chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". 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: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral treatment start from Jul2022 to Jul2022. After having COVID for 6 days, patient took 5-day course of Paxlovid, patient was tested negative for 1 day, and then began testing positive again. Slightly different symptoms this second time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: ER8734), on 30Mar2021 as dose 2, single (Lot number: EN625), on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) and on 21May2022 as dose 4, (booster) single (Lot number: 7553) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sjogrens disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Past drug history included: Septra, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive and the next day started a 5 day course of Paxlovid; Negative, notes: I tested negative for four days; Positive, notes: tested positive Day 10 and Day 11; Positive, notes: tested positive Day 10 and Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient had taken other medication in 2 weeks. COVID 19 Treatment, Brand: Paxlovid, Treatment start date was reported as 12Jul2022, Treatment stop date was reported as 16Jul2022, Indication was reported as treatment of COVID-19. Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: En6198), in left arm, on 18Mar2021 as dose 2, single (Lot number: Er2613), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: E60187) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 01Oct2020, stop date: 24Jul2022; LATANOPROST, start date: 01Jun2021, stop date: 24Jul2022; OMEPRAZOLE, start date: 01Dec2021, stop date: 24Jul2022. Past drug history included: Oxicodone, reaction(s): "Known allergies: Oxicodone". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19 and vaccination failure.  Clinical information: Other medication in 2weeks included Simvastatin, Latanoprost and Omeprazole. Known allergies: Oxicodone and Other medical history: Cancer  No follow-up attempts are possible. No further information is expected.
Age: 41.0
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 42-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6202), in right arm, on 23Mar2021 as dose 2, single (Lot number: EP6955), in right arm and on 06Jan2022 as dose 3 (booster), single (Lot number: TL3197) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Nerve pain treatment" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: GABAPENTIN taken for neuralgia, start date: May2022. Past drug history included: Metformin, start date: Aug2016, for Diabetes Treatment, notes: medical history: Type 2 Diabetes; Glyburide, start date: Aug2016, for Diabetes Treatment, notes: medical history: Type 2 Diabetes. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I tested myself, and resulted Positive; (05Jul2022) positive, notes: On 05Jul2022, I tested positive for COVID; (16Jul2022) negative, notes: 3 days after finishing Paxlovid, I tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 07Jul2021 to 11Jul2021 for COVID 19 treatment. On 05Jul2022, patient tested positive for COVID. Received the Paxlovid medication on 08Jul, and immediately took the medicine for 5 days. 3 days after finishing Paxlovid, tested negative. However, as of that morning (22Jul2022), felt a light cough, runny nose and weakness. Tested myself and resulted Positive. Called the COVID nurse [address withheld], and the nurse described his condition as paxlovid covid rebound. He was told to quarantine for five more days without another Paxlovid prescription.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for COVID 13Jul2022; I tested positive for COVID 13Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: EN0170), in left arm and on 01Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hashimotos disease" (unspecified if ongoing), notes: Other medical history: hashimotos disease; "depression" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; MIRENA; CETIRIZINE. Past drug history included: Prednisone, reaction(s): "Known allergies", notes: Known allergies: prednisone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "not recovered" and all described as "I tested positive for COVID 13Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: I tested positive for COVID 13Jul2022; (18Jul2022) Negative, notes: I tested negative on 18Jul2022 and 19Jul2022; (19Jul2022) Negative, notes: I tested negative on 18Jul2022 and 19Jul2022; (23Jul2022) Positive, notes: Today (23Jul2022), I woke up with a sore throat and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had received other medication in 2 weeks. She had received Paxlovid treatment for COVID on 13Jul2022 and stop on 18Jul2022. She had Paxlovid rebound. She tested positive for COVID 13Jul2022, and took a full course of the medication. She tested negative on 18Jul2022 and 19Jul2022. Today (23Jul2022), she woke up with a sore throat and teste positive again.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 16:00 as dose 1, single (Lot number: EL9261), in left arm, on 09Feb2021 at 16:00 as dose 2, single (Lot number: EM9709), in left arm and on 12Oct2021 at 17:30 as dose 3 (booster), single (Lot number: FE1304) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Apr2022 at 16:00 as dose 4 (booster), single (Lot number: 065k21A), in left arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Brochiectasis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Chronic sinusitis" (unspecified if ongoing); "Cholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; SINGULAIR; VITAMIN D3; B-12; ATORVASTATIN; AZITHROMYCIN. Past drug history included: Levofloxacin for Allergy; Cefapime for Allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment from 11Jul2022 to 15Jul2022. Recurrence of COVID symptoms: congested sinuses, cough, headache, fatigue.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 60-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fNHL" (unspecified if ongoing). Concomitant medication(s) included: XARELTO, stop date: 15Jul2022 (Other medication in 2weeks product).  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid for COVID-19 treatment from 15Jul2022 to 20Jul2022.  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: 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. Concomitant medication(s) included: OTEZLA, start date: 06Sep2017, stop date: 24Jul2022.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive, notes: 3 days after finishing paxlovid; (unspecified date) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient received treatment of COVID-19 with Paxlovid from 08Jul2022 to 12Jul2022.  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: Blood pressure measurement, COVID-19, Computerised tomogram, Electrocardiogram, Fibrin D dimer
Clinical narrative: Still positive with a light line on 24Jul; Still positive with a light line on 24Jul; 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 11Oct2021 as dose 3 (booster), single (Lot number: 30135BA) 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: "High blood pressure" (ongoing); "Overweight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Still positive with a light line on 24Jul". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Unknown results; Computerised tomogram: (unspecified date) good; Electrocardiogram: (unspecified date) good; Fibrin D dimer: (unspecified date) elevated; SARS-CoV-2 test: (19Jul2022) Positive; (25Jul2022) Positive; X-ray: (unspecified date) good. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure, X-ray
Clinical narrative: Still positive with a light line on 24Jul; Still positive with a light line on 24Jul; 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 11Oct2021 as dose 3 (booster), single (Lot number: 30135BA) 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: "High blood pressure" (ongoing); "Overweight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Still positive with a light line on 24Jul". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Unknown results; Computerised tomogram: (unspecified date) good; Electrocardiogram: (unspecified date) good; Fibrin D dimer: (unspecified date) elevated; SARS-CoV-2 test: (19Jul2022) Positive; (25Jul2022) Positive; X-ray: (unspecified date) good. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. The patient did not receive other medication in two weeks. Vaccine administration date: 31Nov2021 (as reported). Vaccine administration time: 04:00 PM. Anti-viral details for COVID 19 treatment included Paxlovid (Treatment start date: 15Jul2022, Treatment stop date: 19Jul2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Started being symptomatic with Covid on 11Jul; Started being symptomatic with Covid on 11Jul; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing), notes: Other medical history: diabetes type 2. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "unknown" and all described as "Started being symptomatic with Covid on 11Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took other medication in 2weeks. Treatment received with Paxlovid from 12Jul2022 to 16Jul2022. Started being symptomatic with Covid on 11Jul. 12Jul woke up with fever of 101, deep painful cough, hoarse voice and congestion. Called to get Paxlovid and took 2 does that day. Improved substantially by Saturday, day 5. Day 10 after taking Paxlovid have redeveloped deep cough, congestion and fatigue and low grade fever. Also took toujeo insulen, start date was 04Jul2022, stop date was 24Jul2022. Patient also took Moderna covid-19 vaccine, start date was 08Sep2021, stop date was 08Sep2021 (Dose 3), Moderna covid-19 vaccine, start date: 11May2022, stop date: 11May2022 (Dose 2) and Moderna covid-19 vaccine, start date: 08Sep2021, stop date: 08Sep2021, for Covid-19 immunization on Arm left. Batch number was unknown for all doses (as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 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), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=24Jul2022, Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Tiredness; fever; chills; This is a spontaneous report received from contactable reporter(s) (Other HCP) via COVID-19 Adverse Event Self-Reporting Solution.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 20Jul2022 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 3 years, in right leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 22Jul2022 at 08:00, outcome "not recovered", described as "Tiredness"; CHILLS (non-serious) with onset 22Jul2022 at 08:00, outcome "not recovered"; PYREXIA (non-serious) with onset 22Jul2022 at 08:00, outcome "not recovered", described as "fever". The events "tiredness", "fever" and "chills" required physician office visit. Therapeutic measures were not taken as a result of fatigue, pyrexia, chills.  Additional information: No other vaccine in four weeks. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. No corrective treatment received. No covid prior vaccination and no covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 symptoms returned 5 days after completion of paxlovid - including: tachycardia, coughing, rhinirrhea, fatigue, night sweats. COVID 19 Treatment, brand Paxlovid treatment start date 13Jul2022, treatment stop date 17Jul2022 indication Treatment of COVID-19. no other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low WBC" (unspecified if ongoing), notes: other medical history: Low WBC. Concomitant medication(s) included: OMEPRAZOLE; EZETIMIBE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Negative covid test after 10 days from first test; Positive, notes: COVID Rebound after 15 days; Unknown results, notes: Negative covid test after 10 days from first test COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201001918 Same patient, different product and event;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID19; Contracted COVID19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Apr2021 at 13:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Nov2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "DM T2" (unspecified if ongoing); "Major Depressive Disorder" (unspecified if ongoing). The patient had no known allergy. Facility type vaccine was Workplace clinic. Patient did not receive any other vaccine in four weeks. Concomitant medication(s) included: LEXAPRO; GABAPENTIN; SEGLUROMET. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022, outcome "recovering" and all described as "Contracted COVID19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient was put on steroids and nerve meds  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pallor, Pyrexia
