chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound COVID; Rebound COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 01May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for COVID-19 immunization; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medications included: ADDERALL; ALBUTEROL [SALBUTAMOL]; LEXAPRO. Past drug history included: Effexor, reaction(s): "Drug allergy", notes: made her super agitated and hyper; Effexor, reaction(s): "Agitated". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Rebound COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Negative; (29Jun2022) Positive; (08Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: The patient had symptoms and tested positive on 29Jun2022. She started Paxlovid on the same day and took all her doses on schedule. She had mild to medium symptoms, with worst symptoms from 30Jun2022 to 02Jul2022. The last of her Paxlovid was on 03Jul2022 and was feeling much better. On 04Jul2022, she was just tired. On 05Jul2022, she felt great and tested negative. On 06Jul2022, she felt great too. On 07Jul2022, she woke up with sore throat again, tired, bad headache all day, but she was able to work. On 08Jul2022, she woke up feeling even worse, with symptoms progressing all day. The patient felt sick as she did on days 0-2 of the initial infection, possibly even worse. She decided to test again on a Binax test, and it was a very strong line of positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 15May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left leg 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: "Type 1 DM" (unspecified if ongoing). The patient took concomitant medications. 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: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient had no known allergies. The patient had other medication in 2 weeks since vaccination. Paxlovid was given as treatment from 30Jun2022 to 04Jul2022. It seems patient had rebound symptoms: aches, chills, sore throat, mild fever (99.2-99.5F), after taking paxlovid.  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 Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
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 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: En6199), in right arm, on 27Mar2021 as dose 2, single (Lot number: Ep6955), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: Ff2590), in right arm and on 14Jun2022 as dose 4 (booster), single (Lot number: Fj4989) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Stenosis" (unspecified if ongoing); "arthritis in neck" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive; (09Jul2022) Postive, notes: tested positive again, today and the test registered positive, very quickly. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: 6 days after completing the Paxlovid, and progressively feeling better every day during those days, my symptoms returned and I felt as I did when I first got sick, sneezing, congestion, coughing, headache, low grade fever and diarrhea. I tested positive again today and the test registered positive very quickly. Now I am having to start isolation all over again and exposed friend I was around on day 11 thinking I was well.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 62-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 at 13:15 as dose number unknown, single (Lot number: ER8727) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme" (unspecified if ongoing); "babesiosis" (unspecified if ongoing). No known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19: received Paxlovid for Covid-19 treatment from 30Jun2022 to 04Jun2022.
Age: 65.0
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (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". 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. Patient took anti viral Paxlovid started on 26Jun2022 and stopped on 30Jun2022. There were no known allergies. There were no other medication in two weeks.  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: 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 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Tested negative for 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received anti-viral treatment with Paxlovid from 02Jul2022 to 06Jul2022. Patient did not received other medication in 2 weeks. Paxlovid rebound, tested negative for 2 days after and then milder. Symptoms occurred and tested positive again  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/ tested positive for covid; Treatment of COVID-19/ tested positive for covid; 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 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 09:30 as dose 1, single (Lot number: EL9265), in right arm, on 25Feb2021 at 09:30 as dose 2, single (Lot number: EN6201), in right arm and on 27Sep2021 at 11:30 as dose 3 (booster), single (Lot number: FC83ifn) at the age of 76 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 at 12:00 as dose 4(booster, single) (Lot number: O48L21A), in right arm for covid-19 immunisation. Patient had no known allergies. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 16Sep2019, stop date: 30Jun2022; ROSUVASTIN, start date: 16Sep2019, stop date: 30Jun2022; MELOXICAM, start date: 16Sep2019, stop date: 30Jun2022; HYDROCHLOROTHIAZIDE, start date: 16Sep2019, stop date: 30Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19/ tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: still tested positive for covid on 08Jul2022, 9 days after my first positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Latex" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Tested and positive; (29Jun2022) negative, notes: I was previously negative 29Jun. 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.  Clinical information: Vaccine has been received and other medication in 2weeks too. Paxlovid has been taken on 22Jun2022 and stopped on 26Jun2022 for COVID 19 Treatment. Other medication details includes Armor Thyroid (brand=Armor). Patient was tested for COVID-19 and is positive. She was previously negative on 29Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 2 (booster), single (Lot number: FF2590) at the age of 43 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (non-serious), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) positive, notes: on day 1 of symptoms/positive test; (Jul2022) Negative, notes: Tested negative on day 4, 6 and 8; (Jul2022) Positive, notes: Light positive test on day 9; (Jul2022) Positive, notes: Started experiencing symptoms again on day 11 immediate dark positive test result on home rapid test on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information:Covid Rebound. Started Paxlovid treatment on day 1 of symptomspositive test. Symptomatic for 2 days (fever, aches, nausea, swollen lymph nodes) then symptom free by day 3. Completed the treatment. Tested negative on day 4, 6 and 8. Light positive test on day 9. Started experiencing symptoms again on day 11 immediate dark positive test result on home rapid test on day 11. New symptoms include swollen lymph nodes, fatigue, head congestion, headache. Anti viral details:product=COVID 19 Treatment,Treatment start date=28Jun2022,Treatment stop date=01Jul2022,Indication=Treatment of COVID-19. Other medication details:other medication in 2weeks product= Iron supplement,Other medication in 2weeks brand=Mini blood builder,Other medication in 2weeks start date=20Jun2022,Other medication in 2weeks stop date=27Jun2022
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, 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) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2022 as dose 1, single (Lot number: EL3246), in left arm, on 04Feb2021 as dose 2, single (Lot number: El9265), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: Fd8448), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens Syndrome" (unspecified if ongoing); "Lichen sclerosus" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; METHOTREXATE, start date: 06Feb2022, stop date: 26Jun2022. 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: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 which included paxlovid.
