chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration
Clinical narrative: Had a bad reaction to the three Moderna shots; They also stated that their first dose of the Moderna covid19 vaccine was on 29Marhc2021 with lot number 020b21a, second dose was on 6MAy2021 with lot 017c21a; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They also stated that their first dose of the Moderna covid19 vaccine was on 29MArhc2021 with lot number 020b21a, second dose was on 6MAy2021 with lot 017c21a) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts, Allergy to grains (allergy to wheat) and Milk allergy (can not drink milk). Concomitant products included ESTRADIOL (DIVIGEL) for an unknown indication.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They also stated that their first dose of the Moderna covid19 vaccine was on 29MArhc2021 with lot number 020b21a, second dose was on 6MAy2021 with lot 017c21a). On an unknown date, the patient experienced IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots). At the time of the report, IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They also stated that their first dose of the Moderna covid19 vaccine was on 29MArhc2021 with lot number 020b21a, second dose was on 6MAy2021 with lot 017c21a) outcome was unknown.            Concomitant drug Divigel, which was a topical hormonal cream was reported.   It was reported that patient never had COVID positive test or diagnosis.  No treatment medications were reported.   This case was linked to MOD-2022-586368, MOD-2022-586557 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My booster felt like either a shark bit off my arm/brutal pain/Unbearable; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (My booster felt like either a shark bit off my arm/brutal pain/Unbearable) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Pregnancy (2 births).  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (My booster felt like either a great white bit off my arm/brutal pain/Unbearable). At the time of the report, PAIN IN EXTREMITY (My booster felt like either a great white bit off my arm/brutal pain/Unbearable) outcome was unknown.      No concomitant medications were reported. It was reported that patient's booster felt like either a great white bit off arm (not being dramatic) with no anesthesia or someone took a chainsaw to it with no anesthesia. Patient had felt worst pain in the entire life including two births and did not get covid ore vaccine in august of 2011 and have not had since. So, she would never known if it was worth that level of excruciating pain and the pain level with booster was bad. Patient first shot made bed ridden sick for a week and no pain. Patient stated that can handle the sick part, but the brutal pain of booster was unbearable. No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  No treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial stored post puncture in fridge; Expired Vaccine Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered) and PRODUCT STORAGE ERROR (the vial stored post puncture in fridge) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022 at 1:20 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial stored post puncture in fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered) and PRODUCT STORAGE ERROR (the vial stored post puncture in fridge) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. One dose was administered. The vial was initially stored in the refrigerator on 31-May-2022. The vial was first punctured on 08-Jun-2022 at 2:48 PM. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius = 46 degree Celsius to 77 degree Fahrenheit) for 15 minutes.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Received the Pfizer vaccine; she may have tested positive for Covid; Received the Pfizer vaccine; she may have tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955, Expiration Date: 30Jun2021), in left arm, on 14Apr2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021), in left arm and on 08Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE taken for migraine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Received the Pfizer vaccine; she may have tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she may have tested positive for Covid.  Investigation result received on 31May2022. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP6955 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. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I was infected with COVID-19; I was infected with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: en6206), on 01Apr2021 as dose 2, single (Lot number: er8733) and on 09Dec2021 as dose 3 (booster), single (Lot number: ew0196) at the age of 28 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 29May2022, outcome "recovering" and all described as "I was infected with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: en6208), as dose 2, single (Lot number: ew0161) and on 20Dec2021 as dose 3 (booster), single (Lot number: fl3197) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "recovering" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with paxlovid for treatment of COVID-19. Treatment start date: 20May2022. Treatment stop date: 25May2022.; 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product administered at inappropriate site, SARS-CoV-2 test
Clinical narrative: Contracted Covid. Since then he has experienced long covid symptoms such as brain fog, memory issues, visual problems (floaters, sensitivity to light, etc), headaches and other cognitive challenges; Contracted Covid. Since then he has experienced long covid symptoms such as brain fog, memory issues, visual problems (floaters, sensitivity to light, etc), headaches and other cognitive challenges; Vaccine administered at inappropriate site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 12May2021 as dose 2, single (Lot number: EP6955), in left arm and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left leg, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset Dec2021, outcome "unknown", described as "Vaccine administered at inappropriate site"; DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "not recovered" and all described as "Contracted Covid. Since then he has experienced long covid symptoms such as brain fog, memory issues, visual problems (floaters, sensitivity to light, etc), headaches and other cognitive challenges". The events "contracted covid. since then he has experienced long covid symptoms such as brain fog, memory issues, visual problems (floaters, sensitivity to light, etc), headaches and other cognitive challenges" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old patient received BNT162b2 (BNT162B2), on 24Mar2022 as dose 4 (booster), single (Lot number: FJ991) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: Jan2000, stop date: Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, 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 on two different home antigen tests; (unspecified date) Positive, notes: tested positive on two different home antigen tests; (25May2022) Negative, notes: tested negative the morning of 25May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies were noted. The patient took COVID 19 treatment with Paxlovid (Treatment start date: 20May2022, Treatment stop date: 25May2022) and tested negative on the morning of 25May2022. On 26May2022, the patient flew home. Since then, had virtually no contact with anyone. Today (unspecified date), the patient had a sore throat.
