chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Nausea
Clinical narrative: Fever (101F), chills, nausea, myalgias, injection site soreness extending to shoulder and down to elbow, fatigue
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (101F), chills, nausea, myalgias, injection site soreness extending to shoulder and down to elbow, fatigue
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: arm more sore than first shot; diarrhea- mild
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural
Clinical narrative: Dizziness when getting up after lying down. Did not have prior to receiving the vaccine. It continues to occur every day.; This is a spontaneous report from a non-contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date unknown), via intramuscular route of administration, on 24Dec2020 at 07:15 AM (at the age of 67 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypertension and known allergies to chocolate, strawberries. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ramipril, Atorvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Ramipril, Atorvastatin within 2 weeks of vaccination. On 25Dec2020, at 07:00 AM, the patient experienced dizziness when getting up after lying down which she did not have prior to receiving the vaccine. It continues to occur every day. No treatment was received for the event dizziness when getting up after lying down. The outcome of the event dizziness when getting up after lying down was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: fever; cough; cold; body aches; This is a spontaneous report from a contactable nurse, the patient.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unknown date, over a week after the patient received the vaccine, the patient started to develop symptoms of  fever of a 100.9 degrees Fahrenheit, cough, cold, and body aches.  She reported that her husband was sick and had similar symptoms on 31Dec2020. The clinical outcomes of the fever of 100.9 degrees Fahrenheit, cough, cold, and body aches were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site hyperaesthesia, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the left arm on 31Dec2020 at 11:00 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021, the patient experienced left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection. The reporter assessed the events as non-serious. The patient did not receive any treatment for all the events. The patient was not recovered from the events "left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection."
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the left arm on 31Dec2020 at 11:00 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021, the patient experienced left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection. The reporter assessed the events as non-serious. The patient did not receive any treatment for all the events. The patient was not recovered from the events "left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection."
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 19Dec2020 100 degree temp - self resolved/fever; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 48-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) intramuscular (left arm) on 18Dec2020 at 11:30, at a single dose, for COVID-19 immunization. Relevant medical history included psoriasis. Concomitant medications included unspecified vitamins and herbal supplements. The patient previously received gluten and penicillin and experienced allergies. Patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccines 4 weeks prior vaccination. The vaccine was administered in the hospital. The patient received the vaccine on 18Dec2020. On 19Dec2020, at 19:00, the patient had 100-degree temperature (self-resolved). On 24Dec2020, the patient had a 101 fever which was resolved with Tylenol. The patient had fever of 102.1 on 30Dec2020, 101.4 on 31Dec2020, 102.8 on 01Jan2021, and 101.9 on 02Jan2021 which were not resolved with Tylenol. Outcome of the event was not recovered. Since vaccination, the patient has not been tested for COVID-19.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Urticaria
Clinical narrative: Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1 of the Pfizer-BioNTech COVID-19 vaccine.  She self-ambulated to the clinic where she was assessed, vitals taken (which were stable), and offered an injection of Benadryl 25mg IM, which she accepted.  Patient was continually monitored and reassessed 15, 30, and 60 minutes after her arrival at which time she was starting to feel better, less flushed, with a visible reduction in her mild hives.  Patient was released to her own self-care and stated she would be calling her husband to pick her up from work.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Vaccination site pain
Clinical narrative: My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me are straight up in the air.; My arm where I received the shot is now hurting more and I can't lift my arm up out in front of me are straight up in the air.; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 18Dec2020 at 06:15 a.m., at single dose, for COVID-19 immunization. The patient has no relevant medical history. Concomitant medications included vitamins and calcium chews (one a day) and cetirizine hydrochloride (ZYRTEC). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccine four weeks prior vaccination. The vaccine was administered in the hospital. On 01Jan2021, the arm where patient received the shot was now hurting more. Patient can't lift her arm up out in front of her and straight up in the air. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling in my cheeks.; My left arm also was extremely hard, sore, and tender/swollen.; My left arm also was extremely hard, sore, and tender/swollen.; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on 22Dec2020 16:00 at single dose at arm (for confirmation) for COVID-19 immunization. Medical history included anxiety. The patient's concomitant medications were not reported. On 22Dec2020 17:00, Shortly after receiving the vaccine the patient felt a flushed feeling in her cheeks. The patient's left arm also was extremely hard, sore, and tender/swollen. About an hour afterwards, 18:00 I got a pulsating headache that lasted for 3 days. It was only mildly relieved with Tylenol and ibuprofen. It felt similar to a migraine and accompanied with some nausea on 23Dec2020 day 2. The patient received treatment for the events. The outcome of the events was recovered on an unspecified date in Dec2020.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Paresthesia's throughout arms and legs over the last few days. 25 minutes after shot I had severe pins and needles (falling asleep sensation) in my left leg. Progressed to numbness/squeezing sensation in my left lower leg and numbness in L hamstring throughout the rest of the day. Wednesday I had numbness/squeezing sensation in both of my lower legs and feet and numbness throughout both hamstrings and quads. Wednesday night I had numbness throughout my right forearm after my legs started to improve slightly. Thursday I had less consistent numbness throughout my legs and forearms though still present and started getting tingling into my left hand. This morning (Friday) I have tingling occasional tingling into my lower legs and left hand.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm for day and a half; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; This is a spontaneous report from a contactable nurse (patient).  A 50-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the right arm on 31Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital.  There were no concomitant medications.  It was reported that the patient was the patient diagnosed with COVID-19 prior to vaccination on 12Dec2020 (pending clarification). On 31Dec2020 22:00 (approximately 14 hours after vaccination), the patient had a sore arm for day and a half and onset of chills, body aches, low grade fever were noted. It was mentioned that the symptoms were treated with acetaminophen (TYLENOL) and ibuprofen. The patient was not tested for COVID-19 since the vaccination. The patient recovered from sore arm  on 02Jan2021 10:00 (day and a half) and from the remaining events on 01Jan2021 14:00 (lasted for approx. 16 hours off/on).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chills, Cough, Headache
Clinical narrative: sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by fever up to 104.7, abdominal pain, nausea and vomiting, myalgia, and cough.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by fever up to 104.7, abdominal pain, nausea and vomiting, myalgia, and cough.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Fatigue, Hypersensitivity
Clinical narrative: she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; tired; feels like she doesn't have enough energy; dry cough; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Dec2020, the patient experienced signs and symptoms of allergic reactions which was progressing. Mentioned that she had fever, fever with temperature ranging from 98.7°F-102.2°F, body ache, tired and feels like she doesn't have enough energy, dry cough. Wants to know how long does the symptoms last. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: she experienced signs and symptoms of allergic reactions which was progressing; fever; body ache; tired; feels like she doesn't have enough energy; dry cough; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Dec2020, the patient experienced signs and symptoms of allergic reactions which was progressing. Mentioned that she had fever, fever with temperature ranging from 98.7°F-102.2°F, body ache, tired and feels like she doesn't have enough energy, dry cough. Wants to know how long does the symptoms last. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Chills; Aches; Sweating; Dyspnea; Wheezing; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 21Dec2020, the patient experienced chills, aches, sweating, dyspnea, wheezing, and fatigue. The events are considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Chills; Aches; Sweating; Dyspnea; Wheezing; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 21Dec2020, the patient experienced chills, aches, sweating, dyspnea, wheezing, and fatigue. The events are considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Fatigue, Pain
Clinical narrative: Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection via an unspecified route of administration on left arm on 22Dec2020 02:30 at a single dose for Covid-19 immunization. Medical history included CREST Syndrome, type 2 diabetes, osteoarthritis, allergies to Sulfa and Dermabond tape. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient took other medications in the last two weeks. On 26Dec2020, the patient experienced average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also, she experienced achiness, and tiredness on 26Dec2020. No treatment received for the events. The patient was not diagnosed with Covid-19 and has not been tested prior to vaccination. Outcome of the events was unknown.  No follow-up activities are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy, Off label use, Product use issue
