chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Apathy, Asthenia, Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: Dose 1 on 07Jul2021 and Dose 2 on 07Sep2021; no energy; no motivation; sore arm; nauseous; BP went up; dizziness; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 10:30 (Lot number: FC3184) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (ongoing), notes: Ca. 7yrs; "Blood pressure" (ongoing), notes: Ca. 7yrs; "Diverculitis" (ongoing), notes: Ca 7 years; "Constipation" (ongoing), notes: Ca years, Appendix, ear cataract Ca 1950 Ca 2014; "Thyroid nodules" (ongoing), notes: Varion stripped both legs Ca 1998 Ca 1986; "hernia", start date: 1941 (unspecified if ongoing), notes: 3x hernia 1yr / 20yr / 7yr/ 1941 Ca 1963/ Ca 2014. Family history included: "heart attack" (unspecified if ongoing), notes: Mother, Brother, Brother, Brother (4person); "stroke" (unspecified if ongoing), notes: sister, sister (2 persons); "Thyroid" (unspecified if ongoing), notes: sister, sister (2 persons). Concomitant medication(s) included: TRULANCE taken for diverticulitis (ongoing); PANTOPRAZOLE taken for oesophageal disorder (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: Left arm, Lot no: EW087, Time: 11:00 AM), administration date: 07Jul2021, when the patient was 80 years old, for COVID-19 immunization, reaction(s): "Dizziness", "No energy/tired", "sleep problems", "No appetite", "Nauseous". The following information was reported: ASTHENIA (non-serious) with onset Sep2021, outcome "unknown", described as "no energy"; APATHY (non-serious) with onset Sep2021, outcome "unknown", described as "no motivation"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "unknown", described as "sore arm"; NAUSEA (non-serious) with onset Sep2021, outcome "unknown", described as "nauseous"; BLOOD PRESSURE INCREASED (non-serious) with onset Sep2021, outcome "unknown", described as "BP went up"; DIZZINESS (non-serious) with onset Sep2021, outcome "unknown", described as "dizziness"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "tired"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Sep2021 10:30, outcome "unknown", described as "Dose 1 on 07Jul2021 and Dose 2 on 07Sep2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, apathy, pain in extremity, nausea, blood pressure increased, dizziness, fatigue.  Additional information: The patient received no Prior vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Dose 1 on 07Jul2021 and Dose 2 on 07Sep2021; no energy; no motivation; sore arm; nauseous; BP went up; dizziness; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 10:30 (Lot number: FC3184) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (ongoing), notes: Ca. 7yrs; "Blood pressure" (ongoing), notes: Ca. 7yrs; "Diverculitis" (ongoing), notes: Ca 7 years; "Constipation" (ongoing), notes: Ca years, Appendix, ear cataract Ca 1950 Ca 2014; "Thyroid nodules" (ongoing), notes: Varion stripped both legs Ca 1998 Ca 1986; "hernia", start date: 1941 (unspecified if ongoing), notes: 3x hernia 1yr / 20yr / 7yr/ 1941 Ca 1963/ Ca 2014. Family history included: "heart attack" (unspecified if ongoing), notes: Mother, Brother, Brother, Brother (4person); "stroke" (unspecified if ongoing), notes: sister, sister (2 persons); "Thyroid" (unspecified if ongoing), notes: sister, sister (2 persons). Concomitant medication(s) included: TRULANCE taken for diverticulitis (ongoing); PANTOPRAZOLE taken for oesophageal disorder (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: Left arm, Lot no: EW087, Time: 11:00 AM), administration date: 07Jul2021, when the patient was 80 years old, for COVID-19 immunization, reaction(s): "Dizziness", "No energy/tired", "sleep problems", "No appetite", "Nauseous". The following information was reported: ASTHENIA (non-serious) with onset Sep2021, outcome "unknown", described as "no energy"; APATHY (non-serious) with onset Sep2021, outcome "unknown", described as "no motivation"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "unknown", described as "sore arm"; NAUSEA (non-serious) with onset Sep2021, outcome "unknown", described as "nauseous"; BLOOD PRESSURE INCREASED (non-serious) with onset Sep2021, outcome "unknown", described as "BP went up"; DIZZINESS (non-serious) with onset Sep2021, outcome "unknown", described as "dizziness"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "tired"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Sep2021 10:30, outcome "unknown", described as "Dose 1 on 07Jul2021 and Dose 2 on 07Sep2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, apathy, pain in extremity, nausea, blood pressure increased, dizziness, fatigue.  Additional information: The patient received no Prior vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Insomnia, Palpitations
