chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Painful respiration
Clinical narrative: Took the booster shot. My chest has been hurting especially when I breathe.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, Central venous catheterisation, Cerebrovascular accident
Clinical narrative: 73-year-old female who presented to the emergency department with altered mental status.  Patient was brought in by the husband.  As per EMS she was minimally responsive on arrival and was hypoxic at 84% but improved to 95% on a 4 L nasal cannula. Patient underwent evaluation and found to have respiratory failure due to COVID-19. Patient developed acute hypoxic respiratory failure and had MSSA bacteremiaReportedly the patient had TTE which showed no vegetation and the patient was supposed to get TEE for concern of endocarditis, tee was not done as the patient could not tolerate it. PICC line was placed and the patient was started on Ancef treatment. In hospital patient with worsening respiratory status requiring HFNC. PT/OT also recommending post acute screen patient refusing wanting to be discharged home by all means.  She was discharged in stable condition on 2/3/22 after 28 days spent at hospital.   On 2/10/22  patient presented to medical center The patient was brought to the ED for worsening breathing with poor oral intake and increased confusion. Later the patient was transferred to ICU for further management.  The patient was on mechanical ventilatory support for acute hypoxic respiratory failure, patient was off sedation and off analgesia with no response to verbal or physical stimuli for a few days. Patient had a previous CVA with an acute CVA/subarachnoid hemorrhage for which we had Neurology on board for assistance in the management. Patient also had post COVID pulmonary fibrosis. Patient developed AKI most probably multifactorial. The patient had multiorgan system failure with a very poor prognosis. The patient prognosis, status, and further goals of care were discussed with the husband, he referred understanding, and ultimately decided to change the patient's status to CMO. Sadly the patient was pronounced dead on February 23, 2022 at 12:01 a.m..
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Death, Dyspnoea, Echocardiogram normal, Hypophagia
Clinical narrative: 73-year-old female who presented to the emergency department with altered mental status.  Patient was brought in by the husband.  As per EMS she was minimally responsive on arrival and was hypoxic at 84% but improved to 95% on a 4 L nasal cannula. Patient underwent evaluation and found to have respiratory failure due to COVID-19. Patient developed acute hypoxic respiratory failure and had MSSA bacteremiaReportedly the patient had TTE which showed no vegetation and the patient was supposed to get TEE for concern of endocarditis, tee was not done as the patient could not tolerate it. PICC line was placed and the patient was started on Ancef treatment. In hospital patient with worsening respiratory status requiring HFNC. PT/OT also recommending post acute screen patient refusing wanting to be discharged home by all means.  She was discharged in stable condition on 2/3/22 after 28 days spent at hospital.   On 2/10/22  patient presented to medical center The patient was brought to the ED for worsening breathing with poor oral intake and increased confusion. Later the patient was transferred to ICU for further management.  The patient was on mechanical ventilatory support for acute hypoxic respiratory failure, patient was off sedation and off analgesia with no response to verbal or physical stimuli for a few days. Patient had a previous CVA with an acute CVA/subarachnoid hemorrhage for which we had Neurology on board for assistance in the management. Patient also had post COVID pulmonary fibrosis. Patient developed AKI most probably multifactorial. The patient had multiorgan system failure with a very poor prognosis. The patient prognosis, status, and further goals of care were discussed with the husband, he referred understanding, and ultimately decided to change the patient's status to CMO. Sadly the patient was pronounced dead on February 23, 2022 at 12:01 a.m..
