chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 24Mar2021 as dose 2, single (Lot number: ER8727), in right arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FD0809), in right arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: MTX [METHOTREXATE] taken for rheumatoid arthritis, stop date: 13May2022. Past drug history included: Known allergies: macrodantin, reaction(s): "Known allergies: macrodantin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Fatigue, Pain, Pyrexia
Clinical narrative: Doesn't know if after first or second dose Vaccine, had normal aches and was really fatigued for two days; Doesn't know if after first or second dose Vaccine, had normal aches and was really fatigued for two days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 01Apr2021 as dose 2, single (Lot number: ER8733) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "carpal tunnel", start date: 07Mar2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Doesn't know if after first or second dose Vaccine, had normal aches and was really fatigued for two days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional Context: The caller is a consumer who received second booster shot at (Name) in (City), (State) where the caller lives. Agent attempts to clarify product name multiple times, caller states Pfizer Vaccine and provides lot: FM7553. The caller received the Second booster Pfizer Vaccine at 1600 and had a really severe reaction, nothing like caller had experienced with original Pfizer Vaccine shots. Doesn't know if after first or second dose Vaccine, had normal aches and was really fatigued for two days: The caller doesn't know if it was after first or second dose Pfizer Vaccine, but the caller had normal aches and was really fatigued for two days. The normal aches and fatigue were no big deal. Pfizer Vaccine: First dose: 12Mar2021, Pfizer Vaccine: First dose: 12Mar2021. Patient Age at Time of Vaccination in Months: or Years: 70 years    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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 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: "HTN" (unspecified if ongoing); "cardiac murmur" (unspecified if ongoing); "overweight" (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 "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (24May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19May2022 to 23May2022 via oral route. Clinical course: It was unknown whether patient received other medication in 2weeks or not. Patient had rebound COVID after Paxlovid. Symptoms completely resolved, multiple days of negative tests, today return of symptoms and positive test (24May2022). The patient had no Known drug allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 05Mar2021 at 18:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 02Apr2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive; (09May2022) Negative; (14May2022) Negative; (15May2022) Positive; (20May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course- The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications the patient received within 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 14:00 as dose 1, single (Lot number: EN6207), in left arm, on 31Mar2021 as dose 2, single (Lot number: EN5712), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 07May2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE, start date: 10Jun2020. Past drug history included: Sulfamethoxazole, reaction(s): "Known Allergy sulfamethoxazole"; Trimethoprim, reaction(s): "Known Allergy Trimethoprim". The following information was reported: COVID-19 (medically significant) with onset 22May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive, notes: I tested covid positive; (16May2022) Negative, notes: Tested negative; (22May2022) Positive, notes: positive test result. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested COVID positive on 11May2022 and started Paxlovid evening dose 11May2022 and completed Paxlovid morning dose on 16May2022. Tested negative for COVID on 16May2022. COVID symptoms started again on 21May2022 and positive test result on 22May2022.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: First tested positive for COVID on 08May2022 Sunday; First tested positive for COVID on 08May2022 Sunday; 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 male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6207), in right arm, on 06Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUSPIRONE, stop date: 08May2022; LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 08May2022, outcome "unknown", COVID-19 (medically significant) with onset 08May2022, outcome "recovered" (24May2022) and all described as "First tested positive for COVID on 08May2022 Sunday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: positive for COVID on 08May2022; (13May2022) Negative; (14May2022) Negative, notes: Tested negative each day 14May2022 - 20May2022; (20May2022) Negative, notes: Tested negative each day 14May2022 - 20May2022; (21May2022) Positive, notes: Tested positive on 21May2022; (22May2022) Positive, notes: Tested positive on 22May2022, 23May2022; (23May2022) Positive, notes: Tested positive on 22May2022, 23May2022; (24May2022) Negative, notes: tested negative today 24May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Report about covid treatment was Yes. If vaccine received and other medication in 2 weeks were reported as Yes. Anti-viral details product: COVID 19 treatment, brand: Pfizer, treatment start date: 09May2022, treatment stop date: 09May2022, indication: Treatment of COVID-19. Adverse event was Paxlovid Rebound- First tested positive for COVID on 08May2022 Sunday. Then I started Paxlovid on Monday 09May2022 and took all doses through Friday 13May2022. Tested negative on Friday 13May2022. Tested negative each day 14May2022-20May2022 Tested positive on 21May2022, largely asymptomatic. Tested positive on 22May2022, 23May2022, and then tested negative today 24May2022. Never really had any symptoms-thought they were allergies. Known allergies reported as No.
Age: 37.0
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) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), on 13Jun2021 as dose 2, single (Lot number: EL3248) and on 27Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Acne" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received vaccine and other medication in 2 weeks. The patient received Anti-viral from 13May2022 to 17May2022, Indication: Treatment of COVID-19. The Adverse event: Covid symptom recurrence, occurred on: 20May2022 at  08:00 AM, Ae resulted in: [None of the above],  If patient recovered: Not recovered, If treatment ae: No.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Age: 44.0
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) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic HTN" (unspecified if ongoing); "SVT" (unspecified if ongoing); "POTS" (unspecified if ongoing); "PVD" (unspecified if ongoing). Concomitant medication(s) included: LOPRESSOR; HYDROCHLOROTHIAZIDE; MAGNESIUM; POTASSIUM; GABAPENTIN; METHOCARBAMOL. Past drug history included: Ambien, reaction(s): "known allergies: ambien".  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 Result; (19May2022) Negative, notes: Negative on 19May and 20May; (20May2022) Negative, notes: Negative on 19May and 20May; (23May2022) Positive, notes: Had positive test on 23May. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was reported as yes.  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 provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200755003 Same reporter/patient, different drug/events
Sex: U
Vaccine: COVID19
Symptoms: Illness, Neuralgia, Parkinson's disease
Clinical narrative: neuralgia; Parkinson's disease; sicked; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 06Mar2021, for Covid-19 Immunization. The following information was reported: PARKINSON'S DISEASE (medically significant) with onset 26Apr2021, outcome "unknown"; ILLNESS (medically significant) with onset 26Apr2021, outcome "unknown", described as "sicked"; NEURALGIA (medically significant) with onset 27Apr2021, outcome "unknown".  The clinical course was reported as: In Jul2019, I was told that I had Parker disease all the symptoms. On 26Apr & 27Apr I sicked since 2nd shot I told my doctor of the shot change of my body All symptoms by Pfizer. 27Apr I have neuralgia+ she said I show the sign of Parkinson's disease Is there anything in the Pfizer shot that caused they had with Parkinson's disease? otherwise it is a miracle.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 23.0
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 non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3, single (Lot number: FF2593) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; BUDESONIDE; ALYACEN. Vaccination history included: covid-19 vaccine (Dose 1, Single, Lot No. EL9261), administration date: 23Jan2021, for Covid-19 immunisation; covid-19 vaccine (Dose 2, Single, Lot No. EL9261), administration date: 15Feb2021, for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Sex: F
Vaccine: HPVX, MENB
Symptoms: Syncope
Clinical narrative: syncope; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; hpv vaccine (HPV VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (non-serious), outcome "unknown". 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 currently available, a possible contributory role of the suspect drug trumenba to all the reported event syncope Cannot be completely excluded based on temporal association and known drug safety profile 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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: Tested positive 5 days after final treatment and 2 negative results; (unspecified date) negative, notes: Tested positive 5 days after final treatment and 2 negative results; (24May2022) positive, notes: Tested positive 5 days after final treatment and 2 negative results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Adverse event: Tested positive 5 days after final treatment and 2 negative results. Anti-viral started on 15May2022 for COVID 19 Treatment and stopped on 19May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chronic disease
Clinical narrative: chronic health issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 64-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ARTHROTEC. Past drug history included: Arthrotec 75, reaction(s): "Drug allergy", notes: I have taken for over 20 plus years. Vaccination history included: Covid-19 vaccine (Primary series Immunization completed but manufacture name unknown), for COVID-19 Immunization. The following information was reported: CHRONIC DISEASE (non-serious), outcome "unknown", described as "chronic health issues".  Additional information: The patient was advised that their order of Arthrotec 75 mg was delivered to the doctor's office on 18Apr. The patient confirmed that they did not receive that order. While speaking about the Arthrotec 50 mg, the patient stated, "The 75 was not available so was told him to go ahead and order the 50. The patient still have 1 bottle left of the 50 and then almost out of the second bottle of the 50 but  preferred to only take it twice a day and not three times a day because it was still the same amount. It was still 150 mg total but if I take the 75, which have taken for over 20 plus years, it was only twice a day. The 50, yes, that's what I was currently taking.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster) (Lot number: FE3594) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22May2022, outcome "unknown", COVID-19 (medically significant) with onset 22May2022, outcome "recovering" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of Covid symptoms and positive test after three days of negative Covid tests and no symptoms except coughing. Symptoms suddenly restarted on day 12 after starting Paxlovid treatment; positive, notes: Rebound of Covid symptoms and positive test after three days of negative Covid tests and no symptoms except coughing. Symptoms suddenly restarted on day 12 after starting Paxlovid treatment. Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that rebound of Covid symptoms and positive test after three days of negative Covid tests and no symptoms except coughing. Symptoms suddenly restarted on day 12 after starting Paxlovid treatment.
