chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspepsia, Immunisation, Pain
Clinical narrative: indigestion; dizziness; light headed; After covid booster; chills; body ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via a Pfizer sales representative, This consumer reported for a female patient that:  A female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing); "TIA" (unspecified if ongoing), notes: history of TIA so dizziness brought her memory to her last light headed experience. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "After covid booster"; CHILLS (non-serious) with onset Nov2021, outcome "recovered" (21Nov2021), described as "chills"; DYSPEPSIA (non-serious) with onset 22Nov2021, outcome "recovered" (23Nov2021), described as "indigestion"; DIZZINESS (non-serious) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "dizziness"; DIZZINESS (non-serious) with onset 22Nov2021, outcome "recovered" (24Nov2021), described as "light headed"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (21Nov2021), described as "body ache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Racing heart; breathing was a little more difficult; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 16:30 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; MONTELUKAST. The following information was reported: HEART RATE INCREASED (non-serious) with onset 24Nov2021 12:00, outcome "recovered" (Nov2021), described as "Racing heart"; DYSPNOEA (non-serious) with onset 24Nov2021 12:00, outcome "recovered" (Nov2021), described as "breathing was a little more difficult". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, dyspnoea.  Additional information: Patient had not diagnosed with COVID-19 prior to vaccination. Patient had not tested for COVID-19 since the vaccination. The lab data includes Heart rate, it was over 100 for about 5-6 hours and began about 20 hours after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: booster; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 44-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Nov2021 (Lot number: FJ1620) at the age of 44 years 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: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 17Mar2021, when the patient was 43 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 07Apr2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome unknown; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021, outcome recoverin. Therapeutic measures were not taken as a result of pain in extremity.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Muscular weakness
Clinical narrative: Leg Weakness; Unable to walk; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 08:00 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included: "Allergy to Pin" (unspecified if ongoing); "diagnosed with COVID-19" (unspecified if ongoing), notes: Prior to vaccination. Concomitant medication(s) included: MULTIVITAMIN [VITAMINS NOS] within 2 weeks of vaccination. Past drug history included: Propanolol, reaction(s): "drug allergy". The following information was reported: MUSCULAR WEAKNESS (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Leg Weakness"; GAIT INABILITY (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Unable to walk". The patient was hospitalized for muscular weakness, gait inability (hospitalization duration: 3 day(s)). The events "leg weakness" and "unable to walk" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of muscular weakness, gait inability. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty   in triggering the onset of  MUSCULAR WEAKNESS and GAIT INABILITY cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy colon, Colitis ulcerative, Colonoscopy, Computerised tomogram abdomen, Computerised tomogram pelvis
Clinical narrative: UC flare; This is a literature report.  Introduction: The advent of mRNA vaccines has been a major component of the vaccination effort against COVID-19. Immunization with mRNA vaccines has been associated with a systemic inflammatory response. We present two cases of patients with ulcerative colitis (UC) in long-term remission who experienced flare following vaccination.   Case description/methods: Patient 2: A 52-year-old female with history of UC in remission of 5 years on mesalamine who received both doses of the BNT162b2 mRNA vaccine, 21 days apart, presented with abdominal pain, diarrhea, and bloody stool that developed 1 day after dose 2. Abdominopelvic CT demonstrated diffuse colitis, and she underwent colonoscopy, which was aborted due to extensive colitis. Sigmoid colon biopsy confirmed crypt abscess formation architectural distortion and ulceration. She was treated with mesalamine and methylprednisolone. Her acute disease was complicated by bowel perforation, and she underwent total colectomy.  Discussion(s): The presence of an environmental trigger is frequently linked to onset of disease flare in patients with UC. These two patients were in symptomatic remission on 5-ASA maintenance agents for several years prior to vaccination. The lack of clear alternate environmental changes in these patients suggests provocation of flare by the inflammatory response following vaccination. Existing literature evaluating SARSCoV- 2 mRNA vaccine adverse-events in patients with UC suggests that gastrointestinal side-effects are uncommon. In addition, biologic agent use may decrease rate of vaccine- elated adverse events. Recommendations from an expert consensus favors vaccination of patients with UC. In addition, recent literature demonstrates strong immunologic response following vaccination of patients with UC despite concurrent use of biologic agents. Consideration should be given to pretreatment of patients with UC in remission to decrease risk of flare.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Ulcerative colitis relapse and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Heart rate, Heart rate increased, Left ventricular dilatation, Nausea
