chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 18Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 03Dec2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Apr2022, outcome "not recovered" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I did a home test and it was a strong positive; (unspecified date) Positive, notes: I had a PCR on 31Apr2022 that confirmed positive; (18Apr2022) Positive, notes: tested positive for Covid on 18Apr which was confirmed with a PCR test; (24Apr2022) Negative, notes: I did a rapid test and was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient tested positive for Covid on 18Apr which was confirmed with a PCR test. She started Paxlovid the evening of 19Apr2022 till 24May2022 for the treatment of COVID-19. Started feeling better within a day. Cough was gone, still very fatigued. Followed CDC guidelines. On 24Apr she did a rapid test and was negative. Still fatigued but no other symptoms. On 28Apr2022, she woke up with extreme nasal congestion, watering eyes, sneezing, and slight headache. She did a home test and it was a strong positive. She had a PCR on 31Apr2022 that confirmed positive. Patient did not have other medical history. She did not know that she had known allergy. Patient received Zyertec medication in 2weeks and Prednisone from 12May2022 to 16May2022.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 28Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Seasonal allergies" (unspecified if ongoing), notes: Known allergies: Seasonal allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Felt better from Covid symptoms; Felt better from Covid symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL1284), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL1284), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood presurre" (unspecified if ongoing), notes: High blood pressure only mostly due to anxiety; "Anxiety" (unspecified if ongoing), notes: High blood pressure only mostly due to anxiety; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: TERAZOSIN, start date: 01Apr2021; LOSARTAN, start date: 04Dec2018; CARVEDILOL, start date: 01Mar2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Felt better from Covid symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient had taken Paxlovid (anti viral) for COVID 19 Treatment from 19May2022 to 23May2022. Felt better from Covid symptoms (headache, cough, runny nose, fatigue) after taking Paxlovid. On 3rd day after taking drug symptoms came back. Lost taste and Smell a few days later although have returned. Runny nose, cough stopped after 3 days, mild sinus headache on and off and scratchy throat now never had fever. There were other medications in 2 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 11Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL oral, start date: 03Jan2022; EFFEXOR oral, start date: 01Jan2019. 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: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Adverse event experienced with a very strong metallic taste in his mouth a few hours after the first dose on 01Jun2022. All food consumed had a metallic taste. Patient took other medication in 2 weeks. Treatment using Paxlovid start date was 01Jun2022, lot number, FY9918, oral for treatment of COVID-19.He experienced significant muscle spasm in mid-lower, right-hand side of back while seated and drinking coffee about 24 hours after starting treatment. The painful muscle spasm was reported as continued in lower back at the time of reporting. He contacted doctor's office and was instructed to stop taking Paxlovid treatment. However, he had continued to take the medication. At the time of reporting, had completed doses for 01Jun2022 and 02Jun2022. Adverse events start date was 01Jun2022, start time: 03:00 PM, patient was not recovered without any treatment, and had no Known allergies. other medication in 2weeks product included Fiber supplement.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Upper respiratory tract infection, Vaccination failure
Clinical narrative: Reoccurrence of upper respiratory; positive antigen test; positive antigen test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 17May2022, stop date: 20May2022; MUCINEX, start date: 18May2022, stop date: 19May2022; NYQUIL, start date: 18May2022, stop date: 20May2022; ZINC, start date: 17May2022, stop date: 22May2022; VITAMIN C [ASCORBIC ACID], start date: 17May2022, stop date: 22May2022; VITAMIN B12 [MECOBALAMIN], start date: 17May2022, stop date: 22May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "not recovered" and all described as "positive antigen test"; UPPER RESPIRATORY TRACT INFECTION (medically significant), outcome "not recovered", described as "Reoccurrence of upper respiratory". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive; (26May2022) Negative; (02Jun2022) Positive; (17May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, upper respiratory tract infection.  Clinical course : Reoccurrence of upper respiratory symptoms and positive antigen test on day 16 (02Jun2022) after initial symptoms and positive pcr and antigen test taken on 17May2022 (started paxlovid). Had made full recovery (no symptoms) and negative antigen test on day 9 (26May2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, 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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 41 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: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: CLARITINE, start date: 01Feb2022, stop date: 02Jun2022. 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: (23May2022) Negative; (24May2022) Positive; (25May2022) Negative; (26May2022) Positive; (27May2022) Negative; (28May2022) Positive; (02Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 18May2022 to 22May2022.  Clinical course: Patient received vaccines and other medication in two weeks also had no known allergies. Adverse event: Rebound of Covid symptoms & strong positive on rapid antigen test on 28May2022 (day 12 after symptoms started & day 6 after completing course of paxlovid). Tested negative on 23May, faintly positive again on 24May, negative again on 25May, positive 26May, negative 27May & morning of 28May. I've continued to test positive through 02Jun & symptoms have worsened from mild allergy symptoms on 28May (itchy throat) to mild flu symptoms on 02Jun (sore throat, chills, headache, malaise).  Follow up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