Age: 68.0
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) (Consumer or other non HCP).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 04Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "interchange of vaccine products" (unspecified if ongoing), notes: Dose 1 &2 - Moderna, Dose 3 &4 Booster- PFizer. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Relapse in symptoms 2 days after testing negative. Tested positive 1 day later; Relapse in symptoms 2 days after testing negative. Tested positive 1 day later; 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 received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated blood pressure" (unspecified if ongoing), notes: Elevated blood pressure controlled with medication; "Known allergies" (unspecified if ongoing), notes: yes. Concomitant medication(s) included: ATORVASTATIN; ATENOLOL; LOSARTAN; GABAPENTIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID [FAMOTIDINE]; VIVISCAL [SILICON DIOXIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 01Jun2022, outcome "not recovered" and all described as "Relapse in symptoms 2 days after testing negative. Tested positive 1 day later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Relapse in symptoms 2 day after testing negative. Tested positive 1 day later; Positive, notes: Relapse in symptoms 2 day after testing negative. Tested positive 1 day later. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: COVID 19 Treatment, Brand: Paxlovid, Treatment start date:22May2022,Treatment stop date:26May2022, Indication: Treatment of COVID-19. Adverse event start date: 01Jun2022. If patient recovered: Recovering. If treatment ae: No. Known allergies: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Meningitis, SARS-CoV-2 test
Clinical narrative: Relapse in symptoms 2 days after testing negative. Tested positive 1 day later; Relapse in symptoms 2 days after testing negative. Tested positive 1 day later; 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 received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated blood pressure" (unspecified if ongoing), notes: Elevated blood pressure controlled with medication; "Known allergies" (unspecified if ongoing), notes: yes. Concomitant medication(s) included: ATORVASTATIN; ATENOLOL; LOSARTAN; GABAPENTIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID [FAMOTIDINE]; VIVISCAL [SILICON DIOXIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 01Jun2022, outcome "not recovered" and all described as "Relapse in symptoms 2 days after testing negative. Tested positive 1 day later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Relapse in symptoms 2 day after testing negative. Tested positive 1 day later; Positive, notes: Relapse in symptoms 2 day after testing negative. Tested positive 1 day later. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: COVID 19 Treatment, Brand: Paxlovid, Treatment start date:22May2022,Treatment stop date:26May2022, Indication: Treatment of COVID-19. Adverse event start date: 01Jun2022. If patient recovered: Recovering. If treatment ae: No. Known allergies: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: getting COVID after being vaccinated; getting COVID after being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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), COVID-19 (medically significant), outcome "unknown" and all described as "getting COVID after being vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: getting COVID after being vaccinated. Clinical course: The reporter did not realize that getting COVID after being vaccinated was considered an adverse event until she received the postcard that was sent to colleagues today. Once she saw that she reported immediately. The same situation occurred for her husband and son which she was going to report tonight so she could gather all the relevant info (Vaccine dates and lots) from them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200797971 same reporter and drug, different patient
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperacusis, SARS-CoV-2 test
Clinical narrative: I've had a headache 24/7 for almost 9 months. It started after the booster and presented as a mild headache with some lightheadedness; I've had a headache 24/7 for almost 9 months. It started after the booster and presented as a mild headache with some lightheadedness; I had hyper-sensitivity to sound and motion during months 3 and 4.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 13Sep2021 at 12:30 as dose 3 (booster), single (Lot number: FC3182) at the age of 63 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Intolerance for onions and garlic" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP75134, Vaccine Administration Time: 02:30 PM), administration date: 17Mar2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 24Feb2021, when the patient was 63-year-old, for Covid-19 immunization. The following information was reported: HYPERACUSIS (disability) with onset 14Sep2021, outcome "not recovered", described as "I had hyper-sensitivity to sound and motion during months 3 and 4."; HEADACHE (disability), DIZZINESS (disability) all with onset 14Sep2021, outcome "not recovered" and all described as "I've had a headache 24/7 for almost 9 months. It started after the booster and presented as a mild headache with some lightheadedness". The events "i've had a headache 24/7 for almost 9 months. it started after the booster and presented as a mild headache with some lightheadedness" and "i had hyper-sensitivity to sound and motion during months 3 and 4." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab Covid test name post vaccination: PCR, Cue, etc. Therapeutic measures were taken as a result of headache, dizziness, hyperacusis and included treatment with amitriptyline, rizatriptan, Topamax and prednisone. Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks: Famotidine. Prior to the vaccination, the patient was not diagnosed with COVID-19. I have had a headache 24/7 for almost 9 months. It started after the booster and presented as a mild headache with some lightheadedness. After 3 months it felt more like a regular headache, still 24/7. I had hypersensitivity to sound and motion during months 3 and 4. Since the vaccination, the patient had been tested for COVID-19 (Covid test type post vaccination: Nasal swab, Covid test name post vaccination: PCR, Cue, etc).  No follow-up attempts are possible. No further information is expected.
