspecified if ongoing), notes: non hodgkins lymphoma follicular. The patient had no Known allergies. Concomitant medication(s)/Other medication in 2 weeks included: LEVOTHYROXINE, start date: 12Jul2006, stop date: 27Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: rebound COVID-19 infection 4 days after testing negative; Positive, notes: rebound COVID-19 infection 4 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Antiviral details-[{Product- COVID 19 Treatment, Brand- Paxlovid, Treatment start date- 14Apr2022, Treatment stop date- 19Apr2022, Indication-Treatment of COVID-19}]. Covid vaccine details: [{Vaccine brand -Pfizer / BioNTech, Vaccine brand unknown- False, Vaccine administration date- Aug2021, Vaccine lot unknown- True, Vaccine lot unknown reason- Not available/provided to reporter at the time of report completion, Vaccine dose number- 3, Vaccine dose number unknown- False, Vaccine location- Left arm}, {Vaccine brand -Pfizer / BioNTech, Vaccine brand unknown- False, Vaccine administration date- Feb2021, Vaccine lot unknown- True, Vaccine lot unknown reason- Not available/provided to reporter at the time of report completion, Vaccine dose number- 2, Vaccine dose number unknown- False, Vaccine location- Left arm}, {Vaccine brand - Pfizer / BioNTech, Vaccine brand unknown- False, Vaccine administration date- 26Dec2020, Vaccine lot unknown- True, Vaccine lot unknown reason- Not available/provided to reporter at the time of report completion, Vaccine dose number- 1, Vaccine dose number unknown- False, Vaccine location- Left arm}]. Adverse event- rebound COVID-19 infection 4 days after testing negative  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "Hypothyroid" (unspecified if ongoing); "Known allergies: Coconut" (unspecified if ongoing). Concomitant medication(s) included: JUNEL; LEVOTHYROXINE. Past drug history included: Sulfa, reaction(s): "Known allergies: Sulfa". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Apr2022, outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Got better, tested negative; (25Apr2022) Positive, notes: about 8 days after start of treatment got significantly worse and testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient started Paxlovid on 16Apr2022 and treatment stopped on 20Apr2022 for the treatment of Covid-19. Other medication in 2weeks Junelle and Levoxy. Got better, tested negative, about 8 days after start of treatment got significantly worse and testing positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: Ff2593) at the age of 42 years, in left 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 24Apr2022, outcome "not recovered" and all described as "Covid-19". Adverse event: I started taking Paxlovid on day 0 of my infection and had no symptoms by Day 2. I started testing negative for Covid on days 6 and 8 of my infection. I stopped taking Paxlovid on day 5. On the evening of day 8, I had a sore throat and on day 9 worsening cold symptoms and a positive at-home Covid test. My family stopped masking and isolating due to the negative test on day 6 but 2 members of my family tested positive on my day 11 and I can only assume it was because I was contagious on days 8-11. Ae resulted in: [None of the above]. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 16Apr2022, Treatment stop date: 21Apr2022, Indication: Treatment of COVID-19. Other medication in 2weeks: No. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive, notes: I started taking Paxlovid on day 0 of my infection; (22Apr2022) Negative, notes: I started testing negative for Covid on days 6 and 8 of my infection; (24Apr2022) Positive, notes: positive at-home Covid test; (24Apr2022) Negative, notes: I started testing negative for Covid on days 6 and 8 of my infection. Therapeutic measures were not taken as a result of covid-19. Covid vaccine details: vaccine brand: Pfizer / BioNTech, Vaccine brand unknown: False.   No follow-up attempts are possible. No further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid-19; tested positive for covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthmatic" (unspecified if ongoing); "Upper respiratory infection" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient did not have medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 17Apr2022, outcome "not recovered" and all described as "tested positive for covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: I tested positive for covid-19 on 17Apr22; (24Apr2022) Negative, notes: tested negative with a home test 24Apr- 26Apr; (26Apr2022) Negative, notes: tested negative with a home test 24Apr- 26Apr; (27Apr2022) Positive, notes: It is now 27Apr and my Home test is fully positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Anti viral details; product: COVID 19 Treatment, Brand Paxlovid, Treatment start date was 18Apr2022, Treatment stop date was 23Apr2022, Lot number was Not sure, Indication was Treatment of COVID-19. The patient tested positive for covid-19 on 17Apr22 and began the Paxlovid course the night of 18Apr as she was prone to asthma with respiratory illness. Felt symptoms progressing and tested negative with a home test 24Apr- 26Apr. 26Apr she developed a cough and more congestion which got progressively worse overnight. It was now 27Apr and her Home test was fully positive. Keep reading about rebound cases like her so figured she would share the data. Adverse event start date: 26Apr2022. Patient was not recovered. Ae treatment given was Antibiotics for secondary bacterial Infection.