chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: barely able to walk; inflammation in my legs; can barely move my arms due to inflammation in my shoulders; can barely move my arms due to inflammation in my shoulders; barely able to get into and out of the bed; Anemia; can barely move my arms due to inflammation in my shoulders; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), when the patient was 71 years old, for Covid-19 Immunization, reaction(s): "joint pain", "joint pain inflammation", "aching muscles and joints after the first shot for a week continued aching muscle and joint pain inflammation". The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "barely able to walk"; INFLAMMATION (non-serious), outcome "unknown", described as "inflammation in my legs"; LIMB DISCOMFORT (non-serious), ARTHRITIS (non-serious), HYPOKINESIA (non-serious), outcome "unknown" and all described as "can barely move my arms due to inflammation in my shoulders"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "barely able to get into and out of the bed"; ANAEMIA (non-serious), outcome "unknown", described as "Anemia".  Additional information: It was reported that the patient had aching muscles and joints after the first shot for a week continued aching muscle and joint pain inflammation as separate of eighty and anemia. The patient was barely able to walk due to inflammation in legs, can barely move arms due to inflammation in shoulders, was barely able to get into and out of the bed.The patient had aching muscles and joints after the first shot for a week, continued aching muscle and joint pain, inflammation at sed rate of eighty and anemia after the 2nd vaccine it had been 10 weeks and patient was barely able to walk.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Malaise, Pain
Clinical narrative: 1st Dose: Within 15 min HA; 1st Dose: Dizziness Later that day, Dizziness lasting 3 days inn be; 1st Dose: Chills; 1st Dose: Fever; 1st Dose: Full Body Aches; 1st Dose: Not feeling well; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Jul2021 12:45 (Lot number: FW0181) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "OA" (unspecified if ongoing); "Intermittant Vertigo" (unspecified if ongoing); "Trigeminal Neuralgia" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN; HYDRALAZINE. Past drug history included: Tylox, reaction(s): "Known allergies: Tylox", notes: some other pain meds don't remember names.  The following information was reported: HEADACHE (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Within 15 min HA"; DIZZINESS (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Dizziness Later that day, Dizziness lasting 3 days inn be"; CHILLS (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Chills"; PYREXIA (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Fever"; PAIN (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Full Body Aches"; MALAISE (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Not feeling well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, dizziness, chills, pyrexia, pain, malaise.  Additional Information: 1st Dose: Within 15 min HA, Dizziness Later that day Chills/Fever, Full Body Aches, Not feeling well, Dizziness lasting 3 days inn bed and HA 5 `5days. No other vaccine in four weeks. No covid prior to vaccination and tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: 1st Dose: Within 15 min HA; 1st Dose: Dizziness Later that day, Dizziness lasting 3 days inn be; 1st Dose: Chills; 1st Dose: Fever; 1st Dose: Full Body Aches; 1st Dose: Not feeling well; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Jul2021 12:45 (Lot number: FW0181) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "OA" (unspecified if ongoing); "Intermittant Vertigo" (unspecified if ongoing); "Trigeminal Neuralgia" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN; HYDRALAZINE. Past drug history included: Tylox, reaction(s): "Known allergies: Tylox", notes: some other pain meds don't remember names.  The following information was reported: HEADACHE (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Within 15 min HA"; DIZZINESS (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Dizziness Later that day, Dizziness lasting 3 days inn be"; CHILLS (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Chills"; PYREXIA (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Fever"; PAIN (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Full Body Aches"; MALAISE (non-serious) with onset Jul2021, outcome "not recovered", described as "1st Dose: Not feeling well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, dizziness, chills, pyrexia, pain, malaise.  