chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Adenomyosis, Back pain, Contusion, Discomfort, Dysmenorrhoea
Clinical narrative: Painful period; Painful, heavy period beginning 3 days after first injection, extremely abnormal; Next 3 periods were also very heavy/menstrual flow was twice as heavy as it had been for the past 10 years; Horrible lower back pain 10 daysbefore menstruating began.; Pain; Discomfort; Symptoms was similar to adenomyosis; Abdomen feels bruised a few days before cycle begins and a few days after; Spotting before most recent period which was something that never occurs; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 17Feb2021 at 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, sleep apnea and penicillin allergy. The patient has taken unspecified concomitant medications. The patient previously took cephalosporin nos (MANUFACTURER UNKNOWN) and experienced allergy on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 09:00, the patient experienced painful, heavy period beginning 3 days after first injection, extremely abnormal for her, the next 3 periods were also very heavy and resulted in horrible lower back pain 10 days before menstruating began, ultrasound showed no uterine abnormalities to indicate the pain and discomfort, symptoms was similar to adenomyosis and her abdomen felt bruised a few days before her cycle begins and a few days after and had spotting before her most recent period which was something that never occurs for her and her menstrual flow was twice as heavy as it had been for the past 10 years, none of this occurred for her until 3 days after her initial injection, now once a month she was in misery for 1/3 of it. Therapeutic measures were not taken as a result of these events. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events painful, heavy period beginning 3 days after first injection, extremely abnormal for her, the next 3 periods were also very heavy and resulted in horrible lower back pain 10 days before menstruating began, pain and discomfort, adenomyosis and her abdomen felt bruised a few days before her cycle begins and a few days after and had spotting, her menstrual flow was twice as heavy as it had been for the past 10 years was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular, Pain, Ultrasound uterus
Clinical narrative: Painful period; Painful, heavy period beginning 3 days after first injection, extremely abnormal; Next 3 periods were also very heavy/menstrual flow was twice as heavy as it had been for the past 10 years; Horrible lower back pain 10 daysbefore menstruating began.; Pain; Discomfort; Symptoms was similar to adenomyosis; Abdomen feels bruised a few days before cycle begins and a few days after; Spotting before most recent period which was something that never occurs; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 17Feb2021 at 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, sleep apnea and penicillin allergy. The patient has taken unspecified concomitant medications. The patient previously took cephalosporin nos (MANUFACTURER UNKNOWN) and experienced allergy on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 09:00, the patient experienced painful, heavy period beginning 3 days after first injection, extremely abnormal for her, the next 3 periods were also very heavy and resulted in horrible lower back pain 10 days before menstruating began, ultrasound showed no uterine abnormalities to indicate the pain and discomfort, symptoms was similar to adenomyosis and her abdomen felt bruised a few days before her cycle begins and a few days after and had spotting before her most recent period which was something that never occurs for her and her menstrual flow was twice as heavy as it had been for the past 10 years, none of this occurred for her until 3 days after her initial injection, now once a month she was in misery for 1/3 of it. Therapeutic measures were not taken as a result of these events. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events painful, heavy period beginning 3 days after first injection, extremely abnormal for her, the next 3 periods were also very heavy and resulted in horrible lower back pain 10 days before menstruating began, pain and discomfort, adenomyosis and her abdomen felt bruised a few days before her cycle begins and a few days after and had spotting, her menstrual flow was twice as heavy as it had been for the past 10 years was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Missed menstrual cycle, usually have a 26 day cycle, has been 60 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date 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. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient missed menstrual cycle (usually has a 26-day cycle, has been 60 days). The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event missed menstrual cycle, usually have a 26-day cycle, has been 60 days was not recovered 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: sore arm; patient was pregnant at time of vaccination.; This is a spontaneous report from a contactable consumer (patient) communicated to a sales representative. This consumer reported information for mother. This is a maternal report.   A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), first dose on 09Apr2021 12:30 (Lot number: ER8729) as dose 1 single and second dose on 02May2021 11:00 (lot number: EW0172) (age at vaccination 37-year-old) as dose 2 single both intramuscularly administered in left arm for COVID-19 Immunisation at Pharmacy/drug store. The patient was pregnant at time of vaccination of 23 weeks and pregnancy due date was 29Aug2021. No other vaccine in four weeks. The patient medical history not reported. The patient's concomitant medications were not received within 2 weeks of vaccination. The patient was pregnant at time of vaccination on 09Apr2021 and sore arm on 02May2021. No covid prior vaccination. No covid tested post vaccination. Treatment was not received for event sore arm. The outcome of event pain in arm recovered in 2021 and other event was unknown.  Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Itchy rash appeared on underside of both forearms continues n itchy rash on upper chest, itchy spots on top of feet, on top of toes, on top of hands and fingers, a few spots on face, a few spots on upper arms.; Tiny spot near two moles on underside of left forearm.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 11Mar2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergy and poison ivy rash. Concomitant medications included fluticasone propionate (MANUFACTURER UNKNOWN), fluticasone propionate, salmeterol (MANUFACTURER UNKNOWN) and loratadine (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm left on 18Feb2021 at 14:15 as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021, the patient experienced itchy rash appeared on underside of both forearms. About four days earlier it started with a tiny spot near two moles on underside of left forearm on 06May2021. Itchy rash continues on forearms till 17May2021, but includes an itchy rash on upper chest, itchy spots on top of feet, on top of toes, on top of hands and fingers, a few spots on face, a few spots on upper arms. It was not poison Ivy but she had poison Ivy before and it reminds her of it, except the itchy rash and bumps just stay as was, no evolving into crusty/painful areas. So this was not poison Ivy, but the itch was similar. She had not gone out of her house at all prior to this rash starting so that's why she thought it could be related to the COVID vaccine. It was worth noting this was right at high allergy season there, and in the past she had allergy shots for 5 years. She stopped the shots a few years ago, but continued to take: fluticasone propionate nasal spray, fluticasone propionate & salmeterol, loratadine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events itchy rash and spot like rash was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable other Health care professional (patient). A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283) via an unspecified route of administration, in the left arm on 23Jan2021 at 13:00 (at the age of 43-years-old) as dose 1, single for COVID-19 immunization at Public Health Clinic Administration facility. Medical history included seasonal allergy. There were no concomitant medications. The patient previously took Augmentin and experienced drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, patient has not been tested for COVID-19.  It was reported that later patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration, in the left arm on 25Feb2021 at 14:45 (at the age of 43-years-old) as dose 2, single for COVID-19 immunization. On an unspecified date in Jan2021, after first vaccination, the patient experienced vertigo. The seriousness criteria of event vertigo was reported as persistent/significant disability/incapacity. It was reported that no treatment was received for the event, as the event did not require the initiation of new medication/other treatment/procedure. Went to physician on 12Jul2021 after symptoms of vertigo had already stopped. Vertigo persisted daily for 4 Months. The patient underwent lab tests and procedures which included biopsy breast resulted negative on 06Jan2021. This report may be a duplicate if the reporter also submitted directly to his/her local agency. Reporter consider the Pfizer product had a causal effect to the adverse events. Outcome of event vertigo recovered on 30May2021.  Follow-up attempts are completed. No further information is expected.  Follow-up (12Aug2021): New information received from a contactable other HCP. This other HCP reported in response to HCP letter [sent to other HCP] via follow-up letter which included that: Reporter information updated, Suspect product details (Dose details, date and time, site and route of injection, anatomical site of injection, Lot number), Vaccination facility type, Lab details (relevant test), Adverse event details (onset date, seriousness criteria, outcome, date of recovery) were updated.  No follow up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus, Vertigo
Clinical narrative: Loud tinnitus in both ears approximately 12 hours after shot.; dizziness; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 51-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 29Apr2021 at 09:15(at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA ALLERGY) for seasonal allergy from an unknown date for unknown indication. 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 vaccination. On 29Apr2021 at 21:00, the patient experienced loud tinnitus, dizziness and vertigo. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event loud tinnitus, dizziness and vertigo was not recovered at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Disturbance in attention, Dysarthria, Pain in extremity
