chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 09:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no other relevant medical history and no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included estradiol (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient had received other vaccines within four weeks prior to the vaccination that included second dose of varicella zoster vaccine (MANUFACTURER UNKNOWN) on 19Feb2021 for shingles vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Mar2021 at 06:00 the patient experienced tinnitus. 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 been tested for COVID-19. The clinical outcome of the event tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 45-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6200), at the age of 45, via an unspecified route of administration, in the left arm, on Mar 11, 2021, at 14:00, single dose, for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, patient was diagnosed with COVID-19. Concomitant medications included minocycline hydrochloride and Xyzal (levocetirizine dihydrochloride); both for unknown indication from unknown date and unknown if ongoing. The patient previously received Bactrium (sulfamethoxazole; trimethoprim) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 12, 2021, at 14:00, patient experienced fatigue, arm pain, swollen sore lymph node under arm on the injection side. 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, patient has not tested for COVID-19. The outcome of fatigue, arm pain, swollen/sore lymph node underarm on the injection site: recovering (at this time of this report). No follow-up attempts needed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen sore arm at injection site. 6 days after injection; Swollen sore arm at injection site. 6 days after injection; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 07Mar2021 at 14:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The medical history included diaverticulosus and osteoporosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included pantoprazole (PANTOPRAZOL), colecalciferol (VITAMIN D3), alendronate sodium (FOSAMAX) and Multivitamin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPRIN) and experienced drug allergy. On 13Mar2021 at 21:00, 6 days after injection, the patient experienced swollen sore arm at injection site. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen sore arm at injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Facial and chest acne; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 17Feb2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 27Jan2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 24Feb2021, the patient experienced facial and chest acne. The event 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 reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event facial and chest acne was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature increased, Chills, Pain
Clinical narrative: Elevated temperature; Body aches; Chills; Strong abdominal cramps; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in right arm on 24Feb2021 at 15:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and allergy to antibiotics. 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 losartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 03Feb2021 at 15:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. On 11Mar2021 at 16:00, 2 weeks after second vaccine, the patient experienced elevated temperature, body aches, chills and strong abdominal cramps. 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 of elevated temperature, body aches, chills and strong abdominal cramps was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Disorientation, Dizziness, Dyspepsia, Fatigue
Clinical narrative: Sweating; disoriented; Severe burning inside my stomach; Fatigue; Nauseous; I had sensitivity to light, dizzy and was throwing up bile and couldnt hold down any liquid or food down for 2 days 10 hours.; I had sensitivity to light, dizzy and was throwing up bile and couldnt hold down any liquid or food down for 2 days 10 hours.; I had sensitivity to light, dizzy and was throwing up bile and couldnt hold down any liquid or food down for 2 days 10 hours.; I had constipation for 3 1/2 days; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EN6206) via an unspecified route of administration in the arm left on 10Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, kidney stones and type 2 diabetes mellitus. 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 lisinopril (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), sitagliptin phosphate (JANUVIA) and benzalkonium chloride, choline salicylate (ZYTEE) all for unknown indication from unknown date and unknown if ongoing. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM), sulfanilamide (SULFA), repaglinide(MANUFACTURER UNKNOWN), guaifenesin; phenylephrine hydrochloride; phenylpropanolamine hydrochloride (ENTEX), cefalexin (KEFLEX) and glipizide (MANUFACTURER UNKNOWN) and experienced allergy. On 11Mar2021 at 03:00 the patient experienced fatigue, nauseous and had sensitivity to light, dizzy and was throwing up bile and couldn't hold down any liquid or food down for 2 days 10 hours. On 11Mar2021 at 03:00 the patient also had constipation for 3 1/2 days. On 11Mar2021 at 03:30 the patient woke up sweating, disoriented and had severe burning inside stomach so bad that could not move for 2 hours. The recovery was slow and gradual. 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 fatigue, nauseous, had sensitivity to light, dizzy, throwing up bile and couldn't hold down any liquid or food down for 2 days 10 hours, constipation for 3 1/2 days, woke up sweating, disoriented and had severe burning inside stomach so bad that could not move for 2 hours were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Photosensitivity reaction, Vomiting
