chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: just diagnosed with shingles/suspected vaccination failure; shingles; Blisters around her eye, forehead and scalp; This case was reported by a nurse via interactive digital media and described the occurrence of vaccination failure in a 86-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-MAR-2022 Reporter's Comment:  This case was reported by a patient's son/daughter via interactive digital media  The patient had shingles before and had also been vaccinated.  The patient was just diagnosed with shingles.  The patient experienced blisters around her eye, forehead and scalp.  The reporter stated that obviously, that was a waste of money, as this time it was worse than before. As a nurse it disgusts him/her to see how drugs, especially vaccines were pushed on people. Additional supportive information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-day-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 29th March 2022, the patient received Engerix B pediatric. On 29th March 2022, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The patient received an expired dose of Engerix B pediatric. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Engerix B pediatric which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus, Thrombosis
Clinical narrative: she developed blood clots which are gone now; she also has an autoimmune condition, she has lupus, and it is not getting any better; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (she developed blood clots which are gone now) and SYSTEMIC LUPUS ERYTHEMATOSUS (she also has an autoimmune condition, she has lupus, and it is not getting any better) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (she developed blood clots which are gone now) (seriousness criterion medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (she also has an autoimmune condition, she has lupus, and it is not getting any better) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (she developed blood clots which are gone now) had resolved and SYSTEMIC LUPUS ERYTHEMATOSUS (she also has an autoimmune condition, she has lupus, and it is not getting any better) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Patient stated that she had the vaccine in January last year and she developed blood clots which were gone now, but she also had an autoimmune condition, she had lupus, and it was not getting any better. Patient stated that she never got health problems like these before taking the vaccines.  Treatment drug information was not provided.  Company comment: This spontaneous case concerns a female patient (age not specified) with relevant medical history of Systemic lupus erythematosus, who experienced the unexpected serious (medically significant) events Thrombosis (AESI) and Systemic lupus erythematosus, on an unspecified date after a dose of mRNA-1273. The patient experienced blood clots and Systemic lupus erythematosus. At the time of report thrombosis had resolved and Systemic lupus erythematosus had not resolved. Medical history of Systemic lupus erythematosus could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient (age not specified) with relevant medical history of Systemic lupus erythematosus, who experienced the unexpected serious (medically significant) events Thrombosis (AESI) and Systemic lupus erythematosus, on an unspecified date after a dose of mRNA-1273. The patient experienced blood clots and Systemic lupus erythematosus. At the time of report thrombosis had resolved and Systemic lupus erythematosus had not resolved. Medical history of Systemic lupus erythematosus could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (Patient administered with vaccine that has been stored in the refrigerator for 31 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. In March 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine that has been stored in the refrigerator for 31 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient administered with vaccine that has been stored in the refrigerator for 31 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (Patient administered with vaccine that has been stored in the refrigerator for 31 days) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient did not have any adverse event. The reporter stated that they had administered 4 doses to 4 patient's from the vaccine from the vial that was initially stored in the refrigerator on 15 Feb 2022. Out of which 3 doses were administered on 11 Mar 2022 and 1 dose on 21 Mar 2022. No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (pericarditis) in a 69-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant). The patient was treated with COLCHICINE for Pericarditis, at an unspecified dose and frequency. At the time of the report, PERICARDITIS (pericarditis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PERICARDITIS (pericarditis) to be related.    Concomitant information was not reported. This report describes a 69-year-old female who presented with three days of chest pain that started one day after a booster shot of the Moderna COVID-19 vaccine. The patient was diagnosed with pericarditis. Treated with Colchicine and later steroids.  Company comment:  This literature non-study case concerns a 69 year old female, with no reported medical history, who experienced the serious (medically significant), expected AESI of pericarditis. Patient experienced 3 days of chest pain which started 1 day after the booster dose of mRNA 1273 COVID-19 vaccine. The patient was diagnosed with pericarditis and was treated with Colchicine and later on steroids. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This literature non-study case concerns a 69 year old female, with no reported medical history, who experienced the serious (medically significant), expected AESI of pericarditis. Patient experienced 3 days of chest pain which started 1 day after the booster dose of mRNA 1273 COVID-19 vaccine. The patient was diagnosed with pericarditis and was treated with Colchicine and later on steroids. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Very very ill with the last shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very very ill with the last shot) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very very ill with the last shot). At the time of the report, ILLNESS (Very very ill with the last shot) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2022: No new information received.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old received 1st dose of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received 1st dose of Moderna) in a 14-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received 1st dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received 1st dose of Moderna) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depressed mood, Insomnia, Malaise