Clinical narrative: Headache; She was pregnant at the time of vaccination; She was pregnant at the time of vaccination; She was pregnant at the time of vaccination; This is a spontaneous report from a contactable nurse (patient). A 38-year-old pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) solution for injection, via an unspecified route of administration on left arm on 01Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included diabetes, and depression. Concomitant medications included escitalopram oxalate (LEXAPRO), ascorbic acid, biotin, minerals NOS, nicotinic acid, retinol, tocopherol, vitamin b NOS, vitamin D NOS (PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS]), progesterone (PROGESTERONE), and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient reported she was pregnant at the time of vaccination on 01Jan2021 15:00. She was at 9 weeks gestational period and will be due to deliver on 01Aug2021. The patient experienced headache on 02Jan2021 16:00 but did not receive any treatment. Outcome of the event headache was recovering while for the other event was unknown.  No follow-up activities are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: left eyelid began to twitch and to this day has been off and on everyday; This is a spontaneous report from a contactable healthcare professional. A 36-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection, intramuscular on left arm on 18Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included seasonal allergies. Concomitant medication included liothyronine. On 19Dec2020 at 23:00, patient reported his left eyelid began to twitch and up to this day it has been off and on everyday. No treatment was given. The event was reported as non-serious. The patient was not diagnosed of Covid-19 prior to vaccination and has not been tested for Covid-19 since vaccination. Outcome of the event was unknown.  No follow-up activities are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Increased left hand pain. More pain than typical arthritis pain; This is a spontaneous report from a contactable consumer.  A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at the left arm on  30Dec2020 17:00 at a single dose for COVID-19 immunization at a hospital.  Medical history included ventricular septal defect (VSD), psoriasis, inflammatory arthritis, and migraines. Concomitant medications included fish oil, magnesium, paracetamol (TYLENOL ARTHRITIS).  The patient previously took naproxen and experienced allergies. The patient experienced increased left hand pain that was more pain than typical arthritis pain on 31Dec2020, 12:00. The patient did not received any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient has not recovered from the events.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Haematemesis, Hyperhidrosis, Lip swelling
Clinical narrative: The patient complained of dizziness, itching, immense sweating within one hour of the vaccine administration. Over the next 12-24 hrs the patient had bloody emesis, diarrhea and noticeable swelling of tongue/lips.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue
Clinical narrative: The patient complained of dizziness, itching, immense sweating within one hour of the vaccine administration. Over the next 12-24 hrs the patient had bloody emesis, diarrhea and noticeable swelling of tongue/lips.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash dots on back of both hands/rash on shoulders and mid-back/rash on upper legs/rash on lower legs and arms; This is a spontaneous report received from a contactable nurse (who is also the patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EH9899), intramuscular in left arm, on 17Dec2020 13:00, at single dose, for COVID-19 immunization. Medical history included ulcerative colitis diagnosed in 2002, and "Allergies to medications, food, or other products: Sulfa medications - cause rash". The patient is not pregnant. Concomitant medication included mesalamine, lithium, lamotrigine and an unspecified birth control pill. It was reported that on 23Dec2020 15:00 (also reported as 17:00, pending clarification), she noticed rash dots on back of both hands. On 26Dec2020 15:00, she noticed rash on shoulders and mid-back. On 28Dec2020 17:00, she noticed rash on upper legs. On 29Dec2020 17:00, she noticed rash on lower legs and arms. On 01Jan2021, she went to urgent care for evaluation and was treated with methylprednisolone dose pack. The patient did not receive any other vaccines with 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering. The reporter assessed the report as non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: got COVID-19 from his son and tested positive; got COVID-19 from his son and tested positive; This is a spontaneous report from a contactable physician.  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient got COVID-19 from his son and he tested positive 31Dec2020. The patient's son got the COVID-19 virus on 20Dec202020. The patient is due to have 2nd vaccine on 07Jan2021. Outcome of the events was unknown.   Information on batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Chills, muscle pain, headache, pain at injection site
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid disorder, Glossitis, Paraesthesia oral
Clinical narrative: Lip tingle; Tongue- back, Each side-felt full; Eye lids dropped; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK5730, expiry date not reported), intramuscular in the left arm on 21Dec2020 16:15 at single dose, for Covid-19 immunisation. Medical history included asthma. Prior to vaccination the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included liothyronine, levothyroxine sodium (LEVOXYL), ergocalciferol (VIT D) and fluticasone propionate (FLOVENT). The patient experienced lip tingle, tongue- back, each side-felt full, eye lids dropped on 21Dec2020 16:15. He went to professional office/clinic visit/Emergency room/department or urgent care. An unknown treatment was given to the patient. The outcome of events was recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Chills, Diarrhoea, Dizziness