Clinical narrative: Sweating; disoriented; Severe burning inside my stomach; Fatigue; Nauseous; I had sensitivity to light, dizzy and was throwing up bile and couldnt hold down any liquid or food down for 2 days 10 hours.; I had sensitivity to light, dizzy and was throwing up bile and couldnt hold down any liquid or food down for 2 days 10 hours.; I had sensitivity to light, dizzy and was throwing up bile and couldnt hold down any liquid or food down for 2 days 10 hours.; I had constipation for 3 1/2 days; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EN6206) via an unspecified route of administration in the arm left on 10Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, kidney stones and type 2 diabetes mellitus. 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 lisinopril (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), sitagliptin phosphate (JANUVIA) and benzalkonium chloride, choline salicylate (ZYTEE) all for unknown indication from unknown date and unknown if ongoing. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM), sulfanilamide (SULFA), repaglinide(MANUFACTURER UNKNOWN), guaifenesin; phenylephrine hydrochloride; phenylpropanolamine hydrochloride (ENTEX), cefalexin (KEFLEX) and glipizide (MANUFACTURER UNKNOWN) and experienced allergy. On 11Mar2021 at 03:00 the patient experienced fatigue, nauseous and had sensitivity to light, dizzy and was throwing up bile and couldn't hold down any liquid or food down for 2 days 10 hours. On 11Mar2021 at 03:00 the patient also had constipation for 3 1/2 days. On 11Mar2021 at 03:30 the patient woke up sweating, disoriented and had severe burning inside stomach so bad that could not move for 2 hours. The recovery was slow and gradual. 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 fatigue, nauseous, had sensitivity to light, dizzy, throwing up bile and couldn't hold down any liquid or food down for 2 days 10 hours, constipation for 3 1/2 days, woke up sweating, disoriented and had severe burning inside stomach so bad that could not move for 2 hours were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light Headed and Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6209) via an unspecified route of administration on the left arm on 01Mar2021, at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included Bovine Heart valve. The patient previously received amoxycillin (MANUFATURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN); hydrochlorothiazide (MANUFACTURER UNKNOWN); metoprolol (MANUFACTURER UNKNOWN) and esomeprazole (MANUFACTURER UNKNOWN); all for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, at 13:00, the patient experienced light headed/dizziness. It was reported that light headed and dizziness persisted 13 days post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit and also, emergency room/department visit or urgent care. Therapeutic measures were not 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 light headed and dizziness was not recovered 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: Gait disturbance, Joint lock, Pain in extremity
Clinical narrative: My left leg from the joint that connect the hip to the leg got stuck the second day; I barely could move it and I couldn't put pressure on it at all, I have to drag it when I needed to use it; The second day 80 percent of the pain is gone and the day after only 10 percent of the pain left; This is a spontaneous report from a contactable consumer, the patient. A 42-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 11Mar2021 at 18:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. On 12Mar2021 at 12:30, the patient had her left leg from the joint that connected the hip to the leg got stuck the second day, she barely could move it and she could not put pressure on it at all, she dragged it when she needed to use it, the second day 80 percent of the pain had gone and the day after only 10 percent of the pain left. 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 her left leg from the joint that connected the hip to the leg got stuck the second day, she barely could move it and she could not put pressure on it at all, she dragged it when she needed to use it, the second day 80 percent of the pain had gone and the day after only 10 percent of the pain left was recovered with sequelae on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease (CKD), high blood pressure (high BP), high cholesterol and massive heart attack. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN) and cinacalcet (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. On 12Mar2021 at 16:00, the patient experienced soreness at injection site. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness at injection site was resolved with sequelae on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in lips, tongue, and face; Tingling in lips, tongue, and face; This is a spontaneous report from a contactable consumer. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 14Mar2021, at 10:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medications. On 14Mar2021 at 11:00, the patient experienced tingling in lips, tongue and face. It was reported as mild, but noticeable tingling in lips, tongue and face about 20 minutes after the injection. It lasted about 20 minutes and was never a worry, but the patient noticed it. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 tingling in lips, tongue and face was resolved on 14Mar2021 at 11.20, after the duration of 20 minutes.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen and red lymph node on left side between chest and armpit; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included rosacea and allergy to rats. 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 COVID vaccine. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), estradiol (CLIMARA), vitamin d nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 12Mar2021, the patient experienced swollen and red lymph node on left side between chest and armpit. The events did not result in doctor or other healthcare professional office or clinic visit and 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 event swollen and red lymph node on left side between chest and armpit was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Complaints of a scratchy throat minutes after receiving Pfizer vaccine.; This is a spontaneous report from a contactable healthcare professional. A 22-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an intramuscular route of administration in the right arm on 14Mar2021 at 15:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient had an unspecified medical history and known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The concomitant medication included unspecified medications. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 14Mar2021 at 15:00, minutes after the vaccine, the patient experienced a scratchy throat. The event resulted in the emergency room/department or urgent care. Therapeutic measures were taken as a result of the event included treatment with diphenhydramine hydrochloride (BENADRYL) via the intravenous route. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event scratchy throat was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain, Vomiting