Clinical narrative: Dizziness / Light-headed; Lost of strength; Heart palpitations; Lack of sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Verbatim: Asthma. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (when he was a teenage to the flu shot,other details other than it was to the flu vaccine.). The following information was reported: DIZZINESS (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Dizziness / Light-headed"; ASTHENIA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "Lost of strength"; PALPITATIONS (non-serious) with onset 14Sep2021, outcome "recovered" (Sep2021), described as "Heart palpitations"; INSOMNIA (non-serious) with onset Sep2021, outcome "not recovered", described as "Lack of sleep". Therapeutic measures were not taken as a result of dizziness, asthenia, palpitations, insomnia.  Additional information: Then, the heart palpitations stopped. However, he continued to have improper sleep, lightheadedness, dizzy spells, and loss of strength. This is causing him to to be able to work. This started after he got the first dose, 14Sep2021. He clarified the dizziness, light-headed, had lost of strength and energy, he also had heart palpitations, and lack of sleep started shortly after getting the vaccine on the same day. He confirmed the dizzy spells are not as bad. Heart palpitations: These are completely gone. It stopped the third day after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: Nauseous; I am not feeling so good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 24Sep2021 09:30 (Lot number: FA6780) 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: NAUSEA (non-serious) with onset 24Sep2021, outcome "unknown", described as "Nauseous"; MALAISE (non-serious) with onset 24Sep2021, outcome "unknown", described as "I am not feeling so good".  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Bone densitometry, Condition aggravated, Tinnitus
Clinical narrative: at 8000 hertz my right ear is 20db worse than my left ear; developed tinnitus in my ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Jan2021 (Lot number: EL9263) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's Thyroiditis", start date: 01Jan1990 (ongoing); "Glaucoma", start date: 01Jun2019 (ongoing), notes: Patient Details: Surgery both eyes 2019; "Lymphedema", start date: 01Jan1983 (ongoing); "Mycobacterium Avium Intracellulare", start date: 17Dec2019 (unspecified if ongoing); "Depression" (ongoing). Concomitant medication(s) included: CELEXA [CELECOXIB] taken for depression, start date: Jan2000 (ongoing); SYNTHROID taken for autoimmune thyroiditis, start date: Jan1990 (ongoing); LUMIGAN taken for glaucoma, start date: Aug2020. The following information was reported: TINNITUS (non-serious) with onset 22Jan2021, outcome "not recovered", described as "developed tinnitus in my ear"; CONDITION AGGRAVATED (non-serious) with onset 25Aug2021, outcome "unknown", described as "at 8000 hertz my right ear is 20db worse than my left ear". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. Additional information- It was reported that patient received  her first covid vaccine on 20Jan2021. She noticed tinnitus in her right ear on 22Jan2021. Her hearing test of 25Aug2021 showed some loss in the (at 8000 hertz my right ear is 20db worse than my left ear). No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cancer gene carrier, Obesity
Clinical narrative: obese; high risk for cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OBESITY (non-serious), outcome "unknown", described as "obese"; CANCER GENE CARRIER (non-serious), outcome "unknown", described as "high risk for cancer".  Additional information: Reporter reported she is obese and is high risk for cancer. Had both doses of the Pfizer Covid 19 vaccines. Now inquiring to coordinate to receive the booster dose because she needs to set an appointment for an xray and mammogram.    Follow-up: 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 completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: diarrhea; pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Sep2021 11:45 (Lot number: FE3592) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hashimotos" (unspecified if ongoing), notes: hashimotos; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: LORATADINE. The following information was reported: DIARRHOEA (non-serious) with onset 22Sep2021 07:00, outcome "recovered" (Sep2021), described as "diarrhea"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2021 07:00, outcome "recovered" (Sep2021), described as "pain at injection site". Therapeutic measures were not taken as a result of diarrhoea, vaccination site pain.  Additional information: It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The female consumer reported for herself and her female friend, this case is for her female friend.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious) with onset 22Sep2021, outcome "recovering", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: redness at the site where the shot was and it''s kind of spread out like a rash; redness at the site where the shot was and it''s kind of spread out like a rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 22Sep2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), outcome "unknown" and all described as "redness at the site where the shot was and it''s kind of spread out like a rash".  Additional information: It was reported that she asked if this was normal or should she be worried and had not yet reported this to her doctor.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm is swollen and very painful; Arm is swollen and very painful/pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 24Sep2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Flu shot. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "not recovered", described as "Arm is swollen and very painful"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "Arm is swollen and very painful/pain in arm". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity.  Follow-up (29Oct2021): 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 completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: it hurts a little bit more; it looks like there is a big, red area around the shot; the area was very sore/ it is swelling up; it looks like there is a big, red area around the shot; the area was very sore; it looks like there is a big, red area around the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 24Sep2021 (Lot number: 30135BA) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT: EN2003), administration date: 26Feb2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, LOT:  ER2613), administration date: 28Mar2021, for COVID-19 immunization, reaction(s): "Tiredness". The following information was reported: PAIN (non-serious) with onset 24Sep2021, outcome "not recovered", described as "it hurts a little bit more"; VACCINATION SITE SWELLING (non-serious) with onset 24Sep2021, outcome "not recovered", described as "it looks like there is a big, red area around the shot; the area was very sore/ it is swelling up"; VACCINATION SITE PAIN (non-serious) with onset 24Sep2021, outcome "not recovered", described as "it looks like there is a big, red area around the shot; the area was very sore"; VACCINATION SITE ERYTHEMA (non-serious) with onset 24Sep2021, outcome "not recovered", described as "it looks like there is a big, red area around the shot".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness after the second Covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 28Mar2021 (Lot number: ER2613) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, single, Lot number: EN2003, Route of administration: Not reported), administration date: 26Feb2021, for covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness after the second Covid shot". No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Movement disorder, Myalgia, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "I am freezing cold"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body is aching so bad like it is hard to get out/I am in too much pain inside"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "My muscles are sore"; MOVEMENT DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I can barely get up/hard to get out". Additional information: Vaccination second dose scheduled on 15Oct2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: over the last ten years the hair loss has slowly increased to 60-70%. After I took the Pfizer vaccine, hair loss increased to over 75%; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Alopecia" (ongoing); "stress management" (unspecified if ongoing). Concomitant medication(s) included: CLOBETASOL; ROGAINE. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "over the last ten years the hair loss has slowly increased to 60-70%. After I took the Pfizer vaccine, hair loss increased to over 75%".  Additional information: The patient reported she was single 71 yo. female with two adult children who has struggled with Alopecia for nearly 40 years. She had been treated with cortisone shots, Clobetasol, Rogain and stress management. Given that treatment, over the last ten years the hair loss had slowly increased to 60-70%. After she took the Pfizer vaccine, hair loss increased to over 75%. She was so concerned she looked for clinical studies and found a research study which she volunteered for. This study is looking at DNA predisposition to alopecia. It included three biopsies. Following, She met with the alopecia specialist, Dr. PRIVACY who recommended Xeljanz has the best potential treatment. She have insurance which will not cover Xeljanz for alopecia as it is not yet approved for this diagnosis. The out of pocket cost for me would be over $3000 per month. The patient was a (Privacy) with a private practice. She made a solid income but given home and business expenses,  she was not able to spend $36,000 per year for Xeljanz. She was hoping we will consider this appeal as it is an important and effective drug. Folks like her have struggled with this condition and have no access to this Important treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She has been feeling unwell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  An 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Apr2021 (Batch/Lot number: unknown) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "She has been feeling unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "not recovered", described as "high blood pressure".  Additional information: Reporter verbatim: I got the 2 Pfizer shots and I had / have high blood pressure now which I have NEVER had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Hormone level abnormal, Malaise, Menstrual disorder, Premenstrual syndrome
