chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on 15Apr2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included diverticulosis. The patient had known allergies to surgical adhesives. The patient received unknown concomitant medication within two weeks of vaccination. 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 previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER6955) via an unspecified route of administration on 22Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021 the patient experienced tinnitus. 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 reported event. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures, which included COVID-19 virus test (nasal swab) on 20Jul2021 and tested negative. The clinical outcome of the event tinnitus was not recovered at the time of this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 58-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 21Jul2021 at 13:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. The patient did not have any allergies to food, medications, or other products. Concomitant medications included multi-vitamin for an unknown indication on an unknown date and unknown if ongoing. 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 30Jun2021 at 13:00 (at the age of 58-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 22Jul2021 at 04:00, the patient experienced rapid heartbeat. The patient's heart speeds up and then it goes back to normal and then it speeds up and goes back to normal. When it speeds up it's a much stronger heartbeat then when it the normal heartbeat. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rapid heartbeat was not recovered at the time of reporting.   The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Dry throat, Headache, Illness, Nausea
Clinical narrative: She was sick; Nausea; Vomiting; Headache; Dry face; Dry throat; This is a spontaneous report from a contactable consumer. A female patient of 55-year-old age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Jun2021 as single dose for COVID-19 immunization. The patient had no medical history and concomitant medications reported. After couple of days patient experienced sick with nausea, vomiting, headache, dry face, and a dry throat. The patient was concerned about receiving the second dose. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: She was sick; Nausea; Vomiting; Headache; Dry face; Dry throat; This is a spontaneous report from a contactable consumer. A female patient of 55-year-old age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Jun2021 as single dose for COVID-19 immunization. The patient had no medical history and concomitant medications reported. After couple of days patient experienced sick with nausea, vomiting, headache, dry face, and a dry throat. The patient was concerned about receiving the second dose. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Omental infarction
Clinical narrative: Omental infarction; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the patient received second dose of the COVID-19 vaccine from Pfizer and developed omental infarction. The reporter stated that there were only 50 cases reported in the literature from 1896-2012, but there was a recent related case in the UK and hospital paediatricians mentioned that they had two other recent cases, it seems to her that this information should be considered. The patient was mistakenly diagnosed with appendicitis with clarification. Outcome of the event was unknown.  Information about the Lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscle soreness at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 21Jul2021at 11:30 as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medication included supplements (unspecified). The patient's history of known allergies was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Jul2021, the patient had muscle soreness at injection site. Therapeutic measures were not taken as a result of the event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle soreness at injection site was recovering at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Arm pain,; Armpit pain; This is a spontaneous report from a non-contactable consumer. An unspecified aged non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Jul2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 22Jul2021, the patient experienced arm pain and armpit pain after administration. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of event arm pain and armpit pain was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: arm soreness at injection site for 3 days; felt tired since getting the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female 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 16Jul2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Patient had no known allergies. 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 COVID-19 vaccine. Concomitant medications included herbal tea (MANUFACTURER UNKNOWN), hydration and beauty drops (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. On 17Jul2021, the patient experienced arm soreness at injection site for 3 days, felt tired since getting the vaccine. 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 event arm soreness at injection site for 3 days was recovered on 20Jul2021. Whereas, that of felt tired since getting the vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Heart rate increased, Pyrexia
Clinical narrative: Really bad headache high fever and really bad stomache pain. And fast heart rate; Really bad headache high fever and really bad stomache pain. And fast heart rate; Really bad headache high fever and really bad stomache pain. And fast heart rate; Really bad headache high fever and really bad stomache pain. And fast heart rate; This is a spontaneous report from a contactable consumer, the patient. A 13-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 on 21Jul2021 at 15:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had known allergies (unspecified). It was not reported if the patient received any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Jun2021 at 13:15 (at the age of 13-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 21Jul2021 at 20:00, the patient experienced really bad headache high fever and really bad stomache pain. And fast heart rate. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of really bad headache high fever and really bad stomache pain; and fast heart rate and included treatment with intravenous (Iv) fluids blood work and migraine medicine. The clinical outcome of the events really bad headache high fever and really bad stomache pain; and fast heart rate was resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Vision blurred, Vomiting
