chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Fatigue
Clinical narrative: severe chills; chest pain returned; dizziness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Nov2021 08:30 (Lot number: FJ8757) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose; 1, Time: 09:00, Anatomical site of injection: right upper arm, Route of administration: Intramuscular, Lot: FE3590), administration date: 17Oct2021, when the patient was 36 years old, for Covid-19 immunization, reaction(s): "Chest pain". The following information was reported: CHILLS (non-serious) with onset 21Nov2021 09:00, outcome "recovered", described as "severe chills"; CHEST PAIN (non-serious) with onset 21Nov2021 09:00, outcome "recovered", described as "chest pain returned"; DIZZINESS (non-serious) with onset 21Nov2021 09:00, outcome "recovered", described as "dizziness"; FATIGUE (non-serious) with onset 21Nov2021 09:00, outcome "recovered", described as "fatigue". Therapeutic measures were not taken as a result of chills, chest pain, dizziness, fatigue.  Follow-Up (17Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Head discomfort, Headache
Clinical narrative: lightheadedness; headache; pressure in head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 12:00 (Lot number: FF2587) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 27Sep2021, Time (24hr): 12:00 PM, Anatomical site of Location: Right upper arm, Batch/Lot number: Lot # FF2587), administration date: 27Sep2021, for Covid-19 immunization, reaction(s): "extreme pressure in brain / cranial area", "Brain just feels swollen", "headache", "dizzy spell", "migraine". The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "lightheadedness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "pressure in head". The events "lightheadedness", "headache" and "pressure in head" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, headache, head discomfort.  Additional information: Vaccination Facility Type: Hospital. Vaccine Administered at Military Facility: No. Prior vaccinations: None. Concomitant drugs: None. Patients Medical History: None. As of 06Nov2021, patient still feel headache and pressure in head going to see neurologist. Specific relevant test for thromboembolic events with thrombocytopenia: None. Patient took the second vaccine on the opposite arm as worked for the government and was forced to take it. The second shot had a moment of lightheadedness but did not feel rush to head as did with the first shot. The pressure and extreme headache has been with me since the first shot and to this day has never left. patient did go to the emergency room 20Oct2021, where a CAT scan was done and they found nothing. They prescribed a headache medication Benzonatate which does nothing. Patient took Aleve, which elevated the pressure mildly for two seconds. As of today 29Nov2021 still suffering from the cranial pressure and headache.   No follow-up attempts are possible. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101342058 Same patient, different dose/AEs.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Right side of my face went numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:00 (Lot number: EN6206) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE taken for seasonal allergy.  The following information was reported: HYPOAESTHESIA (non-serious) with onset 11Mar2021 09:27, outcome "recovered" (11Mar2021 18:27), described as "Right side of my face went numb". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: Patient received BNT162B2, administered in right arm, administration date 01Apr2021 09:35 (Lot number: ER8730) as a DOSE 2, Single for Covid 19 immunization.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: developed a weird taste in my mouth. Taste like metal and salt.; developed a weird taste in my mouth. Taste like metal and salt.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Gr8734) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30(at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included ibuprofen (ADVIL) and paracetamol (TYLENOL); both from unknown indication and start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 10:45, the patient developed a weird taste in mouth which tasted like metal and salt. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event developed a weird taste in mouth which tasted like metal and salt were not resolved.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: First name of reporter slide#2 removed and moved to Institution field. Best doctor phone added.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in arm pit; Lymph nodes in arm pit painful; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the left arm on 05Apr2021 at 09:45 (at the age of 17-year-old) as dose 2, single for COVID-19 immunization. Medical history included asthma. The patient had known allergies to contrast media and penicillin. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 09:15 (at the age of 17-year-old) as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced swollen lymph nodes in arm pit, painful and tender armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Narrative amended.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Mild headache; pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Apr2021 at 11:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took Amoxicillin on unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 11:45 the patient experienced mild headache and pain at injection site. The adverse events did not result in doctor or other healthcare professional office, or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcomes of the event mild headache and vaccination site pain was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (02Aug2021): This follow-up report is being submitted to amend previously reported information: Reporter/patient's name amended. Facility type vaccine Pharmacy or Drug Store added.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Tinnitus
