chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: It was reported as vaccine received as yes. The patient had no other medication in 2 weeks. The patient was treated for COVID-19 with antiviral Paxlovid orally from 26May2022 to 01Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive (symptoms including postnasal, cough, fatigue, aches) 15May; Tested positive (symptoms including postnasal, cough, fatigue, aches) 15May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 2 (booster), single (Lot number: 3203080) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Major depression" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing), notes: other medical history: Sulfa allergy; "borderline blood pressure" (unspecified if ongoing), notes: other medical history: borderline blood pressure; "hyperthyroid" (unspecified if ongoing), notes: other medical history: hyperthyroid; "obesity" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Apr2016; PROZAC, start date: Apr2017; WELLBUTRIN, start date: Feb2019; HYDROCHLOROTHIAZIDE, start date: Apr2019; LISINOPRIL, start date: May2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "unknown" and all described as "Tested positive (symptoms including postnasal, cough, fatigue, aches) 15May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive; (23May2022) negative; (27May2022) Positive, notes: Tested positive again; (03Jun2022) positive, notes: Still testing positive with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was taking other medications within 2 weeks of starting COVID-19 treatment. Patient tested positive for COVID-19 on 15May2022 with symptoms including postnasal, cough, fatigue, aches. She started Pavloxid on 16May2022. She experienced significant bitter flavor that lasted around 6 hours whenever she took the pills. She finished Pavloxid on 20May2022. She was tested negative on 23May2022 and tested positive again on 27May2022, with symptom recurrence (postnasal, cough, fatigue, aches). She was still testing positive with symptoms on 03Jun2022.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dysgeusia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive (symptoms including postnasal, cough, fatigue, aches) 15May; Tested positive (symptoms including postnasal, cough, fatigue, aches) 15May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 2 (booster), single (Lot number: 3203080) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Major depression" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing), notes: other medical history: Sulfa allergy; "borderline blood pressure" (unspecified if ongoing), notes: other medical history: borderline blood pressure; "hyperthyroid" (unspecified if ongoing), notes: other medical history: hyperthyroid; "obesity" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Apr2016; PROZAC, start date: Apr2017; WELLBUTRIN, start date: Feb2019; HYDROCHLOROTHIAZIDE, start date: Apr2019; LISINOPRIL, start date: May2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "unknown" and all described as "Tested positive (symptoms including postnasal, cough, fatigue, aches) 15May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive; (23May2022) negative; (27May2022) Positive, notes: Tested positive again; (03Jun2022) positive, notes: Still testing positive with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was taking other medications within 2 weeks of starting COVID-19 treatment. Patient tested positive for COVID-19 on 15May2022 with symptoms including postnasal, cough, fatigue, aches. She started Pavloxid on 16May2022. She experienced significant bitter flavor that lasted around 6 hours whenever she took the pills. She finished Pavloxid on 20May2022. She was tested negative on 23May2022 and tested positive again on 27May2022, with symptom recurrence (postnasal, cough, fatigue, aches). She was still testing positive with symptoms on 03Jun2022.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm and on 29Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "1st and 2nd dose: Moderna/ 3rd dose: Pfizer" (unspecified if ongoing), notes: 1st and 2nd dose: Moderna/ 3rd dose: Pfizer. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Negative; (04Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Vaccine lot unknown as it was not Available/provided to reporter at the time of report completion. The patient previously received a COVID-19 Vaccine. Patient previously had initial symptoms 23May2022 evening, no symptoms by 28May2022, negative antigen test on 31May2022. Patient took Paxlovid as treatment of COVID-19 from 24May2022 to 29May202 via oral route. Recurrence of mild sore throat (no fever) evening of 03Jun2022 and positive antigen test on 04Jun2022.  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 in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure. Concomitant medication(s) included: EFFEXOR XR; RISPERIDONE; AMLODIPINE. Past drug history included: Amoxycillin, reaction(s): "known allergies: Amoxycillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received Paxlovid for treatment of COVID-19, from 24May2022 to 28May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test negative, Suspected COVID-19
