chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, C-reactive protein, C-reactive protein increased
Clinical narrative: Ankylosing Spondylitis; Elevated C-reactive protein level; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4416880-00 (Company).  A 44-year-old female patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown"; C-REACTIVE PROTEIN INCREASED (non-serious), outcome "unknown", described as "Elevated C-reactive protein level". The patient underwent the following laboratory tests and procedures: C-reactive protein: Elevated. The action taken for adalimumab was dosage not changed. On unknown dates, the patient experienced elevated c-reactive protein level and ankylosing spondylitis. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality of Humira (solution for injection in pre-filled pen) (Adalimumab) for the event (s) of Elevated C-Reactive Protein Level and Ankylosing Spondylitis was not provided. The reporter's causality of Pfizer Biontech Covid-19 Vaccine(Tozinameran) for the event (s) of Elevated C-Reactive Protein Level was not reported and for Ankylosing Spondylitis was provided as possible.  The reporter's assessment of the causal relationship of "ankylosing spondylitis" and "elevated c-reactive protein level" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. 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 current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events ankylosing spondylitis and c-reactive protein increased cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 13:30 as dose 1, single (Lot number: EN6199), in left arm, on 25Mar2021 at 14:00 as dose 2, single (Lot number: ER8732), in left arm, on 30Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Known allergy:Dairy" (unspecified if ongoing). Patient did not receive other medication in 2 weeks. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "recovered" (01Jun2022) 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 vaccination failure, covid-19. Anti-viral details: Product- COVID 19 Treatment, Treatment start date: 26May2022, Treatment stop date: 31May2022, Lot number: 00069-1085-30, Indication- Treatment of COVID-19.
Age: 66.0
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) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: ENG203), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Benign Prostate Enlargement" (unspecified if ongoing). Concomitant medication(s) included: TADALAFIL, start date: Jul2021, stop date: 18May2022; TAMSULOSIN, start date: Jul2021; FINASTERIDE, start date: Jul2021; ATORVASTATIN, start date: Jan2019, stop date: 18May2022. Past drug history included: No, reaction(s): "Allergy". 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: (18May2022) Positive; (24May2022) Negative; (28May2022) Negative; (29May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19 included with Paxlovid. The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6203 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations and an analysis of complaint history for the reported lot. and product type. The final scope included the reported finished goods lot EN6203, fill lot EN5336, and the formulated drug product lot EN5324. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Clinical course: Patient reported that he started Paxlovid the day he tested positive, 18May. he completed Paxlovid on 23May his symptoms were gone, and he tested negative on a home antigen test on 24May. His symptoms were mild during this initial bout with Covid, congestion, tiredness, and a low grade fever. On 28May, patient felt tired and a little congested but again tested negative. On 29May he tested positive. His symptoms have been mild on rebound, mostly congestion and some tiredness, no fever. No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 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: "immunocompromise" (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-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not received other medication in 2weeks. Anti viral details: product: COVID 19 treatment, Brand: Paxlovid, treatment start on 22May2022, stopped on 26May2022, Lot number: fx8140 Indication: Treatment of COVID-19. Covid vaccine details: Vaccine brand: Pfizer / BioNTech, Vaccine brand unknown: False, Vaccine administration date: 11May2022, Vaccine lot unknown: True, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion, vaccine dose number: 4, vaccine dose number unknown: False, vaccine location: Left arm. Adverse event: After reducing symptoms, symptoms returned in full 1 week after taking Paxlovid. If patient recovered: Not recovered. If treatment ae: No. Known allergies: No. Other medical history: immuno-compromised.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid rebound.  Covid symptoms 5/21/22, positive PCR test taken afternoon of 5/22. First Paxlovid dose evening of 5/23, complete course morning of 5/28. Two negative antigen tests on 5/29/22.; Covid rebound.  Covid symptoms 5/21/22, positive PCR test taken afternoon of 5/22. First Paxlovid dose evening of 5/23, complete course morning of 5/28. Two negative antigen tests on 5/29/22.; 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 10Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 01Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "blood clot in leg", start date: 2017 (unspecified if ongoing), notes: blood clot in leg in 2017. The patient's concomitant medications were not reported. Past drug history included: Biaxin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "not recovered" and all described as "Covid rebound. Covid symptoms 5/21/22, positive PCR test taken afternoon of 5/22. First Paxlovid dose evening of 5/23, complete course morning of 5/28. Two negative antigen tests on 5/29/22.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Negative; (29May2022) Negative; (02Jun2022) Positive, notes: in the afternoon; (22May2022) Positive, notes: positive PCR test taken afternoon of 22May. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: No Other medication in 2 weeks.Covid rebound. Covid symptoms 21May2022, positive PCR test taken afternoon of 22May. First Paxlovid dose evening of 23May2022, complete course morning of 28May2022. Two negative antigen tests on 29May2022. Headache, sore throat, upset stomach morning of 02Jun2022 and Positive antigen test in the afternoon of 02Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