Additional Information: 1st Dose: Within 15 min HA, Dizziness Later that day Chills/Fever, Full Body Aches, Not feeling well, Dizziness lasting 3 days inn bed and HA 5 `5days. No other vaccine in four weeks. No covid prior to vaccination and tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: experienced migraine the whole day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 24Mar2021, outcome "unknown", described as "experienced migraine the whole day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Soreness in Arm and Shoulder Area; body aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in Arm and Shoulder Area"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional Information: The patient got second vaccine dose yesterday and today reported soreness in arm and shoulder area. Also minor body aches and chills.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling abnormal, Overdose, Pain
Clinical narrative: inadvertently given an undiluted dose; inadvertently given an undiluted dose; 101 fever; lightheaded and fuzzy, loopy; lightheaded and fuzzy/ lightheaded and fuzzy, loopy; shaking and aching all over; shaking and aching all over; 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 35-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Oct2021 (Lot number: FG3527) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot number: EL3249), administration date: 20Jan2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (2nd dose, Lot number: EL9261), administration date: 10Feb2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 27Oct2021, outcome "unknown" and all described as "inadvertently given an undiluted dose"; PYREXIA (non-serious) with onset 27Oct2021, outcome "not recovered", described as "101 fever"; DIZZINESS (non-serious) with onset 27Oct2021, outcome "not recovered", described as "lightheaded and fuzzy, loopy"; FEELING ABNORMAL (non-serious) with onset 27Oct2021, outcome "not recovered", described as "lightheaded and fuzzy/ lightheaded and fuzzy, loopy"; TREMOR (non-serious), PAIN (non-serious) all with onset 27Oct2021, outcome "not recovered" and all described as "shaking and aching all over". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: she received her booster shot yesterday at the Walgreens and later yesterday afternoon the pharmacist called her to tell her instead of receiving the 30mcg she was given 150-180mcg because it had not been diluted. she is only taking birth control. Response: Provided response from attached VR document: Beyond what is described in the Pfizer BioNTech Covid 19 vaccine Prescribing Information, Pfizer does not have information on administration of higher dose of the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error, Pyrexia, Tremor
Clinical narrative: inadvertently given an undiluted dose; inadvertently given an undiluted dose; 101 fever; lightheaded and fuzzy, loopy; lightheaded and fuzzy/ lightheaded and fuzzy, loopy; shaking and aching all over; shaking and aching all over; 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 35-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Oct2021 (Lot number: FG3527) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot number: EL3249), administration date: 20Jan2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (2nd dose, Lot number: EL9261), administration date: 10Feb2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 27Oct2021, outcome "unknown" and all described as "inadvertently given an undiluted dose"; PYREXIA (non-serious) with onset 27Oct2021, outcome "not recovered", described as "101 fever"; DIZZINESS (non-serious) with onset 27Oct2021, outcome "not recovered", described as "lightheaded and fuzzy, loopy"; FEELING ABNORMAL (non-serious) with onset 27Oct2021, outcome "not recovered", described as "lightheaded and fuzzy/ lightheaded and fuzzy, loopy"; TREMOR (non-serious), PAIN (non-serious) all with onset 27Oct2021, outcome "not recovered" and all described as "shaking and aching all over". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: she received her booster shot yesterday at the Walgreens and later yesterday afternoon the pharmacist called her to tell her instead of receiving the 30mcg she was given 150-180mcg because it had not been diluted. she is only taking birth control. Response: Provided response from attached VR document: Beyond what is described in the Pfizer BioNTech Covid 19 vaccine Prescribing Information, Pfizer does not have information on administration of higher dose of the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cerebrovascular accident, Giant cell myocarditis, Immune system disorder, Memory impairment
