chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect route of product administration, Vaccination site pain
Clinical narrative: Headache; Vaccine route of administration is intravenous; Slight pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient received BNT162B2 (BNT162B2), intravenous, administered in arm left, administration date 24Feb2021 01:30 (Lot number: EL6203, Expiration Date: 02Jun2021) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, single (Batch/Lot number: EL9264, Expiration Date: May2021) via intravenous in the left upper arm at 12:00 PM), administration date: 03Feb2021, when the patient was 69 years old, for Covid-19 Immunization, reactions: "Headache", "Sinus congestion", "Cough", "Fatigue", "Slight pain at injection site", "Vaccine administered via IV". The following information was reported: HEADACHE (non-serious) with onset 24Feb2021 07:30, outcome "recovered" (24Feb2021 17:30), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Slight pain at injection site"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Feb2021 01:30, outcome "unknown", described as "Vaccine route of administration is intravenous".  The reporter considered "headache" and "slight pain at injection site" not related to BNT162B2.  Additional Information: The patient did not receive any recent vaccines for any other conditions and for SARS-COV-2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the close temporal association the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out ,Linked Report(s) : US-PFIZER INC-2021120725 Same patient and product; Different dose and events
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever of 102 next day and migraine from 1/17-present. Unsure of when migraine will stop. A migraine lasting more than 12 hrs has never happened to patient. Prescribed medication (Imitrex) not working. Nausea and vomiting occurred 1/20 and again today, 1/22.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Breakthrough COVID-19 case:   Reason for Hospitalization: Patient is a 51 y.o. female presents with worsening COVID symptoms. Symptoms started around christmas. Main symptoms are fatigue and cannot completely care of herself. Over the last few days, pt reports increased fatigue and DOE. Reports could only walk short distances then would have to stop to catch her breath. Denies n/v, sore throat, muscle aches. Reports fevers. No diarrhea. Hasn't been eating or drinking much lately due to fatigue. Pt presented to the ED with the above symptoms. O2 sat was 79% on room air, improved to 94% on 3-4L NC.    Hospital Course by Problem List:  51 yo female with COVID symptoms since christmas, presents with worsening DOE and fatigue. CTA of chest on admit, 1/11/22, no PE.    #acute hypoxemic respiratory failure from COVID 19 pneumonia:  -decadron, had three days in the hospital, will finish 7 days at home  -remdesivir  -supplemental oxygen  -overall pt has improved and believes she can care for herself, reports can ambulate in the room without DOE. Pt is requesting DC today. Pt is willing to pay for home oxygen as she does not have insurance. Appreciate RT arranging home oxygen.    #new dx of DMII:  Hba1c: 8.1%  -will dc pt on metformin and have pt follow up with PCP for further mtg    #hypokalemia -replaced    #hypomagnesemia:  -replaced   #depression:  -cont paxil daily    DNR/DNI    VTE ppy: lovenox
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea exertional, Fatigue, Glycosylated haemoglobin increased, Hypokalaemia
Clinical narrative: Breakthrough COVID-19 case:   Reason for Hospitalization: Patient is a 51 y.o. female presents with worsening COVID symptoms. Symptoms started around christmas. Main symptoms are fatigue and cannot completely care of herself. Over the last few days, pt reports increased fatigue and DOE. Reports could only walk short distances then would have to stop to catch her breath. Denies n/v, sore throat, muscle aches. Reports fevers. No diarrhea. Hasn't been eating or drinking much lately due to fatigue. Pt presented to the ED with the above symptoms. O2 sat was 79% on room air, improved to 94% on 3-4L NC.    Hospital Course by Problem List:  51 yo female with COVID symptoms since christmas, presents with worsening DOE and fatigue. CTA of chest on admit, 1/11/22, no PE.    #acute hypoxemic respiratory failure from COVID 19 pneumonia:  -decadron, had three days in the hospital, will finish 7 days at home  -remdesivir  -supplemental oxygen  -overall pt has improved and believes she can care for herself, reports can ambulate in the room without DOE. Pt is requesting DC today. Pt is willing to pay for home oxygen as she does not have insurance. Appreciate RT arranging home oxygen.    #new dx of DMII:  Hba1c: 8.1%  -will dc pt on metformin and have pt follow up with PCP for further mtg    #hypokalemia -replaced    #hypomagnesemia:  -replaced   #depression:  -cont paxil daily    DNR/DNI    VTE ppy: lovenox
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomagnesaemia, Hypophagia, Impaired self-care, Lung disorder, Lung opacity
