chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Heart rate
Clinical narrative: do experience some  increased fatigue at intervals.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (do experience some  increased fatigue at intervals.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (do experience some  increased fatigue at intervals.). At the time of the report, FATIGUE (do experience some  increased fatigue at intervals.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: low (Low) Mid forties to low fifties beats per minute and 38 (Low) At rest patient have recorded it at 38 beats per minute at times.         No concomitant medications were reported.  Treatment information was not provided. Patient received 2 doses of Moderna in March. Since then, the heart rate has lowered from seventies to the mid forties and low fifties. At rest patient have recorded it at 38 beats per minute at times.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Cheilitis, Lip dry, Lip pruritus, Lip swelling
Clinical narrative: Swollen dry itchy lips; swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip; swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip; swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip; yellow tiny pimples on the upper lip. The yellow raised bumps are wet to touch; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen dry itchy lips), LIP DRY (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), LIP PRURITUS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), CHEILITIS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip) and ACNE (yellow tiny pimples on the upper lip. The yellow raised bumps are wet to touch) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21A, 016B21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swollen dry itchy lips), LIP DRY (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), LIP PRURITUS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), CHEILITIS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip) and ACNE (yellow tiny pimples on the upper lip. The yellow raised bumps are wet to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swollen dry itchy lips) was resolving and LIP DRY (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), LIP PRURITUS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), CHEILITIS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip) and ACNE (yellow tiny pimples on the upper lip. The yellow raised bumps are wet to touch) had not resolved.            Concomitant medication was not provided. Treatment also included oral steroid.  The patient called her health care provider and prescribed treatment. Patient was not sure what  caused the side effects and was not sure if it was staph infection. The swelling has gone down a bit.   This case was linked to MOD-2021-421613 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Colonoscopy after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Colonoscopy after vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Colonoscopy after vaccine). At the time of the report, VACCINATION COMPLICATION (Colonoscopy after vaccine) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Colonoscopy scheduled on 19 Mar 2021.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received third full dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received third full dose without being immunocompromised) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced ACCIDENTAL OVERDOSE (Received third full dose without being immunocompromised). In September 2021, ACCIDENTAL OVERDOSE (Received third full dose without being immunocompromised) had resolved.            No concomitant medications were reported.  Treatment information was not provided. Caller stated that he received a full third dose in September and claims to be a healthy person, not immunocompromised. The third dose was given 7 months after the second dose.   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 039K20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PYREXIA (Fever of 103). At the time of the report, PYREXIA (Fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 103 (High) fever of 103.         No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash pruritic
Clinical narrative: red circle under arm; itchy circle under arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red circle under arm) and RASH PRURITIC (itchy circle under arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red circle under arm) and RASH PRURITIC (itchy circle under arm). At the time of the report, ERYTHEMA (red circle under arm) and RASH PRURITIC (itchy circle under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No Treatment medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Left Arm after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Left Arm after booster) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 030M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore Left Arm after booster). On 23-Dec-2021, VACCINATION SITE PAIN (Sore Left Arm after booster) had resolved.            No Concomitant medication was reported.    No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: Pain in extremity; very itchy; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH PRURITIC (very itchy) and PAIN IN EXTREMITY (Pain in extremity) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (very itchy) and PAIN IN EXTREMITY (Pain in extremity). At the time of the report, RASH PRURITIC (very itchy) had resolved and PAIN IN EXTREMITY (Pain in extremity) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The dates of the vaccines are unknown, but they were over 6 months ago. The patient is in 50s. Patient want to know whether should get the booster.  Concomitant medications were not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: I know he has to have it with in three days of testing positive; I know he has to have it with in three days of testing positive; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the parent. Other Case identifier(s): 202101789414 (1).  A male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE (Batch/Lot number: unknown) as DOSE 2, SINGLE and (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 26Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "I know he has to have it with in three days of testing positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101789414 same reporter/patient/product, different dose/event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Immunisation, SARS-CoV-2 test
Clinical narrative: I know he has to have it with in three days of testing positive; I know he has to have it with in three days of testing positive; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the parent. Other Case identifier(s): 202101789414 (1).  A male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE (Batch/Lot number: unknown) as DOSE 2, SINGLE and (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 26Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "I know he has to have it with in three days of testing positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101789414 same reporter/patient/product, different dose/event.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Thrombosis, Vaccination failure
Clinical narrative: SARS-CoV-2 test positive; SARS-CoV-2 test positive; I developed blood clots that were found in June after flying in a plane.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 14:30 (Batch/Lot number: unknown) at the age of 33 years as DOSE 2, SINGLE and administered in arm left, administration date 25Mar2021 14:20 (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Oct2021, outcome "unknown" and all described as "SARS-CoV-2 test positive"; THROMBOSIS (medically significant) with onset 21Jun2021 12:30, outcome "not recovered", described as "I developed blood clots that were found in June after flying in a plane.". The event "i developed blood clots that were found in june after flying in a plane." was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Oct2021) positive, notes: Nasal Swab. Therapeutic measure Blood thinner medication was taken as a result of thrombosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Immunisation, Pain
Clinical narrative: Anaphlylactic reaction; booster; Aches and pains; This is a spontaneous report received from a contactable reporter, Consumer.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Dec2021 15:15 (Lot number: FD7218) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: Seafood" (unspecified if ongoing); "Allergies: Iodine" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6206, Route of Administration: Intramuscular, Location of injection: Arm Left, Vaccine Administration Time: 08:45 AM), administration date: 24Mar2021, when the patient was 57 years old, for COVID-19 Immunization, reaction: body aches; Bnt162b2 (lot number =EN5318,, administration time=09:30 AM,, vaccine location =Left arm., dose number=1), administration date: 02Mar2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: anaphylactic reaction (medically significant) with onset 13Dec2021 15:30, outcome recovered (Dec2021); immunisation (medically significant) with onset 13Dec2021 15:30, outcome recovered (Dec2021); pain (non-serious) with onset 13Dec2021 15:30, outcome recovered (Dec2021), described as "Aches and pains". Therapeutic measures were not taken as a result of anaphylactic reaction, immunisation, pain.; Sender's Comments: Linked Report(s) : PFIZER INC-2021325756 Same patient, different dose and event.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Gastroenteritis viral, Gastrointestinal disorder, Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe gastro; fever > 103 at home; viral gastroenteritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 17:30 (Lot number: FK5618) at the age of 11 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, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 05:30 PM), administration date: 15Nov2021, when the patient was 10 years old, for COVID-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (medically significant) with onset 07Dec2021 11:00, outcome "recovering", described as "Severe gastro"; PYREXIA (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "fever > 103 at home"; GASTROENTERITIS VIRAL (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "viral gastroenteritis". The events "severe gastro", "fever > 103 at home" and "viral gastroenteritis" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (07Dec2021) >103; sars-cov-2 test: (07Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of gastrointestinal disorder, pyrexia, gastroenteritis viral.  Clinical course: Patient Was sent home from school on 07Dec with severe gastro and fever > 103 at home. Diagnosis at ER was viral gastroenteritis. Patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Malignant melanoma, Neoplasm malignant
Clinical narrative: melanoma carcinoma on his scalp; melanoma carcinoma on his scalp; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A 85 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), MALIGNANT MELANOMA (medically significant), outcome "unknown" and all described as "melanoma carcinoma on his scalp". Therapeutic measures were taken as a result of neoplasm malignant, malignant melanoma.  Clinical information: The reporter stated that the patient within 3 months of receiving the suspect vaccine (purple cap) first dose developed a very rare and strange melanoma carcinoma on his scalp and that they now had to cut-off the melanoma carcinoma and he will have an open wound for a year. The reporter regarding the information on of the suspect vaccine stated that this information does not have the specific information developing a very rare and strange 'melanoma-carcinoma' on the scalp following vaccination with the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). The reporter stated that the people that work at Pfizer had no integrity for being a part of a company that fails to be transparent and called in Feb and Mar but received the same information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the reported events and suspect drug BNT162B2 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.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Exploding head syndrome, Hallucination, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; I wake up hallucinating extremely loud noises 4 or 5 times a night; exploding head syndrome/he has experienced it several times a night; exploding head syndrome/he has experienced it several times a night; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Dec2021 15:00 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "exploding head syndrome" (unspecified if ongoing), notes: less than once a year. No known allergies. No covid prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. Vaccination history included: Bnt162b2 (Dose 2, 03:00 PM, Right arm), administration date: 09Jun2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, 03:00 PM, Right arm), administration date: 19May2021, when the patient was 48 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (medically significant) with onset 11Dec2021 15:00, outcome "unknown", described as "Booster"; HALLUCINATION (medically significant) with onset 11Dec2021, outcome "not recovered", described as "I wake up hallucinating extremely loud noises 4 or 5 times a night"; EXPLODING HEAD SYNDROME (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 11Dec2021, outcome "not recovered" and all described as "exploding head syndrome/he has experienced it several times a night". The patient underwent the following laboratory tests and procedures: Oral covid test: negative, notes: covid test type post vaccination: Other. Therapeutic measures were not taken as a result of hallucination, exploding head syndrome, condition aggravated. Clinical course: Patient rarely (less than once a year) has "exploding head syndrome" but since the 3rd vaccination he has experienced it several times a night. He wake up hallucinating extremely loud noises 4 or 5 times a night, probably when he's leaving REM and entering lucid sleep.     The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Pleural effusion, Pleurisy, SARS-CoV-2 test
