chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Interchange of vaccine products
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "vestibular migraines" (unspecified if ongoing), notes: vestibular migraines; "migraines" (unspecified if ongoing), notes: migraines; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Apr2022 at 14:00, outcome "unknown", described as "Dose Number: 4 was Pfizer; Dose Number: 1,2,3 was Moderna"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 01Sep2022, outcome "recovering", described as "Rebound infection". Therapeutic measures were taken as a result of covid-19, drug ineffective. Therapeutic measures were not taken as a result of disease recurrence. Clinical information: Patient received treatment with Paxlovid from 22Aug2022 to 26Aug2022. The patient had a rebound infection on 01Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EP7533), in left arm, on 25Apr2021 as dose 2, single (Lot number: ER8736), in left arm, on 03Nov2021 as dose 3 (booster), single (Lot number: FH8023), in left arm, on 22Apr2022 as dose 4 (booster), single (Lot number: FKA893), in left arm and on 12Aug2022 as dose 5 (booster), single (Lot number: FP1260) at the age of 65 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYCLOSPORINE, start date: 04Jun2020, stop date: 03Sep2022. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Experienced symptoms on 30Aug2022"; VACCINATION FAILURE (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: (unspecified date) Positive, notes: Treatment of COVID-19; (26Aug2022) negative, notes: Tested negative on 26Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Vaccine received was mentioned as Yes, There was Other medication in 2 weeks. Known allergies was mentioned as None. Other medical history was mentioned as None.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: COVID-19 Vaccine is my worst enemy it causes a lot of health problem, causing a lot of heart problem; Vaccine need to work; I was forced to take poison; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "COVID-19 Vaccine is my worst enemy it causes a lot of health problem, causing a lot of heart problem; Vaccine need to work; I was forced to take poison".  Additional information: As consumer was not willing to proceed the call and abruptly. Hence further probing could not be done. Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 05Apr2021 as dose 1, single (Lot number: EP6966) and on 26Apr2021 as dose 2, single (Lot number: EW0161) at the age of 51 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2021 as dose 3 (booster), single (Lot number: 012F21A) and on 01May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history Asthma; "allergies" (unspecified if ongoing), notes: Other medical history: allergies; "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish; "sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "Known allergies: antibiotics" (unspecified if ongoing), notes: Known allergies: antibiotics. Concomitant medication(s) included: Lisinopril; Budesonide; Proair HFA; Azelastine; Flonase [Fluticasone Propionate]. 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: Negative, notes: I was negative after 6 days; Positive, notes: I tested Positive; Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: anti-viral product for COVID 19 Treatment, start date was 20Aug2022 and treatment stop date was 24Aug2022. Patient was negative after 6 days and felt fine. Then she started not feeling well 5 days later Aug 30. She tested Positive. she felt sicker than she did during the initial 5 days. It really exacerbated her asthma. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-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 23Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 23Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 2022, outcome "recovering", described as "Rebound case of Covid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound case of Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Patient had no known allergies. Patient received Paxlovid from 18Aug2022 to 22Aug2022 for COVID-19 treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: Overall declined in health since he was forced to get these shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 1, single (Lot number: 32030BD) at the age of 52 years, in right deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Had COVID 6 weeks before being forced into getting first shot. There were no concomitant medications. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset 2021, outcome "not recovered", described as "Overall declined in health since he was forced to get these shots".  Additional information: The patient did not have any family medical history relevant to the adverse event. The patient received first shot at mass medical event through battalion. The patient had COVID 6 weeks before being forced into getting first shot. Sense of taste and smell came back after that and was pretty good and everything was normal. Everything was pretty good after being forced to take first shot. The patient had overall declined in health since he was forced to get these shots. The patient wanted to know how long the side effects would last. The patient stated that he was wondering about the longevity of the side effects. No investigations were done. The case was reported as non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 10Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus; "asthma" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLORIC ACID, start date: 17Jan2014; GABAPENTIN, start date: 12Mar2022; MELOXICAM, start date: 20May2020. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient also received Breo Inhaler in 2 weeks with the start date of 12Mar2022. The patient received anti viral treatment with Paxlovid for COVID-19 from 26Aug2022 to 30Aug2022. Device Date 04Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EW0150) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously".  Additional information: Patient had one vaccine and three boosters. After the third booster, she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously. Lot of pain in her arm lasted 5 to 7 days. She clarified she thought she had 4 doses total but she only had three doses. She got the vaccine it's all over news and commercials said it was available now for all persons over the age of 50 and a great idea to get it now. That is why she went to get it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201117917 same reporter/patient, different dose/events;US-PFIZER INC-202201118307 same reporter/patient, different dose/events;US-PFIZER INC-202201118308 same reporter/patient, different dose/events;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: She had a shortness of breath after getting the first dose of the COVID-19 booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 11Aug2022 as dose 3 (booster), single (Lot number: FT7150) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; ARMOUR THYROID; AMLODIPINE; AMOXAPINE; HALOPERIDOL. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "She had a shortness of breath after getting the first dose of the COVID-19 booster shot". Therapeutic measures were not taken as a result of dyspnoea.  Additional information: Reporter stated, "The date patient had 11Aug2022. Stated that she don't see any expiration date, on the card it's just Pfizer FT7150 and it was says 11Aug2022. Expiry Date of COVID-19 Vaccine was Unknown. Regarding Lab work reporter stated, "Nag-g 500mg (further it was not clarified, and it was not paraphrased).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: FJ1611) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0150), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously".  Additional information: The patient had no other conditions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201118303 same reporter/patient/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old female patient received BNT162b2 (BNT162B2), on 22Jul2022 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: "slightly elevated blood pressure" (unspecified if ongoing), notes: Other medical history: slightly elevated blood pressure; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: shellfish. Concomitant medication(s) included: AMLODIPINE, start date: 01Jul2020. 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: (unspecified date) Positive; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: En6208), on 07Apr2021 as dose 2, single (Lot number: Er8727), on 07Nov2021 as dose 3 (booster), single (Lot number: 3203bd) and on 25May2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ABILIFY, start date: 02Feb2021; LAMOTRIGINE; PRIMIDONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Resumption of symptoms rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical information: The patient had received other medication within 2 weeks of vaccine administration. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid started on 23Aug2022 and stooped on 28Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Tested negative/A few days later, tested positive again"; 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, notes: Treatment of COVID-19; Negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive any other medications in 2 weeks. Reason for lot number unknown reported as not available at the time of report completion. It was reported that anti viral details of Paxlovid treatment started on 24Aug2022 and stopped at 28Aug2022. Patient also reported that continued to have fever during treatment, tested negative and a few days later again tested positive, still have a fever. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Pollens" (unspecified if ongoing); "Molds" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; ROSUVASTATIN. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: VACCINATION FAILURE (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: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 26Aug2022 to 30Aug2022. 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 current available limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the use of suspect product cannot be fully excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: EWO171) and on 11May2021 as dose 2, single (Lot number: EWO182) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Dec2021 as dose 3 (booster), single (Lot number: 013H2B) for covid-19 immunisation. The patient's relevant medical history included: "IBD" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: HYOSCYAMINE; FAMOTIDINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "not recovered", described as "Rebound-tested positive again 3 days after negative test and symptoms returned". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (30Aug2022) Negative, notes: Rebound-tested positive again 3 days after negative test and symptoms returned; (02Sep2022) Positive, notes: Rebound-tested positive again 3 days after negative test and symptoms returned. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: Patient received Other medication in 2 weeks and had no known allergies. Rebound-tested positive again 3 days after negative test and symptoms returned. Patient received Paxlovid for treatment of COVID-19 from 23Aug2022 to 27Aug2022.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose number unknown, single (Lot number: FC3182) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "not recovered", described as "Covid rebound following Paxlovid. Tested positive 2 days after negative test and am still positive 5 days out from the original positive rebound test"; 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: (unspecified date) Positive, notes: COVID 19 Treatment; (2022) Negative, notes: Tested positive 2 days after negative; (2022) Positive, notes: still positive 5 days out from the original positive rebound test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical Information: Adverse event: Patient started Paxlovid on 20Aug2022 for Covid 19 Treatment and stop on 25Aug2022. Covid rebound following Paxlovid. Tested positive 2 days after negative test and was still positive 5 days out from the original positive rebound test. Adverse event start date was 30Aug2022. Adverse event resulted in None of the above. Patient was not recovered. Taken no treatment for AE. Other medical history: Diabetes, high blood pressure, high cholesterol.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 62 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: "Diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", COVID-19 (medically significant), 10 days after the suspect product(s) administration, 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-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 01Mar2021 as dose 1, single (Lot number: En6203), in left arm, on 22Mar2021 as dose 2, single (Lot number: Ep7534), in left arm and on 13Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3 (booster), single (Lot number: 013h21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 endometriosis" (unspecified if ongoing); "hEDS" (Hypermobile Ehlers-Danlos syndrome) (unspecified if ongoing); "Asthma" (unspecified if ongoing); "positive speckled ANA" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (unspecified date) Positive, notes: positive speckled ANA; SARS-CoV-2 test: (30Aug2022) Positive, notes: 6-9: finish Paxlovid course in the am. Testing daily, very faint positive; (31Aug2022) Positive, notes: 6-9: finish Paxlovid course in the am. Testing daily, very faint positive; (01Sep2022) Positive, notes: 6-9: finish Paxlovid course in the am. Testing daily, very faint positive; (02Sep2022) Positive, notes: 6-9: finish Paxlovid course in the am. Testing daily, very faint positive; (03Sep2022) Positive, notes: Day 10 (today) strongly positive test; (24Aug2022) Negative, notes: (Day 0) negative rapid test; (25Aug2022) Positive, notes: Day 1: positive rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Covid 19 Treatment with Paxlovid from 25Aug2022 to 30Aug2022. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Device Date : 04Sep2022. No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Disease Recurrence; 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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 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), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 03Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Negative, notes: I tested negative on day ten; (03Sep2022) Positive, notes: tested positive on day 11. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID rebound; 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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE; METFORMIN; NOVOLOG; ADVAIR; MULTIVITAMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19"; DISEASE RECURRENCE (medically significant) with onset 03Sep2022, outcome "unknown", described as "COVID rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical Course: Patient received Covid-19 treatment with Paxlovid from 23Aug2022 to 28Aug2022. Known allergies: No. COVID rebound on 03Sep2022.  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, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Recurrence of Covid symptoms and confirmed positive test; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 15Jul2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 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: "Wheat amkwrgy" (unspecified if ongoing), notes: Known allergies: Wheat amkwrgy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "recovering", described as "Recurrence of Covid symptoms and confirmed positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Recurrence of Covid symptoms and confirmed positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if therapeutic measures were taken as a result of disease recurrence. Patient was treated with paxlovid from 24Aug2022 to 29Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: el3247), in left arm and on 19Feb2021 as dose 2, single (Lot number: el9269) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 as dose 3 (booster), single (Lot number: 060h21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "acid refluxmigraines" (unspecified if ongoing); "migraine" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Benadryl, reaction(s): "known allergies: benadryl". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: other medication in 2weeks was no. Patient received paxlovid,  indication was treatment of COVID-19treatment start date was 03Aug2022.; Sender's Comments: Based on the information in the case report, a causal association between reported events vaccination failure, Covid 19 and suspect BNT162B2 cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; antigen test showed faintest of pink line last Tuesday, 3 days after completion of paxlovid, next evening felt sick with return of head cold symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3248), on 15Nov2021 as dose 2, single (Lot number: Fm9809) and on 25Oct2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15May2022 as dose 4 (booster), single (Lot number: 838A22a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "antigen test showed faintest of pink line last Tuesday, 3 days after completion of paxlovid, next evening felt sick with return of head cold symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) confirmed Covid, notes: Started Paxlovid on day 2 of symptoms with  antigen confirmed Covid; (30Aug2022) faintest of pink line, notes: antigen test showed faintest of pink line last Tuesday. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical course: Patient received lisinopril as other medication in 2 weeks. Anti-viral details: patient received antiviral as covid-19 treatment from 22Aug2022 to 27Aug2022 for Treatment of COVID-19. Patient Started Paxlovid on day 2 of symptoms with antigen confirmed Covid, stated to feel better each day antigen test showed faintest of pink line last Tuesday. 3 days after completion of paxlovid, next evening felt sick with return of head cold symptoms and cough headache tested bright red Wednesday am, felt a bit better. Thursday, now lingering with head cold and cough not improving. 14 days after onset of symptoms, 7 days after ending Paxlovid
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: administered the vaccine yesterday after the vaccine's 10 week expiration date; administered the vaccine yesterday after the vaccine's 10 week expiration date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 01Sep2022 as dose number unknown (maroon cap), single (Lot number: FT9142) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 01Sep2022, outcome "unknown" and all described as "administered the vaccine yesterday after the vaccine's 10 week expiration date".  Additional information: The reporter called regarding the orange cap. Later reporter stated that, he was looking into it a little bit further and actually the children, the magenta cap so not 5 to 11 but 6 months to 4 years. COVID-19 vaccine. He reported that they administered the vaccine day before the reporting day after the vaccine's 10 week expiration date of 31Aug2022. So he wanted to know what they need to do. He wanted to make sure first of all that was the 10 weeks duration for refrigeration from the freezer and also after was there any further study showing whether or not if that counted in a valid administration or not at this point.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 19Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 01Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 15Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL, start date: Jun1988. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: having a negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 24Aug2022 to 29Aug2022.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 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: "Marfan's syndrome" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Treatment was received with Paxlovid, treatment start date was 25Aug2022 and stop date was 29Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2022 as dose 3 (booster),single (Batch/Lot number: unknown) at the age of 36 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: "PCOS" (unspecified if ongoing); "Insulin Resistant" (unspecified if ongoing), notes: other medical history:Insulin Resistant; "known allergies: Pencillin" (unspecified if ongoing), notes: known allergies: Pencillin. Concomitant medication(s) included: METFORMIN; LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 13:15 as dose 1, single (Lot number: EN5318), in left arm, on 03Mar2021 at 14:30 as dose 2, single (Lot number: EM9810), in left arm and on 23Aug2021 at 10:00 as dose 3 (booster), single (Lot number: FC3182) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 045L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "high Cholesterol" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; IRBESARTAN; PROZAC; WELLBUTRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, no known allergies. The patient received Paxlovid from 23Aug2022 to 27Aug2022 for treatment of Covid-19 . Rebound covid symptoms 6 days after stopping Paxlovid. Fever, sneezing and congestion. Other medications received in 2 weeks.