Clinical narrative: Breakthrough COVID-19 case:   Reason for Hospitalization: Patient is a 51 y.o. female presents with worsening COVID symptoms. Symptoms started around christmas. Main symptoms are fatigue and cannot completely care of herself. Over the last few days, pt reports increased fatigue and DOE. Reports could only walk short distances then would have to stop to catch her breath. Denies n/v, sore throat, muscle aches. Reports fevers. No diarrhea. Hasn't been eating or drinking much lately due to fatigue. Pt presented to the ED with the above symptoms. O2 sat was 79% on room air, improved to 94% on 3-4L NC.    Hospital Course by Problem List:  51 yo female with COVID symptoms since christmas, presents with worsening DOE and fatigue. CTA of chest on admit, 1/11/22, no PE.    #acute hypoxemic respiratory failure from COVID 19 pneumonia:  -decadron, had three days in the hospital, will finish 7 days at home  -remdesivir  -supplemental oxygen  -overall pt has improved and believes she can care for herself, reports can ambulate in the room without DOE. Pt is requesting DC today. Pt is willing to pay for home oxygen as she does not have insurance. Appreciate RT arranging home oxygen.    #new dx of DMII:  Hba1c: 8.1%  -will dc pt on metformin and have pt follow up with PCP for further mtg    #hypokalemia -replaced    #hypomagnesemia:  -replaced   #depression:  -cont paxil daily    DNR/DNI    VTE ppy: lovenox
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Type 2 diabetes mellitus, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID-19 case:   Reason for Hospitalization: Patient is a 51 y.o. female presents with worsening COVID symptoms. Symptoms started around christmas. Main symptoms are fatigue and cannot completely care of herself. Over the last few days, pt reports increased fatigue and DOE. Reports could only walk short distances then would have to stop to catch her breath. Denies n/v, sore throat, muscle aches. Reports fevers. No diarrhea. Hasn't been eating or drinking much lately due to fatigue. Pt presented to the ED with the above symptoms. O2 sat was 79% on room air, improved to 94% on 3-4L NC.    Hospital Course by Problem List:  51 yo female with COVID symptoms since christmas, presents with worsening DOE and fatigue. CTA of chest on admit, 1/11/22, no PE.    #acute hypoxemic respiratory failure from COVID 19 pneumonia:  -decadron, had three days in the hospital, will finish 7 days at home  -remdesivir  -supplemental oxygen  -overall pt has improved and believes she can care for herself, reports can ambulate in the room without DOE. Pt is requesting DC today. Pt is willing to pay for home oxygen as she does not have insurance. Appreciate RT arranging home oxygen.    #new dx of DMII:  Hba1c: 8.1%  -will dc pt on metformin and have pt follow up with PCP for further mtg    #hypokalemia -replaced    #hypomagnesemia:  -replaced   #depression:  -cont paxil daily    DNR/DNI    VTE ppy: lovenox
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Resting heart rate went from under 70 bpm to over 100 bpm. Body Aches. Chills. High Fever
Sex: F
Vaccine: COVID19
Symptoms: Staphylococcal infection
Clinical narrative: Staphylococcus aureus infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A female patient 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: STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown", described as "Staphylococcus aureus infection".  Additional information: Reporter was calling to ask for medical information, reporter's daughter, she developed a reaction after the vaccine, she developed a staph infection, very serious staph infection after vaccine, like 4 days after the vaccine and reporter wanted to ask what do you have in your data, do you have (Incomplete sentence) Reporter wanted to search your database and let know if there is any history of that what we can expect reporter was trying to find if she can get second vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Soreness; Light headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EP6955, Expiration Date: 30Jun2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Soreness"; HEADACHE (non-serious), outcome "unknown", described as "Light headache".  Additional information: Description of Event: Soreness Light headache. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Lot number: ER8727) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headache".  Additional information: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "recovered", described as "Rash". Therapeutic measures were taken as a result of rash.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Rhinorrhoea