Clinical narrative: vomiting; lightheaded; Dizziness; pain; blurred vision; headache; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration on 22Jul2021 at 03:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On an unknown date in Jul2021 the patient experienced vomiting, lightheaded, dizziness, pain, blurred vision and headache. Therapeutic measures were taken as a result of the events which included first aid and vitals. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. 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 vomiting, lightheaded, dizziness, pain, blurred vision and headache were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Muscle contracture, Pain
Clinical narrative: I am having stomach spasms; going through spasms; Muscle contract across my stomach; Painful it is; This is a spontaneous report from a contactable consumer (patient). An unknown age and unspecified gender patient started to receive BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date were not reported) via on an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant were not reported. On an unspecified date the patient experienced, that the patient took about 2 hours ago your first shot and I am having stomach spasms; going through spasms, Muscle contract across my stomach and Painful it is. The clinical outcome of the events was unknown.  Information about lot/batch number has been requested
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia
Clinical narrative: Numbness in left leg for a few days; Within three weeks have been experiencing headaches or pressure in my head.; Within three weeks have been experiencing headaches or pressure in my head.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 01Jul2021 at 18:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jul2021, the patient experienced numbness in left leg for a few days. On an unknown date in Jul2021, within three weeks, the patient experienced headaches and pressure in head. 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 headaches, pressure in head and numbness in left leg for a few days was not recovered at the time of this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, SARS-CoV-2 test
Clinical narrative: I started having uncontrolled leg twitching. All over my legs. Sometimes its worse or better. I have been to my general doctor, spine doctor and Nuerologist and all have ruled out the big things; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously took acetylsalicylic acid (ASPIRIN) for unknown indication on unknown date and experienced drug allergy. It was not reported if patient took any concomitant medication taken within two weeks of vaccination. 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 06Jun2021, the patient started having uncontrolled leg twitching. All over her legs. Sometimes it was worse or better. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had been to her general doctor, spine doctor and Nuerologist and all had ruled out the big things like restless legs syndrome (RLS), electrolyte deficiencies and neurological problems. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 23Jun2021, the patient underwent COVID- 19 test via nasal swab and the result was negative. The clinical outcome of the event started having uncontrolled leg twitching, all over legs; sometimes it was worse or better was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body ache; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 57-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 20Jul2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included penn allergy (allergy nos). Concomitant medication 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 vaccination. 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 22Jun2021 at 17:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 21Jul2021, the patient experienced headache (6-12 hours after second injection). On 21Jul2021 at 17:00, the patient experienced body ache (24 hours after the injection). 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. The clinical outcome of the event body ache and headache was recovered on unknown date in Jul2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Headache, Pyrexia
Clinical narrative: continuous headache for 2 days; tiredness; slept a lot; Highest temp was 99.8; felt hot; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in left arm on 17Jul2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, hyperthyroidism, high blood pressure and gout. The patient had known allergies to scallops and tuna. The patient received unspecified medication within two weeks prior to the vaccination. The patient received other vaccines within four weeks prior to the vaccination which included varicella zoster vaccine (RZV as reported)(MANUFACTURER UNKNOWN) in the left arm on 11Jun2021 for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in left arm on 26Jun2021 at 12:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 18Jul2021, the patient experienced continuous headache for 2 days, tiredness, slept a lot, highest temperature was 99.8 and felt hot. 