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: (Jun2022) negative, notes: Rebound of Covid two days after testing negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Anti viral details was Paxlovid for COVID 19 Treatment. Treatment start date was 25May2022 and treatment stop date was 30May2022. Indication was treatment of COVID 19. Vaccine lot unknown reason was misplaced or discarded. Rebound of Covid two days after testing negative. Patient took paxlovid which was stopped taking two days before she tested negative. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "other pulmonary issues, heart disease" (unspecified if ongoing); "allergies: Peanuts" (unspecified if ongoing); "allergies: dogs" (unspecified if ongoing); "allergies: feathers" (unspecified if ongoing); "allergies: dust" (unspecified if ongoing); "allergies: pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flexril, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 66-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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Jun2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient received Anti-viral medication for COVID 19 Treatment from 03Jun2022 to 04Jun2022. Patient experienced event metallic taste in mouth from 03Jun2022 at 12:00 am.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 2.0
Sex: M
Vaccine: PNC20
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: He had significantly larger than normal redness, swelling, and heat around injection site; He had significantly larger than normal redness, swelling, and heat around injection site; He had significantly larger than normal redness, swelling, and heat around injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (004756). The reporter is the parent.  A 3-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31May2022 as dose 5, single (Lot number: FJ2602) at the age of 2 years, in left thigh for immunisation; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), on 31May2022 as 3.7 ml (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: prevnar 13 (Dose 1: Prevnar 13, Lot# :AF5647, left thigh), administration date: 29Jul2019, for Immunization; prevnar 13 (Dose 2:Prevnar 13 , Lot# : AF5647, left thigh), administration date: 07Oct2019, for Immunization; prevnar 13 (Dose 3: Prevnar 13, Lot# : AG8356, left thigh), administration date: 19Dec2019, for Immunization; prevnar 13 (Dose 4: Prevnar 13, Lot# : CY4766, left thigh), administration date: 21Sep2020, for Immunization. The following information was reported: INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious), INJECTION SITE WARMTH (non-serious) all with onset 31May2022, outcome "unknown" and all described as "He had significantly larger than normal redness, swelling, and heat around injection site". Therapeutic measures were taken as a result of injection site erythema, injection site swelling, injection site warmth.  Additional Information: Caller states she is actually the parent of the three year old who was given Prevnar 20 at his pediatrician's office and she works in the medical field, states at the doctors office at the time of the vaccination a vaccine handout was not provided to her at the time, during the visit she remembered being told at the provider's office that the patient was due for Prevnar, the new updated shot, states that sentence stuck with her. Patient received the Prevnar 20 vaccine in his left thigh, states he had significantly larger than normal redness, swelling, and heat around injection site, states it was not serious but definitely more than normal, states he did not have a fever, but that the patient was tired and irritable afterwards, caller states she treated the patient with Tylenol on Tuesday evening and Wednesday evening after the vaccine. Caller states the child did take 3.7mL of children's Zyrtec morning 31May2022, the day of the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
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 non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient has no Known allergies. Concomitant medication(s) included: IBUPROFEN (within 2weeks of Covid vaccine). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24May2022, outcome "unknown", COVID-19 (medically significant) with onset 24May2022, outcome "not recovered" and all described as "COVID-19". Clinical Course: The patient was tested positive for Covid on 24May2022. Therefore, started to take the Paxlovid on the same day. After taking the Paxlovid pills, the patient was tested negative for Covid on 31May2022. However, she started to have runny nose again on 02Jun2022 so that she took another test on 03Jun2022.she tested positive again. The patient wanted to report this Covid rebound case. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: I was tested positive for Covid on 24May2022; (31May2022) Negative, notes: I was tested negative for Covid on 31May2022; (03Jun2022) Positive, notes: I took another test on 03Jun2022. I tested positive again. Therapeutic measures were taken as a result of covid-19 with Paxlovid from 24May2022 to 28May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was put on Paxlovid yesterday. He started the dose this morning, three tablets. He has a terrible taste in his mouth now.It was an acid like taste. The pharmacist didn't know much about it. The regular pharmacy he goes to didn't even carry it. He tested positive for Covid. He had all Pfizer Covid shots. He had Pfizer shots in the spring and had booster in Nov. He should have gotten another shot.  Caller did not wish to proceed with report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208), on 05Oct2021 as dose 2, single (Lot number: 301458A) and on 17Feb2022 as dose 3 (booster), single (Lot number: FL9266) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DELSYM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: Treatment drug included Paxlovid from 20May2022 to 26May2022. Other medication in 2weeks included the concomitant drugs mentioned above.
