chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
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) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: gj6739) at the age of 56 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: Positive test result following Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid treatment start date: 04Feb2023 to 08Feb2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 19 with fever, general malaise, and congestion; Tested positive for COVID 19 with fever, general malaise, and congestion; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CITALOPRAM; PANTOPRAZOLE; PREMPRO; CELECOXIB. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Feb2023, outcome "recovered" (11Feb2023) and all described as "Tested positive for COVID 19 with fever, general malaise, and congestion". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Feb2023) Positive; (11Feb2023) Negative; (16Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: 60 year old female with no underlying health conditions or risk factors for severe COVID-19 was fully vaccinated with primary series of Pfizer COVID-19 vaccine plus original booster plus new Bivalent booster in Oct2022. tested positive for COVID 19 with fever, general malaise, and congestion on 03Feb2023. Paxlovid was prescribed and taken on 03Feb. Course was completed on 08Feb Symptoms resolved quickly and fever resolved by 08Feb also. COVID test was negative on 11Feb. On 16Feb, runny nose and slight cough returned. COVID test was positive. No fever.   The lot number for the vaccine [BNT162B2, BNT162B2 OMI BA.4-5; BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events Drug Ineffective and COVID-19 and the suspect drug cannot be completely excluded.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: Fm7553) at the age of 62 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: "Seasonal allergies" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes a COVID 19 Treatment from 03Feb2023 to 07Feb2023.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine_brand_other=Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Lot number: IN6203), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroidectomy" (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 07Feb2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine_brand_other=Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (07Feb2023) Positive; (15Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient initially tested positive for COVID-19 on 07Feb2023. She started taking PAXLOVID that same evening and finished the course on 12Feb2023. Because her kidney function tests were somewhat low, her doctor instructed her to take only one of the nirmatrelvir tablets. She tested negative for the first time on 15Feb2023. On 17Feb2023, she started feeling like she was getting a cold. She did two rapid tests from two different manufacturers, and they were both positive. Concomitant medication active drug substance included Antihistamine/Decongestant and Multivitamins. Patient had no known allergy.
Age: 57.0
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 product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 at 13:00 as dose 1, single (Lot number: FR8732), in left arm, on 21Apr2021 at 14:00 as dose 2, single (Lot number: FR8731), in left arm, on 23Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 09Aug2022 at 13:00 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Remission for breast cancer" (unspecified if ongoing); "double mastectomy", start date: Jun2022 (unspecified if ongoing); "radiation", stop date: 19Sep2022; "chemotherapy", stop date: 23May2022; "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LYRICA, start date: 01Feb2022, stop date: 17Feb2023. Past drug history included: Keytruda, stop date: 19Jan2023, for immunotherapy, notes: immunotherapy with Keytruda ended 19Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 08Feb2023, Treatment stop date: 12Feb2023, Indication: Treatment of COVID-19
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gall bladder removal" (unspecified if ongoing); "Uterine cancer" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Lymphedema" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, 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, drug ineffective.  Clinical information: Other medication in 2 weeks: No. Anti-viral details: Paxlovid, Product: COVID 19 Treatment Brand: Pfizer, Treatment start date: 07Feb2023, Treatment stop date: 12Feb2023, lot number=GF6392, Indication: Treatment of COVID-19.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis, Fatigue, Immune system disorder, SARS-CoV-2 test, Sinus disorder
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gall bladder removal" (unspecified if ongoing); "Uterine cancer" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Lymphedema" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, 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, drug ineffective.  Clinical information: Other medication in 2 weeks: No. Anti-viral details: Paxlovid, Product: COVID 19 Treatment Brand: Pfizer, Treatment start date: 07Feb2023, Treatment stop date: 12Feb2023, lot number=GF6392, Indication: Treatment of COVID-19.
