chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Biopsy, Candida infection, Diarrhoea, Full blood count
Clinical narrative: MOOD SWINGS; NOT SLEEPING; THRUSH; INFLAMMATION; VASCULITIS; ITCHING; RASH ALL OVER; HIVES; DIARRHEA; VOMITING/THROWING UP; SLIGHT MEMORY LOSS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: back injury, and concurrent conditions included: fibromyalgia, high cholesterol, food allergy, penicillin allergy, drug allergy, smoker, and alcohol user, and other pre-existing medical conditions included: Patient had reported allergies to egg (severe stomach pain), crab (tingling of tongue), penicillin (tongue tingling and swollen) and Advil Liqui gel only. No drug abuse or illicit drug usage was reported. The patient consumes alcohol once in a great while because of all the medication. The patient is a smoker and smokes half a pack to 3/4 in a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: 19/SEP/2021) dose was not reported, 1 total administered on 02-APR-2021 to Left Arm for prophylactic vaccination (dose series number 1). No concomitant medications were reported.  On 02-APR-2021, the patient experienced slight memory loss, diarrhea, and vomiting/throwing up. On 04-APR-2021, the patient experienced itching, rash all over, and hives. On 21-APR-2021, Laboratory data included: Biopsy (NR: not provided) Abnormal. On MAY-2021, the patient experienced vasculitis. On 19-OCT-2021, Laboratory data included: Complete blood count (NR: not provided) Normal. On an unspecified date, the patient experienced mood swings, not sleeping, thrush, and inflammation. Treatment medications (dates unspecified) included: famotidine, hydroxyzine hydrochloride, triamcinolone, clotrimazole, diphenhydramine hydrochloride, cetirizine hydrochloride, montelukast sodium, doxycycline, fexofenadine hydrochloride, hydrocortisone, cortisone, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, rash all over, and hives, and the outcome of diarrhea, vomiting/throwing up, slight memory loss, mood swings, not sleeping, thrush, vasculitis and inflammation was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Insomnia, Mood swings, Pruritus, Rash
Clinical narrative: MOOD SWINGS; NOT SLEEPING; THRUSH; INFLAMMATION; VASCULITIS; ITCHING; RASH ALL OVER; HIVES; DIARRHEA; VOMITING/THROWING UP; SLIGHT MEMORY LOSS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: back injury, and concurrent conditions included: fibromyalgia, high cholesterol, food allergy, penicillin allergy, drug allergy, smoker, and alcohol user, and other pre-existing medical conditions included: Patient had reported allergies to egg (severe stomach pain), crab (tingling of tongue), penicillin (tongue tingling and swollen) and Advil Liqui gel only. No drug abuse or illicit drug usage was reported. The patient consumes alcohol once in a great while because of all the medication. The patient is a smoker and smokes half a pack to 3/4 in a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: 19/SEP/2021) dose was not reported, 1 total administered on 02-APR-2021 to Left Arm for prophylactic vaccination (dose series number 1). No concomitant medications were reported.  On 02-APR-2021, the patient experienced slight memory loss, diarrhea, and vomiting/throwing up. On 04-APR-2021, the patient experienced itching, rash all over, and hives. On 21-APR-2021, Laboratory data included: Biopsy (NR: not provided) Abnormal. On MAY-2021, the patient experienced vasculitis. On 19-OCT-2021, Laboratory data included: Complete blood count (NR: not provided) Normal. On an unspecified date, the patient experienced mood swings, not sleeping, thrush, and inflammation. Treatment medications (dates unspecified) included: famotidine, hydroxyzine hydrochloride, triamcinolone, clotrimazole, diphenhydramine hydrochloride, cetirizine hydrochloride, montelukast sodium, doxycycline, fexofenadine hydrochloride, hydrocortisone, cortisone, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, rash all over, and hives, and the outcome of diarrhea, vomiting/throwing up, slight memory loss, mood swings, not sleeping, thrush, vasculitis and inflammation was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vasculitis, Vomiting
