chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: After receiving the second dose Pfizer Covid Vaccine, the caller lost sense of smell for a day; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for COVID -19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELEBREX (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: Dec2020, for COVID -19 immunization.  The following information was reported: ANOSMIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "After receiving the second dose Pfizer COVID Vaccine, the caller lost sense of smell for a day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: The patient's doctor told not to take the Pfizer Covid Vaccine. The doctor did not recommend the booster dose Pfizer Covid Vaccine. 25 years ago the patient took Celebrex and was on Celebrex and after calling Pfizer, Pfizer use to send Celebrex when the caller used to be in and that was okay. But now the patient has everything. The patient needed to get the Pfizer Covid Vaccine, so received the Pfizer Covid Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling, Pain
Clinical narrative: joints swelled; had increased pain; difficulty walking; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "joints swelled"; PAIN (non-serious), outcome "unknown", described as "had increased pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking". Therapeutic measures were taken as a result of joint swelling, pain, gait disturbance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: low grade fever; headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional event: After receiving 3rd/booster dose patient experienced low grade fever, headache, and fatigue.Event took place after use of product.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Headache, Immunisation
Clinical narrative: Getting his booster; He feels tired; Headache; His body is not normal after the booster and he is not concentrating right; 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), administration date 21Oct2021 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Lot number: EN6204), administration date: 11Mar2021, for COVID-19 immunization, reaction(s): "received his series, first and second dose and after 3 months, he tested positive for COVID"; Bnt162b2 (Dose:02, Lot number; EP7534), administration date: 01Apr2021, for COVID-19 immunization, reaction(s): "received his series, first and second dose and after 3 months, he tested positive for COVID". The following information was reported: IMMUNISATION (non-serious) with onset 21Oct2021, outcome "unknown", described as "Getting his booster"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "He feels tired"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; DISTURBANCE IN ATTENTION (non-serious) with onset Oct2021, outcome "unknown", described as "His body is not normal after the booster and he is not concentrating right".  He received his series, first and second dose and after 3 months, he tested positive for COVID. His first dose was on 11Mar. His second dose was 01Apr. COVID positive 18Aug, and then he got his booster dose on 21Oct. He said after receiving his booster dose, he feels tired and have a headache. He said his body is not normal after the booster and he is not concentrating right.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Inflammation, Mobility decreased, Pain
Clinical narrative: booster dose; it was painful; whole right side was severely inflamed and they could not lift their head up (with no headache) and arm; whole right side was severely inflamed and they could not lift their head up (with no headache) and arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; PAIN (non-serious), outcome "unknown", described as "it was painful"; INFLAMMATION (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "whole right side was severely inflamed and they could not lift their head up (with no headache) and arm".  Follow-up (01Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Nervous system disorder
Clinical narrative: severe cardiac and neurological ae; severe cardiac and neurological ae; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (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: NERVOUS SYSTEM DISORDER (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "severe cardiac and neurological ae".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101631180 same reporter and vaccine, different patient and AE
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Illness, Immunisation
Clinical narrative: booster dose; Needle pain; Sick; Coughing; Have a pressure in my lungs; didn't sleep overnight; I have a fever of 100; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; PAIN (non-serious), outcome "unknown", described as "Needle pain"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; COUGH (non-serious), outcome "unknown", described as "Coughing"; LUNG DISORDER (non-serious), outcome "unknown", described as "Have a pressure in my lungs"; SLEEP DISORDER (non-serious), outcome "unknown", described as "didn't sleep overnight"; PYREXIA (non-serious), outcome "not recovered", described as "I have a fever of 100"; FATIGUE (non-serious), outcome "recovered", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- When requested to take the number for Pfizer medical information, consumer denied taking the number and hung up abruptly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder, Pain, Pyrexia, Sleep disorder