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hyporesponsive to stimuli, Intensive care, Mechanical ventilation, Mental status changes, Multiple organ dysfunction syndrome
Clinical narrative: 73-year-old female who presented to the emergency department with altered mental status.  Patient was brought in by the husband.  As per EMS she was minimally responsive on arrival and was hypoxic at 84% but improved to 95% on a 4 L nasal cannula. Patient underwent evaluation and found to have respiratory failure due to COVID-19. Patient developed acute hypoxic respiratory failure and had MSSA bacteremiaReportedly the patient had TTE which showed no vegetation and the patient was supposed to get TEE for concern of endocarditis, tee was not done as the patient could not tolerate it. PICC line was placed and the patient was started on Ancef treatment. In hospital patient with worsening respiratory status requiring HFNC. PT/OT also recommending post acute screen patient refusing wanting to be discharged home by all means.  She was discharged in stable condition on 2/3/22 after 28 days spent at hospital.   On 2/10/22  patient presented to medical center The patient was brought to the ED for worsening breathing with poor oral intake and increased confusion. Later the patient was transferred to ICU for further management.  The patient was on mechanical ventilatory support for acute hypoxic respiratory failure, patient was off sedation and off analgesia with no response to verbal or physical stimuli for a few days. Patient had a previous CVA with an acute CVA/subarachnoid hemorrhage for which we had Neurology on board for assistance in the management. Patient also had post COVID pulmonary fibrosis. Patient developed AKI most probably multifactorial. The patient had multiorgan system failure with a very poor prognosis. The patient prognosis, status, and further goals of care were discussed with the husband, he referred understanding, and ultimately decided to change the patient's status to CMO. Sadly the patient was pronounced dead on February 23, 2022 at 12:01 a.m..
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary fibrosis, Respiratory failure, SARS-CoV-2 test positive, Staphylococcal bacteraemia, Subarachnoid haemorrhage
Clinical narrative: 73-year-old female who presented to the emergency department with altered mental status.  Patient was brought in by the husband.  As per EMS she was minimally responsive on arrival and was hypoxic at 84% but improved to 95% on a 4 L nasal cannula. Patient underwent evaluation and found to have respiratory failure due to COVID-19. Patient developed acute hypoxic respiratory failure and had MSSA bacteremiaReportedly the patient had TTE which showed no vegetation and the patient was supposed to get TEE for concern of endocarditis, tee was not done as the patient could not tolerate it. PICC line was placed and the patient was started on Ancef treatment. In hospital patient with worsening respiratory status requiring HFNC. PT/OT also recommending post acute screen patient refusing wanting to be discharged home by all means.  She was discharged in stable condition on 2/3/22 after 28 days spent at hospital.   On 2/10/22  patient presented to medical center The patient was brought to the ED for worsening breathing with poor oral intake and increased confusion. Later the patient was transferred to ICU for further management.  The patient was on mechanical ventilatory support for acute hypoxic respiratory failure, patient was off sedation and off analgesia with no response to verbal or physical stimuli for a few days. Patient had a previous CVA with an acute CVA/subarachnoid hemorrhage for which we had Neurology on board for assistance in the management. Patient also had post COVID pulmonary fibrosis. Patient developed AKI most probably multifactorial. The patient had multiorgan system failure with a very poor prognosis. The patient prognosis, status, and further goals of care were discussed with the husband, he referred understanding, and ultimately decided to change the patient's status to CMO. Sadly the patient was pronounced dead on February 23, 2022 at 12:01 a.m..
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: 73-year-old female who presented to the emergency department with altered mental status.  Patient was brought in by the husband.  As per EMS she was minimally responsive on arrival and was hypoxic at 84% but improved to 95% on a 4 L nasal cannula. Patient underwent evaluation and found to have respiratory failure due to COVID-19. Patient developed acute hypoxic respiratory failure and had MSSA bacteremiaReportedly the patient had TTE which showed no vegetation and the patient was supposed to get TEE for concern of endocarditis, tee was not done as the patient could not tolerate it. PICC line was placed and the patient was started on Ancef treatment. In hospital patient with worsening respiratory status requiring HFNC. PT/OT also recommending post acute screen patient refusing wanting to be discharged home by all means.  She was discharged in stable condition on 2/3/22 after 28 days spent at hospital.   On 2/10/22  patient presented to medical center The patient was brought to the ED for worsening breathing with poor oral intake and increased confusion. Later the patient was transferred to ICU for further management.  The patient was on mechanical ventilatory support for acute hypoxic respiratory failure, patient was off sedation and off analgesia with no response to verbal or physical stimuli for a few days. Patient had a previous CVA with an acute CVA/subarachnoid hemorrhage for which we had Neurology on board for assistance in the management. Patient also had post COVID pulmonary fibrosis. Patient developed AKI most probably multifactorial. The patient had multiorgan system failure with a very poor prognosis. The patient prognosis, status, and further goals of care were discussed with the husband, he referred understanding, and ultimately decided to change the patient's status to CMO. Sadly the patient was pronounced dead on February 23, 2022 at 12:01 a.m..
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysuria, Headache, Influenza like illness, Pain
Clinical narrative: Moderate headache and minor/medium body aches (flu like).  A bit painful to urinate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: Headache onset each time after shot. Last for about a month or so; did not seek treatment. I filled out the VSAFE questionnaire and someone called suggested I fill out this form.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccine positive rechallenge
Clinical narrative: I got my vaccines in Jan 2021. In September, I started having "ringing" in my ears. In Feb 2022, I got my booster shot. As soon as I got my booster shot that day, my ringing got worse. I finally put the two and two together.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: The patient died approximately 24 hours after administration.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Electrocardiogram, Faeces discoloured, Pain
Clinical narrative: COVID booster 5 days ago.   Felt achey later that night, associated with fever, diarrhea, had some black stool X 2.  Normal today.  Starting to eat today.  Hydration was definitely down, 10 oz daily.  Had some episodes of racing heart, never took her pulse.  Has resolved in the past 24 hours.  Does have known history of atrial fibrillation status post pacemaker placement for heart block.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: COVID booster 5 days ago.   Felt achey later that night, associated with fever, diarrhea, had some black stool X 2.  Normal today.  Starting to eat today.  Hydration was definitely down, 10 oz daily.  Had some episodes of racing heart, never took her pulse.  Has resolved in the past 24 hours.  Does have known history of atrial fibrillation status post pacemaker placement for heart block.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Developed a rash that my doctor is calling chronic hives.  Going through treatment to get them under control. Extreme itchiness, and red rashes on hands, legs, and stomach.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 10:00 (Lot number: EN6203) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "recovering", described as "hair falling out".  Additional information: It was reported that the initial case was missing the following minimum criteria: ICH-Unspecified number of patient. Upon receipt of follow-up information on 27Aug2021, this case now contains all required information to be considered valid. Prior vaccinations, Relevant test: None. Patient had also received the 2nd dose.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: injection site pain; injection site swelling; injection site redness; rash on arm of injection; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 09:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy dog dander, cats," (unspecified if ongoing), notes: Known allergies: Yes, dog dander, cats, strawberry, dust, citrus fruits; "allergy strawberry, citrus fruits" (unspecified if ongoing), notes: Known allergies: Yes, dog dander, cats, strawberry, dust, citrus fruits; "allergy dust" (unspecified if ongoing), notes: Known allergies: Yes, dog dander, cats, strawberry, dust, citrus fruits. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Jun2021 19:00, outcome "recovering", described as "injection site pain"; VACCINATION SITE SWELLING (non-serious) with onset 09Jun2021 19:00, outcome "recovering", described as "injection site swelling"; VACCINATION SITE ERYTHEMA (non-serious) with onset 09Jun2021 19:00, outcome "recovering", described as "injection site redness"; VACCINATION SITE RASH (non-serious) with onset 09Jun2021 19:00, outcome "recovering", described as "rash on arm of injection"; ARTHRALGIA (non-serious) with onset 09Jun2021 19:00, outcome "recovering", described as "joint pain". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema, vaccination site rash, arthralgia.  Additional information: Adverse events were also reported after the second dose of vaccine administered on 09Jun2021 at 9 AM. At 07PM on 10Jun2021, patient had Fever, body ache, head ache, tiredness and no appetite. Stop date of events were 12Jun2021. It was unknown if the Patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19, since the vaccination, patient has not been tested for COVID-19. Lot number was unknown as it was unable to locate or read the details.  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: Inappropriate schedule of product administration, Menstruation irregular
Clinical narrative: My period has not happened as it should/had consistent spotting for no clear reason; Dose 2 on 27May2021 and dose 1 on 13May2021; This is a spontaneous report received from 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 27May2021 13:00 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Some pollen but I don't know what" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Administration time=01:00 PM, Dose 1 at Left arm), administration date: 13May2021, when the patient was 37 years old, for Covid-19 Immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27May2021, outcome "unknown", described as "Dose 2 on 27May2021 and dose 1 on 13May2021"; MENSTRUATION IRREGULAR (non-serious) with onset 27May2021 13:00, outcome "not recovered", described as "My period has not happened as it should/had consistent spotting for no clear reason". The event "my period has not happened as it should/had consistent spotting for no clear reason" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Other vaccine in four weeks and other medications in two weeks: No. Covid prior vaccination and tested post vaccination: No. Doctor said nothing obvious wrong with me, and she expressed no concern.  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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: Sore Throat; Body muscle sore; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 17-years-old) as dose number unknown single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore throat and body muscle sore. The clinical outcome of the events sore throat and body muscle sore was unknown 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.  Amendment: This follow-up report is being submitted to amend previously reported information: Added vaccination Facility Country.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Dry eye, Dry skin, Myalgia
Clinical narrative: Joint pain; Muscle pain; Heart racing; Extreme thirst; Feeling of excessive dehydration; body, skin, eyes, feel dry; body, skin, eyes, feel dry; feeling of decreased urination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 31Aug2021 (Lot number: EW0169) at the age of 50 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: THIRST (non-serious) with onset 31Aug2021, outcome "not recovered", described as "Extreme thirst"; PALPITATIONS (non-serious) with onset Sep2021, outcome "not recovered", described as "Heart racing"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain"; MYALGIA (non-serious), outcome "not recovered", described as "Muscle pain"; DEHYDRATION (non-serious) with onset 31Aug2021, outcome "not recovered", described as "Feeling of excessive dehydration"; DRY SKIN (non-serious), DRY EYE (non-serious) all with onset 31Aug2021, outcome "unknown" and all described as "body, skin, eyes, feel dry"; URINE OUTPUT DECREASED (non-serious) with onset 31Aug2021, outcome "unknown", described as "feeling of decreased urination". The events "extreme thirst" and "feeling of excessive dehydration" were evaluated at the physician office visit.  Additional information: Patient did not receive any other vaccines within four weeks prior to the suspect administration. Patient had received one allergy shot but no vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Thirst, Urine output decreased
Clinical narrative: Joint pain; Muscle pain; Heart racing; Extreme thirst; Feeling of excessive dehydration; body, skin, eyes, feel dry; body, skin, eyes, feel dry; feeling of decreased urination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 31Aug2021 (Lot number: EW0169) at the age of 50 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: THIRST (non-serious) with onset 31Aug2021, outcome "not recovered", described as "Extreme thirst"; PALPITATIONS (non-serious) with onset Sep2021, outcome "not recovered", described as "Heart racing"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain"; MYALGIA (non-serious), outcome "not recovered", described as "Muscle pain"; DEHYDRATION (non-serious) with onset 31Aug2021, outcome "not recovered", described as "Feeling of excessive dehydration"; DRY SKIN (non-serious), DRY EYE (non-serious) all with onset 31Aug2021, outcome "unknown" and all described as "body, skin, eyes, feel dry"; URINE OUTPUT DECREASED (non-serious) with onset 31Aug2021, outcome "unknown", described as "feeling of decreased urination". The events "extreme thirst" and "feeling of excessive dehydration" were evaluated at the physician office visit.  Additional information: Patient did not receive any other vaccines within four weeks prior to the suspect administration. Patient had received one allergy shot but no vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Antibody test, Blood follicle stimulating hormone
Clinical narrative: After receiving my second COVID Vaccine. I stopped having periods; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 20Jan2021 15:00 (Lot number: EL9261) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing); "ADHD" (ongoing); "Insomnia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Time: 16:00 , Anatomical site of injection: right deltoid, Route of administration: Intramuscular, Batch/Lot number: EJ1886), administration date: 29Dec2020, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "After receiving my second COVID Vaccine. I stopped having periods". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had 3rd Dose on 01Oct2021 around 10:30-11 AM, anatomical site of injection: left deltoid, route of administration: Intramuscular and batch/Lot number: 301458A. Specific relevant test for Thromboembolic events with Thrombocytopenia: None. In Jul/Aug2021, I was confirmed to be post-menopausal the age of 38. The patient was seen by PCP, OB-Gyn, and Endocrine, Endocrinologist diagnosed ovarian failure, autoimmune. I don't know that the 2 events are related, but the timing is of concern. The patient was not sure what additional testing or treatment she should seek. If you are doing any trials on this type of event, I would be willing to participate.  The Pfizer product had a possible casual effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood pressure measurement, Chills, Decreased appetite
Clinical narrative: felt dizzy and a little weak; felt dizzy and a little weak; profuse vomiting; being cold with chills; a little stomach pain; had a severe headache; decreased appetite; swollen lymph nodes; light headed; Dates for doesn't feel like he normally does; 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 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 04:30 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single and administered in arm left, administration date 28Dec2021 04:45 (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: DIZZINESS (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "felt dizzy and a little weak"; VOMITING (non-serious), outcome "unknown", described as "profuse vomiting"; CHILLS (non-serious), outcome "unknown", described as "being cold with chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "a little stomach pain"; HEADACHE (non-serious), outcome "unknown", described as "had a severe headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes"; DIZZINESS (non-serious), outcome "unknown", described as "light headed"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Dates for doesn't feel like he normally does". Relevant laboratory tests and procedures are available in the appropriate section. The caller was a consumer who received his second dose of the Pfizer COVID 19 Vaccine on Tuesday. He received the vaccine early Tuesday afternoon and woke up at 1AM with side effects. After receiving the vaccine the caller reported having felt dizzy and a little weak, profuse vomiting, being cold with chills, and then a little stomach pain. He also notes having had a severe headache with decreased appetite and swollen lymph nodes. The caller does also note that he has not had any joint pain or diarrhea as well as no rash. State that when he went home and started to eat dinner he wasn't feeling well and he went to bed and woke up throwing up profusely, he was cold and had chills. Caller states it was 3-4 times from 1am-6am. Caller states he had a little bit of stomach pain, a really severe headache, and all day just stayed in bed on Wednesday. Caller states that yesterday he got up and felt fine and is a little better today, he is a little light headed and has a little weakness. States he has been taking his blood pressure and it is basically normal, 130/77 and his pulse was 93 beats per minutes. Caller states that is an average of 3 times.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Heart rate, Lymphadenopathy
Clinical narrative: felt dizzy and a little weak; felt dizzy and a little weak; profuse vomiting; being cold with chills; a little stomach pain; had a severe headache; decreased appetite; swollen lymph nodes; light headed; Dates for doesn't feel like he normally does; 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 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 04:30 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single and administered in arm left, administration date 28Dec2021 04:45 (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: DIZZINESS (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "felt dizzy and a little weak"; VOMITING (non-serious), outcome "unknown", described as "profuse vomiting"; CHILLS (non-serious), outcome "unknown", described as "being cold with chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "a little stomach pain"; HEADACHE (non-serious), outcome "unknown", described as "had a severe headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes"; DIZZINESS (non-serious), outcome "unknown", described as "light headed"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Dates for doesn't feel like he normally does". Relevant laboratory tests and procedures are available in the appropriate section. The caller was a consumer who received his second dose of the Pfizer COVID 19 Vaccine on Tuesday. He received the vaccine early Tuesday afternoon and woke up at 1AM with side effects. After receiving the vaccine the caller reported having felt dizzy and a little weak, profuse vomiting, being cold with chills, and then a little stomach pain. He also notes having had a severe headache with decreased appetite and swollen lymph nodes. The caller does also note that he has not had any joint pain or diarrhea as well as no rash. State that when he went home and started to eat dinner he wasn't feeling well and he went to bed and woke up throwing up profusely, he was cold and had chills. Caller states it was 3-4 times from 1am-6am. Caller states he had a little bit of stomach pain, a really severe headache, and all day just stayed in bed on Wednesday. Caller states that yesterday he got up and felt fine and is a little better today, he is a little light headed and has a little weakness. States he has been taking his blood pressure and it is basically normal, 130/77 and his pulse was 93 beats per minutes. Caller states that is an average of 3 times.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: felt dizzy and a little weak; felt dizzy and a little weak; profuse vomiting; being cold with chills; a little stomach pain; had a severe headache; decreased appetite; swollen lymph nodes; light headed; Dates for doesn't feel like he normally does; 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 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 04:30 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single and administered in arm left, administration date 28Dec2021 04:45 (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: DIZZINESS (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "felt dizzy and a little weak"; VOMITING (non-serious), outcome "unknown", described as "profuse vomiting"; CHILLS (non-serious), outcome "unknown", described as "being cold with chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "a little stomach pain"; HEADACHE (non-serious), outcome "unknown", described as "had a severe headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes"; DIZZINESS (non-serious), outcome "unknown", described as "light headed"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Dates for doesn't feel like he normally does". Relevant laboratory tests and procedures are available in the appropriate section. The caller was a consumer who received his second dose of the Pfizer COVID 19 Vaccine on Tuesday. He received the vaccine early Tuesday afternoon and woke up at 1AM with side effects. After receiving the vaccine the caller reported having felt dizzy and a little weak, profuse vomiting, being cold with chills, and then a little stomach pain. He also notes having had a severe headache with decreased appetite and swollen lymph nodes. The caller does also note that he has not had any joint pain or diarrhea as well as no rash. State that when he went home and started to eat dinner he wasn't feeling well and he went to bed and woke up throwing up profusely, he was cold and had chills. Caller states it was 3-4 times from 1am-6am. Caller states he had a little bit of stomach pain, a really severe headache, and all day just stayed in bed on Wednesday. Caller states that yesterday he got up and felt fine and is a little better today, he is a little light headed and has a little weakness. States he has been taking his blood pressure and it is basically normal, 130/77 and his pulse was 93 beats per minutes. Caller states that is an average of 3 times.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; aches; chills; headache; 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 58 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 25Mar2021 10:00 (Lot number: ER8727) as dose 2, single and intramuscular, administered in arm, administration date 06Mar2021 09:30 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "aches"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: Prior Vaccinations (within 4 weeks) were none. Reporter informed that on 07Dec2021- was administered the Pfizer Booster shot and had similar side effects to the first 2 Pfizer shots, fever, aches, chills, headache etc. It lasted its usual 24 to 48 hours.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: 72 hours later I still have a terrible headache; Chills; muscle ache fir 48 hours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Jan2022 11:30 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: ZINC; VITAMIN C [ASCORBIC ACID]; B12 [CYANOCOBALAMIN]. The following information was reported: HEADACHE (non-serious) with onset 22Jan2022 21:00, outcome "not recovered", described as "72 hours later I still have a terrible headache"; CHILLS (non-serious) with onset 22Jan2022 21:00, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 22Jan2022 21:00, outcome "not recovered", described as "muscle ache fir 48 hours.". Therapeutic measures were not taken as a result of headache, chills, myalgia.  Additional information: Patient had no other vaccine in four weeks. Patient was not tested COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Illness
Clinical narrative: illness/sickness; lost her voice to an extent as of this morning.; sickness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Brand: Unknown), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "illness/sickness"; APHONIA (non-serious), outcome "unknown", described as "lost her voice to an extent as of this morning."; ILLNESS (non-serious), outcome "unknown", described as "sickness".  Additional information: I'm convinced she is vaccinated fully, but don't know what vaccine or when or if already boosted. Cannot confirm 100% but highly likely. She is likely in 40s or 50s. I am not sure what the "sickness" vs "illness" events were. Regardless, I do not know which vaccine this person received or the vaccine the person in AER received, so these both can be closed. The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Follow-up (02Mar2022): 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: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergic reaction".  Additional information: Caller was asking for her patient who had a shot of her Pfizer Covid 19 Vaccine for the 1st dose, but experienced a severe allergic reaction because of it. Caller stated that for the patient's 2nd dose she got a shot of the Jansenn vaccine. Caller was asking if they could give Jansenn as her booster.  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: Tremor