Clinical narrative: dilated left Ventricle of the heart; weight loss; prolonged rapid HR; nausea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 13:00 (Lot number: ER2613) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history and did not have covid prior vaccination. No Known allergies. Concomitant medication(s) included: BLISOVI FE 1/20. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number=EN6202, administration time=01:00PM, vaccine location=Left arm), administration date: 27Feb2021, when the patient was 26 years old, for COVID-19 immunization. No other vaccine received in four weeks.  The following information was reported: LEFT VENTRICULAR DILATATION (medically significant) with onset 18Aug2021 07:00, outcome "recovering", described as "dilated left Ventricle of the heart"; WEIGHT DECREASED (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "weight loss"; HEART RATE INCREASED (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "prolonged rapid HR"; NAUSEA (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "nausea"; DECREASED APPETITE (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "loss of appetite". Adverse event: Discovered a dilated left Ventricle of the heart after experiencing symptoms of prolonged rapid HR, nausea, loss of appetite, weight loss (etc. not otherwise explained by another medical condition). Symptoms were intense and lasted for 2+ months. Still investigating the cause. The events "dilated left ventricle of the heart", "weight loss", "prolonged rapid hr", "nausea" and "loss of appetite" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (18Aug2021) prolonged rapid; sars-cov-2 test: (23Aug2021 PCR) negative, notes: Nasal Swab; (23Nov2021 Rapid antigen) negative, notes: Nasal Swab; weight: (18Aug2021) loss. Therapeutic measures were not taken as a result of left ventricular dilatation, weight decreased, heart rate increased, nausea, decreased appetite.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event Left ventricular dilatation and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Weight, Weight decreased
Clinical narrative: dilated left Ventricle of the heart; weight loss; prolonged rapid HR; nausea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 13:00 (Lot number: ER2613) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history and did not have covid prior vaccination. No Known allergies. Concomitant medication(s) included: BLISOVI FE 1/20. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number=EN6202, administration time=01:00PM, vaccine location=Left arm), administration date: 27Feb2021, when the patient was 26 years old, for COVID-19 immunization. No other vaccine received in four weeks.  The following information was reported: LEFT VENTRICULAR DILATATION (medically significant) with onset 18Aug2021 07:00, outcome "recovering", described as "dilated left Ventricle of the heart"; WEIGHT DECREASED (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "weight loss"; HEART RATE INCREASED (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "prolonged rapid HR"; NAUSEA (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "nausea"; DECREASED APPETITE (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "loss of appetite". Adverse event: Discovered a dilated left Ventricle of the heart after experiencing symptoms of prolonged rapid HR, nausea, loss of appetite, weight loss (etc. not otherwise explained by another medical condition). Symptoms were intense and lasted for 2+ months. Still investigating the cause. The events "dilated left ventricle of the heart", "weight loss", "prolonged rapid hr", "nausea" and "loss of appetite" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (18Aug2021) prolonged rapid; sars-cov-2 test: (23Aug2021 PCR) negative, notes: Nasal Swab; (23Nov2021 Rapid antigen) negative, notes: Nasal Swab; weight: (18Aug2021) loss. Therapeutic measures were not taken as a result of left ventricular dilatation, weight decreased, heart rate increased, nausea, decreased appetite.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event Left ventricular dilatation and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Immunisation
Clinical narrative: who administered the booster shot to her son accidentally rubbed it; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. Relevant medical history included PTSD (unspecified if ongoing); covid, start date: Mar2020 (unspecified if ongoing). The patient's 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 22Nov2021, outcome unknown; IMMUNISATION (non-serious) with onset 22Nov2021, outcome unknown. Caller said that her son had severe PTSD. They had covid last Mar2020. And they already got the vaccine, both doses. And she mentioned that her son got his booster dose yesterday, and she is worried about the injection site because the person who administered the booster shot to her son accidentally rubbed it.  The lot number for bnt162b2 was not provided and will be requested during follow up. Linked Report(s): US-PFIZER_INC-202101655502 Same reporter, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Vaccination site pain