Clinical narrative: Lip tingle; Tongue- back, Each side-felt full; Eye lids dropped; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK5730, expiry date not reported), intramuscular in the left arm on 21Dec2020 16:15 at single dose, for Covid-19 immunisation. Medical history included asthma. Prior to vaccination the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included liothyronine, levothyroxine sodium (LEVOXYL), ergocalciferol (VIT D) and fluticasone propionate (FLOVENT). The patient experienced lip tingle, tongue- back, each side-felt full, eye lids dropped on 21Dec2020 16:15. He went to professional office/clinic visit/Emergency room/department or urgent care. An unknown treatment was given to the patient. The outcome of events was recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Eyelid ptosis, Headache, Laboratory test normal, Malaise
Clinical narrative: Lip tingle; Tongue- back, Each side-felt full; Eye lids dropped; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK5730, expiry date not reported), intramuscular in the left arm on 21Dec2020 16:15 at single dose, for Covid-19 immunisation. Medical history included asthma. Prior to vaccination the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included liothyronine, levothyroxine sodium (LEVOXYL), ergocalciferol (VIT D) and fluticasone propionate (FLOVENT). The patient experienced lip tingle, tongue- back, each side-felt full, eye lids dropped on 21Dec2020 16:15. He went to professional office/clinic visit/Emergency room/department or urgent care. An unknown treatment was given to the patient. The outcome of events was recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Nausea, Paraesthesia oral, Salivary hypersecretion
Clinical narrative: Lip tingle; Tongue- back, Each side-felt full; Eye lids dropped; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK5730, expiry date not reported), intramuscular in the left arm on 21Dec2020 16:15 at single dose, for Covid-19 immunisation. Medical history included asthma. Prior to vaccination the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included liothyronine, levothyroxine sodium (LEVOXYL), ergocalciferol (VIT D) and fluticasone propionate (FLOVENT). The patient experienced lip tingle, tongue- back, each side-felt full, eye lids dropped on 21Dec2020 16:15. He went to professional office/clinic visit/Emergency room/department or urgent care. An unknown treatment was given to the patient. The outcome of events was recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Wheezing
Clinical narrative: Lip tingle; Tongue- back, Each side-felt full; Eye lids dropped; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK5730, expiry date not reported), intramuscular in the left arm on 21Dec2020 16:15 at single dose, for Covid-19 immunisation. Medical history included asthma. Prior to vaccination the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included liothyronine, levothyroxine sodium (LEVOXYL), ergocalciferol (VIT D) and fluticasone propionate (FLOVENT). The patient experienced lip tingle, tongue- back, each side-felt full, eye lids dropped on 21Dec2020 16:15. He went to professional office/clinic visit/Emergency room/department or urgent care. An unknown treatment was given to the patient. The outcome of events was recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid disorder, Glossitis, Paraesthesia oral
Clinical narrative: 1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness,  shakes, overall malise, chest tightness.  Later that day, mild diarrhea, mikd nausea.  Day 3- woke with wheezing.  Symptoms all continued for next 10 days off and on. The lip, tongue  seemed to get shorter and shorter in duration. Also has mouth watering.  Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec.  Back to  urge t care day 6,  Ed day 8.  Day 14 abd 15 awful chills, muscke ache and shaking.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Chills, Diarrhoea, Dizziness
Clinical narrative: 1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness,  shakes, overall malise, chest tightness.  Later that day, mild diarrhea, mikd nausea.  Day 3- woke with wheezing.  Symptoms all continued for next 10 days off and on. The lip, tongue  seemed to get shorter and shorter in duration. Also has mouth watering.  Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec.  Back to  urge t care day 6,  Ed day 8.  Day 14 abd 15 awful chills, muscke ache and shaking.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Eyelid ptosis, Headache, Laboratory test normal, Malaise
Clinical narrative: 1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness,  shakes, overall malise, chest tightness.  Later that day, mild diarrhea, mikd nausea.  Day 3- woke with wheezing.  Symptoms all continued for next 10 days off and on. The lip, tongue  seemed to get shorter and shorter in duration. Also has mouth watering.  Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec.  Back to  urge t care day 6,  Ed day 8.  Day 14 abd 15 awful chills, muscke ache and shaking.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Nausea, Paraesthesia oral, Salivary hypersecretion
Clinical narrative: 1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness,  shakes, overall malise, chest tightness.  Later that day, mild diarrhea, mikd nausea.  Day 3- woke with wheezing.  Symptoms all continued for next 10 days off and on. The lip, tongue  seemed to get shorter and shorter in duration. Also has mouth watering.  Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec.  Back to  urge t care day 6,  Ed day 8.  Day 14 abd 15 awful chills, muscke ache and shaking.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Wheezing