Clinical narrative: MOOD SWINGS; NOT SLEEPING; THRUSH; INFLAMMATION; VASCULITIS; ITCHING; RASH ALL OVER; HIVES; DIARRHEA; VOMITING/THROWING UP; SLIGHT MEMORY LOSS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: back injury, and concurrent conditions included: fibromyalgia, high cholesterol, food allergy, penicillin allergy, drug allergy, smoker, and alcohol user, and other pre-existing medical conditions included: Patient had reported allergies to egg (severe stomach pain), crab (tingling of tongue), penicillin (tongue tingling and swollen) and Advil Liqui gel only. No drug abuse or illicit drug usage was reported. The patient consumes alcohol once in a great while because of all the medication. The patient is a smoker and smokes half a pack to 3/4 in a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: 19/SEP/2021) dose was not reported, 1 total administered on 02-APR-2021 to Left Arm for prophylactic vaccination (dose series number 1). No concomitant medications were reported.  On 02-APR-2021, the patient experienced slight memory loss, diarrhea, and vomiting/throwing up. On 04-APR-2021, the patient experienced itching, rash all over, and hives. On 21-APR-2021, Laboratory data included: Biopsy (NR: not provided) Abnormal. On MAY-2021, the patient experienced vasculitis. On 19-OCT-2021, Laboratory data included: Complete blood count (NR: not provided) Normal. On an unspecified date, the patient experienced mood swings, not sleeping, thrush, and inflammation. Treatment medications (dates unspecified) included: famotidine, hydroxyzine hydrochloride, triamcinolone, clotrimazole, diphenhydramine hydrochloride, cetirizine hydrochloride, montelukast sodium, doxycycline, fexofenadine hydrochloride, hydrocortisone, cortisone, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, rash all over, and hives, and the outcome of diarrhea, vomiting/throwing up, slight memory loss, mood swings, not sleeping, thrush, vasculitis and inflammation was not reported. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Pulse absent, Resuscitation, Sudden death, Syncope
Clinical narrative: SUDDEN DEATH; MI SECONDARY TO HYPERTENSION, THIRDLY TO INCREASED LIPIDS; This spontaneous report received from a health care professional concerned a 75 year old male of unspecified race. The patient's weight was 190 pounds, and height was 68 inches. The patient's past medical history included: quit smoking, carotid stent and concurrent conditions included: controlled hypertension, hyperlipidemia, asthma, low-grade b-cell lymphoma, and seasonal allergies/hayfever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported (dose number in series 1), 1 total, administered to left arm on 06-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient dropped dead at 11:30, fell in the aisle, on the way down hit/lacerated his head. It was reported that the patient had no chest pain, no symptoms and a nurse nearby did CPR for 35 minutes, the patient was gasping, AED was applied, but unable to get a rhythm via AED and the patient was pronounced expired at 12:05-12:10. The death certificate stated MI secondary to Hypertension, thirdly to increased lipids as cause of death. Laboratory data (dates unspecified) included: Blood test (NR: not provided) UNKNOWN, Bone marrow biopsy (NR: not provided) UNKNOWN, Coronary calcium scan (NR: not provided) 500 (units unspecified), Haemoglobin (NR: not provided) low, Hematocrit (NR: not provided) low, Lipids (NR: not provided) increased, Lymphocytes (NR: not provided) chronic elevated, Platelet count (NR: not provided) 120 (units unspecified), and White blood cells (NR: not provided) 22, 000 (units unspecified). On 08-MAR-2021, the patient died from mi secondary to hypertension, 3rd to increased lipids. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden death and mi secondary to hypertension on 08-MAR-2021. This report was serious (Death). This report was associated with product quality complaint: 90000207898.; Sender's Comments: V0: 20211244691-Covid-19 vaccine ad26.cov2.s- Sudden death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.  V0: 20211244691-Covid-19 vaccine ad26.cov2.s-MI secondary to hypertension, thirdly to increased lipids. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: MI SECONDARY TO HYPERTENSION, 3RD TO INCREASED LIPIDS
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Blood test, Computerised tomogram coronary artery, Haematocrit, Haemoglobin
