chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: No adverse event; The vaccine was given BUD; Administration error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was given BUD), PRODUCT ADMINISTRATION ERROR (Administration error) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     It was also unknown if there was any acute illness at the time of vaccination or any chronic or long standing health conditions of the patient.     On 27-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was given BUD) and PRODUCT ADMINISTRATION ERROR (Administration error). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was given BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown and PRODUCT ADMINISTRATION ERROR (Administration error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was given BUD) and PRODUCT ADMINISTRATION ERROR (Administration error).    No concomitant medication was reported. It was unknown if the patient was ever diagnosed with or tested COVID-19 positive.  BUD date was given as 23-Jun-22. Reporter further reported that as per Moderna, the lot was still active and patient need not to be re-vaccinated.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-599989 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-599989:Master case
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was given one day past BUD) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was given one day past BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was given one day past BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was given one day past BUD). No concomitant medication was reported. It was unknown that the patient ever got COVID-19. BUD date was given as 23-Jun-22. No treatment information were provided. This case was linked to MODERNATX, INC.-MOD-2022-599989 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-599989:Master case
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had anti viral Paxlovid treatment for COVID 19 started on 19Jul2022 and stopped on 24Jul2022. The patient's dose 4 lot no. was now available/provided to reporter at the time of report completion. The patient had rebound of covid symptoms after day 10. The patient had adverse event on 27Jul2022 at 12:15 pm, of which outcome was recovering. No other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jun2022 as dose number unknown, single (Lot number: FM9992) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: SYNTHROID; WIXELA INHUB. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive, notes: Positive 19Jul2022; (23Jul2022) Negative, notes: negative 23Jul2022; (27Jul2022) Positive, notes: positive again 27Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Rebound COVID infection. Positive 19Jul2022, negative 23Jul2022, positive again 27Jul2022. Very mild symptoms both times
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: Paxlovid relapse after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 18Jul2022 to 24Jul2022 for COVID 19.  Clinical course: The patient received other medication in 2weeks Ssri, other medication in 2week brand Lexapro.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
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) (Nurse) from product quality group. The reporter is the patient. A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EK5730), on 01Jan2021 as dose 2, single (Lot number: EK4176) and on 29Sep2021 as dose 3 (booster), single (Lot number: EW0170) at the age of 43 years for Covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, stop date: 10Jul2022; FLUOXETINE; ATIVAN; SPIRONOLACTONE; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The event "Covid-19 treatment" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Negative, notes: in the morning. went to ER on 25Jul and nothing has been found. Covid antigen test is negative also; (unspecified date) Positive, notes: Treatment of COVID-19; (10Jul2022) Unknown results, notes: test on 10Jul. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Other medication in 2 weeks product are Albuterol, stop date: 10Jul2022; FLUOXETINE; ATIVAN; SPIRONOLACTONE; ALBUTEROL [SALBUTAMOL]. On 24Jul (day 14 after Covid+ test on 10Jul) I began experiencing tachycardia, fatigue, tingling in my arms, mild cough restarted, no appetite and shakiness in the morning. Went to ER on 25Jul and nothing has been found. Covid antigen test is negative also. Today is day 4 of these symptoms. Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 73.0
Sex: M
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) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP7533), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: Aug2018, stop date: 19Jul2022; VALSARTAN, start date: Aug2018; ASPIRIN 81, start date: Aug2018; VITAMIN D3, start date: Aug2018.  The following information was reported: VACCINATION FAILURE (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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Took vaccine. Took other medication in 2 weeks. The reason to answer all these questions was to say patient  had a Covid rebound occurrence from 21Jul2022 to 27Jul22. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Indication: Treatment of COVID-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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: "Allergies/ Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had no other vaccine in two weeks. Report about COVID treatment: Yes  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Aug2021 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 27Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and on 11May2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Common variable immunodeficiency" (unspecified if ongoing); "ehlers danlos syndrome" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "autistic" (unspecified if ongoing); "Known allergies: Sulfa drug" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Positive; (23Jun2022) Negative, notes: day 6; (24Jun2022) Negative, notes: day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with ritonavir (PAXLOVID), from 12Jun2022 to 17Jun2022 for covid-19 treatment.  Clinical course: The patient had adverse event Rebound COVID. Symptoms largely alleviated early in Paxlovid course. By day 6, tested negative on RAT (rapid antigen test), negative again on day 7. Then symptoms returned day 8 and tested positive with mild symptoms through day 14.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 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: "Generalized anxiety disorder" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Doxycycline, reaction(s): "Known allergies: Doxycycline"; Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Day 3 of illness; Negative, notes: Day 4 of illness; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was initiated as treatment from 22Jul2022 to 24Jul2022. Was unable to finish course after 2 full days of treatment due to side effects. Tested negative on home antigen day 3 and Day 4 of illness. On Day 6 she started having a cough, itchy throat, and runny nose. Tested again and was positive on home antigen test. Patient also took other medications in 2 weeks.  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 , there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19 and the suspect drug BNT162b2 .
