chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Condition aggravated, Ear, nose and throat examination, Tinnitus
Clinical narrative: the ringing in my left ear has gotten worse and louder; the ringing in my left ear has gotten worse and louder; 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 (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 12:30 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyrodism" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LEVOTHYROXINE; CALCIUM; BIOTIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Right, Vaccine Administration Time: 10:30), administration date: 24Apr2021, when the patient was 63-year-old, for covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right, Vaccine Administration Time: 14:15), administration date: 02Apr2021, when the patient was 63-year-old, for covid-19 immunization, reaction(s): "lost some hearing in the left ear", "ringing in my left ear/tinnitus". The following information was reported: TINNITUS (disability), CONDITION AGGRAVATED (disability) all with onset 2021, outcome "not recovered" and all described as "the ringing in my left ear has gotten worse and louder". The events "the ringing in my left ear has gotten worse and louder" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (unspecified date) lost some hearing in the left ear, notes: He also performed an extensive hearing test and I have lost some hearing in the left ear; Ear, nose and throat examination: (05Oct2021) tinnitus, notes: I had an ENT confirm in an appt on 05Oct2021 that I have tinnitus. Therapeutic measures were not taken as a result of tinnitus, condition aggravated. Clinical course: The patient had not take any other vaccine in four weeks. The patient had not Covid prior vaccination and had not test Covid post vaccination. The patient had no known allergies.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 at 11:00 as dose 2, single (Lot number: EW0158) at the age of 35 years, in right arm 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After completing five days of treatment, symptoms returned. On 06Jul2022, she started Paxlovid for covid19 treatment and stopped on 11Jul2022. On 12Jul2022 at 07:30 AM, she had symptoms. After completing five days of treatment, symptoms returned. No treatment received. It was unknown if event recovered or not.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on 01Jul; tested positive on 01Jul; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 35-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "tested positive on 01Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) positive; (11Jul2022) positive; (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxolovid from 01Jul2022 to 06Jul2022 administered orally. Clinical Information: COVID rebound: Patient developed symptoms on 01Jul and tested positive on 01Jul and began treatment with Paxlovid at the recommended doses for 5 days including on July 6. Patient became asymptomatic about day 4 today 5. Patient tested negative around day 7 but had recurrent symptoms beginning yesterday 11Jul2022 and tested positive via home antigen test. Presumptively, we assume that this represents a rebound COVID situation. Recommended he needed to restart isolation as recommended.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  all the reported events Drug ineffective  ,covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Age: 70.0
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) (Nurse).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Batch/Lot number: unknown), on 04Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "morbid obesity" (unspecified if ongoing); "htn" (unspecified if ongoing), notes: htn; "depression" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ZOLPIDEM oral, start date: 04Feb2021; ABILIFY oral, start date: 01May2020; METOPROLOL oral, start date: 15Oct2019; WELLBUTRIN, start date: 03Aug2020; SIMVASTATIN oral, start date: 05Oct2020, stop date: 29Jun2022; LOSARTAN oral, start date: 01Feb2021; ZETIA oral, start date: 01May2021. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive, notes: rebound of COVID symptoms after paxlovid treatment with recurrence of positive antigen test. Therapeutic measures were taken as a result of covid-19. Clinical course: The patient received treatment for COVID-19 with paxlovid, oral (start date: 30Jun2022, stop date: 04Jul2022). The patient had rebound of COVID symptoms after paxlovid treatment with recurrence of positive antigen test occurred on 09Jul2022. The patient had no known allergies, The patient had other medications within 2 weeks of starting COVID-19 treatment.  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 available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and vaccination failure
Age: 37.0
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 non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). 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. The patient received paxlovid as COVID 19 Treatment.  Clinical Course: The patient did not received any other medications within 2 weeks of starting COVID-19. The patient previously received a COVID-19 Vaccine  No follow-up attempts are possible. No further information is expected.; 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 drug ineffective (LOE) cannot be ruled out.