Age: 41.0
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) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes (type 1)" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; PAXIL CR. 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) Negative, notes: Positive covid test seven days after finishing Paxlovid treatment and testing negative on rapid and PCR; (23May2022) Positive, notes: Positive covid test seven days after finishing Paxlovid treatment and testing negative on rapid and PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL0140), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL0140), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Jun2014. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. The patient received Paxlovid as treatment of COVID-19 as other medication in 2weeks. The treatment start date was reported as 15May2022 and stop date was 20May2022. The patient also took Sertraline as Antidepressant as other medication in 2weeks product.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 07:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03Apr2021 at 07:15 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Oct2021 at 18:00 as dose 3 (booster), single (Lot number: FH8020) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Colon Cancer", start date: 2016 (unspecified if ongoing); "Chemo" (unspecified if ongoing), notes: Chemo/Radiation Rx; "Chronic reflux" (unspecified if ongoing), notes: Chronic reflux; "Radiation" (unspecified if ongoing), notes: Chemo/Radiation Rx. Concomitant medication(s) included: IMODIUM, start date: 16Apr2017; PRILOSEC [OMEPRAZOLE MAGNESIUM], start date: 01Nov1995; MAGNESIUM CITRATE, start date: 17Apr2017; DIPHENHYDRAMINE, start date: 22May2016; B COMPLEX [VITAMIN B COMPLEX], start date: 15May2016; COQ-10, start date: 01Dec2018. Past drug history included: Compazine, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE(medically significant), COVID-19 (medically significant) all with onset 05May2022 at 06:00, outcome "not recovered" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: If vaccine received: Yes, Other medication in 2weeks: Yes. Other medication in 2weeks product: Patis 30 Fotified Silver Solution, Other medication in 2weeks brand: Patis, Other medication in 2weeks start date: 01Sep2020. Known allergies: Compazine. Other medical history: Colon Cancer 2016/ Chemo/Radiation Rx, Chronic reflux  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 reported information, causal association of event vaccination failure, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 at 10:00 as dose 4, single (Batch/Lot number: unknown) at the age of 45 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: "Diabetes" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hypercholestemia" (unspecified if ongoing); "Allergy: Eggs" (unspecified if ongoing), notes: known allergies: Eggs. Concomitant medication(s) included: METFORMIN; LANTISEPTIC PROTECTIVE OINTMENT; NOVALINA; ATORVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022 at 13:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Treatment of covid-19 with anti-viral product, brand-paxlovid, treatment start date 08may2022, treatment stop date 13may2022, lot number fl4517, administrator route oral. 10 days post completing treatment employee is having Headache, Nasesa, Diarrhea, and Runny Nose.  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 reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report for the following literature source(s): DOI:doi.org/10.21203/rs.3.rs-1588371/v2.  A 69-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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 "recovered" and all described as "SARS-COV 2 PCR test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Day 0-3; negative, notes: Day 4-9; 28.6, notes: Day 2; 25.8, notes: day 10; 36.4, notes: Day 12. 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.; 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.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report for the following literature source(s): A 50-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: 20.4, notes: Day 1; 28.9, notes: Day 4; 22.3, notes: Day 9; 25.3, notes: Day 11; 34.5, notes: Day 13. 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.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report.  A 63-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". Therapeutic measures were taken as a result of sars-cov-2 test positive, drug ineffective. 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 available information and possible temporal association the causal relationship between the reported event and suspect drug cannot be excluded.The case will be reviewed further with FU information. 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,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report.  A 31-year-old female patient (unknown if pregnant) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Lot number: unknown), as dose 2, single (Lot number: unknown) and as dose 3 (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report for the following literature source(s).  