Clinical narrative: SUDDEN DEATH; MI SECONDARY TO HYPERTENSION, THIRDLY TO INCREASED LIPIDS; This spontaneous report received from a health care professional concerned a 75 year old male of unspecified race. The patient's weight was 190 pounds, and height was 68 inches. The patient's past medical history included: quit smoking, carotid stent and concurrent conditions included: controlled hypertension, hyperlipidemia, asthma, low-grade b-cell lymphoma, and seasonal allergies/hayfever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported (dose number in series 1), 1 total, administered to left arm on 06-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient dropped dead at 11:30, fell in the aisle, on the way down hit/lacerated his head. It was reported that the patient had no chest pain, no symptoms and a nurse nearby did CPR for 35 minutes, the patient was gasping, AED was applied, but unable to get a rhythm via AED and the patient was pronounced expired at 12:05-12:10. The death certificate stated MI secondary to Hypertension, thirdly to increased lipids as cause of death. Laboratory data (dates unspecified) included: Blood test (NR: not provided) UNKNOWN, Bone marrow biopsy (NR: not provided) UNKNOWN, Coronary calcium scan (NR: not provided) 500 (units unspecified), Haemoglobin (NR: not provided) low, Hematocrit (NR: not provided) low, Lipids (NR: not provided) increased, Lymphocytes (NR: not provided) chronic elevated, Platelet count (NR: not provided) 120 (units unspecified), and White blood cells (NR: not provided) 22, 000 (units unspecified). On 08-MAR-2021, the patient died from mi secondary to hypertension, 3rd to increased lipids. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden death and mi secondary to hypertension on 08-MAR-2021. This report was serious (Death). This report was associated with product quality complaint: 90000207898.; Sender's Comments: V0: 20211244691-Covid-19 vaccine ad26.cov2.s- Sudden death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.  V0: 20211244691-Covid-19 vaccine ad26.cov2.s-MI secondary to hypertension, thirdly to increased lipids. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: MI SECONDARY TO HYPERTENSION, 3RD TO INCREASED LIPIDS
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lipids, Lymphocyte count, Myocardial infarction, Platelet count, Sudden death
Clinical narrative: SUDDEN DEATH; MI SECONDARY TO HYPERTENSION, THIRDLY TO INCREASED LIPIDS; This spontaneous report received from a health care professional concerned a 75 year old male of unspecified race. The patient's weight was 190 pounds, and height was 68 inches. The patient's past medical history included: quit smoking, carotid stent and concurrent conditions included: controlled hypertension, hyperlipidemia, asthma, low-grade b-cell lymphoma, and seasonal allergies/hayfever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported (dose number in series 1), 1 total, administered to left arm on 06-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient dropped dead at 11:30, fell in the aisle, on the way down hit/lacerated his head. It was reported that the patient had no chest pain, no symptoms and a nurse nearby did CPR for 35 minutes, the patient was gasping, AED was applied, but unable to get a rhythm via AED and the patient was pronounced expired at 12:05-12:10. The death certificate stated MI secondary to Hypertension, thirdly to increased lipids as cause of death. Laboratory data (dates unspecified) included: Blood test (NR: not provided) UNKNOWN, Bone marrow biopsy (NR: not provided) UNKNOWN, Coronary calcium scan (NR: not provided) 500 (units unspecified), Haemoglobin (NR: not provided) low, Hematocrit (NR: not provided) low, Lipids (NR: not provided) increased, Lymphocytes (NR: not provided) chronic elevated, Platelet count (NR: not provided) 120 (units unspecified), and White blood cells (NR: not provided) 22, 000 (units unspecified). On 08-MAR-2021, the patient died from mi secondary to hypertension, 3rd to increased lipids. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden death and mi secondary to hypertension on 08-MAR-2021. This report was serious (Death). This report was associated with product quality complaint: 90000207898.; Sender's Comments: V0: 20211244691-Covid-19 vaccine ad26.cov2.s- Sudden death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.  V0: 20211244691-Covid-19 vaccine ad26.cov2.s-MI secondary to hypertension, thirdly to increased lipids. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: MI SECONDARY TO HYPERTENSION, 3RD TO INCREASED LIPIDS
