chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dysstasia, Gait inability, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 95-year-old female patient received BNT162b2 (BNT162B2), on 03Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 94 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid disorder" (unspecified if ongoing); "eye drops" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; DORZOLAMIDE + TIMOLOL taken for eye drop instillation; LATANOPROST. The following information was reported: DYSSTASIA (non-serious), outcome "unknown", described as "Her mother couldn't stand that day after her first Pfizer COVID-19 Vaccine"; GAIT INABILITY (non-serious), outcome "unknown", described as "not able to walk". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: No additional vaccines was administered on same date of the Pfizer Suspect. The patient had no prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had home COVID test and was negative and an official COVID test was done on 01Aug2022 with results on 03Aug2022 prior to her chest x-ray. The patient was not a big person for shots and her daughter was very worried her mother would pass away and has not had all her vaccines (as reported). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9262), on 20Feb2021 as dose 2, single (Lot number: EN6201) and on 25Oct2021 as dose 3 (booster), single (Lot number: EWO177) at the age of 81 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 11Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "post MI with stent", start date: Aug2021 (unspecified if ongoing), notes: post MI with stent 21Aug; "arthritis" (unspecified if ongoing); "hyperthyroid" (unspecified if ongoing); "heartburn" (unspecified if ongoing); "Lichen sclerosus" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 27Aug2021, stop date: 19Jul2022; BAYER LOW DOSE, start date: 27Aug2021; TOPROL XL, start date: 27Aug2021; ZESTRIL, start date: 27Aug2021; SLEEP AID, start date: 09Mar2021; D3, start date: 14Oct2021. Past drug history included: Prilosec, start date: 11Apr2018; Levothyroxine, start date: 17Sep2008, notes: levothyroxine 0.112 mg. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jul2022, 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) Positive, notes: I took Paxlovid when I first got Covid; (27Jul2022) Negative; (31Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 24Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 16Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 24Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "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; (unspecified date) Positive, notes: Rebound COVID symptoms and positive test; (26Jul2022) Positive, notes: Originally tested positive on 26Jul2022,; (01Aug2022) Negative, notes: tested negative 01Aug2022; (05Aug2022) Positive, notes: tested positive 05Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information:- The patient had no known allergies. The patient had not received other medication in 2 weeks. Patient received paxlovid covid-19 treatment on 26Jul2022 and the treatment stop date was 31Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Developed ecchymotic areas on body 2.5 by 2.5 circle/square at the injection site and they are not fading; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 24Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 24Jul2022, outcome "unknown", described as "Developed ecchymotic areas on body 2.5 by 2.5 circle/square at the injection site and they are not fading".  Additional Information: The reporter was a registered nurse was calling in regards to her husband. The reporter stated that her husband received his 2nd booster dose of the Pfizer Covid 19 vaccine on 24Jul2022 and shortly after developed ecchymotic areas on his body and they are not fading. Caller asked if that affected his absorption of the booster dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: 6n6205), in left arm and on 24Mar2021 as dose 2, single (Lot number: 6p7534) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 18Nov2021 as dose 3 (booster), single (Lot number: 031h21a), in left arm and on 29Jun2022 at 14:30 as dose 4 (booster), single (Lot number: 060a22a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Addisons disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient had no known allergies. The patient took Hydrocortisone, Prednisone, omeprisol and Florinef in 2weeks (lot number for all products: Unknown). The patient took COVID 19 Treatment with Paxlovid (Treatment start date: 21Jul2022, Treatment start date: 26Jul2022, Lot number: unknown, Indication: Treatment of COVID-19).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from 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 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 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), notes: Other medical history: Asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown that the patient received any other medication within 2 weeks of vaccination. The patient received anti-viral drug (Paxlovid) from 20Jul2022 to 25Jul2022 for the treatment of COVID-19. Rebound infection with symptoms worse than initial symptoms. Congestion, headache, sinus drainage. Tested negative for two days prior to testing positive again. Still symptomatic a week after test positive again. No known allergies were reported. Report about covid treatment was yes. Adverse event start date reported as 30Jul2022 and patient recovered. Known allergies reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; COVID-19 VACCINE, unknown manufacturer administered as dose 1, 2, 3, and 4; BNT162B2 as dose 5 (booster); This is a spontaneous report received from a non-contactable reporter (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 5 (booster), single (Lot number: FM0173) at the age of 61 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing); "erosive arthritis" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: Penicillin (pcn)" (unspecified if ongoing). Concomitant medication (in 2 weeks) included: SPIRONOLACTONE, start date: Jan2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18May2022, outcome "unknown", described as "COVID-19 VACCINE, unknown manufacturer administered as dose 1, 2, 3, and 4; BNT162B2 as dose 5 (booster)"; DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Negative, notes: patient was asymptomatic and tested negative after full course Paxlovid; Negative, notes: continued to test negative on day 6; Negative, notes: continued to test negative on day 7; Negative, notes: continued to test negative on day 8; Positive, notes: cough and sore throat returned day 9 and also tested positive day 9; Positive, notes: treatment of COVID-19. Therapeutic measures were taken as a result of covid-19.  