chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy rash at injection site on arm approximately 4 inches around.; Red rash at injection site on arm approximately 4 inches around; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included an allergy to mango skin/syrup, poison oak and poison ivy. The patient was prone to contact dermatitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date  and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 15Apr2021 at 20:00, the patient experienced an itchy and red rash at injection site on arm approximately 4 inches around. 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 itchy and red rash at injection site on arm approximately 4 inches around were resolved with lasting effects on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasal congestion, Nasal dryness, Pain
Clinical narrative: Vertigo; very dry nasal; Stuffy nasal congestion; Severe chills; Body aches particularly in upper back and neck; Fatigue; Fever; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 13Apr2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Other medical history included aneurysm of ascending aorta and depression. The patient had no known allergies. 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: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 11:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient received unspecified other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 02:30, the patient experienced severe chills, body aches particularly in upper back and neck, fatigue and fever. On 15Apr2021, the patient experienced very dry, stuffy nasal congestion. On 16Apr2021, after woke up, the patient experienced vertigo. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported event(s) which included treatment with unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of severe chills, body aches particularly in upper back and neck, fatigue and fever was recovered on an unknown date in Apr2021 (lasted for 24 hours), while the outcome of the events of  very dry nasal, stuffy nasal congestion and vertigo was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Vertigo; very dry nasal; Stuffy nasal congestion; Severe chills; Body aches particularly in upper back and neck; Fatigue; Fever; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 13Apr2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Other medical history included aneurysm of ascending aorta and depression. The patient had no known allergies. 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: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 11:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient received unspecified other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 02:30, the patient experienced severe chills, body aches particularly in upper back and neck, fatigue and fever. On 15Apr2021, the patient experienced very dry, stuffy nasal congestion. On 16Apr2021, after woke up, the patient experienced vertigo. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported event(s) which included treatment with unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of severe chills, body aches particularly in upper back and neck, fatigue and fever was recovered on an unknown date in Apr2021 (lasted for 24 hours), while the outcome of the events of  very dry nasal, stuffy nasal congestion and vertigo was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dermatitis atopic, Eczema, Erythema
Clinical narrative: atopic dermatitis on the face, neck, and hands which became moderate to severe; red patches; bruised-around my face and neck; flared up eczema; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 13Apr2021 at 17:45 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, type 2 diabetes mellitus, urticaria, atopic dermatitis and asthma. 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. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), vitamin b12 nos (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN) all from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 23Mar2021 at 18:15 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 12:00, the patient had reported an underlying condition of atopic dermatitis on the face, neck, and hands which became moderate to severe in the morning after the second dose of vaccination. The patient had red patches that almost look bruised around the face and neck which were extremely dry, tight, and flaky, and dried up after minutes of applying thick lotion/cream. It flared up eczema and the patient had not experienced this severe reaction in over one year. There was with no changes in any products used or the diet of the patient. Therapeutic measures included treatment with unknown lotion/cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events atopic dermatitis on the face, neck and hands which became moderate to severe, red patches almost look bruised and flared up eczema was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 64, via an unspecified route of administration, right arm, on Apr 12, 2021, at 04:15, single dose, for COVID-19 immunisation. The patient did not have any reported medical history. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Nexium (esomeprazole magnesium) from an unknown date for unspecified indication. The patient previously received the first dose (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, right arm, on Mar 22, 2021, at 00:15, single dose, for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On Apr 13, 2021, at 13:30, patient experienced headache, fever, chills and nausea. Since the vaccination, patient has not tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures taken as a result of the reported events. The clinical outcome of events headache, fever, chills and nausea resolved on an unknown date in Apr 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Pain, Vaccination site warmth
Clinical narrative: Warm at injection site; Headache; Body aches; Fatigue; The patient received second dose vaccination on 13Apr2021 (within 15 days); This is a spontaneous report from a contactable consumer, the patient. A 46-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 13Apr2021 at 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. 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. Concomitant medications included aciclovir (ACYCLOVIR), emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 15:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 16:00, the patient experienced warm at injection site, headache, body aches and fatigue. 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. The clinical outcome of the events warm at injection site, headache, body aches and fatigue was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Uterine spasm