Age: 76.0
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) (Nurse). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 at 13:30 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Aug2021 at 14:30 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Borderline >cholesterol" (unspecified if ongoing); "constapaton" (unspecified if ongoing); "Fx of 3 ribs 8,9,10, 2021 we'll healed", stop date: 2021, notes: Fx of 3 ribs 8,9,10, 2021 we'll healed. 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: Unknown results, notes: Treatment of COVID-19. 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 04:00 as dose 1, single (Lot number: EN6208), in right arm, on 08Apr2021 at 04:00 as dose 2, single (Lot number: EP7533), in left arm and on 08Oct2021 at 03:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "food to shrimp" (unspecified if ongoing), notes: known allergies: food to shrimp. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 31May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I resulted positive of COVID in a rapid test; (unspecified date) Positive, notes: I decided to do rapid tested and results positive again; (27May2022) Negative, notes: after 9 days of isolation I have two negative rapid test 27May & 28May; (28May2022) Negative, notes: after 9 days of isolation I have two negative rapid test 27May & 28May. Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  Clinical course: Adverse event: Rebound COVID.I resulted positive of COVID in a rapid test, I consulted with my Dr and she recommended to took 5 days treatment Paxlovid, starting may 19/22 then after 9 days of isolation I have two negative rapid test 27May & 28May, however I started with minor symptoms after 5 days, minor cold symptoms during 1 day, I decided to do rapid tested and results positive again so was necessary begin with isolation for 7 days more. No additional problems it was total asymptotic rest of time. The patient did not received any other medications prior to 2 weeks. No other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Computerised tomogram, Drug ineffective, Suspected COVID-19
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6207) and on 14Apr2021 as dose 2, single (Lot number: ER8733) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Chronic Kidney Disease Stage 2 mild" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "gastric issues" (unspecified if ongoing); "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30May2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 30May2022, outcome "recovering" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: Blood cholesterol: High; Blood pressure measurement: High; Computerised tomogram: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Clinical course: She states her Covid-19 Vaccinations were Pfizer. She was fine after her first dose of the Covid-19 Vaccine but she had a reaction after her 2nd dose. She was out of commission for 10 days with an inner ear infection in both ears. Her rheumatologist said given her reaction and being a lupus player and trying the Benlysta Infusion, she should not receive any boosters for the Covid-19 Vaccine. The Benlysta Infusion was done at a center and she had her last one in March because the infusion was not working. Caller got Covid on Monday, 30May2022. She has today and tomorrow left to take Paxlovid that was prescribed.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Labyrinthitis, SARS-CoV-2 test
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6207) and on 14Apr2021 as dose 2, single (Lot number: ER8733) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Chronic Kidney Disease Stage 2 mild" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "gastric issues" (unspecified if ongoing); "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30May2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 30May2022, outcome "recovering" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: Blood cholesterol: High; Blood pressure measurement: High; Computerised tomogram: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Clinical course: She states her Covid-19 Vaccinations were Pfizer. She was fine after her first dose of the Covid-19 Vaccine but she had a reaction after her 2nd dose. She was out of commission for 10 days with an inner ear infection in both ears. Her rheumatologist said given her reaction and being a lupus player and trying the Benlysta Infusion, she should not receive any boosters for the Covid-19 Vaccine. The Benlysta Infusion was done at a center and she had her last one in March because the infusion was not working. Caller got Covid on Monday, 30May2022. She has today and tomorrow left to take Paxlovid that was prescribed.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0151), in left arm and on 29Apr2021 as dose 2, single (Lot number: EW0171) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Negative, notes: thrilled to test negative for Covid on 31May on two different rapid tests; (03Jun2022) Positive, notes: By today, 03Jun2022, my rapid tests were solidly positive once again; (Jun2022) Negative, notes: Over the next few days I went between testing negative; (Jun2022) Positive, notes: having a faint positive line on rapid tests. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no known allergies. The patient did not receive other medication in 2 weeks. The patient reported Covid rebound. The patient took Paxlovid and was thrilled to test negative for Covid on 31May2022 on two different rapid tests, after the patient finished course of Paxlovid. Over the next few days, the patient went between testing negative and having a faint positive line on rapid tests. Assumed it was clearing her system. By today, 3Jun2022, the patient rapid tests were solidly positive once again. The patient received Paxlovid for Treatment of COVID-19 on 26May2022 and stopped on 30May2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 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 09Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : treatment start date: 19May2022, treatment stop date:24May2022.