chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Swollen rash on back side of right thigh; Swollen rash on back side of right thigh; This is a spontaneous report from a non-contactable consumer, the patient. A 33-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 left arm on 29Jun2021 at 10:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included chiari malformation. 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 patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (ADVIL) and paracetamol (TYLENOL); both from unknown dates for unspecified indications. On 03Jul2021 at 19:00, the patient experienced swollen rash on back side of right thigh. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the  event and included treatment with steroid cream (MANUFACTURER UNKNOWN). The clinical outcome of the event swollen rash on back side of right thigh was resolving at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic Taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 25Jun2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder, Hashimoto's disease and non-Hodgkin's lymphoma. The patient had no known allergies. Concomitant medications included thyroid (ARMOUR THYROID), omeprazole (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and ubidecarenone, linum usitatissimum seed oil, conjugated linoleic acid (COQ10), all taken for unspecified indications from unknown dates. 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 25Jun2021 at 12:00, the patient experienced metallic taste in mouth instantly as the vaccine was administered and had been continuing 11 days after the vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken as a result of the event. The clinical outcome of the event metallic taste in mouth was not resolved at the time of this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: skipped one menstrual cycle; having a period lasting for 3 weeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via intramuscular route of administration in right arm on 02Apr2021 15:00 (at age of 45-years-old) as dose 2, single for covid-19 immunisation in public health clinic. The patient medical history was not reported. Patient had no known allergies and no other medical history. There were no concomitant medications. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiration date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On an unspecified date in May2021, the patient skipped one menstrual cycle and then having a period lasting for 3 weeks. No therapeutic measures were taken. The outcome of the events skipped one menstrual cycle and then having a period lasting for 3 weeks was unknown.    Information about lot/batch number has been requested.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: headache.; fever; chills; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient, self-reporting). A 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0164 and expiration date was no reported), dose 1 via an unspecified route of administration in arm right on 26Apr2021 as single dose for COVID-19 immunisation. Medical history included Known allergies for Penicillin from an unknown date and unknown if ongoing and patient had COVID-19 from Nov2020 to an unknown date. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On unspecified date in Apr2021 the patient experienced a normal reaction the day after each shot that was fever, chills and headache. On unspecified date of Nov2020 the patient underwent lab tests and procedures which included COVID-19 found to be positive. The patient did not receive any treatment for the adverse event. The outcome of the events was unknown.  Follow-up (27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Dizziness, Fatigue, Headache
Clinical narrative: Body aches; Balance issues; Fever; Nausea; Joint pain; Tired; Headache; Dizziness; Arm pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Jul2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included TBI (traumatic brain injury), hypertension and anxiety. The patient had known allergies to fish oil and sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and pethidine hydrochloride (DEMEROL) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Jul2021 at 22:45, the patient experienced fever, nausea, body aches, joint pain, tired, headache, dizziness, balance issues and arm pain at injection site. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events fever, nausea, body aches, joint pain, tired, headache, dizziness, balance issues and arm pain at injection site were not resolved at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Body aches; Balance issues; Fever; Nausea; Joint pain; Tired; Headache; Dizziness; Arm pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Jul2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included TBI (traumatic brain injury), hypertension and anxiety. The patient had known allergies to fish oil and sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and pethidine hydrochloride (DEMEROL) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Jul2021 at 22:45, the patient experienced fever, nausea, body aches, joint pain, tired, headache, dizziness, balance issues and arm pain at injection site. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events fever, nausea, body aches, joint pain, tired, headache, dizziness, balance issues and arm pain at injection site were not resolved at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Recurring itchy skin rash on both arms; Hives on both arms; This is a spontaneous report from a contactable consumer. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via intramuscular route of administration in the left arm on 29Mar2021 at 11:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included leaky heart valve, underactive thyroid and allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and alprazolam (MANUFACTURER UNKNOWN); all started from an unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via intramuscular route of administration in the left arm on 06Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 05Apr2021, the patient experienced recurring itchy skin rash/hives on both the arms. 