chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 30 minutes post 1st dose an ache across my clavicle, lasted for approximately one hour; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 12:00 (Lot number: EW0150) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: DULERA; MONTELUKAST; AZELASTINE. The following information was reported: PAIN (non-serious) with onset 21Apr2021 14:00, outcome "not recovered", described as "30 minutes post 1st dose an ache across my clavicle, lasted for approximately one hour". Therapeutic measures were not taken as a result of pain.  Additional information: 30 minutes post 1st dose an ache across my clavicle, lasted for approximately one hour. 26 hours post 2nd dose experienced Supraclavicular Lymphadenopathy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received dulera, montelukast, azelastine other medications in two weeks. The second dose was received 20Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: AST/ALT ratio, Alanine aminotransferase normal, Albumin globulin ratio, Anion gap, Aspartate aminotransferase increased
Clinical narrative: Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Basophil count, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium
Clinical narrative: Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chloride, Blood creatine, Blood creatinine, Blood glucose, Blood potassium
Clinical narrative: Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood sodium, Blood test, Blood urea, Carbon dioxide
Clinical narrative: Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil count, Fatigue, Full blood count, Globulin, Glomerular filtration rate
Clinical narrative: Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit, Haemoglobin, Headache, Heart rate, Immature granulocyte count increased
Clinical narrative: Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Mean platelet volume, Metabolic function test
Clinical narrative: Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count, Platelet count, Protein total, Red blood cell agglutination, SARS-CoV-2 test
Clinical narrative: Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell agglutination present
Clinical narrative: Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Insomnia, Pain
Clinical narrative: 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 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EWO169) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE. LOT# for first shot: ER87Z7. administration of vaccine: Left arm.), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Patient head is hurting extremely"; FATIGUE (non-serious), outcome "unknown", described as "I am overall now the super tired like I just keep sitting my bed"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "my stomach hurts a lot, I threw up few times"; PAIN (non-serious), outcome "unknown", described as "overall my whole body is super week and sore"; INSOMNIA (non-serious), outcome "unknown", described as "I can't sleep". No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: axilla lymph node swell; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) 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. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization.  The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "axilla lymph node swell".  Additional information: Physician told me he got both shots. The second shot caused his axilla lymph node to swell and the affected node was on the same arm as the injection. The swelling subsided on its own.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain lower, Bladder discomfort, Computerised tomogram, Epiploic appendagitis
Clinical narrative: Sharp pain in lower left of abdomen, in pelvis area; Pressure on bladder; bloated abdomen; Pain increasing overnight; Epiploic appendagitis descending colon; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 17:00 (Lot number: ER8730) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Penicillin, reaction(s): "Known allergies: Gastric intolerance "; Amoxicillin, reaction(s): "Known allergies: Gastric intolerance "; Morphine, reaction(s): "Known allergies: Gastric intolerance "; Toradol, reaction(s): "Known allergies: Gastric intolerance ". The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (07Apr2021), described as "Sharp pain in lower left of abdomen, in pelvis area"; BLADDER DISCOMFORT (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (2021), described as "Pressure on bladder"; ABDOMINAL DISTENSION (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (2021), described as "bloated abdomen"; PAIN (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (07Apr2021), described as "Pain increasing overnight"; EPIPLOIC APPENDAGITIS (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (2021), described as "Epiploic appendagitis descending colon". The events "sharp pain in lower left of abdomen, in pelvis area", "pressure on bladder", "bloated abdomen", "pain increasing overnight" and "epiploic appendagitis descending colon" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain lower, bladder discomfort, abdominal distension, pain, epiploic appendagitis.  