chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Dizziness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Knee and foot pain; Knee and foot pain; Noticeable stiffness; Loss of balance; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 19Mar2021 at 10:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, Chronic Obstructive Pulmonary Disease (COPD) and prostate cancer. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), febuxostat (ULORIC), montelukast (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 26Feb2021 at 10:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 01Jun2021, the patient experienced knee and foot pain, noticeable stiffness, loss of balance and dizziness. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events knee and foot pain, noticeable stiffness, loss of balance and dizziness were not resolved at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune flare ups including hives and nerve and joint issues. Concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 21Mar2021 at 12:00, 36 hours after the second shot, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included unspecified treatment (two doctor visits-medications). The clinical outcome of the event shingles was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Titinitis in both ears. Worse in left ear.; 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; Lot Number: EN6205) via an unspecified route of administration in the left arm on 28Feb2021 at 15:30 (at the age of 60-year-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 13:30, the patient experienced Titinitis in both ears, worse in left ear.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event titinitis in both ears, worse in left ear was not resolved at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Dizzy; Weakness; Arm was still sore; Chills; Muscle aches; Headache; No rash but Itchy from head to toe; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 16Jul2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, meniere's disease, TMJ syndrome and fibro. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine sodium (CYTOMEL), potassium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), cyanocobalamin (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) all from an unknown date for an unspecified indication. The patient previously took prednisone (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 16Jul2021 at 10:45, the patient experienced day 3 arm was still sore, chills, muscle aches, weakness, headache, dizzy, no rash but itchy from head to toe. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events day 3 arm was still sore, chills, muscle aches, weakness, headache, dizzy, no rash but itchy from head to toe was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Dizzy; Weakness; Arm was still sore; Chills; Muscle aches; Headache; No rash but Itchy from head to toe; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 16Jul2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, meniere's disease, TMJ syndrome and fibro. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine sodium (CYTOMEL), potassium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), cyanocobalamin (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) all from an unknown date for an unspecified indication. The patient previously took prednisone (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 16Jul2021 at 10:45, the patient experienced day 3 arm was still sore, chills, muscle aches, weakness, headache, dizzy, no rash but itchy from head to toe. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events day 3 arm was still sore, chills, muscle aches, weakness, headache, dizzy, no rash but itchy from head to toe was not recovered.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Muscle twitching
Clinical narrative: Left arm started twitching today at the injection site; Left calf started to spasm regularly and started to have periodic muscle cramping in the left foot; Left calf started to spasm regularly and started to have periodic muscle cramping in the left foot; Periodic headaches; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Jan2021 at 09:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously took acetylsalicylic acid (ASPIRINE) on unknown date for an unspecified indication and experienced drug allergy. On an unknown date in May2021, about 4 months after the 2nd dose the patient experienced left calf started to spasm regularly and he started to have periodic muscle cramping in the left foot along with periodic headaches. On an unknown date in Jul2021, now 2 months later, his left arm started twitching today at the injection site. The events resulted in emergency room/department visit or urgent care. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left calf started to spasm regularly and he started to have periodic muscle cramping in the left foot along with periodic headaches, started twitching today at the injection site were not resolved at the time of reporting.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Nausea, Pain
Clinical narrative: 101.5 fever for 3 days; nausea; debilitating aches and pains over entire body; excessive sweating and chills; excessive sweating and chills; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 15Jul2021 at 17:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and fenofibrate (MANUFACTURER UNKNOWN); both for unspecified indication from unknown dates, unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Jul2021 at 09:00, the patient experienced 101.5 fever for 3 days, nausea, debilitating aches and pains over entire body, excessive sweating and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 101.5 fever was recovered on 18Jul2021, which lasted for 3 days. The clinical outcome of the events nausea, debilitating aches and pains over entire body, excessive sweating and chills was recovering at the time of the report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101.5 fever for 3 days; nausea; debilitating aches and pains over entire body; excessive sweating and chills; excessive sweating and chills; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 15Jul2021 at 17:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and fenofibrate (MANUFACTURER UNKNOWN); both for unspecified indication from unknown dates, unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Jul2021 at 09:00, the patient experienced 101.5 fever for 3 days, nausea, debilitating aches and pains over entire body, excessive sweating and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 101.5 fever was recovered on 18Jul2021, which lasted for 3 days. The clinical outcome of the events nausea, debilitating aches and pains over entire body, excessive sweating and chills was recovering at the time of the report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild to bad head aches almost every day since getting the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the left arm on 19May2021 at 18:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: Ew0167) in the left arm on 28Apr2021 at 18:00 (at the age of 39-years-old) as a single dose for COVID-19 Vaccination. On 24May2021 at 12:00 the patient experienced mild to bad headaches almost every day since getting the vaccine. No therapeutic measures were taken as a result of reported events. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild to bad headaches almost every day since getting the vaccine was not recovered at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peroneal nerve palsy