Clinical narrative: Normal sore arm; a little fatigue; the shocker was Ringing in my ears/ had some tinnitus, but has gotten much worse just from the first dose; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 13:00 (at the age of 63-year-old) as dose 1, single for COVID-19 immunization. Medical history included HIV (human immunodeficiency virus infection) positive and tinnitus (ongoing). The patient's known allergies noted as penicillin. Concomitant medications included emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate (ODEFSEY) (reported as odefsy) from an unknown date for an unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, at 15:00, the patient had normal sore arm, a little fatigue, but the shocker was ringing in the ears. It was reported that, the patient had some tinnitus, but had gotten much worse just from the first dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Relevant medical history, products tab, events tab and narrative were amended.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue
Clinical narrative: diarrhoea; stomach cramps; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 03:45 (at the age of 46-years-old) as dose 2, single for COVID-19 immunisation. Medical history included rheumatoid arthritis, latex allergy, sulfa allergy and allergy to erythromycin and tetracycline. Concomitant medications included levothyroxine sodium (SYNTHROID), simponi aria (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) for unknown indication on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 13:30 hours, the patient experienced diarrhoea, stomach cramps and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the event diarrhoea, stomach cramp and fatigue was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of past drug event, relevant medical history and Concomitant drug information.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: A very light headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and bronchitis. Concomitant medications included epinephrine (PRIMATENE MIST) inhalation aerosol taken from on an unknown date for an unknown indication. The patient had not known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Mar2021 at 00:00, the patient experienced a very light headache that did not go away since 14 days after the first shot. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event a very light headache and included treatment with TYLENOL. The clinical outcome of the event a very light headache was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended patient's middle name in patient tab and narrative.
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Magnetic resonance imaging head, Tinnitus
Clinical narrative: sudden onset unilateral tinnitus to the side of the vaccine administration (left).; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. The patient had no known allergies.  Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced a sudden onset unilateral tinnitus to the side of the vaccine administration on the left side. The patient denied any associated hearing loss, otalgia, otorrhea, prior tinnitus, or history of loud noise exposure. He stated that it was present after the first shot and then mildly improved, and then significantly worsened after the second shot. The patient further described the tinnitus as high pitched buzzing, non pulsatile and he had no issues on the right side. This event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus and included treatment with prednisone (60mg) for 5 days and the patient underwent MRI brain scan with internal auditory canal (IACs) which was normal, audiogram was essentially normal with mild left high frequency sensory neural hearing loss. The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended Start date and stop date of vaccine were removed, reporter information, and anatomical location.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Foot deformity
Clinical narrative: COVID TOES; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 09Mar2021(at the age of 69-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not provided. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) 30mg, meloxicam (MANUFACTURER UNKNOWN) 15mg and fluvastatin (MANUFACTURER UNKNOWN) 20m; all from an unknown date for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration in the left arm on 16Feb2021 at 13:45 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021, the patient experienced COVID toes. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event COVID toes was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021): This follow-up report is being submitted to amend previously reported information: Amended HCP last name and Suffix; Postal Code in patient tab;Age and units for historical Vaccine.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Heart rate decreased, Heart rate increased
Clinical narrative: Started on Sunday, November 7 with dizziness the feeling of passing out. On November 9 ended up in the ER all day. CT scans ran everything OK. Bloodwork done everything fine. Still have the dizziness heart rate was dropping pulse rate going up. Was sent home told to drink plenty of fluids. They really didn?t think it was the shot but it was a coincidence that it happened I had the test on Friday this started on Sunday.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal
Clinical narrative: Started on Sunday, November 7 with dizziness the feeling of passing out. On November 9 ended up in the ER all day. CT scans ran everything OK. Bloodwork done everything fine. Still have the dizziness heart rate was dropping pulse rate going up. Was sent home told to drink plenty of fluids. They really didn?t think it was the shot but it was a coincidence that it happened I had the test on Friday this started on Sunday.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Frustration tolerance decreased, Gait disturbance, Impaired driving ability
Clinical narrative: 4 days after the first Moderna shot, I got several crazy migraines. 4 days after the second shot, I started spinning and woke up the following morning with extreme vertigo and vomiting. Went to Urgent Care. I am moving into week 7 and still unable to function due to dizziness. Also having lots of headaches/migraines. I am basically lying in bed most of the time (unable to drive, bothered by head movement, unable to spend to much time on screens, walking difficulty). This is debilitating and I am self employed (Losing thousands in pay). I am so frustrated and regret getting the vaccine. It feels like the vaccine caused an attack on my vestibular system.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Migraine, Mobility decreased, Neurological examination
Clinical narrative: 4 days after the first Moderna shot, I got several crazy migraines. 4 days after the second shot, I started spinning and woke up the following morning with extreme vertigo and vomiting. Went to Urgent Care. I am moving into week 7 and still unable to function due to dizziness. Also having lots of headaches/migraines. I am basically lying in bed most of the time (unable to drive, bothered by head movement, unable to spend to much time on screens, walking difficulty). This is debilitating and I am self employed (Losing thousands in pay). I am so frustrated and regret getting the vaccine. It feels like the vaccine caused an attack on my vestibular system.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vestibular disorder, Vomiting
Clinical narrative: 4 days after the first Moderna shot, I got several crazy migraines. 4 days after the second shot, I started spinning and woke up the following morning with extreme vertigo and vomiting. Went to Urgent Care. I am moving into week 7 and still unable to function due to dizziness. Also having lots of headaches/migraines. I am basically lying in bed most of the time (unable to drive, bothered by head movement, unable to spend to much time on screens, walking difficulty). This is debilitating and I am self employed (Losing thousands in pay). I am so frustrated and regret getting the vaccine. It feels like the vaccine caused an attack on my vestibular system.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound scan
Clinical narrative: I was 3 weeks pregnant at time of booster and my baby was just diagnosed with Spina Bifida.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Insomnia, Tinnitus
Clinical narrative: Significant ringing in ears (Tinnitus) which occurred originally after shot #2 on March 2, 2021 and lasted approximately 6-7 months.  Upon receiving shot #3 February 1, 2022 Tinnitus returned and is currently mostly moderate in intensity but bothersome sometimes affecting sleep.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm pain for 2 days, tiredness for 1 day.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Headache, Influenza like illness, Laboratory test normal, Myalgia
Clinical narrative: Flu-like symptoms, myalgia, headache
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Patient stated she had swelling of her hands, feet and legs after the vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Muscle spasms
Clinical narrative: Numbness in feet/legs; and muscle spasms in legs started February 15, 2022. Visited doctor. CAT scan and follow-up with neurologist scheduled.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Headache, Nausea
Clinical narrative: Redness and swelling in left arm, armpit and shoulder. Dizziness, headache, chills, nausea for 3 days. Lost feeling in arm off and on for 2 days.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Swelling
Clinical narrative: Redness and swelling in left arm, armpit and shoulder. Dizziness, headache, chills, nausea for 3 days. Lost feeling in arm off and on for 2 days.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Blepharitis, Pain
Clinical narrative: pimples in face and neck; inflamed eyelid; overall body aches for 10 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 16:00 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergy: sulfites; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergy: Sulfa drugs; "Penicillin allergy" (unspecified if ongoing), notes: Known allergy: Penicillin; "Factor V Leiden heterozygote" (unspecified if ongoing), notes: Factor V Leiden heterozygous. Concomitant medication(s) included: VITAMIN D NOS; ZINC; MAGNESIUM; VITAMIN B 12 [VITAMIN B12 NOS]. Past drug history included: Erythromycin, reaction(s): "drug allergy", notes: Known allergy: erythromycin. The following information was reported: ACNE (non-serious) with onset 26Mar2021 19:00, outcome "recovering", described as "pimples in face and neck"; BLEPHARITIS (non-serious) with onset 26Mar2021 19:00, outcome "recovering", described as "inflamed eyelid"; PAIN (non-serious) with onset 26Mar2021 19:00, outcome "recovering", described as "overall body aches for 10 days". Therapeutic measures were not taken as a result of acne, blepharitis, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 14:00 (at the age of 52-years-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 started on an unknown date. The patient had no known allergies. The patient did not receive any other medication in two weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 18:00, the patient experienced sore arm and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm and fatigue was recovering at the time of this report.