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: SUDDEN DEATH; MI SECONDARY TO HYPERTENSION, THIRDLY TO INCREASED LIPIDS; This spontaneous report received from a health care professional concerned a 75 year old male of unspecified race. The patient's weight was 190 pounds, and height was 68 inches. The patient's past medical history included: quit smoking, carotid stent and concurrent conditions included: controlled hypertension, hyperlipidemia, asthma, low-grade b-cell lymphoma, and seasonal allergies/hayfever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported (dose number in series 1), 1 total, administered to left arm on 06-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient dropped dead at 11:30, fell in the aisle, on the way down hit/lacerated his head. It was reported that the patient had no chest pain, no symptoms and a nurse nearby did CPR for 35 minutes, the patient was gasping, AED was applied, but unable to get a rhythm via AED and the patient was pronounced expired at 12:05-12:10. The death certificate stated MI secondary to Hypertension, thirdly to increased lipids as cause of death. Laboratory data (dates unspecified) included: Blood test (NR: not provided) UNKNOWN, Bone marrow biopsy (NR: not provided) UNKNOWN, Coronary calcium scan (NR: not provided) 500 (units unspecified), Haemoglobin (NR: not provided) low, Hematocrit (NR: not provided) low, Lipids (NR: not provided) increased, Lymphocytes (NR: not provided) chronic elevated, Platelet count (NR: not provided) 120 (units unspecified), and White blood cells (NR: not provided) 22, 000 (units unspecified). On 08-MAR-2021, the patient died from mi secondary to hypertension, 3rd to increased lipids. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden death and mi secondary to hypertension on 08-MAR-2021. This report was serious (Death). This report was associated with product quality complaint: 90000207898.; Sender's Comments: V0: 20211244691-Covid-19 vaccine ad26.cov2.s- Sudden death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.  V0: 20211244691-Covid-19 vaccine ad26.cov2.s-MI secondary to hypertension, thirdly to increased lipids. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: MI SECONDARY TO HYPERTENSION, 3RD TO INCREASED LIPIDS
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alpha 2 globulin increased, Antinuclear antibody negative, Blood 25-hydroxycholecalciferol, Blood folate, Blood glucose increased
Clinical narrative: Covid PCR: Positive; Covid PCR: Positive; 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), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single and administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney donor" (unspecified if ongoing); "Known allergies: nuts oranges, grapefruit" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Patient didn't have COVID prior vaccination. Concomitant medication(s) included: ESTROGEN patch, 0.375 mg. No other vaccine was administered in four weeks. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Covid PCR: Positive". The event "covid pcr: positive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive, notes: Blood test; sars-cov-2 test: (14Jul2020) negative; (24Sep2020) negative, notes: Nasal Swab; (05Mar2021) negative, notes: Nasal Swab; (09Jul2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (29Aug2021) negative, notes: Nasal Swab; (20Oct2021) negative, notes: Nasal Swab; (06Dec2021) positive, notes: Nasal Swab; serology test: (14Jul2020) negative, notes: Blood test; (20Dec2020) negative, notes: Blood test; (16Jan2021) negative, notes: Blood test; (03Apr2021) negative, notes: Blood test; (18Nov2021) negative, notes: Blood test.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood iron, Blood zinc, Glycosylated haemoglobin, Herpes simplex test negative, Hypoaesthesia
Clinical narrative: Covid PCR: Positive; Covid PCR: Positive; 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), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single and administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney donor" (unspecified if ongoing); "Known allergies: nuts oranges, grapefruit" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Patient didn't have COVID prior vaccination. Concomitant medication(s) included: ESTROGEN patch, 0.375 mg. No other vaccine was administered in four weeks. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Covid PCR: Positive". The event "covid pcr: positive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive, notes: Blood test; sars-cov-2 test: (14Jul2020) negative; (24Sep2020) negative, notes: Nasal Swab; (05Mar2021) negative, notes: Nasal Swab; (09Jul2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (29Aug2021) negative, notes: Nasal Swab; (20Oct2021) negative, notes: Nasal Swab; (06Dec2021) positive, notes: Nasal Swab; serology test: (14Jul2020) negative, notes: Blood test; (20Dec2020) negative, notes: Blood test; (16Jan2021) negative, notes: Blood test; (03Apr2021) negative, notes: Blood test; (18Nov2021) negative, notes: Blood test.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Monoclonal gammopathy, Oral discomfort, Paraesthesia, Red blood cell count decreased, Serum ferritin