Clinical narrative: Shooting pains in right breast (opposite from the arm where the injection was received).; Uterine cramping; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included a known allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control medications (MANUFACTURER UNKNOWN) from an unknown date for birth control and an unknown if ongoing. The patient previously received ampicillin (MANUFACTURER UNKNOWN) and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 11:45, the patient reported that during the 30 minutes waiting time, she experienced uterine cramping. On 08Apr2021, the next morning after the patient received the vaccine, she experienced shooting pain in the right breast (opposite from the arm where the patient received the injection). 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 event shooting pain in the right breast (opposite from the arm where the patient received the injection) was resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 27-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0126), at the age of 27, via an unspecified route of administration, left arm, on Apr 15, 2021, at 09:00, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included Descovy (emtricitabine-tenofovir alafenamide fumarate) from an unknown date for unknown indication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, unknown site, on an unknown date, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 15, 2021, at 18:15, patient experienced chills, aches and fatigue. No therapeutic measures taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergency visit. Since the vaccination, patient has not tested for COVID-19. The outcome of chills, aches and fatigue: recovering (at the time of report). No follow-up attempts possible. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: 99.8 F Fever; Chills; Nausea; Headache; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 26-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. 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. On an unknown date in 2021, the patient experienced 99.8-degree Fahrenheit fever, chills, nausea, headache and pain at injection site. . On an unknown date in 2021, the patient underwent lab tests and procedures, which included test for body temperature and the result was 99.8 degrees Fahrenheit. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events 99.8-degree Fahrenheit fever, chills, nausea, headache and pain at injection site were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 99.8 F Fever; Chills; Nausea; Headache; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 26-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. 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. On an unknown date in 2021, the patient experienced 99.8-degree Fahrenheit fever, chills, nausea, headache and pain at injection site. . On an unknown date in 2021, the patient underwent lab tests and procedures, which included test for body temperature and the result was 99.8 degrees Fahrenheit. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events 99.8-degree Fahrenheit fever, chills, nausea, headache and pain at injection site were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscular weakness, Myalgia
Clinical narrative: Fatigue; Muscle weakness; Muscle soreness; Painful injection site; Swelling at injection site; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and 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-19 vaccination. On an unknown date, the patient experienced fatigue, muscle weakness and soreness, painful swelling at injection site, chills and headache. The events did not result in a visit to the 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 been tested for COVID-19. On 13Apr2021, the patient underwent a PCR (polymerase chain reaction) (nasal swab) test and tested negative. The clinical outcome of the events fatigue. muscle weakness and soreness, painful swelling at injection site, chills, headache was resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fatigue; Muscle weakness; Muscle soreness; Painful injection site; Swelling at injection site; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and 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-19 vaccination. On an unknown date, the patient experienced fatigue, muscle weakness and soreness, painful swelling at injection site, chills and headache. The events did not result in a visit to the 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 been tested for COVID-19. On 13Apr2021, the patient underwent a PCR (polymerase chain reaction) (nasal swab) test and tested negative. The clinical outcome of the events fatigue. muscle weakness and soreness, painful swelling at injection site, chills, headache was resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Migraine, Palpitations
Clinical narrative: shiver like freezing cold was under 3 blankets and could not warm up.; pains at the lymph glands at underarms and necks.; Severe Migraine; heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E46162) via an unspecified route of administration in the left arm on 15Apr2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included azithromycin (AZITHROMYCIN PACK); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) 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: EP6455) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 56-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 15Apr2021, the patient did shiver from 22:00 like freezing cold and was under 3 blankets and could not warm up. The patient had pains at the lymph glands at underarms and necks and severe migraine and heart palpitations. 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 event pains at the lymph glands at underarms and necks, severe migraine and heart palpitations were not recovered at the time of this report while the event shiver like freezing cold was under 3 blankets and could not warm up was recovered on 16Apr2021 at 04:00.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Menstrual bleeding in post menopausal woman. For about 1 week after injection and then restarted 17 days after injection.  Restart is heavier than initial. Today is 1st day of restart; This is a spontaneous report from a contactable consumer (patient).   A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 8730), via an unspecified route of administration, administered in Left arm on 29Mar2021 18:30 at the age of 56-years-old as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Facility type vaccine was pharmacy or drug store. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 31Mar2021, the patient experienced Menstrual bleeding in post-menopausal woman. For about 1 week after injection and then restarted 17 days after injection. Restart is heavier than initial. Today is 1st day of restart. No treatment was received for adverse event. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain, Parosmia