Clinical narrative: booster dose; Needle pain; Sick; Coughing; Have a pressure in my lungs; didn't sleep overnight; I have a fever of 100; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; PAIN (non-serious), outcome "unknown", described as "Needle pain"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; COUGH (non-serious), outcome "unknown", described as "Coughing"; LUNG DISORDER (non-serious), outcome "unknown", described as "Have a pressure in my lungs"; SLEEP DISORDER (non-serious), outcome "unknown", described as "didn't sleep overnight"; PYREXIA (non-serious), outcome "not recovered", described as "I have a fever of 100"; FATIGUE (non-serious), outcome "recovered", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- When requested to take the number for Pfizer medical information, consumer denied taking the number and hung up abruptly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site warmth
Clinical narrative: booster dose; Arm where the shot was, is warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1/had her 2 Pfizer shots and that was over 6 months ago), for Covid-19 immunization; Bnt162b2 (Dose 2/had her 2 Pfizer shots and that was over 6 months ago), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "booster dose"; VACCINATION SITE WARMTH (non-serious) with onset 18Nov2021, outcome "unknown", described as "Arm where the shot was, is warm".  Additional information: clinical course: It was reported that patient got her booster shot, well she has had her 2 Pfizer shots and that was over 6 months ago and on Thursday she got her booster shot of Pfizer, her arm where the shot was, is warm.   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, FLUX
Symptoms: Fatigue, Headache, Immunisation, Nausea, Pain
Clinical narrative: patient experience Grade 1 body ache; Grade 1 nausea; Grade 1 pain at site of injection; Grade 1 headache; Fatigue G1; Received COMINARTI booster shot on 19Nov2021. Flu shot was also administered on the same day; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Nov2021 (Lot number: FH8030) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Asthma", start date: 1978 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Intramuscular, left arm, Lot number: EL3248), administration date: 04Mar2021, for COVID-19 immunization; Bnt162b2 (Dose 1, Single, Intramuscular, Left arm, Lot number: EL3248, Lot number: EP655), administration date: 25Mar2021, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "Received COMINARTI booster shot on 19Nov2021. Flu shot was also administered on the same day"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "patient experience Grade 1 body ache"; NAUSEA (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 nausea"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 pain at site of injection"; HEADACHE (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 headache"; FATIGUE (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Fatigue G1". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, vaccination site pain, headache. Therapeutic measures were not taken as a result of nausea, fatigue.  Addition information: The patient took 400mg Ibuprofen on 19Nov2021 orally for Grade 1 body ache, Grade 1 headache, and on morning of 20Nov2021. It was unknown if the patient had received any other vaccine within 4 weeks of Covid-19 vaccine. No relevant test was performed for thromboembolic events with thrombocytopenia.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain assessment, Product use issue, Vaccination site pain
Clinical narrative: patient experience Grade 1 body ache; Grade 1 nausea; Grade 1 pain at site of injection; Grade 1 headache; Fatigue G1; Received COMINARTI booster shot on 19Nov2021. Flu shot was also administered on the same day; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Nov2021 (Lot number: FH8030) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Asthma", start date: 1978 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Intramuscular, left arm, Lot number: EL3248), administration date: 04Mar2021, for COVID-19 immunization; Bnt162b2 (Dose 1, Single, Intramuscular, Left arm, Lot number: EL3248, Lot number: EP655), administration date: 25Mar2021, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "Received COMINARTI booster shot on 19Nov2021. Flu shot was also administered on the same day"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "patient experience Grade 1 body ache"; NAUSEA (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 nausea"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 pain at site of injection"; HEADACHE (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 headache"; FATIGUE (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Fatigue G1". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, vaccination site pain, headache. Therapeutic measures were not taken as a result of nausea, fatigue.  Addition information: The patient took 400mg Ibuprofen on 19Nov2021 orally for Grade 1 body ache, Grade 1 headache, and on morning of 20Nov2021. It was unknown if the patient had received any other vaccine within 4 weeks of Covid-19 vaccine. No relevant test was performed for thromboembolic events with thrombocytopenia.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Diarrhoea, Immunisation
Clinical narrative: nausea; GI upset; chills; low grade fever; Diarrhea (mild); booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Nov2021 11:30 (Lot number: EW0196, Expiration Date: Dec2021) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroid", start date: 2005 (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 2005 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Date: 25Feb2021, Time: Unk, anatomical site of injection: Right arm, Batch/lot number: EL3247), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, Date: 18Mar2021, Time: Unk, anatomical site of injection: Right arm, Batch/lot number: EL3247), administration date: 18Mar2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 11:30, outcome "unknown", described as "booster"; NAUSEA (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "nausea"; ABDOMINAL DISCOMFORT (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "GI upset"; CHILLS (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "chills"; PYREXIA (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "low grade fever"; DIARRHOEA (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "Diarrhea (mild)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, abdominal discomfort, chills, pyrexia, diarrhoea.