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 recurring itchy skin rash/hives on both the arms was not recovered at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: HAVING AN INFECTION AFTER EACH VACCINE; This is a spontaneous report from a contactable Nurse. A 44-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. Took XELJANZ XR 11mg tablet (Lot Number: Unknown, Expiration date: 28Feb2023) via oral for rheumatoid arthritis from 21Oct2020. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced having an infection after each vaccine. Patient stated that stopped XELJANZ due to covid vaccine and having an infection after each vaccine, had been on and off of the XELJANZ for 4 weeks total and reports 4 urinary tract infections on XELJANZ. MD is aware. The outcome of event was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes, Urticaria
Clinical narrative: Recurrence of hives and HSV-1 lesions both on lips; Recurrence of hives and HSV-1 lesions both on lips; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration on an unknown date (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included hives and Herpes Simplex Virus (HSV)-1 lesions both on lips on an unknown date. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced recurrence of hives and HSV-1 lesions both on lips after 25 years being dormant. The recurrences began within 2 weeks of the second dose. The clinical outcome of the events recurrence of hives and HSV-1 lesions both on lips were unknown at the time of this report.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure via breastmilk; This is a spontaneous report from a contactable consumer. A child patient of an unknown gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: unknown and expiry date: unknown), transmammary on 27May2021 at 12:00 PM at dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. It was reported that the patient experienced vaccine exposure via breastmilk on an unknown date. The reporter considered the event to be non-serious. The patient did not receive any treatment for the reported event. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Rash, Vision blurred
Clinical narrative: Blurred vision; Swollen lymph node in armpit; Headache; Rash on arm; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ew0185) via an unspecified route of administration on 30Jun2021 as a single dose for COVID-19 immunisation. Medical history,  concomitant medications and past drug history were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in 2021, the patient experienced swollen lymph node in armpit, headache, blurred vision and rash on arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node in armpit, headache, blurred vision and rash on arm was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Hunger, Nausea
Clinical narrative: 100 degree fever; Joint aches; Teeth hurting a little; Felt very tired; Sudden feeling of hunger; Nausea; Little redness around the injection site; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0178) via an unspecified route of administration in the left arm on 19Jun2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and latex allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0178) via an unspecified route of administration in the  left arm on 29May2021 at 11:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. 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 20Jun2021 at 06:00 the patient experienced 100 degree fever, joint aches, teeth hurting a little, and felt very tired. Later in the afternoon, the patient had a sudden feeling of hunger, for less than a minute and then that feeling went away and immediately after I felt intense nausea which lasted about a minute. After that the nausea slowly went away, she felt tired tired the rest of the day and the next day but was slowly feeling better. By the fourth day she felt completely better and felt great.  Starting on 19Jun2021, the patient had a little redness around the injection site for several days after the shot and the patient reported to have had zero symptoms from the first 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. No therapeutic measures were taken for the reported events. The clinical outcome of the 100 degree fever, joint aches, teeth hurting a little, felt very tired, sudden feeling of hunger and nausea were recovered on an unknown date in Jun2021 and little redness around the injection site was recovered on an unknown date in 2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Toothache, Vaccination site erythema
Clinical narrative: 100 degree fever; Joint aches; Teeth hurting a little; Felt very tired; Sudden feeling of hunger; Nausea; Little redness around the injection site; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0178) via an unspecified route of administration in the left arm on 19Jun2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and latex allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0178) via an unspecified route of administration in the  left arm on 29May2021 at 11:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. 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 20Jun2021 at 06:00 the patient experienced 100 degree fever, joint aches, teeth hurting a little, and felt very tired. Later in the afternoon, the patient had a sudden feeling of hunger, for less than a minute and then that feeling went away and immediately after I felt intense nausea which lasted about a minute. After that the nausea slowly went away, she felt tired tired the rest of the day and the next day but was slowly feeling better. By the fourth day she felt completely better and felt great.  Starting on 19Jun2021, the patient had a little redness around the injection site for several days after the shot and the patient reported to have had zero symptoms from the first 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. No therapeutic measures were taken for the reported events. The clinical outcome of the 100 degree fever, joint aches, teeth hurting a little, felt very tired, sudden feeling of hunger and nausea were recovered on an unknown date in Jun2021 and little redness around the injection site was recovered on an unknown date in 2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Rash pruritic
