chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus". Additional information: Caller's daughter received the first and second dose of the Pfizer COVID-19 vaccine. Caller's daughter received the vaccine "when she was 15" years old. Caller mentioned that her daughter "now has lupus" and the vaccine "gave her Lupus".  Caller also added that "no one in her side or her husband's side of the family has that type of auto-immune disease". Caller also mentioned that she read from the government's website that the "Pfizer vaccine causes this type of auto-immune disease". Caller is frustrated that her "daughter is sick" and that her daughter's "life is flipped upside down". Caller added that her daughter's "dreams of her future, of what she wanted to do is totally gone because now she won't be medically fit for it". Caller was also concerned with the medical bills and her daughter's "life long treatment". Caller asked if it is possible to be given the first and second dose of the Pfizer COVID-19 vaccine with the same lot numbers. Caller asked if Pfizer is going to help with the medical bills and her daughter's life-long treatment related to her daughter's experienced as described. Follow-up attempts are completed. No further information is expected.
Age: 53.0
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) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 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) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: I tested negative on days 6 and 7 post-first positive trestle; (Jun2022) Positive, notes: on day 11 and tested positive again that day; (Jun2022) Positive, notes: It's now day 15 and I'm still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Covid-19 treatment with Paxlovid from 29May2022 to 31May2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech: Dose Number: 1,2,3; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 1,2,3; Paxlovid: 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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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 had no relevant medical history. Concomitant medication(s) included: LEXAPRO taken for antidepressant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 1,2,3; Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies. Other medication in 2weeks product: Antidepressant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
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) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hiashimoto disease" (unspecified if ongoing); "high cholestrol" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin"; Daptomycin, reaction(s): "Known allergies: daptomycin". 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: Negative, notes: Had 2 consecutive negative test; Positive, notes: tested Friday and positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: EW0217) 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: "Hypertension" (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 "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not receive other medication in 2 weeks. The patient had no known allergies. On 02Jun2022, the patient received Paxlovid for Covid-19 treatment and stopped on 06Jun2022. On 11Jun2022 at 02:00 pm, the patient had rebound infection.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 16:45 as dose 4 (booster), single at the age of 51 years for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Drug allergy". Vaccination history included: Covid-19 (PRIMARY IMMUNISATION SERIES COMPLETED, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were not taken as a result of drug ineffective, Covid-19. Additional Information: Antiviral COVID 19 Treatment Paxlovid  Pfizer with start date: 07Jun2022 and stop date: 11Jun2022 Lot number: GA1529. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 29Aug2020 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Sep2020 at 16:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Aug2021 at 16:00 as dose 3 (booster), single (Lot number: EP7533) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Jan2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulphonamided" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 05Jun2022 at 12:00, outcome "recovering" 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 covid-19, drug ineffective.  Clinical Course: No other medication in 2weeks. Anti-viral details, with product COVID 19 Treatment, brand was Paxlovid, treatment start date was 29May2022 and treatment stop date was 02Jun2022, indication was Treatment of COVID-19. Rebound after completing Paxlovid. No treatment for AE.  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: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Jan2022 as dose 3 (booster), single (Lot number: FJ-1614-PFIZER-2021), in left arm for covid-19 immunisation. The patient's relevant medical history included: "OCD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; LAMICTAL; BUSPAR; CLARITIN ALLERGIC; GABAPENTIN; IBUPROFEN. The following information was reported: VACCINATION FAILURE (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: (10Jun2022) Positive, notes: Positive COVID PCR test posttreatment with Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  Additional information: The patient had no known allergies. Patient received treatment for COVID-19. Anti-viral details: Product=COVID 19 Treatment. Brand- Paxlovid. Treatment start date- 04Jun2022. Treatment stop date- 08Jun2022. Indication- Treatment of COVID-19. Other medication in last 2 weeks details: Wellbutrin, Lamictal, Buspar, Claritin, Gabapentin Ibuprofen. Adverse event: Positive COVID PCR test post treatment with Paxlovid. Return of sore throat, chest soreness, fatigue, nasal congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 29May2021 as dose 2, single (Lot number: Ew 0186), in right arm and on 14Dec2021 as dose 3 (booster), single (Lot number: Fh8027) at the age of 55 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes (onset)" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Allergy to Strawberries" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; MULTIVITAMINS [VITAMINS NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (01Jun2022) Negative, notes: He tested negative on the 1st of June; (05Jun2022) Negative, notes: tested negative again on the 5th of June; (10Jun2022) Positive, notes: Retested on the 10th of June, tested positive. Therapeutic measures were taken as a result of covid-19. It was reported that, the patient tested negative on 01Jun2022 and tested negative again on 05Jun2022. Stated that, the patient returned to work on 06Jun2022 and re-tested on 10Jun2022, tested positive. Stated that, no fever. Acting his usual self. Retested due to travel plans. Therapeutic measures included anti-viral details: Product COVID 19 Treatment, Brand: Paxlovid, Treatment started on 28May2022 and stopped on 05Jun2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EL0140), in right arm, on 08Jan2021 as dose 2, single (Lot number: EL1284), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CIALIS, start date: 08Apr2022, stop date: 31May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: Negetive; positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information : Patient received other medication in 2 weeks of vaccination. Anti-viral details:Product: COVID 19 Treatment Brand: Paxlovid : Treatment start date: 31May2022,Treatment stop date: 04Jun2022.Indication: Treatment of COVID-19. Rebound of mild symptoms and COVID positive test after testing negative.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 12:30 as dose 4 (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), 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: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". 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. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
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 and Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 at 13:30 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 31May2022 at 14:30 as dose 4 (booster), single (Lot number: FJ4989) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Mar2021 at 13:00 as dose 1, single (Lot number: 001B21A), in left arm and on 08Apr2021 at 13:00 as dose 2, single (Lot number: 016B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN, start date: Jan2020; ALLEGRA, start date: Jan1994; XYZAL, start date: Jan2012; NASACORT AQ, start date: Jan1998. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "recovered" (Jun2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive; (07Jun2022) Negative; (10Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid, treatment start date-01Jun2022 and treatment stop date-05Jun2022. Rebound/recurrence of COVID symptoms with concurrent positive COVID test on 10Jun. He tested positive for COVID with symptom onset on 01Jun. He started taking Paxlovid on 01Jun. Symptoms disappeared by 06Jun. He tested negative for COVID on 07Jun. Mild symptoms returned on 10Jun, and he tested positive again on 10Jun.
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "reflux" (unspecified if ongoing), notes: Other medical history: reflux. Concomitant medication(s) included: EZETIMIBE; FAMOTIDINE; REPATHA; BABY ASPIRIN; PRILOSEC [OMEPRAZOLE]; ROSUVASTATIN; FLONASE [FLUTICASONE PROPIONATE]; TYLENOL; VITAMIN C [ASCORBIC ACID]; VIT D [COLECALCIFEROL]; ZINC. Past drug history included: Benzodiazepine, reaction(s): "Known allergies: Paradoxical reaction to benzodiazepine", notes: Known allergies: Paradoxical reaction to benzodiazepine. 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: (10Jun2022) so faint it was almost invisible, notes: By Friday my BinaxNow test was so faint it was almost invisible, and I was mostly symptom free; (12Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment with Plaxlovid from 03Jun2022 to 08Jun2022.   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
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 17Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 05Jan2022 as dose 3 (booster), single (Lot number: 3302513D), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Extra-ventricular tachycardia" (unspecified if ongoing). Concomitant medication(s) included: Lisinopril; Diltiazem; Atorvastatin. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: I noticed a diminished sense of taste and smell following taking the first dose. This was followed by a persistent very strong bitter metallic taste in my mouth that was strong enough to wake me at night at times. When eating I can only taste very strong flavors or spices. Patient received other medication in 2weeks. Patient did not received if treatment to AE. No any known allergies. Other medical history: Extra-ventricular tachycardia.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2021 as dose 2 (booster), single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "allergic sinusitis" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "fatty liver" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: May2022, stop date: Jun2022; XYZAL, start date: Mar2022, stop date: Jun2022; FLUTICASONE PROPIONATE, start date: 18May2022, stop date: 09Jun2022. 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: (23May2022) Positive, notes: Original test pos. 23May; (30May2022) Negative, notes: Negative RAT 30May; (01Jun2022) Negative, notes: Negative RAT 01Jun; (02Jun2022) Positive, notes: Positive RAT 02Jun; (10Jun2022) Positive, notes: RAT continues positive thru 10Jun. Therapeutic measures were taken as a result of drug ineffective, Covid-19.Clinical course: Rapid Antigen Test positive after negative for 3 days after completion of Paxlovid. Original test pos. 23May, Paxlovid ended 29May. Negative RAT 30May & 01Jun. Positive RAT 02Jun & returned milder symptoms end 09Jun. RAT continues positive through 10Jun.If treatment ae: Yes AE treatment: Azithromycin. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Aug2020 as dose 1, single (Lot number: P220395-0012L), on 26Aug2020 as dose 2, single (Lot number: P220395-001) and on 08Oct2021 as dose 3 (booster), single (Lot number: P223937-0002L) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication(s) included: ARMODAFINIL; DESVENLAFAXINE; DAYQUIL AND NYQUIL SEVERE+ VICKS VAPOCOOL COLD AND FLU. Past drug history included: Bactrim, reaction(s): "Known allergies: bactrim". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient had received Other medication in 2weeks. Patient had received Paxlovid as Anti viral drug for the COVID 19 Treatment from 28May2022 to 01Jun2022. Symptoms resolved after course of Paxlovid and initial isolation period. Around day 10, a cough started. On day 14, the cough worsened and patient started to feel fatigue, congestion, and sore throat. Patient  took a home COVID test and it was positive. Patient found the CDC guidance for Paxlovid rebound, including this reporting link and guidance to isolate again.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: GI upset; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: E6955), administration date: 29Mar2021, when the patient was 27-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EP6955), administration date: 19Apr2021, when the patient was 27-year-old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 09Jun2022, outcome "unknown", described as "GI upset"; DIARRHOEA (non-serious) with onset 09Jun2022, outcome "unknown", described as "diarrhea". It was unknown if therapeutic measures were taken as a result of abdominal discomfort, diarrhoea.  Additional information: Prior to vaccination, the patient had not been affected with COVID-19. The patient had been tested for COVID-19 after the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 39-year-old male patient received BNT162b2 (BNT162B2), on 16May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 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: "HIV (undetectable)" (unspecified if ongoing). Concomitant medication(s) included: GENVOYA oral. 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 results; (12Jun2022) positive. 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. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID-19 Treatment; Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: 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 59-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: En6202), on 22Mar2021 as dose 2, single (Lot number: En6206) and on 21Oct2021 as dose 3 (booster), single (Lot number: Ff2587) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID-19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. A 28-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: E6955), on 19Apr2021 as dose 2, single (Lot number: EP6955) and on 14Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "Covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: Nasal Swab; (09Jun2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19. If other vaccine in four weeks was unknown. Adverse event: SX GI upset and diarrhea 09Jun with two positive tests AG likely exposure taking public transport. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. No follow-up attempts are Possible: No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Vaccination failure", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical information: He has a question about Paxlovid. He just found out yesterday that he is positive for COVID. His first shot was J&J COVID Vaccine, and booster was Pfizer COVID vaccine. His only concern is, he was looking at paperwork for FDA approved medication. He read that there is a possibility in future that if someone gets HIV, that some medications won't work properly or would not work at all. He is at higher risk of getting HIV because he is gay. He took it last night and a dose this morning. He stopped taking it after reading this. He would like to know if something will happen if he stops taking it. There was a product complaint to report.  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: Positive test; Positive test; This is a literature report.  A 68-year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), as dose 1, single (Lot number: Unknown), as dose 2, single (Lot number: Unknown), as dose 3 (booster), single (Lot number: Unknown) and as dose 4 (booster), single (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 "Positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive test. Additional Information: The author stated this patient received 4 doses of Comirnaty; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Drug ineffective.,Linked Report(s) : US-PFIZER INC-202200740728 Same article, other patient;US-PFIZER INC-202200832854 Same article, other patient;
Age: 59.0
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 a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 09Jan2021 as dose 2, single (Lot number: ET1686), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FC3180), in left arm and on 12May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ1685) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sesame, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Adverse event: Rebound Covid. Recovered quickly while on Paxlivid tested negative on day three. Initial main symptoms were sore throat and body aches and fatigue. four days after completing packs with it she had a little bit of a sore throat then the next day had a profound runny nose and tested positive. she had major sneezing congestion body aches and headaches. I tested negative on day six  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, vaccination failure and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection sites still cause pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Aug2021 at 14:30 as dose 1, single (Lot number: FC3183) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sensitivity" (unspecified if ongoing); "kidney 3- chronic pain" (unspecified if ongoing); "Known allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Aug2021 at 15:45, outcome "not recovered", described as "Injection sites still cause pain". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: product=COVID 19, brand=Pfizer, lot number=FC8193, administration date=15Sep2021, administration time=01:00 PM, dose number=2, vaccine location=Right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks reported as yes.