Clinical narrative: started my period early; messed with my hormones; PMS symptoms; emotionally all over the place; felt generally unwell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 08:00 (Lot number: FA7485) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "consistently long cycle. The only time it was ever short" (unspecified if ongoing), notes: this was when on the pill over 15 years ago. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 02Aug2021 10:00, outcome "recovered" (03Aug2021), described as "felt generally unwell"; MENSTRUAL DISORDER (non-serious) with onset 06Aug2021, outcome "recovered" (Aug2021), described as "started my period early"; HORMONE LEVEL ABNORMAL (non-serious) with onset 02Aug2021 10:00, outcome "recovered" (03Aug2021), described as "messed with my hormones"; PREMENSTRUAL SYNDROME (non-serious) with onset 02Aug2021 10:00, outcome "recovered" (03Aug2021), described as "PMS symptoms"; EMOTIONAL DISORDER (non-serious) with onset 02Aug2021 10:00, outcome "recovered" (03Aug2021), described as "emotionally all over the place". Therapeutic measures were not taken as a result of malaise, menstrual disorder, hormone level abnormal, premenstrual syndrome, emotional disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no covid  prior vaccination and not tested for covid post vaccination. No known drug allergy. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: My period early shortly after getting the shot. The following month I also started early.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 11:00 (Lot number: FC3180) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Usually have a consistently long cycle/ it was ever short" (unspecified if ongoing), notes: it was ever short like this was when I was on the pill over 15 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FA7485, Administration time: 08:00 AM, Vaccine location: Left arm, Dose number: 1), administration date: 02Aug2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 31Aug2021 08:00, outcome "recovered" (2021), described as "My period early shortly after getting the shot. The following month I also started early.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Facility where the most recent COVID-19 vaccine administered was Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination and not tested for COVID post vaccination. I usually have a consistently long cycle. The only time it was ever short like this was when I was on the pill over 15 years ago.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lip exfoliation, Oropharyngeal discomfort
Clinical narrative: lip peeling; Sensation in throat; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Sep2021 (Lot number: 30130BA) at the age of 39 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SINGULAIR; FISH OIL. The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious) with onset 23Sep2021, outcome "recovering", described as "Sensation in throat"; LIP EXFOLIATION (non-serious), outcome "recovering", described as "lip peeling". Therapeutic measures were not taken as a result of oropharyngeal discomfort, lip exfoliation.  Additional information: Prior to vaccination,  the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Fatigue, Heart rate, Malaise
Clinical narrative: feeling sick; laying down right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 58 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization; Bnt162b2 (DOSE: 2), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "feeling sick"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "laying down right now". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (28Sep2021) 126/88; body temperature: (28Sep2021) 98.9; heart rate: (28Sep2021) 99.  Additional Information: Consumer reported her 58-year-old son with special needs received the booster dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday, 28SEP2021. Consumer wanted to know if the pulse rate was still normal. She also said that her son was still feeling sick and was laying down right now. She wanted to know if that was normal. Consumer provided mailing address and stated patient was doing fine.   Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 "sick".  Additional information: The patient grandfather reported for the patient that she got very sick from the vaccine.   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 completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101281144 same reporter, different patient
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immune-mediated adverse reaction
Clinical narrative: she received quite a strong immune response after the second dose; she expected to feel lousy and she received quite a strong immune response after the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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), for COVID-19 immunization. The following information was reported: IMMUNE-MEDIATED ADVERSE REACTION (non-serious), outcome "unknown", described as "she received quite a strong immune response after the second dose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she expected to feel lousy and she received quite a strong immune response after the second dose".  Additional information: Patient reported she just her Pfizer booster on Saturday and had no side effects  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 completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Osteopenia, Pain in extremity