Clinical narrative: pleurisy; bilateral pleural effusions; bronchitis; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 09:00 (Lot number: EN6205) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. Vaccination history included: Comirnaty (lot number: EL1283, Administration time: 09:0 AM, dose number: 1, Vaccine location: Left arm), administration date: 09Feb2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: PLEURISY (medically significant) with onset 26Jul2021, outcome "not recovered", described as "pleurisy"; PLEURAL EFFUSION (medically significant) with onset 26Jul2021, outcome "not recovered", described as "bilateral pleural effusions"; BRONCHITIS (medically significant) with onset 26Jul2021, outcome "not recovered", described as "bronchitis". The events "pleurisy", "bilateral pleural effusions" and "bronchitis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pleurisy, pleural effusion, bronchitis and included treatment with corticosteroids for 3 months. Clinical course: It was reported that the patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient received the vaccine at hospital.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Pain in extremity, Pleural effusion, Bronchitis and the suspect drug BNT162B2 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, SARS-CoV-2 test, Vasculitis
Clinical narrative: ANCA-associated vasculitis; ANCA-associated vasculitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Nov2021 10:00 (Lot number: FH8030) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: MULTIVITAMIN [VITAMINS NOS]; INFLUENZA taken for immunisation, administration date 18Oct2021. Vaccination history included: Bnt162b2 (Dose 2, single, lot number: Ew0151, administration time: 02:00 hours, location: left arm), administration date: 12Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single, lot number: E96955, time: 02:30 hours, location: Right arm), administration date: 22Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (prolonged hospitalization, disability, life threatening), VASCULITIS (prolonged hospitalization, disability, life threatening) all with onset 14Nov2021 08:00, outcome "not recovered" and all described as "ANCA-associated vasculitis". The patient prolonged hospitalization for antineutrophil cytoplasmic antibody, vasculitis (hospitalization duration: 4 day(s)). The event "anca-associated vasculitis" and "anca-associated vasculitis" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Dec2021) negative. Therapeutic measures were taken as a result of antineutrophil cytoplasmic antibody, vasculitis. The patient received treatment with high-dose Solumedrol. The patient did not have Covid prior vaccination, was Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing), notes: The caller also has a heart condition. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2021, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jul2021) positive. Therapeutic measures were taken as a result of covid-19. Then on 23Jul2021, she received the monoclonal infusion. The patient wanted to know when she should get the booster dose since she already had 2 doses of the vaccines and an infusion. The patient clarified that because of her heart condition she had the monoclonal infusion treatment done after she tested positive for Covid. Because the patient has had the Covid shots and the monoclonal infusion she did not know how much time she should wait until she could get the booster dose. The patient tested positive for Covid on 20Jul2021 and received the monoclonal infusion on 23Jul2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: a patient who thinks he had COVID or was COVID positive sometime after getting the primary dose of the Pfizer-BioNTech COVID-19 Vaccine/ Tested positive for Covid after second dose; a patient who thinks he had COVID or was COVID positive sometime after getting the primary dose of the Pfizer-BioNTech COVID-19 Vaccine/ Tested positive for Covid after second dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2020 (Batch/Lot number: unknown) as dose 2, single and administration date 2020 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "a patient who thinks he had COVID or was COVID positive sometime after getting the primary dose of the Pfizer-BioNTech COVID-19 Vaccine/ Tested positive for Covid after second dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The reporter reported about a patient who thought he had COVID or was COVID positive sometime after getting the primary dose of the Pfizer-BioNTech COVID-19 Vaccine. He was asking about the recommendations of giving the booster dose to the patient. The reporter stated the patient lived in a nursing home and the 2 vaccines would have been given around this time last year because they live at a long term care facility, so they were the first ones to get shots. The reporter stated exact dates are unknown of first and second vaccines, but he knew they were Pfizer. The reporter stated that the patient tested positive about 3 weeks ago. Reportedly, this report was related to a study or programme.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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: Acute respiratory failure, COVID-19 pneumonia, Drug ineffective
