chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chest discomfort, Chest pain, Chills
Clinical narrative: burning sensation over sternum with heaviness in chest; burning sensation over sternum with heaviness in chest; Burning in chest; Insomnia; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills/ pain in joints; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) , intramuscular on left arm on 15Jan2021 07:00 at a single dose  for COVID-19 immunization. The patient's medical history included known allergies to penicillin and avocado, attention deficit disorder (ADD), exercise induced asthma and osteoarthritis. The patient was not pregnant at the time of vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and ibuprofen. The patient previously took first dose of BNT162B2 (lot number: EL0140) on 28Dec2020 16:15 intramuscular on left arm for COVID-19 immunization. No other vaccine in four weeks. On 15Jan2021 1500, the patient had pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills on same day at 2200. With ibuprofen and Tylenol throughout 16Jan2021, pain went away only to return in ribs and pelvis that evening as well as a return of intermittent chills. On 17Jan2021, pain in joints gone but patient had burning sensation over sternum with heaviness in chest and continued intermittent chills. Burning in chest comes and goes as well as the chills, the chills started from base of skull and wave downward to ankles multiple times lasting a few minutes to as long as 30 to 40 minutes. Insomnia starting 16Jan2021 and persists. No COVID prior vaccination and no COVID test post vaccination. The outcome of the event insomnia was not recovered, and other events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal chest pain, Neck pain, Pelvic pain, Spinal pain
Clinical narrative: burning sensation over sternum with heaviness in chest; burning sensation over sternum with heaviness in chest; Burning in chest; Insomnia; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills/ pain in joints; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; Pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) , intramuscular on left arm on 15Jan2021 07:00 at a single dose  for COVID-19 immunization. The patient's medical history included known allergies to penicillin and avocado, attention deficit disorder (ADD), exercise induced asthma and osteoarthritis. The patient was not pregnant at the time of vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and ibuprofen. The patient previously took first dose of BNT162B2 (lot number: EL0140) on 28Dec2020 16:15 intramuscular on left arm for COVID-19 immunization. No other vaccine in four weeks. On 15Jan2021 1500, the patient had pain started in neck and shoulder blades progressing to neck, spine, ribs and pelvis with chills on same day at 2200. With ibuprofen and Tylenol throughout 16Jan2021, pain went away only to return in ribs and pelvis that evening as well as a return of intermittent chills. On 17Jan2021, pain in joints gone but patient had burning sensation over sternum with heaviness in chest and continued intermittent chills. Burning in chest comes and goes as well as the chills, the chills started from base of skull and wave downward to ankles multiple times lasting a few minutes to as long as 30 to 40 minutes. Insomnia starting 16Jan2021 and persists. No COVID prior vaccination and no COVID test post vaccination. The outcome of the event insomnia was not recovered, and other events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysuria, Eye pain, Flushing, Headache
Clinical narrative: Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pain, SARS-CoV-2 test, Tachycardia
Clinical narrative: Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hypoaesthesia, Inappropriate schedule of product administration, Influenza like illness, Paraesthesia
Clinical narrative: Date of start of drug 01Jan2021;Date of start of drug 18Jan2021; Numbness and tingling of fingers on vaccine arm; Numbness and tingling of fingers on vaccine arm; bruise on back of arm away from injection site; flu like symptoms; This is a spontaneous report from a contactable pharmacist. A 25-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 18Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medication included buspirone hydrochloride (BUSPAR), ethinylestradiol, levonorgestrel (CAMRESE), desvenlafaxine succinate (PRISTIQ) and trazodone. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Jan2021 (first dose). It was reported that the patient had numbness and tingling of fingers on vaccine arm, bruise on back of arm away from injection site and flu like symptoms; all on 19Jan2021 at 05:00. No treatment was received for the events. The outcome of the events was recovered on unspecified dates.   Information about lot/batch number was requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Pain in extremity, Vomiting