Clinical narrative: chills; mild nausea; pallor; fatigue; LGT (100.5); This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jul2022 as dose 3 (booster), single (Lot number: FL8094) at the age of 10 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=1), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE , prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=2), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022), described as "LGT (100.5)"; CHILLS (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022); FATIGUE (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022); NAUSEA (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022), described as "mild nausea"; PALLOR (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022). Therapeutic measures were taken as a result of chills, nausea, pallor, fatigue, pyrexia.  Additional information: 20h after injection: chills, mild nausea, pallor, fatigue and LGT (100.5). Sx lasted 5h and resolved c rest and 300mg of ibuprofen. Patient did not receive any other vaccines in four weeks prior covid-19 immunisation. It was unknown if patient tested covid-19 post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Guillain-Barre syndrome, Paralysis, Pneumonia
Clinical narrative: He was paralyzed, He was put into hospital he came into another hospital, He spend two months in a hospital; her husband got GBS; Pneumonia; Her husband got the Pfizer (COVID-19) Vaccine, was tested positive for COVID now.; Her husband got the Pfizer (COVID-19) Vaccine, was tested positive for COVID now.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose number unknow, single (Lot number: EN6202) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (hospitalization, medically significant), outcome "unknown", described as "He was paralyzed, He was put into hospital he came into another hospital, He spend two months in a hospital"; GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "unknown", described as "her husband got GBS"; PNEUMONIA (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her husband got the Pfizer (COVID-19) Vaccine, was tested positive for COVID now.". The patient was hospitalized for paralysis, guillain-barre syndrome (hospitalization duration: 60 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of paralysis, guillain-barre syndrome.  Clinical course: The reporter mentioned that her husband got the Pfizer vaccine and her husband was tested positive for COVID now, she added as well that her husband got pneumonia as well her husband got GBS and she mention that she feels GBS was the symptom of Pfizer vaccine." The reporter mentioned that her husband got pneumonia as well GBS and she wants to clarify if GBS was the symptom of Pfizer Vaccine?". Regarding Lot no, Consumer stated, "Which one do you want? For COVID Pfizer EN6202 (Clarified and captured in tab) and second one it says COVID Pfizer it looks like EDAEP I can't read the second letter and then its 69SS." Expiration date: Reporter stated, "No, there was no expiration date on there." Treatment for the side effect: Reporter stated, "Yes, he was paralyzed from, he ended up with GBS. He was put into hospital he came into another hospital. He spend two months in a hospital in and out and he was in rehab he was, at the towards the end of rehab at that time in his right leg he has 8 muscles out of 10 that are not working so he looked like he was paralyzed from the neck down."
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: He was paralyzed, He was put into hospital he came into another hospital, He spend two months in a hospital; her husband got GBS; Pneumonia; Her husband got the Pfizer (COVID-19) Vaccine, was tested positive for COVID now.; Her husband got the Pfizer (COVID-19) Vaccine, was tested positive for COVID now.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose number unknow, single (Lot number: EN6202) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (hospitalization, medically significant), outcome "unknown", described as "He was paralyzed, He was put into hospital he came into another hospital, He spend two months in a hospital"; GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "unknown", described as "her husband got GBS"; PNEUMONIA (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her husband got the Pfizer (COVID-19) Vaccine, was tested positive for COVID now.". The patient was hospitalized for paralysis, guillain-barre syndrome (hospitalization duration: 60 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of paralysis, guillain-barre syndrome.  Clinical course: The reporter mentioned that her husband got the Pfizer vaccine and her husband was tested positive for COVID now, she added as well that her husband got pneumonia as well her husband got GBS and she mention that she feels GBS was the symptom of Pfizer vaccine." The reporter mentioned that her husband got pneumonia as well GBS and she wants to clarify if GBS was the symptom of Pfizer Vaccine?". Regarding Lot no, Consumer stated, "Which one do you want? For COVID Pfizer EN6202 (Clarified and captured in tab) and second one it says COVID Pfizer it looks like EDAEP I can't read the second letter and then its 69SS." Expiration date: Reporter stated, "No, there was no expiration date on there." Treatment for the side effect: Reporter stated, "Yes, he was paralyzed from, he ended up with GBS. He was put into hospital he came into another hospital. He spend two months in a hospital in and out and he was in rehab he was, at the towards the end of rehab at that time in his right leg he has 8 muscles out of 10 that are not working so he looked like he was paralyzed from the neck down."