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) (Physician). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Lot number: 3013084) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT "ASTRAZENECA", start date: 24May2022; ALBUTEROL [SALBUTAMOL], start date: 24May2022; VITAMIN D3, start date: 24May2022; TYLENOL, start date: 24May2022; AIRBORNE, start date: 24May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) negative; (03Jun2022) positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient did take other medications in two weeks. Patient took Paxlovid, starting on 24May2022 and Treatment stop date was 28May2022 for treatment of COVID-19. Rebound COVID. Started with being symptomatic on 02Jun2022, 5 days after completing Paxlovid. Developed nasal congestion, worsening cough, shortness of breath, sore throat, swelling of neck lymph nodes. COVID swab on 29May2022 was negative, COVID swab today 03Jun2022 was positive. Adverse events start date was 02Jun2022 and patient had outcome not recovered without any treatment, patient had no known allergies.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: having uncomfortable time of it with COVID/tested positive for Covid-19; having uncomfortable time of it with COVID/tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "having uncomfortable time of it with COVID/tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: My husband was diagnosed, tested positive for Covid-19 on May 26. He was prescribed Paxlovid for the emergency use authorization. He is 73, his symptoms he was having chills and was having uncomfortable time of it with COVID. He is fully vaccinated and fully boosted but he is immunocompromised. So he has taken the fully course of the Paxlovid and his symptoms began to improve. Everyday he got better for 5 days that he was taking it. The product details of Paxlovid, consumer stated, the LOT number FY6859. Yesterday he was doing well although we certainly quarantine and isolated as much as we can from each other and he has been masked and much of the time. He tested negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, 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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: 301308A), 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 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 "COVID-19". The patient underwent the following laboratory tests and procedures: Oxygen saturation: low o2 (94), notes: low o2 (94); SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: Brand=Paxlovid, started on 21May2022 and stopped on 25May2022. On 02Jun2022 10:00 PM, the patient had Coughing fits, short of breath, chest tightness, low o2 (94), not treatment received for this and not recovered from this event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: When caller received the other 3 doses, caller just had a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EP6955) at the age of 60 years, on 02Apr2021 as dose 2, single (Lot number: PR8734) and on 24Oct2021 as dose 3 (booster), single (Lot number: FF2590) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "When caller received the other 3 doses, caller just had a sore arm".  Additional information: The patient also received BNT162b2 (BNT162B2), on 31May2022 at 15:00 as dose 4 (booster), 1.8 ml single (Lot number: 9729) at the age of 61 years for covid-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200793526 same patient and drug, different dose/different event separated in time
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2022 at 12:00 as dose 4 (booster), single (Lot number: Fk9895), 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: Shellfish" (unspecified if ongoing); "Known allergies: bee stings" (unspecified if ongoing). There were no concomitant medications within two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "pulmonary hypertension" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (03Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received the COVID 19 Treatment from 23May2022 to 27May2022 through the oral route. Rebound COVID-19 symptoms with positive test.  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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "getting COVID after being vaccinated". Clinical information: The patient wife did not realize that getting COVID after being vaccinated was considered an adverse event until she received the postcard that was sent to colleagues. After that she reported immediately. The same situation occurred with her husband and son for which she reported and could gather all the relevant info (VX dates and lots) from them. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Central nervous system lesion
Clinical narrative: I have MS and have been in remission for 5 years. I now have a new lesion on my brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: AUBAGIO; OMEPRAZOLE; ZOLOFT; SIMVASTATIN; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose 2; Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Aug2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (Dose 1; Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: CENTRAL NERVOUS SYSTEM LESION (non-serious) with onset Apr2022, outcome "recovering", described as "I have MS and have been in remission for 5 years. I now have a new lesion on my brain". The events "i have ms and have been in remission for 5 years. i now have a new lesion on my brain" required physician office visit. Therapeutic measures were taken as a result of central nervous system lesion.  Additional information: The patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. Other medications in two weeks inlcuded Aubagio, omerprozole, zoloft, simvistatin, c, d. No covid prior vaccination and no covid tested post vaccination. It was reported that, the patient took dose 3 on Jan2022 at 10:00 AM. Therapeutic measures included stronger MS medicine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 24Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: EW0176) at the age of 73 years, in left arm for Covid-19 immunization. The patient had no relevant medical history. Patient had no known allergies. Concomitant medication(s) included: PRAMIPEXOLE; METOPROLOL RETARD, also reported as other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "recovered" (29May2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: Tested positive with symptoms for Covid 10May2022; (22May2022) Positive, notes: On 22May2022 started showing symptoms again and tested positive; (29May2022) Negative, notes: Tested negative on 29May2022. Therapeutic measures were taken as a result of vaccination failure, Covid-19 included Paxlovid started on 10May2022 to 15May2022. Clinical course was reported as, patient tested positive with symptoms for Covid 10May2022. Doctor prescribed Paxlovid and started that day, felt fine after a couple days with no more symptoms. Completed Paxlovid 15May2022. On 22May2022 started showing symptoms again and tested positive. Doctor could give me nothing. Ill with fever, chills, aches, pains and tiredness for 5 days. very runny nose and chest congestion lasted another week. Tested negative on 29May2022.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL9263), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: 330368D) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Oct2021; CITALOPRAM, start date: 01Oct2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received other medications in 2 weeks. Patient received treatment for COVID-19 as Paxlovid from 25May2022 to 30May2022.The patient had no Known allergies.  No follow up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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), 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: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (05Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received other medication in 2 weeks. Patient received treatment of Covid-19 from 28May2022 to 01Jun2022. Rebound, symptoms returned 2 days later, tested positive 05June2022. Patient having known allergies.  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, 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) (Physician). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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) Positive, notes: tested positive again; (29May2022) Negative, notes: Completed 5 days of Paxlovid. Had a negative test; (03Jun2022) Positive, notes: started having symptoms again and tested positive again. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient had no known allergies. The patient had no other medical history. The patient's COVID got rebound while the patient was on unspecified Anti Viral details: Product covid-19 Treatment (Lot number: GA2279) for COVID-19 from 25May2022 to 29May2022. Other medication in 2 weeks product: Tylenol from 25May2022 to 26May2022. Completed 5 days of Paxlovid. Had a negative test. 5 day later, he started having symptoms again and tested positive again.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.; 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 26Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Stage zero breast cancer" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (31May2022) Negative; (04Jun2022) Positive; (05Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Tumeric, Gaia, Wellness Formula, Source Naturals from 22May2022 to 25May2022. Patient received Paxlovid from 25May2022 to 29May2022 for COVID-19. After testing negative for Covid since 31May2022 patient tested positive with apparent rebound Covid on 04Jun2022 and continue to test positive 05Jun2022. The antigen test positive test line was bright and immediate. Patient started to get a bit of congestion the evening of 03Jun2022 as well as a headache. When she woke up with chest congestion 04Jun2022 event felt very similar to Covid she took a test and was positive. The chest congestion and cough was worse today. Because she had asthma she started taking Advair at the same time of the medication and a couple days before.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 49-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1,single (Batch/Lot number: unknown), on 09Apr2021 as dose 2,single (Batch/Lot number: unknown), on 18Oct2021 as dose 3,(booster) single (Batch/Lot number: unknown) and on 17May2022 as dose 4,(booster) single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: None. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 29May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (29May2022) Positive, notes: 5 days after finishing course (29May2022), I developed new Covid symptoms and tested positive. Therapeutic measures were taken as a result of covid-19 and drug ineffective.  Clinical Course: There were no known allergies. It was reported that patient had  initially diarrhea. 