Additional information: COVID-19 treatment included Paxlovid, brand: Pfizer (Lot number: GE6376), administered orally from 28Jul2022 to 01Aug2022. The patient was asymptomatic and tested negative after full course Paxlovid. The patient continued to test negative on days 6, 7, 8. Cough and sore throat returned on day 9 and also tested positive on day 9.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough infection 04Aug2022; Breakthrough infection 04Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER8732), in left arm, on 28Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 35 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no Known allergies. Patient did not have covid prior to the vaccination. The patient's concomitant medications were not reported. Patient did not received any other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04Aug2022, outcome "not recovered", COVID-19 (medically significant) with onset 04Aug2022, outcome "not recovered" and all described as "Breakthrough infection 04Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 04Aug2022 for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: FW0161) and on 20Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Essential tremor" (unspecified if ongoing); "known allergies: gadolinium" (unspecified if ongoing); "known allergies: gluten" (unspecified if ongoing); "known allergies: Puffer fish" (unspecified if ongoing). Concomitant medication(s) included: STELARA taken for crohn's disease, start date: 18Nov2021. Past drug history included: Amoxicillin, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid was given as treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given Paxlovid from 26Jul2022 to 31Jul2022 as COVID-19 treatment. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 75-year-old female patient received BNT162b2 (BNT162B2), on 10Jul2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications in 2 weeks . The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment was started in 21Jul2022 till 26Jul2022 for the treatment of COVID-19. On 03Aug2022, the patient experienced Rebound positivity with outcome as unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19 with Paxlovid from 22Jul2022 to 24Jul2022; Treatment of COVID-19 with Paxlovid from 22Jul2022 to 24Jul2022; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose number unknown, single (Lot number: F#8027) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication included: ADVIL [IBUPROFEN], start date: 22Jul2022, stop date: 23Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19 with Paxlovid from 22Jul2022 to 24Jul2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 13:45 as dose 1, single (Lot number: EL9261), in left arm, on 24Mar2021 at 13:45 as dose 2, single (Batch/Lot number: unknown), in left arm, on 12Oct2021 at 14:30 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 07Jun2022 at 11:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "hypothyroid-senior citizen" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: LEVOCETIRIZINE; SYNTHROID. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive, notes: COVID-19 Treatment; (26Jul2022) Negative; (26Jul2022) Negative; (31Jul2022) positive again; (05Aug2022) still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID. After treatment with PAXLOVID was completed on Thursday 26Jul2022, she had 2 negative tests and then symptoms returned around 31Jul2022 and tested positive again. On, 05Aug2022 and still testing positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 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: "Colitis ulcerative" (unspecified if ongoing); "known allergies: Sulfa" (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 "COVID 19 Treatment". 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: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Product preparation error, Somnolence
Clinical narrative: inadvertently was given a dose of the Pfizer Covid 19 vaccine yesterday that was not diluted; inadvertently was given a dose of the Pfizer Covid 19 vaccine yesterday that was not diluted; usually does not take naps or sleep a lot because he does not product melatonin/ has been asleep for 3 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 5-year-old patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history included: "hemophilia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 04Aug2022, outcome "unknown" and all described as "inadvertently was given a dose of the Pfizer Covid 19 vaccine yesterday that was not diluted"; SOMNOLENCE (non-serious) with onset Aug2022, outcome "unknown", described as "usually does not take naps or sleep a lot because he does not product melatonin/ has been asleep for 3 hours".  Additional Information: The reporter is the mother of a 5 year old male who inadvertently was given a dose of the Pfizer COVID-19 vaccine yesterday that was not diluted. She would like to know what they should do. She relayed that he usually does not take naps or sleep a lot because he does not product melatonin. He has been asleep for 3 hours. He also has hemophilia. The reporter said that her five year old daughter (further clarification unknown, if the reporter is reporting for daughter or the son) received her second dose of the vaccine yesterday and she was telling that the nurse administered the vaccine and they didn't dilute it and the caller does not know the color of the cap, the Pfizer COVID-19 Vaccine. Reporter just wanted to know what to do for her son (Further not clarified appropriately, if reporter is reporting for the son or the daughter) that was administered the vaccine incorrectly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