Clinical narrative: Pain in arm; Pain in bones; Chills; Continue pain in male testicles; Pain in feet; Hard on speaking; Hard on focusing; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0177) via an unspecified route of administration in the right arm on 14May2021 at 14:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Patient had no allergy to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955) via an unspecified route of administration in the right arm on 23Apr2021 at 14:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 16:00 the patient experienced pain in arm, bone pain, chills, continue pain in testicles, hard on speaking and focusing and pain in feet. It was unknown whether therapeutic measures were taken for the adverse 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 event pain in arm, bone pain, chills, continue pain in testicles, hard on speaking and focusing and pain in feet was resolved with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: Pain in arm; Pain in bones; Chills; Continue pain in male testicles; Pain in feet; Hard on speaking; Hard on focusing; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0177) via an unspecified route of administration in the right arm on 14May2021 at 14:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Patient had no allergy to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955) via an unspecified route of administration in the right arm on 23Apr2021 at 14:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 16:00 the patient experienced pain in arm, bone pain, chills, continue pain in testicles, hard on speaking and focusing and pain in feet. It was unknown whether therapeutic measures were taken for the adverse 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 event pain in arm, bone pain, chills, continue pain in testicles, hard on speaking and focusing and pain in feet was resolved with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Mouth ulceration
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 43-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 43, via an unspecified route of administration,  left arm, on May 14, 2021, at 12:30, single dose, for COVID-19 immunisation. Medical history: none. Patient has no known allergies. Concomitant medications included ibuprofen, from an unknown date, for an unspecified indication. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On May 16, 2021, patient experienced upset stomach and mouth ulcers. The patient did not receive any treatment for 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 upset stomach and mouth ulcers: not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: Soreness throughout injected arm; Soreness throughout injected arm including joints of wrist, elbow, and shoulder; Nausea; GI upset; 99.5F fever; Chills.; Fatigue.; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 04May2021 at 14:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 11:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 13:30, the patient experienced soreness throughout injected arm including joints of wrist, elbow and shoulder, nausea, GI upset, 99.5F fever, chills and fatigue. 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 events. The clinical outcome of the events of soreness throughout injected arm including joints of wrist, elbow and shoulder, nausea, GI upset, 99.5F fever, chills and fatigue were recovered on unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Soreness throughout injected arm; Soreness throughout injected arm including joints of wrist, elbow, and shoulder; Nausea; GI upset; 99.5F fever; Chills.; Fatigue.; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 04May2021 at 14:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 11:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 13:30, the patient experienced soreness throughout injected arm including joints of wrist, elbow and shoulder, nausea, GI upset, 99.5F fever, chills and fatigue. 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 events. The clinical outcome of the events of soreness throughout injected arm including joints of wrist, elbow and shoulder, nausea, GI upset, 99.5F fever, chills and fatigue were recovered on unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Pain in the injection site for a day; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177), via an unspecified route of administration in the left arm on 15May2021 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021, the patient experienced pain in the injection site for a day and on evening headache. Headache was not continuous, however prolonged for a long duration even though the patient took ibuprofen. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with ibuprofen. The clinical outcome of the events pain in the injection site for a day was recovering and headache was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Fatigue
Clinical narrative: extreme muscle/ body aches; extreme muscle/ body aches; loss of appetite; fatigue; fever (101); nausea; chills; headache; low energy; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 06Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or other non hcp.  A 65-yearsold patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) Dose 2 via an unspecified route of administration, administered in in the left arm on 04Feb2021 at 16:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included coeliac disease from 31Oct2016 and ongoing Pertinent details: Endoscopy done by GI doctor , biopsy from 2004 to an unknown date Verbatim: Excisional Biopsy  Pertinent details: L.Breast. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of BNT162b2 on 14Jan202 at 15:00 (Lot Number: EL1284)  via an unspecified route of administration in the left arm for COVID-19 immunisation. On 05Feb2021 at 15:30, the patient experienced extreme muscle/ body aches , loss of appetite, fatigue (in bed approx 36 hrs), some fever (101), some nausea (briefly), chills, headache (some), very low energy; all medically significant events. I guess the vaccine was working. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 05Feb2021 , sars-cov-2 test: negative on 29Jul2021 Same day testing. The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of all the events. The patient recovered from all the events in 2021. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: extreme muscle/ body aches; extreme muscle/ body aches; loss of appetite; fatigue; fever (101); nausea; chills; headache; low energy; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 06Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or other non hcp.  A 65-yearsold patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) Dose 2 via an unspecified route of administration, administered in in the left arm on 04Feb2021 at 16:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included coeliac disease from 31Oct2016 and ongoing Pertinent details: Endoscopy done by GI doctor , biopsy from 2004 to an unknown date Verbatim: Excisional Biopsy  Pertinent details: L.Breast. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of BNT162b2 on 14Jan202 at 15:00 (Lot Number: EL1284)  via an unspecified route of administration in the left arm for COVID-19 immunisation. On 05Feb2021 at 15:30, the patient experienced extreme muscle/ body aches , loss of appetite, fatigue (in bed approx 36 hrs), some fever (101), some nausea (briefly), chills, headache (some), very low energy; all medically significant events. I guess the vaccine was working. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 05Feb2021 , sars-cov-2 test: negative on 29Jul2021 Same day testing. The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of all the events. The patient recovered from all the events in 2021. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: extreme muscle/ body aches; extreme muscle/ body aches; loss of appetite; fatigue; fever (101); nausea; chills; headache; low energy; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 06Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or other non hcp.  A 65-yearsold patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) Dose 2 via an unspecified route of administration, administered in in the left arm on 04Feb2021 at 16:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included coeliac disease from 31Oct2016 and ongoing Pertinent details: Endoscopy done by GI doctor , biopsy from 2004 to an unknown date Verbatim: Excisional Biopsy  Pertinent details: L.Breast. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of BNT162b2 on 14Jan202 at 15:00 (Lot Number: EL1284)  via an unspecified route of administration in the left arm for COVID-19 immunisation. On 05Feb2021 at 15:30, the patient experienced extreme muscle/ body aches , loss of appetite, fatigue (in bed approx 36 hrs), some fever (101), some nausea (briefly), chills, headache (some), very low energy; all medically significant events. I guess the vaccine was working. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 05Feb2021 , sars-cov-2 test: negative on 29Jul2021 Same day testing. The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of all the events. The patient recovered from all the events in 2021. Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Menstruation delayed
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 24-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# not reported), at the vaccination age 24, via an unspecified route of administration, on an unspecified date, in Mar 2021, single dose, for COVID-19 immunisation. Medical history: none. There were no concomitant medications. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Reportedly, she always had her period on time. She was never late. On an unspecified date, patient was 3 days late and her period was very light. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken for the events. On an unspecified date in Apr 2021, patient underwent lab tests and procedures, which included nasal swab resulted as negative. The outcomes of reported events: unknown (at the time of reporting). The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Off label use, Product use issue, Pyrexia
Clinical narrative: He is 15 male; He is 15 male; High fever of 102 post first Covid vaccine; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Lot Number: EW1076) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever of 102 post first Covid vaccine. He was 15 male on an unspecified date. Event took place after use of product. The patient underwent lab tests and procedures which included body temperature: 102 on an unspecified date. Outcome of fever of 102 was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chloasma
Clinical narrative: Large brown spot on right cheek and small brown spot on two fingers; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0186) via an unspecified route of administration in the left arm on 15May2021 at 15:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medications or other products. Concomitant medication included RIDDLIN for unknown indication and start date. 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 had not been tested for COVID-19. On 17May2021 at 07:00, the patient experienced large brown spots on right cheek and small brown spot on two fingers. It was reported that the event did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event large brown spots on right cheek and small brown spot on two fingers was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Light swelling or clot in the nerve near left shoulder; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 22Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included dairy products allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021, the patient experienced light swelling or clot in the nerve near left shoulder. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event light swelling or clot in the nerve near left shoulder was unknown at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer. A 70-years-old male patient (father) received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EN0176) (at the age of 70-years-old) as SINGLE for covid-19 immunization and administered at Walgreens. Patient denied for any medical history and concomitant medications. The reporter's dad had the first dose and he was supposed to get the second dose in 2 or 3 days; but he had a fever on 17May2021 and just want to know if he can have it later. The patient did not received any treatment. The patient was scheduled for second dose on 20May2021. The outcome of event was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Face rash; Low grade fever; Body aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included allergy to Pecan. Concomitant medications were not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced face rash, low grade fever, body aches and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events face rash, low grade fever, body aches and chills were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: mild rash on the abdominal area and back.; This is a spontaneous report from a non-contactable consumer, the patient. A  patient of an unknown gender and age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182), via an unspecified route of administration in the right arm on 15May2021 at 10:30 as a single dose for COVID-19 immunisation. Medical was reported as not available and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications included loratadine (CLARITIN), acetylsalicylic acid (BAYER ASPIRIN) and vitamin d nos (VITAMIN D) all from an unknown date for an unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172), via an unspecified route of administration in the right arm on 24Apr2021 at 14:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 00:00, the patient experienced mild rash on the abdominal area and back. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the event mild rash on the abdominal area and back was recovered on 17May2021.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Hyperaesthesia teeth, Toothache
Clinical narrative: Tooth pain in upper jaw; All upper molar teeth were uncomfortable with pressure and extra sensitivity; All upper molar teeth were uncomfortable with pressure and extra sensitivity; This is a spontaneous report from a non-contactable consumer, the patient. A 36-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 16May2021 at 11:15 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 16:30, the patient experienced tooth pain in upper jaw, all upper molar teeth were uncomfortable with pressure and extra sensitivity. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of tooth ache, tooth discomfort and sensitivity of teeth was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood test, Decreased appetite, Dizziness, Liver function test
Clinical narrative: Body aches; Fever; Loss of appetite; Dizziness; Elevated liver function test; Anemia; This is a spontaneous report from a contactable consumer or other non hcp.   An 84-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6201), dose 2 intramuscularly, administered in Deltoid Left on 12Mar2021 as dose 2, single for covid-19 immunisation. Medical history included, hypertension, Blood pressure/Hypertension, gastroesophageal reflux disease, hyperlipidaemia, anaemia, anxiety. Concomitant medication(s) included sertraline (SERTRALINE); hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ); alprazolam (ALPRAZOLAM; melatonin (MELATONIN).Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Right deltoid on 10:00 as DOSE 1, lot number= EN6208 SINGLE for covid-19 immunisation   The patient was not pregnant at the time of vaccination. The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, after second dose, had body aches, fever, loss of appetite, dizziness that lasted for more than 2 weeks. Loss of appetite and dizziness continued, so saw my doctor and did blood work, which showed elevated liver function test and anaemia. Never had history of either problems before the vaccine. Repeated blood tests 1.5 months later and anaemia resolved, and liver function test is back to normal. On an unspecified date in 2021 with outcome of recovered. No treatment was received.The patient underwent lab tests and procedures which included blood test: anaemia on 2021, blood test: anaemia resolved on 2021,liver function test: elevated on 2021     Follow-up (13Jul2021): This is a follow-up spontaneous report received from a contactable physician. This physician reported in response to HCP letter sent for patient which included.  Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test increased, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Loss of appetite; Dizziness; Elevated liver function test; Anemia; This is a spontaneous report from a contactable consumer or other non hcp.   An 84-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6201), dose 2 intramuscularly, administered in Deltoid Left on 12Mar2021 as dose 2, single for covid-19 immunisation. Medical history included, hypertension, Blood pressure/Hypertension, gastroesophageal reflux disease, hyperlipidaemia, anaemia, anxiety. Concomitant medication(s) included sertraline (SERTRALINE); hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ); alprazolam (ALPRAZOLAM; melatonin (MELATONIN).Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Right deltoid on 10:00 as DOSE 1, lot number= EN6208 SINGLE for covid-19 immunisation   The patient was not pregnant at the time of vaccination. The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, after second dose, had body aches, fever, loss of appetite, dizziness that lasted for more than 2 weeks. Loss of appetite and dizziness continued, so saw my doctor and did blood work, which showed elevated liver function test and anaemia. Never had history of either problems before the vaccine. Repeated blood tests 1.5 months later and anaemia resolved, and liver function test is back to normal. On an unspecified date in 2021 with outcome of recovered. No treatment was received.The patient underwent lab tests and procedures which included blood test: anaemia on 2021, blood test: anaemia resolved on 2021,liver function test: elevated on 2021     Follow-up (13Jul2021): This is a follow-up spontaneous report received from a contactable physician. This physician reported in response to HCP letter sent for patient which included.  Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected