chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Meloicam, reaction(s): "Known allergies: Meloicam".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received Anti-viral Product for COVID 19 Treatment, Lot number: Ga7394. The patient experienced Extreme aftertaste, does not dissipate with gargling or brushing teeth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 at 11:00 as dose 2, single (Lot number: FJ8757) at the age of 36 years, 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: I started feeling sick a few days later and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment with Paxlovid.  Additional information: patient had no known allergies.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2022 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Antiviral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 29May2022 and stop date: 02Jun2022, indication is used for treatment of COVID-19, Administrator route: Oral. The patient did not receive other medication in 2 weeks. Adverse event experienced on 11Jun2022. Rebound Covid. The outcome of event was not recovering. The patient did not receive treatment.   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: 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 male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EM9808), in left arm, on 23Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 12Apr2022 at 08:00 as dose 4 (booster), single (Lot number: 3303680), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Keflex series of antibiotics" (unspecified if ongoing), notes: Known allergies: Keflex series of antibiotics. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks were reported as, yes. Anti-viral details was Brand name Paxlovid, Treatment start date was 13Jun2022, Lot number: FW4118, Indicated for treatment of COVID-19. Other medication in 2 weeks products with start date 12Jun2022 was Lipitor, Chorthalidone, Hygroton, Gabapentin, Multi-Vitamin and Vitamin C. Metallic Taste in mount (continuous), Diarreha (2 days), Severe night sweats (enough to soak the sheets and my pajamas on nights 2 and 3 of the medication. No treatment.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
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 42-year-old male patient received BNT162b2 (BNT162B2), on 05Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (04Jun2022) Negative; (05Jun2022) Negative; (06Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Covid 19 treatment: Antiviral Paxlovid 30May2022 and stop date 03Jun2022. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment/Retested & this time it was positive.; COVID-19 Treatment/Retested & this time it was positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 at 14:30 as dose 1, single (Lot number: EK9231), in right arm, on 01Feb2021 at 14:30 as dose 2, single (Lot number: EL3299), in right arm and on 29Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FC3180) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 31Dec1999.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 Treatment/Retested & this time it was positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (28May2022) negative, notes: On 6th day self-tested for Covid. Test was negative; (01Jun2022) Positive, notes: Retested & this time it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- Took Paxlovid for 5 days. On 6th day self-tested for Covid. Test was negative. 4 days later- started to feel crappy again. Retested & this time it was positive. The patient had no known allergy. The patient  received vaccine and took other medication in 2weeks.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
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 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 27Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: 3012S8A) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12May2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hypertension / high blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Bee stings" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE; LOSARTAN; SYNTHROID. 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 t1he following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (14Jun2022) Negative; (17Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as yes.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red swollen area, pain and hot at injection site the day after shot; Red swollen area, pain and hot at injection site the day after shot; Red swollen area, pain and hot at injection site the day after shot; Red swollen area, pain and hot at injection site the day after shot; Next day itchy instead of pain, still red & hot; This is a spontaneous report received from 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 13Jun2022 at 12:00 as dose 1, single (Lot number: 0238761-18090) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Liver cirrhosis" (unspecified if ongoing); "deep vein thrombosis" (unspecified if ongoing); "poor circulation" (unspecified if ongoing), notes: poor circulation; "varicose veins" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "ascites" (unspecified if ongoing); "damaged spleen" (unspecified if ongoing), notes: damaged spleen. Concomitant medication(s) included: PROPRANOLOL; OMEPRAZOLE; FUROSEMIDE; SPIRONOLACTONE. Past drug history included: Cipro, reaction(s): "allergy". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 13Jun2022 at 12:00, outcome "not recovered" and all described as "Red swollen area, pain and hot at injection site the day after shot"; VACCINATION SITE PRURITUS (non-serious) with onset 13Jun2022 at 12:00, outcome "not recovered", described as "Next day itchy instead of pain, still red & hot". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pain, vaccination site warmth, vaccination site pruritus.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received other medications within 2 weeks of vaccination: Propranolol, Omeprazole, , Furosemide, Spiranolact. Reported Event: Red swollen area, pain & hot @ injection site the day after shot. Next day itchy instead of pain, still red & hot.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight, Weight decreased
Clinical narrative: losing a little bit of weight; he received 2 doses of the Pfizer Covid-19 vaccine as well as 1 booster dose of the Pfizer Covid-19 vaccine. Caller provided that he is still testing positive for Covid; he received 2 doses of the Pfizer Covid-19 vaccine as well as 1 booster dose of the Pfizer Covid-19 vaccine. Caller provided that he is still testing positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure medication" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; D3 VITAMIN; FOLIC ACID; METFORMIN; LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "he received 2 doses of the Pfizer Covid-19 vaccine as well as 1 booster dose of the Pfizer Covid-19 vaccine. Caller provided that he is still testing positive for Covid"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "losing a little bit of weight". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: testing positive for Covid 10 days ago; Weight: (unspecified date) losing a little bit of weight, notes: Caller provided that he is "losing a little bit of weight".  Clinical course: Caller was prescribed Paxlovid, after testing positive for Covid 10 days ago. Caller stated that he received 2 doses of the Pfizer Covid-19 vaccine as well as 1 booster dose of the Pfizer Covid-19 vaccine. He still tested positive for Covid, but did not have symptoms real bad." He still had his taste and smell, had an appetite, and had been eating normal for more than a week. Was losing a little bit of weight and did not have much fever. He remained isolated since he has tested positive. He was advised to take cholesterol medication but he had stopped taking, however he was also taking fish oil, D3 vitamin, folic acid, high blood pressure medication, metformin, and losartan. Caller is worried about taking Paxlovid and was not sure if he should take it. Caller read that the product was under EUA and stated that he did not feel he needed it in an emergency. Caller provided that his daughter had covid for 5 days then tested negative and his wife was testing negative as well. Caller agreed to contact his HCP to discuss his concerns. He was asking if he had to take Paxlovid.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received 4 doses of the Pfizer COVID-19 vaccine but unfortunately he has tested positive for COVID via a PCR test; received 4 doses of the Pfizer COVID-19 vaccine but unfortunately he has tested positive for COVID via a PCR test; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), 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: "diabetic" (ongoing), notes: he is a diabetic. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); CRESTOR, start date: 18Jun2022 (ongoing); ALTACE (ongoing); VITAMIN C [ASCORBIC ACID] (ongoing); VITAMIN D [COLECALCIFEROL] (ongoing); ZINC [ZINC SULFATE] (ongoing); PEPCID [FAMOTIDINE] (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received 4 doses of the Pfizer COVID-19 vaccine but unfortunately he has tested positive for COVID via a PCR test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that patient received 4 doses of the Pfizer COVID-19 vaccine but unfortunately, he has tested positive for COVID via a PCR test. The caller states that he is a high risk COVID patient as he is a diabetic.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia, Rash, Sciatica
Clinical narrative: Noticeable heart beat in stomach; Deep pain in hamstring area; Sciatic pain; Chest rash; Pain/tender back of head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Aug2021 at 12:00 as dose 1, single (Lot number: EW0173) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Chest rash"; MYALGIA (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Deep pain in hamstring area"; HEART RATE INCREASED (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Noticeable heart beat in stomach"; HEADACHE (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Pain/tender back of head"; SCIATICA (non-serious) with onset 01Sep2021 at 11:00, outcome "not recovered", described as "Sciatic pain". The events "noticeable heart beat in stomach", "deep pain in hamstring area", "sciatic pain", "chest rash" and "pain/tender back of head" required physician office visit. Therapeutic measures were not taken as a result of heart rate increased, myalgia, sciatica, rash, headache.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200857479 same patient/ drug, different dose/event;
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3248) and on 09Feb2021 as dose 2, single (Lot number: EL3248) at the age of 52 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Known allergies: yes, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2022, outcome "unknown" and all described as "covid-19". The event "covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: If other vaccine in four weeks was reported as No. Other medications in two weeks was reported as No treatment Paxlovid. If covid prior vaccination was reported as no. If covid tested post vaccination as reported as yes.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got Covid but caught it on day 1 since he was testing every day; got Covid but caught it on day 1 since he was testing every day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Old and over weight" (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 10Jun2022 at 01:00, outcome "recovered" (14Jun2022) and all described as "got Covid but caught it on day 1 since he was testing every day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: was testing every day; (10Jun2022) Positive, notes: got Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 (treatment of Paxlovid from 10Jun2022 to 15Jun2022).  Clinical course: No known allergies. No other medication in 2weeks. The patient reported he just wanted to say Paxlovid was a miracle drug. His wife was so sick she did not have the energy to speak. She tested Negative so the Doctor said she did not have Covid, but he made her test again and she did indeed have Covid. Thankfully we heard about Paxlovid and 4 days after taking Paxlovid she went from to weak to move to doing light work around the house. He also got Covid but caught it on day 1 since he was testing every day. He also took Paxlovid and had no symptoms during the whole time. He was now on Day 7 and still no symptoms. He just wanted to thank Pfizer for this wonder drug. His neighbor was on day 20 of Covid and still having problems. Another fiend was on day 15 and still having problems. They did not know about Paxlovid. But thanks to Pfizer's medicine by wife who was severely sick recovered in 4 days and he never showed any symptoms despite being old and severely over weight. Pfizer's drug worked for them, and they thank Pfizer from the bottom of our hearts.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech / COVID-19 Treatment; Pfizer / BioNTech / COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL 1284), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL 9264), in left arm, on 18Aug2021 as dose 3 (booster) single (Lot number: FA 7484) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: Diabetes (T1D). There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "known allergies Augmentin". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech / COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid test approximately 8 days after completing Paxlovid; Unknown results. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Addition information: Return of minor Covid symptoms and positive Covid test approximately 8 days after completing Paxlovid. Start date of treatment for COVID-19 was 31Jun2022. Stop date of treatment for COVID-19 was 05Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jun2022 at 07:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 62 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: METOPROLOL; HYPOTHIAZIDE. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 17Jun2022 at 22:00, outcome "not recovered", described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 17Jun2022 at 22:00, outcome "not recovered", described as "swelling of lymph nodes onset within 15 hours of injection"; PAIN (non-serious) with onset 18Jun2022 at 23:30, outcome "not recovered", described as "Severe pain"; SWELLING (non-serious) with onset 18Jun2022 at 23:30, outcome "not recovered". Therapeutic measures were not taken as a result of pyrexia, lymphadenopathy, pain, swelling. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. No known allergies. The patient experienced fever and swelling of lymph nodes onset within 15 hours of injection.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: ff2589) at the age of 37 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 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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient was asked if he was taking any other medication or product to which the patient said yes but the name was not provided. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlocvid orally with lot number gc3409 from 14Jun2022 to Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 03:00 as dose 1, single (Lot number: EN6198), in left arm, in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 07Oct2021 at 02:00 as dose 3 (booster), single (Lot number: FC3180), in left arm and on 06Apr2022 at 10:15 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD; "CLL" (unspecified if ongoing), notes: CLL. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: I took Paxlovid and after 5 day quarantine I still tested positive for COVID; (Jun2022) Positive, notes: After 5 more days I still tested positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.   Clinical course: I took Paxlovid and after 5 day quarantine I still tested positive for COVID. After 5 more days I still tested positive. New symptoms came on day11. No Known allergies reported. No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "HBP" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Omeprazole; Enalapril. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient had no known allergies. The patient did not receive any other medication in 2weeks. The patient took Paxlovid for COVID 19 Treatment. The treatment start date was reported as 01Jun2022 and stop date was 05Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as 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: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 29Jan2021 as dose 2, single (Lot number: EL8982), in left arm and on 18Aug2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis (ocular)" (unspecified if ongoing), notes: Myasthenia gravis (ocular); "Slight hypertension" (unspecified if ongoing), notes: Slight hypertension; "Slight cholesterol issue - all under control." (unspecified if ongoing), notes: Slight cholesterol issue - all under control.; "Known allergies: Penicillin (maybe - childhood response)" (unspecified if ongoing), notes: Known allergies: Penicillin (maybe - childhood response). Concomitant medication(s) included: PYRIDOSTIGMINE, start date: May2021; PREDNISONE, start date: May2021; LISINOPRIL, start date: Jan2019; PRAVASTATIN, start date: Jan2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 29Jan2021 as dose 2, single (Lot number: EL8982), in left arm and on 18Aug2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis (ocular)" (unspecified if ongoing), notes: Myasthenia gravis (ocular); "Slight hypertension" (unspecified if ongoing), notes: Slight hypertension; "Slight cholesterol issue - all under control." (unspecified if ongoing), notes: Slight cholesterol issue - all under control.; "Known allergies: Penicillin (maybe - childhood response)" (unspecified if ongoing), notes: Known allergies: Penicillin (maybe - childhood response). Concomitant medication(s) included: PYRIDOSTIGMINE, start date: May2021; PREDNISONE, start date: May2021; LISINOPRIL, start date: Jan2019; PRAVASTATIN, start date: Jan2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: 3 weeks after 3rd dose, another bout of Myasthenia gravis. occurred, and was treated with infusion therapy at home.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis (ocular)" (unspecified if ongoing), notes: Myasthenia gravis (ocular); "slight hypertension" (unspecified if ongoing), notes: slight hypertension; "slight cholesterol issue - all under control" (unspecified if ongoing), notes: slight cholesterol issue - all under control; "Known allergies: penicillin (maybe - childhood response)" (unspecified if ongoing), notes: Known allergies: penicillin (maybe - childhood response). Concomitant medication(s) included: PYRIDOSTIGMINE, start date: May2021; LISINOPRIL, start date: Jan2019; PRAVASTATIN, start date: Jan2019; PREDNISONE, start date: May2021. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3246, Location of injection: Arm Left), administration date: 08Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 2, Batch/Lot No: EL8982, Location of injection: Arm Left), administration date: 29Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; bnt162b2 (Dose Number: 2, Batch/Lot No: EL8982, Location of injection: Arm Left, 3 months after 2nd dose, a first episode occurred of autoimmune disease Myasthenia gravis, that required hospitalization), administration date: 29Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "Myasthenia gravis". The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant) with onset 2021, outcome "recovered", described as "3 weeks after 3rd dose, another bout of Myasthenia gravis. occurred, and was treated with infusion therapy at home.". Therapeutic measures were taken as a result of myasthenia gravis. Clinical course: No initial response to vaccine. 3 months after 2nd dose, a first episode occurred of autoimmune disease Myasthenia gravis, that required hospitalization. 3 weeks after 3rd dose, another bout of M.G. occurred, and was treated with infusion therapy at home. The patient queried whether there was a link between vaccine stimulating Immune System and onset of Autoimmune Disease and stated no idea but treating neurologist has recommended that patient to not get any additional vaccines at this time. Ae treatment: IVIG infusion therapy + medication.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myasthenia gravis
Clinical narrative: 3 weeks after 3rd dose, another bout of Myasthenia gravis. occurred, and was treated with infusion therapy at home.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis (ocular)" (unspecified if ongoing), notes: Myasthenia gravis (ocular); "slight hypertension" (unspecified if ongoing), notes: slight hypertension; "slight cholesterol issue - all under control" (unspecified if ongoing), notes: slight cholesterol issue - all under control; "Known allergies: penicillin (maybe - childhood response)" (unspecified if ongoing), notes: Known allergies: penicillin (maybe - childhood response). Concomitant medication(s) included: PYRIDOSTIGMINE, start date: May2021; LISINOPRIL, start date: Jan2019; PRAVASTATIN, start date: Jan2019; PREDNISONE, start date: May2021. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3246, Location of injection: Arm Left), administration date: 08Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 2, Batch/Lot No: EL8982, Location of injection: Arm Left), administration date: 29Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; bnt162b2 (Dose Number: 2, Batch/Lot No: EL8982, Location of injection: Arm Left, 3 months after 2nd dose, a first episode occurred of autoimmune disease Myasthenia gravis, that required hospitalization), administration date: 29Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "Myasthenia gravis". The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant) with onset 2021, outcome "recovered", described as "3 weeks after 3rd dose, another bout of Myasthenia gravis. occurred, and was treated with infusion therapy at home.". Therapeutic measures were taken as a result of myasthenia gravis. Clinical course: No initial response to vaccine. 3 months after 2nd dose, a first episode occurred of autoimmune disease Myasthenia gravis, that required hospitalization. 3 weeks after 3rd dose, another bout of M.G. occurred, and was treated with infusion therapy at home. The patient queried whether there was a link between vaccine stimulating Immune System and onset of Autoimmune Disease and stated no idea but treating neurologist has recommended that patient to not get any additional vaccines at this time. Ae treatment: IVIG infusion therapy + medication.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: 3 months after 2nd dose, a first episode occurred of autoimmune disease Myasthenia gravis, that required hospitalization; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Lot number: EL8982) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis (ocular)" (unspecified if ongoing), notes: Myasthenia gravis (ocular), Slight hypertension, Slight cholesterol issue - all under control.; "Slight hypertension" (unspecified if ongoing), notes: Myasthenia gravis (ocular), Slight hypertension, Slight cholesterol issue - all under control.; "Slight cholesterol issue" (unspecified if ongoing), notes: Myasthenia gravis (ocular), Slight hypertension, Slight cholesterol issue - all under control.; "Penicillin (maybe - childhood response) allergy" (unspecified if ongoing), notes: Penicillin (maybe - childhood response) allergy. Concomitant medication(s) included: LISINOPRIL, start date: Jan2019; PRAVASTATIN, start date: Jan2019. Vaccination history included: pfizer / BioNTech (Dose Number: 1, Batch/Lot No: EL3246, Location of injection: Arm Left), administration date: 08Jan2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: MYASTHENIA GRAVIS (hospitalization) with onset Apr2021, outcome "recovered" (May2021), described as "3 months after 2nd dose, a first episode occurred of autoimmune disease Myasthenia gravis, that required hospitalization". The patient was hospitalized for myasthenia gravis (hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of myasthenia gravis. Clinical Course: It was reported that 3 weeks after 3rd dose, another bout of M.G. [myasthenia gravis] occurred, and was treated with infusion therapy at home. Is there a link between vaccine stimulating immune system and onset of autoimmune disease? No idea but treating neurologist has recommended that patient not get any additional vaccines at this time. The patient took other medications/products within 2 weeks of starting COVID-19 treatment? Yes. The patient had previously received a COVID-19 Vaccine.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2021 as dose 2 (booster), single (Batch/Lot number: unknown), on 22Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 21Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) and on 20Mar2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Enteropathic Arthritis" (unspecified if ongoing); "Spinal Stenosis" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: Dose 1 Janssen, Dsoe 2,3,4,5 are pfizer. Concomitant medication(s) included: HUMIRA, start date: 23May2022, stop date: 23May2022; NEURONTIN; GABAPENTIN; CYCLOBENZAPRINE. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin"; Morphine, reaction(s): "Drug allergy"; Hydromorphone, reaction(s): "Drug allergy"; Phenothiazines, reaction(s): "Drug allergy"; Metronidazole, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: Tested positive via both rapid antigen and health care administered PCR test on 05Jun2022; (05Jun2022) positive, notes: Tested positive via both rapid antigen and health care administered PCR test on 05Jun2022; (12Jun2022) Negative, notes: Tested negative via rapid antigen test on 12Jun2022 (day 7); (16Jun2022) positive, notes: Tested positive via rapid antigen test on 16Jun (day 11). Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 04Jun2022, treatment stop date: 09Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: U
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) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), on 18Jan2021 at 08:30 as dose 1, single (Lot number: EL1283), in left arm, on 08Feb2021 at 08:30 as dose 2, single (Lot number: EM9809), in left arm, on 04Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 11Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure (controlled)" (unspecified if ongoing), notes: High blood pressure (controlled). The patient's concomitant medications were not reported. Past drug history included: O, reaction(s): "O drug allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received treatment for COVID-19 as Paxlovid from 07Jun2022 to 11Jun2022. Seriousness criteria was reported as no for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.