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 66-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 at 12:00 as dose number unknown, single (Lot number: Wl9264), in left arm, on 09Mar2021 at 12:00 as dose number unknown, single (Lot number: En6203), in left arm and on 16Sep2021 at 11:00 as dose number unknown, single (Lot number: Fe3592) at the age of 65 years, in left arm for covid-19 immunisation; rosuvastatin (ROSUVASTATIN), from 01Jan2020 (Batch/Lot number: unknown) to 23May2022. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive, notes: tested positive 23May; (28May2022) Negative; (30May2022) Negative; (02Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication Rosuvastatin in two weeks of vaccination. The patient got Covid on 21May2022, tested positive 23May2022, started paxlovid 23May2022. Took 5-day course of paxlovid. Covid gone in 5 days. Tested negative on 28May2022 and 30May2022. Started getting symptoms and tested positive 02Jun2022. Sounds like paxlovid rebound. The patient had no other medical history and no known allergies.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: PR8734) at the age of 60 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE1, Lot number: EP6955, Vaccine expiry date: Unknown), administration date: 12Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "When caller received the other 3 doses, caller just had a sore arm.". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "When caller received the other 3 doses, caller just had a sore arm.".
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 61 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number: 1, Batch/lot number: EP6955, Vaccine expiry date: unknown), administration date: 12Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "When caller received the other 3 doses, caller just had a sore arm"; BNT162b2 (Dose number: 2, Batch/lot number: PR8734, Vaccine expiry date: unknown), administration date: 02Apr2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "When caller received the other 3 doses, caller just had a sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "When caller received the other 3 doses, caller just had a sore arm.".
Age: 66.0
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). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 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. Concomitant medication(s) included: ATORVASTATIN; TADALAFIL. 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) Unknown results, notes: COVID 19 Treatment; (2022) Negative, notes: I had previously tested "negative" upon completion of the Paxlovid 5-day course; (03Jun2022) Positive, notes: I also tested "positive" with an at-home rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Treatment drug included Paxlovid from 25May2022 to 29May2022. Five days after completion of Paxlovid treatment, patient again experiencing sympoms (sniffles, chill, body aches, sneezing). He also tested "positive" with an at-home rapid test. He had previously tested "negative" upon completion of the Paxlovid 5-day course. Patient had no Known allergies.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 15Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 20Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years, in left arm for covid-19 immunisation. Patient had no Known allergies. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 21May2022, stop date: 22May2022; TUSSIN DM, start date: 22May2022, stop date: 23May2022. 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: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course :Treatment start date: 21May2022. Treatment stop date: 26May2022.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Severe acute respiratory syndrome, 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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "recovered" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2022) Positive, notes: covid test type post vaccination=Nasal Swab, covid test name post vaccination=On/Go. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient was not taken any other vaccine in four weeks and other medications in two weeks.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a 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 21Nov2021 as dose number unknown, single (Lot number: FH8030) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polycystic ovarian syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 13 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) COVID symptoms again on 02Jun2022, notes: COVID symptoms again on 02Jun2022, namely chills, nausea and dizziness. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received vaccine. The patient did not receive other medication in 2weeks. Anti-viral details: The patient received Paxlovid for COVID 19 Treatment, treatment start date was 20May2022 and stop date was 24May2022. Adverse event: The patient completed Paxlovid course on 24May2022 and began experiencing COVID symptoms again on 02Jun2022, namely chills, nausea and dizziness. Adverse event start date was 02Jun2022. The patient had not recovered. The patient did not receive ae treatment and had no Known allergies.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Tingling of feet then hands and chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 18Sep2021 as dose 1, single (Lot number: FE3592) at the age of 38 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: DICLOFENAC; OMEPRAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: PARAESTHESIA (disability) with onset 24Sep2021, outcome "not recovered", described as "Tingling of feet then hands and chest". The events "tingling of feet then hands and chest" required physician office visit. The patient underwent the following laboratory tests and procedures: Test: (29Dec2021) diagnosed with Multiple sclerosis; SARS-CoV-2 test: (unspecified date) Negative, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of paraesthesia. Clinical course: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks: Diclofenac, omeprazole, Zyrtec, pine bark extract. Started with tingling of feet then hands and chest. Soon the chest and feet stopped tingling but the hands never did. Had multiple tests ran and was diagnosed with Multiple sclerosis on 29Dec2021. Adverse event treatment: Kesimpta. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EL 3302), in left arm, on 06Apr2021 as dose 2, single (Lot number: EN 6201), in left arm and on 06Nov2021 as dose 3 (booster), single (Lot number:  PH8020) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient previously received a COVID-19 vaccine. The patient did not received any treatment.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
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 a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 11Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: EV0191), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "S/P Breast CA with rads tx and Tamoxifen" (unspecified if ongoing), notes: S/P Breast CA with rads tx and Tamoxifen; "IBM" (unspecified if ongoing); "Hashimoto's Thyroiditis" (unspecified if ongoing); "S/P Breast CA with rads tx and Tamoxifen" (unspecified if ongoing), notes: S/P Breast CA with rads tx and Tamoxifen. Concomitant medication(s) included: TAMOXIFEN taken for breast cancer female; LEVOTHYROXINE; MOXIFLOXACIN. Past drug history included: Reflex, reaction(s): "known allergies: reflex", notes: known allergies: reflex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow up attempts are needed. No Further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "heart attack 10 years ago" (unspecified if ongoing), notes: heart attack 10 years ago. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment start date: 20May2022, treatment stop date: 24May2022, indication: Treatment of COVID-19. Adverse event: It was reported that 5 days post completion of treatment patient developed a bad cough that he didn't had before and he was tested a strong positive for covid. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date : 03Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: El9269), in right arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 24Sep2021 as dose 3 (booster), single (Lot number: 30145ba), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient started Paxlovid (Lot: Fy8914) on 25May2022 and stopped on 27May2022 for the treatment of COVID-19. The Patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.  The information o on n 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: The daughter tested positive last 28May for the COVID-19 Virus; The daughter tested positive last 28May for the COVID-19 Virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "unknown" and all described as "The daughter tested positive last 28May for the COVID-19 Virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Positive.   Clinical course: Reporter stated that she scheduled an appointment for the 2nd booster shot on 04Jun for her daughter and mentioned that the daughter tested positive last 28May for the COVID-19 Virus. Reporter is asking if that matters or does the daughter need to be held in the quarantine facility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 47-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 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 and concomitant medications were not reported. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was taking covid-19 treatment from 01Jun2022 to 04Ju2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dyskinesia, Streptobacillus test positive, Streptococcus test
Clinical narrative: involuntary muscle movement; positive strep culture; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  An 8-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DYSKINESIA (non-serious), outcome "unknown", described as "involuntary muscle movement"; STREPTOBACILLUS TEST POSITIVE (non-serious), outcome "unknown", described as "positive strep culture". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyskinesia.  Additional information: These muscular issues required physical therapy. Clinician shared that child had a positive strep culture around the same time that muscle movements occurred.  The information on the batch/lot number for BNT162b2 was requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pyrexia, 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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 55 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Penicillin allergy" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; LISINOPRIL; HCTZ; LIPITOR; ADVIL [IBUPROFEN]; TYLENOL. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: 320308D, Location of injection: Arm Right), administration date: 19Oct2021, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 24Feb2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 04Feb2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious), PYREXIA (non-serious), HEADACHE (non-serious), DIARRHOEA (non-serious) all with onset 14May2022 at 19:00, outcome "recovered" (2022) and all described as "Severe body aches, mild fever, headache, diarrhea starting ~12 hours after vaccine and lasting several days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, pyrexia, headache, diarrhea. Additional information: It was reported the patient did not receive other vaccine within four weeks. The patient took Metoprolol, Lisinopril, HCTZ, Lipitor, Advil, Tylenol in two weeks. Adverse events included severe body aches, mild fever, headache, diarrhea starting 12 hours after vaccine and lasted for several days. The patient did not receive any treatment for the events. No covid prior vaccination. Covid tested negative post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 10:00 as dose 1, single (Lot number: EL1284), in right arm, on 10Feb2021 at 10:00 as dose 2, single (Lot number: EL1284), in right arm and