chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthritis, Gait disturbance, Impaired work ability, Intervertebral disc degeneration, Muscle spasms
Clinical narrative: excruciating low back pain; difficulty walking; significant fatigue; lot of sleeping; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "total knee replacement", start date: 2012, stop date: 2012. No known allergies. Concomitant medication(s) included: WELLBUTRIN; VITAMIN E [TOCOPHEROL]; ZINC; CHLORTHALIDONE and multi vitamin. There was no other vaccine in four weeks. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot number: ER8737, Administrator route: Intramuscular, Administrator time: 04:45 PM, Vaccine location: Left arm), administration date: 02Apr2021, when the patient was 52-year-old, for Covid-19 immunization, reaction(s): "muscle aches especially in my low back"; BNT162b2 (DOSE 1, SINGLE, Lot number: EN6204, Administrator route: Intramuscular, Administrator time: 04:45 PM, Vaccine location: Left arm), administration date: 12Mar2021, when the patient was 52-year-old, for Covid-19 immunization. The following information was reported: BACK PAIN (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "excruciating low back pain"; GAIT DISTURBANCE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "difficulty walking"; SOMNOLENCE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "lot of sleeping"; FATIGUE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "significant fatigue". The events " excruciating low back pain", "difficulty walking", "significant fatigue" and "lot of sleeping" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of back pain, gait disturbance, fatigue, somnolence. Treatment was Muscle relaxer. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events cannot be completely excluded based on temporal association and known drug safety profile The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle tightness, Spinal X-ray abnormal
Clinical narrative: excruciating low back pain; difficulty walking; significant fatigue; lot of sleeping; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "total knee replacement", start date: 2012, stop date: 2012. No known allergies. Concomitant medication(s) included: WELLBUTRIN; VITAMIN E [TOCOPHEROL]; ZINC; CHLORTHALIDONE and multi vitamin. There was no other vaccine in four weeks. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot number: ER8737, Administrator route: Intramuscular, Administrator time: 04:45 PM, Vaccine location: Left arm), administration date: 02Apr2021, when the patient was 52-year-old, for Covid-19 immunization, reaction(s): "muscle aches especially in my low back"; BNT162b2 (DOSE 1, SINGLE, Lot number: EN6204, Administrator route: Intramuscular, Administrator time: 04:45 PM, Vaccine location: Left arm), administration date: 12Mar2021, when the patient was 52-year-old, for Covid-19 immunization. The following information was reported: BACK PAIN (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "excruciating low back pain"; GAIT DISTURBANCE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "difficulty walking"; SOMNOLENCE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "lot of sleeping"; FATIGUE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "significant fatigue". The events " excruciating low back pain", "difficulty walking", "significant fatigue" and "lot of sleeping" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of back pain, gait disturbance, fatigue, somnolence. Treatment was Muscle relaxer. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events cannot be completely excluded based on temporal association and known drug safety profile The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sulfa antibiotics" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ampicillin, 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid Treatment start date: 04Jul2022, Treatment start date: 8Jul2022,Indication: Treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient reported about covid treatment. The patient had received vaccine. No other medication in 2 weeks. Anti viral details for COVID 19 Treatment included product brand as Paxlovid on 30Jun2022, (lot number=1910753A) for Treatment of COVID-19 and treatment stopped on 05Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 48.0
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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; Negative, notes: Covid rebound positive test after negative test a few days earlier; Positive, notes: Covid rebound positive test after negative test a few days earlier. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; 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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 06Feb2021 as dose 2, single (Lot number: EL9261), in left arm and on 05Aug2021 as dose 3 (booster), single (Lot number: Ew0186) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Jan2022 as dose 4 (booster), single (Lot number: 028kz1a), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, stop date: 10Apr2022; VITAMIN D3; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received anti-viral (Paxlovid) as COVID 19 treatment from 11Apr2022 to 16Apr2022. Clinical course: The patient received other medication within 2 weeks of vaccination. Return of symptoms and pos test 8 days after treatment. No known allergies were reported.