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid with a PCR test; Tested positive for Covid with a PCR test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus sle" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (unknown series of vaccination  (Manufacture unknown)), for Covid-19 Immunization. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 21Apr2022, outcome "recovering" and all described as "Tested positive for Covid with a PCR test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Apr2022) positive; (unspecified date) Negative, notes: antigen test; (unspecified date) positive, notes: antigen test. Therapeutic measures were taken as a result of sars-cov-2 test positive. Therapeutic measures were not taken as a result of drug ineffective.  Clinical Course: Clinical course: No other medication in 2weeks Anti viral details product COVID 19 treatment, brand Paxlovid, treatment start date 05Apr2022,treatment stop date 09Apr2022,indication, treatment of COVID-19. Adverse event Tested positive for Covid with a PCR test on 04Apr2022. After taking paxlovid, she felt better and tested negative on antigen test. 21 days later symptoms returned, and she then tested positive on an antigen test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years 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: "Idiopathic Intercranial Hypertension" (unspecified if ongoing); "Factor V Leiden mutation" (unspecified if ongoing), notes: other medical history: Factor 5 Leiden. Known allergies: No. Other medication in 2weeks product concomitant medication(s) included: VIT D [COLECALCIFEROL]; CETRIZINE; FLONASE ALLERGY RELIEF. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 20Apr2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: Test: (Apr2022) high viral load; SARS-CoV-2 test: (12Apr2022) Negative, notes: Tested negative, 12Apr & 16Apr on at home test; (Apr2022) Positive, notes: Symptoms started back up 20Apr2022 and then tested positive on at home test; (16Apr2022) Negative, notes: Tested negative. April 12Apr & 16Apr on at home test. Therapeutic measures were taken as a result of covid-19. It was reported that, Anti viral details: product=COVID-19 Treatment, Brand= Paxlovid, Treatment start date=06Apr2022,, Treatment stop date=11Apr2022, Indication=Treatment of COVID-19. Patient Had a reinfection 8 days after ending treatment of Paxlovid. Tested negative 12Apr & 16Apr on at home test. Symptoms started back up 20Apr and then tested positive on at home test. Local Hospital did a test and found high viral load, said more than likely was infected. Adverse event start date: 20Apr2022. Patient recovered: Recovered. Treatment ae: No. 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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested COVID positive 05Apr2022; Tested COVID positive 05Apr2022; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 at 15:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 at 15:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Mild depression" (unspecified if ongoing); "OA" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing); "Known allergies: Thimerasol" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM, start date: Mar2019; OXYBUTYNIN, start date: Nov2021; SERTRALINE HCL, start date: Jan2012; LOSARTAN/HCTZ, start date: Jan2015; ALBUTEROL SULFATE HFA, start date: Jan2015; FLOVENT HFA, start date: Jan2015. Past drug history included: Lotensin, reaction(s): "Known allergies: Lotensin"; Protonix, reaction(s): "Known allergies: Protonix". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Apr2022, outcome "unknown" and all described as "Tested COVID positive 05Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2022) Positive; (09Apr2022) Negative, notes: cold-like symptoms mostly gone; (15Apr2022) Positive. Therapeutic measures were taken as a result of covid-19. The patient received other medication in 2 weeks were Montelukast sod., Oxybutynin, Sertraline HCL, Losartan/ HCTZ, Albuterol Sulfate HFA and Flovent HFA. Tested COVID positive 05Apr2022, took Paxlovid x 5 days, tested negative 09Apr2022, with cold-like symptoms mostly gone. Her symptoms rebounded 15Apr2022 and she tested positive again 15Apr2022, this time with much worse symptoms: cough, wheezing, sore throat, stuffy nose, plugged up ears, left enlarged lymph node under chin, lethargy, hoarseness, Shortness of breath and laryngitis. MD prescribed 5 day course of Prednisone 40mg/day and 2 Tessalon perles 3 x day, As of 27Apr2022 she was still coughing and have sinus drainage, mild tiredness and hoarse voice. Treatment start date was 05Apr2022 and Treatment stop date was 10Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, Covid 19 and the suspect product BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb mass, Nausea, Pain
Clinical narrative: very bad headache; body aches; lump under left arm; Nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 11:30 as dose 4 (booster), single (Lot number: FL3197) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing). Concomitant medication(s) included: VIT C. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 (BOOSTER), Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 26Apr2022 at 18:00, outcome "recovering", described as "Nauseous"; PAIN (non-serious) with onset 26Apr2022 at 18:00, outcome "recovering", described as "body aches"; LIMB MASS (non-serious) with onset 26Apr2022 at 18:00, outcome "recovering", described as "lump under left arm"; HEADACHE (non-serious) with onset 26Apr2022 at 18:00, outcome "recovering", described as "very bad headache". Therapeutic measures were not taken as a result of headache, pain, limb mass, nausea.  No follow-up attempts are needed. No further information is expected.