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. No therapeutic measures were taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was recovered on 20Jul2021 after a duration of 2 days. The clinical outcome of the events tiredness, slept a lot, highest temperature was 99.8 and felt hot was recovered on an unknown date in Jul2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: continuous headache for 2 days; tiredness; slept a lot; Highest temp was 99.8; felt hot; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in left arm on 17Jul2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, hyperthyroidism, high blood pressure and gout. The patient had known allergies to scallops and tuna. The patient received unspecified medication within two weeks prior to the vaccination. The patient received other vaccines within four weeks prior to the vaccination which included varicella zoster vaccine (RZV as reported)(MANUFACTURER UNKNOWN) in the left arm on 11Jun2021 for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in left arm on 26Jun2021 at 12:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 18Jul2021, the patient experienced continuous headache for 2 days, tiredness, slept a lot, highest temperature was 99.8 and felt hot. 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. No therapeutic measures were taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was recovered on 20Jul2021 after a duration of 2 days. The clinical outcome of the events tiredness, slept a lot, highest temperature was 99.8 and felt hot was recovered on an unknown date in Jul2021.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Pain in extremity, Serology test
Clinical narrative: Had a serology and had a level of 3.9 but her other family members tested above 20.; Her husband just told her that her arm hurt a little after getting it; This is a spontaneous report from a contactable consumer (wife reported for her husband). A male 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 1, single, and dose 2 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 medical history and concomitant medications were not reported. The caller stated she and her other family members does not have a history of Covid. Had a serology and had a level of 3.9 but her other family members tested above 20. She added that she knew that there are also people who are fully vaccinated and tested zero on their antibodies test. She stated that she got the double vaccine as well as the rest of her entire family. While reporting for herself, she stated that her husband just told her that his arm hurt a little after getting it. It was like a tetanus shot but nothing bad. The patient underwent lab tests and procedures which included serology test: tested above 20 (other family members tested above 20) on an unspecified date of 2021. The outcome of events was unknown. Information on Lot/Batch information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Serology test, Vaccination site pain
Clinical narrative: Had a serology and had a level of 3.9 but her other family members tested above 20.; pain in their arm; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was Reported that, Received call from consumer regarding the Pfizer COVID Vaccine. She got the double vaccine as well as the rest of her entire family.  While reporting for herself, she stated that the rest of her family got their vaccines at the same time as hers and had pain in their arm and she had no reactions whatsoever.Her husband just told her that her arm hurt a little after getting it.  It was like a tetanus shot but nothing bad. This report is to capture information on her husband's arm pain.She did not wish to complete a report on herself and did not wish to complete a report on her family.  She did not wish to provide a mailing address, email, date of birth or any further details.No further details provided. The outcome of the serology and had a level of 3.9 but her other family members tested above 20, pain in their arm on an unspecified date with outcome of unknown.The patient underwent lab tests and procedures which included serology test: 20 on serology test: 29 on.   Follow-up (22Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported information included.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone swelling, Chest discomfort, Inflammation, Pain
Clinical narrative: Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Heart palpitations; Pressure in my chest area; Swelling on my left side underneath my arm around the rib cage; This is a spontaneous report from a contactable consumer (Patient) reporting for herself.   A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation; solution for injection, Lot Number: not reported), via an unspecified route in left Arm on 01Jan2021, as dose 1, single for COVID-19 immunization. The patient medical history included Thyroid condition, High Blood Pressure and Fibromyalgia and concomitant medications included Levothyroxine, Amlodipine. It was reported that, on 03Jan2021, the patient experienced sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you could not touch it was painful and on an unspecified date in 2021, she had Heart palpitations, Pressure in her chest area and swelling on her left side underneath her arm around the rib cage. Other medication that she took for high blood pressure, thyroid medication, and Pain relief for Fibromyalgia, she does not have any, but she does not take anything else, but supplements and lab Test was not had any test. She just has not totally back to herself again but no she was not experiencing those problems, they lasted for 7 days. The patient did not receive any treatment, but she did go to her physician because she was worried. The outcome of event was recovering (Improving with some persistence) for all events.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Swelling
Clinical narrative: Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Heart palpitations; Pressure in my chest area; Swelling on my left side underneath my arm around the rib cage; This is a spontaneous report from a contactable consumer (Patient) reporting for herself.   A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation; solution for injection, Lot Number: not reported), via an unspecified route in left Arm on 01Jan2021, as dose 1, single for COVID-19 immunization. The patient medical history included Thyroid condition, High Blood Pressure and Fibromyalgia and concomitant medications included Levothyroxine, Amlodipine. It was reported that, on 03Jan2021, the patient experienced sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you could not touch it was painful and on an unspecified date in 2021, she had Heart palpitations, Pressure in her chest area and swelling on her left side underneath her arm around the rib cage. Other medication that she took for high blood pressure, thyroid medication, and Pain relief for Fibromyalgia, she does not have any, but she does not take anything else, but supplements and lab Test was not had any test. She just has not totally back to herself again but no she was not experiencing those problems, they lasted for 7 days. The patient did not receive any treatment, but she did go to her physician because she was worried. The outcome of event was recovering (Improving with some persistence) for all events.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Musculoskeletal stiffness, Nasopharyngitis