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 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy:amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: Covid-19 treatment; (Jul2022) Negative, notes: Day 7 of paxlovid; (Jul2022) Positive, notes: Tested positive with mild symptoms on Day 10; (Jul2022) Negative, notes: on Day 5 of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient was treated with anti-viral product for COVID 19 Treatment (Paxlovid) from 03Jul2022 to 07Jul2022. Patient was tested negative on Day 5 of paxlovid and again 2 days later (Day 7). No symptoms from Day 5-9. Tested positive with mild symptoms on Day 10. Covid rebound on 12Jul2022 and treatment was not received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 at 13:15 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 03Mar2021 at 15:30 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Apr2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "chronic migraine" (unspecified if ongoing), notes: other medical history: chronic migraine; "prediabetes" (unspecified if ongoing), notes: other medical history: prediabetes; "high body weight" (unspecified if ongoing), notes: other medical history: high body weight; "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: 5 HTP [OXITRIPTAN], start date: 01May2022; KAVINACE ULTRA PM, start date: 08Feb2022, stop date: 03Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive, notes: Tested positive on both "Day 5 and "Day 9"; (06Jul2022) Positive, notes: Tested positive on both "Day 5 and "Day 9"; (11Jul2022) Positive, notes: Still testing positive on "Day 14."; (27Jun2022) Positive, notes: Received Paxlovid 27Jun2022, on the same day I tested positive for COVID-19 using home test ("Day 0"). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product Paxlovid, Brand: Pfizer, treatment started on 04Jul2022 to Treatment stopped 09Jul2022 for Indication treatment of COVID-19. If vaccine received: Yes. Other medication in 2weeks: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound COVID symptoms on 7/12/2022; Rebound COVID symptoms on 7/12/2022; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose 3, (booster) single (Batch/Lot number: unknown) at the age of 47 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: "PTG20210 mutation" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Heparin, reaction(s): "known allergies:Heparin"; Topamax, reaction(s): "known allergies:Topamax". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Rebound COVID symptoms on 7/12/2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment as Paxlovid orally from 02Jul2022 to 06Jul2022 for Covid-19. Patient did not received any other medication within 2 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 62.0
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.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2022 as dose 3 (booster), single (Lot number: F159884) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Mar2021 as dose 1, single (Lot number: 046A21A), in left arm and on 28Apr2021 as dose 2, single (Lot number: 041B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2005 (unspecified if ongoing), notes: Other medical history: Breast cancer (2005); "malignant melanoma", start date: 2019 (unspecified if ongoing), notes: Other medical history: malignant melanoma (2019); "Known allergies: iodine dye (IVP)" (unspecified if ongoing), notes: Known allergies: iodine dye (IVP); "Known allergies: pistachios" (unspecified if ongoing), notes: Known allergies: pistachios; "Known allergies: bee venom" (unspecified if ongoing), notes: Known allergies: bee venom. Concomitant medication(s) included: RED YEAST RICE, start date: 12Mar2022; COQ10 [UBIDECARENONE], start date: 12Mar2022; CINNAMON, start date: 12Mar2022; CHROMIUM, start date: 12Mar2022; BUPROPION HCL ER, start date: 02Feb2022; L-THYROXINE [LEVOTHYROXINE SODIUM], start date: 22Feb2022. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: Known allergies: Erythromycin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (09Jul2022) Negative, notes: positive test on 12Jul2022 after testing negative on 09Jul2022; (12Jul2022) Positive, notes: positive test on 12Jul2022 after testing negative on 09Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Vaccine brand unknown, Vaccine lot unknown and Vaccine dose number unknown: False), on 14Apr2022 as dose 4 (booster), single (Lot number: FJ4989) 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: "Type II DM" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "HTN" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: Product: COVID 19 Treatment. Other medication details: Other medication in 2weeks product: Paxlovid EUA, Other medication in 2weeks start date: 26Jun2022, Other medication in 2weeks stop date: 01Jul2022, Other medication in 2weeks administrator route: oral, Adverse event: COVID-19 Rebound. Adverse event start date: 06Jul2022. AE treatment: Supportive care, prescription med. Known allergies: No.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19  and Drug ineffective
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient 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 patient had no allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "SARS-CoV-2 infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: paxlovid, from 02Jul2022 to 06Jul2022, for 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 at 15:00 as dose 1, single (Lot number: EL9263), in right arm, on 21Mar2021 at 15:00 as dose 2, single (Lot number: EN6208), in right arm and on 17Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FJ1611) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: No Other medication in 2weeks, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date was 07Jul2022, Treatment stop date was 05Jul2022, Indication: Treatment of COVID-19. Adverse event: Muscle tremors and cramps have n feet, Adverse event start date: 10Jul2022, Adverse event start time: 12:00 AM, If patient recovered: Recovering, If treatment ae: No, Other medical history: None.