Clinical narrative: sore arm; started developing early osteopenia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FN5318) as dose 1, single and (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; OSTEOPENIA (non-serious), outcome "unknown", described as "started developing early osteopenia". Therapeutic measures were taken as a result of osteopenia.  Additional Information: Transferring agent stated, He is 78 years old (Further not clarified hence not captured) and he was calling to ask a medical information question and while saying he reported that during his first two doses of the Pfizer COVID-19 Vaccine he only experience the sore arm. He also said that his son he also received the vaccine series and do not feel well for a day and then other than that he didn't have any other symptoms. (Further clarifications unknown hence split was not made) So, he is here to share that information. So I just had a little bit of issue with the sore arm. Caller did state he started developing early osteopenia, and this was after his pfizer covid-19 vaccine shots.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Skin hypopigmentation
Clinical narrative: skin condition something like Vitiligo from middle of his neck to his chest/strange streak on his neck where the skin looks like there is no pigment in there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0172) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MONTELUKAST (ongoing); CETIRIZINE HYDROCHLORIDE taken for drug hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Suspect Product: First Vaccine   , Batch/lot number: EW0172   , Dosage text: Second dose, left arm , Indication for use in the case: COVID-19    , Date of start of drug: 05Apr2021    , Action(s) taken with drug: Unknown), administration date: 05Apr2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: SKIN HYPOPIGMENTATION (non-serious) with onset Jul2021, outcome "recovering", described as "skin condition something like Vitiligo from middle of his neck to his chest/strange streak on his neck where the skin looks like there is no pigment in there".  Additional information: Patient stated that he was vaccinated in April and after his Second Shot, he doesn't know if this was a reaction, but after he was in the sun in July, he got this strange streak on his neck where the skin looks like there is no pigment in there. Patient states it is weird because he has always tanned and had a lot of melanin. He states it looks like the disease where a person starts losing melanin. He asked is that a possible side effect.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Fatigue, Laboratory test, Magnetic resonance imaging, Migraine
Clinical narrative: Migraines triggered after both doses; her left arm was still hurting/ Left arm pain at injection site; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (ongoing), notes: Seasonal allergies. Concomitant medication(s) included: ALLEGRA taken for hypersensitivity. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Apr2021, outcome "unknown", described as "her left arm was still hurting/ Left arm pain at injection site"; FATIGUE (non-serious) with onset 29Apr2021, outcome "unknown", described as "fatigue"; MIGRAINE (non-serious), outcome "unknown", described as "Migraines triggered after both doses". The patient underwent the following laboratory tests and procedures: cardiac stress test: normal; laboratory test: normal, notes: for UTI; magnetic resonance imaging: normal, notes: checked for neuropathy; ultrasound bladder: normal.  Additional Information: Initially, she had symptoms where she felt fatigued during 1st dose for 3 weeks and did not think she had any side effects outside of that. It started on the same date as first dose around 28May2021 or something like that. She later corrected to 28Apr2021 for her first dose. She also had Left arm pain at injection site that lasted until 3-4 weeks which was still painful when she got her 2nd injection. Other than allergies she never had any health issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound bladder, Vaccination site pain
Clinical narrative: Migraines triggered after both doses; her left arm was still hurting/ Left arm pain at injection site; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (ongoing), notes: Seasonal allergies. Concomitant medication(s) included: ALLEGRA taken for hypersensitivity. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Apr2021, outcome "unknown", described as "her left arm was still hurting/ Left arm pain at injection site"; FATIGUE (non-serious) with onset 29Apr2021, outcome "unknown", described as "fatigue"; MIGRAINE (non-serious), outcome "unknown", described as "Migraines triggered after both doses". The patient underwent the following laboratory tests and procedures: cardiac stress test: normal; laboratory test: normal, notes: for UTI; magnetic resonance imaging: normal, notes: checked for neuropathy; ultrasound bladder: normal.  