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of product data and narrative as Dose Description updated to DOSE 1, SINGLE, Dose Number added as 1.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration on 06Apr2021 (at the age of 22-year-old), as dose number unknown, single for COVID-19 immunisation. Medical history included asthma started on an unknown date. The patient didn't have any known allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and budesonide; formoterol fumarate (SYMBICORT) both for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced fatigue and arm soreness. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event fatigue and arm soreness was recovering.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of narrative data as "known_allergies: No" provided and Final sentence was updated.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Paraesthesia
Clinical narrative: Tingling on face and left arm; Headache; Fatigue; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm right on 07Apr2021 at 09:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to latex, penicillin and dairy. The patient did not take any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no other vaccines in other two weeks. On 07Apr2021 at 10:00 the patient experienced tingling on face and left arm, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events tingling on face and left arm, headache and fatigue was resolving.    No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended: Patient full name added, address added. Reporter was patient, VAERS Primary Reporter Addl Qualification updated to patient. Protect Confidentiality was ticked. Known allergy: dairy was recoded as MILK ALLERGY per MedDRA.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swelling and pain in the armpit of the left arm of the injection sight.; Swelling and pain in the armpit of the left arm of the injection sight.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 27Apr2021 at 09:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included lansoprazole DR (MANUFACTURER UNKNOWN) 30 mg and lisinopril-hydrochorthiazide (Lisinopril HCTZ) 20-12.5 mg, both for an unknown indication and since an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 06Apr2021 at 10:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 11:00, the patient experienced swelling and pain in the armpit of the left arm of the vaccination site. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events swollen lymph node and armpit pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended dose description auto-populated for Concomitant drug.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: Lost balance in a 40%; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 634592236) via an unspecified route of administration in the left arm on 15Apr2021 at 10:45 (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation. Patient also received the first dose of unspecified vaccine(Lot Number:Fw0169) via an unspecified route of administration on 15Apr2021. Medical history included none. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 at 12:00 the patient experienced Loss of balance in a 40 percent not enough to fall but patient felt like the ground was moving every time when he bend down. It was very noticeable at first and fade out with the time. It was reported that patient was going take the second dose now, hopefully it was not going to be worse. The clinical outcome of the event Lost balance in a 40% was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of patient information and narrative data.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dysgeusia, Feeling hot, Headache, Muscle twitching
Clinical narrative: reduction in lactation; Metallic taste; Short term memory problems; Head ache; Pain at injection sight; Slight blurred vision; Both arm muscle twinge; Warmth in breasts; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 04May2021 at 16:45 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, fibromyalgia, fatigue, attention deficit disorder/ attention-deficit hyperactivity disorder (ADD/ADHD), anxiety, depression and obsessive-compulsive disorder (OCD). Concomitant medications included paracetamol (TYLENOL), omeprazole (OMEPRAZOL), prenatals and mitragyna speciosa (KRATOM) all for unknown indication from an unknown date. Medical history included known allergies to Nicolen, antidepressants. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 20:00 the patient experienced warmth in breasts, reduction in lactation, metallic taste, short term memory problems, head ache, pain at injection site, slight blurred vision and both arm muscle twinge. The clinical outcomes of the events warmth in breasts, reduction in lactation, metallic taste, short term memory problems, head ache, pain at injection site, slight blurred vision, both arm muscle twinge was unknown at the time of this report. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended past drug event, Relevant Med History, event coding, treatment received and narrative. drug allergy" was coded for "Past Drug Event: Nicolen" 2. A new slide "Relevant Med History" added for "known_allergies: antidepressants" 3. "VITAMIN D NOS" was removed from product tab and left in narrative only. 4. Event updated from "Sore breasts" to "Feeling hot" per MedDra. 5.  "Treatment Received? No" was ticked for all events. 6. "No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care." added in narrative. 7. "The patient previously took aluminium phosphate gel; magnesium trisilicate; sodium alginate (NICOLEN) and antidepressants." removed and updated to "Medical history included known allergies to Nicolen, antidepressants."