on 28Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 41 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative for COVID on two at home antigen tests; (unspecified date) Negative, notes: tested negative for COVID on two at home antigen tests; (Jun2022) Positive, notes: My worsening symptoms corresponded to a positive at home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Experienced a rebound of symptoms on day six after completing the treatment. I had previously tested negative for COVID on two at home antigen tests. My worsening symptoms corresponded to a positive at home antigen test. None of the known allergies reported. Other medication in 2 weeks were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: diagnosed with Covid after receiving primary series and booster; diagnosed with Covid after receiving primary series and booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 53-year-old female patient received BNT162b2 (COMIRNATY), 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 immunization. The patient had no relevant medical history, reported as no underlying medical conditions. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid after receiving primary series and booster". Clinical course was reported as, Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Relapse of Covid on day 9 after testing negative for several days. Mild symptoms, positive antigen test result.; Relapse of Covid on day 9 after testing negative for several days. Mild symptoms, positive antigen test result.; A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 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 included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "migraine" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: PREDNISONE, start date: May2022, stop date: May2022, taken in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022 at 07:00, outcome "recovering" and all described as "Relapse of Covid on day 9 after testing negative for several days. Mild symptoms, positive antigen test result.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive, notes: Relapse of Covid on day 9 after testing negative for several days. Mild symptoms, positive antigen test result; (2022) Negative, notes: negative for several days. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 24May2022 to 28May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: en5318), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 301485A), in left arm and on 01Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "I currently have Type 2 Diabetes" (ongoing); "High Blood Pressure" (ongoing); "Cholesteryl" (ongoing). Concomitant medication(s) included: ICOSAPENT ETHYL; QUINAPRIL; JANUMET XR; FARXIGA; OZEMPIC; ATORVASTATIN; NIACIN; ASPRIN; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Clinical course: Patient received other medication in 2 weeks. Patient received orally, Pfizer drug for COVID 19 Treatment started on 02Jun2022, Lot number: ga1189. Other concomitant medication in 2weeks includes : 50+ Women's vitamin, brand, daily.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Multiple sclerosis, SARS-CoV-2 test
Clinical narrative: Multiple sclerosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 2, single (Lot number: FF2590) at the age of 38 years, in left arm for covid-19 immunisation at Pharmacy or Drug Store. The patient's relevant medical history was not reported. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication(s) included: DICLOFENAC; OMEPRAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (Dose number=1, Lot number=FE3592, Vaccine location=Left arm), administration date: 18Sep2021, when the patient was 38-year-old, for COVID-19 Immunization, reaction(s): "Tingling of feet then hands and chest". The following information was reported: MULTIPLE SCLEROSIS (disability, medically significant) with onset 29Dec2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: multiple tests: (29Dec2021) Multiple sclerosis; SARS-CoV-2 test: (unspecified date) Negative. Patient was tested for Covid post the vaccination. Therapeutic measures were taken as a result of multiple sclerosis.  Clinical course: Adverse event started with tingling of feet then hands and chest. Soon the chest and feet stopped tingling but the hands never did. Had multiple tests ran and was diagnosed with Multiple sclerosis on 29Dec2021. Other medications in two weeks included pine bark extract.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vaccine_brand Pfizer / BioNTech/product COVID 19 Treatment; vaccine_brand Pfizer / BioNTech/product COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 at 10:15 as dose 1, single (Lot number: EN206), in left arm, on 21Mar2021 at 10:15 as dose 2, single (Lot number: ER8733), in left arm and on 29Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "eczema" (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 "vaccine_brand Pfizer / BioNTech/product COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I am testing extremely strongly positive on antigen tests again, for the third day in a row; positive, notes: I am testing extremely strongly positive on antigen tests again, for the third day in a row; positive, notes: I am testing extremely strongly positive on antigen tests again, for the third day in a row. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: known allergies :No. I'm experiencing a rebound of COVID symptoms that arose 3 days after finishing my Paxlovid series. Symptoms are more mild and cold like than the original COVID infection, which felt like the flu. I am testing extremely strongly positive on antigen tests again, for the third day in a row.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265), in left arm, on 18Feb2021 as dose 2, single (Lot number: EL9267), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "depression" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: known allergies Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received treatment with Paxlovid, treatment start date=31May2022, lot number=GA1189, indication=Treatment of COVID-19.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.