Clinical narrative: full body muscle aches; patient received first dose on 27Dec2020 and 2nd dose on 13Jan2021; arm muscle sore; Extreme fatigue; vomited 4 times; legs and arms are still store; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302 and Expiration date: May2021), intramuscular at the left arm on 13Jan2021 15:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination.  Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC) and spironolactone. The patient previously received the 1st dose of bnt162b2 for COVID-19 immunization at the age of 23 years old on 27Dec2020 @ 2PM at the left arm, Lot number: ET1685 and Expiration date: Mar2021. On 13Jan2021, the patient experienced arm muscles sore. The next day on 14Jan2021, full body muscle aches slowly developed. Extreme fatigue two nights later (Jan2021) and vomited 4 times 6 days later (Jan2021). Legs and arms are still store from Jan2021, still fatigued. The patient received first dose on 27Dec2020 and 2nd dose on 13Jan2021. This was assessed as Inappropriate schedule of vaccine administered. Treatment was not received for the adverse events arm muscle sore, full body muscle aches, extreme fatigue, vomited 4 times and legs and arms are still store .The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events arm muscle sore, full body muscle aches, extreme fatigue, vomited 4 times and legs and arms are still store was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Skin disorder, Urticaria
Clinical narrative: A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; woke up with bumps on both of the arms; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 16Jan2021 12:30 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, osteoarthritis, allergies: general anaesthesia. The patient was not pregnant. Concomitant medication included phentermine and vitamin D3. On 17Jan2021 at 10:00 am the patient woke up with bumps on both of the arms. A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives. Patient began to take Benadryl twice a day. On 18Jan2021 at 6:00 am the hives began to appear on both arms again and back. On 19Jan2021 the patient woke up at 6:00 am and the hives appeared on both arms, back, chest, stomach, both legs, neck and parts of the face. Therapeutic measures were taken as a result of rash papular and urticaria which included Benadryl, while no treatment received for skin disorder. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Facility type vaccine was other. No other vaccine in four weeks. No COVID prior vaccination. Not COVID tested post vaccination.  Information on lot/batch number has been requested.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Chest pain; shortness of breath and difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the left arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date (AFib, diagnosed around 10 years ago), pulmonary issues from an unknown date and unknown if ongoing (pulmonary issues started within the last year), bad heart from an unknown date and unknown if ongoing.  There were no concomitant medications.  The patient experienced chest pain, shortness of breath and difficulty breathing on an unspecified date. The patient further reported that she has a lot of the symptoms that she lives with daily, she has a bad heart, has A Fib, has a pulmonary doctor and she discussed this with her doctor and they told her to go ahead and get the vaccination, so she went ahead with the vaccine, about 3-4 days later, got these chest pains, she has not had any chest pains connected to her Afib before, she also had shortness of breath and difficulty breathing 3-4 days after the vaccination, when she sat down and waited for this to pass, when it did pass, does not know if it was 5 min or 10 minutes, when that went away she felt very good. The patient also reported that she has not had any more chest pains since the first episode, she is still struggling with the difficulty breathing but unsure if this is just her body and prior conditions or due to the vaccine. Does not know what it was, thought maybe she had a heart attack, wants to know if she should go ahead and get the second vaccine. Does not want to get any of the side effects worse than what she had, states someone told her the second one hits you harder and wants to know if this is true. The patient did not recover from shortness of breath and difficulty breathing while the outcome of the rest of the events was unknown.  Information on the batch number/lot number  has been requested
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: fatigue; Fever; chills; flu like sxs; body aches; sweats; This is a spontaneous report from an other healthcare professional, the patient. This 44 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), dose 2, single dose via an unspecified route of administration  in left arm on 18Jan2021 (at 11:30) for COVID-19 vaccination (at the age of 44 years old). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included sulfa allergy, penicillin and erythromycin. Historical vaccine history included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1686, first dose on 28Dec2020 at 04:30 PM in left arm. There were no other medications received within two weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021 at 21:00, the patient  experienced fever (100.5), chills, sweats, flu like symptoms, body aches and fatigue. No treatment was given for the events. The outcome of the events fever (100.5), chills, sweats, flu like symptoms, body aches and fatigue was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fatigue; Fever; chills; flu like sxs; body aches; sweats; This is a spontaneous report from an other healthcare professional, the patient. This 44 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), dose 2, single dose via an unspecified route of administration  in left arm on 18Jan2021 (at 11:30) for COVID-19 vaccination (at the age of 44 years old). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included sulfa allergy, penicillin and erythromycin. Historical vaccine history included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1686, first dose on 28Dec2020 at 04:30 PM in left arm. There were no other medications received within two weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021 at 21:00, the patient  experienced fever (100.5), chills, sweats, flu like symptoms, body aches and fatigue. No treatment was given for the events. The outcome of the events fever (100.5), chills, sweats, flu like symptoms, body aches and fatigue was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache after taking the Covid-19 vaccine this morning; This is a spontaneous report from a Pfizer sponsored program. A non-contactable male consumer (patient) receive BNT162B2 (COVID-19 Vaccine) on 19Jan2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient wanted to know if he could take tylenol/ibuprofen due to headache after taking the Covid-19 vaccine this morning. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Vaccination site pain
Clinical narrative: Chills; Muscle pain; Joint pain; Pain near or surrounding injection site; This is a spontaneous report from a non-contactable healthcare professional. A non-pregnant 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left arm, on 19Jan2021 at 13:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a workplace clinic facility. On an unspecified date, the patient experienced chills, muscle pain, joint pain, and pain near or surrounding injection site. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Feeling generally tired; A little achy; Fever/elevated temperature at 100.5; Chills; This is a spontaneous report from a contactable nurse. A 75-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL0142), via an unspecified route of administration in the right arm on 18Jan2021 at 10:30 (at the age of 75-years) as a single dose for Covid-19 immunization. Medical history included COVID-19 virus in Dec2020. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. On 18Jan2021 at 20:30, the patient started to have fever / elevated temperature at 100.5 and chills and took paracetamol (TYLENOL). The morning of 19Jan2021, the patient's temperature was 99.6 and he was just feeling generally tired and a little achy. The patient would usually working in the shop early in the morning. On 19Jan2021, the patient was still experiencing side effects until and was also feeling generally tired but was already feeling somewhat better now. The patients most recent temperature was 99.5. The patient's chills had resolved in Jan2021. The clinical outcome of the event chills was recovered in Jan2021, fever was not recovered, tired was recovering, and the outcome of event achy was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal rigidity, Body temperature, Chest discomfort, Chills, Dysstasia
Clinical narrative: Mild fatigue/extreme fatigue (difficulty standing); strong chest/abdominal tightness (described similar to indigestion); strong chest/abdominal tightness (described similar to indigestion); chills (severe shaking/trembling); chills (severe shaking/trembling); deep breathing; Mild fatigue/extreme fatigue (difficultly standing); elevated temperature (99.3-7); sensitivity to cold for 24-48 hours; This is a spontaneous report from a non-contactable consumer. A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL3246) via an unspecified route of administration at right arm on 14Jan2021, at 10:00 AM at a single dose for COVID-19 immunization. Age at vaccination was 28-year-old. Medical history included blood pressure. No other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as 2 - blood pressure (identity not disclosed). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL0140) at right arm on 23Dec2020 at a single dose for COVID-19 immunization and no symptoms reported. Facility where the most recent COVID-19 vaccine was administered at hospital. It was reported mild fatigue within first few hours for second dose. Around 12 hours after injection (11:30 PM) had rapid onset of strong chest/abdominal tightness (described similar to indigestion), extreme fatigue (difficultly standing), chills (severe shaking/trembling), and deep breathing. These strong symptoms lasted for around 15 minutes. Over next few hours elevated temperature (99.3-7) and sensitivity to cold for 24-48 hours.  Symptoms resolved. Events with start date on 14Jan2021 at 11:30 PM. The outcome of events was resolved in Jan2021. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperventilation, Pyrexia, Temperature intolerance, Tremor
Clinical narrative: Mild fatigue/extreme fatigue (difficulty standing); strong chest/abdominal tightness (described similar to indigestion); strong chest/abdominal tightness (described similar to indigestion); chills (severe shaking/trembling); chills (severe shaking/trembling); deep breathing; Mild fatigue/extreme fatigue (difficultly standing); elevated temperature (99.3-7); sensitivity to cold for 24-48 hours; This is a spontaneous report from a non-contactable consumer. A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL3246) via an unspecified route of administration at right arm on 14Jan2021, at 10:00 AM at a single dose for COVID-19 immunization. Age at vaccination was 28-year-old. Medical history included blood pressure. No other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as 2 - blood pressure (identity not disclosed). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL0140) at right arm on 23Dec2020 at a single dose for COVID-19 immunization and no symptoms reported. Facility where the most recent COVID-19 vaccine was administered at hospital. It was reported mild fatigue within first few hours for second dose. Around 12 hours after injection (11:30 PM) had rapid onset of strong chest/abdominal tightness (described similar to indigestion), extreme fatigue (difficultly standing), chills (severe shaking/trembling), and deep breathing. These strong symptoms lasted for around 15 minutes. Over next few hours elevated temperature (99.3-7) and sensitivity to cold for 24-48 hours.  Symptoms resolved. Events with start date on 14Jan2021 at 11:30 PM. The outcome of events was resolved in Jan2021. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 3 of her staff members tested positive after taking the 1st dose/They got a result for asymptomatic 3 employees that tested positive with COVID 19; 3 of her staff members tested positive after taking the 1st dose/They got a result for asymptomatic 3 employees that tested positive with COVID 19; This is a spontaneous report from a Pfizer Sponsored Program. A contactable Nurse reported similar events for 3 patients. This is 1st of 3 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive with COVID 19 on 11Jan2021. Outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and tested positive with COVID-19 on 11Jan2021.  No complete protection of the suspect vaccine could be reasonably achieved to prevent from the targeted infection due to the very short time lag. The positive COVID-19 is more likely pre-existing infection prior to vaccine use, and unrelated to BNT162B2 based on the limitedly available information.,Linked Report(s) : US-PFIZER INC-2021049694 Pfizer, Same drug, same event, different patient;US-PFIZER INC-2021049695 Pfizer, Same drug, same event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 3 of her staff members tested positive after taking the 1stdose/3 of her workers tested positive for Covid; 3 of her staff members tested positive after taking the 1stdose/3 of her workers tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect.  A contactable nurse reported same events for 3 patients. This is second of 3 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive after taking the first dose on 11Jan2021. The event was reported as non-serious. The patient underwent lab tests and procedures which included Covid: positive on an unspecified date. The outcome of events was unknown. Got the first shot on the 05Jan2021 for all of the 50 employees and 70 residents. On 11Jan2021, they got a result for asymptomatic 3 employees that tested positive with COVID 19. Health professional had questions about 2nd dose guidelines.   Information about lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and COVID-19 test positive on 11Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-2021049693 same reporter/ drug/ event, different patients;US-PFIZER INC-2021049695 same reporter/ drug/ event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive after taking the 1stdose/tested positive for Covid/they got a result for asymptomatic employee that tested positive with COVID 19; tested positive after taking the 1stdose/tested positive for Covid/they got a result for asymptomatic employee that tested positive with COVID 19; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable Nurse reported similar events for 3 patients.This is 3rd of 3 reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan202 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid after taking the 1st dose/got a result for asymptomatic employee that tested positive with covid 19 on 11Jan2021. The nurse reported that got the first shot on the 05Jan2021 for all of the 50 employees and 70 residents. On 11Jan2021, they got a result for asymptomatic 3 employees that tested positive with COVID 19. HCP had questions about 2nd dose guidelines, if they can take the second shot after testing positive. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021049693 same reporter/ drug/ event, different patients.;US-PFIZER INC-2021049694 same reporter/ drug/ event, different patients.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: left armpit and left breast lymph node swelling; left armpit and left breast lymph node swelling and still hurting; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 15Jan2021 at 09:15 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included the patient was a diabetic; penicillin, crustacean, rye, wheat and barley allergy; and COVID-19 diagnosed prior to the vaccination. Concomitant medications included metformin, atorvastatin, dapagliflozin propanediol monohydrate (FARXIGA) and an unspecified hormone replacement. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 15Jan2021 at 13:00, the patient experienced left armpit and left breast lymph node swelling, which was still hurting and swelling at the time of this report. The events resulted in a doctor or other healthcare professional visit. The patient was treated with ibuprofen (ADVIL) every 6-8 hours for pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of left armpit and left breast lymph node swelling and still hurting was not resolved at the time of this report.  information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Movement disorder