Clinical narrative: Massive stroke; He is having difficulties with memory; His immune system was super boosted by the Pfizer vaccine, and instead of doing what it was supposed to it started destroying his heart.; Diagnosed with giant cell myocarditis; Low grade temperature; 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. Other Case identifier(s): US-PFIZER INC-202200175796 (Pfizer).  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: E18982, Anatomical location: left arm, Dose no: 1), administration date: 17Jan2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Massive stroke"; GIANT CELL MYOCARDITIS (medically significant) with onset 18Mar2021, outcome "unknown", described as "Diagnosed with giant cell myocarditis"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "He is having difficulties with memory"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "Low grade temperature"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "His immune system was super boosted by the Pfizer vaccine, and instead of doing what it was supposed to it started destroying his heart.". The event "massive stroke" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: low grade, notes: low grade. Therapeutic measures were taken as a result of giant cell myocarditis. Clinical course: The patient now takes 20 pills a day to keep this Giant cell Myocarditis at bay.The second dose lot number was reported either says DM9810 or BM9810. The patient went a final time on 18Mar2021 and told them there was something wrong and didn't feel right. He even had a low grade temperature. He just felt off. He went down to 318, and they thought he was having a massive stroke, and he wasn't feeling anything. He went to the Emergency room and no arteries were clogged. They had to put him on a pump system because something had gone awry.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Massive stroke; He is having difficulties with memory; His immune system was super boosted by the Pfizer vaccine, and instead of doing what it was supposed to it started destroying his heart.; Diagnosed with giant cell myocarditis; Low grade temperature; 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. Other Case identifier(s): US-PFIZER INC-202200175796 (Pfizer).  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: E18982, Anatomical location: left arm, Dose no: 1), administration date: 17Jan2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Massive stroke"; GIANT CELL MYOCARDITIS (medically significant) with onset 18Mar2021, outcome "unknown", described as "Diagnosed with giant cell myocarditis"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "He is having difficulties with memory"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "Low grade temperature"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "His immune system was super boosted by the Pfizer vaccine, and instead of doing what it was supposed to it started destroying his heart.". The event "massive stroke" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: low grade, notes: low grade. Therapeutic measures were taken as a result of giant cell myocarditis. Clinical course: The patient now takes 20 pills a day to keep this Giant cell Myocarditis at bay.The second dose lot number was reported either says DM9810 or BM9810. The patient went a final time on 18Mar2021 and told them there was something wrong and didn't feel right. He even had a low grade temperature. He just felt off. He went down to 318, and they thought he was having a massive stroke, and he wasn't feeling anything. He went to the Emergency room and no arteries were clogged. They had to put him on a pump system because something had gone awry.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Lymphadenopathy
Clinical narrative: Had flu like symptoms that resolved after first week; 15 days (current) extremely swollen glands in both breasts, undr both arms, and in groin.; Painful joints in lower back and right knee; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Oct2021 16:45 (Lot number: FE3592) at the age of 67 years as dose 3(booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCIN), administered in arm right, administration date 13Oct2021 (Lot number: DK). Relevant medical history included: "back surgery/pain" (unspecified if ongoing); "fibramyalgia IBS" (unspecified if ongoing); "diplopia" (unspecified if ongoing); "gluten intolerance" (unspecified if ongoing); "mild lactose" (unspecified if ongoing); "sulfa" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: SHINGRIX, start date: 20Sep2021, stop date: 20Sep2021, administered in arm right; CALCIUM; FLUCONAZOLE; ALENDRONATE; MULTIVIT [VITAMINS NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 17Mar2021, when the patient was 67 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 24Feb2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 13Oct2021 19:45, outcome "not recovered", described as "15 days (current) extremely swollen glands in both breasts, undr both arms, and in groin."; ARTHRALGIA (non-serious) with onset 13Oct2021 19:45, outcome "not recovered", described as "Painful joints in lower back and right knee"; INFLUENZA LIKE ILLNESS (non-serious) with onset 13Oct2021 19:45, outcome "recovered" (Oct2021), described as "Had flu like symptoms that resolved after first week". The events "15 days (current) extremely swollen glands in both breasts, undr both arms, and in groin.", "painful joints in lower back and right knee" and "had flu like symptoms that resolved after first week" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, arthralgia, influenza like illness.  