Age: 28.0
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) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Negative, notes: tested negatively on home tests; (04Jun2022) Positive, notes: Today I tested positive again on two different tests; (04Jun2022) Positive, notes: Today I tested positive again on two different tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment for covid-19 from 17May2022 to 22May2022 and in 2 weeks patient took other medications such as Adderall, Trazodone, Clonazepam and Fluoxetine. It was reported that congestion, sore throat, laryngitis. Patient tested negatively on home tests, numerous brands, starting on 24May2022. Today (04Jun2022), patient tested positive again on two different tests and have complete laryngitis, which was a new symptom.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough COVID infection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: she was feeling unwell; She reported flu-like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2022 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 but unknown manufacturer), for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 02Jun2022, outcome "unknown", described as "She reported flu-like symptoms"; MALAISE (non-serious) with onset 02Jun2022, outcome "unknown", described as "she was feeling unwell".  Additional information: It was reported that the event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 59-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (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 covid-19, covid-19 included PAXLOVID from 18May2022 to 24May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 76-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 at 10:15 as dose 1, single (Batch/Lot number: unknown), in left arm and on 02Feb2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (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 covid-19 included: PAXLOVID. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
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 a contactable reporter(s) (Physician).  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2022 as dose 1, single (Batch/Lot number: unknown) and on 05Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Sep2016, stop date: May2022; HYDROCHLOROTHIAZIDE, start date: Sep2014, stop date: May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" 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: (25May2022) positive, notes: with a test on 25May that was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies. The patient took other medication in 2 weeks. Patient was exposed to COVID-19 on 21May2022 and developed symptoms on 22May2022, with a test on 25May2022 that was positive. Her symptoms were dizziness, diarrhea, mild cough and minimal SOB. She was prescribed Paxlovid on 27May2022 and subsequently developed nausea, vomiting, and lower leg muscle cramps. She presented to the ER in the evening on 28May2022 where her sodium was found to be 109. All home medications, including Paxlovid, were discontinued and she was admitted to the ICU. Her hyponatremia was slowly corrected with her transferring to acute care on 31May2022 (sodium 122). Her sodium was slowly corrected to 129 with her discharging on 2Jun2022. She never required in hospital treatment for COVID-19, nor did she develop oxygen requirement.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KEPPRA [LEVETIRACETAM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "unknown" 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: Negative; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Re-lapse Covid. After testing negative for 5 days, on the 6th day, I started to test positive again. The complaint for lot FF2589 was investigated.  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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Hyperhidrosis
Clinical narrative: Today is Day 17 since first positive antigen test for COVID; Today is Day 17 since first positive antigen test for COVID; Extreme fatigue; congestion; cough; sweats; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2 , single (Lot number: EW0169), in left arm, on 02Dec2021 as dose 3 (booster) , single (Lot number: EW0217) at the age of 55 years, in left arm and on 25Mar2021 as dose 1 , single (Lot number: ER8733), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraine" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies: Sulfa drugs" (unspecified if ongoing); "allergies:shrimp" (unspecified if ongoing); "allergies:crab" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered", described as "Extreme fatigue"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022 at 19:00, outcome "not recovered" and all described as "Today is Day 17 since first positive antigen test for COVID"; CHILLS (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered"; HYPERHIDROSIS (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered", described as "sweats". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Day 17 since first positive antigen test for COVID; Negative, notes: Tested negative antigen test on Day 10; Positive, notes: Symptoms rebounded and are worse starting on Day 14. Therapeutic measures were not taken as a result of vaccination failure, covid-19, fatigue, nasal congestion, cough, hyperhidrosis, chills.  