chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives covering neck and torso; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 05Apr2021 at 12:45 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included second dose of varicella zoster vaccine (MANUFACTURER UNKNOWN) in the left arm for immunisation on 22Mar2021 and simvastatin (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), vitamin d nos (VITAMIN D), zinc (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C); all for unspecified indication from unknown date.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food and other products. On 11Apr2021 at 12:00, the patient developed hives covering neck and torso five days following COVID vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event, which included treatment with prednisone. The clinical outcome of the event developed hives covering neck and torso was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: Extreme pain in my inner ears; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient 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 13Apr2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to Shellfish. Concomitant medications included alprazolam (XANAX), multivitamin and fluoxetine hydrochloride (PROZAC); taken for unknown indication on unknown date. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 18:00, the patient experienced extreme pain in inner ears. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event extreme pain in inner ears was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache across forehead; This is a spontaneous report from a contactable consumer, the patient. An 83-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 83-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. 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. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, around 10 days after the second shot, the patient experienced severe headache across the forehead. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severe headache across the forehead was resolved on an unknown date in Apr2021.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Slight fever; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 10:00, the patient experienced slight fever and soreness at injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events slight fever and soreness at injection site was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint lock
Clinical narrative: SI-Joints locked up; SI-Joints in excruciating pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 13Apr2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included PSA-ankylosing spondylitis and spondylitis. It was reported that the patient had previously been diagnosed with Psoriatic arthritis (PSA) and it had been effecting his SI Joints back in 2012- 2018. Been in a remission stage since late 2018. The patient had allergy to Humira- Biologics. Concomitant medications include steroid injection (MANUFACTURER UNKNOWN) in right knee on 12Apr2021. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 23Mar2021 at 08:45 (at the age of 51-year-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 14Apr2021 morning around 02:30 the patient woke up with both SI-Joints locked up and in excruciating pain. The patient enquired if the medication could identify another area that needed attention. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of the events SI-Joints locked up and in excruciating pain were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Migraine
Clinical narrative: Early onset of menstruation despite being on oral contraceptives (forgot to list on prior page) and severe menstrual migraine; severe menstrual migraine; This is a spontaneous report from a contactable physician. A 47-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 in the arm left on 05Apr2021 at 16:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome and hypothyroidism. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), metformin hydrochloride (METFORMIN) and drospirenone (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if on going. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 15Mar2021 at 16:30 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 09Apr2021 the patient experienced early onset of menstruation despite and severe menstrual migraine. Therapeutic measures were taken as a result of menstruation d and severe menstrual migraine and included treatment with Tylenol and Advil . The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events, menstruation despite and severe menstrual migraine was recovered on unknown date on Apr2021  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in upper arm around injection site; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8713) via an unspecified route of administration in the left arm on 13Apr2021 at 16:45 (at the age of 62-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 13Apr2021 at 17:30, the patient experienced pain in upper arm around injection site. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in any of these 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 event. The clinical outcome of the event pain in upper arm around injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pruritus
Clinical narrative: Some of the middle toes on right foot became red and inflamed. The worst toe was the middle toe.; Middle toe, it was very, very, itchy; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 18Mar2021 at 08:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included high blood pressure, obesity and idiopathic urticaria. The patient reported that she had no food allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT) from an unknown date for an unknown indication and unknown if ongoing and hydrochlorothiazide (HCTZ) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 25Feb2021 at 08:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 25Mar2021, about seven days after the second dose, the patient reported that some of the middle toes on her right foot became red and inflamed. The worst toe was the middle toe which was very, very, itchy and inflamed and looked as if it might develop into an open sore. The patient considered going to a local walk-in clinic, but decided to wait it out.  The patient reported that after checking the web, the toes looked similar to chilblains. The patient reported that the toes had gradually gotten better over time and they were no longer itchy, but the middle toe still had some residual redness. 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, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events middle toes on right foot became red and inflamed and very itchy middle toe was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Incorrect route of product administration, Pain in extremity, Vaccination site erythema