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Suppressed lactation, Vaccination site pain, Vision blurred
Clinical narrative: reduction in lactation; Metallic taste; Short term memory problems; Head ache; Pain at injection sight; Slight blurred vision; Both arm muscle twinge; Warmth in breasts; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 04May2021 at 16:45 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, fibromyalgia, fatigue, attention deficit disorder/ attention-deficit hyperactivity disorder (ADD/ADHD), anxiety, depression and obsessive-compulsive disorder (OCD). Concomitant medications included paracetamol (TYLENOL), omeprazole (OMEPRAZOL), prenatals and mitragyna speciosa (KRATOM) all for unknown indication from an unknown date. Medical history included known allergies to Nicolen, antidepressants. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 20:00 the patient experienced warmth in breasts, reduction in lactation, metallic taste, short term memory problems, head ache, pain at injection site, slight blurred vision and both arm muscle twinge. The clinical outcomes of the events warmth in breasts, reduction in lactation, metallic taste, short term memory problems, head ache, pain at injection site, slight blurred vision, both arm muscle twinge was unknown at the time of this report. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended past drug event, Relevant Med History, event coding, treatment received and narrative. drug allergy" was coded for "Past Drug Event: Nicolen" 2. A new slide "Relevant Med History" added for "known_allergies: antidepressants" 3. "VITAMIN D NOS" was removed from product tab and left in narrative only. 4. Event updated from "Sore breasts" to "Feeling hot" per MedDra. 5.  "Treatment Received? No" was ticked for all events. 6. "No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care." added in narrative. 7. "The patient previously took aluminium phosphate gel; magnesium trisilicate; sodium alginate (NICOLEN) and antidepressants." removed and updated to "Medical history included known allergies to Nicolen, antidepressants."
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Vaccination site pain
Clinical narrative: Fatigue; Soreness at injection site; Diarrhea; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 (at the age of 34-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history was not reported. The patient didn't have any known allergies. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, the patient experienced fatigue, soreness at injection site, diarrhea and headache. The patient didn't receive any treatment for the events. The clinical outcome of the events fatigue, soreness at injection site, diarrhea and headache was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of event data as Treatment Received updated to No and narrative updated; known allergies: No captured in narrative.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears that still continues.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 09Apr2021 at 11:15 (at the age of 63-years-old) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medications with in two weeks of the COVID-19 vaccination. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. One week after the vaccination, on 16Apr2021 at 00:00, the patient experienced ringing in his ears that still continued at the time of this report. The patient reported that he never had tinnitus in his life and now he had constant ringing in his ears. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event ringing in ears that still continued was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021): via regulatory authority. This follow-up report is being submitted to amend previously reported information: Amendment of Reporter data as Reporter's post code (withheld) amended and event data as Treatment: No added for event and Narrative information as "The patient had no allergies to medications, food, or other products" amended and "The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.".
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Left supra-clavicular lymph node swelling and tenderness; Left supra-clavicular lymph node tenderness; This is a spontaneous report from a contactable physician, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 03May2021 at 15:00 (at the age of 43-year-old) as dose 2, single for COVID-19 immunization. Medical history included depression and migraine.The patient had no allergies to medications, food, or other products. Concomitant medications included fluoxetine hydrochloride (FLUOXETINE) and desipramine (MANUFACTURER UNKNOWN) both from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 43-year-old) at 09:00 as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 09:00, the patient experienced left supra-clavicular lymph node swelling and tenderness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event left supra-clavicular lymph node swelling and tenderness was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021): This follow-up report is being submitted to amend previously reported information: Products tab, events tab and narrative were amended.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm left arm has been throbbing on and off for two weeks; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 06Apr2021 at 16.30 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy. Concomitant medications included loratadine (CLARITIN) on an unknown date for allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 16 Mar2021 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Apr2021, two weeks after the second dose of vaccination, the patient's left arm has been throbbing on and off for two weeks near the original site of vaccination. The patient did not have any side effects immediately after the second shot but the symptoms began two weeks later. The patient was not sure if it was a muscle strain or related to the vaccine. The patient did not received any treatment for the event. The clinical outcome of the event left arm has been throbbing on and off for two weeks near the original site of vaccination was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended treatment received in event tab and narrative.