Clinical narrative: nausea; vomiting; body aches; lightheaded ness; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 13Mar2021 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included hydrocephalus. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 22:00, the patient experienced nausea, vomiting, body aches and lightheaded ness. 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 nausea, vomiting, body aches and lightheaded ness was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Transient pains in LEFT arm; Transient pains in LEFT arm and head- Not a headache!; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Mar2021 at 14:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy (unspecified) to medications, food, or other products. The patient had received concomitant medications (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021, the patient experienced transient pains in left arm and head which was not a headache. This persisted for 10 days and unlike anything the patient had ever experienced before. The pain was not bad but the head pain was alarming as it welled up and resided. 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 outcome of the event transient pains in left arm and head which was not a headache; this persisted for 10 days and unlike anything the patient had ever experienced before; the pain was not bad but the head pain was alarming as it welled up and resided was unknown 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site erythema, Vaccination site inflammation, Vaccination site irritation, Vaccination site swelling
Clinical narrative: The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.it was about the size of a gold ball; Dizziness and lightheaded ness started.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 16Jan2021 at 14:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and migraines. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included folic acid (MANUFACTURER UNKNOWN) and carbamazepine (CARBATROL) for unknown indication from an unknown date unknown if ongoing. The patient received the shot on Saturday 16Jan2021. Tuesday 3 days later, on 19Jan2021 at 08:00, the patient experienced dizziness and light-headedness. Symptoms had continued none since then. Also, 1 week later, on Saturday 23Jan2021, the injection site became inflamed, irritated, red, swollen and hot. It was about the size of a gold ball. That lasted approximately 3 days and did not return. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events dizziness and light-headedness which included treatment with vestibular therapy at the time of this report. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site became inflamed, irritated, red, swollen, and hot. It was about the size of a gold ball was resolved on an unknown date in Jan2021; while that of the events dizziness and light-headedness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.; The injection site became inflamed, irritated, red, swollen, and hot.it was about the size of a gold ball; Dizziness and lightheaded ness started.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 16Jan2021 at 14:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and migraines. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included folic acid (MANUFACTURER UNKNOWN) and carbamazepine (CARBATROL) for unknown indication from an unknown date unknown if ongoing. The patient received the shot on Saturday 16Jan2021. Tuesday 3 days later, on 19Jan2021 at 08:00, the patient experienced dizziness and light-headedness. Symptoms had continued none since then. Also, 1 week later, on Saturday 23Jan2021, the injection site became inflamed, irritated, red, swollen and hot. It was about the size of a gold ball. That lasted approximately 3 days and did not return. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events dizziness and light-headedness which included treatment with vestibular therapy at the time of this report. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site became inflamed, irritated, red, swollen, and hot. It was about the size of a gold ball was resolved on an unknown date in Jan2021; while that of the events dizziness and light-headedness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Paranoia
Clinical narrative: Paroniod jittery feeling; Paroniod jittery feeling; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hormones (unspecified) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021 at 10:00, the patient experienced paranoid jittery feeling. Therapeutic measures were not taken as a result of the events. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event paranoid jittery feeling was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Pain in extremity