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) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), 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, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Shrimp" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" (2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: rebound; (Jul2022) Negative, notes: 2 days negative. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: Anti-viral details: product: COVID-19 Treatment (brand: Pfizer) from 28Jul2022 to 31Jul2022. From 30Jul2022 08:00 AM, severe bad taste in mouth and nausea. Also had rebound with positive COVID test after 2 days negative, and mild symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 at 08:00 as dose 1, single (Lot number: Fk9231), in left arm, on 13Jan2021 at 08:00 as dose 2, single (Lot number: FL8982), in right arm and on 04Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 42 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), 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 vaccination failure, COVID-19. Clinical course: Treatment of COVID-19 was from 21Jul2022 to 25Jul2022. Rebound symptoms started from 30Jul2022 (07:00) and ended on 04Aug2022.; 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 lack of efficacy  cannot be ruled out.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; a recurrence and tested positive on 03Jul2022; 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 (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 at 12:30 as dose 1, single (Lot number: EN6095), in right arm, on 21Feb2022 at 14:30 as dose 2, single (Lot number: EN6198), in right arm and on 15Apr2022 at 12:30 as dose 3 (booster), single (Lot number: EN6204) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: 04Jan2010, stop date: 07Aug2022; VALSARTAN, start date: 05Dec2011, stop date: 07Aug2022. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 03Jul2022 at 10:30, outcome "recovered" (09Jul2022), described as "a recurrence and tested positive on 03Jul2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Neagtive, notes: Tested negative on 01July2022; (03Jul2022) Positive, notes: tested positive on 03July2022; (09Jul2022) Neagtive, notes: 09July2022 to get a negative result again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Additional information: Tested negative on 01Jul2022, then had a recurrence and tested positive on 03Jul2022 and tested myself every day and it took till 09Jul2022 to get a negative result again. No Known allergies were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 28Jan2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 29Sep2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 02Apr2022 at 08:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Chronic knee and hip pain" (unspecified if ongoing), notes: Chronic knee and hip pain; "hip pain" (unspecified if ongoing), notes: hip pain. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19..  Clinical course: Antiviral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=24Jul2022, Treatment stop date=29Jul2022, Lot number=Unknown, Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 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), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Mar2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer history" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Patient was healthy overall. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Negative, notes: COVID rebound tested positive 2 days (today) after negative test; (06Aug2022) Positive, notes: COVID rebound tested positive 2 days (today) after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid (Lot number: GC2132) from 29Jul2022, to 02Aug2022 for the treatment of COVID-19. It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient took 8 doses of Paxlovid and discontinued due to severe headache and terrible metallic taste. COVID rebound tested positive 2 days (today) after negative test, rebound symptoms different and milder than initially.  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: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Lot number: EL9267), in right arm, on 10Mar2021 as dose 2, single (Lot number: EN603), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "multiple meningiomas" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Eczema" (unspecified if ongoing). No known allergies. Concomitant medications included: BUPROPION HCL; PREGABALIN; CITALOPRAM; THYROXINE; HYDROCORTISONE; MEMANTINE; CELECOXIB; METFORMIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". Clinical course: Patient had sneezing, sore throat, congestion, diarrhea and fatigue, tested positive and started Paxlovid days after the onset of symptoms. After 10 days she was feeling better and tested negative. Her symptoms returned a couple of days later and she tested positive again. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (Jul2022) Negative, notes: After 10 days; (29Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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: "Chronic Kidney Disease (CKD) Stage 1" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included: PF-07321332, ritonavir (PAXLOVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 14Aug2021 as dose 3 (booster), single (Lot number: FC3181), in right arm and on 03Jan2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 72 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: "Rheumatoid arhritis" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 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, covid-19 and included treatment with Paxlovid.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 50-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 50 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). Patient has no known allergies. Concomitant medications included: OMEPRAZOLE; ROSUVASTATIN. Patient received PAXLOVID as COVID 19 Treatment from 06Jul2022 to 10Jul2022 and experienced rebound symptoms, retested positive on rapid test (AER#202201041789). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Retested positive on rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Outcome of the events was not recovered.