Clinical narrative: he experienced was tenderness/soreness at the injection site for approximately 1 day after each of the 3 doses; he experienced was tenderness/soreness at the injection site for approximately 1 day after each of the 3 doses; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101739613 (Pfizer).  An elderly male patient received bnt162b2 (BNT162B2), administration date Nov2021 (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), administration date: May2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Booster dose"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovered" and all described as "he experienced was tenderness/soreness at the injection site for approximately 1 day after each of the 3 doses". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain.  Additional information: The patient experienced tenderness /soreness at the injection site for approximately 1 day after each of the 3 doses. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device time stamp on 25Nov2021  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Postmenopausal vaginal bleeding; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 17:30 (Lot number: FF3587) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], reported as other medication in two weeks. No other vaccine received in four weeks. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 24Nov2021 14:30, outcome "not recovered", described as "Postmenopausal vaginal bleeding". The event "postmenopausal vaginal bleeding" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of postmenopausal haemorrhage. No covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 16Jul2021 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Nov2021, outcome "unknown" and all described as "tested positive for Covid". Patient was given her final shot of the Pfizer Covid vaccine on 16Jul2021 recently tested positive for Covid (22Nov021). Her symptoms were mild, but they existed, and they were not as mild as consumer unvaccinated younger son who had Covid last week. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Platelet count, Platelet count decreased
Clinical narrative: blood platelets count dropped to 19 from 140 in Apr2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 01Feb2021 (Lot number: EL9262) at the age of 79 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Heart bypass" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "Gall bladder removed" (unspecified if ongoing). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: TOPROL; LISINOPRIL. Vaccination history included: BNT162B2 (first dose, Lot number: PFREL3246, in arm left at 10:00 AM), administration date: 09Jan2021, when the patient was 79 years old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PLATELET COUNT DECREASED (life threatening) with onset Apr2021, outcome "unknown", described as "blood platelets count dropped to 19 from 140 in Apr2021". The event "blood platelets count dropped to 19 from 140 in apr2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (unspecified date) unknown results. Therapeutic measures were taken as a result of platelet count decreased, which included prednisone. Since the vaccination, the patient has not been tested for COVID-19.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Vertigo
Clinical narrative: anxiety; Extremely debilitating; Severe vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Oct2021 16:45 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, 09:00 AM, left arm), administration date: 04Oct2021, when the patient was 28 years old, for Covid-19 Immunization. The following information was reported: ASTHENIA (medically significant) with onset 28Oct2021, outcome "not recovered", described as "Extremely debilitating"; VERTIGO (medically significant) with onset 28Oct2021, outcome "not recovered", described as "Severe vertigo"; ANXIETY (medically significant) with onset 28Oct2021 05:00, outcome "not recovered", described as "anxiety". The events "extremely debilitating", "severe vertigo" and "anxiety" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of asthenia, vertigo, anxiety included "meclizine and buspar". Neither was helping. Clinical course: Didn't have any anxiety before until after the second shot. Vertigo started about 3 days after the vaccine. Anxiety started about 5. Extremely debilitating. Have been to the hospital 3 times over the vertigo and anxiety. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Headache, Immunisation, Myalgia
Clinical narrative: Fever of 100 to 102; lower back pain; headache; muscle pain; dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Nov2021 15:30 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gilbert's syndrome" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single administered via Intramuscular route in right arm), administration date: 12May2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single administered via Intramuscular route in left arm), administration date: 19Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 15:30, outcome "unknown", described as "dose number 3"; PYREXIA (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "Fever of 100 to 102"; BACK PAIN (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "lower back pain"; HEADACHE (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "headache"; MYALGIA (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, back pain, headache, myalgia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 100 to 102; lower back pain; headache; muscle pain; dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Nov2021 15:30 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gilbert's syndrome" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single administered via Intramuscular route in right arm), administration date: 12May2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single administered via Intramuscular route in left arm), administration date: 19Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 15:30, outcome "unknown", described as "dose number 3"; PYREXIA (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "Fever of 100 to 102"; BACK PAIN (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "lower back pain"; HEADACHE (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "headache"; MYALGIA (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, back pain, headache, myalgia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Chills, Headache
Clinical narrative: Fever 102 f; Extreme chill; Pain in joints and bones; Pain in joints and bones; Headache; Swollen, itchy, painful arm and armpit; Swollen, itchy, painful arm and armpit; painful arm and armpit; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Nov2021 10:45 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Allergic Asthma (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, prev dose product=COVID 19,, prev dose brand=Pfizer), administration date: 22Mar2021, when the patient was 47 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM, prev dose product=COVID 19,, prev dose brand=Pfizer), administration date: 01Mar2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 23Nov2021 10:45, outcome unknown; PYREXIA (non-serious) with onset 23Nov2021 16:00, outcome not recovered; CHILLS (non-serious) with onset 23Nov2021 16:00, outcome recovering; ARTHRALGIA (non-serious), BONE PAIN (non-serious) all with onset 23Nov2021 16:00, outcome not recovered; HEADACHE (non-serious) with onset 23Nov2021 16:00, outcome not recovered; PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious) all with onset 23Nov2021 16:00, outcome recovering; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021 16:00, outcome not recovered. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, arthralgia, bone pain, headache, and pain in extremity. Therapeutic measures were not taken as a result of chills, peripheral swelling, and pruritus.  On 23Nov2021 the patient's fever was 102F.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Fever 102 f; Extreme chill; Pain in joints and bones; Pain in joints and bones; Headache; Swollen, itchy, painful arm and armpit; Swollen, itchy, painful arm and armpit; painful arm and armpit; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Nov2021 10:45 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Allergic Asthma (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, prev dose product=COVID 19,, prev dose brand=Pfizer), administration date: 22Mar2021, when the patient was 47 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM, prev dose product=COVID 19,, prev dose brand=Pfizer), administration date: 01Mar2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 23Nov2021 10:45, outcome unknown; PYREXIA (non-serious) with onset 23Nov2021 16:00, outcome not recovered; CHILLS (non-serious) with onset 23Nov2021 16:00, outcome recovering; ARTHRALGIA (non-serious), BONE PAIN (non-serious) all with onset 23Nov2021 16:00, outcome not recovered; HEADACHE (non-serious) with onset 23Nov2021 16:00, outcome not recovered; PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious) all with onset 23Nov2021 16:00, outcome recovering; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021 16:00, outcome not recovered. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, arthralgia, bone pain, headache, and pain in extremity. Therapeutic measures were not taken as a result of chills, peripheral swelling, and pruritus.  On 23Nov2021 the patient's fever was 102F.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pyrexia
Clinical narrative: swollen lymph nodes in arm pit; low grade fever (101F); Booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 10:00 (Lot number: 33026bd) at the age of 18 years as dose 3 (booster), single for covid-19 immunization; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 24Nov2021 (Batch/Lot number: unknown) as unk unk, single.   The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Allergy", notes: known allergies: ibuprofen. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ep6955, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 17 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ep6955), administration date: 27Mar2021, when the patient was 17 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 10:00, outcome "unknown", described as "Booster shot"; LYMPHADENOPATHY (non-serious) with onset 25Nov2021, outcome "recovering", described as "swollen lymph nodes in arm pit"; PYREXIA (non-serious) with onset 25Nov2021, outcome "recovering", described as "low grade fever (101F)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, pyrexia.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Seizure
Clinical narrative: Seizure; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via .  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Nov2021 09:45 (Lot number: Fk5618) at the age of 6 years as dose 2, single for covid-19 immunisation in Pharmacy/drug store. Relevant medical history included: "Epilepsy" (unspecified if ongoing). Concomitant medication(s) within 2 weeks of vaccination included: OXCARBAZEPINE, complete multivitamin, immune-c. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk3127, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 05Nov2021, when the patient was 6 years old, for Covid-19 Immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: SEIZURE (medically significant) with onset 27Nov2021 05:15, outcome "recovering", described as "Seizure"; PYREXIA (non-serious) with onset 27Nov2021 05:15, outcome "recovering", described as "Fever". The events "seizure" and "fever" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (27Nov2021) fever. It was unknown if therapeutic measures were taken as a result of seizure, pyrexia.   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, COVID-19, Drug ineffective, Echocardiogram, Magnetic resonance imaging heart
Clinical narrative: covid test result=Positive; covid test result=Positive; myocarditis; heart arrhythmia; tachycardia; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2, administered in arm right, administration date 16Mar2021 09:00 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: LEVOTHYROXINE. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 09Nov2021, outcome "unknown" and all described as "covid test result=Positive"; MYOCARDITIS (medically significant) with onset 16Mar2021 21:00, outcome "not recovered", described as "myocarditis"; ARRHYTHMIA (medically significant) with onset 16Mar2021 21:00, outcome "not recovered", described as "heart arrhythmia"; TACHYCARDIA (non-serious) with onset 16Mar2021 21:00, outcome "not recovered", described as "tachycardia". The events "myocarditis", "heart arrhythmia" and "tachycardia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) positive, notes: covid test name post vaccination: PCR; magnetic resonance imaging heart: (2021) unknown results, notes: AE treatment: Cardiac MRI; echocardiogram: (2021) unknown results, notes: AE treatment: Echocardiogram. Therapeutic measures were taken as a result of myocarditis, arrhythmia, tachycardia (treatment AE: beta blocker medication).  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test, Tachycardia
Clinical narrative: covid test result=Positive; covid test result=Positive; myocarditis; heart arrhythmia; tachycardia; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2, administered in arm right, administration date 16Mar2021 09:00 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: LEVOTHYROXINE. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 09Nov2021, outcome "unknown" and all described as "covid test result=Positive"; MYOCARDITIS (medically significant) with onset 16Mar2021 21:00, outcome "not recovered", described as "myocarditis"; ARRHYTHMIA (medically significant) with onset 16Mar2021 21:00, outcome "not recovered", described as "heart arrhythmia"; TACHYCARDIA (non-serious) with onset 16Mar2021 21:00, outcome "not recovered", described as "tachycardia". The events "myocarditis", "heart arrhythmia" and "tachycardia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) positive, notes: covid test name post vaccination: PCR; magnetic resonance imaging heart: (2021) unknown results, notes: AE treatment: Cardiac MRI; echocardiogram: (2021) unknown results, notes: AE treatment: Echocardiogram. Therapeutic measures were taken as a result of myocarditis, arrhythmia, tachycardia (treatment AE: beta blocker medication).  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Magnetic resonance imaging, Platelet count, Platelet count decreased
Clinical narrative: My blood platelets count dropped to 19 from 140 in Apr2021; dose number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 09:30 (Lot number: FF2687) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 01Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Heart bypass" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "Gall bladder removed" (unspecified if ongoing). No known allergy. No covid prior vaccination. Concomitant medication(s) included: TOPROL; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1,Batch/Lot No: PFREL3246, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09Jan2021, when the patient was 79 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9262, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 01Feb2021, when the patient was 79 years old, for Covid-19 immunization. No other vaccine in four weeks. The following information was reported: IMMUNISATION (life threatening) with onset 01Oct2021 09:30, outcome "unknown", described as "dose number: 3"; PLATELET COUNT DECREASED (life threatening) with onset 10Nov2021, outcome "unknown", described as "My blood platelets count dropped to 19 from 140 in Apr2021". The event "my blood platelets count dropped to 19 from 140 in apr2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (unspecified date) unknown results; platelet count: (Apr2021) 140; (10Nov2021) dropped to 19. No covid tested post vaccination. Therapeutic measures were taken as a result of platelet count decreased including Prednisone and MRI.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: received a positive COVID rapid test; received a positive COVID rapid test; lost sense of smell and taste; lost sense of smell and taste; felt rundown; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) as dose 1, single and administered in arm left, administration date 13Apr2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The patient has not took any other vaccine in four weeks and there were no known allergies. The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 29Nov2021, outcome "not recovered" and all described as "received a positive COVID rapid test"; FEELING ABNORMAL (non-serious) with onset 26Nov2021, outcome "not recovered", described as "felt rundown"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 29Nov2021, outcome "not recovered" and all described as "lost sense of smell and taste". The events "received a positive covid rapid test", "received a positive covid rapid test", "felt rundown", "lost sense of smell and taste" and "lost sense of smell and taste" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, feeling abnormal, ageusia, anosmia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any known allergies. Reporter stating events as non serious.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: received a positive COVID rapid test; received a positive COVID rapid test; lost sense of smell and taste; lost sense of smell and taste; felt rundown; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) as dose 1, single and administered in arm left, administration date 13Apr2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The patient has not took any other vaccine in four weeks and there were no known allergies. The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 29Nov2021, outcome "not recovered" and all described as "received a positive COVID rapid test"; FEELING ABNORMAL (non-serious) with onset 26Nov2021, outcome "not recovered", described as "felt rundown"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 29Nov2021, outcome "not recovered" and all described as "lost sense of smell and taste". The events "received a positive covid rapid test", "received a positive covid rapid test", "felt rundown", "lost sense of smell and taste" and "lost sense of smell and taste" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, feeling abnormal, ageusia, anosmia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any known allergies. Reporter stating events as non serious.  Follow-up attempts are completed. No further information is expected.