Clinical narrative: Covid PCR: Positive; Covid PCR: Positive; 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), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single and administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney donor" (unspecified if ongoing); "Known allergies: nuts oranges, grapefruit" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Patient didn't have COVID prior vaccination. Concomitant medication(s) included: ESTROGEN patch, 0.375 mg. No other vaccine was administered in four weeks. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Covid PCR: Positive". The event "covid pcr: positive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive, notes: Blood test; sars-cov-2 test: (14Jul2020) negative; (24Sep2020) negative, notes: Nasal Swab; (05Mar2021) negative, notes: Nasal Swab; (09Jul2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (29Aug2021) negative, notes: Nasal Swab; (20Oct2021) negative, notes: Nasal Swab; (06Dec2021) positive, notes: Nasal Swab; serology test: (14Jul2020) negative, notes: Blood test; (20Dec2020) negative, notes: Blood test; (16Jan2021) negative, notes: Blood test; (03Apr2021) negative, notes: Blood test; (18Nov2021) negative, notes: Blood test.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thyroid function test, Varicella virus test negative, Vitamin B1, Vitamin B12 decreased, Vitamin B2
Clinical narrative: Covid PCR: Positive; Covid PCR: Positive; 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), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single and administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney donor" (unspecified if ongoing); "Known allergies: nuts oranges, grapefruit" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Patient didn't have COVID prior vaccination. Concomitant medication(s) included: ESTROGEN patch, 0.375 mg. No other vaccine was administered in four weeks. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Covid PCR: Positive". The event "covid pcr: positive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive, notes: Blood test; sars-cov-2 test: (14Jul2020) negative; (24Sep2020) negative, notes: Nasal Swab; (05Mar2021) negative, notes: Nasal Swab; (09Jul2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (29Aug2021) negative, notes: Nasal Swab; (20Oct2021) negative, notes: Nasal Swab; (06Dec2021) positive, notes: Nasal Swab; serology test: (14Jul2020) negative, notes: Blood test; (20Dec2020) negative, notes: Blood test; (16Jan2021) negative, notes: Blood test; (03Apr2021) negative, notes: Blood test; (18Nov2021) negative, notes: Blood test.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vitamin B6
Clinical narrative: Covid PCR: Positive; Covid PCR: Positive; 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), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single and administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney donor" (unspecified if ongoing); "Known allergies: nuts oranges, grapefruit" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Patient didn't have COVID prior vaccination. Concomitant medication(s) included: ESTROGEN patch, 0.375 mg. No other vaccine was administered in four weeks. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Covid PCR: Positive". The event "covid pcr: positive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive, notes: Blood test; sars-cov-2 test: (14Jul2020) negative; (24Sep2020) negative, notes: Nasal Swab; (05Mar2021) negative, notes: Nasal Swab; (09Jul2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (29Aug2021) negative, notes: Nasal Swab; (20Oct2021) negative, notes: Nasal Swab; (06Dec2021) positive, notes: Nasal Swab; serology test: (14Jul2020) negative, notes: Blood test; (20Dec2020) negative, notes: Blood test; (16Jan2021) negative, notes: Blood test; (03Apr2021) negative, notes: Blood test; (18Nov2021) negative, notes: Blood test.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Serology test, Vaccination failure
Clinical narrative: Covid PCR: Positive; Covid PCR: Positive; 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), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single and administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney donor" (unspecified if ongoing); "Known allergies: nuts oranges, grapefruit" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Patient didn't have COVID prior vaccination. Concomitant medication(s) included: ESTROGEN patch, 0.375 mg. No other vaccine was administered in four weeks. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Covid PCR: Positive". The event "covid pcr: positive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive, notes: Blood test; sars-cov-2 test: (14Jul2020) negative; (24Sep2020) negative, notes: Nasal Swab; (05Mar2021) negative, notes: Nasal Swab; (09Jul2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (29Aug2021) negative, notes: Nasal Swab; (20Oct2021) negative, notes: Nasal Swab; (06Dec2021) positive, notes: Nasal Swab; serology test: (14Jul2020) negative, notes: Blood test; (20Dec2020) negative, notes: Blood test; (16Jan2021) negative, notes: Blood test; (03Apr2021) negative, notes: Blood test; (18Nov2021) negative, notes: Blood test.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia, Oral disorder, Oral pain, Paraesthesia
Clinical narrative: Covid PCR: Positive; Covid PCR: Positive; 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), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single and administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney donor" (unspecified if ongoing); "Known allergies: nuts oranges, grapefruit" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Patient didn't have COVID prior vaccination. Concomitant medication(s) included: ESTROGEN patch, 0.375 mg. No other vaccine was administered in four weeks. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Covid PCR: Positive". The event "covid pcr: positive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive, notes: Blood test; sars-cov-2 test: (14Jul2020) negative; (24Sep2020) negative, notes: Nasal Swab; (05Mar2021) negative, notes: Nasal Swab; (09Jul2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (29Aug2021) negative, notes: Nasal Swab; (20Oct2021) negative, notes: Nasal Swab; (06Dec2021) positive, notes: Nasal Swab; serology test: (14Jul2020) negative, notes: Blood test; (20Dec2020) negative, notes: Blood test; (16Jan2021) negative, notes: Blood test; (03Apr2021) negative, notes: Blood test; (18Nov2021) negative, notes: Blood test.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tongue disorder
Clinical narrative: Covid PCR: Positive; Covid PCR: Positive; 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), administered in arm left, administration date 17Feb2021 15:45 (Lot number: EN6200) at the age of 62 years as dose 2, single and administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney donor" (unspecified if ongoing); "Known allergies: nuts oranges, grapefruit" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: mushrooms" (unspecified if ongoing). Patient didn't have COVID prior vaccination. Concomitant medication(s) included: ESTROGEN patch, 0.375 mg. No other vaccine was administered in four weeks. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Covid PCR: Positive". The event "covid pcr: positive" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (18Nov2021) positive, notes: Blood test; sars-cov-2 test: (14Jul2020) negative; (24Sep2020) negative, notes: Nasal Swab; (05Mar2021) negative, notes: Nasal Swab; (09Jul2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (19Aug2021) negative, notes: Nasal Swab; (29Aug2021) negative, notes: Nasal Swab; (20Oct2021) negative, notes: Nasal Swab; (06Dec2021) positive, notes: Nasal Swab; serology test: (14Jul2020) negative, notes: Blood test; (20Dec2020) negative, notes: Blood test; (16Jan2021) negative, notes: Blood test; (03Apr2021) negative, notes: Blood test; (18Nov2021) negative, notes: Blood test.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Pericarditis
Clinical narrative: First episode 2/17 Hospital--2/18 Emergency room transport by ambulance Diagnosed Dr  2/19 echos done on 2/19+ 2/24 + 2/26 Began Prednisone 2/20 40mg/ 10 day drops to through 10 mg  Saw Dr follow up on 3/10 Completed Prednisone course on 3/22  Symptoms returned on 3/25 Began 3 month course of Colchicine .6 2x per day per Dr Follow up Echo 4/7 visit md 4/8  Symptoms returned with chest pressure on 4/10. Called office was told to take ibuprofen for pain since echo was so recent.  ER, admit in 4/14 severe pericarditis plural effusions. Fever. Followed by Dr. Had 1.3 L of fluid removed from my left long.  Discharged on 4/21. Followed up with Dr and Rheumatologist for additional testing. 4/28 visit with Dr. Pericardectomy to be set for 521 To be weened down off of Prednisone one week before surgery.  Completed Prednisone on Friday May 14 Symptoms returned full blown 15th which resulted in an ER admission on the night of the 15th. New echo on the 16th revealed additional inflammation. In addition to be found in my last one once again 800 mL was removed on 5/17. On 5/18 I went onto Afib.brought back to normal rhythm with days of medication Transfer occurred on the 19th.  Open heart surgery performed on 5/21/21. Pericardium was stuck to the heart in two places and had to be peeled off. Fluid was very abnormal looking  gelatinous.    Loop monitor was implanted in July to continuously monitor Afib episodes. Weened of of Prednisone in October.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aspiration pleural cavity, Atrial fibrillation, Cardiac operation, Chest discomfort, Echocardiogram abnormal