Additional Information: Initially, she had symptoms where she felt fatigued during 1st dose for 3 weeks and did not think she had any side effects outside of that. It started on the same date as first dose around 28May2021 or something like that. She later corrected to 28Apr2021 for her first dose. She also had Left arm pain at injection site that lasted until 3-4 weeks which was still painful when she got her 2nd injection. Other than allergies she never had any health issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm was sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Spinal leak (Diagnosed with a spinal leak" (ongoing), notes: Spinal Leak, 1-1/2 year ago; "Oral lichen planus" (ongoing), notes: Oral lichen planus 10-15 years ago; "Rheumatoid arthritis" (ongoing); "food allergies" (unspecified if ongoing); "long as she stayed away from gluten, chicken, tomatoes & some other things" (unspecified if ongoing), notes: she stayed away from gluten, chicken, tomatoes & some other things, she did not have a problem with her rheumatoid arthritis.; "long as she stayed away from gluten, chicken, tomatoes & some other things" (unspecified if ongoing); "fractured her L4 vertebrae", start date: 2020 (unspecified if ongoing); "sciatica", start date: Feb2020 (unspecified if ongoing), notes: sciatica from Feb2020 (pinched sciatic nerve since Feb2020),; "Bone density issue" (unspecified if ongoing), notes: Bone density issue.; "she stayed away from gluten" (unspecified if ongoing). Concomitant medication(s) included: DIPHENHYDRAMINE; TYLENOL; ADVIL [IBUPROFEN]; GABAPENTIN. Past drug history included: Gluten, reaction(s): "triggered her rheumatoid arthritis". Vaccination history included: Flu vaccine, reaction(s): "Mouth sores". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "left arm was sore". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient said that her left arm was sore after her first COVID-19 Vaccine dose. She said she didn't treat her left arm soreness, and the left arm soreness went away after 2-3 days. She clarified she had a flu vaccine about 15 years ago, and the day after the flu vaccine, she got mouth sores, and the mouth sores got worse. She said her local doctors didn't know how to treat. She stayed away from gluten, chicken, tomatoes & some other things, she did not have a problem with her rheumatoid arthritis.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Vaccination site pain
Clinical narrative: Pain and swelling in arm pit, arm where vaccine was administered; Pain and swelling in arm pit, arm where vaccine was administered; Pain and swelling in arm pit, arm where vaccine was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 11:30 (Lot number: Unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing); "Shellfish" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: LEXAPRO. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 27Sep2021, outcome "recovering" and all described as "Pain and swelling in arm pit, arm where vaccine was administered". Therapeutic measures were not taken as a result of axillary pain, swelling, vaccination site pain.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Body aches; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "Body aches"; HEADACHE (non-serious), outcome "not recovered", described as "headaches". Therapeutic measures were taken as a result of pain, headache.  Additional information:Consumer explained that she had her first dose of Pfizer Covid 19 vaccine on 9 SEP 2021 and is scheduled for second dose on 30 SEP 2021. She explained she took two Motrin 17 days later. She noted Body aches and headaches that are ongoing but would not provide specifics. She is concerned. She would like to know how ling would these side effects last and should she get her second dose. Response: Serious side effects that could cause a long-term health problem are extremely unlikely following any vaccination, including COVID-19 vaccination. Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose. Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body is building protection and should go away within a few days.Explained she would need to consult her vaccine provider or HCP for vaccine guidance for second dose of Pfizer Covid 19 vaccine. Pfizer unable to provide medical/treatment advice.Question: Consumer took two Motrin 17 days after first dose of Pfizer Covid 19 vaccine. She is concerned and would like to know is this was safe to take after vaccination.Response:These interim considerations state that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate.Please be sure to discuss any questions about taking a fever-reducing drug or pain reliever before or after vaccination with your vaccination provider, doctor, or other health care professional."Question: Caller explained she is having difficulty hearing from her end.Response: Able to hear consumer. Apologized. Spoke clearly and loud. Agent noted headphone was on and functioning appropriately. Is report related to a study or programme:No.Reporter seriousness for Unspecified event: Unspecified.Reason for no lot number: of Covid-19 Vaccine: Caller unwilling to complete the report.Expiry Date of Covid-19 Vaccine: Not Provided.Other Products: Not Provided. Patient History: Not Provided.Investigation Assessment: Not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.