Age: 41.0
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) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 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. 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: Unknown results; Positive; Negative; Negative; Negative; Positive. Therapeutic measures were taken as a result of covid-19. Clinical information: No other medication in 2 weeks. No known allergies. She became symptomatic and tested positive again for covid after completing 5 days paxlovid which started from 30May2022 to 04Jun2022. She had already had 3 negative tests then became mildly symptomatic again after 7 days of completing paxlovid.  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 known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal swab test positive; Nasal swab test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL9261), in right arm, as dose 2, single (Lot number: EN6200), in right arm, as dose 3 (booster), single (Lot number: FF2588), in right arm and as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic carcinoma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VIT D3; ASPIRIN [ACETYLSALICYLIC ACID]; PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Feb2022, outcome "unknown", COVID-19 (medically significant) with onset Feb2022, outcome "recovered" (Apr2022) and all described as "Nasal swab test positive". The event "nasal swab test positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive; (Apr2022) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical information: Facility type vaccine: Pharmacy or Drug Store. The patient had not received other vaccine in four weeks of vaccination. Other medications in two weeks: Calcium, Vit D3, low dose aspirin, pantoprazole. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Physical therapy. Patient had not covid prior vaccination. The patient covid tested post vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Nasal swab test positive; Nasal swab test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL9261), in right arm, as dose 2, single (Lot number: EN6200), in right arm, as dose 3 (booster), single (Lot number: FF2588), in right arm and as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic carcinoma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VIT D3; ASPIRIN [ACETYLSALICYLIC ACID]; PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Feb2022, outcome "unknown", COVID-19 (medically significant) with onset Feb2022, outcome "recovered" (Apr2022) and all described as "Nasal swab test positive". The event "nasal swab test positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive; (Apr2022) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical information: Facility type vaccine: Pharmacy or Drug Store. The patient had not received other vaccine in four weeks of vaccination. Other medications in two weeks: Calcium, Vit D3, low dose aspirin, pantoprazole. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Physical therapy. Patient had not covid prior vaccination. The patient covid tested post vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Peripheral numbness feet, legs; tingling in hands; right foot/leg and fingers were affected and right leg worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 at 10:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic carcinoma" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing); "Physical therapy" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VIT D3; ASPIRIN [ACETYLSALICYLIC ACID]; PANTOPRAZOLE. Vaccination history included: BNT162b2 (other vaccine same date product=Covid pfizer,, other vaccine same date lot number=FF2588,, other vaccine same date vaccine date=20May2022,, other vaccine same date dose number=3,, other vaccine same date vaccine location=Right arm), administration date: 20May2022, for covid-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Peripheral numbness feet, legs"; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling in hands"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "right foot/leg and fingers were affected and right leg worse". The events "peripheral numbness feet, legs", "tingling in hands" and "right foot/leg and fingers were affected and right leg worse" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, condition aggravated.  Additional information: Peripheral numbness feet, legs and tingling in hands. Started after first dose but didn't equate it with vaccine until after the most recent booster. Initially in left foot/leg only about two three weeks after shot. A week after the 4th booster my right foot/leg and fingers were affected and right leg worse. Then connected the dots from beginning. No other vaccines in four weeks.  No follow-up attempts are possible. No further information is expected.