Clinical narrative: Hard to sleep; Not energetic; Not feeling well; Feeling a little bit down; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard to sleep), ASTHENIA (Not energetic), MALAISE (Not feeling well) and DEPRESSED MOOD (Feeling a little bit down) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-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 INSOMNIA (Hard to sleep) and ASTHENIA (Not energetic). an unknown date, the patient experienced MALAISE (Not feeling well) and DEPRESSED MOOD (Feeling a little bit down). At the time of the report, INSOMNIA (Hard to sleep), ASTHENIA (Not energetic) and MALAISE (Not feeling well) outcome was unknown and DEPRESSED MOOD (Feeling a little bit down) had resolved.            Patient was taking medication for diabetes, high blood pressure and cholesterol. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2022: Follow up contains No New Information.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess, Blood test, Feeling of despair, Investigation, Pruritus
Clinical narrative: itching was already in my throat, genitals, buttocks; itching was already in throat, genitals, buttocks; I am getting pumps; I am desperate; not stopped itching all over my body/ itching was already in throat, genitals, buttocks; The initial case was missing the following minimum criteria: [Info not qualifying for AE reporting - All other sources]. Upon receipt of follow-up information of 25Mar2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 10:00 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion , Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 04May2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: THROAT IRRITATION (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "itching was already in my throat, genitals, buttocks"; PRURITUS GENITAL (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "itching was already in throat, genitals, buttocks"; ABSCESS (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "I am getting pumps"; FEELING OF DESPAIR (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "I am desperate"; PRURITUS (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "not stopped itching all over my body/ itching was already in throat, genitals, buttocks". The events "itching was already in my throat, genitals, buttocks", "itching was already in throat, genitals, buttocks", "i am getting pumps", "i am desperate" and "not stopped itching all over my body/ itching was already in throat, genitals, buttocks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of throat irritation, pruritus genital, abscess, feeling of despair, pruritus.  Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed was the patient diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus genital, SARS-CoV-2 test, Throat irritation
Clinical narrative: itching was already in my throat, genitals, buttocks; itching was already in throat, genitals, buttocks; I am getting pumps; I am desperate; not stopped itching all over my body/ itching was already in throat, genitals, buttocks; The initial case was missing the following minimum criteria: [Info not qualifying for AE reporting - All other sources]. Upon receipt of follow-up information of 25Mar2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 10:00 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion , Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 04May2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: THROAT IRRITATION (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "itching was already in my throat, genitals, buttocks"; PRURITUS GENITAL (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "itching was already in throat, genitals, buttocks"; ABSCESS (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "I am getting pumps"; FEELING OF DESPAIR (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "I am desperate"; PRURITUS (non-serious) with onset 10Aug2021 02:00, outcome "not recovered", described as "not stopped itching all over my body/ itching was already in throat, genitals, buttocks". The events "itching was already in my throat, genitals, buttocks", "itching was already in throat, genitals, buttocks", "i am getting pumps", "i am desperate" and "not stopped itching all over my body/ itching was already in throat, genitals, buttocks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of throat irritation, pruritus genital, abscess, feeling of despair, pruritus.  Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed was the patient diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, Tinnitus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): Regulatory Authority. A 41-year-old male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 41 years 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: COVID-19 PNEUMONIA (medically significant) with onset Dec2021, outcome "recovered", described as "COVID Pneumonia"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "recovered" and all described as "COVID"; TINNITUS (non-serious) with onset Dec2021, outcome "recovered", described as "Tinnitus". The clinical course reported as on 04Mar2021, patient started therapy with Covid-19 vaccination (UNK INGREDIENTS) for vaccine COVID-19. On Dec2021, it was reported that patient experienced with tinnitus, COVID, COVID Pneumonia. The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up (22Mar2022): This is a follow-up spontaneous report received from the same contactable consumer. This consumer (patient) reported for himself that: Updated Information: Added case became valid, product start/stop date added, new events (Covid-19, drug ineffective, Covid-19 pneumonia, tinnitus added), event outcome updated, clinical information. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Tinnitus/Three months later ear still feels stuffy and ringing; Three months later ear still feels stuffy and ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing); "Interchange of vaccine" (unspecified if ongoing). Concomitant medication(s) included: CENTRUM FOR WOMEN. Past drug history included: Erythromiacin, reaction(s): "Allergy". Vaccination history included: Moderna (Dose Number: 2, Lot No: Unknown. Arm Left), administration date: May2021, when the patient was 48 years old, for Covid-19 Immunization; Moderna (Dose Number: 1, Lot No: Unknown. Arm Left), administration date: Apr2021, when the patient was 48 years old, for Covid-19 Immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: TINNITUS (disability) with onset Dec2021, outcome "not recovered", described as "Tinnitus/Three months later ear still feels stuffy and ringing"; EAR DISCOMFORT (disability) with onset Dec2021, outcome "not recovered", described as "Three months later ear still feels stuffy and ringing". Therapeutic measures were not taken as a result of tinnitus, ear discomfort. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 12Jan2022 12:00 (Lot number: 3014BA) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior vaccination. Date of last menstrual period: 17Dec2021. The patient was 4 weeks pregnant at the time of exposure to bnt162b2. The patient was 4 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 23Sep2022. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Azithromycin, reaction(s): "Known allergies: Azithromycin". Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN5318, Administration time: 08:00 AM, Vaccine location: Right arm), administration date: 26Feb2021, when the patient was 30 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot number: EN6205, Administration time: 02:00 PM, Vaccine location: Right arm), administration date: 19Mar2021, when the patient was 30 years old, for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not been tested for COVID-19 post vaccination. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 11Mar2022 15:30, outcome "recovering", described as "Miscarriage". The event "miscarriage" was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion (23Sep2022). The fetal outcome is intrauterine death. Therapeutic measures were taken as a result of abortion spontaneous (medication to assist with miscarriage).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose; I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose; I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 16:00 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for covid-19 immunisation.  Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes.  The patient did not have any known allergies. Concomitant medication included: paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: CHEST PAIN (prolonged hospitalization), CHEST DISCOMFORT (prolonged hospitalization), DYSPNOEA (prolonged hospitalization) all with onset 12Dec2021, outcome "not recovered" and all described as "I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose".  The event "I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose", "I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose" and "I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose" was evaluated at the physician office visit and emergency room visit.  Therapeutic measures were not taken as a result of I'm getting a lot of chest pain and shortness of breath chest feels very heavy after first dose . It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient received BNT162B2 dose 2 administration date 07Jan2022, administration time 03:00 PM, vaccine location was Right arm.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, COVID-19, Chest discomfort
Clinical narrative: COVID test result= Positive; COVID test result= Positive; blood pressure was 168 over 126; my armed and legs started shaking/felt a vibrating feeling in my arms and joints; dizzy; anxious; Tightness in my chest when breathing; felt irregular heart beats; felt a vibrating feeling in my arms and joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 11:30 (Lot number: 30130BA) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "COVID test result= Positive"; BLOOD PRESSURE INCREASED (medically significant) with onset 19Sep2021 13:00, outcome "not recovered", described as "blood pressure was 168 over 126"; TREMOR (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "my armed and legs started shaking/felt a vibrating feeling in my arms and joints"; DIZZINESS (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "dizzy"; ANXIETY (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "anxious"; CHEST DISCOMFORT (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "Tightness in my chest when breathing"; HEART RATE IRREGULAR (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "felt irregular heart beats"; JOINT VIBRATION (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "felt a vibrating feeling in my arms and joints". The events "blood pressure was 168 over 126", "my armed and legs started shaking/felt a vibrating feeling in my arms and joints", "dizzy", "anxious", "tightness in my chest when breathing", "felt irregular heart beats" and "felt a vibrating feeling in my arms and joints" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Sep2021) 168 over 126; heart rate: (19Sep2021) irregular; sars-cov-2 test: (26Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of blood pressure increased.  Clinical Course: It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Patient went to the urgent care and was suggested to go to the hospital. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Drug ineffective, Heart rate, Heart rate irregular, Joint vibration