Clinical narrative: My thing was like if you feel cold, if you have a cold; My thing was like if you feel cold, if you have a cold; I feel my shoulder stiff or something; This is a spontaneous report from a contactable consumer or other non HCP (patient). This is the second case out of the 2 cases. A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation; solution for injection), dose 2 via an unspecified route of administration on 29Apr2021 (Batch/Lot Number: EW0169) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication was not reported. Historical vaccine included BNT162B2 first dose (Batch/Lot number; EW0162) for Covid-19 immunization. The patient stated "It was not like a serious. I din't have fever, nothing but just mine was okay, it was minor, I felt my shoulder stiff or something, maybe it was nothing to do with this". The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Nausea, Pain
Clinical narrative: all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; headache; so tried; unable to sleep; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 on unspecified date for COVID-19 immunisation. It was reported that received her 2nd dose yesterday (22Jul2021), patient experienced all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy on 23Jul2021. It was reported that from night patient had been aching and she was wondering if she can Tylenol or Ibuprofen. because she got headache and ache. Reporter stated that she went back in her room, she needs to write a number down. she woke up and so tried, unable to sleep. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy today.; headache; so tried; unable to sleep; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 on unspecified date for COVID-19 immunisation. It was reported that received her 2nd dose yesterday (22Jul2021), patient experienced all over aches, pain in the injection arm, pain in her other arm and nausea/ queasy on 23Jul2021. It was reported that from night patient had been aching and she was wondering if she can Tylenol or Ibuprofen. because she got headache and ache. Reporter stated that she went back in her room, she needs to write a number down. she woke up and so tried, unable to sleep. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: It's been, kind a like, somebody sitting on my chest.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. No medical history and concomitant medications were not reported. On an unspecified date, the patient reported it was been, kind a like, somebody sitting on my chest. The patient reported he had got the vaccine yesterday (Jul2021) and today (Jul2021), it was been, kind a like, somebody sitting on his chest. Patient said, he was just wondering, if he should just go back to where, he got the shot from. He enquired if this was a sign of some kind of a serious allergic reaction to it or was normal. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Vaccination site discolouration, Vaccination site rash
Clinical narrative: Developed a small spot, rash on my arm near the site of the injection; red rash size of a quarter on my arm where I got the injection; Developed a small spot, rash on my arm near the site of the injection; red rash size of a quarter on my arm where I got the injection; Developed a small spot, rash on my arm near the site of the injection; red rash size of a quarter on my arm where I got the injection; I have spots over different places in my entire upper torso, generally upper arms and my chest and my back, my stomach; This is a spontaneous report from a contactable consumer or other non hcp.    A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot Number: EN6204) via an unspecified route of administration, administered in Arm on 20Mar2021 as single dose for COVID-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number: was not reported) via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunisation.  On unknown date in Mar2021, The patient had developed a small spot, rash on my arm near the site of the injection; red rash size of a quarter on my arm where I got the injection. It was surely after getting his/her second shot, he/she did not know exactly when it was, precisely 3 days or four days or a week. It had actually continued to grow 'not in' the armpits, that spot is not growing very much but now he/she had spots over different places in his/her entire upper torso, generally upper arms and chest and back, stomach, not that much but he/she had gotten them, so it seems like it was growing. His/her clinic dermatologist could not schedule anything for 2 months. The seriousness of events was non-serious. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: Cough started the same day of vaccination, productive, 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Jul2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no 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 vaccination within four weeks prior to the vaccination.  On 11Jul2021, the patient had cough started the same day of vaccination, which was productive, 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cough started the same day of vaccination, productive, 2 weeks was not recovered at the time of this report.   The batch/lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Condition aggravated, Pain, Pain in extremity