Clinical narrative: Heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later; Heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later; Heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later; Heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jun2021 13:15 (Age at vaccination 64 years old) as DOSE 1, SINGLE for covid-19 immunisation. No medical history reported. Concomitant medications included levothyroxine sodium, rosuvastatin, cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), biotin taken for an unspecified indication, start and stop date were not reported. Not pregnant at time of vaccination. If covid prior vaccination, If covid tested post vaccination, Known allergies, other vaccine in four weeks were not received. On 30Jun2021 the patient experienced heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later. The patient did not received treatment. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: First dose: Bad for a couple of days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient reported that first dose was bad for couple of days. Later she stated the first shot wasn't so bad, it was bad for a couple of days and went away. At the time of this report, the outcome of event was recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: consumer wants to know how long the arm is supposed to hurt after the 2nd dose; This is a spontaneous report received from a contactable consumer (Patient himself). A 85-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not provided) as single dose for COVID-19 immunisation. It was reported that "I have a patient on the other line reporting a side effect with PFIZER-BIONTECH COVID-19 Vaccine. He was 85 years old and he wanted to know how long his arm was supposed to hurt after receiving the second dose but I was not able to confirm specifically on how long his arm has been hurting but he just wanted to know that information and just to inform you, I did give him the answer to his question and I already referred to him to his HCP. I am just transferring him over to you, so that you can get more details about the reaction that he had." Patient experienced event was on an unspecified date. Outcome of event was unknown.   Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nervousness, Toxicity to various agents
Clinical narrative: She wants to get the smaller dose for the second one instead of full 30 mcg. She thought its too much and too toxic; she feels weird after getting the first shot; She feels shaky and quavering inside; This is a spontaneous report received from a Pfizer sponsored program via a contactable consumer (patient herself). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch and Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date it was reported as the patient mentioned that she doesn't want to get the full dose of 30 mcg shot because she feels weird after getting the first shot, she feels shaky and quavering inside. She wants to get the smaller dose for the second one instead of full 30 mcg. She thought its too much and too toxic. She is saying that she knows that there is a small risk but every day she is just reading stuff. Its toxic, poison and we need a smaller dose. The vaccines are not only based on people weight they are also based on people age. She is a small person and receiving the same dose as her husband is four times. She wants to know if she can get the second dose and not the full shot of the dose, if not if she can just get one dose of the vaccines since she cannot tolerate the side effects. She is wondering if there is any information on taking partial doses of the COVID vaccine as she does not want full dose. The seriousness of the events was considered as non-serious. The outcome of the events was unknown.   Information on lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: Headache on left side of head; rash on face; This is a spontaneous report from a non-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: EW0161) via an unspecified route of administration in the left arm on 11May2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. 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 vaccine within four weeks prior to the COVID vaccine. Concomitant medication included multivitamin (MANUFACTURER UNKNOWN) from unknown start date and for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced headache on left side of head and rash on face. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of headache and rash on face and included treatment with muscle(unspecified) relaxer, ADVIL, TYLENOL from unknown start dates to unknown stop dates. The clinical outcome of the events headache and rash on face were recovered on an unknown date in 2021 at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: crp was elevated after 2nd dose; cough; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 04Feb2021 14:00 (at the age of 79-year-old) (Batch/Lot Number: EL9265) as dose 2, single for covid-19 immunisation. Medical history included, ongoing coronary artery disease Onset Date 5 years Pertinent Details ID. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 14Jan2021 14:00 (Batch/Lot Number: EK9231) as dose 1, single for covid-19 immunisation. On an unspecified date in Feb2021 ,the patient experienced C-reactive protein was elevated after 2nd dose and cough. The patient underwent lab tests and procedures which included x-ray: stable on 25Feb2021 and C-reactive protein was elevated on an unspecified date in Feb2021. Physician unsure if dose was related X-ray was stable on 25Feb2021. The clinical outcome of the event C-reactive protein elevated was unknown whereas cough was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Somnolence