Additional information: There were other vaccines taken in four weeks. The adverse event 15 days (current) extremely swollen glands in both breasts, under both arms, and in groin. Painful joints in lower back and right knee. Had flu like symptoms that resolved after first week. It was unknown if the patient had covid prior vaccination. The patient was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: body aches; mild fever; headache; When I had the first two shots, I had fatigue for like 3 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FE35929) as dose 3, single (booster) for covid-19 immunisation. Relevant medical history included: "Basedow's disease" (unspecified if ongoing), notes: Verbatim: Graves'' disease; "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety. Concomitant medication(s) included: ARMOUR THYROID; ASPIRINA.  The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "When I had the first two shots, I had fatigue for like 3 weeks"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "mild fever"; HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were taken as a result of fatigue, pain, pyrexia.  Follow-up (25Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Vaccination site pain
Clinical narrative: Mild injection site pain that resolved by end of day on 27Mar; moderate fatigue that resolved by 28Mar; mild chills around 2 am in the morning (might have lasted 1 hour but not sure); mild headache; mild injection site pain that resolved by end of day on 27Mar; moderate fatigue that resolved by 28Mar; mild chills around 2 am in the morning (might have lasted 1 hour but not sure); mild headache; mild injection site pain that resolved by end of day on 27Mar; moderate fatigue that resolved by 28Mar; mild chills around 2 am in the morning (might have lasted 1 hour but not sure); mild headache; mild injection site pain that resolved by end of day on 27Mar; moderate fatigue that resolved by 28Mar; mild chills around 2 am in the morning (might have lasted 1 hour but not sure); mild headache; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (Pfizer BioNTech COVID-19 Vaccine), administered in arm left, administration date 26Mar2021 09:00 (Lot number: EL3248) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Advil, reaction(s): "allergies", notes: Known allergies. Vaccination history included: Bnt162b2 (Dose number=1, Product=COVID-19, Brand=Pfizer/BNT, Lot number=EN6203, Lot unknown=False, Administration date=04Mar2021, Administration time=09:00 AM, Vaccine location=Left arm), administration date: 04Mar2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Mar2021, outcome "recovered" (27Mar2021), described as "Mild injection site pain that resolved by end of day on 27Mar; moderate fatigue that resolved by 28Mar; mild chills around 2 am in the morning (might have lasted 1 hour but not sure); mild headache"; FATIGUE (non-serious), CHILLS (non-serious), HEADACHE (non-serious) all with onset 26Mar2021, outcome "recovered" (28Mar2021) and all described as "mild injection site pain that resolved by end of day on 27Mar; moderate fatigue that resolved by 28Mar; mild chills around 2 am in the morning (might have lasted 1 hour but not sure); mild headache"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "not feeling well". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, headache. Additional information: There was delayed in submitting the report due to not feeling well. She also work on the COVID vaccine study and got distracted with the work she had to do. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Chest X-ray, Electrocardiogram, Hypertension
Clinical narrative: Hypertensive Blood Pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administration date 13Apr2021 (Lot number: EP7533, expiration date unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lymes Disease", start date: 1990 (unspecified if ongoing), notes: Treated with Doxycycline; "Dengue Fever", start date: 2010 (unspecified if ongoing), notes: After travelling to (country name); "Reguilt of left wrist", start date: 2005 (unspecified if ongoing); "Melanoma", start date: 2015 (unspecified if ongoing), notes: Melanome removal of Right arm; "blood pressure increased" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing), notes: wheel chair bound for many years. Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: 2018 (ongoing); VIT C; VIT B12. Vaccination history included: Bnt162b2 (Dose: 01, Time: Afternoon, Route of administration: IM, Lot no. EP7534), administration date: 22Mar2021, for Covid-19 immunization, reaction(s): "major blood pressure spikes", "retina damage to right eye". The following information was reported: HYPERTENSION (medically significant), outcome "recovered", described as "Hypertensive Blood Pressure". The event "hypertensive blood pressure" was evaluated at the physician office visit and emergency room visit. Clinical course: 24Nov2021: Retina Specialist (Physician Name Withheld) Retina Unit. Discovered elevated blood pressure during referred to 03Dec2021: (Name Withheld). 08Dec2021: (Clinic name) (Increased B.P). 13Dec2021: (Name withheld) (Increased B.P). 20Dec2021: Orally (Only increased Lisinopril) (Increased B.P). 30Dec2021: Cardiologist (Name). (Office name) - Out on (medication name) as ACE inhibitor med. no longer effective after Pfizer vaccine due to it's injection. The patient underwent the following laboratory tests and procedures: blood pressure measurement: blood test: (13Dec2021) basophils high; chest x-ray: (13Dec2021) unknown results; electrocardiogram: (13Dec2021) unknown results; slit-lamp examination: (24Nov2021) cup of disc ratio 25; ultrasound scan: (28Dec2021) unknown results. Therapeutic measures were taken as a result of hypertension.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Slit-lamp examination, Ultrasound scan
Clinical narrative: Hypertensive Blood Pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administration date 13Apr2021 (Lot number: EP7533, expiration date unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lymes Disease", start date: 1990 (unspecified if ongoing), notes: Treated with Doxycycline; "Dengue Fever", start date: 2010 (unspecified if ongoing), notes: After travelling to (country name); "Reguilt of left wrist", start date: 2005 (unspecified if ongoing); "Melanoma", start date: 2015 (unspecified if ongoing), notes: Melanome removal of Right arm; "blood pressure increased" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing), notes: wheel chair bound for many years. Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: 2018 (ongoing); VIT C; VIT B12. Vaccination history included: Bnt162b2 (Dose: 01, Time: Afternoon, Route of administration: IM, Lot no. EP7534), administration date: 22Mar2021, for Covid-19 immunization, reaction(s): "major blood pressure spikes", "retina damage to right eye". The following information was reported: HYPERTENSION (medically significant), outcome "recovered", described as "Hypertensive Blood Pressure". The event "hypertensive blood pressure" was evaluated at the physician office visit and emergency room visit. Clinical course: 24Nov2021: Retina Specialist (Physician Name Withheld) Retina Unit. Discovered elevated blood pressure during referred to 03Dec2021: (Name Withheld). 08Dec2021: (Clinic name) (Increased B.P). 13Dec2021: (Name withheld) (Increased B.P). 20Dec2021: Orally (Only increased Lisinopril) (Increased B.P). 30Dec2021: Cardiologist (Name). (Office name) - Out on (medication name) as ACE inhibitor med. no longer effective after Pfizer vaccine due to it's injection. The patient underwent the following laboratory tests and procedures: blood pressure measurement: blood test: (13Dec2021) basophils high; chest x-ray: (13Dec2021) unknown results; electrocardiogram: (13Dec2021) unknown results; slit-lamp examination: (24Nov2021) cup of disc ratio 25; ultrasound scan: (28Dec2021) unknown results. Therapeutic measures were taken as a result of hypertension.  Follow-up attempts are completed. No further information is expected.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chest X-ray, Pleural effusion, SARS-CoV-2 test
Clinical narrative: Bilateral pulmonary infusion; pos (home test)coronavirus with COVID symptoms; pos (home test)coronavirus with COVID symptoms; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 92 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 23Feb2021 13:00 (Lot number: EN6203) as dose 2, single and intramuscular, administration date 02Feb2021 13:00 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 02Jan2022, outcome "recovered" (06Jan2022) and all described as "pos (home test) coronavirus with COVID symptoms"; PLEURAL EFFUSION (medically significant), outcome "recovered", described as "Bilateral pulmonary infusion". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 99-100; chest x-ray: (unspecified date) unknown result; sars-cov-2 test: (02Jan2022) pos, notes: coronavirus with COVID symptoms. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Application with pulmonologist 12Feb2022 (took 3 month to get appointment). On 02Jan2022 to 06Jan2022, the patient experienced Temp 99-100 (unit unknown), headache, sore throat, cough increase productive weakness, pos (home) coronavirus. Rx Bioxin antibiotics.; Sender's Comments: Based on temporal association, the reported events vaccination failure, covid 19 and pleural effusion are possibly related to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .,Linked Report(s) : US-PFIZER INC-202101578125 same patient/vaccine, different dose/events