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: I tested positive for COVID-19; I tested positive for COVID-19; first booster from Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested positive for COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "first booster from Moderna". The event "i tested positive for covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive for COVID-19; Positive, notes: Today I tested positive for COVID-19 again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Description of Product Complaint: Transferring agent stated, "I have a consumer on the line. This was about Paxlovid and the COVID-19 Vaccine. This patient mentioned that he was fully vaccinated. He received the whole primary series and one boosters with Pfizer's COVID-19 Vaccine and one of the boosters was from Moderna. However, he tested positive for COVID-19. Now he had to take Paxlovid and his last dose was this Sunday and today he tested positive again for COVID-19. So there was a rebound and that was all the information that I have. He disconnected." He went to urgent care because he tested positive for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 76-year-old male patient received BNT162b2 (BNT162B2 NOS), on 28Oct2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart stents" (unspecified if ongoing), notes: Heart stents. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter (consumer) from Medical Information Team. The reporter is the patient. A 73-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 30Mar2021 at 14:00 as dose 2, single (lot number ER8733) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "cirrhosis from hepatitis C" (unspecified if ongoing); "hepatitis C", start date: 1981 (unspecified if ongoing), notes: got this from a hospital 40 years ago (from 2023); "car accident" (unspecified if ongoing); "encephalopathy" (ongoing); "didn't know own name or name of president" (unspecified if ongoing). Concomitant medications included: XIFAXAN taken for encephalopathy, start date: 2020; ZINC; GENERLAC taken for hepatic cirrhosis; LACTULOSE taken for hepatic cirrhosis. Past drug history included: ammonia, reaction: "goes into the brain, messes your brain up". Vaccination history included: BNT162b2 (dose 1; lot number EN6199), administration date: 06Mar2021, for COVID-19 immunization, reaction: "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2021, outcome "recovered" (2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: For medical history hepatitis C, the patient got this from a hospital 40 years ago. She was in a car accident and they didn't screen the blood for hepatitis C, they didn't even know hepatitis C existed yet. When she got this, it kind of messed up her liver, so she got cirrhosis. If not for Xifaxan and Generlac she would probably be in a home, because she ended up in hospital; couldn't figure out how to go to bathroom. She knew she had to go, couldn't figure out how to do it, didn't know her own name or the name of the president. They just loaded her up with Generlac and that was about it. Xifaxan really, really helps, she wouldn't be able to function without it. It has to do with gut, kills bad bacteria, that's why it works. On 30Mar2021 the patient experienced just a sore arm; usually just a little sore when she slept on that side, a little uncomfortable; no other side effects whatsoever. The sore arm recovered completely a couple of days later. She has not required any treatment or medical interventions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073682 same patient/product, different vaccine dose/event;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Pain in extremity
Clinical narrative: just a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Cirrhosis From Hepatitis C" (unspecified if ongoing), notes: Hepatitis C She got this from a hospital 40 years ago; "Cirrhosis From Hepatitis C" (unspecified if ongoing), notes: she got cirrhosis.; "Car accident" (unspecified if ongoing), notes: She was in a car accident; "Encephalopathy" (ongoing), notes: Encephalopathy. Concomitant medication(s) included: XIFAXAN taken for encephalopathy, start date: 2020 (ongoing); ZINC; GENERLAC taken for hepatic cirrhosis; LACTULOSE taken for hepatic cirrhosis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6199, NDC/Expiry: Unknown, this is not on the CDC vaccine record card.), administration date: 06Mar2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Just a sore arm"; BNT162b2 (DOSE 2, SINGLE, Lot: ER8733, NDC/Expiry: Unknown, this is not on the CDC vaccine record card., Administered at 14:00.), administration date: 30Mar2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Just a sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Oct2021, outcome "recovered" (2021), described as "just a sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity. Additional information: patient reported she got hepatitis C  from a hospital 40 years ago. She was in a car accident and they didnt screen the blood for Hepatitis C, they didnt even know Hepatitis C existed yet. When she got this, it kind of messed up her liver, so she got cirrhosis.Theres too much ammonia that goes into the brain, messes your brain up. If not for Xifaxan and Generlac would probably be in a home, because ended up in hospital; couldnt figure out how to go to bathroom. She knew she had to go, couldnt figure out how to do it, didnt know own name or name of president.They just loaded her up with Generlac and that was about it. Xifaxan really, really helps, she wouldnt be able to function without it; It has to do with gut, kills bad bacteria, thats why it works. Patient did not take a dose of Xifaxan because nauseous, didnt want to be more nauseous. Generlac: If the pharmacy is out of this they will give her Lactulose instead since its the same. Tastes really sweet, if youre trying not to eat sugar, theres no sugar or corn syrup, its a good sugar fix.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073682 same patient, different dose and event;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: just a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Cirrhosis From Hepatitis C" (unspecified if ongoing); "Hepatitis C" (unspecified if ongoing), notes: Hepatitis C She got this from a hospital 40 years ago.; "Encephalopathy" (ongoing); "She was in a car accident" (unspecified if ongoing), notes: She was in a car accident. Concomitant medication(s) included: XIFAXAN taken for encephalopathy, start date: 2020; ZINC; GENERLAC taken for hepatic cirrhosis; LACTULOSE taken for hepatic cirrhosis. Vaccination history included: BNT162b2 (Dose: 01, Lot: EN6199, NDC/Expiry: Unknown, this is not on the CDC vaccine record card., Sore arm: From date: 06Mar2021, Stop date: Unknown other than a couple of days later. , Outcome: Recovered completely.), administration date: 06Mar2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 02, Lot: ER8733, NDC/Expiry: Unknown, this is not on the CDC vaccine record card., Administered at 14:00., Sore arm: From date: 30Mar2021, Stop date: Unknown other than a couple of days later. , Outcome: Recovered completely.), administration date: 30Mar2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Sore arm"; BNT162b2 (Dose: 03, Lot: FH8020, NDC/Expiry: Unknown, this is not on the CDC vaccine record card., Administering facility name on CDC vaccine record card: Withheld, Sore arm: From date: 22Oct2021, Stop date: Unknown other than a couple of days later. , Outcome: Recovered completely), administration date: 22Oct2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06May2022, outcome "recovered" (2022), described as "just a sore arm". Therapeutic measures were not taken as a result of pain in extremity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073682 same patient, different dose and event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; received Moderna vaccine as booster dose; 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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6204), in left arm and on 31Mar2021 as dose 2, single (Lot number: ER8737) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Oct2021 as dose 3 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 07Sep2022 as dose 4 (booster), single (Lot number: 157143C), 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: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Oct2021, outcome "unknown", described as "received Moderna vaccine as booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient was treated with PAXLOVID from 08Feb2023 to 12Feb2023.