Clinical narrative: injected in the wrong area; He says in the joint he can feel it in there; under his arm pit down kind of close to his rib cage.; Shoulder Injury Related to Vaccine Administration; inflammation in the shoulder joint; history of shoulder pain because of arthritis, but it wasn't bothering him until after he got the vaccine; bad shoulder and arm pain; bad shoulder and arm pain; This is a spontaneous report from a contactable consumer. This 69-year-old Male consumer (patient, reported for self). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0161, Expiration date: Unknown), via an unspecified route of administration, administered in Arm Left on 06Jul2021 as (At the age of 69-years) dose 1, single for COVID-19 immunisation. Medical history included arthritis (shoulder pain because of arthritis) from an unknown date and unknown if ongoing. There were no concomitant medications reported by the reporter (Other Products: No). It was reported that on 06Jul2021 around between 1:00PM to 1:30PM parient received the first dose. Reporter stated that it was after this vaccination, that the pain began a couple days after that he had bad shoulder and arm pain. He says this started a couple days after that and it has not gone away or gotten any better. Reporter stated his pain is in the shoulder and arms closer to his elbow, and under his arm pit down kind of close to his rib cage. He says in the joint he can feel it in there. It was reported that he has a history of shoulder pain because of arthritis, but it wasn't bothering him until after he got the vaccine. Upon Follow-up it was reported that reporter was 70 years old but noted that he was 69 when he got the Pfizer- BioNTech COVID-19 Vaccine. The reporter state that bad shoulder and arm pain has not gone away and not gotten better. His main concern was having Shoulder Injury Related to Vaccine Administration (SIRVA) an injury and inflammation in the shoulder joint due to the vaccine being injected in the wrong area. Reporter hung up before survey could be offered. No investigation assessment. Reporter stated he was currently taking medication for pain, Hydrocodone, which came in an orange pill bottle. He says the Hydrocodone dose is 7.5-325mg, and it comes from (Place name withheld) Home RX in (redacted). Hydrocodone LOT/EXP: Unknown, product dispensed in pharmacy bottle. Hydrocodone NDC: 65162-0115-11. He says he takes this once every 6 hours.  The outcome of event bad shoulder and arm pain had not recovered, outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: injected in the wrong area; He says in the joint he can feel it in there; under his arm pit down kind of close to his rib cage.; Shoulder Injury Related to Vaccine Administration; inflammation in the shoulder joint; history of shoulder pain because of arthritis, but it wasn't bothering him until after he got the vaccine; bad shoulder and arm pain; bad shoulder and arm pain; This is a spontaneous report from a contactable consumer. This 69-year-old Male consumer (patient, reported for self). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0161, Expiration date: Unknown), via an unspecified route of administration, administered in Arm Left on 06Jul2021 as (At the age of 69-years) dose 1, single for COVID-19 immunisation. Medical history included arthritis (shoulder pain because of arthritis) from an unknown date and unknown if ongoing. There were no concomitant medications reported by the reporter (Other Products: No). It was reported that on 06Jul2021 around between 1:00PM to 1:30PM parient received the first dose. Reporter stated that it was after this vaccination, that the pain began a couple days after that he had bad shoulder and arm pain. He says this started a couple days after that and it has not gone away or gotten any better. Reporter stated his pain is in the shoulder and arms closer to his elbow, and under his arm pit down kind of close to his rib cage. He says in the joint he can feel it in there. It was reported that he has a history of shoulder pain because of arthritis, but it wasn't bothering him until after he got the vaccine. Upon Follow-up it was reported that reporter was 70 years old but noted that he was 69 when he got the Pfizer- BioNTech COVID-19 Vaccine. The reporter state that bad shoulder and arm pain has not gone away and not gotten better. His main concern was having Shoulder Injury Related to Vaccine Administration (SIRVA) an injury and inflammation in the shoulder joint due to the vaccine being injected in the wrong area. Reporter hung up before survey could be offered. No investigation assessment. Reporter stated he was currently taking medication for pain, Hydrocodone, which came in an orange pill bottle. He says the Hydrocodone dose is 7.5-325mg, and it comes from (Place name withheld) Home RX in (redacted). Hydrocodone LOT/EXP: Unknown, product dispensed in pharmacy bottle. Hydrocodone NDC: 65162-0115-11. He says he takes this once every 6 hours.  The outcome of event bad shoulder and arm pain had not recovered, outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: Unknown), via unspecified route of administration, on an unknown date, as dose 1, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced fatigue after first dose for three weeks. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms, Neuralgia
Clinical narrative: They diagnosed that it was a spasm; severe back and nerve pain; severe back and nerve pain; This is a spontaneous report from a contactable consumer. A 45-year-old male received BNT162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination was 45 years) as single dose for COVID-19 immunisation. The patient's medical history included bipolar 1 on an unspecified date. The patient's concomitant medications were not reported. The reporter was calling for her son. On 20Jul2021, the patient was in the ER (emergency room) two days ago with severe back and nerve pain and she clarified as lower back nerve pain. They diagnosed that it was a spasm and gave him a muscle relaxer and a few pain meds. the patient got the second Pfizer vaccine just a couple of weeks ago. The patient's body metabolizes things differently because he has bipolar 1. The outcome of the events back pain and neuralgia were recovering, muscle spasms was unknown.