Clinical course: Sharp pain in lower left of abdomen, in pelvis area. Pressure on bladder, and bloated abdomen. Pain increasing overnight. Visit with GP on 07Apr at 10:15am. Instructed to go to the Emergency Room for a CT scan of the abdomen. Diagnosis: Epiploic appendagitis descending colon. Instructed to take Tylenol for a few days. Pain disappeared in 24 hours. Phone conversation with Gastroenterologist to establish a cause: none found. Due to recent vaccination (5 days prior), out of precaution, they decided to report it to Pfizer. Other medications in two weeks: Dietary supplements. The patient received treatment of Tylenol to calm inflammation. No covid prior vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sharp pain in lower left of abdomen, in pelvis area; Pressure on bladder; bloated abdomen; Pain increasing overnight; Epiploic appendagitis descending colon; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 17:00 (Lot number: ER8730) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Penicillin, reaction(s): "Known allergies: Gastric intolerance "; Amoxicillin, reaction(s): "Known allergies: Gastric intolerance "; Morphine, reaction(s): "Known allergies: Gastric intolerance "; Toradol, reaction(s): "Known allergies: Gastric intolerance ". The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (07Apr2021), described as "Sharp pain in lower left of abdomen, in pelvis area"; BLADDER DISCOMFORT (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (2021), described as "Pressure on bladder"; ABDOMINAL DISTENSION (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (2021), described as "bloated abdomen"; PAIN (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (07Apr2021), described as "Pain increasing overnight"; EPIPLOIC APPENDAGITIS (non-serious) with onset 06Apr2021 12:00, outcome "recovered" (2021), described as "Epiploic appendagitis descending colon". The events "sharp pain in lower left of abdomen, in pelvis area", "pressure on bladder", "bloated abdomen", "pain increasing overnight" and "epiploic appendagitis descending colon" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain lower, bladder discomfort, abdominal distension, pain, epiploic appendagitis.  Clinical course: Sharp pain in lower left of abdomen, in pelvis area. Pressure on bladder, and bloated abdomen. Pain increasing overnight. Visit with GP on 07Apr at 10:15am. Instructed to go to the Emergency Room for a CT scan of the abdomen. Diagnosis: Epiploic appendagitis descending colon. Instructed to take Tylenol for a few days. Pain disappeared in 24 hours. Phone conversation with Gastroenterologist to establish a cause: none found. Due to recent vaccination (5 days prior), out of precaution, they decided to report it to Pfizer. Other medications in two weeks: Dietary supplements. The patient received treatment of Tylenol to calm inflammation. No covid prior vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lymphadenopathy, Ultrasound breast
Clinical narrative: swollen left under arm-nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 10:00 (Lot number: EL3246) at the age of 67 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 (Dose 1), administration date: 21Jan2021, for COVID-19 Vaccination, reaction(s): "Left Arm Red, Hot and raised", "Left Arm Red, Hot and raised", "Left Arm Red, Hot and raised", fine now. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Feb2021, outcome "not recovered", described as "swollen left under arm-nodes". The patient underwent the following laboratory tests and procedures: laboratory test: (24Feb2021) unknown results; ultrasound breast: (16Mar2021) unknown results, notes: Swollen lymph node (Have to go back in June). Therapeutic measures were not taken as a result of lymphadenopathy.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lip dry, Pain in extremity, Skin lesion
Clinical narrative: Breaking out in lesions/Caller reported that not all of the lesions itch, and that some hurt; Sore arm; Lips constantly dry, more than usual; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 10:15 (Lot number: EN6208) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Narcolepsy", start date: 2020 (ongoing), notes: Verbatim: Narcolepsy; "Depression" (ongoing), notes: Verbatim: Depression; "respiratory problems" (ongoing), notes: Verbatim: History of respiratory problems; "Unspecified thyroid condition" (ongoing), notes: Verbatim: Unspecified thyroid condition; "Surgical history" (unspecified if ongoing), notes: Verbatim: Surgical history. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing); LEXAPRO taken for depression (ongoing); MODAFINIL taken for narcolepsy, start date: 2021 (ongoing); HYDROCODONE/APAP taken for pain (ongoing); ESTER-C [ASCORBIC ACID] (ongoing). Vaccination history included: Shingles vaccine; Flu vaccine; Pneumonia vaccines.  The following information was reported: SKIN LESION (non-serious) with onset 13Apr2021, outcome "recovering", described as "Breaking out in lesions/Caller reported that not all of the lesions itch, and that some hurt"; PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovered" (11Apr2021), described as "Sore arm"; LIP DRY (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Lips constantly dry, more than usual". The event "breaking out in lesions/caller reported that not all of the lesions itch, and that some hurt" was evaluated at the physician office visit. Therapeutic measures were taken as a result of skin lesion.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lip disorder
Clinical narrative: bumps under his lips; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (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: LIP DISORDER (non-serious) with onset 20Apr2021, outcome "unknown", described as "bumps under his lips".  Additional Information: The patient got his first dose today (20Apr2021), he had bumps under his lips and wasn't sure if it's from the vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: he hasn't slept for days; tinnitus has gotten worse since the 1st dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "he hasn't slept for days"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus has gotten worse since the 1st dose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 19Apr2021, outcome "recovered" (2021), described as "flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm; Stiff arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: EL9267) at the age of 70 years as dose 1, single and administered in arm left, administration date 09Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol increased", start date: 2021 (ongoing), notes: Verbatim: High cholesterol. The patient took concomitant medications. Vaccination history included: Flu shot (Had a sniffle that was gone after 24 hours), reaction(s): "sniffle". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Feb2021, outcome "recovered" (2021), described as "Sore arm"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Feb2021, outcome "not recovered", described as "Stiff arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: Concomitant medications included Unspecified statin, 1/2 tablet at night for Cholesterol since 15Feb2021. It was reported that Caller reported that he began taking a statin about a month ago, but he is not sure of the name or dosage.  Caller reported that he keeps forgetting to take the cholesterol medication. Caller reported that he was diagnosed with high cholesterol about a month ago. Sore arm: Caller reported that his arm started hurting an hour or so after getting home on 15Feb2021 after getting the first dose of the Covid-19 vaccine. Caller reported that the pain was not so much on the surface of his arm, but was closer to the bone. Caller later reported that the pain in his arm went away after 2-3 days.  Caller reported that he put a heating pad on his arm to help it.  Caller reported that he recovered completely in 3-4 days.Caller reported that he is still experiencing stiffness in his arm.  Caller reported that he has a fellow friend that is experiencing the same stiffness. Stiff arm: Caller reported that his arm feels tight.  Caller reported that the stiffness is still ongoing.  Caller reported that he doesn't know what's going on but that he can still move his arm. Second dose: Date: 09Mar2021; Lot Number: EN6198 or EN6148. Additional Administered Vaccines was no. The adverse events has not resulted in Emergency Room or Physician Office visit. Prior Vaccinations (within 4 weeks) was no. Caller reported that when he got his flu shot last year, he had a sniffle that was gone after 24 hours.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Confusional state, Dry mouth, Headache, Hypertension
Clinical narrative: dry mouth; comprehension level went down; elevated blood pressure; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (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: DRY MOUTH (non-serious) with onset 13Apr2021, outcome "unknown", described as "dry mouth"; CONFUSIONAL STATE (non-serious) with onset 13Apr2021, outcome "unknown", described as "comprehension level went down"; BLOOD PRESSURE INCREASED (non-serious) with onset 13Apr2021, outcome "unknown", described as "elevated blood pressure"; HEADACHE (non-serious) with onset 13Apr2021, outcome "unknown", described as "headache". 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.  Additional information: Approximately ten minutes after administration patient experienced dry mouth (to the point it was difficult to swallow), comprehension level went down (she didn't recognize that he & the nurse were speaking with her),  elevated blood pressure & headache.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiff arm".  Additional information: Report was not related to a study or programme. Caller was self-reported on adverse events he experienced following the Covid-19 vaccine.  the patient, that reported that he had been experiencing a stiff arm since receiving the Pfizer Covid-19 vaccine. Caller was unable to provide full patient details, patient HCP information, product details, patient history, or investigations. Caller reported that he did not know any personal information about the patient.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sinus headache
Clinical narrative: Sinus headache for 3 days after first shot, sore left arm.; Sinus headache for 3 days after first shot, sore left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 14:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MOTRIN [IBUPROFEN]; ZYTREC; WELLBUTRIN. The following information was reported: SINUS HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "recovering" and all described as "Sinus headache for 3 days after first shot, sore left arm.". Therapeutic measures were not taken as a result of sinus headache, pain in extremity.  Additional Information: Lot number was unknown as it got misplaced/discarded. Patient did not receive any other vaccine in four weeks. There was no covid prior to vaccination. Patient was not covid tested post vaccination. There are no known allergies or other medical history. Patient received second dose on 15Apr2021 on the right arm. Headache was manageable Fatigued for about a day, 24 hrs after second shot. Patient had Headache, sore right arm. Three days after shot, tongue and lips burning for 24-36 hrs. Patient reported that it might be from food but unsure. It is not normal and this is why patient submitted the report.  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: Burning sensation, Fatigue, Headache, Pain in extremity
Clinical narrative: sore right arm; 3 days after shot, tongue and lips burning for 24-36 hrs.; Headache; Fatigued for about a day, 24 hrs after second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MOTRIN [IBUPROFEN]; ZYTREC; WELLBUTRIN. Vaccination history included: Bnt162b2 (Dose number: 1, Lot unknown reason: Misplaced/discarded, Administration date: 25Mar2021, Administration time: 02:00 PM, Vaccine location: Left arm), administration date: 25Mar2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "sinus headache", "Sore left arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Apr2021 17:00, outcome "recovering", described as "sore right arm"; BURNING SENSATION (non-serious) with onset 17Apr2021 17:00, outcome "recovering", described as "3 days after shot, tongue and lips burning for 24-36 hrs."; HEADACHE (non-serious) with onset 17Apr2021 17:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 17Apr2021 17:00, outcome "recovering", described as "Fatigued for about a day, 24 hrs after second shot". Therapeutic measures were not taken as a result of pain in extremity, burning sensation, headache, fatigue.  Additional information: It was reported that the events might be from food but unsure so was listing because not normal. The patient did not have any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested COVID post vaccination. The patient did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysphemia, Echocardiogram, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Stuttering in his speech; Difficulty Spelling; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Apr2021 14:00 (Lot number: ER8733) at the age of 65 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 (First dose, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot number: EN6202,First dose, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot number: EN6202), administration date: 11Mar2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "Difficulty walking", "Disease recurrence", "Speech impairment NOS", "Stroke".  The following information was reported: DYSPHEMIA (non-serious) with onset Apr2021, outcome "unknown", described as "Stuttering in his speech"; MEMORY IMPAIRMENT (non-serious) with onset Apr2021, outcome "unknown", described as "Difficulty Spelling". The events "stuttering in his speech" and "difficulty spelling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysphemia, memory impairment.  Additional Information: Upon 2nd vaccine 01Apr2021 within 24 hours. Has difficulty spelling and stuttering in his speech. Change in Medication was done by (withheld) (Neurologist).  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Physiotherapy
Clinical narrative: Stuttering in his speech; Difficulty Spelling; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Apr2021 14:00 (Lot number: ER8733) at the age of 65 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 (First dose, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot number: EN6202,First dose, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot number: EN6202), administration date: 11Mar2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "Difficulty walking", "Disease recurrence", "Speech impairment NOS", "Stroke".  The following information was reported: DYSPHEMIA (non-serious) with onset Apr2021, outcome "unknown", described as "Stuttering in his speech"; MEMORY IMPAIRMENT (non-serious) with onset Apr2021, outcome "unknown", described as "Difficulty Spelling". The events "stuttering in his speech" and "difficulty spelling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysphemia, memory impairment.  Additional Information: Upon 2nd vaccine 01Apr2021 within 24 hours. Has difficulty spelling and stuttering in his speech. Change in Medication was done by (withheld) (Neurologist).  No follow-up attempts are possible. No further information is expected.