Clinical narrative: First episode 2/17 Hospital--2/18 Emergency room transport by ambulance Diagnosed Dr  2/19 echos done on 2/19+ 2/24 + 2/26 Began Prednisone 2/20 40mg/ 10 day drops to through 10 mg  Saw Dr follow up on 3/10 Completed Prednisone course on 3/22  Symptoms returned on 3/25 Began 3 month course of Colchicine .6 2x per day per Dr Follow up Echo 4/7 visit md 4/8  Symptoms returned with chest pressure on 4/10. Called office was told to take ibuprofen for pain since echo was so recent.  ER, admit in 4/14 severe pericarditis plural effusions. Fever. Followed by Dr. Had 1.3 L of fluid removed from my left long.  Discharged on 4/21. Followed up with Dr and Rheumatologist for additional testing. 4/28 visit with Dr. Pericardectomy to be set for 521 To be weened down off of Prednisone one week before surgery.  Completed Prednisone on Friday May 14 Symptoms returned full blown 15th which resulted in an ER admission on the night of the 15th. New echo on the 16th revealed additional inflammation. In addition to be found in my last one once again 800 mL was removed on 5/17. On 5/18 I went onto Afib.brought back to normal rhythm with days of medication Transfer occurred on the 19th.  Open heart surgery performed on 5/21/21. Pericardium was stuck to the heart in two places and had to be peeled off. Fluid was very abnormal looking  gelatinous.    Loop monitor was implanted in July to continuously monitor Afib episodes. Weened of of Prednisone in October.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Implantable cardiac monitor insertion, Inflammation, Laboratory test, Pain, Pericarditis
Clinical narrative: First episode 2/17 Hospital--2/18 Emergency room transport by ambulance Diagnosed Dr  2/19 echos done on 2/19+ 2/24 + 2/26 Began Prednisone 2/20 40mg/ 10 day drops to through 10 mg  Saw Dr follow up on 3/10 Completed Prednisone course on 3/22  Symptoms returned on 3/25 Began 3 month course of Colchicine .6 2x per day per Dr Follow up Echo 4/7 visit md 4/8  Symptoms returned with chest pressure on 4/10. Called office was told to take ibuprofen for pain since echo was so recent.  ER, admit in 4/14 severe pericarditis plural effusions. Fever. Followed by Dr. Had 1.3 L of fluid removed from my left long.  Discharged on 4/21. Followed up with Dr and Rheumatologist for additional testing. 4/28 visit with Dr. Pericardectomy to be set for 521 To be weened down off of Prednisone one week before surgery.  Completed Prednisone on Friday May 14 Symptoms returned full blown 15th which resulted in an ER admission on the night of the 15th. New echo on the 16th revealed additional inflammation. In addition to be found in my last one once again 800 mL was removed on 5/17. On 5/18 I went onto Afib.brought back to normal rhythm with days of medication Transfer occurred on the 19th.  Open heart surgery performed on 5/21/21. Pericardium was stuck to the heart in two places and had to be peeled off. Fluid was very abnormal looking  gelatinous.    Loop monitor was implanted in July to continuously monitor Afib episodes. Weened of of Prednisone in October.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pleural effusion, Pyrexia, Scan, X-ray
Clinical narrative: First episode 2/17 Hospital--2/18 Emergency room transport by ambulance Diagnosed Dr  2/19 echos done on 2/19+ 2/24 + 2/26 Began Prednisone 2/20 40mg/ 10 day drops to through 10 mg  Saw Dr follow up on 3/10 Completed Prednisone course on 3/22  Symptoms returned on 3/25 Began 3 month course of Colchicine .6 2x per day per Dr Follow up Echo 4/7 visit md 4/8  Symptoms returned with chest pressure on 4/10. Called office was told to take ibuprofen for pain since echo was so recent.  ER, admit in 4/14 severe pericarditis plural effusions. Fever. Followed by Dr. Had 1.3 L of fluid removed from my left long.  Discharged on 4/21. Followed up with Dr and Rheumatologist for additional testing. 4/28 visit with Dr. Pericardectomy to be set for 521 To be weened down off of Prednisone one week before surgery.  Completed Prednisone on Friday May 14 Symptoms returned full blown 15th which resulted in an ER admission on the night of the 15th. New echo on the 16th revealed additional inflammation. In addition to be found in my last one once again 800 mL was removed on 5/17. On 5/18 I went onto Afib.brought back to normal rhythm with days of medication Transfer occurred on the 19th.  Open heart surgery performed on 5/21/21. Pericardium was stuck to the heart in two places and had to be peeled off. Fluid was very abnormal looking  gelatinous.    Loop monitor was implanted in July to continuously monitor Afib episodes. Weened of of Prednisone in October.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aortic aneurysm, Cardiac failure acute, Cardiac failure congestive, Computerised tomogram
