chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling in the glands between my neck and left shoulder; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0169) via an unspecified route of administration, in the left arm on 21Apr2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included high triglycerides and low good cholesterol. The patient had known allergies to MSG (monosodium glutamate) chocolate, nuts artificial color, artificial sweetener, sulfur based drugs, penicillin and more. Concomitant medications included gemfibrozil (MANUFRATURER UNKNOWN), niacin (MANUFRATURER UNKNOWN), vitamin C (MANUFRATURER UNKNOWN), fish oil (MANUFRATURER UNKNOWN) and antihistamine (MANUFRATURER UNKNOWN) all were from unknown date and for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021, at 22:30 the patient noticed a swelling in the glands between the neck and left shoulder, the arm which was vaccinated.  It has been two weeks since the first shot, the patient know it was possible but want to report it for the data points. The adverse events did not result in a visit to the 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 swelling in the glands between the neck and left shoulder 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: Amended reporter information,Treatment received and narrative was updated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Fatigue, Headache, Hot flush
Clinical narrative: dehydrated; slight HA; hot and cold flashes; fatigue; moderate diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old 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 arm right on 04May2021(at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraines, anxiety, depression. The patient was allergic to kiwi (fruit allergy) and latex allergy. Concomitant medications included topiramate (MANUFACTURER UNKNOWN), Sertraline (MANUFACTURER UNKNOWN), Rizatriptan (MANUFACTURER UNKNOWN), Paracetamol (TYLENOL), Ibuprofen (IBU) AND Spironolactone (MANUFACTURER UNKNOWN), B1 (UNKNOWN MANUFACTURER), multivitamin (MANUFACTURER UNKNOWN) and nurdec etc (MANUFACTURER UNKNOWN). The patient previously took minocycline in the past for unknown indication. 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 03Apr2021 (at the age of 34-years-old) 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 04May2021 at 14:00, About 4.5 hours of after the vaccine, the patient experienced hot and cold flashes, fatigue and moderate diarrhea. It is currently the next day, On 05May2021, the patient experienced dehydrated and slight HA (headache nos) and mild diarrhea still. The clinical outcome of the event's hot flashes, cold flashes, fatigue, moderate diarrhea, dehydrated and slight HA was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow up (02Aug2021) via an agency: This follow-up report is being submitted to amend previously reported information: Past Drug Event reaction; Drug start and stop time; Event coding; Narrative updated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: started experiencing excruciating lower back pain radiating through legs; excruciating lower back pain radiating through my legs. pain was unbearable and could barely stand completely upright; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04May2021 at 07:00(at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and hashimoto's disease. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cyanocobalamin (B12), colecalciferol (VIT D3)all from unknown date for unknown indication. The patient has allergies to Gluten and dairy intolerant. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 13Apr2021 at 07:00(at the age of 35-year-old) as a single dose for COVID-19 immunisation. 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 04May2021 at 20:15 the patient started experiencing excruciating lower back pain(back pain) radiating through her legs. she have not experienced any lower back or leg pain previously nor she have a history of anytime of pain in the lower extremities. The pain was unbearable that she could barely stand completely upright(pain in lower extremities). She explains about her as a healthy eating and exercise routine, Vegan, Work out 4x per week, No Alcohol, No Tobacco or Drugs. Therapeutic measures were taken as a result of adverse event and included treatment with several over the counter pain relievers (so that she could sleep comfortably, but she was still experiencing pain on the first day post vaccination). The clinical outcome of the event started experiencing excruciating lower back pain(back pain) radiating through legs(pain in lower extremities) were not resolved.    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 medical history.
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Recurring migraine headaches the week following each injection; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included High blood pressure and cholesterol. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. 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 27Feb2021 at 07:00, the patient experienced recurring migraine headaches the week following each vaccination. Typical frequency is 3-4 per year, the patient had 4 after week after the first shot, 2 the week after the second shot. 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 recurring migraine headaches the week following each vaccination was unknown 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: Patient Country and contact information added. Relevant Med History Cholesterol was updated to Cholesterol high. Treatment Received was selected as No. Information "if treatment ae: No" and "known allergies: No" provided. Narrative "Medical history included blood pressure high and cholesterol" was updated to "Medical history included High blood pressure and cholesterol".