Age: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 , single (Batch/Lot number: unknown), as dose 2 , single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cll" (ongoing). There were no concomitant medications. No known allergies. 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. 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 29Mar2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Recurrent breast cancer" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE; AREDS; VITAMIN D [VITAMIN D NOS]. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Pcn carbocaine, reaction(s): "Known allergies: PCN carbocaine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (04Jul2022) Positive; (07Jul2022) Negative; (09Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, on 28Jun2022 patient received drug Paxlovid for the treatment of COVID-19 and with drawn on 03Jul2022. It was also reported that, patient took paxlovid Day 1-5 tested positive Day 6, tested negative Day 9, Symptoms of headache, runny nose and constant cough returned on Day 11 Tested positive Day11.  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 available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EK5730), on 12Jan2021 as dose 2, single (Lot number: EL3246), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 01Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 57 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Breast Cancer" (unspecified if ongoing), notes: Last chemo treatment 18Apr2022. Concomitant medication(s) included: QUNOL TURMERIC EXTRA STRENGTH, start date: 14Aug2020; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, start date: 14Aug2020; D3, start date: 14Aug2020; L-LYSINE [LYSINE], start date: 01May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive, notes: 30Jun Covid positive (home antigen test); (06Jul2022) Negative, notes: 06Jul Covid negative (home antigen test); (10Jul2022) Positive, notes: 10Jul Covid positive (home antigen test.). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information:30Jun Covid positive (home antigen test), started Paxlovid. 02Jul symptoms resolved. 06Jul Covid negative (home antigen test). 09Jul symptoms returned. 10Jul Covid positive (home antigen test.); Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  all the reported events Vaccination failure, COVID-19 cannot be completely excluded based on temporal association and known drug safety profile
Age: 26.0
Sex: M
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 non-contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 08Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 26 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: SERTRALINE HCL, start date: Apr2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medication in 2 weeks of vaccination. Anti viral details included COVID 19 Treatment, started on 03Jul2022 to 08Jul2022, lot number was 1914705A. Paxlovid rebound. Tested negative for SARS-CoV-2, then next day tested positive. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 01May2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21May2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 08May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, 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), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound - tested positive after testing negative; Positive, notes: Covid rebound - tested positive after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 52-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 at 09:30 as dose 1, single (Lot number: EP6955), in left arm, on 28Mar2021 at 09:30 as dose 2, single (Lot number: ER8734), in left arm, on 12Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 04May2022 at 10:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "asthma" (unspecified if ongoing). No known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" (08Jun2022) and all described as "covid-19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19: received Paxlovid for treatment of Covid-19 from 20May2022 to 25May2022.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 22Nov2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 26Apr2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertrophic Cardiomyopathy" (unspecified if ongoing); "implanted defibrillator in place" (unspecified if ongoing), notes: implanted defibrillator in place; "cholecystectomy" (unspecified if ongoing), notes: 10 years ago; "benign hypertrophic prostate" (unspecified if ongoing), notes: benign hypertrophic prostate; "skin cancer" (unspecified if ongoing), notes: surgically treated skin cancer 8 years ago. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID rebound. Finished Paxlovid on July 2nd, tested positive July 10th; COVID rebound. Finished Paxlovid on July 2nd, tested positive July 10th; 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 30Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER8735), in left arm, on 09Nov2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 21Jun2022 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "One kidney" (unspecified if ongoing); "eczema" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION; CETIRIZINE; ACETAMINOPHEN; IBUPROFEN; ATORVASTATIN. The following information was reported: COVID-19 (medically significant) with onset 10Jul2022, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID rebound. Finished Paxlovid on July 2nd, tested positive July 10th". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (10Jul2022) Positive, notes: Finished Paxlovid on 02Jul, tested positive 10Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 77.0