Clinical narrative: Strong headache; Joints pain; Very sleepy; This is a spontaneous report from a contactable consumer, the patient. A 35-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 05Jul2021 at 14:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was not known whether the patient had any allergies to medications, food, or other products. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Jul2021 at 23:00, the patient experienced strong headache, joints pain and very sleepy. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events strong headache, joints pain and very sleepy were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Pfizer Clinical Trials Contact Center. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm.  It was reported that patient interested in participating in this study since patient took rituximab and do not seem to have any spike protein antibodies, despite having two shots of the Pfizer vaccine in Mar2021 and Apr2021 of this year. Had a sore arm with both shots, felt tired and cold after second shot. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Pain in extremity
Clinical narrative: Sore arm; Felt tired and cold after second shot; Felt tired and cold after second shot; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date in Mar2021 for covid-19 immunization and experienced Sore arm. It was reported that patient interested in participating in this study since patient took rituximab and do not seem to have any spike protein antibodies, despite having two shots of the Pfizer vaccine in Mar2021 and Apr2021 of this year. had a sore arm with both shots, felt tired and cold after second shot. The outcome for the events was reported as unknown at the time of this report.   Information on the lot/batch number has been requested
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: It was very red and itchy for about 4 days; I had a rash on the injection arm. It was a bout 6 inches long and 2.5 inches wide.; It was very red and itchy for about 4 days; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 21Jun2021 at 13:00 (age at vaccination 68-years-old) as dose 1, single for covid-19 immunisation. Medical history included colectomy from 01Jun2021 to 01Jun2021, patient had colon surgery on June 1 and she was told she could get her vaccine. She waited 3 weeks. she also had a rash the day after surgery. she thinks it was what my body does. Patient had Known allergies included Penicillin and all its derivatives. Past drug history included Avelox, she was very sensitive and get rashes very often. The patient's concomitant medications were not reported.  The Patient did not receive any other vaccines within 4 weeks Prior to vaccination. The Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Consumer stated that, on 29Jun2021 13:00 (Day Eight after the shot), she had a rash on the injection arm. It was about 6 inches long and 2.5 inches wide. It was very red and itchy for about 4 days. she still has it slightly day 15. She sent a photo to her Primary Doctor. She read up on it and treated it with cool compresses, which helped. She heard this was rare, so she was reported it. she still planned to get 2nd shot on 12Jul2021. The adverse event resulted in a visit to Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was recovering.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Tired; Low grade fever; This is a spontaneous report from a contactable consumer (patients daughter). A female patient of an unspecified age received bnt162b2 (Solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1 single and on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer COVID 19 vaccine and had 2 doses. The patient experienced normal side effects and now has none. Reporter did not remember the side effects, but said her mother was tired and had low grade fever but did not experienced joint pain. On unknown date the patient was tired and experienced low-grade fever. Outcome of the events were recovered on unknown date.  Information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Musculoskeletal stiffness, Scab, Temporomandibular joint syndrome
Clinical narrative: Tmj; the area on his chin was still bruised up; there was an area on the chin that was hard and scabby; there was an area on the chin that was hard and scabby; This is a spontaneous report from a contactable other HCP (Nurse). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient injected with 1cc of Restylane Lyft in the chin on 12Jun2021. Patient also received a neuromodulator, Jeuveau, into the jaw line to treat TMJ at the same visit. Patient called the healthcare professional on 14Jun2021 at 05:06pm and reported that the area on his chin was still bruised up and there was an area on the chin that was hard and scabby. Patient denied any pain, numbness or tinging. Patient denied any signs and symptoms of infection. HCP advised patient to call back if he had any worsening signs and symptoms and to see her in office on 15Jun2021. HCP saw the patient in office on 15Jun2021. The HCP believed that the bruising and hard scab may have been due to abrasive scrubbing with alcohol during the injection. At this time, HCP was advised to grab 3 vials of Hylenex and take the patient down the street to office, where she was more equipped to handle a possible vascular occlusion. HCP injected the patient with 2 vials of Hylenex (300 units) at 11:41 am. HCP massaged the area and there were no changes, there was still bruising and a small scab. Events are ongoing. Patient had NKDA and no medical history. It was unknown if patient had received fillers in the past. Patient received the COVID-19 vaccination a while ago (exact dates unknown) and the HCP believes it was Pfizer. Patient did not report any illness leading up to the injection and has had no dental work in the past 6-12 months. It was unknown if patient had any other vaccinations in the past 6-12 months. The clinical outcome of the events were unknown whereas bruising and small scab was not recovered. Follow-up activities closed: Batch/lot number not available for BNT162B2.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chills, Confusional state, Dyspnoea, Emotional disorder
Clinical narrative: Redness at the site went up to my neck into the left side of the face, under my left eye and temple.; Tingling in this patterned area; Difficulty breathing; Vision impaired with black/white specks; Vision impaired with black/white specks; Server chills; Muscle aches; Inflammation in joints; Emotional.; Redness at the site went up to my neck into the left side of the face, under my left eye and temple.; Lack of clarity; This is a spontaneous report from a contactable other hcp. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 42-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced redness at the site went up to my neck into the left side of the face, under my left eye and temple, tingling in this patterned area, difficulty breathing, vision impaired with black/white specks, server chills, muscle aches, inflammation in joints, emotional and Lack of clarity. Facility where the most recent COVID-19 vaccine was administered was withheld. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. Outcome of the events were unknown.  Information about batch/lot number has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye disorder, Myalgia, Ocular hyperaemia, Paraesthesia
Clinical narrative: Redness at the site went up to my neck into the left side of the face, under my left eye and temple.; Tingling in this patterned area; Difficulty breathing; Vision impaired with black/white specks; Vision impaired with black/white specks; Server chills; Muscle aches; Inflammation in joints; Emotional.; Redness at the site went up to my neck into the left side of the face, under my left eye and temple.; Lack of clarity; This is a spontaneous report from a contactable other hcp. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 42-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced redness at the site went up to my neck into the left side of the face, under my left eye and temple, tingling in this patterned area, difficulty breathing, vision impaired with black/white specks, server chills, muscle aches, inflammation in joints, emotional and Lack of clarity. Facility where the most recent COVID-19 vaccine was administered was withheld. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. Outcome of the events were unknown.  Information about batch/lot number has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Redness at the site went up to my neck into the left side of the face, under my left eye and temple.; Tingling in this patterned area; Difficulty breathing; Vision impaired with black/white specks; Vision impaired with black/white specks; Server chills; Muscle aches; Inflammation in joints; Emotional.; Redness at the site went up to my neck into the left side of the face, under my left eye and temple.; Lack of clarity; This is a spontaneous report from a contactable other hcp. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 42-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced redness at the site went up to my neck into the left side of the face, under my left eye and temple, tingling in this patterned area, difficulty breathing, vision impaired with black/white specks, server chills, muscle aches, inflammation in joints, emotional and Lack of clarity. Facility where the most recent COVID-19 vaccine was administered was withheld. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. Outcome of the events were unknown.  Information about batch/lot number has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Decreased appetite, Diarrhoea
Clinical narrative: with the second dose last 06Jun, she had whole back pain and with upset stomach; with the second dose last 06Jun, she had whole back pain and with upset stomach; I have diarrhea and I couldn't eat, I am just in bed for about 6 weeks; I have diarrhea and I couldn't eat, I am just in bed for about 6 weeks; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional via Pfizer-sponsored program  Support. A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 06Jun2021 11:15 (Batch/Lot number was not reported) as single dose (at the age of 70-year-old) for covid-19 immunization. Medical history included Hypertension, Bad kidney, Bad lungs, Bad Heart and Bad liver from an unknown date and unknown if ongoing. Patient took about 17 pills a day. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 17May2021 11:00 (at the age of 70-year-old) as dose 1, single for covid-19 immunization and experienced headache and very sore shoulder and neck. The patient did not take other vaccines 4 weeks prior to Covid19 vaccine. No family history. On 06Jun2021, the patient experienced whole back pain and with upset stomach. On an unspecified date in 2021, patient experienced diarrhea and couldn't eat, I am just in bed for about 6 weeks. Therapeutic measures were taken as a result of upset stomach (abdominal discomfort) included Alka-Seltzer. The outcome of the events was resolved on an unspecified date in 2021 (as reported; it's just about all gone).  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: Little lump on the side of her neck; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 29Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 06Jul2021 patient found like a little lump on the side of her neck. She does not know if she should go to the doctor or put something or ice on it. The little lump is not in the center; she was searching on the internet and knows it's very common to get lump under the armpit or center of the neck but hers is on the side. She wanted to know if there have been some other cases like this. The outcome of the event was unknown.  Information about lot/batch number has been requested.