A 47-year-old female patient (unknown if pregnant) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". 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.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the event  and suspect drug  cannot be excluded.The case will be reviewed further with FU information. 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,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report.  A 55-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: 17.2, notes: Day 12; 22.9, notes: Day 14; 22.9, notes: day 16. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Prescribed paxlovid after vaccination; Prescribed paxlovid after vaccination; 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 male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 08Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 14May2022, outcome "recovered" (19May2022), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Prescribed paxlovid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 at 15:00 as dose 3 (booster), single (Lot number: Ff4554) at the age of 60 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 14Mar2021 at 10:00 as dose 1, single (Lot number: 1805022), in left arm and on 23Oct2021 at 09:00 as dose 2, single (Lot number: 1822809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyper coagulation" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) received in 2 weeks of vaccination, which included: LYRICA, start date: 01Apr2022, stop date: 25May2022; VIMPAT, start date: 01Apr2022, stop date: 25May2022; ELIQUIS, start date: 01Apr2022, stop date: 25May2022. No known allergies were reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022 at 20:00, outcome "recovered with sequelae" (13May2022) and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (09May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Adverse event: Rebound of covid symptoms and positive test 5 days after paxlovid treatment ended.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 24Apr2022 as dose 4 (booster), single (Lot number: F24989) at the age of 53 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 13Mar2021 as dose 1, single (Lot number: 031A21A), in left arm, on 10Apr2021 as dose 2, single (Lot number: 020B21A), in left arm and on 08Nov2021 as dose 3 (booster), single (Lot number: 05121A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). The patient had no Known allergies. Concomitant medication(s)/Other medication in 2 weeks included: AZELASTINE; ESCITALOPRAM; HYDROCHLOROTHIAZIDE; LOSARTAN; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]; ALLEGRA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TURMERIC [CURCUMA LONGA]; LEUTINIB, Multi-vitamin and Tri-chromium. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Negative, notes: I tested negative (with a home antigen rapid test) on 12May2022; (03May2022) Positive, notes: After testing positive for Covid on 03May2022; (15May2022) Positive, notes: she tested at home on 15May2022 and it was positive; (23May2022) Positive, notes: As of 23May2022 I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Anti-viral details: product: COVID-19 Treatment, Brand: Paxlovid, Treatment start date: 03May2022, Treatment stop date: 08May2022. Adverse event: After testing positive for Covid on 03May2022 and taking the full 5 day course of Paxlovid, she tested negative (with a home antigen rapid test) on 12May2022. At this point most of her symptoms had resolved and she not had a fever since 04May2022. On 14May2022 she developed a sore throat again and by 15May2022 it was worse, and she had a cough. She tested at home on 15May2022, and it was positive. As of 23May2022 she was still testing positive. My mild symptoms have resolved however she was having daily headaches.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: washed out; doesn't have any energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 17May2022 as dose number unknown (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; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (First Booster, unknown manufacturer), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "washed out"; ASTHENIA (non-serious), outcome "not recovered", described as "doesn't have any energy".  Additional information: Consumer calling about her husband and her getting their second booster shot last Thursday. She doesn't know what shot it was, but then states it was her second shot for Covid 19. She got her first shot, the second shot and both were boosters. The first one was Covid 19, then the second booster shot, then another booster shot. Caller refers to her last vaccine received as her second booster. Aware this is discrepant, but details were confirmed and documented as provided by the caller. Caller feels like she is washed out and doesn't have any energy. States it is the same with her husband, he has the same thing.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.