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Fatigue, Headache, Photophobia
Clinical narrative: Patient described 2 weeks of bone pain; Headache; Photophobia; Back pain; Fatigue; This is a spontaneous report received from a contactable reporter physician. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was healthy. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced two weeks of bone pain, headache, photophobia, back pain and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment for events. On 05May2021, the patient underwent COVID-19 virus test and the result was pending. The clinical outcome of the events headache, bone pain, photophobia, back pain, and fatigue were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Follow up (01Aug2021): This follow-up report is being submitted to amend previously reported information: Amendment of reporter data, patient information, Lab data, Vaccination details, Event data and narrative.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Patient described 2 weeks of bone pain; Headache; Photophobia; Back pain; Fatigue; This is a spontaneous report received from a contactable reporter physician. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was healthy. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced two weeks of bone pain, headache, photophobia, back pain and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment for events. On 05May2021, the patient underwent COVID-19 virus test and the result was pending. The clinical outcome of the events headache, bone pain, photophobia, back pain, and fatigue were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Follow up (01Aug2021): This follow-up report is being submitted to amend previously reported information: Amendment of reporter data, patient information, Lab data, Vaccination details, Event data and narrative.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: Swelling of right wrist and forearm; Swelling of right wrist and forearm; Deep pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0153) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 57-years-old), as dose number unknown, single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL) 300 mg; metoprolol (MANUFACTURER UNKNOWN) 50 mg and omeprazole (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date.The past known allergy was reported as Keflex and Celestone . 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 20Apr2021, the patient experienced swelling of right wrist, forearm and deep pain in arm. The patient underwent ultrasound to rule out deep vein thrombosis (DVT) on an unknown date in 2021 and the result was unknown. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events swelling of right wrist, forearm and deep pain in arm and included treatment with an unspecified antibiotics and ultrasound to rule out deep vein thrombosis (DVT). The clinical outcome of the events swelling of right wrist, forearm and deep pain in arm were recovering 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: Amendment of reporter data, Past Drug Event data, Lb data and narrative.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: Injection arm swollen below injection site.; Injection arm swollen behind injection site.; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO158), via an unspecified route of administration in the left arm on 03May2021 at 14:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included calcium carbonate; Colecalciferol (CALTRATE), acetylsalicylic acid (ASPIRIN) (low dose) and vitamin d nos (VITAMIN D). The patient previously received ampicillin. 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 COVID-19 vaccination. On 03May2021 at 23:00, nine hours after the vaccination, the patient reported that the injection arm was swollen behind and below injection site. The clinical outcome of the event injection arm swollen behind and below injection site was not resolved at the time of this report.   The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported: Facility information updated. Treatment Received updated to NO for all AEs. "The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received" added in narrative. Event verbatim added for past drug Ampicillin allergy.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased immune responsiveness, Headache, Nausea, Pain
Clinical narrative: Nausea; stomach cramps; headaches/ Painful in head to have eyes open.; achiness; Had to take work off and slept off and on throughout day; Debilitating immune response.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm left on 04May2021 at 10:30 (at the age of 29-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 29-years-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 04May2021 at 22:00, the patient experienced debilitating immune response, onset at night. Nausea, stomach cramps, headaches, achiness. Painful in head to have eyes open. Patient had to take work off, and slept off and on throughout day. Patient also reported that he did workout much harder than he usually does in the afternoon. The patient did not receive any treatment for the events. The clinical outcome of events was not recovered 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: Events tab and narrative were amended.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Nausea; stomach cramps; headaches/ Painful in head to have eyes open.; achiness; Had to take work off and slept off and on throughout day; Debilitating immune response.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm left on 04May2021 at 10:30 (at the age of 29-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 29-years-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 04May2021 at 22:00, the patient experienced debilitating immune response, onset at night. Nausea, stomach cramps, headaches, achiness. Painful in head to have eyes open. Patient had to take work off, and slept off and on throughout day. Patient also reported that he did workout much harder than he usually does in the afternoon. The patient did not receive any treatment for the events. The clinical outcome of events was not recovered 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: Events tab and narrative were amended.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Very sore arm; bad body aches; Chills; sweating; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 05May2021(at the age of 18-years-old) at 11:00 as a single dose for COVID-19 immunisation and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 15Apr2021(at the age of 18-years-old) at 03:30 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to COVID 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 05May2021 at 21:00 hours the patient experienced very sore arm, bad body aches, chills and sweating. The clinical outcome of the events very sore arm, bad body aches, chills, and sweating were recovering at the time of this report and No treatment were received.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's "Age at Vaccination/Units" updated from "51 years" to "18 years".  2. For suspect vaccine, Start/Stop Date updated from "05-MAY-2021 00:00" to "05-MAY-2021 11:00" per source reported.  3. For all events: "Treatment Received?" captured as "No" per source reported "if treatment ae: No"--this also missed in consolidated narrative.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder discomfort, Bladder pain
Clinical narrative: Bladder pressure and pain; Bladder pressure and pain; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medications included Birth Control medications, Concomitant vaccine included influenza vaccine (FLU) on 23Mar2021 for influenza immunisation within four weeks of COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient did not had any allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19 or not. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced bladder pressure and pain with lot of discomfort, UTI, symptoms but no UTI. It was unknown if the patient received any treatment for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event of bladder pain was recovering 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: 1.Vaccination Facility Type added. 2.AE: Bladder pressure and pain also coded as Bladder discomfort. 3.Narrative added: Concomitant medications included Birth Control medications.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Feeling week; light headed; exhausted; This is a spontaneous report from a contactable consumer, the patient. A 49-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 17Apr2021 at 17:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to foods like tree nuts, apples and others. Concomitant medications included rosuvastatin calcium (CRESTOR) 20 mg, piroxicam (PAXIL) 30 mg and cetirizine hydrochloride (ZYRTEC) 10 mg all for unknown indication on 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 05May2021, the patient felt weak, light headed and exhausted for the past three days. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events feeling weak, light headed and exhausted for the past three days was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment (04Aug2021): This follow-up report is being submitted to amend previously reported information: reporter's fax number added, Vaccine Facility Information added, con-med Paxil/Zyrtec recoded.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: Uncontrollable chills; Body aches; Headache; fatigue; Fog brain; This is a spontaneous report from a non-contactable consumer, the patient. A 34-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 right arm on 01May2021 at 10:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included acetylsalicylic acid (ASPIRIN) 81mg, prenatal vitamins (MANAFACTURER UNKNOWN) all from an unknown for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 14:00 (at the age of 34-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 01May2021 at 22:00 the patient experienced uncontrollable chills, body aches, head ache, brain fog, fatigue. No therapeutic measures were taken for the events. The clinical outcome of the events chills, general body pain, headache, fatigue, foggy feeling in head recovered on an unspecified date in May2021.  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 tab, historical vaccine, Concomitant drug recoded, treatment received checked no and updated in narrative, therapeutic measures no updated in narrative.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Breast mass, Mammogram, Ultrasound breast
Clinical narrative: I found a lump in my left breast. After consulting with my doctor. I went in for an exam. By that time the lump had grown. I then scheduled a mammogram and ultrasound.  The lump has shrunk in that time but was still visible on imaging. Dr. then determined it was a cyst. No further treatment was recommended.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Lacrimation increased, Petechiae, Pruritus
Clinical narrative: Pt stated feeling SOB, tearing, itching, and petechiae.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Immediate post-injection reaction, Lacrimation increased, Petechiae
Clinical narrative: Pt stated feeling SOB, tearing, itching, and petechiae.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Pt stated feeling SOB, tearing, itching, and petechiae.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Lacrimation increased, Petechiae, Pruritus
Clinical narrative: anaphylaxis--eyes water, short of breath, itching all over, petechiae immediately.  Treated with pepcid, hydroxyzine, albuterol inhaler, epipen
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Immediate post-injection reaction, Lacrimation increased, Petechiae
Clinical narrative: anaphylaxis--eyes water, short of breath, itching all over, petechiae immediately.  Treated with pepcid, hydroxyzine, albuterol inhaler, epipen
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: anaphylaxis--eyes water, short of breath, itching all over, petechiae immediately.  Treated with pepcid, hydroxyzine, albuterol inhaler, epipen
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Neck pain
Clinical narrative: Patient states : Arm was painful right after injection on left arm and continued. Injection site pain worsened and went up to neck and down to elbow within the next day to neck day and a half. Within 2 days noticed decrease range of motion and pain persisted. Patient used a heat pack with some resolution in pain, but no tylenol or advil. At day 5, consulted with Dr through a video appointment about arm pain and told to continue to utilize heat pack if it helps. Patient told MD will start to take advil for pain, Md agreed to treatment.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Erythema, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Started with a low grade fever, clouded thoughts, and fatigue. Low grade fever continues to climb over the course of the next day. Arm soreness and redness
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral small vessel ischaemic disease, Magnetic resonance imaging head, Magnetic resonance imaging neck, Muscle spasticity, Spinal flattening
Clinical narrative: Increased tremor and spasticity or left arm presenting within a few days of receiving COVID vaccination
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Ultrasound Doppler, Vertebral foraminal stenosis
Clinical narrative: Increased tremor and spasticity or left arm presenting within a few days of receiving COVID vaccination
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt's father requested Moderna booster for patient who had completed a primary Pfizer series. Vaccination proceeded with consent. As per phone conversation with father on 3/5/2022, Patient feels fine and denied any reactions from the booster.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: NONE
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Bone lesion, Computerised tomogram abnormal, Injection site pain, Injection site swelling
Clinical narrative: Development of painful swelling in the left upper arm, gradually worsening and increasing in size subsequently diagnosed as subcutaneous panniculitis -like T-cell lymphoma
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Panniculitis, Positron emission tomogram abnormal, Skin lesion, Splenomegaly
Clinical narrative: Development of painful swelling in the left upper arm, gradually worsening and increasing in size subsequently diagnosed as subcutaneous panniculitis -like T-cell lymphoma
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive
Clinical narrative: Ana positive Scl-70 positive
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Real tired, hands hurt, fingers hurt, thighs hurt and comes and goes and been going on about a year.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: patient was given the 12+ formulation, instead of the pediatric formulation - no known adverse effects per father
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Skipped menstrual cycle during the month of March; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-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 12Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization. The patient later 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 02Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation  Medical history included allergy to dairy and the allergic reaction was worst with non-organic dairy products. Concomitant medications were unknown. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 the patient skipped menstrual cycle during the month of March. Her expected due date for the month of March was the 25Mar2021, 2 weeks after her first vaccine date. The patient did not receive any treatment for the event. 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 patient skipped menstrual cycle during the month of March was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.   Follow-Up (04Aug2021) This follow-up report is being submitted to amend previously reported information: Dose 2 was removed from suspect dose regimen tab. Dose 2 start date updated in narrative. Reporter's first name added and last name leave blank.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vision blurred
Clinical narrative: Blurry vision; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0158), via an unspecified route of administration in the left arm on 13Apr2021 at 17:45(at the age of 40-year-old), as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0173), via an unspecified route of administration in the left arm on 05May2021 at 14:00 (at the age of 40-year-old), as dose 2, single for COVID-19 immunization. Medical history was reported as not applicable. The patient was not a pregnant at the time of vaccination. The patient was allergic to wheat and lactose. Concomitant medications included multivitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On an unspecified date in 2021, the patient underwent nasal swab test (SARS-CoV-2 test) and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced blurry vision. On 05May2021, the patient again experienced blurry vision. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event blurry vision (started on 13Apr2021) was recovered on 14Apr2021 and that of the event blurry vision (started on 05May2021) was resolved on 06May2021.   No follow-up attempts are needed. No further information is expected.  Amendment (03Aug2021): This follow-up report is being submitted to amend previously reported information which included updated Age at Vaccination to 40 years, dose 2 Anatomical Location added, Vaccine Facility Information added, lab test time captured as 2021 since test post vaccination, per narrative "Blurry vision that started soon after and lasted until next day. It happened after each dose", merge event in one slide and event start date/stop date leave blank since it is also happened after first dose, Medical history was reported as none" updated as medical history was reported as not applicable.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Superficial redbumps; This is a spontaneous report from a contactable pharmacist.   