Clinical narrative: Swollen/tender lymph nodes under right arm; Swollen/tender lymph nodes under right arm; Hard for movement; This is a spontaneous report from a non-contactable nurse (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the right arm, on 18Jan2021 08:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant at the time of vaccination. There were no other medications received within 2 weeks of vaccination. The patient experienced swollen/tender lymph nodes under right arm and hard for movement on 19Jan2021 08:00. Patient was recovering from the events and no treatment was received. The events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Laboratory test, Pruritus, Skin mass, Skin swelling
Clinical narrative: large blister to front half of scalp; itching to front half of scalp; Started to have small swelling nodes in the scalp; Started to have small swelling nodes in the scalp; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL1284), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history included allergy to dust, runny nose and blood pressure. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) for allergy to dust and runny nose, patient also took some medicines to control blood pressure. It was reported that the patient experienced large blister and itching to front half of scalp. The clinical course was as follows. He took the vaccine on last Monday 11Jan2021, and three days later (14Jan2021) that blisters appeared in his scalp. He noticed when he woke up the morning on his front half was a large blister and itching. He wanted to know if it is a reaction and what should he do. The physician looked at him and gave prednisone to take for 5 days. Blisters were gone. Three days after the vaccine (14Jan2021), patient started to have small swelling nodes in the scalp. Patient had about two or three nodes in his scalp. Patient didn't have a fever. Due date of second shot was 01Feb2021. Patient had lab test once in a month and everything was okay. No problem. For treatment in response to event small swelling nodes in the scalp: patient stated no, he was taking fexofenadine hydrochloride. Patient just took it by himself it was an anti-allergic. Patient normally take if he has allergy to dust or a runny nose. The outcome of blisters to front half of scalp was recovered in Jan2021, and for other events was unknown. No investigation assessment.  Information on the lot/batch number has been requested.  Follow-up (17Jan2021): New information reported from a contactable consumer (patient) includes: patient details, medical history, concomitant medications, lab data, new events (add small swelling nodes in the scalp).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Disease recurrence, Ear pain, Muscle spasms, Trigeminal neuralgia
Clinical narrative: Backache and back spasms; Backache and back spasms; Ear pain on right side of head; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; This is a spontaneous report from a contactable Other Health Professional reporting for herself  A 43 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 18Jan2021 at 12:15  at single dose intramuscular on arm left  for COVID-19 immunization. Medical history included Trigeminal Neuralgia, asthma, High blood pressure, CSF leak out of my nose (which has spontaneously healed), Seasonal allergies, milk allergies to lactose, Allergy to arthropod sting (tongue swelled up once from a hornet sting on hand) and allergic reaction to antibiotics (hands swell up). Concomitant medications included propranolol. On 18Jan2021 soon after vaccination (reported as 18Jan2021 at 12:15), patient experienced backache and back spasms. Ear pain on right side of head. Patient had trigeminal Neuralgia and it made her face temporarily flare up with the side face pain (as reported). Patient didn't received treatment. At the time of the reporting the patient was recovering from the events.   information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: her hand was slightly swollen and today it is even more swollen; This is a spontaneous report from a   consumer (patients husband).  A 50-year-old female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the flu shot on August 29th. The consumer reported that his wife took the second dose of the vaccine on "Monday" morning. Yesterday she noticed that her hand was slightly swollen and today it is even more swollen. The event was non-serious. The clinical outcome of the event swelling of hands was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive after receiving the Covid-19 vaccine; tested positive after receiving the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. This case refers to the first of three employees tested positive for Covid-19 after receiving the vaccine.  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140, expiry date Mar2021), via an unspecified route of administration, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 51-years-old. Medical history and concomitant medications were unknown. The patient was tested on 08Jan2021. She received the results on 12Jan2021 and tested positive after receiving the Covid-19 vaccine. She is asymptomatic. It hasn't affected her but she has not been able to work. The event was reported serious as medically significant. Outcome was unknown. She states she was asking about getting 2nd vaccine.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile. However the short duration of 3 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive after receiving the Covid-19 vaccine; tested positive after receiving the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. This case refers to the first of three employees tested positive for Covid-19 after receiving the vaccine.  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140, expiry date Mar2021), via an unspecified route of administration, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 51-years-old. Medical history and concomitant medications were unknown. The patient was tested on 08Jan2021. She received the results on 12Jan2021 and tested positive after receiving the Covid-19 vaccine. She is asymptomatic. It hasn't affected her but she has not been able to work. The event was reported serious as medically significant. Outcome was unknown. She states she was asking about getting 2nd vaccine.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile. However the short duration of 3 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disturbance in attention, Fatigue
Clinical narrative: I felt weak; hard to focus; fatigued; This is a spontaneous report from a contactable healthcare professional (the patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 19Jan2021 at 12:45 (at the age of 52-years-old) as a single dose for Covid-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient's concomitant medications included omeprazole (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Jan2021 at 13:30, the patient experienced felt weak, hard to focus, and fatigued. It was reported that the shot was at 12:45 pm, the patient had to lay down until she went to bed. Felt 80% better in the morning. The patient did not receive any treatment for the events. The clinical outcome of the events asthenia, disturbance in attention and fatigue was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Arthralgia, Nausea, Pain, Pain in extremity
Clinical narrative: nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate vasomotor symptoms; body aches; This is a spontaneous report from contactable nurse (patient herself). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:00 in right deltoid at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 19Jan2021, patient experienced mild to moderate arm pain in arm that had shot, more than just injection site pain. Pain was from wrist to shoulder. 2-3 hours later moderate vasomotor symptoms followed with body aches. She took celecoxib (CELEBREX)and paracetamol (TYLENOL), body aches got better. 7 hours post injection, she felt nauseous and took ondansetron (ZOFRAN). Outcome of events were unknown.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate vasomotor symptoms; body aches; This is a spontaneous report from contactable nurse (patient herself). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:00 in right deltoid at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 19Jan2021, patient experienced mild to moderate arm pain in arm that had shot, more than just injection site pain. Pain was from wrist to shoulder. 2-3 hours later moderate vasomotor symptoms followed with body aches. She took celecoxib (CELEBREX)and paracetamol (TYLENOL), body aches got better. 7 hours post injection, she felt nauseous and took ondansetron (ZOFRAN). Outcome of events were unknown.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Facial paralysis, Viral test negative
Clinical narrative: Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower left pain under ear, sudden onset; This is a spontaneous report from two contactable consumers. A 50-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 08:30 at single dose for COVID-19 immunisation.  Medical history included depression, anxiety, Post-traumatic stress disorder (PTSD), elevated pressure increased (BP), elevated cholesterol, spondylosis with radiculopathy. Known allergies: NSAID's and augmentin. Concomitant medications included hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), hydroxyzine, atorvastatin and ascorbic acid;betacarotene;biotin; calcium; chloride; chromium; copper; folic acid; iodine; iron; magnesium; manganese; molybdenum; nickel; nicotinic acid; pantothenic acid; phosphorus; potassium; pyridoxine hydrochloride; riboflavin; selenium; silicon; thiamine; vanadium; vitamin B12 NOS; vitamin D NOS; vitamin E NOS; vitamin K NOS; xantofyl; zinc (CENTRUM SILVER WOMEN 50+). On 05Jan2021 at 13:00, patient experienced lower left pain under ear, sudden onset. Then, noticed symptoms of a stroke. Left sided face droop. Patient went to ER (emergency room). Patient was diagnosed with Bell's Palsy from Covid-19 injection (1st dose). Patient received treatments for the events included prednisone, acyclovir, ointment to protect eye and eye patch for covering of left eye. Lab test included Nasal Swab: negative on 07Jan2021. Outcome of the events was resolving.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: antibody test done 18Jan2021 and the results were negative; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization on 18Dec2020. Patient received the second dose of the Pfizer vaccine on 08Jan2021 and had an antibody test performed on 18Jan2021. The results were AB IGG negative response. Patient asked "Have you encountered this in your trials? Is there a point of contact that I could talk to about my immune response? I take no medications, have no significant medical history. I think it would be important information for me and my patients to know if some people just don't make antibodies to COVID-19." The outcome of the event antibody test/negative was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.