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 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 at 10:00 as dose 1, single (Lot number: EW6200), in left arm, on 19Mar2021 as dose 2, single (Lot number: P6955), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: TT2589), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: P54991) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "I have arthritis" (unspecified if ongoing), notes: I have arthritis; "had breast cancer 11 years ago" (unspecified if ongoing), notes: had breast cancer 11 years ago. Concomitant medication(s) included: BACLOFEN, start date: Jun2020; TRAMADOL, start date: Jun2020; CELECOXIB, start date: Sep2021. Past drug history included: Amox-clav anti-biotic, reaction(s): "Known allergies; amox-clav anti-biotic"; Gabapentin, reaction(s): "Known allergies; gabapentin". 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: Unknown results, notes: Treatment of COVID-19; Positive, notes: The only unusual thing I'vedone is take a rapid test. It started within a few hours of that. It was positive; Positive, notes: the next day I took another and it was positive, too. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received pregabapentin on Sep2021.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 02Oct2021 as dose 3 booster, single (Lot number: FF2589), in left arm and on 23Apr2022 as dose 4 booster, single (Lot number: FK9895) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 21Jun2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) positive; (22Jun2022) positive; (09Jul2022) positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course included Anti-viral details: Product-COVID 19 Treatment, Brand-Paxlovid, treatment start date-22Jun2022, treatment stop date-26Jun2022 for treatment of COVID-19. Patient had Paxlovid rebound. Ongoing fatigue and cough prompted another Covid test. Originally tested positive on 21Jun, 22Jun. Test had faint line on 29Jun. No further tests until 09Jul and tested positive.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 63.0
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Lot number: unknown) at the age of 63 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not any known allergies. Patient received Paxlovid from 29Jun2022 to 04Jul2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(Consumer). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: VITAFUSION MULTIVITES, start date: 01Sep2018, stop date: 10Jul2022; PROBIOTICS, start date: 01Sep2018, stop date: 10Jul2022. The following information was reported: COVID-19 (medically significant) with onset 25Jun2022, outcome "not recovered", described as "COVID-19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 25Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Unknown results; (08Jul2022) Positive, notes: I tested positive on day 13 with mild cold symptoms; (10Jul2022) Positive, notes: Still testing positive on day 15. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 60-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 20May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 16Sep2020, stop date: 08Jul2022. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "GERD" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: food onions" (unspecified if ongoing); "Known allergies: Cipro medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of 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 included Paxlovid. Clinical course: COVID 19 Treatment with Anti viral: Paxlovid (Lot: GC4027) from 07Jul2022 to 09Jul2022. 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 non-contactable reporter(s) (Physician).  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Undifferentiated connective tissue disease" (unspecified if ongoing); "regurgitation" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE, stop date: 24Jun2022; TADALAFIL oral; PANTOPRAZOLE oral; PREDNISOLONE, start date: 06Jun2022, stop date: 27Jun2022. 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: (unspecified date) Unknown Result; (29Jun2022) Negative, notes: Patient had negative pcr and rapid test on 29Jun; (29Jun2022) Negative, notes: Patient had negative pcr and rapid test on 29Jun; (05Jul2022) Positive, notes: Rapid antigen turned positive on 05Jul. Therapeutic measures were taken because of drug ineffective, covid-19.  Clinical course:  Patient had negative pcr and rapid test on 29Jun. Rapid antigen turned positive on 05Jul. Symptoms began 04Jul. Other medical history Undifferentiated connective tissue disease, regurgitation, raynauds  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected 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). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), on 18Mar2021 as dose 2, single (Lot number: EN6205) and on 07Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED 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: Unknown results. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Paxlovid treatment was started on 30Jun2022 to 04Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillins" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cephilexon, reaction(s): "Known allergies: cephilexon". 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive other medication in 2weeks. Patient was treated with Paxlovid from 07Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 16:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 033f21a), 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 had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient did not receive other medication in 2 weeks. No known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Pnl allergies" (unspecified if ongoing). Concomitant medication(s) included: LIAN HUA QING WEN, start date: 27Jun2022, stop date: 04Jul2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective: Paxlovid from 04Jul2022 to 08Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.