Clinical narrative: Numbness and tingling in right foot and lower right leg.; Tingling in right foot and lower right leg.; Drop foot on right leg.; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 07May2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 16Apr2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021 at 08:00, the patient experienced numbness and tingling in right foot and lower right leg and drop foot on right leg. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in right foot and lower right leg and drop foot on right leg was recovering at the time of this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Ageusia, Anosmia, Cough, Fatigue
Clinical narrative: been sick everyday then; arm soreness; fatigue; fever; coughing; lost her sense of smell and taste; lost her sense of smell and taste; stomach upset; This is a spontaneous report from a contactable consumer. This consumer reported for her 17-year-old patient (daughter) received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: EW0171, expiry date not reported)(at the age of 17 year) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, solution for injection), for covid-19 immunization. The patient was sick everyday then and the side effects are other than the arm soreness, fatigue, the fever, she is coughing now and she has lost her sense of smell and taste and I don't see any side effect on the left side. Reporter stated, "She also has stomach upset." Exact date for the side effects: Reporter stated," On Jul 13 it started, the day of the shot". The outcome of the events was reported as unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Vaccination site pain
Clinical narrative: been sick everyday then; arm soreness; fatigue; fever; coughing; lost her sense of smell and taste; lost her sense of smell and taste; stomach upset; This is a spontaneous report from a contactable consumer. This consumer reported for her 17-year-old patient (daughter) received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: EW0171, expiry date not reported)(at the age of 17 year) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, solution for injection), for covid-19 immunization. The patient was sick everyday then and the side effects are other than the arm soreness, fatigue, the fever, she is coughing now and she has lost her sense of smell and taste and I don't see any side effect on the left side. Reporter stated, "She also has stomach upset." Exact date for the side effects: Reporter stated," On Jul 13 it started, the day of the shot". The outcome of the events was reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pyrexia
Clinical narrative: low grade fever; feels shaky right now; This is a spontaneous report from a from a non-contactable consumer (parent) received from Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low grade fever and feels shaky right now. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the pain in her arm worsened; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in the right arm on 21Apr2021 (at the age of 41 years old) as dose 2, single for COVID-19 immunisation. Medical history included known allergies: cillin based medicine. She was not pregnant at the time of  report. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and other medications within two weeks of vaccination. The patient previously received first dose of BNT162B2, administered in the right arm, on 21Apr2021, at 16:30 (as reported; being clarified) (at the age of 41 years old) for COVID-19 immunisation. The patient reported that her arm was sore after shot 1. The pain subsided and then came back. After shot 2, the pain in her arm worsened on 19May2021, at 16:45. She stated it hurt to move and lift. She said she needed help and she can't afford a doctor (Dr.). The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the event. The patient has not recovered from the event at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021908424 same patient, drug, and event; different dose
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache; Nauseous; He threw up; This is a spontaneous report from a contactable consumer (parent). A 12-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8731) via an unspecified route of administration in left arm on 17Jul2021 at 12:00 (at the age of 12-year-old) as single dose for COVID-19 immunization. Patient had no medical history and was very healthy. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration as single dose for COVID-19 immunization and nothing happened [no adverse event]. On 17Jul2021, after second dose of vaccination when patient got home, he experienced headache and then he was nauseous and then once he threw up. Corrective treatment included Tylenol. Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Pressure in chest when laying down; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 08Jun2021 at 15:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 19May2021 at 08:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously received azithromycin (MANUFACTURER UNKNOWN) on unknown date for an unknown indication and experienced drug allergy. On 15Jun2021, the patient experienced pressure in chest when laying down. This occurred a week after the second dose of vaccine and lasted for a week. Three weeks after the second dose, the patient had pressure in his chest when taking a deep breath. This pressure was just to the right of his sternum. This lasted for about 10 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pressure in chest when laying down was resolving at the time of this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Faeces soft, Limb discomfort, Myalgia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: soft stool; felt the heaviness in my arm; the injection site is red warm there's mild swelling; the injection site is red warm there's mild swelling; the injection site is red warm there's mild swelling; it's firm and hard to the touch as pain in the muscle of my arm and it's tender; This is a spontaneous report from a contactable consumer (reported for herself). A 47-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 16Jul2021 (at the age of 47-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that after directly after receiving the vaccine the patient felt the heaviness in her arm, she