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: nausea; GI upset; chills; low grade fever; Diarrhea (mild); booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Nov2021 11:30 (Lot number: EW0196, Expiration Date: Dec2021) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroid", start date: 2005 (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 2005 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Date: 25Feb2021, Time: Unk, anatomical site of injection: Right arm, Batch/lot number: EL3247), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, Date: 18Mar2021, Time: Unk, anatomical site of injection: Right arm, Batch/lot number: EL3247), administration date: 18Mar2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 11:30, outcome "unknown", described as "booster"; NAUSEA (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "nausea"; ABDOMINAL DISCOMFORT (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "GI upset"; CHILLS (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "chills"; PYREXIA (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "low grade fever"; DIARRHOEA (non-serious) with onset 19Nov2021 11:30, outcome "recovered" (21Nov2021), described as "Diarrhea (mild)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, abdominal discomfort, chills, pyrexia, diarrhoea.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Immunisation, Malaise
Clinical narrative: extreme itching under left arm; tiredness; headache; fever; feeling unwell; diarrhea; arm pain; dose received:3; 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 15Nov2021 01:00 (Lot number: F00809) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; HYDROCHLOROTHIAZIDE; NORVASC; PAXIL. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 10:00), administration date: 11Feb2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 10:00), administration date: 03Mar2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021 01:00, outcome "unknown", described as "dose received:3"; PRURITUS (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "extreme itching under left arm"; FATIGUE (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "tiredness"; HEADACHE (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "feeling unwell"; DIARRHOEA (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "diarrhea"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "arm pain". Therapeutic measures were not taken as a result of pruritus, fatigue, headache, pyrexia, malaise, diarrhoea, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: extreme itching under left arm; tiredness; headache; fever; feeling unwell; diarrhea; arm pain; dose received:3; 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 15Nov2021 01:00 (Lot number: F00809) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; HYDROCHLOROTHIAZIDE; NORVASC; PAXIL. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 10:00), administration date: 11Feb2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 10:00), administration date: 03Mar2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021 01:00, outcome "unknown", described as "dose received:3"; PRURITUS (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "extreme itching under left arm"; FATIGUE (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "tiredness"; HEADACHE (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "feeling unwell"; DIARRHOEA (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "diarrhea"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021 06:00, outcome "recovering", described as "arm pain". Therapeutic measures were not taken as a result of pruritus, fatigue, headache, pyrexia, malaise, diarrhoea, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Immunisation, Pain in extremity, Pain in jaw
Clinical narrative: Booster dose; jaw pain; Sore arm; headache; sinus pressure; earache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24May2021 11:15 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Oral anti Inflammatorys" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: THYROXINE.  Vaccination history included: Bnt162b2 ((product=COVID 19, brand=Pfizer, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=23Mar2021, administration time=11:15 AM, dose number=1,, vaccine location=Left arm)), administration date: 23Mar2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "administration date=23Mar2021/administration date=24May2021"; TREMOR (non-serious) with onset 24May2021 23:00, outcome "recovering", described as "Severe shaking after 12hrs.Elevated heart rate during rest Severe drenching night sweat 60 hrs later."; HEART RATE INCREASED (non-serious), NIGHT SWEATS (non-serious) all with onset 24May2021 23:00, outcome "recovering" and all described as "Severe shaking after 12hrs.Elevated heart rate during restSevere drenching night sweat 60 hrs later.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inappropriate schedule of product administration, tremor, heart rate increased, night sweats.  Additional information: Patient had not received any other vaccine with in four weeks, No prior vaccination patient has not been taken. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort
Clinical narrative: Booster dose; jaw pain; Sore arm; headache; sinus pressure; earache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24May2021 11:15 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Oral anti Inflammatorys" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: THYROXINE.  Vaccination history included: Bnt162b2 ((product=COVID 19, brand=Pfizer, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=23Mar2021, administration time=11:15 AM, dose number=1,, vaccine location=Left arm)), administration date: 23Mar2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "administration date=23Mar2021/administration date=24May2021"; TREMOR (non-serious) with onset 24May2021 23:00, outcome "recovering", described as "Severe shaking after 12hrs.Elevated heart rate during rest Severe drenching night sweat 60 hrs later."; HEART RATE INCREASED (non-serious), NIGHT SWEATS (non-serious) all with onset 24May2021 23:00, outcome "recovering" and all described as "Severe shaking after 12hrs.Elevated heart rate during restSevere drenching night sweat 60 hrs later.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inappropriate schedule of product administration, tremor, heart rate increased, night sweats.  Additional information: Patient had not received any other vaccine with in four weeks, No prior vaccination patient has not been taken. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Pain in extremity, Pruritus, Rash
Clinical narrative: he noticed rash appearing all over his body, trunk, legs, hands, everywhere except his head and neck.; sore arm.; Caller states the rash is going away and it was a little itchy; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Sep2021 (Lot number: FT8839) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Caller states he had the 1st dose of the Pfizer Covid vaccine on 26Jan2021 with lot EL9262 and expiry date 31May2021., he had the 1st and 2nd doses of the Pfizer COVID vaccine also and had no kind of reaction except for a sore arm), administration date: 26Jan2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, the 2nd dose on 16Feb2021 with lot EL9267 and expiry date 31May2021., he had the 1st and 2nd doses of the Pfizer COVID vaccine also and had no kind of reaction except for a sore arm.), administration date: 16Feb2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 24Sep2021, outcome "unknown", described as "booster dose"; RASH (non-serious), outcome "recovered" (Nov2021), described as "he noticed rash appearing all over his body, trunk, legs, hands, everywhere except his head and neck."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm."; PRURITUS (non-serious), outcome "unknown", described as "Caller states the rash is going away and it was a little itchy". The event "he noticed rash appearing all over his body, trunk, legs, hands, everywhere except his head and neck." was evaluated at the physician office visit.   Additional information: Consumer stated that, he was fine now and he had already consulted his dermatologist. Patient's Medical History reported as none. Family Medical History Relevant to AE(s) reported as none. Another vaccine was not administered on same day of Pfizer suspect. Consumer stated that a week later after the booster dose of the Pfizer vaccine, he also had the high dose flu shot on 01Oct2021 and had no name of the flu shot, manufacturer, or lot number to provide and states he is thinking the flu shot was administered to his right arm but does not remember and that is how good his memory is these days. He stated that he had soreness in his arm from that flu shot and also had arm soreness from the 1st, 2nd and booster dose of the Pfizer Covid vaccine also; states the arm soreness has resolved and went away pretty quickly.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: he noticed rash appearing all over his body, trunk, legs, hands, everywhere except his head and neck.; sore arm.; Caller states the rash is going away and it was a little itchy; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Sep2021 (Lot number: FT8839) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Caller states he had the 1st dose of the Pfizer Covid vaccine on 26Jan2021 with lot EL9262 and expiry date 31May2021., he had the 1st and 2nd doses of the Pfizer COVID vaccine also and had no kind of reaction except for a sore arm), administration date: 26Jan2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, the 2nd dose on 16Feb2021 with lot EL9267 and expiry date 31May2021., he had the 1st and 2nd doses of the Pfizer COVID vaccine also and had no kind of reaction except for a sore arm.), administration date: 16Feb2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 24Sep2021, outcome "unknown", described as "booster dose"; RASH (non-serious), outcome "recovered" (Nov2021), described as "he noticed rash appearing all over his body, trunk, legs, hands, everywhere except his head and neck."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm."; PRURITUS (non-serious), outcome "unknown", described as "Caller states the rash is going away and it was a little itchy". The event "he noticed rash appearing all over his body, trunk, legs, hands, everywhere except his head and neck." was evaluated at the physician office visit.   Additional information: Consumer stated that, he was fine now and he had already consulted his dermatologist. Patient's Medical History reported as none. Family Medical History Relevant to AE(s) reported as none. Another vaccine was not administered on same day of Pfizer suspect. Consumer stated that a week later after the booster dose of the Pfizer vaccine, he also had the high dose flu shot on 01Oct2021 and had no name of the flu shot, manufacturer, or lot number to provide and states he is thinking the flu shot was administered to his right arm but does not remember and that is how good his memory is these days. He stated that he had soreness in his arm from that flu shot and also had arm soreness from the 1st, 2nd and booster dose of the Pfizer Covid vaccine also; states the arm soreness has resolved and went away pretty quickly.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Body temperature abnormal, Body temperature increased, Feeling abnormal