Clinical narrative: Right Hand shaking; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2022 10:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: Known allergies: Amoxicillin. The following information was reported: TREMOR (non-serious) with onset 28Jan2022 07:00, outcome "unknown", described as "Right Hand shaking". The event "right hand shaking" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tremor.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reporter seriousness of the events: non serious. The reporter was unable to locate or read the lot number details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: With the other two shots I only had like a Sore arm you know it's little bit of swelling; With the other two shots I only had like a Sore arm you know it's little bit of swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date 18May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "With the other two shots I only had like a Sore arm you know it's little bit of swelling". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling.  Additional information: Height 5 foot 5 (inches) and weight was probably about 195 (pounds)."The patient stated that the other two shots only had like a sore arm you know it's little bit of swelling and that was about it but this is the third one and it's kind of like but guess the way they gave me the shot it was like close to my arm, would say like it was like close to the top of arm, the way they gave me the shot, instead of like more of the middle part of the arm you know like they gave you to you on the side it was more like close to the top where the connection to the bone. The patient received booster dose (batch number: FJ1614) on 26Jan2022, and experienced headache, itching really bad, it's red and it's like a fever in the shoulder, it feels really warm; It's itching and it's kind of like a fever on the arm, it's still swollen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Parosmia, Taste disorder, Vertigo
Clinical narrative: vertigo; altered smell and taste; altered smell and taste; sharp pains in left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "Known allergies: seafood" (unspecified if ongoing), notes: Known allergies: seafood. Concomitant medication(s) included: SERTRALINE; DRAMAMINE. The following information was reported: VERTIGO (non-serious) with onset 31Dec2021, outcome "not recovered", described as "vertigo"; PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 31Dec2021, outcome "not recovered" and all described as "altered smell and taste"; PAIN (non-serious) with onset 31Dec2021, outcome "not recovered", described as "sharp pains in left side". The events "vertigo", "altered smell and taste", "altered smell and taste" and "sharp pains in left side" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, parosmia, taste disorder, pain.  Additional information: There was no other vaccine in for weeks. There was no covid tested post vaccination. Treatment included Dramamine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Investigation, Muscular weakness, Myositis
Clinical narrative: weakness in his legs; Myositis; The weakness progressed to his arms and then to the point where he couldn't walk.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 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: MUSCULAR WEAKNESS (non-serious) with onset 2022, outcome "not recovered", described as "weakness in his legs"; MYOSITIS (non-serious) with onset 2022, outcome "not recovered", described as "Myositis"; GAIT INABILITY (non-serious) with onset 2022, outcome "not recovered", described as "The weakness progressed to his arms and then to the point where he couldn't walk.". The events "weakness in his legs", "myositis" and "the weakness progressed to his arms and then to the point where he couldn't walk." were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscular weakness, myositis, gait inability.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (07Mar2022): 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: F
Vaccine: COVID19
Symptoms: Affective disorder, Fatigue, Heavy menstrual bleeding
Clinical narrative: Mood swings are bad; Fatigue; Bleeding heavily; I started my cycle 10Jan and here it is 31Jan and I am still bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (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: Covid-19 vaccine (Dose number: 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 10Jan2022, outcome "not recovered", described as "I started my cycle 10Jan and here it is 31Jan and I am still bleeding"; AFFECTIVE DISORDER (non-serious), outcome "unknown", described as "Mood swings are bad"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Bleeding heavily".  Additional information: Patient was spoken to a half dozen women in my immediate area who all say they went through the same thing after getting the vaccine. One woman bled for 3 months and had to have a blood transfusion.   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.