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Bilateral pulmonary infusion; pos (home test)coronavirus with COVID symptoms; pos (home test)coronavirus with COVID symptoms; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 92 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 23Feb2021 13:00 (Lot number: EN6203) as dose 2, single and intramuscular, administration date 02Feb2021 13:00 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 02Jan2022, outcome "recovered" (06Jan2022) and all described as "pos (home test) coronavirus with COVID symptoms"; PLEURAL EFFUSION (medically significant), outcome "recovered", described as "Bilateral pulmonary infusion". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 99-100; chest x-ray: (unspecified date) unknown result; sars-cov-2 test: (02Jan2022) pos, notes: coronavirus with COVID symptoms. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Application with pulmonologist 12Feb2022 (took 3 month to get appointment). On 02Jan2022 to 06Jan2022, the patient experienced Temp 99-100 (unit unknown), headache, sore throat, cough increase productive weakness, pos (home) coronavirus. Rx Bioxin antibiotics.; Sender's Comments: Based on temporal association, the reported events vaccination failure, covid 19 and pleural effusion are possibly related to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .,Linked Report(s) : US-PFIZER INC-202101578125 same patient/vaccine, different dose/events
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Myalgia, Nasal discomfort
Clinical narrative: sinusitis; sneezing; running nose/sinus drainage; headache; stuffiness; muscle aches; fatigue; raw wet feeling nasal passage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose: 2, Date/Time: 23Mar2021, Anatomical Site of Injection: left arm, Batch/Lot number: EN5318), administration date: 23Mar2021, for COVID-19 Immunization; Bnt162b2 (dose: 1, Date/Time: 02Mar2021, Anatomical Site of Injection: Left Arm, Batch/Lot number: EN5318), administration date: 02Mar2021, for COVID-19 Immunization. The following information was reported: SINUSITIS (non-serious), outcome "recovered" (2021), described as "sinusitis"; SNEEZING (non-serious), outcome "unknown", described as "sneezing"; RHINORRHOEA (non-serious) with onset 04Jan2022, outcome "recovered" (Jan2022), described as "running nose/sinus drainage"; HEADACHE (non-serious) with onset 04Jan2022, outcome "recovered" (Jan2022), described as "headache"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 04Jan2022, outcome "unknown", described as "stuffiness"; MYALGIA (non-serious) with onset 04Jan2022, outcome "unknown", described as "muscle aches"; FATIGUE (non-serious) with onset 04Jan2022, outcome "unknown", described as "fatigue"; NASAL DISCOMFORT (non-serious) with onset 04Jan2022, outcome "unknown", described as "raw wet feeling nasal passage". The event "sinusitis" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of sinusitis. Therapeutic measures were taken as a result of rhinorrhoea, headache, musculoskeletal stiffness, myalgia.  The sinus drainage and a headache that resolved with Zyrtec and Advil. Patient took 400mg of Advil again and the headache resolved.   Additional info: Patient received no treatment for Covid and the symptoms had resolved by the morning of 26Nov2021. I have felt fine since until yesterday morning 04Jan2022.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Sinusitis, Sneezing
Clinical narrative: sinusitis; sneezing; running nose/sinus drainage; headache; stuffiness; muscle aches; fatigue; raw wet feeling nasal passage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose: 2, Date/Time: 23Mar2021, Anatomical Site of Injection: left arm, Batch/Lot number: EN5318), administration date: 23Mar2021, for COVID-19 Immunization; Bnt162b2 (dose: 1, Date/Time: 02Mar2021, Anatomical Site of Injection: Left Arm, Batch/Lot number: EN5318), administration date: 02Mar2021, for COVID-19 Immunization. The following information was reported: SINUSITIS (non-serious), outcome "recovered" (2021), described as "sinusitis"; SNEEZING (non-serious), outcome "unknown", described as "sneezing"; RHINORRHOEA (non-serious) with onset 04Jan2022, outcome "recovered" (Jan2022), described as "running nose/sinus drainage"; HEADACHE (non-serious) with onset 04Jan2022, outcome "recovered" (Jan2022), described as "headache"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 04Jan2022, outcome "unknown", described as "stuffiness"; MYALGIA (non-serious) with onset 04Jan2022, outcome "unknown", described as "muscle aches"; FATIGUE (non-serious) with onset 04Jan2022, outcome "unknown", described as "fatigue"; NASAL DISCOMFORT (non-serious) with onset 04Jan2022, outcome "unknown", described as "raw wet feeling nasal passage". The event "sinusitis" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of sinusitis. Therapeutic measures were taken as a result of rhinorrhoea, headache, musculoskeletal stiffness, myalgia.  