Clinical narrative: elevated temperature maxing out at 102; general flu like symptoms; extreme headache; achy joints; generally miserable; lymph nodes in my arm pit are enlarged; My right armpit is also enlarged; Both are tender to the touch; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 13:30 (Lot number: FH8027) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drug. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN0176, Location of injection: Arm Left), administration date: 05May2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN8729), administration date: 05Apr2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Booster dose"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "elevated temperature maxing out at 102"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "general flu like symptoms"; HEADACHE (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "extreme headache"; ARTHRALGIA (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "achy joints"; FEELING ABNORMAL (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "generally miserable"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "recovering", described as "lymph nodes in my arm pit are enlarged"; AXILLARY PAIN (non-serious) with onset 23Nov2021, outcome "recovering", described as "My right armpit is also enlarged"; TENDERNESS (non-serious) with onset 23Nov2021, outcome "recovering", described as "Both are tender to the touch". The patient underwent the following laboratory tests and procedures: body temperature abnormal: 102, notes: Elevated temperature maxing out at 102,. It was unknown if therapeutic measures were taken as a result of body temperature increased, influenza like illness, headache, feeling abnormal, lymphadenopathy, axillary pain, tenderness. Therapeutic measures were taken as a result of arthralgia.  Additional information: it was reported that the patient was not received any vaccine in four weeks and was not tested for covid post vaccination. The patient had not covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Influenza like illness, Lymphadenopathy, Tenderness
Clinical narrative: elevated temperature maxing out at 102; general flu like symptoms; extreme headache; achy joints; generally miserable; lymph nodes in my arm pit are enlarged; My right armpit is also enlarged; Both are tender to the touch; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 13:30 (Lot number: FH8027) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drug. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN0176, Location of injection: Arm Left), administration date: 05May2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN8729), administration date: 05Apr2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Booster dose"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "elevated temperature maxing out at 102"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "general flu like symptoms"; HEADACHE (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "extreme headache"; ARTHRALGIA (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "achy joints"; FEELING ABNORMAL (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "generally miserable"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "recovering", described as "lymph nodes in my arm pit are enlarged"; AXILLARY PAIN (non-serious) with onset 23Nov2021, outcome "recovering", described as "My right armpit is also enlarged"; TENDERNESS (non-serious) with onset 23Nov2021, outcome "recovering", described as "Both are tender to the touch". The patient underwent the following laboratory tests and procedures: body temperature abnormal: 102, notes: Elevated temperature maxing out at 102,. It was unknown if therapeutic measures were taken as a result of body temperature increased, influenza like illness, headache, feeling abnormal, lymphadenopathy, axillary pain, tenderness. Therapeutic measures were taken as a result of arthralgia.  Additional information: it was reported that the patient was not received any vaccine in four weeks and was not tested for covid post vaccination. The patient had not covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Immunisation, Pain in extremity, Vaccination site pain
Clinical narrative: Booster only.; Booster only. Had side effects .Pain in left arm , sore left arm injection site pain. Felt better in 2 days; Pain in left arm; sore left arm injection site pain; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 43 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 (Lot number: Fh8027) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient is expected to deliver a baby(s) on 03Jul2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=En6208, previous dose administrator route=Intra muscular, previous dose administration date=19Mar2021, previous Dose Number: 2, Previous Dose vaccine location : Left Arm), administration date: 19Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number= En6205, previous dose administrator route=Intra muscular, previous dose administration date=26Feb2021, previous Dose Number: 1, Previous Dose vaccine location : Arm Left), administration date: 26Feb2021, when the patient was 42 years old, for COVID-19 Immunization.  The following information was reported: EXPOSURE DURING PREGNANCY (non-serious) with onset 18Nov2021, outcome "unknown", described as "Booster only. Had side effects .Pain in left arm , sore left arm injection site pain. Felt better in 2 days"; IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Booster only."; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Pain in left arm"; VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "sore left arm injection site pain". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain. The was patient was treated with Tylenol.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Pyrexia
Clinical narrative: 103F temperature for a few hours; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "103F temperature for a few hours"; IMMUNISATION (non-serious), outcome "unknown", described as "Dose number=3". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.