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Nov2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20May2022 at 13:00 as dose 3 (booster), 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), notes: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single, 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 and concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment start date 08Feb2023 to 13Feb2023. Other medication in 2 weeks: product Herbal tea (01Feb2023 to 08Feb2023), Enzymes (start date 14Sep2022 to 08Feb2023). Patient has no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 30 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: "Crohns Disease (immune suppressed)" (unspecified if ongoing), notes: Crohns Disease (immune suppressed). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID (COVID 19 Treatment)  from 08Feb2023 to 13Feb2023.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician).  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 76 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN9581), on 17Feb2021 as dose 2, single (Lot number: EL9266) and on 28Sep2021 as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "High Cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, latency 1 year 11 months 29 days 20 hrs 30 min after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 06Feb2023 to 11Feb2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (VACCINATION FAILURE, COVID 19) and BNT162B2.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4 Moderna; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 17:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Jan2021 at 10:00 as dose 1, single (Lot number: EM9899), in left arm, on 26Jan2021 at 10:00 as dose 2, single (Lot number: EL1283), in left arm, on 17Aug2021 at 09:00 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 28Jul2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Dec2021 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "NASH" (unspecified if ongoing); "insomnia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Allergy", notes: Known allergies: Clindamycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Dec2021, outcome "unknown", described as "Dose Number: 4 Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccines to interchange of vaccine products, COVID-19 and drug ineffectiveness cannot be ruled out.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product: COVID 19 Treatment; product: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 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: "Depression" (unspecified if ongoing). Concomitant medication(s) included: PROZAC, start date: 01Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product: 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 with Paxlovid from 08Feb2023 to 12Feb2023.  Clinical course: The vaccine lot number was unknown due to it was misplaced/discarded. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report , a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand=Pfizer / BioNTech; vaccine dose number=5/ vaccine brand other=Moderna; vaccine dose number=4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2022 as dose 4 (booster), siingle (Lot number: 049CZ1A), 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: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech; vaccine dose number=5/ vaccine brand other=Moderna; vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: No other medication in 2 weeks, for COVID 19 Treatment received Paxlovid from 07Feb2023 to 11Feb2023.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Nov2022 as dose 5 (booster), single (Lot number: 6H9702) at the age of 54 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks: No. Anti viral details, Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=05Feb2023, Treatment stop date=10Feb2023, Indication=Treatment of COVID-19
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 19-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 19 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0153), on 01May2021 as dose 2, single (Lot number: EW0162) and on 22Nov2021 as dose 3 (booster), single (Lot number: 012H21B) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "autism spectrum high functioning," (unspecified if ongoing); "ADD" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (07Feb2023) Positive, notes: tested positive 07Feb2023; (17Feb2023) Positive, notes: positive home test 17Feb2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks. Anti-viral details includes COVID 19 Treatment, Paxlovid, treatment started on 07Feb2023 and stopped on 11Feb2023. Patient did not have known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hodgkin lymphoma x 2 yrs" (unspecified if ongoing), notes: Hodgkin lymphoma x 2 yrs; "Asthma" (unspecified if ongoing); "known allergies:sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "known allergies: milk products" (unspecified if ongoing), notes: known allergies: milk products. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 09Feb2023 to 13Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Jan2023 as dose 5 (booster), single (Lot number: GJ3275) at the age of 39 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: ER8734), in left arm, on 03May2021 as dose 2, single (Lot number: EN0162), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 28Sep2022 as dose 4 (booster), single (Lot number: FP7138), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: All the cillins" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Feb2023) negative, notes: tested negative then at day 4 after my series was completed; (Feb2023) positive, notes: tested positive for covid again; so a rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products: Pfizer/ Moderna; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Lot number: 6J6738) at the age of 58 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 08Apr2021 as dose 2, single (Lot number: EP7533), in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm and on 23Aug2022 as dose 4 (booster), single (Lot number: O118ZZA), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication included: LOSARTAN, start date: 17Nov2022. Past drug history included: Cipro, reaction: "Known allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products: Pfizer/ Moderna"; DRUG INEFFECTIVE (medically significant) with onset 03Feb2023, outcome "not recovered", COVID-19 (medically significant) with onset 03Feb2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Feb2023) Positive; (11Feb2023) Negative; (12Feb2023) Negative; (17Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 05Feb2023 to 10Feb2023. Clinical course: The patient got COVID and started taking PAXLOVID from 05Feb (Day 3) in the evening for 5 days, then both 11Feb and 12Feb, she got negative COVID results with different test kit. On 15Feb and 16Feb nights, she got rash, 17Feb morning dry coughs and running nose, then she got again COVID positive.