Clinical narrative: Rhinorrhea; Tiredness/Fatigue; Low back pain; This is a spontaneous report received from a contactable Other HCP (patient). A 39-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via unspecified route on 28Jan2021 at 15:30 (at the age of 39-years-old) in the Deltoid Left as a dose 1, single for COVID-19 immunization. Patient's medical history was not reported, and concomitant medications was reported as none. It was reported that the patient did not receive other vaccines within 4 weeks. The patient did not have COVID-19 prior vaccination and not tested post vaccination. No Covid prior vaccination and No Covid tested post vaccination. On 31Jan2021, the patient experienced tiredness/fatigue, low back pain and on 01Feb2021, the patient experienced rhinorrhoea. The events assessed as non-serious. The outcome of the events tiredness/fatigue, low back pain was resolved on an unspecified date in 2021 and outcome of event rhinorrhoea was unknown.   The clinical course was as follows: The patient dose 2 was scheduled on 22Feb2021.  Information about Lot/batch Number has been requested.  Follow-up (19Mar2021 and 07May2021): This is a follow-up spontaneous report received from a contactable other HCP. This other HCP (patient) reported in response to HCP letter sent via follow-up letter which included that: Dose 1 and Dose 2 information. Concomitant drugs updated as none. The events seriousness criteria and case closure comment.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Bacteraemia, Blood pressure increased, Blood test, Body temperature, Body temperature increased
Clinical narrative: elevated temperature of 105F; elevated blood pressure; bacteria on the blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 11Mar2021 (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: BODY TEMPERATURE INCREASED (hospitalization) with onset 12Mar2021, outcome "unknown", described as "elevated temperature of 105F"; BLOOD PRESSURE INCREASED (hospitalization) with onset 12Mar2021, outcome "unknown", described as "elevated blood pressure"; BACTERAEMIA (medically significant) with onset 12Mar2021, outcome "unknown", described as "bacteria on the blood". The events "elevated temperature of 105f" and "elevated blood pressure" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (12Mar2021) she has bacteria on the blood, notes: she has bacteria on the blood; body temperature: (12Mar2021) 105 Fahrenheit.  Additional information: They were asking for compensation since they believe that the cause of her hospitalization was the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: just a few days later she hurt her back/sore back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (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: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "just a few days later she hurt her back/sore back". Therapeutic measures were taken as a result of back pain. Additional information: Patient stated that everything went great after the vaccination and then she threw her back out and took anti-inflammatories over the weekend. It was reported that just a few days later after the vaccination, the patient hurt her back and went in to see her HCP who gave her a steroid injection for her sore back. Caller stated she was now worried that she did something wrong and wanted to know if steroid injections affect the efficacy of the vaccine. Patient would also like to know if she should wait a certain amount of time to receive the second dose since receiving the steroid injection.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Pneumonia shot (my arm hurt a little bit, I've had other shots that hurt 10x worse), for immunisation, reaction(s): "my arm hurt"; Tetanus shot (his arm was much more sore after the tetanus shot), for immunisation, reaction(s): "arm was much more sore". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm hurt a little bit". Additional information: The patient is taking blood thinners before taking the first dose until now and wanted to know if it was okay. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Sluggishness, Vaccination site pain
Clinical narrative: slightly light-headed the morning after; Very sore at injection site; tired/sluggish; tired/sluggish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Mar2021 11:00 (Lot number: EP6955) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies to tree nuts" (unspecified if ongoing); "Allergies to shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Mar2021, outcome "recovering", described as "Very sore at injection site"; FATIGUE (non-serious), SLUGGISHNESS (non-serious) all with onset 17Mar2021, outcome "recovering" and all described as "tired/sluggish"; DIZZINESS (non-serious) with onset 18Mar2021, outcome "recovering", described as "slightly light-headed the morning after". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, sluggishness, dizziness.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. The patient had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal pain
Clinical narrative: bowel cramping/ pains; 3 loose bowel movements/ would not call the movements diarrhea since they are not watery; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 10Mar2021 10:00 (Lot number: EN5318) at the age of 74 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Heart attack", stop date: 2020, notes: about a year ago; "Blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "stent placed in one of the coronary arteries", start date: 2020 (unspecified if ongoing), notes: about a year ago. Concomitant medications included: SHORT ACTING INSULIN taken for diabetes mellitus; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal; LANTUS taken for diabetes mellitus. The following information was reported: GASTROINTESTINAL PAIN (non-serious) with onset 17Mar2021, outcome "unknown", described as "bowel cramping/ pains"; DIARRHOEA (non-serious) with onset 17Mar2021, outcome "recovering", described as "3 loose bowel movements/ would not call the movements diarrhea since they are not watery". Therapeutic measures were not taken as a result of gastrointestinal pain, diarrhoea.  Additional information: The reporter stated that he takes a lot of medication. He takes high blood pressure pills and other stuff. He felt the most important medication he takes is insulin for diabetes. The patient did not receive any other vaccines within four weeks prior to vaccination. The events did not require a visit to emergency room or physician office.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Nausea
Clinical narrative: Sick for 3 days; Felt tired; Nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 13:45 (Lot number: EN6201) at the age of 79 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot number: EN6201, Administration time: 09:45, Vaccine location: Right arm), administration date: 12Feb2021, when the patient was 78 years old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 05Mar2021, outcome "recovering", described as "Felt tired"; NAUSEA (non-serious) with onset 05Mar2021, outcome "recovered" (14Mar2021), described as "Nauseated"; ILLNESS (non-serious) with onset 08Mar2021, outcome "recovered" (11Mar2021), described as "Sick for 3 days".  Additional information: The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior COVID vaccine. The patient spoked to a nurse who told her that the events were normal.   No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Trigger finger
Clinical narrative: right pinky and right ring fingers started to 'act up."/trigger fingers (stiff and can't bend her fingers); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 85 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 07Mar2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "trigger finger" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cortisone injection shots for trigger finger. The following information was reported: TRIGGER FINGER (non-serious) with onset Mar2021, outcome "unknown", described as "right pinky and right ring fingers started to 'act up."/trigger fingers (stiff and can't bend her fingers)".  Additional information: This report was received from Pfizer sponsored program. Clinical course: Patient stated that after receiving the vaccine, her right pinky and right ring fingers started to act up/experiencing trigger fingers (stiff and can't bend her fingers). She reported she had a history of trigger finger and they "act up" on a regular basis and she received cortisone injection shots when that occurs. She wanted to know if she can take a cortisone shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Speech disorder, Vaccination site erythema
Clinical narrative: injection site is about 1/8 inch in size and is all red/Injection site is starting to turn red; the patient can't walk or talk or communicate with him; the patient can't walk or talk or communicate with him; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 12Mar2021 13:00 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 70 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Stroke", start date: 2017 (unspecified if ongoing), notes: had 4 strokes about 4 years ago; "Grand mal seizure", start date: 2017 (unspecified if ongoing), notes: 9-10 grand mal seizures; began the same time when she had strokes; not had a seizure for over a year; "Diabetes" (ongoing), notes: diagnosed with diabetes at least 20 years ago; monitors the patient's blood sugar four times per day; "High cholesterol" (ongoing), notes: diagnosed with high cholesterol probably also more than 20 years ago; "Acid reflux" (ongoing), notes: diagnosed with acid reflux more than 20 years ago; "Hiatal hernia" (ongoing), notes: diagnosed with around the same time she was diagnosed with acid reflux more than 20 years ago. Concomitant medication(s) included: BABY ASPIRIN taken for blood cholesterol increased (ongoing); BASAGLAR taken for diabetes mellitus (ongoing); NOVOLOG taken for diabetes mellitus (ongoing); METOPROLOL (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); VALPROIC ACID taken for seizure, start date: 2017 (ongoing); PHENYTOIN taken for seizure, start date: 2017 (ongoing); LISINOPRIL taken for gastrooesophageal reflux disease, start date: 2018 (ongoing). Past drug history included: Losartan. Vaccination history included: Smallpox injection. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 18Mar2021, outcome "unknown", described as "injection site is about 1/8 inch in size and is all red/Injection site is starting to turn red"; GAIT INABILITY (non-serious), SPEECH DISORDER (non-serious) all with onset 2021, outcome "unknown" and all described as "the patient can't walk or talk or communicate with him". Additional information: The patient weighed "130" about a year ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. BNT162B2 was injected right below where the patient received a smallpox injection. The patient started taking Baby Aspirin, Basaglar, Novolog, Metoprolol, and Atorvastatin more than 10 years ago. The events did not result in an emergency room visit. The patient was scheduled to be brought to the doctor on 19Mar2021 due to redness at injection site.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Malaise, Nausea, Pain
Clinical narrative: feeling really sick; everything she smells, smelling like the sickening sweet dried cat food smell; wasn't really that unpleasant to begin with but with everything tasting and smelling like that; feeling really bad and aching all over; feeling really bad and aching all over; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (Lot number: EN6205) at the age of 69 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "sleeping difficulty" (unspecified if ongoing). Concomitant medication(s) included: SEROQUEL taken for insomnia, start date: 04Mar2021. Vaccination history included: BNT162B2 (dose 1, lot no.: EN6203), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 16Mar2021, outcome "unknown", described as "feeling really sick"; PAROSMIA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "everything she smells, smelling like the sickening sweet dried cat food smell"; DYSGEUSIA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "wasn't really that unpleasant to begin with but with everything tasting and smelling like that"; FEELING ABNORMAL (non-serious), PAIN (non-serious) all with onset 16Mar2021, outcome "recovering" and all described as "feeling really bad and aching all over"; NAUSEA (non-serious) with onset 16Mar2021, outcome "recovering", described as "nausea".  Additional information: Clinical course: She went for the second one Tuesday morning and she was fine for about 5-6 hours then she started feeling really sick/feeling really bad and aching all over, she had a little bit of nausea and she called a united healthcare nurse and asked she said she thought that was pretty normal for the second shot so she was not too worried about that. But one of symptoms was strange, it smells like, everything she smells, smelling like the sickening sweet dried cat food smell and the thing she is really kind of worried about with this thing was she would be testing positive and if she could give this to her father who is in his 90s. It was not really that unpleasant to begin with but with everything tasting and smelling like that, and she still had that. Other than that, she was feeling about 75 percent better. With the taste and smell that was still ongoing, it had stayed about the same but with everything else she feels about 75 percent better.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: feeling really sick; everything she smells, smelling like the sickening sweet dried cat food smell; wasn't really that unpleasant to begin with but with everything tasting and smelling like that; feeling really bad and aching all over; feeling really bad and aching all over; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (Lot number: EN6205) at the age of 69 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "sleeping difficulty" (unspecified if ongoing). Concomitant medication(s) included: SEROQUEL taken for insomnia, start date: 04Mar2021. Vaccination history included: BNT162B2 (dose 1, lot no.: EN6203), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 16Mar2021, outcome "unknown", described as "feeling really sick"; PAROSMIA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "everything she smells, smelling like the sickening sweet dried cat food smell"; DYSGEUSIA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "wasn't really that unpleasant to begin with but with everything tasting and smelling like that"; FEELING ABNORMAL (non-serious), PAIN (non-serious) all with onset 16Mar2021, outcome "recovering" and all described as "feeling really bad and aching all over"; NAUSEA (non-serious) with onset 16Mar2021, outcome "recovering", described as "nausea".  Additional information: Clinical course: She went for the second one Tuesday morning and she was fine for about 5-6 hours then she started feeling really sick/feeling really bad and aching all over, she had a little bit of nausea and she called a united healthcare nurse and asked she said she thought that was pretty normal for the second shot so she was not too worried about that. But one of symptoms was strange, it smells like, everything she smells, smelling like the sickening sweet dried cat food smell and the thing she is really kind of worried about with this thing was she would be testing positive and if she could give this to her father who is in his 90s. It was not really that unpleasant to begin with but with everything tasting and smelling like that, and she still had that. Other than that, she was feeling about 75 percent better. With the taste and smell that was still ongoing, it had stayed about the same but with everything else she feels about 75 percent better.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: arm soreness/Left upper arm injection site soreness; My arm hurts and there is a little discomfort/when discomfort started; 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 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 16:00 (Lot number: EN6205) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing), notes: Diagnosed 12-15 years ago., does take oral medication for diabetes; "High Cholesterol" (unspecified if ongoing), notes: Diagnosed 15 years ago. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Mar2021 16:00, outcome "not recovered", described as "arm soreness/Left upper arm injection site soreness"; VACCINATION SITE DISCOMFORT (non-serious) with onset 17Mar2021 16:00, outcome "not recovered", described as "My arm hurts and there is a little discomfort/when discomfort started". Therapeutic measures were taken as a result of vaccination site pain, vaccination site discomfort. Additional information: The patient takes oral medication for diabetes (unspecified). Patient had no previous history of immunization with the Pfizer vaccine considered as suspect and had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks) and no adverse event following prior vaccinations. Patient took Excedrin this morning and it did work, took 2 of 500 mg capsules.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Disorientation, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Felt over heated/three to five minutes he felt a rush; Sweating through my clothes; Black vision; Very close to passing out/he felt like fainting; I couldn't form a sentence to come out of my mouth to ask for water from him; Very fatigued; Nausea; Headache/pressure at the crown of his head; Felt disoriented like super forgetful; Felt disoriented like super forgetful; His motor functions not on point like trying to operate electronics; 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 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injcetion), administered in arm left, administration date 12Mar2021 13:30 (Lot number: EN6208) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Oral surgery" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Felt over heated/three to five minutes he felt a rush"; HYPERHIDROSIS (non-serious) with onset 12Mar2021, outcome "recovered" (14Mar2021), described as "Sweating through my clothes"; VISUAL IMPAIRMENT (non-serious) with onset 12Mar2021, outcome "unknown", described as "Black vision"; PRESYNCOPE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Very close to passing out/he felt like fainting"; SPEECH DISORDER (non-serious) with onset 12Mar2021, outcome "not recovered", described as "I couldn't form a sentence to come out of my mouth to ask for water from him"; FATIGUE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Very fatigued"; NAUSEA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Headache/pressure at the crown of his head"; MEMORY IMPAIRMENT (non-serious), DISORIENTATION (non-serious) all with onset 12Mar2021, outcome "not recovered" and all described as "Felt disoriented like super forgetful"; IMPAIRED DRIVING ABILITY (non-serious) with onset Mar2021, outcome "not recovered", described as "His motor functions not on point like trying to operate electronics". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The events did not require a visit to emergency room (ER) and physician. The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired driving ability, Memory impairment, Nausea, Presyncope, SARS-CoV-2 test negative
Clinical narrative: Felt over heated/three to five minutes he felt a rush; Sweating through my clothes; Black vision; Very close to passing out/he felt like fainting; I couldn't form a sentence to come out of my mouth to ask for water from him; Very fatigued; Nausea; Headache/pressure at the crown of his head; Felt disoriented like super forgetful; Felt disoriented like super forgetful; His motor functions not on point like trying to operate electronics; 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 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injcetion), administered in arm left, administration date 12Mar2021 13:30 (Lot number: EN6208) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Oral surgery" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Felt over heated/three to five minutes he felt a rush"; HYPERHIDROSIS (non-serious) with onset 12Mar2021, outcome "recovered" (14Mar2021), described as "Sweating through my clothes"; VISUAL