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955) and on 12Apr2021 as dose 2, single (Lot number: EP6955) at the age of 55 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. The patient had received paxlovid, oral (lot number: GC4800) for COVID 19 treatment on 27Jul2022 and stop on 27Jul2022.
Age: 69.0
Sex: F
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 69 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 Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Lot number: EW0177) intramuscular, on 18Jun2021 as dose 2, single (Lot number: EW0177) and on 15Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 16 years intramuscular 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 27Jul2022, outcome "recovering" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive, notes: covid test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
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) (Other HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "known allergies : Sulfa" (unspecified if ongoing), notes: known allergies : Sulfa. Concomitant medication(s) included: LISINOPRIL; SERTRALINE received in two weeks. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies : Morphine. 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". 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 with anti viral medication, Paxlovid. Treatment start date was 27Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: ENH6203), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Dec2014, stop date: 28Jul2022. 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". Therapeutic measures were taken as a result of vaccination failure, covid-19. from 26Jul2022.taken Paxlovid with lot 2815223.  No follow-up attempts are needed. No further information is expected.
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) (Nurse) from product quality group. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EW0182) 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: "Gerd" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient Age group was reported as Adult (18-64 Years). Patient did not receive any other medication within 2 weeks of vaccination. Paxlovid (Lot no Lot number: GD7763) was used as treatment for Covid-19 from 27Jul2022 to 28Jul2022. Patient experienced Severe abdominal cramping and pain and watery diarrhea after paxlovid.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jul2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 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 was not reported. There were no concomitant medications. The patient did not receive other medication in two weeks. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin; Levaquin, reaction(s): "known allergies: Levaquin", notes: known allergies: Levaquin. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 11Jul2022 to 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included/other medication in 2 weeks: ASPIRIN (E.C.); ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 27Jul2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive, notes: On 27Jul patient had recurrence of sore throat, headache and congestion and tested positive again for COVID19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with anti-viral and details included: brand: Paxlovid, treatment start date: 18Jul2022, treatment stop date: 22Jul2022, indication: Treatment of COVID-19, administrator route: Oral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
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 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL9261), on 09Feb2021 as dose 2, single (Lot number: EN9581), on 29Aug2021 as dose 3 (booster), single (Lot number: EW0185) and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetic" (unspecified if ongoing), notes: other medical history: type 1 diabetic. Concomitant medication(s) included: INSULIN; VANCOMYCIN; ELIQUIS; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: After testing positive 13Jul2022; (22Jul2022) Negative, notes: tested negative on 22Jul2022; (27Jul2022) Positive, notes: Testing positive again on 27Jul2022. Therapeutic measures were taken as a result of covid-19. Clinical course included Adverse event: Anti-viral details: product=COVID 19 Treatment. Treatment start date was 13Jul2022, Treatment stop date was 18Jul2022.  If treatment ae: No, known allergies: no, other medical history: type 1 diabetic, after testing positive 13Jul2022 on and taking 5 days of Paxlovid tested negative on 22Jul2022. Tested positive again on 27Jul2022  No follow-up attempts are possible. No further information is expected.