Age: 68.0
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 68-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 68 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: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Negative, notes: tested negative on 09Jul and was without symptoms for 3 days; (13Jul2022) Positive, notes: on 13Jul  runny nose, headache and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid (Lot number: GA9630) was started in 04Jul2022 till 08Jul2022 for the COVID-19 Treatment. After completing a round of Paxlovid on 08July2022, the patient tested negative on 09Jul2022 and was without symptoms for 3 days. On 12Jul2022 02:30PM runny nose started, again and on Jul 13 runny nose, headache and the patient tested positive. The patient was not recovered. The patient did not have any allergies and did not have a treatment adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: With my second vaccination I experienced extreme muscle aches especially in my low back, which sent me to an urgent care facility after a couple of days with it not getting any better; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 16:45 as dose 2 , single (Lot number: ER8737) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "total knee replacement in 2012", start date: 2012 (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; CHLORTHALIDONE; VITAMIN E [TOCOPHEROL]; ZINC. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Prev dose brand: Pfizer , Prev dose brand unknown: False, Prev dose lot number: EN6204, Prev dose lot unknown: False, Prev dose administrator route: Intramuscular,, Prev dose administration date: 12Mar2021, Prev dose administration time: 04:45 PM, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 12Mar2021, when the patient was 52-year-old, for Covid-19 immunization, reaction(s): Covid-19. The following information was reported: BACK PAIN (non-serious) with onset 10Oct2021 at 01:00, outcome "recovered", described as "With my second vaccination I experienced extreme muscle aches especially in my low back, which sent me to an urgent care facility after a couple of days with it not getting any better". The event "with my second vaccination she experienced extreme muscle aches especially in my low back, which sent me to an urgent care facility after a couple of days with it not getting any better" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of back pain.  Additional information: Facility type vaccine was pharmacy or drug store. There was no other vaccine in four weeks. Reporter stated that with her second vaccination she experienced extreme muscle aches especially in low back, which sent me to an urgent care facility after a couple of days with it not getting any better. With her 3rd/booster vaccination, she ended up in the ER on day three with excruciating low back pain, difficulty walking, significant fatigue resulting in a lot of sleeping. AE resulted leads to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.Patient was on treatment (Muscle relaxer) for AE. Patient had no COVID prior vaccination and COVID tested post vaccination. There was no known allergies.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-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 24Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, 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: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Apr2022. 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: (10Jul2022) Negative, notes: test negative on 10Jul after taking paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, had symptoms go away and test negative on 10Jul after taking paxlovid 01Jul-06Jul. Weak positive and mild symptoms returned 11Jul2022. No known allergies. The patient received other medication within two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Respiration abnormal
Clinical narrative: after the booster the breathing became very bad; after the booster the breathing became very bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 at 13:15 as dose 3 (booster), single (Lot number: ff2593) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 11Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "breathing started in February/March of 2021"; coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EL9262, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 21Jan2021, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: RESPIRATION ABNORMAL (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "after the booster the breathing became very bad".  Additional information: Patient had COPD and was managing it with the COPD medicine. But his breathing started in February/March of 2021, after the booster the breathing became very bad. There was no other medicine or treatments during this time.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pyrexia, Vaccination site pain
Clinical narrative: Extremely swollen gland under arms; Pain in glands; Pain in shot site/Shot arm left arm worse; slight fever; tiredness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jul2022 at 17:30 as dose 1, single (Lot number: FN2908) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Coconut" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; PREMARIN. Past drug history included: Macrotatin, reaction(s): "Allergy"; Benydryl, reaction(s): "Allergy". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "Extremely swollen gland under arms"; LYMPH NODE PAIN (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "Pain in glands"; VACCINATION SITE PAIN (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "Pain in shot site/Shot arm left arm worse"; PYREXIA (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "slight fever"; FATIGUE (non-serious) with onset 12Jul2022 at 07:00, outcome "not recovered", described as "tiredness". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, vaccination site pain, pyrexia, fatigue.  Additional information: There were no other vaccine in four weeks.
Age: 49.0
Sex: F
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history included Obesity. 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 "Treatment of COVID-19".  Clinical course: Patient had received Anti-viral Product for COVID 19 Treatment, Brand Paxlovid, Treatment started on date02Jul2022 and was stopped on date 06Jul2022, It was reported covid symptoms returned 5 days after finishing paxlovid and tested negative 2 days after finishing paxlovid. Also tested positive for covid 6 days after finishing paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Antiviral details: The patient received Paxlovid, antiviral drug treatment on 04Jul2022 to 09Jul2022 for an COVID-19. The patient did not had any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 a contactable reporter(s) (Pharmacist).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, 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 received other medication in 2weeks. product: COVID 19 Treatment, brand: Paxlovid treatment start date: Jul2022, treatment stop date: Jul2022 for Treatment of COVID-19, adverse event start date: 13Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 42.0