Age: 58.0
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) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose number unknown, single (Lot number: FJ4989) at the age of 58 years, in right 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 27Jul2022 to 01Aug2022.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 at 12:15 as dose 3 (booster), single (Lot number: FK9893) at the age of 67 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2022) Positive, notes: On 4th day after finishing Paxlovid, tested positive; (10Aug2022) Negative, notes: after 3 days of testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: On 4th day after finishing Paxlovid, tested positive after 3 days of testing negative. Symptom so far appear to be a mild sore throat. No Known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 83-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, 0.3 ml single (Lot number: En6199) at the age of 83 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 "unknown", described as "sore arm". Additional information: caller states she had a reaction the first time she got the first one, she had a sore arm.
Age: 35.0
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) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Jan2021 as dose 1, single (Lot number: 025J20A) and on 29Jan2021 as dose 2, single (Lot number: 026L20A) for covid-19 immunisation. The patient's relevant medical history included: "History of pediatric stroke" (unspecified if ongoing), notes: History of pediatric stroke; "tourette's" (unspecified if ongoing), notes: tourette's. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: 30Jun2000; MIRENA, start date: 20Oct2021, "Iud". The following information was reported: DRUG INEFFECTIVE (medically significant), 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, covid-19.; Sender's Comments: The contributory role of the suspect product bnt162b2 to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller's mother was vaccinated but doesn't know if it was Pfizer vaccine/took Paxlovid for Covid; Caller's mother was vaccinated but doesn't know if it was Pfizer vaccine/took Paxlovid for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller's mother was vaccinated but doesn't know if it was Pfizer vaccine/took Paxlovid for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: took Paxlovid for Covid; Positive, notes: He found out three days ago that she had symptoms again for rebound case of Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Is report related to a study or programme was reported as No. Other Conditions was Not Provided. Investigations was Not Provided. Caller asks if she was supposed to report someone took Paxlovid and was using it to treat Covid and then got rebound case of Covid. Are we supposed to report like when someone gets Covid after having the Pfizer vaccine. Caller's mother, (Name with-held), took Paxlovid for Covid a week or so ago. He found out three days ago that she had symptoms again for rebound case of Covid. Also, he didn't know if supposed to report that or not. Caller does not think his mother required any treatment. Paxlovid NDC/LOT/Expiration was unknown. Description of Product Complaint: Description of complaint: Had Covid after unspecified Covid vaccine. Doesn't know if it was the Pfizer Covid vaccine. Caller declined to complete report. Full details unable to be obtained. Patient received treatment with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: FATIGUE; CHILLS; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4383471-00.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown".  Additional information: It was also reported that it was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Patient had second dose on 27Mar2021. Causality as per reporter for event chills and fatigue was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Painful injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4383471-00.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: unknown; Route of administration: intramuscular), administration date: 06Mar2021, when the patient was 71-year-old, for Covid-19 immunisation, reaction(s): "fatigue", "Chills"; BNT162b2 (DOSE 2, SINGLE, Lot number: unknown; Route of administration: intramuscular), administration date: 27Mar2021, when the patient was 71-year-old, for Covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Painful injection".  Additional information: It was also reported that it was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality as per reporter for event vaccination site pain was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter's Comments: Non-serious spontaneous case routed to Distribution.