A 19-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via intramuscular route of administration in the left arm on 29Apr2021 (at the age of 19-year-old), as dose 1, single for COVID-19 immunization. Patient relevant medical history included food allergy (known allergies: fish containing products). Patient took unknown concomitant medications. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an intramuscular route of administration in the left arm on 08Apr2021 (at the age of 19-year-old), as dose 1, single for COVID-19 immunization. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021, the patient experienced superficial red bumps. The patient reported that superficial red bumps did not previously recall on left inner thigh; the patient was encouraged to stay further after drinking 16 fluid ounces of water. The patient did not receive any treatment for the events. The adverse 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 superficial red bumps was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter's PC box unticked, Patient's initials updated, Patient's email removed, Vaccination facility country added, "Prior to the vaccination, the patient was diagnosed with COVID-19" removed from narrative, Concomitant therapy captured as yes.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes at neck and armpit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04May2021 09:00 (Batch/Lot number: unknown) at the age of 48 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, SINGLELot number: UNKNOWN), administration date: 13Apr2021, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04May2021 23:45, outcome "recovering", described as "Swollen lymph nodes at neck and armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   Follow-up (03Aug2021): Amendment: This follow-up report is being submitted to amend previously reported information: Age at vaccination captured as 48.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: pretty sick; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (22Jul2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: EN6200) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "pretty sick".  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: dizziness; Headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2021 10:00 (Lot number: EL3302) at the age of 56 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 21Jan2021 09:50, outcome "recovered" (2021), described as "dizziness"; HEADACHE (non-serious) with onset 21Jan2021 09:50, outcome "recovered" (2021), described as "Headache"; NAUSEA (non-serious) with onset 21Jan2021 09:50, outcome "recovered" (15Feb2021), described as "Nausea". Therapeutic measures were not taken as a result of dizziness, headache. Therapeutic measures were taken as a result of nausea.  Additional information:1st vaccine dose, had mild side effect. 2nd vaccine dose, nausea, vomiting, fever, body aches, chills, headaches lasted 3 days from date of 2nd vaccination administration consulted with physician nurse on 11Feb2021 and with physician via E-visit on 12Feb2021 due to side effect medication was prescribed for nausea and vomiting.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: My wife started menstrual cycle after second shot. She had been in menopause for over a year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 12:30 (Lot number: EW0162) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: ER8727, Administration time:10:00, Dose number 1, Vaccine location: Left arm), administration date: 22Mar2021, for Covid-19 immunisation. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 18Apr2021, outcome "unknown", described as "My wife started menstrual cycle after second shot. She had been in menopause for over a year". Therapeutic measures were not taken as a result of postmenopausal haemorrhage. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient was not tested for COVID.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue
Clinical narrative: States there was a pharmacist in from a temp agency and that pharmacist took an expired vial(expired one week prior) and diluted and gave to 6 patients; Tiredness; This is a spontaneous report from Medical Information Team. A contactable pharmacist reported that a 35-year-old (at the age of 35 years old) male patient received bnt162b2 (BNT162B2, Solution for injection, lot number :EW0178) via intramuscular on arm left on 22May21 as dose 1 single 09:35 and bnt162b2 (BNT162B2, Solution for injection, lot number: EW0170) via intramuscular on arm left on 14Apr21 as dose 1 single 09:22 for COVID-19 immunisation. Medical history included ongoing Citalopram 20mg for mood,ongoing Lisinopril 40mg, for blood pressure and concomitant medications LEXAPRO, PRINIVIL. Caller stated she was a pharmacist speaking about the Pfizer COVID-19 vaccine. Stated there was a pharmacist in from a temp agency and that pharmacist took an expired vial (expired one week prior) and diluted and gave to 6 patients. This was patient if one of 6 patients. Caller stated the vaccine had no other excursions while being stored. She would like to know if the patients need to be revaccinated. pharmacist pulled an expired vaccine from refrigerator (clearly marked expired and sequential awaiting destruction permission to destroy), reconstituted and administered the vaccine to 6 separate patient. The vaccine was 7 Days expired. The Patients reported no adverse effect only normal side effects (tiredness in this case) and elected not to get another dosage. Outcome of the event was unknown.   No follow-up attempts possible. No further information expected. Information on the lot/batch has been requested.  Follow-up (06Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (23Jul2021): This is a follow-up spontaneous report from a contactable Pharmacist. This Pharmacist reported in response to HCP letter sent that included: Medical history updated, dose details updated, clinical course updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021716440 same drug/reporter /events different patient