Clinical narrative: 1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness,  shakes, overall malise, chest tightness.  Later that day, mild diarrhea, mikd nausea.  Day 3- woke with wheezing.  Symptoms all continued for next 10 days off and on. The lip, tongue  seemed to get shorter and shorter in duration. Also has mouth watering.  Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec.  Back to  urge t care day 6,  Ed day 8.  Day 14 abd 15 awful chills, muscke ache and shaking.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia oral, Presyncope, Visual impairment
Clinical narrative: Near syncope; lightheaded/dizzy; vision narrow; Tingling in lips; This is a spontaneous report from a contactable physician. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via an unspecified route of administration on 20Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced near syncope, lightheaded, dizzy, vision narrow and tingling in lips on 20Dec2020 09:30 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given to the patient for the events. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint effusion
Clinical narrative: R knee pain and effusion 1 week after receiving the vaccine; R knee pain and effusion 1 week after receiving the vaccine; This is a spontaneous report from a contactable physician.  A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0104), intramuscular at the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization at a hospital in an emergency room/department or urgent care.  Medical history included hypothyroidism, allergies with sulfa.  The patient's concomitant medications were not reported.  The patient experienced right knee pain and effusion 1 week after receiving the vaccine on 30Dec2020, 06:00. The patient an unspecified NSAIDS as a treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient has not recovered from the events.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This is a spontaneous report from a contactable other healthcare professional. A 28-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 02Jan2021 12:00 single dose (left arm, dose 1) for COVID-19 immunization. Medical history included bipolar disorder from an unknown date. No other vaccine in four weeks was given. Patient took other unspecified medications in two weeks. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Patient has no known allergies. The patient experienced coughing on 02Jan2021 12:30 with outcome of not recovered. Treatment was not given. The reporter considered the event as non-serious.  Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Corneal oedema, Myopia, Topography corneal, Vision blurred
Clinical narrative: Temporary blurred vision; increased her nearsightedness from -1.25 to -1.75; corneal edema/ Corneal topographies showed swelling in the cornea; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140), intramuscular (left arm, dose number 1) on 01Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa antibiotics, hormonal migraines, and gluten intolerance from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC), and spironolactone from unspecified dates for unspecified indications taken within two weeks. No other vaccine was taken within four weeks. Patient has not COVID prior vaccination. Patient has not been tested for COVID post vaccination. The patient experienced temporary blurred vision in the right eye on 02Jan2021. Patient stated that she is an optometrist so she performed a variety of tests and determined she had corneal edema.  Corneal topographies showed swelling in the cornea, increased her nearsightedness from -1.25 to -1.75. By the time she left work 7 hours later, her vision and corneal topographies returned back to normal. Treatment was not given for the events. Event outcome was recovered on 02Jan2021. The reporter assessed the event was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Heart rate, Heart rate increased, Nausea
Clinical narrative: Sore arm where vaccination was administered; Intermittent nausea; Increased heart rate; anxiety; Tiredness; This is a spontaneous report from a contactable nurse (Patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, lot number: EH9899, Batch/lot number: EK5730 as reported), via an unspecified route of administration at Right arm on 16Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history included General Anxiety Disorder, depression, and COVID-19. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), levonorgestrel (NORTREL[LEVONORGESTREL]). The patient experienced sore arm where vaccination was administered, intermittent nausea for 3 days, increased heart rate and anxiety for 1.5 days, and tiredness; all on 16Dec2020. There was no treatment for the adverse events. The patient did not test positive for COVID post vaccination. The event Nausea recovered in 19Dec2020, while patient recovered from the other events in Dec2020. The vaccine was administered at the hospital. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm where vaccination was administered; Intermittent nausea; Increased heart rate; anxiety; Tiredness; This is a spontaneous report from a contactable nurse (Patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, lot number: EH9899, Batch/lot number: EK5730 as reported), via an unspecified route of administration at Right arm on 16Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history included General Anxiety Disorder, depression, and COVID-19. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), levonorgestrel (NORTREL[LEVONORGESTREL]). The patient experienced sore arm where vaccination was administered, intermittent nausea for 3 days, increased heart rate and anxiety for 1.5 days, and tiredness; all on 16Dec2020. There was no treatment for the adverse events. The patient did not test positive for COVID post vaccination. The event Nausea recovered in 19Dec2020, while patient recovered from the other events in Dec2020. The vaccine was administered at the hospital. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.