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 at 13:30 as dose 1, single (Lot number: EN6207), in left arm, on 11Apr2021 at 14:30 as dose 2, single (Lot number: ER8729), in left arm, on 25Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 15May2022 at 16:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Patient has no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022 at 10:00, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound Covid 5 days after taking Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid ( Lot number GA3595) started on 03Jul2022 and stopped on 07Jul2022, for the Treatment of COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 31Mar2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Nov2021 at 16:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fatty Liver" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, 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) Unknown results, notes: Indication: Treatment of COVID-19; (12Jul2022) Positive, notes: Positive home test results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergies. Positive home test results and recurrence of symptoms after 7 days. Patient was not received other medication in 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies- seasonal" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 02Jul2022, outcome "not recovered"; VACCINATION FAILURE (medically significant) with onset 02Jul2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (10Jul2022) Negative; (12Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid from 02Jul2022 to 08Jul2022 for covid-19. Patient received Mucinex, afrin spray, sore throat, spray from 03Jul2022 to 05Jul2022. Covid rebound (symptoms came back and tested positive on antigen test), after completing 5 day Paxlovid treatment and receiving negative antigen test two days before testing positive.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8780), in left arm, on 22Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 19Nov2021 as dose 3 booster, single (Lot number: FD0809) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies:Sulpha meds" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other Allergy medication in two weeks of vaccination. The patient received Paxlovid from 24Jun2022 to29Jun2022 to treat COVID 19.  No follow-up attempts are possible, no information is necessary.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 19Jan2021 as dose 2, single (Lot number: EL3249), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 06Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: TERAZOSIN; CLARITIN [LORATADINE]; PEPCID [FAMOTIDINE]; METFORMIN; HCTZ; MULTI VITAMINS.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took Anti-viral drug Paxlovid from 14Jun2022 to 19Jun2022 for treatment of COVID-19.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 32-year-old male patient 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID-19 treatment; (07Jul2022) Negative, notes: Tested negative after 5-day treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included COVID 19 Treatment from 02Jul2022 to 06Jul2022, orally. Clinical course: The patient had rebound covid after completing the paxlovid. Tested negative after 5-day treatment. Symptoms reappeared about 5 days after completing treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 41.0
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 contactable reporter (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right 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: "Gastric bypass" (unspecified if ongoing); "Lyme disease chronic" (unspecified if ongoing). Concomitant medication included: CEFDINIR oral, start date: 02Jul2022, stop date: 11Jul2022. Past drug history included: Doxycycline, reaction: "Allergy: Doxycycline"; Augmenting, reaction: "Allergy: augmenting"; Clindamycine, reaction: "Allergy: clindamycine"; Iodine, reaction: "Allergy: Iodine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included received Anti viral drug Paxlovid orally from 06Jul2022 to 11Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: en6202), in left arm, on 22Mar2021 as dose 2, single (Lot number: En6204), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: ff2587), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: fl3197) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "COVID 19 Treatment". 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.  Clinical course: Anti-viral details for COVID 19 Treatment included paxlovid, treatment start date: 04Jul2022, treatment stop date: 08Jul2022.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 14Apr2021 as dose 2, single (Lot number: EP6955), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 24Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 58 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "recovering" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive, notes: Nasal Swab; (11Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: No other vaccine in four weeks and Covid prior vaccination. Patient had Covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2020 at 12:00 as dose 1, single (Lot number: EH9899), in left arm, on 07Jan2021 at 12:00 as dose 2, single (Lot number: EL1284), in left arm, on 01Sep2021 at 14:30 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 08Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FK9896) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Metabolic syndrome" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Hypertriglyceridemia" (unspecified if ongoing); "NASH" (unspecified if ongoing); "preDM" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 13Aug2020, stop date: 12Jul2022; SEMAGLUTIDE, start date: 07Nov2021, stop date: 12Jul2022; ROSUVASTATIN, start date: 13Aug2020, stop date: 12Jul2022; FENOFIBRATE, start date: 13Aug2020, stop date: 12Jul2022; CITALOPRAM, start date: 13Aug2020, stop date: 12Jul2022; TRAZODONE, start date: 13Aug2020, stop date: 12Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  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 reported LOE events and the suspect drug cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 77 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: "Moderate high blood pressure" (unspecified if ongoing), notes: Moderate high blood pressure; "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Negative; (10Jul2022) Negative; (12Jul2022) Positive, notes: Positive again on 12Jul morning. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Other medication in 2weeks: No. Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 03Jul2022, Treatment stop date: 07Jul2022. Adverse event: I start Paxlovid treatment on 03Jul and finished on 07Jul. Test negative on 08Jul and 10 but Positive again on 12Jul morning. If treatment ae: No. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Indication: Treatment of COVID-19; Indication: 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 36-year-old male patient 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 (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication: Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical information: Patient did not took other medication in 2 weeks and took Plaxovid as covid-19 Treatment from 25Jun2022 to 30Jun2022.