IMPAIRMENT (non-serious) with onset 12Mar2021, outcome "unknown", described as "Black vision"; PRESYNCOPE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Very close to passing out/he felt like fainting"; SPEECH DISORDER (non-serious) with onset 12Mar2021, outcome "not recovered", described as "I couldn't form a sentence to come out of my mouth to ask for water from him"; FATIGUE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Very fatigued"; NAUSEA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Headache/pressure at the crown of his head"; MEMORY IMPAIRMENT (non-serious), DISORIENTATION (non-serious) all with onset 12Mar2021, outcome "not recovered" and all described as "Felt disoriented like super forgetful"; IMPAIRED DRIVING ABILITY (non-serious) with onset Mar2021, outcome "not recovered", described as "His motor functions not on point like trying to operate electronics". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The events did not require a visit to emergency room (ER) and physician. The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Visual impairment
Clinical narrative: Felt over heated/three to five minutes he felt a rush; Sweating through my clothes; Black vision; Very close to passing out/he felt like fainting; I couldn't form a sentence to come out of my mouth to ask for water from him; Very fatigued; Nausea; Headache/pressure at the crown of his head; Felt disoriented like super forgetful; Felt disoriented like super forgetful; His motor functions not on point like trying to operate electronics; 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 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injcetion), administered in arm left, administration date 12Mar2021 13:30 (Lot number: EN6208) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Oral surgery" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Felt over heated/three to five minutes he felt a rush"; HYPERHIDROSIS (non-serious) with onset 12Mar2021, outcome "recovered" (14Mar2021), described as "Sweating through my clothes"; VISUAL IMPAIRMENT (non-serious) with onset 12Mar2021, outcome "unknown", described as "Black vision"; PRESYNCOPE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Very close to passing out/he felt like fainting"; SPEECH DISORDER (non-serious) with onset 12Mar2021, outcome "not recovered", described as "I couldn't form a sentence to come out of my mouth to ask for water from him"; FATIGUE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Very fatigued"; NAUSEA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Headache/pressure at the crown of his head"; MEMORY IMPAIRMENT (non-serious), DISORIENTATION (non-serious) all with onset 12Mar2021, outcome "not recovered" and all described as "Felt disoriented like super forgetful"; IMPAIRED DRIVING ABILITY (non-serious) with onset Mar2021, outcome "not recovered", described as "His motor functions not on point like trying to operate electronics". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The events did not require a visit to emergency room (ER) and physician. The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscular weakness, Nausea
Clinical narrative: Chills; Nausea; Muscle Weakness; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 17Mar2021 11:00 (Lot number: EL3247) at the age of 48 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "allergies to Brazil nuts" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; LANSOPRAZOLE; NORETHINDRONE [NORETHISTERONE]; SYMBICORT. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3247, administration time: 01:00 AM, vaccine location: Left arm), administration date: 24Feb2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 18Mar2021, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 18Mar2021, outcome "recovering", described as "Nausea"; MUSCULAR WEAKNESS (non-serious) with onset 18Mar2021, outcome "recovering", described as "Muscle Weakness"; FATIGUE (non-serious) with onset 18Mar2021, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of chills, nausea, muscular weakness, fatigue. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The events were reported as non-serious; did not result in death, caused/prolonged hospitalization, were not disabling/incapacitating, nor lead to congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Illness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 12:10 (Lot number: EN6004) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications.The following information was reported: ILLNESS (non-serious) with onset 13Mar2021, outcome "unknown", described as "Very sick"; ASTHENIA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Very weak"; FEELING ABNORMAL (non-serious) with onset 13Mar2021, outcome "unknown", described as "Doesn't feel like herself".Additional information: The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior COVID vaccine. The events did not require a visit to physician or ER.No follow-up attempts are possible. No further information is expected.