Clinical narrative: Patient had received 2 doses of Pfizer vaccines prior to contracting COVID; Patient had received 2 doses of Pfizer vaccines prior to contracting COVID; acute respiratory failure secondary to COVID pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hospitalization", start date: 2019, stop date: 2019; "Chronic obstructive pulmonary disease" (ongoing); "Congestive heart failure" (ongoing); "Thyroid disorder" (unspecified if ongoing); "wheezing" (unspecified if ongoing); "shortness of breath" (unspecified if ongoing).  Concomitant medication(s) included: ELIQUIS taken for cardiac failure congestive, start date: 2019, stop date: 2021; FUROSEMIDE; LIPITOR; ACETYLSALICYLIC ACID; CITALOPRAM; LOPRESSOR; LEVOTHYROXINE taken for thyroid disorder; SALBUTAMOL taken for wheezing, dyspnoea; SYMBICORT taken for wheezing, dyspnoea. The following information was reported: DRUG INEFFECTIVE (death, hospitalization, medically significant), COVID-19 PNEUMONIA (death, hospitalization, medically significant), outcome "fatal" and all described as "Patient had received 2 doses of Pfizer vaccines prior to contracting COVID"; ACUTE RESPIRATORY FAILURE (death, hospitalization, medically significant), outcome "fatal", described as "acute respiratory failure secondary to COVID pneumonia ". The patient was hospitalized for drug ineffective, covid-19 pneumonia, acute respiratory failure (start date: 14Sep2021).  The patient date of death was 09Oct2021. The reported cause of death was drug ineffective, covid-19 pneumonia, acute respiratory failure. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Patient had received 2 doses of Pfizer vaccines prior to contracting COVID; Patient had received 2 doses of Pfizer vaccines prior to contracting COVID; acute  respiratory failure secondary to COVID pneumonia
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Axillary pain, Chills, Ear infection, Fatigue
Clinical narrative: Stabbing in the heart and under arm pit; Stabbing in the heart and under arm pit; Heart rate of 140; Fever; Chills; Tiredness; Muscle pain; Runny nose; Ear infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 12:15 (Lot number: Er8732) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: En6205, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 08Mar2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant), AXILLARY PAIN (non-serious) all with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021) and all described as "Stabbing in the heart and under arm pit"; HEART RATE INCREASED (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Heart rate of 140"; PYREXIA (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Fever"; CHILLS (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Chills"; FATIGUE (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Tiredness"; MYALGIA (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Muscle pain"; RHINORRHOEA (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Runny nose"; EAR INFECTION (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Ear infection". The patient underwent the following laboratory tests and procedures: heart rate: (29Mar2021) 140. Therapeutic measures were not taken as a result of angina pectoris, axillary pain, heart rate increased, pyrexia, chills, fatigue, myalgia, rhinorrhoea, ear infection.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: Stabbing in the heart and under arm pit; Stabbing in the heart and under arm pit; Heart rate of 140; Fever; Chills; Tiredness; Muscle pain; Runny nose; Ear infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 12:15 (Lot number: Er8732) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: En6205, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 08Mar2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant), AXILLARY PAIN (non-serious) all with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021) and all described as "Stabbing in the heart and under arm pit"; HEART RATE INCREASED (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Heart rate of 140"; PYREXIA (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Fever"; CHILLS (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Chills"; FATIGUE (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Tiredness"; MYALGIA (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Muscle pain"; RHINORRHOEA (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Runny nose"; EAR INFECTION (non-serious) with onset 29Mar2021 23:00, outcome "recovered with sequelae" (2021), described as "Ear infection". The patient underwent the following laboratory tests and procedures: heart rate: (29Mar2021) 140. Therapeutic measures were not taken as a result of angina pectoris, axillary pain, heart rate increased, pyrexia, chills, fatigue, myalgia, rhinorrhoea, ear infection.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nystagmus, Visual impairment
Clinical narrative: Within 2 weeks of having the 2nd dose of covid vaccine. I noticed an increase in eye shaking from the nystagmas; my vision decreased to 20/125; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Feb2021 11:45 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Nystagmus" (unspecified if ongoing); "LCA" (unspecified if ongoing); "Allergies:Tree nuts" (unspecified if ongoing); "Allergies:seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: NEXPLANON. Vaccination history included: Bnt162b2 (Dose Number: 1 single, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 16Jan2021, when the patient was 25 years old, for Covid-19 immunization. The following information was reported: NYSTAGMUS (disability) with onset Feb2021, outcome "not recovered", described as "Within 2 weeks of having the 2nd dose of covid vaccine. I noticed an increase in eye shaking from the nystagmas"; VISUAL IMPAIRMENT (disability) with onset Feb2021, outcome "not recovered", described as "my vision decreased to 20/125". The events "within 2 weeks of having the 2nd dose of covid vaccine. i noticed an increase in eye shaking from the nystagmas" and "my vision decreased to 20/125" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of nystagmus, visual impairment. The patient was not pregnant during the vaccination. The patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 and Since the vaccination, not tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: Booster; Are there active trials for people who are fully vaccinated plus boosted and have contracted COVID-19; Are there active trials for people who are fully vaccinated plus boosted and have contracted COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Are there active trials for people who are fully vaccinated plus boosted and have contracted COVID-19".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: Booster; fully vaccinated plus boosted and have contracted COVID-19; fully vaccinated plus boosted and have contracted COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "fully vaccinated plus boosted and have contracted COVID-19".  Additional information: Reporter was requesting a clinical trial for his son and girlfriend and asked "Are there active trials for people who are fully vaccinated plus boosted and have contracted COVID-19".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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