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 11:45 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Apr2021 at 08:45 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FOLATE; D3 +K2. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, 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: Indication: Covid-19 treatment; (10Jul2022) Negative; (11Jul2022) Negative; (12Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). 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: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received any other medication in 2 weeks. He received treatment of Covid-19 with antiviral Paxlovid Treatment started on 03Jun2022 and stopped on 07Jun2022.  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: 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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 17Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12May2022 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "opiod pain meds" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT, start date: 01Jan2011; ALBUTEROL SULFATE, start date: 01Jan2011; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2011. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknon results, notes: Indication: Covid-19 treatment; (11Jul2022) Positive, notes: Tested positive again 11Jul; (13Jul2022) Positive, notes: still positive on 13Jul with mild symptoms; (Jul2022) Negative, notes: Tested negative on day 3 of paxlovid dosing- and continued to test negative for 6 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EN5318), in left arm, on 25Mar2021 at 10:00 as dose 2, single (Lot number: EN6199), in left arm and on 03Dec2021 at 17:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "depression" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "known allergies: seafood" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: FARXIGA, start date: Jan2019; IRBESARTAN HCTZ, start date: Jan2017; ROSUVASTIN, start date: Jan2014, stop date: 20Jun2022; AMLODIPINE, start date: Jan2017; DESVENLAFAXINE, start date: Jan2016; METFORMIN, start date: Jan2005; OMEPRAZOLE. Past drug history included: Tetracycline, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022 at 08:00, outcome "recovered" (13Jul2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) Positive, notes: home test. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient tested + for covid via home test 19Jun2022, took Paxlovid for 5 days, tested negative around 29Jun2022, became mildly symptomatic again 09Jul2022, tested + (very faint line), felt better 10Jul2022, tested + (very faint line) for 3 days and negative 12- 13Jul2022 and feel fine now. The patient was not sure if this was a rebound infection but wanted to report it just in case.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Age: 68.0
Sex: M
Vaccine: COVID19, 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) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 005M21A) at the age of 68 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: "hypertension" (unspecified if ongoing), notes: other medical history: hypertension; "hypercholesterolemia" (unspecified if ongoing), notes: other medical history: hypercholesterolemia. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all 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: (unspecified date) Unknown results; (unspecified date) Positive, notes: Retested indicates positive result; (06Jul2022) Negative, notes: Previously on day three last dose was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for COVID 19 treatment from 04Jul2022 to 09Jul2022. Severe headache and nasal congestion noted on day 5 from the last dose. Retested indicates positive result. Previously on day three last dose was negative.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded. Case will be reviewed further on receipt of FU information.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Jaundice, Peripheral ischaemia, Renal disorder, 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 68-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 005M21A) at the age of 68 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: "hypertension" (unspecified if ongoing), notes: other medical history: hypertension; "hypercholesterolemia" (unspecified if ongoing), notes: other medical history: hypercholesterolemia. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all 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: (unspecified date) Unknown results; (unspecified date) Positive, notes: Retested indicates positive result; (06Jul2022) Negative, notes: Previously on day three last dose was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for COVID 19 treatment from 04Jul2022 to 09Jul2022. Severe headache and nasal congestion noted on day 5 from the last dose. Retested indicates positive result. Previously on day three last dose was negative.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded. Case will be reviewed further on receipt of FU information.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vasculitis
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 68-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 005M21A) at the age of 68 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: "hypertension" (unspecified if ongoing), notes: other medical history: hypertension; "hypercholesterolemia" (unspecified if ongoing), notes: other medical history: hypercholesterolemia. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all 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: (unspecified date) Unknown results; (unspecified date) Positive, notes: Retested indicates positive result; (06Jul2022) Negative, notes: Previously on day three last dose was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for COVID 19 treatment from 04Jul2022 to 09Jul2022. Severe headache and nasal congestion noted on day 5 from the last dose. Retested indicates positive result. Previously on day three last dose was negative.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded. Case will be reviewed further on receipt of FU information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a 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 11Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 03Nov2021 as dose 3, (booster), single (Lot number: GG2593) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Mar2020; BUPROPION, start date: Aug2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all 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: Negative, notes: After testing negative (home antigen test) on Day 5,; Positive, notes: on Day 10 I tested positive again,; Positive, notes: It is now Day 13 and I am still positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2weeks. The patient was treated with Paxlovid from 01Jul2022 to 05Jul2022 for COVID-19. Adverse event: After testing negative (home antigen test) on Day 5, on Day 10 I tested positive again, and began to have symptoms again. Congestion, fatigue, fever. It is now Day 13 and I am still positive and with symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: Fj4991) 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: "Sulfa Antibiotics: Drug allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "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: (06Jul2022) Negative, notes: Lateral Flow test; (07Jul2022) Negative, notes: Lateral Flow test; (08Jul2022) Negative, notes: Lateral Flow test; (08Jul2022) Negative, notes: Lateral Flow test; (11Jul2022) Positive, notes: Lateral Flow test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She had minimal sore arm for a couple of hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN5318) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "She had minimal sore arm for a couple of hours".  Additional information: The patient stated she was a fan of Pfizer. The first vaccine that was available to caller was Pfizer and she stuck with that. She had minimal sore arm for a couple of hours for side effect. She was happy with it. She doesn't want to be a complainer.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound covid infection 07Jul2022, cold like symptoms. Positive covid home test on 09Jul2022, negative test on 13Jul2022.; Rebound covid infection 07Jul2022, cold like symptoms. Positive covid home test on 09Jul2022, negative test on 13Jul2022.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL3249), in left arm, in Feb2021 as dose 2, single (Lot number: EL9265), in left arm and in Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022, outcome "recovering" and all described as "Rebound covid infection 07Jul2022, cold like symptoms. Positive covid home test on 09Jul2022, negative test on 13Jul2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive; (13Jul2022) Negative. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment started from 27Jun2022 to 02Jul2022 as covid-19 treatment, lot number GE1498. It was reported that the patient previously receive a COVID-19 Vaccine. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 37-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient wasn't taking any other medications/products within 2 weeks of starting COVID-19 treatment. Consistent with Paxlovid rebound. Paxlovid for COVID 19 Treatment from 01Jul2022 to 05Jul2022. Took full dose of Paxlovid. Felt better symptoms went away. Felt normal. 3 Symptoms returned on 09Jul. The patient was recovering. known allergies not that know of.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.