Clinical narrative: red mark the size of a half dollar at the injection site, with some swelling,; Injection site, with some felt hard; Sore arm; Slight headache; Fatigue; Administered the vaccine subcutaneously at a 45 degree angle rather than intramuscular as recommended; Red mark the size of a half dollar at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via subcutaneous route of administration in the left arm on 13Apr2021 at 14:45 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and ethinylestradiol; levonorgestrel (KURVELO). On 13Apr2021 at 14:45, the patient was administered the vaccine subcutaneously at a 45-degree angle rather than intramuscular as recommended and the patient developed a red mark the size of a half dollar at the injection site, with some swelling, and it feels hard, also had a sore arm, slight headache and fatigue. The patient stated that, she was concerned about potential side effects from the vaccine being subcutaneously injected as well as the efficacy this first dose will now have. She had video evidence of the injection happening & have spoken to and shown the video to numerous medical professionals and pharmacists who all agree this is an incorrect injection that should be reported. She contacted the establishment in which she received the vaccine and they advised that they are not concerned and will not be reporting this incident to VAERS even though the CDC website specifically states that it must be reported. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vaccine subcutaneously at a 45-degree angle rather than intramuscular as recommended, developed a red mark the size of a half dollar at the injection site, with some swelling, and it feels hard, also had a sore arm, slight headache and fatigue was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: red mark the size of a half dollar at the injection site, with some swelling,; Injection site, with some felt hard; Sore arm; Slight headache; Fatigue; Administered the vaccine subcutaneously at a 45 degree angle rather than intramuscular as recommended; Red mark the size of a half dollar at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via subcutaneous route of administration in the left arm on 13Apr2021 at 14:45 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and ethinylestradiol; levonorgestrel (KURVELO). On 13Apr2021 at 14:45, the patient was administered the vaccine subcutaneously at a 45-degree angle rather than intramuscular as recommended and the patient developed a red mark the size of a half dollar at the injection site, with some swelling, and it feels hard, also had a sore arm, slight headache and fatigue. The patient stated that, she was concerned about potential side effects from the vaccine being subcutaneously injected as well as the efficacy this first dose will now have. She had video evidence of the injection happening & have spoken to and shown the video to numerous medical professionals and pharmacists who all agree this is an incorrect injection that should be reported. She contacted the establishment in which she received the vaccine and they advised that they are not concerned and will not be reporting this incident to VAERS even though the CDC website specifically states that it must be reported. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vaccine subcutaneously at a 45-degree angle rather than intramuscular as recommended, developed a red mark the size of a half dollar at the injection site, with some swelling, and it feels hard, also had a sore arm, slight headache and fatigue was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Chills; Aches; Fatigue; Nausea; Itchy and painful at injection site; Painful at injection site; Rash at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant 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 13Apr2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included mental illness, fibromyalgia and allergies to cats and dogs. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient received unspecified medications within two weeks of 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 on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:15, the patient experienced fever, chills, aches, fatigue, nausea, itchy and painful at injection site and rash at injection site. 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 fever, chills, aches, fatigue, nausea, itchy and painful at injection site and rash at injection site was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Fever; Chills; Aches; Fatigue; Nausea; Itchy and painful at injection site; Painful at injection site; Rash at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant 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 13Apr2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included mental illness, fibromyalgia and allergies to cats and dogs. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient received unspecified medications within two weeks of 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 on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:15, the patient experienced fever, chills, aches, fatigue, nausea, itchy and painful at injection site and rash at injection site. 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 fever, chills, aches, fatigue, nausea, itchy and painful at injection site and rash at injection site was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Lymph node pain, Lymphadenopathy, Spinal pain
Clinical narrative: Enlarged and tender lymph nodes in both arm pits; Enlarged and tender lymph nodes in both arm pits; Joint stiffness; Soreness in spine; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient medical history included heartburn, overweight and fruit allergy (allergy to pears). The patient previously took Reglan on an unknown date for unknown indication and experienced drug allergy. The patient previously took Levaquin on an unknown date for unknown indication and experienced drug allergy. The patient previously took Monistat on an unknown date and unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included PEPCID, ZYRTEC and ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication; on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced enlarged and tender lymph nodes in both arm pits, joint stiffness and soreness in spine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events enlarged and tender lymph nodes in both arm pits, joint stiffness and soreness in spine were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain, Vaccination site pain
Clinical narrative: Then 2 weeks later till now (so about 3 days) the injection site is hurting again.; Sometimes it is so bad that it affects  movement; 3 hours after I received the shot my arm at the site of the injection hurt for about 2 days; This is a spontaneous report from a contactable consumer, the patient. A 40-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 left arm on 29Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to unspecified chemicals and allergy to formaldehyde. On unknown dates, the patient received bacitracin (MANUFACTURER UNKNOWN) and neomycin (MANUFACTURER UNKNOWN) for unknown indications and experienced drug allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021 at 16:00, the patient experienced at that the site of the injection hurt for about 2 days. On 11Apr2021 at 09:00, 2 weeks later till the time of report (about 3 days), the patient experienced that the injection site was hurting again and sometimes it was so bad that it affected her movement. 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 events. The clinical outcome of the event of at the site of the injection hurt was recovered on 31Mar2021. The clinical outcome of the events exacerbation of pain and affected movement was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Maternal exposure timing unspecified
Clinical narrative: Pregnant at the time of vaccination?: Yes; Body chills; Headache; Fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. This consumer reported information for both mother and fetus/baby. This is a maternal report. A pregnant patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 13Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. The patient experienced body chills, headache and fatigue on Apr2021, pregnant at the time of vaccination?: yes on 13Apr2021. The mother reported she became pregnant while taking bnt162b2. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Severe vertigo upon wakening; Dizziness/ lightheadedness; nausea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 24Mar2021 at 18:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. 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 previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 03Mar2021 at 17:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril dihydrate(LISINOPRIL) and vitamin D nos (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 06:30, approximately 36 hours after second vaccination, the patient experienced severe vertigo upon wakening. On 26Mar2021, the patient experienced dizziness/ lightheadedness and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of severe vertigo upon wakening was recovered on 26Mar2021( lasting for 1-2 hours). The clinical outcome of the events of dizziness/ light-headedness and nausea were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: SWELLING IN LEFT ARMPIT ALONG WITH LIGHT REDNESS AND THE AREA FEELS HOT TO A TOUCH; SWELLING IN LEFT ARMPIT ALONG WITH LIGHT REDNESS AND THE AREA FEELS HOT TO A TOUCH; ITCHING ALONG THE LEFT ARM; AREA FEELS HOT TO A TOUCH; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 11Apr2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (fine under medication). Patient received unspecified other medication within 2 weeks of vaccination. The patient previously took lisinopril (MANUFACTURER UNKNOWN) and experienced allergic reaction. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced swelling in left armpit along with light redness and the area feels hot to a touch and itching along the left arm. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events swelling in left armpit along with light redness and the area feels hot to a touch and itching along the left arm was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Nausea, Palpitations, Paraesthesia
Clinical narrative: Severe heart palpitations; crushing back pain; tingling; nausea; headache; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 10:00(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. 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 28Mar2021, the patient experienced severe heart palpitations, crushing back pain, nausea, headache, tingling, which were persists and worsening. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the events severe heart palpitations, crushing back pain, nausea, headache, tingling, which were persists and worsening was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in left side of neck and left arm; This is a spontaneous report from a contactable consumer, the patient. A 41-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 11Apr2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Other medical history was not reported. Concomitant medications taken within two weeks of vaccination included loratadine, pseudoephedrine sulfate (CLARITIN-D), liothyronine sodium (CYTOMEL), levothyroxine sodium (SYNTHROID) and amlodipine besilate (AMLODIPINE BESYLATE) all from unknown date for unknown indication. 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 21Mar2021 at 16:15 (at the age of 41-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, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced swollen lymph nodes in left side of neck and left arm. 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. The clinical outcome of the event swollen lymph nodes in left side of neck and left arm was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Headache, Nausea, Pain
Clinical narrative: Severe headache; Sore eyeballs; Chills; Body aches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the right arm on 12Feb2021 at 12:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis. The patient had known allergies to penicillin and prochlorperazine edisylate (COMPAZINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VIT D), cod-liver oil (FISH OIL) and calcium (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the right arm on 23Jan2021 at 12:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 at 03:00, the patient experienced severe headache, sore eyeballs, chills, body aches and nausea. 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 headache, sore eyeballs, chills, body aches and nausea were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge, Vaccination site scab
Clinical narrative: Leaking injection site; scab on area of injection; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 08Apr2021 at 14:30 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks of vaccination. 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. It was not known, if the patient had any known allergies to medications, food, or other products. On 10Apr2021 at 10:00, the patient experienced leaking injection site and scab on area of injection. 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 event leaking injection site and scab on area of injection was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Pain, Palatal disorder
Clinical narrative: Lesions on palate were about 10 millimeter in diameter; Burning pain in my mouth; could not drink or eat anything acidic or crusty; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, lichen sclerosis, and penicillin allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 01Mar2021 at 14:00 (at the age of 67-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 25Mar2021 at 23:00, the patient experienced lesions on palate they were about 10 mm in diameter. They caused burning pain in mouth. Patient reported that she could not drink or eat anything acidic or crusty. She sent photos to her doctor who referred her to an ENT doctor. The doctor thought it might be a side effect. The lesions were still healing as of 14Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events lesions on palate, burning pain in mouth, could not drink or eat anything acidic or crusty was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Hot flush, Pain
Clinical narrative: Chest heaviness; Hot flashes; Ached; Chills; Fever; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 13Apr2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included mesial temporal sclerosis (MTS), antiphospholipid syndrome (APS) and clot blood. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took ibuprofen sodium (IBUPROFEN) on an unknown date for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included multivitamin, probiotic, warfarin sodium (WARFARIN), vitamin d nos (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 02:00, the patient experienced sore arm, hot flashes, chills, fever, headache, ached and chest heaviness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of sore arm, hot flashes, chills, fever, headache, ached and chest heaviness was recovered on 14Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chest heaviness; Hot flashes; Ached; Chills; Fever; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 13Apr2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included mesial temporal sclerosis (MTS), antiphospholipid syndrome (APS) and clot blood. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took ibuprofen sodium (IBUPROFEN) on an unknown date for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included multivitamin, probiotic, warfarin sodium (WARFARIN), vitamin d nos (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 02:00, the patient experienced sore arm, hot flashes, chills, fever, headache, ached and chest heaviness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of sore arm, hot flashes, chills, fever, headache, ached and chest heaviness was recovered on 14Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Nausea, Paraesthesia oral
Clinical narrative: Headache; Tiredness; Nausea; Numb; Lips tingle; Vision; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0151) via an unspecified route of administration in the left arm on 08Apr2021 at 12:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergy to sulfate. Concomitant medications included alendronate sodium (ALENDRONATE) for an unknown indication from an unknown date and unknown if ongoing. 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 08Apr2021, the patient experienced headache, tiredness, nausea, vision, numb and lips tingle. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, tiredness, nausea, vision, numb and lips tingle were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Headache; Tiredness; Nausea; Numb; Lips tingle; Vision; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0151) via an unspecified route of administration in the left arm on 08Apr2021 at 12:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergy to sulfate. Concomitant medications included alendronate sodium (ALENDRONATE) for an unknown indication from an unknown date and unknown if ongoing. 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 08Apr2021, the patient experienced headache, tiredness, nausea, vision, numb and lips tingle. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, tiredness, nausea, vision, numb and lips tingle were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.