Clinical narrative: COVID test result= Positive; COVID test result= Positive; blood pressure was 168 over 126; my armed and legs started shaking/felt a vibrating feeling in my arms and joints; dizzy; anxious; Tightness in my chest when breathing; felt irregular heart beats; felt a vibrating feeling in my arms and joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 11:30 (Lot number: 30130BA) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "COVID test result= Positive"; BLOOD PRESSURE INCREASED (medically significant) with onset 19Sep2021 13:00, outcome "not recovered", described as "blood pressure was 168 over 126"; TREMOR (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "my armed and legs started shaking/felt a vibrating feeling in my arms and joints"; DIZZINESS (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "dizzy"; ANXIETY (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "anxious"; CHEST DISCOMFORT (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "Tightness in my chest when breathing"; HEART RATE IRREGULAR (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "felt irregular heart beats"; JOINT VIBRATION (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "felt a vibrating feeling in my arms and joints". The events "blood pressure was 168 over 126", "my armed and legs started shaking/felt a vibrating feeling in my arms and joints", "dizzy", "anxious", "tightness in my chest when breathing", "felt irregular heart beats" and "felt a vibrating feeling in my arms and joints" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Sep2021) 168 over 126; heart rate: (19Sep2021) irregular; sars-cov-2 test: (26Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of blood pressure increased.  Clinical Course: It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Patient went to the urgent care and was suggested to go to the hospital. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: COVID test result= Positive; COVID test result= Positive; blood pressure was 168 over 126; my armed and legs started shaking/felt a vibrating feeling in my arms and joints; dizzy; anxious; Tightness in my chest when breathing; felt irregular heart beats; felt a vibrating feeling in my arms and joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 11:30 (Lot number: 30130BA) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "COVID test result= Positive"; BLOOD PRESSURE INCREASED (medically significant) with onset 19Sep2021 13:00, outcome "not recovered", described as "blood pressure was 168 over 126"; TREMOR (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "my armed and legs started shaking/felt a vibrating feeling in my arms and joints"; DIZZINESS (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "dizzy"; ANXIETY (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "anxious"; CHEST DISCOMFORT (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "Tightness in my chest when breathing"; HEART RATE IRREGULAR (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "felt irregular heart beats"; JOINT VIBRATION (non-serious) with onset 19Sep2021 13:00, outcome "not recovered", described as "felt a vibrating feeling in my arms and joints". The events "blood pressure was 168 over 126", "my armed and legs started shaking/felt a vibrating feeling in my arms and joints", "dizzy", "anxious", "tightness in my chest when breathing", "felt irregular heart beats" and "felt a vibrating feeling in my arms and joints" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Sep2021) 168 over 126; heart rate: (19Sep2021) irregular; sars-cov-2 test: (26Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of blood pressure increased.  Clinical Course: It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Patient went to the urgent care and was suggested to go to the hospital. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: he got the second vaccine and on 08Mar2022 when he went back to the eye specialist, he can't read with that eye nothing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FM0698) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot number: FK9896), administration date: 24Jan2022, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "eye stroke". The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 08Mar2022, outcome "not recovered", described as "he got the second vaccine and on 08Mar2022 when he went back to the eye specialist, he can't read with that eye nothing". The event "he got the second vaccine and on 08mar2022 when he went back to the eye specialist, he can't read with that eye nothing" was evaluated at the physician office visit. Therapeutic measures were taken as a result of visual impairment.  Additional information: The caller stated that he got the Pfizer vaccine, thinks he had some bad things, stated he got the first vaccine 24Jan2022 and on 10Feb2022 when he went to the eye doctor, they said he had an eye stroke, stated the doctor took a picture, told him he had an eye stroke, stated at that time he could read the biggest letters and then on 23Feb2022 he got the second vaccine and on 08Mar2022 when he went back to the eye specialist, he couldn't read with that eye nothing. He stated his right eye was affected. The caller stated that the doctor said this could be due to the vaccines. It was persisting and the doctor told him that he would not get back his vision, stated that it could turn into glaucoma. Gave him a shot, some medicine, details unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200461909 same patient and drug, different event separated in time
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Retinal artery occlusion
Clinical narrative: he got the second vaccine and on 08Mar2022 when he went back to the eye specialist, he can't read with that eye nothing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FM0698) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot number: FK9896), administration date: 24Jan2022, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "eye stroke". The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 08Mar2022, outcome "not recovered", described as "he got the second vaccine and on 08Mar2022 when he went back to the eye specialist, he can't read with that eye nothing". The event "he got the second vaccine and on 08mar2022 when he went back to the eye specialist, he can't read with that eye nothing" was evaluated at the physician office visit. Therapeutic measures were taken as a result of visual impairment.  Additional information: The caller stated that he got the Pfizer vaccine, thinks he had some bad things, stated he got the first vaccine 24Jan2022 and on 10Feb2022 when he went to the eye doctor, they said he had an eye stroke, stated the doctor took a picture, told him he had an eye stroke, stated at that time he could read the biggest letters and then on 23Feb2022 he got the second vaccine and on 08Mar2022 when he went back to the eye specialist, he couldn't read with that eye nothing. He stated his right eye was affected. The caller stated that the doctor said this could be due to the vaccines. It was persisting and the doctor told him that he would not get back his vision, stated that it could turn into glaucoma. Gave him a shot, some medicine, details unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200461909 same patient and drug, different event separated in time
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Arthritis, Headache, Joint swelling, Pain
Clinical narrative: ANKYLOSING SPONDYLITIS KICKED UP SOME DUE TO TRAVELING; BODY ACHE; ANKLE  SWELLING COMES AND GOES; HANDS/LEFT KNEE ARTHRITIS; HEADACHE; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4327158-00.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "ANKYLOSING SPONDYLITIS KICKED UP SOME DUE TO TRAVELING"; PAIN (non-serious), outcome "recovered", described as "BODY ACHE"; JOINT SWELLING (non-serious), outcome "not recovered", described as "ANKLE SWELLING COMES AND GOES"; ARTHRITIS (non-serious), outcome "not recovered", described as "HANDS/LEFT KNEE ARTHRITIS"; HEADACHE (non-serious), outcome "recovered", described as "HEADACHE". The action taken for adalimumab was unknown. The reporter considered "body ache" and "headache" related to bnt162b2.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Ankylosing Spondylitis Kicked Up Some Due to Traveling, Ankle Swelling Comes and Goes, Hands/Left Knee Arthritis, Headache and Body Ache with Humira (Adalimumab) was no reasonable possibility.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran): The reporter's assessment of the causal relationship of the reported events Ankylosing Spondylitis Kicked Up Some Due to Traveling, Ankle Swelling Comes and Goes, Hands/Left Knee Arthritis, Headache and Body Ache with the suspect product(s) bnt162b2 was no reasonable possibility provided at the time of this report. Since determination has been received, the case is managed based on the company causality assessment as related.  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
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Felt a little more tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old 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. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: other medications in two weeks: Blood pressure; "cholesterol" (unspecified if ongoing), notes: other medications in two weeks: cholesterol; "pain" (unspecified if ongoing), notes: other medications in two weeks: pain meds; "antidepressant" (unspecified if ongoing), notes: other medications in two weeks: antidepressant. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset Dec2021, outcome "recovered", described as "Felt a little more tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  Additional Information: Serious was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. List of any other medications the patient received within 2 weeks of vaccination were reported as Blood pressure, cholesterol, pain meds, antidepressant. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Pruritus, Rash macular, Urticaria
Clinical narrative: welts; itchiness in her head; big spots on her head, big spots and rash on her stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (Lot number: ER8736) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "penicillin allergies" (unspecified if ongoing). Concomitant medication(s) included: REQUIP taken for neuropathy peripheral. Vaccination history included: Bnt162b2 (Dose:1, LOT: EN5318), administration date: 14Apr2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset Oct2021, outcome "not recovered", described as "itchiness in her head"; RASH MACULAR (non-serious) with onset Oct2021, outcome "not recovered", described as "big spots on her head, big spots and rash on her stomach"; URTICARIA (non-serious), outcome "not recovered", described as "welts". The events "itchiness in her head", "big spots on her head, big spots and rash on her stomach" and "welts" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient states that she has got an itchy head, to the point where it has opened up in her scalp. She has got spots on her stomach, in big circles, about the size of her palm, in the evening they become welts. In the morning, it is much better than in the evening. There are little teeny tiny spots on her head, all about the same size probably about a quarter of an inch, and smaller, around the side of her neck and underneath the hairline. These spots are smaller than the ones on the stomach. She states she has had this now for several months. Caller states they she just got through a biopsy they did on her scalp. They took one of the spots and it came through that she has an allergic reaction to something. No vaccinations were taken within 4 weeks prior to COVID vaccine. No adverse reactions occurred following prior vaccinations. Clobetasol Propionate foam .05% was advised by doctor to her but still it did not clear.