Clinical narrative: Sore arm; Sore ear/tense to touch feel, on right side 3 days; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm right on 04Mar2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, asthma and penicillin allergy.  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 04Mar2021 at 16:00, the patient experienced sore arm, sore ear and tense to touch feel on right side, 3 days. 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, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm was resolved on 06Mar2021, after the duration of 2 days while that of the event sore ear and tense to touch feel on right side was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Limited arm mobility due to pain; Soar upper arm; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 27Feb2021 at 16:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included coronary disease and known allergies to penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the arm left on 06Feb2021 at 16:15 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. On 27Feb2021 at 17:30, the patient experienced soar upper arm and limited arm mobility due to pain. 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 limited arm mobility due to pain and soar upper arm were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm soreness; Terrible headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old unspecified gender patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 13Mar2021 at 15:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, fibromyalgia, chronic fatigue, chronic pain, migraine, depression, anxiety, insomnia, high cholesterol, obesity, post-traumatic stress disorder. The patient has known allergy to sulfa, seafood, bee stings, corn, pollen, dust and ragweed. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrocodone (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA), levocetirizine dihydrochloride (XYZAL) and ambroxol hydrochloride (AMB); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021 the next morning woke up at 07:00, the patient experienced arm soreness and terrible headache. The patient tried many methods to relieve the pain and nothing helped. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness and terrible headache was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gait disturbance
Clinical narrative: Sunday, 21February 2021 and was just a little tired; Woke up at 5:25 a.m. three days after 1st vaccine on Saturday, 20 February 2021 and was extremely dizzy; Unable to walk; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received 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 17Feb2021 at 10:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure since age 49 year 2003. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril/ hydrochlorothiazide (LISINOPRIL AND HYDROCHLOROTHIAZIDE) and alive vitamin supp (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. The patient woke at 05:25 and On 20Feb2021 at 05:30, three days after first vaccine on Saturday and was extremely dizzy and unable to walk. The patient went back to back and slept from 11:00 to 17:05. Drank some water, ate a little food and went back to bed.  Up at 19:15 for a few minutes and went back to bed until around 6:15 AM Sunday, 21Feb2021 and was just a little tired, but was not dizzy anymore. 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 not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events extremely dizzy and unable to walk and just a little tired was recovered on an unknown date in 2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 10Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot
Clinical narrative: Woke up at night feeling hot; Feeling chills for several hours; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 06Mar2021 at 17:45 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included Gastroesophageal Reflux Disease (GERD) and Sjogren's. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications within two weeks prior to the vaccination. On 06Mar2021, the patient woke up at night feeling hot. Then felt chills for several hours. Some concern since this was first shot. 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 woke up at night feeling hot and feeling chills for several hours were recovered on an unknown date Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Significant back pain, unable to get out of chair; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 10Feb2021 at 15:45(at the age of 73-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included clopidogrel bisulfate (PLAVIX) and simvastatin (MANUFACTURER UNKNOWN) taken for unspecified indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 20Jan2021 at 15:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 12Feb2021 at 13:00, the patient experienced significant back pain and was unable to get out of chair. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event significant back pain and was unable to get out of chair were recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Temp 100; Headache; Chiils; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 13Mar2021 at 15:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure and COVID-19. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021 at 11:00, the patient experienced temperature (Temp) 100, headache, chills and body aches. On 14Mar2021 at 11:00, the patient underwent body temperature test and result was 100 (unspecified unit). 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 temperature (Temp) 100, headache, chills and body aches was not recovered at the time of this report.  No follow up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6208), at the age of 38, via an unspecified route of administration, in the left arm, on Mar 12, 2021, at 13:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. 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 Mar 13, 2021, at 03:00, patient experienced insomnia and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has tested for COVID-19. On an unknown date (also reported as Dec 30, 2020), patient underwent SAR-COV 2-test, NAA via nasal swab and the result: negative. The clinical outcome of the event insomnia and fatigue not resolved (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity
Clinical narrative: Pain in right arm; Headache; Severe diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 50-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 08Mar2021 at 13:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, the patient experienced pain in right arm, headache and severe diarrhea. 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 outcome of the events pain in right arm, headache and severe diarrhea were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.