also felt the needle was still in her arm even though it was not. it's been over 24 hours and the injection site were red warm there's mild swelling it's firm and hard to the touch as pain in the muscle of her arm and it was tender and it would hurt to move her arm a little bit as well. She also had a soft stool, and she don't know if that's related to the injection or not. The outcome of all the events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: soft stool; felt the heaviness in my arm; the injection site is red warm there's mild swelling; the injection site is red warm there's mild swelling; the injection site is red warm there's mild swelling; it's firm and hard to the touch as pain in the muscle of my arm and it's tender; This is a spontaneous report from a contactable consumer (reported for herself). A 47-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 16Jul2021 (at the age of 47-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that after directly after receiving the vaccine the patient felt the heaviness in her arm, she also felt the needle was still in her arm even though it was not. it's been over 24 hours and the injection site were red warm there's mild swelling it's firm and hard to the touch as pain in the muscle of her arm and it was tender and it would hurt to move her arm a little bit as well. She also had a soft stool, and she don't know if that's related to the injection or not. The outcome of all the events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in her head and it was like somebody answer the phone; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613) via an unspecified route of administration in Arm Right on 18Mar2021 (at the age of 80 years old) as single for COVID-19 immunisation. The patient medical history was not reported as no. The patient's received no concomitant medications. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205; Expiration Date: Jun2021) via an unspecified route of administration in Arm Right on 24Feb2021 (at the age of 80 years old) as single for COVID-19 immunisation. The patient experienced ringing in her head and it was like somebody answer the phone on 19Mar2021. Reporter stated, the first dose was nothing, no sore arm or nothing. she confirms the ringing in her head occurred after the second dose. She confirms it was very slight and then it went away by noon of 20Mar2021. Outcome of the event was recovered on 20Mar2021.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Pharyngeal swelling, Pruritus, Skin exfoliation
Clinical narrative: Puffy eyes; Throat swelling; Scaly skin; Itchy skin; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 12Jul2021 at 09:00(at the age of 46-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On an unknown date in Jul2021, the patient experienced puffy eyes, throat swelling, scaly skin and itchy skin. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event puffy eyes, throat swelling, scaly skin and itchy skin was recovered with sequelae on an unknown date in Jul2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Cluster of hives on inner right thigh; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EY0854) via an unspecified route of administration in the right arm on 15Jul2021 at 15:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to pollen. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT), sambucus nigra (ELDERBERRY) and kids multivit; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0185) via an unspecified route of administration in the right arm on 17Jun2021 at 15:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jul2021 at 17:30, the patient experienced cluster of hives on inner right thigh. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure was taken as a result of the event and included treatment with XYZAL 5mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cluster of hives on inner right thigh was resolving at the time of this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Dysstasia
Clinical narrative: Extreme arthritis flare up and all major joints especially in the arms, hands, wrists, shoulders and hips are really inflamed; needed help to stand up and get out of my chair; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0164), via an unspecified route of administration in the right arm, on 16Apr2021 at 03:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, ankylosing spondylitis, hereditary nephritis, penicillin allergy, and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included pantoprazole (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), adalimumab (HUMIRA), and ibuprofen (MANUFACTURER UNKNOWN). The patient previously took tetracycline hydrochloride (MANUFACTURER UNKNOWN) and experienced allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8733) on 26Mar2021 at 02:00 (at the age of 61-years-old) in the left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme arthritis flare up and all major joints especially in the arms, hands, wrists, shoulders and hips are really inflamed and needed help to stand up and get out of my chair on 17Apr2021 at 04:00.  Therapeutic measures were taken as a result of the events, which included unspecified steroids. The clinical outcome of extreme arthritis flare up and all major joints especially in the arms, hands, wrists, shoulders and hips are really inflamed and needed help to stand up and get out of my chair was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Infection, Rhinorrhoea, Sneezing
Clinical narrative: he blows his nose it does "smell pretty bad, like an infection"; sneezing and has a runny nose; sneezing and has a runny nose; if it was really diarrhea or just early morning coffee or something; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 17Jul2021 at 15:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history of the patient were not reported. Patient was not taking any other products/concomitant. Patient did not receive any prior Vaccination (within four weeks). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL10196, it what's that appears to be as per reporter, EW10196 [not clarified]) via an unspecified route of administration on 26Jun2021 (at the age of 60-year-old) at around 12-13:00 as single dose for COVID-19 immunization. Reportedly, after receiving second dose of vaccination, on an unspecified date in 2021, patient experienced sneezing and has a runny nose and when he blows his nose it does "smell pretty bad, like an infection" [as per reporter may be there was some type of sinus infection]. Patient was sitting on the toilet and did not knew if it was really diarrhea or just early morning coffee or something. Patient wondered if it was something common with the second shot or not. Patient took off from work today (report day) and was looking for compensation. Patient asked if he has to take Tylenol on work, how does that work, will patient be compensated for that, if that's related." Patient did not receive any treatment in response to the event. Outcome of the events were not resolved [consumer stated events to be persisting and that was really worse].  