Clinical narrative: aches; mild headache; low grade fever; Chills; muscular soreness near shot site; Phantom aromas; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 16Apr2021 at 13:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included catamenial epilepsy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); both started on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 24Mar2021 at 13:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received phenobarbital (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 16Apr2021, the patient experienced muscular soreness near shot site and 6-10 hours later experienced phantom aromas later, on 17Apr2021, 18 hours after vaccination, the patient experienced mild headache and after 24 hours experienced low grade fever, chills and aches. The patient did not receive any treatment for the events. 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. The clinical outcome of the event muscular soreness near shot site, phantom aromas, mild headache, low grade fever, chills and aches were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: aches; mild headache; low grade fever; Chills; muscular soreness near shot site; Phantom aromas; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 16Apr2021 at 13:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included catamenial epilepsy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); both started on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 24Mar2021 at 13:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received phenobarbital (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 16Apr2021, the patient experienced muscular soreness near shot site and 6-10 hours later experienced phantom aromas later, on 17Apr2021, 18 hours after vaccination, the patient experienced mild headache and after 24 hours experienced low grade fever, chills and aches. The patient did not receive any treatment for the events. 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. The clinical outcome of the event muscular soreness near shot site, phantom aromas, mild headache, low grade fever, chills and aches were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rash, Tenderness, Urticaria
Clinical narrative: Quarter size hives or rash above butt, center, near tail bone; Quarter size hives or rash above butt, center, near tail bone; Joint pain; Tenderness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor and it was stage 1 both breast and had double mastectomy in 2015. The patient's health checks on an unknown date with doctors and primary care were all good. The patient had no allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included anastrozole (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), 1 a day 50+ (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, after several hours of her vaccinations, the patient experienced joint pain and tenderness which went away by next day. On 16Apr2021 at 15:00, around 48 hours after second dose of vaccine, the patient experienced quarter size hives or rash above her butt, center and near tail bone. There were also small bumps not with puss. It did not itch unless she itches it. The patient applied coconut oil on it. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events quarter size hives or rash above butt, center and near tail bone was resolving. The clinical outcome of the events joint pain and tenderness was resolved on an unknown date Apr2021.  No follow-up attempts are required; No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: Approximately 2 inches from my injection site, I developed a blister.; This is a spontaneous report from a contactable nurse, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8725) via an unspecified route of administration in the right arm on 06Apr2021 at 16:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer, rheumatoid arthritis, COVID-19 and penicillin allergy. The patient previously received erythromycin (MANUFACTURER UNKNOWN), cephalosporins (MANUFACTURER UNKNOWN), for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received unspecified medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 07Apr2021 at 09:30 the patient experienced blister approximately 2 inches from her injection site. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event  blister approximately 2 inches from her injection site was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: After the first shot my right arm got numb and I got the shot in the left arm though; tingling in my fingers too; After the first shot my right arm got numb and I got the shot in the left arm though; tingling in my fingers too; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection)(at the age of 78-years-old), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 (Lot Number: EN6198) 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 Couple of hours after (On 02Mar2021) the first shot her right arm got numb and she got the shot in the left arm though. And tingling in her fingers too. It was a few hours after she got the first shot on 02Mar2021, that is the first dose. Patient received second dose of BNT162B2 (Lot Number: ER2613) on 24Mar2021 for COVID-19 Immunization. Regarding treatment for numbness and tingling Consumer stated, No, it went away after a several hours she guesses. she went to bed and by morning she was fine. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo and lightheaded ness starting 4 days after receiving vaccine; Vertigo and lightheaded ness starting 4 days after receiving vaccine; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included colon cancer, asthma and fibromyalgia. The patient had known allergies to azithromycin (ZITHROMAX). 