Sex: M
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 64-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "CHTN" (unspecified if ongoing); "DMII" (unspecified if ongoing); "HLD (hypersensitivity lung disease)" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; METFORMIN; ZOLOFT. 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, notes: antigen home test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the patient was contracting Covid (Coronavirus disease) last month; the patient was contracting Covid (Coronavirus disease) last month; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 41-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in 2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL unknown taken for rheumatoid arthritis, start date: Sep2019, stop date: 2020; ENBREL unknown; PREDNISONE [PREDNISONE ACETATE] unknown; SULFASALAZINE unknown. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "the patient was contracting Covid (Coronavirus disease) last month". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: the patient was contracting Covid (Coronavirus disease).  Clinical course: The patient was contracting Covid (Coronavirus disease) last month and got a Pfizer booster today on 15Jul2022. It was clarified the patient received third COVID vaccines prior to this in the span of three months. first dose was the Moderna vaccine, second and third doses were the Pfizer vaccine.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201019611 same patient, different doses of vaccine different AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), on 08Feb2021 as dose 2, single (Batch/Lot number: unknown), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.   Clinical course: Reportedly, the patient received anti-viral COVID 19 Treatment with Paxlovid from 18Jul2022 to 23Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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 was not reported. Concomitant medication(s) included: WELLBUTRIN; SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: getting a positive test again after testing negative; Negative, notes: getting a positive test again after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, Adverse event: Rebound infection- symptoms returned 5 days after treatment and getting a positive test again after testing negative. Adverse events started on 28Jul2022 and no treatment received for AE. Patient received Paxlovid from 19Jul2022 to 23Jul2022 for treatment of COVID-19.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 07Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 22Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 02May2022 as dose 4 (booster) , single (Lot number: FM0698) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (24Jul2022) positive, notes: positive covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was reported that on 24Jul, 5 days after patient took the last dose of Paxlovid, patient  experienced what her doctor said was "Covid Rebound." Scratchy throat, stuffy nose, fever and positive covid test.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 1, single (Lot number: EL8982), on 06Mar2021 at 12:00 as dose 2, single (Lot number: EN6199) and on 05Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 67 years for Covid-19 immunisation; CoviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 045L2IA) for Covid-19 immunisation. The patient's relevant medical history included: "Nephrectomy" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication was for Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: The patient did not received other medication in 2 weeks. Anti-viral treatment given for COVID-19, treatment start date on 15Jul2022, treatment stop date on 21Jul2022. Follow-up attempts are completed. No further information is expected. Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID positive test result; Negative, notes: Then on day 9, a negative test result; Positive, notes: COVID symptoms returned and positive test result 12 days later. 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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 was not pregnant at time of vaccination. 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) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2weeks was unknown. The patient received treatment brand=Paxlovid, treatment start date=20Jul2022, treatment stop date=25Jul2022. It's actually a GOOD event. I've had a bump on my tongue that was to be removed in a couple weeks. Within a day of finishing the Paxlovid, the bump is completely gone. It was the size of a skin tag and it's gone. It's possible that it was HPV and that the antiviral cured it. Just thought you should know.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
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 33-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 3 (booster) ,single at the age of 32 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: "Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: DULERA; MONTELUKAST; ALLEGRA; AZELASTINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 26.0
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 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8733), on 16Apr2021 as dose 2, single (Lot number: EW0151) and on 26Aug2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: PENTASA, start date: 01Feb2006; 6-MP, start date: 01Oct2007; Aurobindo (birth control pill) on 01Sep2013; Vitafusion multivitamin on 01Jun2017. Past drug history included: Sulfa drugs, reaction(s): "Known allergies: Sulfa drugs". The following information was reported: VACCINATION FAILURE (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) Positive; (27Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient received other medication in 2weeks. Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 18Jul2022, Treatment stop date: 22Jul2022.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; 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 15Apr2022 as dose 1, single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 24 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (23Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks was Nikki Birth Control. Patient received treatment of carvedilol and amlodipine Patient did not have covid prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.