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID symptoms with positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, patient took Paxlovid from 09Jul2022 to 13Jul2022 for treatment of COVID-19. Adverse event reported as rebound COVID symptoms with positive antigen test on 24Jul2022, where reported AE was not recovered and no treatment was received. Patient had no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Pyrexia
Clinical narrative: Fever; Pain in chest; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHEST PAIN (non-serious), outcome "unknown", described as "Pain in chest"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient has taken Tylenol for the treatment of fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ashtma" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: BENICAR; QVAR.  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: 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. ; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: The following morning we had to take him to urgent care as he had difficulty breathing.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2022 as dose 2, single (Batch/Lot number: unknown) at the age of 3 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1: MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 16Jul2022, outcome "unknown", described as "The following morning we had to take him to urgent care as he had difficulty breathing.". Therapeutic measures were taken as a result of dyspnoea.  Additional information: I am writing because my 3 year old son received the second dose of your COVID19 vaccine on Saturday 16Jul2022. The following morning, we had to take him to urgent care as he had difficulty breathing. They gave him a dose of Decadron (dexamethasone). Will this impact his antibody response and attenuate the effectiveness of his vaccine protocol.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown". Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. A 50-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DIPHENHYDRAMINE; FAMOTIDINE, start date: 01Mar2022; SENNA-S [DOCUSATE SODIUM;SENNA ALEXANDRINA]. 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 reusult. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: From 16Jul2022 to 20Jul2022 the patient was treated with Paxlovid for covid-19. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information the reported events  vaccination failure and Covid-19 are assessed as related to suspect drug Comirnaty.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Muscular weakness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: my left arm was very sore/tight; my left arm was very sore/tight; my entire left arm is weak; My left hip and left knee are sore; My left hip and left knee are sore; I am very weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 at 15:00 as dose 1, single (Lot number: FP7139) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tore my tendons right shoulder" (unspecified if ongoing), notes: Tore my tendons right shoulder; "hurt" (unspecified if ongoing), notes: hurt; "Known allergies: Sulfa products ivp dye" (unspecified if ongoing), notes: Known allergies: Sulfa products ivp dye; "Known allergies: cat dander" (unspecified if ongoing), notes: Known allergies: cat dander. There were no concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 08Jul2022 at 15:00, outcome "not recovered", described as "I am very weak"; ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 08Jul2022 at 15:00, outcome "not recovered" and all described as "My left hip and left knee are sore"; MUSCULAR WEAKNESS (non-serious) with onset 08Jul2022 at 15:00, outcome "not recovered", described as "my entire left arm is weak"; PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 08Jul2022 at 15:00, outcome "not recovered" and all described as "my left arm was very sore/tight". The events "my left arm was very sore/tight", "my entire left arm is weak", "my left hip and left knee are sore" and "i am very weak" required physician office visit. Therapeutic measures were not taken as a result of pain in extremity, musculoskeletal stiffness, muscular weakness, arthralgia, arthralgia, asthenia.  Additional information: This report was assessed as non serious. The patient did not receive any other vaccine within four weeks. Immediately after the patient received the vaccine her left arm was very sore/tight. That night it was really very sore and hurt and continued to hurt. Now her entire left arm was weak and hurt. She was very weak. Her left hip and left knee were sore. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination the patient had not tested for COVID.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: developed an escalation in the intensity of my (relatively minor) tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9261) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no Known allergies. Concomitant medication(s) included/Other medication in 2 weeks: ZILEUTON, start date: Feb2014; FOSAMAX, start date: Feb2018. The following information was reported: TINNITUS (non-serious) with onset 22Jan2021 at 20:00, outcome "not recovered", described as "developed an escalation in the intensity of my (relatively minor) tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Adverse event: Approx. three hours after receiving first shot on 22Jan2021 patient developed an escalation in the intensity of her (relatively minor) tinnitus.