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid symptoms rebounded, test came positive after 5 days of negative; Covid symptoms rebounded, test came positive after 5 days of negative; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-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. No Other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid symptoms rebounded, test came positive after 5 days of negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: test came positive after 5 days of negative; Negative, notes: test came positive after 5 days of negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Covid; Breakthrough Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 54-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EJ1685), in left arm, on 23Mar2021 as dose 2, single (Lot number: EJ1685), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: EP6955), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient did not have COVID prior to vaccination. Concomitant medication(s) included: LOSARTAN. Past drug history included: Erthromyocin, reaction(s): "Allergy". The patient did not receive any other vaccine in four weeks prior to vaccination.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "recovered" and all described as "Breakthrough Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient was tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, vaccination failure of the suspected vaccine BNT162B2 cannot be completely excluded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contacted Covid in May2022; Contacted Covid in May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), in right arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in right arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FF25989) at the age of 50 years, in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccine within four weeks prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "recovered" (2022) and all described as "Contacted Covid in May2022". The event "contacted covid in may2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted COVID-19; Contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm; in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm; and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, all intramuscular for COVID-19 immunisation. The patient's relevant medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovered" and all described as "Contracted COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 PCR nasal swab: on 19May2022 (as reported) and was positive. Therapeutic measures were not taken as a result of drug ineffective or COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: 30MAR2021, Date(s) of administration of vaccine : 23-May-2022; Received expired vaccine beyond the 30 day refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator :  30MAR2021, Date(s) of administration of vaccine : 23-May-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator :  30MAR2021, Date(s) of administration of vaccine : 23-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator :  30MAR2021, Date(s) of administration of vaccine : 23-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The vial was initially stored in the refrigerator on 30-MAR-2021. The vial did not undergo any temperature excursions. The patient received second booster dose. No treatment drug was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was exposed to room temperature range for 27.5 hours; administration of vaccine from prefilled syringe drawn for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of vaccine from prefilled syringe drawn for more than 12 hours) and PRODUCT STORAGE ERROR (vial was exposed to room temperature range for 27.5 hours) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 037A22B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2022 at 10:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 03-Jun-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of vaccine from prefilled syringe drawn for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was exposed to room temperature range for 27.5 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of vaccine from prefilled syringe drawn for more than 12 hours) and PRODUCT STORAGE ERROR (vial was exposed to room temperature range for 27.5 hours) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that the patient was administered with an expired vaccine in a prefilled syringe drawn at 7:00am on 02-Jun-2022 was given to patient 03-Jun-2022 at 10:30am. This would have been the patient's first dose. The total amount of time the vial was exposed to room temperature range (8 to 25 degree C= 46 to 77 degree F) was 27.5 hours. The vial did not undergo any temperature excursions. No treatment medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to patient after morethan 24 hours of vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after morethan 24 hours of vial puncture) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2022 at 1:45 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after morethan 24 hours of vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after morethan 24 hours of vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 19-MAY-2022, the vial was initially stored in refrigerator and on 31-MAY-2022 at 8.55 AM the vial was initially punctured.  On 01-JUN-2022 at 1:45 PM, vaccine was administered to patient and vial was stored in fridge post puncture and vial didn't undergo any temperature excursions.  Patient received second booster dose of Moderna COVID-19 Vaccine and patient has not reported any adverse reactions to expired dose.  Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound 8 days after finished the 5 day course; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound 8 days after finished the 5 day course) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Batch/Lot No: ER8732  Location of injection: Arm Left) on 24-Mar-2021 and Pfizer / BioNTech (Batch/Lot No: Ew0775  Location of injection: Arm Left) on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy (Sulfa). Concomitant products included LEVONORGESTREL (MIRENA) and TOPIRAMATE for an unknown indication.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound 8 days after finished the 5 day course). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound 8 days after finished the 5 day course) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient taking any other medication within 2 week of starting covid-19 treatment.  Company comment- This spontaneous case concerns a 42-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient complained of rebound 8 days after finishing the 5-day course of Paxlovid. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 42-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient complained of rebound 8 days after finishing the 5-day course of Paxlovid. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.