Clinical narrative: 12/19/21 78-year-old female with a history of ascending aortic aneurysm, atrial fibrillation, hypertension, coronary disease, CHF, COPD, type 2 diabetes, hyperlipidemia, MI, pneumonia, pulmonary embolism who complains of 2-day history of fever dry cough. Review of Systems  Constitutional: Positive for activity change, appetite change, chills and fever.  HENT: Negative for congestion, sore throat, rhinorrhea and neck pain.   Eyes: Negative.  Negative for discharge.  Respiratory: Positive for cough.   Cardiovascular: Negative.  Negative for leg swelling.  Gastrointestinal: Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative.  Negative for dysuria and frequency.  Musculoskeletal: Negative for back pain.  Skin: Negative for color change.  Neurological: Negative for weakness and headaches.  Psychiatric/Behavioral: Negative for confusion.  All other systems reviewed and are negative.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Decreased appetite, Pyrexia
Clinical narrative: 12/19/21 78-year-old female with a history of ascending aortic aneurysm, atrial fibrillation, hypertension, coronary disease, CHF, COPD, type 2 diabetes, hyperlipidemia, MI, pneumonia, pulmonary embolism who complains of 2-day history of fever dry cough. Review of Systems  Constitutional: Positive for activity change, appetite change, chills and fever.  HENT: Negative for congestion, sore throat, rhinorrhea and neck pain.   Eyes: Negative.  Negative for discharge.  Respiratory: Positive for cough.   Cardiovascular: Negative.  Negative for leg swelling.  Gastrointestinal: Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative.  Negative for dysuria and frequency.  Musculoskeletal: Negative for back pain.  Skin: Negative for color change.  Neurological: Negative for weakness and headaches.  Psychiatric/Behavioral: Negative for confusion.  All other systems reviewed and are negative.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 12/19/21 78-year-old female with a history of ascending aortic aneurysm, atrial fibrillation, hypertension, coronary disease, CHF, COPD, type 2 diabetes, hyperlipidemia, MI, pneumonia, pulmonary embolism who complains of 2-day history of fever dry cough. Review of Systems  Constitutional: Positive for activity change, appetite change, chills and fever.  HENT: Negative for congestion, sore throat, rhinorrhea and neck pain.   Eyes: Negative.  Negative for discharge.  Respiratory: Positive for cough.   Cardiovascular: Negative.  Negative for leg swelling.  Gastrointestinal: Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative.  Negative for dysuria and frequency.  Musculoskeletal: Negative for back pain.  Skin: Negative for color change.  Neurological: Negative for weakness and headaches.  Psychiatric/Behavioral: Negative for confusion.  All other systems reviewed and are negative.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Dyspnoea, Pneumonia
Clinical narrative: DX SOB and COVID-19, 52-year-old female with a past medical history of lung cancer, chronic kidney disease, electrolyte disturbance, who initially was admitted to medical facility on September 25 for shortness of breath and the patient was found to have a COVID positive test.  She was started on treatment with remdesivir.  Also, she found to have bacteremia, 1 of 2 gram-positive cluster, was on vancomycin.  Also anticoagulation with Eliquis, vitamin C, zinc.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: DX SOB and COVID-19, 52-year-old female with a past medical history of lung cancer, chronic kidney disease, electrolyte disturbance, who initially was admitted to medical facility on September 25 for shortness of breath and the patient was found to have a COVID positive test.  She was started on treatment with remdesivir.  Also, she found to have bacteremia, 1 of 2 gram-positive cluster, was on vancomycin.  Also anticoagulation with Eliquis, vitamin C, zinc.