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Worst body aches ever; brain felt like was in a bubble, a complete fog; Fever; lack of energy; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0202) via an unspecified route of administration in the left arm on 06Jul2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received cefalexin (KEFLEX) taken for unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0176) via an unspecified route of administration in the left arm on 25May2021 at 16:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021 at 01:00, the patient experienced worst body aches ever, brain felt like the patient was in a bubble, a complete fog, never experienced anything like it before in her 51 years. The patient had fever, lack of energy and reported that it was horrible, and lasted for days. The patient hoped that she or no one else had to go through these side effects, never again she will put herself through that. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events worst body aches ever, brain felt like was in a bubble, a complete fog, fever and lack of energy were recovered on an unknown date in Jul2021.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: legs started to swell and she still has swelling around her ankles; legs started to swell and she still has swelling around her ankles; This is a spontaneous report from a contactable consumer (sister) from a sponsored program. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced legs started to swell and she still has swelling around her ankles on an unspecified date two weeks after vaccination. The consumer questioned if it could be lymphedema and the patient never had any type of swelling before. The clinical outcome of legs started to swell and she still has swelling around her ankles was not recovered.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Started getting a head ache that hasn't completely gone away; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8734) via an unspecified route of administration on 04Apr2021 (at the age of 44-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0170) via an unspecified route of administration on 26Apr2021 at 09:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. On 14Apr2021, two after his first vaccine the patient started getting a headache that had not completely gone away. Patient reported that it had got worse after only half a beer, which was never the case. On 04Jun2021, the patient underwent SARS-COV-2 test and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event headache was not recovered at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Swelling, Vaccination site pain, Vaccination site warmth
Clinical narrative: Heat from injection spot; Swollen painful armpit lump; Painful armpit lump; Tiredness; Pain and heat from injection spot.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0193) via an unspecified route of administration on 09Jul2021 in the left arm (at an age of 31-year-old) as single dose for COVID-19 immunisation. Medical history included milk protein allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. On an unknown date in Jul2021, the patient experienced tiredness, pain and heat from injection spot and swollen painful armpit lump. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events tiredness, pain and heat from injection spot, Swollen painful armpit lump were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Pain in extremity, Tinnitus
Clinical narrative: Muscle contractions/tightness right side of neck up thru jaw and ear; also made tinnitus much worse; muscle contractions/tightness right side of neck up thru jaw and ear; also made tinnitus much worse; Muscle cramping/soreness in right forearm within 1 minute of injection; lasted 4-5 days.; muscle cramping/soreness in right forearm within 1 minute of injection; lasted 4-5 days.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the right arm on 28Jun2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to MSG (food allergy). The patient was allergic to iron pills sometimes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28June2021 at 13:00, the patient experienced muscle cramping and soreness in right forearm within 1 minute of injection and it was lasted for 4-5 days. On 28June2021 at 13:20, starting within 20 minutes of injection when she was driving home, the patient experienced muscle contractions/tightness on right side of neck up through jaw and ear; also made tinnitus much worse. It had been 3 weeks at the time of report and issues were still there and it also impacted her hearing which was not good. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No therapeutic measures were taken as a result of reported the event(s).  The clinical outcome of the events muscle cramping and soreness in right forearm were recovered in Jul2021. The clinical outcome of the events muscle contractions and tightness right side of neck up thru jaw and ear, and tinnitus were not recovered, at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 2nd dose: had a headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced headache. The patient reported that after getting the second dose she had a headache. The patient also wanted to know the expiration date for the COVID vaccine she got. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder
Clinical narrative: stomach bug; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer reported a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the vaccine, the patient got sick with a "stomach bug". The outcome of the reported event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: history of chronic back pain/ after getting the vaccine, the patient can now do things she couldn't do before; This is a spontaneous report from a non-contactable consumer (patient) received via a Pfizer-sponsored program. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date in Apr2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included chronic back pain for over 30 years. The patient's concomitant medications were not reported. The patient has never taken a flu vaccine. The patient reported that after getting the vaccine on an unspecified date in Apr2021, she can now do things she couldn't do before: clean house, vacuum, sit in a chair without a pillow, work for hours in her yard, sit in the chair for a longer period of time. She's like a new person. Nothing else she has tried for her pain in the past has worked. The patient also reported that she had no "side effects" from the vaccine. The outcome of event was unknown. The patient has received the first dose of the vaccine on an unspecified date in Apr2021 (reported as a holiday) and the second dose three weeks later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.