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 14Apr2021, 4 days after vaccination, the patient experienced vertigo and light-headedness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or 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 vertigo and light-headedness was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Consistent dry cough that happened right after the 2nd shot; Sore arm; Fatigue; This is a spontaneous report from a contactable healthcare professional. the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew 0153) via an unspecified route of administration in the left arm on 13Apr2021 at 19:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and post-traumatic stress disorder (c-ptsd). The patient had no known allergies to medications, food or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT) and fexofenadine hydrochloride (ALLERFLEX) for unknown indications, from an unknown date and unknown if ongoing. Prior to the vaccination, the patient had not been 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: Ep 7534) via an unspecified route of administration in the left arm on 23Mar2021 at 20:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 20:00 right after the second shot patient experienced consistent dry cough. It is been three days now and it still had the cough, sore arm and fatigue had went away. 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 reported events. Since the vaccination, the patient had been tested for COVID-19, which included COVID-19 virus test (nasal swab) on an unknown date and tested negative. The clinical outcome of the events sore arm and fatigue was recovered, on an unknown date in Apr2021. The clinical outcome of the event consistent dry cough that happened right after the second shot was not recovered, at this time of report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red rash on both thumbs and wrist and some in between some fingers; Red rash on both thumbs and wrist and some in between some fingers; Itching in the palms of hand.; Itching at the rash site.; 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 an unknown date in 2021 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, blood pressure high (high b/p), spinal stenosis. The patient had known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on an unknown date in 2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced red rash on both thumbs and wrist. Some in between some fingers. Itching in the palms of hand and also itching at the rash site. Since the vaccination, the patient had not 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. Therapeutic measures were taken as a result of reported events which included treatment with triamcinolone acetonide cream 0.5% (MANUFACTURER UNKNOWN). The clinical outcomes of the events red rash on both thumbs and wrist. Some in between some fingers. Itching in the palms of hand. Also itching at the rash site were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Pain
Clinical narrative: Body aches; Super hot; Cold chills; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 29-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 14Apr2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 in the left arm on 24Mar2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced cold chills, body aches, super hot, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of cold chills, body aches, super hot, headache and fatigue was resolving 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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever (101.9 at highest); aches; chills; headache; extreme fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 43-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 16Apr2021 at 10:15 (age at vaccination:43-years) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 11:30 (age at vaccination:43-years)  as a single dose for COVID-19 immunisation. On 17Apr2021 the patient experienced Fever (101.9 at highest), aches, chills, headache, extreme fatigue. No therapeutic measures were taken as a result of event. On 17Apr2021 the patient checked his body temperature which was 101.9 degree Fahrenheit. 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 had been tested for COVID-19. The clinical outcome of the event Fever (101.9 at highest), aches, chills, headache, extreme fatigue were not resolved at the time of this report   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (101.9 at highest); aches; chills; headache; extreme fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 43-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 16Apr2021 at 10:15 (age at vaccination:43-years) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 11:30 (age at vaccination:43-years)  as a single dose for COVID-19 immunisation. On 17Apr2021 the patient experienced Fever (101.9 at highest), aches, chills, headache, extreme fatigue. No therapeutic measures were taken as a result of event. On 17Apr2021 the patient checked his body temperature which was 101.9 degree Fahrenheit. 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 had been tested for COVID-19. The clinical outcome of the event Fever (101.9 at highest), aches, chills, headache, extreme fatigue were not resolved at the time of this report   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip discolouration, Lip swelling, Musculoskeletal discomfort
Clinical narrative: Top lip discoloration; Top lip discoloration and swelling with a numbness; Top lip discoloration and swelling with a numbness; Discomfort on left side of neck; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 12:15 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD). The patient received unspecified medications within two weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 26Mar2021 at 11:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 14:45, the patient experienced top lip discoloration and swelling with a numbness and discomfort on left side of neck. 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 reported events. The clinical outcome of the events top lip discoloration and swelling with a numbness and discomfort on left side of neck was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral
Clinical narrative: mouth/tongue numbness; metallic taste; This is a spontaneous report from a contactable consumer (friend). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was 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 was not reported. On an unspecified date, the patient experienced mouth/tongue numbness, and metallic taste. The outcome of events was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.