The sinus drainage and a headache that resolved with Zyrtec and Advil. Patient took 400mg of Advil again and the headache resolved.   Additional info: Patient received no treatment for Covid and the symptoms had resolved by the morning of 26Nov2021. I have felt fine since until yesterday morning 04Jan2022.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Chest discomfort, Dyspnoea, Fibrin degradation products, Full blood count
Clinical narrative: difficulty breathing; beating irregularly; myocarditis; tightness in my chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 23-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Aug2021 15:00 (Lot number: FD8448) as dose 1, single and intramuscular, administered in arm left, administration date 10Sep2021 15:00 (Lot number: FD8448) as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 2003 (ongoing). The following information was reported: MYOCARDITIS (medically significant) with onset 22Aug2021, outcome "recovered", described as "myocarditis"; CHEST DISCOMFORT (non-serious) with onset 22Aug2021, outcome "unknown", described as "tightness in my chest"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "beating irregularly". The patient received his first covid vaccine on August 20 and 2days later on 22Aug2021 began feeling tightness in chest. The patient had some difficulty breathing while lying down and heart felt like it was beating irregularly. The patient went to the ER on August 25th at 2 am due to this condition. However, lab results all came back normal. The doctor said he might have had a mild case of myocarditis as a result of the vaccine but said it should clear up. The condition improved, however, it returned again after the second dose for a little over a week. The patient was no longer experiencing any symptoms now. The event "myocarditis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: (25Aug2021) normal, notes: Units:<10 pg/ml; fibrin degradation products: (25Aug2021) normal, notes: Units:<150ng/ml; Comments: platelet count 242 B/L; full blood count: (25Aug2021) abnormal, notes: Units:12.3B/L; Comments: Units for WBC; hepatic function abnormal: (25Aug2021) normal; metabolic function test: (25Aug2021) normal; troponin: (25Aug2021) normal, notes: Units:<4 ng/L. Therapeutic measures were not taken as a result of myocarditis.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Hepatic function abnormal, Metabolic function test, Myocarditis, Troponin
Clinical narrative: difficulty breathing; beating irregularly; myocarditis; tightness in my chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 23-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Aug2021 15:00 (Lot number: FD8448) as dose 1, single and intramuscular, administered in arm left, administration date 10Sep2021 15:00 (Lot number: FD8448) as dose 2, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 2003 (ongoing). The following information was reported: MYOCARDITIS (medically significant) with onset 22Aug2021, outcome "recovered", described as "myocarditis"; CHEST DISCOMFORT (non-serious) with onset 22Aug2021, outcome "unknown", described as "tightness in my chest"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "beating irregularly". The patient received his first covid vaccine on August 20 and 2days later on 22Aug2021 began feeling tightness in chest. The patient had some difficulty breathing while lying down and heart felt like it was beating irregularly. The patient went to the ER on August 25th at 2 am due to this condition. However, lab results all came back normal. The doctor said he might have had a mild case of myocarditis as a result of the vaccine but said it should clear up. The condition improved, however, it returned again after the second dose for a little over a week. The patient was no longer experiencing any symptoms now. The event "myocarditis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: (25Aug2021) normal, notes: Units:<10 pg/ml; fibrin degradation products: (25Aug2021) normal, notes: Units:<150ng/ml; Comments: platelet count 242 B/L; full blood count: (25Aug2021) abnormal, notes: Units:12.3B/L; Comments: Units for WBC; hepatic function abnormal: (25Aug2021) normal; metabolic function test: (25Aug2021) normal; troponin: (25Aug2021) normal, notes: Units:<4 ng/L. Therapeutic measures were not taken as a result of myocarditis.