Additional information: Today was Day 17 since first positive antigen test for COVID. I started taking Paxlovid on Day 2. Felt improvement in symptoms by day9 .Tested negative antigen test on Day 10. Symptoms rebounded and were worse starting on Day 14. Extreme fatigue, congestion, cough, sweats and chills, but no fever. No improvement since Day 14.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Today is Day 17 since first positive antigen test for COVID; Today is Day 17 since first positive antigen test for COVID; Extreme fatigue; congestion; cough; sweats; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2 , single (Lot number: EW0169), in left arm, on 02Dec2021 as dose 3 (booster) , single (Lot number: EW0217) at the age of 55 years, in left arm and on 25Mar2021 as dose 1 , single (Lot number: ER8733), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraine" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies: Sulfa drugs" (unspecified if ongoing); "allergies:shrimp" (unspecified if ongoing); "allergies:crab" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered", described as "Extreme fatigue"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022 at 19:00, outcome "not recovered" and all described as "Today is Day 17 since first positive antigen test for COVID"; CHILLS (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered"; HYPERHIDROSIS (non-serious) with onset 01Jun2022 at 19:00, outcome "not recovered", described as "sweats". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Day 17 since first positive antigen test for COVID; Negative, notes: Tested negative antigen test on Day 10; Positive, notes: Symptoms rebounded and are worse starting on Day 14. Therapeutic measures were not taken as a result of vaccination failure, covid-19, fatigue, nasal congestion, cough, hyperhidrosis, chills.  Additional information: Today was Day 17 since first positive antigen test for COVID. I started taking Paxlovid on Day 2. Felt improvement in symptoms by day9 .Tested negative antigen test on Day 10. Symptoms rebounded and were worse starting on Day 14. Extreme fatigue, congestion, cough, sweats and chills, but no fever. No improvement since Day 14.
Age: 55.0
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 001A21A), in left arm, on 27Mar2021 as dose 2, single (Lot number: 003B21A), in left arm and on 07Sep2021 as dose 3 (booster), single (Lot number: 059E21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes, heart disease" (unspecified if ongoing); "heart disease" (unspecified if ongoing). Concomitant medication(s) included: LANTUS; NOVOLOG; FARXIGA; FUROSEMIDE; ASPIRIN [ACETYLSALICYLIC ACID]; ELIQUIS; METOPROLOL; DIGESTZYMES; PROBIOTICS. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "not recovered", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test. Relapse of COVID symptoms and positive test. Biitter and metallic taste in mouth while taking medication. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 33.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (26May2022) Negative, notes: Negative test following paxlovid on day 6 and 7 (26May, 28May); (28May2022) Negative, notes: Negative test following paxlovid on day 6 and 7 (26May, 28May); (30May2022) Positive, notes: positive test & covid symptoms started again on 30May2022. 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: 60.0
Sex: M
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 a contactable Physician via product quality group.  A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899), as dose 1,single, administered via unspecified route in left arm, on 16Dec2020 and received second dose of BNT162b2,(Lot Number: E L1283), as dose 2,single, administered via unspecified route in left arm, on 15Jan2021 and received dose 3 (booster) of BNT162b2 (Lot number: EW0172) on 27Sep2021 in left arm for covid-19 immunisation, ( age at vaccination was 60 years). The patient also received coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient relevant medical history included hypertension, Prostate cancer and "CAD" (unspecified if ongoing). Concomitant medication(s) included Amlodipine [AMLODIPINE BESILATE], stop date: 16May2022; ASPIRIN (E.C.); Atorvastatin; CALCIUM CARBONATE and SILDENAFIL taken for an unspecified indication, start and stop date were not reported.. The patient experienced vaccination failure and COVID-19. It was reported that, the patient was Covid positive rebound after taking Paxlovid. Covid symptom onset was 13May2022 (day 0). He felt well quickly after starting Paxlovid on day 3 of illness (16May2022) and took full 5 days of medication. He had negative Covid antigen test on day 10 (23May2022) of illness. But on 24May2022 and 25May2022 he tested positive again all, (the repeat tests done due to recurrent symptoms). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Negative, notes: He had negative Covid antigen test on day 10 (23May2022) of illness; (unspecified date) Positive, notes: report Covid positive rebound after taking Paxlovid; (24May2022) Positive, notes: But on 24May and 25 he tested positive again; (25May2022) Positive, notes: But on 24May and 25 he tested positive again; (01Jun2022) Negative, notes: He recovered and on 01Jun2022 tested negative again. Therapeutic measures were taken as a result of the events. The outcome was recovered on 01Jun2022.; 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.