Age: 54.0
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 05Mar2021 as dose 2, single (Lot number: EN6202), in left arm and on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colorectal cancer", start date: 2017 (unspecified if ongoing), notes: Other medical history: Colorectal cancer (surgery required but no chemo) 2017. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: I still have reoccurring symptoms in between days of no symptoms butI have not tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had been experiencing various Covid symptoms on and off since completing the paxlovid treatment (10 days). Patient completed the medication on 30Jun2022 and patient still had reoccurring symptoms in between days of no symptoms but had not tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Pyrexia
Clinical narrative: her son who was breastfeeding; Fever which lasted less than 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient was exposed to BNT162b2 (COMIRNATY), transmammary, administration details for the mother: as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's and the mother's relevant medical history and concomitant medications were not reported. The mother's vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown). The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "her son who was breastfeeding"; PYREXIA (non-serious), outcome "recovered", described as "Fever which lasted less than 24 hours".  Additional information: Respondent received the Comiranty vaccine while breastfeeding after the second dose the respondent felt tired and achy. Additionally, her son who was breastfeeding developed a fever which lasted less than 24 hours. Other medications, Family History, Social History, Other relevant information: unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200022008 same drug, different patient and different event.;
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bmi>30" (unspecified if ongoing), notes: Bmi>30. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022 at 11:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) > 30; SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Treatment of COVID-19; (unspecified date) Negative; (12Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had symptoms while having negative test results then tested positive again many days after ending treatment. Patient did not received any other vaccine in two weeks.Device times tamp: 13Jul2022. No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Fatigue, Gait disturbance, Somnolence
Clinical narrative: excruciating low back pain; difficulty walking; significant fatigue; lot of sleeping; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "total knee replacement", start date: 2012, stop date: 2012. No known allergies. Concomitant medication(s) included: WELLBUTRIN; VITAMIN E [TOCOPHEROL]; ZINC; CHLORTHALIDONE and multi vitamin. There was no other vaccine in four weeks. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot number: ER8737, Administrator route: Intramuscular, Administrator time: 04:45 PM, Vaccine location: Left arm), administration date: 02Apr2021, when the patient was 52-year-old, for Covid-19 immunization, reaction(s): "muscle aches especially in my low back"; BNT162b2 (DOSE 1, SINGLE, Lot number: EN6204, Administrator route: Intramuscular, Administrator time: 04:45 PM, Vaccine location: Left arm), administration date: 12Mar2021, when the patient was 52-year-old, for Covid-19 immunization. The following information was reported: BACK PAIN (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "excruciating low back pain"; GAIT DISTURBANCE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "difficulty walking"; SOMNOLENCE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "lot of sleeping"; FATIGUE (medically significant) with onset 10Oct2021 at 01:00, outcome "recovered", described as "significant fatigue". The events " excruciating low back pain", "difficulty walking", "significant fatigue" and "lot of sleeping" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of back pain, gait disturbance, fatigue, somnolence. Treatment was Muscle relaxer. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events cannot be completely excluded based on temporal association and known drug safety profile The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate