chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Injection site pain; Extreme fatigue; Mild headache; Muscle pain; Chills; Flushed; Dizzy; Loss of appetite; Feel unwell; This is a spontaneous report from a consumer, the patient. A 64-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208), via an unspecified route of administration on left arm on 13Mar2021 at 11:00, (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included epstein barre virus and high blood pressure. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), LIVALO and metoprolol (MANUFACTURER UNKNOWN) and hydroc (MANUFACTURER UNKNOWN) for unknown indication. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 13Mar2021 at 11:30, the patient experienced injection site pain, extreme fatigue, mild headache, muscle pain, chills, flushed, dizzy, loss of appetite (colon cleanse at 3rd night) and the patient felt unwell until 6th day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatments were taken for any events. The clinical outcome of the events injection site pain, extreme fatigue, mild headache, muscle pain, chills, flushed, dizzy, loss of appetite was resolved on an unknown date in Mar2021 and for event feeling unwell was resolved on 19Mar2021 (day 6).   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Genital rash, Rash
Clinical narrative: Body rash that started under both arms below the elbow  and spread to both legs.; rash spread to genital area; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) via unknown route of administration in the left arm on 10Mar2021(at the age of 38-years-old) at 12:30 pm as a single dose for Covid-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since having the vaccine. After 3 days from vaccination, on 13Mar2021 patient started to experienced rash under both arms, then it gradually spreads to both arms below the elbow, stomach, genital area. It also sprayed to both legs, back, and up the back of the neck. Therapeutic measures taken were none for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the rash on body was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Neck pain, Oropharyngeal pain, Pruritus, Rash
Clinical narrative: sore throat; rash with welts on neck; burning on neck; neck itching; neck pain; This is a spontaneous report from a consumer (the patient). A 62-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6206) via unspecified route of administration on 03Mar2021 (at the age of 62-years-old) as a single dose for Covid-19 immunisation. The patients medical history was included kidney failure, diabetes and bad heart valves and COVID-19 suspected. Concomitant medication was reported are insulin (MANUFACTURER UNKNOWN), blood pressure medicines (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) for unknown indication. The patient was allergic to penicillin and bee pollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed positive with COVID-19 prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccine. On 16Mar2021, patient experienced sore throat and rash on neck with welts. Patient also experienced burning, itchy sensation and pain on neck at site of rash. No treatment medications are given. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of burning, itchy sensation and pain on neck at site of rash was reported as not recovered. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Chills, Disorientation, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot number: EN6204) via unspecified route of administration in left arm on 19Mar2021 at 17:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease during last summer. The patient had no known allergies to medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN) and baby aspirin (MANUFACTURER UNKNOWN) all taken for unknown indications, since an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot number: EN6203) via unspecified route of administration in left arm on 26Feb2021 at 17:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had not tested positive for COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. On 19Mar2021 at 21:00 the patient experienced fever of 100 for two days, feeling nauseated and starving at the same time, chills and burning up at the same time, mild headache, severe body aches. The patient had experienced exhaustion and dizziness and disorientation as of Monday (on 22Mar2021). No treatment was given to the patient for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever was resolved on 21Mar2021 (two days), nausea, chills, headache and general body pain were resolved on 20Mar2021 at 07:00 (until 7 oclock Saturday morning), while that of events exhaustion, dizziness and disorientation were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot number: EN6204) via unspecified route of administration in left arm on 19Mar2021 at 17:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease during last summer. The patient had no known allergies to medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN) and baby aspirin (MANUFACTURER UNKNOWN) all taken for unknown indications, since an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot number: EN6203) via unspecified route of administration in left arm on 26Feb2021 at 17:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had not tested positive for COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. On 19Mar2021 at 21:00 the patient experienced fever of 100 for two days, feeling nauseated and starving at the same time, chills and burning up at the same time, mild headache, severe body aches. The patient had experienced exhaustion and dizziness and disorientation as of Monday (on 22Mar2021). No treatment was given to the patient for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever was resolved on 21Mar2021 (two days), nausea, chills, headache and general body pain were resolved on 20Mar2021 at 07:00 (until 7 oclock Saturday morning), while that of events exhaustion, dizziness and disorientation were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Nausea
Clinical narrative: Nausea; fatigue; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER2613) via unspecified route of administration in the left arm on 20Mar2021 at 03:45 PM (at the age of 27-years-old) as a single dose for Covid-19 immunisation. Medical history included anxiety from an unknown date. Concomitant medication included citalopram  30mg/day (MANUFACTURER UNKNOWN) and  norethindrone acetate and ethinyl estradiol(HAILEY)1.5/30 for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-19 since the vaccination. On 21Mar2021, the patient experienced nausea, fatigue and brain fog. Therapeutic measures  were not taken for the reported event. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the nausea, fatigue and brain fog was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Rash vesicular, Swelling
Clinical narrative: itchy rash; swelling on bottom half of  face and jawline; Bubbly rash; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in the left arm on 21Mar2021 at 11:45 (at the age of 25-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other product. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included KYLEENA IUD for an unknown indication from an unknown date. On 21Mar2021 at 23:00, the patient experienced bubbly, itchy rash and swelling on bottom half of face and jawline. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received treatment for the reported events. The clinical outcome of the events bubbly, itchy rash and swelling on bottom half of face and jawline was unknown at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizzy; lightheaded; tired; This is a spontaneous report from a contactable consumer, the patient. A 56 -year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on the right arm on 20Mar2021 at 16:45 (at the age of vaccination was 56 years) as a single dose for COVID-19 immunisation. Medical history was reported as hypertension. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination (names and indications of which, are unknown). The patient had not tested for COVID-19. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient did not have allergies to medications, food, or other product. On 22Mar2021 at 12:00 patient experienced event dizzy, lightheadedness and tired. The clinical outcome of event dizzy, lightheadedness and tired were recovering at the time of reporting. The patient did not receive any treatment for the adverse events.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pruritus, Urticaria
Clinical narrative: Hives all over joint areas of the body; Stomach ache; Itching; This is a spontaneous report from a contactable consumer, the patient. A 40-Year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration on 21Mar2021 at 12:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to doxycycline. Concomitant medications included LIALDA for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced hives all over joint areas of the body with mild itching and stomach ache after the meals on 21Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatments were taken for any events. The therapeutic measures taken for the events was unknown. The clinical outcome of the events hives, itching and stomach aches were not resolved at the time of this report.   No follow-up attempts are needed. No further information was expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at site of injection (minor soreness); This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 21Mar2021 at 16:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 18:30, the patient experienced sore arm at site of injection (minor soreness). The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm at site of injection was recovering at the time of reporting.   Information about lot number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Dizziness; Lose of balance night of 3/21into 3/22; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route in the right arm on 20Mar2021 at 15:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and anxiety. The patient was allergic to latex gloves. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included rosuvastatin (CRESTOR), valsartan (MANUFACTURER UNKNOWN), sertraline (ZOLOFT), bupropion (WELLBUTRIN) and varenicline (CHANTIX) received on unspecified dates for unknown indications. The patient previously took oxycodone (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 02:00, the patient experienced dizziness and lose of balance night of 21Mar2021 into 22Mar2021. Therapeutic measures and treatments were not taken for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of dizziness and lose of balance night of 21Mar2021 into 22Mar2021 were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Excessive eye blinking, Hiccups, Muscle twitching
Clinical narrative: Started early afternoon on June 27, 2021. Patient had hiccups. Parent treated with the hiccups with water, holding breath, brown paper bag breathing. The patient had continuous hiccups Sunday, went to sleep, woke up Monday and didn't have the hiccups. Monday afternoon the hiccups started back up and were more frequent.  Tuesday neck twitching started in addition to hiccups. Wednesday neck twitching, blinking of eyes, and hiccups/gasping for air continuous. Only when in deep sleep does she stop.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspepsia, Dyspnoea, Laryngospasm
Clinical narrative: tachycardia at night with patient unable to breathe, sore throat, laryngothoracic spasms at night and cough or inability to cough, incident of severe chest pain with dyspnea and jaw pain and slight swelling on the neck - resolved with beta-blockers, avula test  positive
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in jaw, Swelling, Tachycardia
Clinical narrative: tachycardia at night with patient unable to breathe, sore throat, laryngothoracic spasms at night and cough or inability to cough, incident of severe chest pain with dyspnea and jaw pain and slight swelling on the neck - resolved with beta-blockers, avula test  positive
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Drug hypersensitivity, Dyspnoea, Headache
Clinical narrative: Symptoms began to appear around 1:00 am, 6/16/2021. Symptoms included labored breathing, pounding heartbeat, lightheadedness, headache, chills, injection site soreness, and feeling unwell. Side effects were eased with Tylenol. Symptoms gradually diminished over the course of approximately seven days.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Palpitations
Clinical narrative: Symptoms began to appear around 1:00 am, 6/16/2021. Symptoms included labored breathing, pounding heartbeat, lightheadedness, headache, chills, injection site soreness, and feeling unwell. Side effects were eased with Tylenol. Symptoms gradually diminished over the course of approximately seven days.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye discharge, Lymphadenopathy, Nausea, Obstruction
Clinical narrative: nausea; vomiting; left underarm lymph node swollen to about softball size; Extreme congestion; eyes were sealed closed with gunk; red face; itchy face; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 18Mar2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, diabetes, von willebrands, sleep apnoea, asthma and lymphedema. The patient had a history of allergy to lactose, soy, orange, tuna, salmon and environmental grass, trees and pollen. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), VICTOZA, metformin (MANUFACTURER UNKNOWN), GLIMEP for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Mar2021, the patient had experienced extreme congestion, eyes were sealed closed with gunk next morning, red and itchy face. On 21Mar2021 (2 days after), the patient experienced nausea, vomiting, left underarm lymph node swollen to about softball size. Therapeutic measure was taken as result of events and included treatment with methylprednisolone. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events extreme congestion, eyes were sealed closed with gunk, red face, itchy face, nausea, vomiting and swollen lymph nodes were resolving at the time of this report.   No follow up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vomiting
Clinical narrative: nausea; vomiting; left underarm lymph node swollen to about softball size; Extreme congestion; eyes were sealed closed with gunk; red face; itchy face; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 18Mar2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, diabetes, von willebrands, sleep apnoea, asthma and lymphedema. The patient had a history of allergy to lactose, soy, orange, tuna, salmon and environmental grass, trees and pollen. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), VICTOZA, metformin (MANUFACTURER UNKNOWN), GLIMEP for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Mar2021, the patient had experienced extreme congestion, eyes were sealed closed with gunk next morning, red and itchy face. On 21Mar2021 (2 days after), the patient experienced nausea, vomiting, left underarm lymph node swollen to about softball size. Therapeutic measure was taken as result of events and included treatment with methylprednisolone. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events extreme congestion, eyes were sealed closed with gunk, red face, itchy face, nausea, vomiting and swollen lymph nodes were resolving at the time of this report.   No follow up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Oligomenorrhoea, Product administered at inappropriate site
Clinical narrative: Hair loss and cycle still in for 40 days now
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site warmth, Rash, Rash erythematous, Rash pruritic
Clinical narrative: About a week after I received the vaccine, I developed a rash on my arm around 1-2 inches below the injection site (below my deltoid). The rash itself has grown over the past few days and is now around 2 inches wide, 3 inches long (an oval shape).  It is red and itchy and feels hot and bruised when touched.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Lip swelling, Paraesthesia, Sneezing
Clinical narrative: Strong repetitive sneezing (6-8 times); Tingling; slight swelling lips; Coughing; Heaviness in chest (while sleeping); This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PP75.34) via an unspecified route of administration in the left arm on 19Mar2021 at 16:15 (at the age of 62-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 18:45, the patient experienced strong repetitive sneezing (6-8 times), tingling, slight swelling lips, coughing (and while sleeping) heaviness in chest. The patient did not receive any treatment for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of strong repetitive sneezing (6-8 times) tingling, slight swelling lips, coughing (and while sleeping), heaviness in chest were resolved.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pharyngeal paraesthesia, Pharyngeal swelling, Vaccination site hypoaesthesia
Clinical narrative: Immediate throat tingliness; Numbness in chest, neck, and lower face; Immediate throat swelling; Numbness in vaccine arm; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration in Arm Right on 17Mar2021 (at the age of 26 years old) as a single dose for covid-19 immunisation. Medical history was not reported. It was unknown if patient had any known allergies. Patient previously received first dose of BNT162B2 via an unspecified route of administration in Arm Right on an unspecified date (Lot Number: EN6198) as a single dose for covid-19 immunisation. Concomitant medication included spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced immediate throat tingliness/swelling, numbness in vaccine arm, chest, neck, and lower face on 17Mar2021 09:15, still lasting through today (20Mar2021). Patient received Epipen and steroid as treatment for events. Event caused emergency room/department or urgent care. The outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Neck pain
Clinical narrative: Lightheadedness; fatigue; Burning at injection site; dull headache; pain in joints; pain in neck; pain in back shoulder blade on left side; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via unspecified route of administration in the left arm on 22Mar2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune psoriasis, sleep apnea, high blood pressure. Concomitant medications included olmasartan (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and probiotic (MANUFACTURER UNKNOWN) all for an unknown indication and from an unknown date.  The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had known allergies to celebrex. On 22Mar2021 at 13:15, about an hour after injection the patient experienced light-headedness, fatigue, burning at injection site, dull headache, pain in joints, neck and back shoulder blade on left side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome of the events light-headedness, fatigue, burning at injection site, dull headache, pain in joints, neck and back shoulder blade on left side was unknown at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Lightheadedness; fatigue; Burning at injection site; dull headache; pain in joints; pain in neck; pain in back shoulder blade on left side; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via unspecified route of administration in the left arm on 22Mar2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune psoriasis, sleep apnea, high blood pressure. Concomitant medications included olmasartan (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and probiotic (MANUFACTURER UNKNOWN) all for an unknown indication and from an unknown date.  The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had known allergies to celebrex. On 22Mar2021 at 13:15, about an hour after injection the patient experienced light-headedness, fatigue, burning at injection site, dull headache, pain in joints, neck and back shoulder blade on left side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome of the events light-headedness, fatigue, burning at injection site, dull headache, pain in joints, neck and back shoulder blade on left side was unknown at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Flushing, Headache, Rash
Clinical narrative: Rash on left neck, left scalp, left shoulder & left ear; burning sensation on left neck, left scalp, left shoulder & left ear; Light headache; Flush feeling; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in left arm on 22Mar2021 at 12:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease and the patient was allergic to nuts. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 12:15, the patient experienced rash on left neck, left scalp, left shoulder & left ear and burning sensation on left neck, left scalp, left shoulder & left ear, light headache and flush feeling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures taken for rash on left neck, left scalp, left shoulder & left ear, burning sensation on left neck, left scalp, left shoulder & left ear, light headache and flush feeling included self-treatment with ZYRTEC-D tablet. The clinical outcomes of the events rash, burning sensation, headache and flushing was recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Severe sore throat about 8 hours after receiving vaccine. The next morning sore throat was only on the left side but was also sore to the touch outside.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EP6955), via an unspecified route of administration in the left arm on 21Mar2021 at 13:30 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included vitamin D (MANUFUTURER UNKNOWN), calcium (MANUFUTURER UNKNOWN), multivitamin (MANUFUTURER UNKNOWN), omega 3 (MANUFUTURER UNKNOWN), super B (MANUFUCTURER UNKNOWN); all from unknown dates for unspecified indications. The patient had no known allergies to medications, food, and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Mar2021 at 20:30, the patient experienced severe sore throat, 8 hours after receiving the vaccine. The next morning sore throat was only on the left side but was also sore to touch outside. Therapeutic measures were taken as a result of sore throat and included treatment with Aleve. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore throat was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pruritus, Rash macular, Swollen tongue
Clinical narrative: 2 circle rash one on chin n one on chest.; Itching all over body; Tongue felt heavy; Tongue swollen; Difficulty breathing normal at night; Headaches; This is a spontaneous report received from a contactable health care professional, the patient. A 38-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 08:15 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. No relevant medical history was provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No concomitant medications were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any medications within 2 weeks of vaccination. On 18Mar2021 at 23:00, the patient experienced 2 circle rash one on chin and one on chest, itching all over body, tongue felt heavy and swollen, experienced headaches for 2 days and difficulty breathing which was normal at night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received as a result of the adverse events. The clinical outcome of event headache was resolved while the outcome of events spot-like rash, itching, tongue discomfort, swollen tongue and difficulty breathing was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: 2 circle rash one on chin n one on chest.; Itching all over body; Tongue felt heavy; Tongue swollen; Difficulty breathing normal at night; Headaches; This is a spontaneous report received from a contactable health care professional, the patient. A 38-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 08:15 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. No relevant medical history was provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No concomitant medications were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any medications within 2 weeks of vaccination. On 18Mar2021 at 23:00, the patient experienced 2 circle rash one on chin and one on chest, itching all over body, tongue felt heavy and swollen, experienced headaches for 2 days and difficulty breathing which was normal at night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received as a result of the adverse events. The clinical outcome of event headache was resolved while the outcome of events spot-like rash, itching, tongue discomfort, swollen tongue and difficulty breathing was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Pain in neck; Pain in head; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old male patient received first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot Number: unknown) as solution for injection on the left arm, on 20Mar2021 at 1245  for COVID-19 immunisation at public health clinic/ veterans administration facility. The patients medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not tested positive for COVID-19 since having the vaccine. On 22Mar2021 at 13:45,  the patient experienced neck pain and head pain (patient had felt that his head was swollen and foggy. Patient was not feeling dizzy). The clinical outcome for neck pain and head pain was not resolved at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pain
Clinical narrative: extreme tiredness; medium grade headache; pain throughout the whole body; High fever (102F); Strong shaking throughout the whole body; pain down the left arm; Tenderness at the injection site; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The concomitant medications included cetirizine (ZYRTEC) for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 26Feb2021 at 15:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously received tetracycline (MANUFACTURER UNKNOWN), vancomycin (MANUFACTURER UNKNOWN) and cipro (MANUFACTURER UNKNOWN) for unknown indications on unknown dates and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 20Mar2021 at 03:45, the patient experienced strong shaking throughout the whole body and pain down the left arm for approximately 30 min at 03:55, the following day after the shot. Pain reduced in severity, but changed to the pain throughout the whole body. High fever (102F) throughout the day, medium grade pain especially on the left side of the body, medium grade headache. On the 2nd day pain and headache subsided but experienced Tenderness at the injection site, Nausea and extreme tiredness throughout the day. On third day most symptoms were gone and had slight tiredness. Therapeutic measures were taken for the events and shaking subsided after 2 (200mg/each) Ibuprofen pills. Pain reduced in severity, but changed to the pain throughout the whole body. Headache, body pain and fever was better controlled with Tylenol (500mg). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events shaking, pain down the left arm, high fever, headache, body pain, Tenderness at the injection site, Nausea and tiredness was recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: extreme tiredness; medium grade headache; pain throughout the whole body; High fever (102F); Strong shaking throughout the whole body; pain down the left arm; Tenderness at the injection site; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The concomitant medications included cetirizine (ZYRTEC) for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 26Feb2021 at 15:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously received tetracycline (MANUFACTURER UNKNOWN), vancomycin (MANUFACTURER UNKNOWN) and cipro (MANUFACTURER UNKNOWN) for unknown indications on unknown dates and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 20Mar2021 at 03:45, the patient experienced strong shaking throughout the whole body and pain down the left arm for approximately 30 min at 03:55, the following day after the shot. Pain reduced in severity, but changed to the pain throughout the whole body. High fever (102F) throughout the day, medium grade pain especially on the left side of the body, medium grade headache. On the 2nd day pain and headache subsided but experienced Tenderness at the injection site, Nausea and extreme tiredness throughout the day. On third day most symptoms were gone and had slight tiredness. Therapeutic measures were taken for the events and shaking subsided after 2 (200mg/each) Ibuprofen pills. Pain reduced in severity, but changed to the pain throughout the whole body. Headache, body pain and fever was better controlled with Tylenol (500mg). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events shaking, pain down the left arm, high fever, headache, body pain, Tenderness at the injection site, Nausea and tiredness was recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to products with sulfa. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. On 02Mar2021 at 13:00, the patient experienced sore arm alone. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pain in arm was recovered on an unspecified date in Mar2021.  Information about lot number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Headache; Nausea; Feeling unwell; Fever; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot Number: Er8727) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto, depression and allergy to shellfish. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021, the patient experienced headache, nausea, feeling unwell and fever on that night but no fever at the time of the report. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department, or urgent care. The clinical outcome of the events headache, nausea and feeling unwell was resolving while the outcome of fever was resolved on an unknown day in Mar2021.   No follow-up attempts are needed. No further information is expected.