5 days after finishing course (29May2022), he developed new Covid symptoms and tested positive. Subsequently symptoms worsened and he ended up in the hospital with shortness of breath/chest pains. After 2 separate hospital visits (31May & 2Jun), doctors diagnosed Covid Rebound due to Paxlovid course.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: son then husband sick but neg Ag tests then she had Mod to severe ST fever myalgias congestion starting 31May2022 + PCR 02Jun2022; son then husband sick but neg Ag tests then she had Mod to severe ST fever myalgias congestion starting 31May2022 + PCR 02Jun2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 34-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EL3247) and on 02Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 34 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 31May2022, outcome "unknown" and all described as "son then husband sick but neg Ag tests then she had Mod to severe ST fever myalgias congestion starting 31May2022 + PCR 02Jun2022". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (02Jun2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The reporter stated that the patient son then husband was sick but negative Ag tests then she (patient) had moderate to severe ST fever, myalgias, and congestion starting 31May2022 + PCR 02Jun2022. It was unknown whether treatment was received by the patient. No Covid prior vaccination, was Covid tested post vaccination. Covid test type post vaccination was nasal swab, test name was PCR, and results were positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events Vaccination failure   ,covid 19 cannot be completely excluded based on temporal association.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) and on 17May2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (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-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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) 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), 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: "Factor 5" (unspecified if ongoing), notes: other medical history: Factor 5. Concomitant medication(s) included: PROGESTERONE; BIOTIN; COLLAGEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" 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: Anti Viral Details:  Product: COVID 19 Treatment Brand: Paxlovid: Treatment start date: 24May2022. Treatment stop date: 28May2022. Indication: Treatment of COVID-19. No allergies  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Lower back ache Legs sore Tired flu like symptoms
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Petechiae, Syncope
Clinical narrative: petechiae (5days after 2. vaccine); Prev dose administration date: 18Apr2021/ dose 2 administration date:02May2021; Fainting-like spells very 2-10mins for 3 hours - 13mins after 2. vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 at 08:30 as dose 2, single (Lot number: EW0162) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "low blood pressure" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: migraines (25+years); "endometriosis" (unspecified if ongoing); "meningioma" (unspecified if ongoing), notes: meningioma in left cavernous sinus. Concomitant medication(s) included: LEVONORGESTREL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 18Apr2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "Suspected vestibular migraine", "Fainting", "overactive stress response and sensory overload, sensitivity to light, sound, temperature change and smell causing dizziness", "electrical flash in brain after watching TV", "dizziness when reading on mobile and scrolling or switching windows on computer; dizziness when reading glossy pages", "erratic blood pressure: increased blood pressure by 20-30 points during most part of a day or too low when tired or after meals (85/55)", "increased heart rate", "heart palpitations", "increased body temperature by 1-2 degrees", "dermatitis-like rash", "dermatitis-like rash". The following information was reported: SYNCOPE (disability, medically significant) with onset 02May2021, outcome "not recovered", described as "Fainting-like spells very 2-10mins for 3 hours - 13mins after 2. vaccine"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02May2021, outcome "unknown", described as "Prev dose administration date: 18Apr2021/ dose 2 administration date:02May2021"; PETECHIAE (disability) with onset 07May2021, outcome "not recovered", described as "petechiae (5days after 2. vaccine)". The events "fainting-like spells very 2-10mins for 3 hours - 13mins after 2. vaccine", "petechiae (5days after 2. vaccine)" and "prev dose administration date: 18apr2021/ dose 2 administration date:02may2021" required physician office visit. Therapeutic measures were taken as a result of syncope, petechiae.  Clinical course: No other vaccine in four weeks. Treatment Meclizine, B2 vitamin. No covid prior vaccination. No Covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 20Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 29 years, in left arm for covid-19 immunisation. The patient's had no relevant medical history. The patient did not have known allergies. Concomitant medication(s) included: ESTARYLLA, start date: 03Mar2019. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "recovering", COVID-19 (medically significant) with onset Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.   Clinical course: From 27May2022 to 31May2022, the patient had Paxlovid for COVID-19. The adverse event symptoms dramatically improved on days 1 and 2 of taking Paxlovid. On day 6 onward, symptoms linger (head congestion, cough). Tested positive (faint positive) on at home test on day 6 and 7 after starting Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. 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, notes: Treatment of COVID-19. 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.