chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Myocardial infarction, Tachycardia
Clinical narrative: one night he felt like his chest was going to explode/heart attack; Hypotension; Tachycardia; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP, daughter). A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Jul2021 (Lot number: FA6780) at the age of 93 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Legally Blind" (unspecified if ongoing). Concomitant medications included: VITAMIN D [ERGOCALCIFEROL] (ongoing) and ongoing eye medication. Vaccination history included: Bnt162b2 (1st dose, Lot: FA6780), administration date: 28Jun2021, when the patient was 93 years old, for COVID-19 Immunization. The following information was reported: HYPOTENSION (hospitalization) with onset 12Sep2021, outcome "recovered" (2021), described as "Hypotension"; TACHYCARDIA (hospitalization) with onset 12Sep2021, outcome "recovered" (2021), described as "Tachycardia"; MYOCARDIAL INFARCTION (hospitalization) with onset 15Sep2021, outcome "recovered" (2021), described as "one night he felt like his chest was going to explode/heart attack". The patient was hospitalized for hypotension, tachycardia, myocardial infarction (start date: 15Sep2021, discharge date: 16Sep2021, hospitalization duration: 1 day(s)). The events "hypotension", "tachycardia" and "one night he felt like his chest was going to explode/heart attack" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of hypotension, tachycardia, myocardial infarction included diltiazem, apixaban (ELIQUIS), acetylsalicylic acid (ASPIRIN) and cardioversion. Clinical course: Caller stated her dad had been fine and after he got the second vaccine he was struggling for 2 weeks after, maybe 3 and then maybe within last 3 days, she didn't realize what was going on, but after walking, he would stay in the bathroom for 40 minutes. Caller states this went unnoticed for a while. Caller stated when they would walk in the park, he would have to stop. Caller stated she was his caretaker, and one night he felt like his chest was going to explode, he was in tachycardia and hypotension and it went on for a couple of days and she was trying to get him to the doctors, they should have went to the ER they learned later. Caller stated after getting him to the Urgent Care, they rushed to him to the ER because he was having a heart attack. Treatment: Caller states they prescribed him diltiazem and apixaban, but diltiazem would lower his blood pressure and instead of apixaban he is just taking acetylsalicylic acid intermittently. Caller states the patient also had a cardioversion.   No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team.  A 10-year-old male patient received bnt162b2 (COMIRNATY), administration date 10Nov2021 (Batch/Lot number: unknown, expiration date unknown) at the age of 10 years 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Nov2021, outcome "unknown" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Nov2021) positive.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Drug ineffective, Covid-19 and suspect drug BNT162B2 cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Fever, chills, body aches, headache,slight cough, fatigue, sore throat/Covid test viral RNA/PCR result, Positive; Fever, chills, body aches, headache,slight cough, fatigue, sore throat/Covid test viral RNA/PCR result, Positive; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) and from product quality group. The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) as dose 2, single and administered in arm left, administration date 01Mar2021 (Lot number: EL3247) as dose 1, single, both at the age of 62 years for COVID-19 immunisation. The patient had no relevant medical history (no other medical history or known allergies). There were no concomitant medications in two weeks or other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever, chills, body aches, headache, slight cough, fatigue, sore throat on 30Nov2021 15:00. Therapeutic measures were not taken as a result of events. The events did not result in emergency room visit or physician office visit. Since the vaccination, the patient had been tested for COVID-19 Viral RNA/PCR test (Nasal Swab) on 01Dec2021 with positive result. The outcome of the events was resolving.   Product Quality Group provided investigational results on 06Dec2021 for bnt162b2: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Chromaturia
Clinical narrative: brown urine; 'brown ear end'; received the Pfizer Covid 19 Vaccine Booster on Wednesday 01Dec2021; General Measles; muscle weakness; tiredness; achy joint/achiness in knees; temperature 101.3/Fever; Chills; Achiness in back; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administered in arm left, administration date 01Dec2021 (Lot number: FD0809) at the age of 35 years as dose number unknown (booster), single for COVID-19 immunisation. Relevant medical history included: "Chronic migraine" (unspecified if ongoing). Concomitant medication included: EMGALITY [GALCANEZUMAB]. Vaccination history included: COVID-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021, outcome "unknown", described as "received the Pfizer Covid 19 Vaccine Booster on Wednesday 01Dec2021"; MEASLES (medically significant) with onset Dec2021, outcome "recovering", described as "General Measles"; MUSCULAR WEAKNESS (non-serious) with onset Dec2021, outcome "recovering", described as "muscle weakness"; FATIGUE (non-serious) with onset Dec2021, outcome "recovering", described as "tiredness"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "recovering", described as "achy joint/achiness in knees"; PYREXIA (non-serious) with onset Dec2021, outcome "recovering", described as "temperature 101.3/Fever"; CHROMATURIA (non-serious) with onset 03Dec2021, outcome "unknown", described as "brown urine"; CHILLS (non-serious) with onset Dec2021, outcome "recovering", described as "Chills"; BACK PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "Achiness in back"; OTORRHOEA (non-serious) with onset 03Dec2021, outcome "unknown", described as "'brown ear end'". The patient underwent the following laboratory tests and procedures: body temperature: (Dec2021) 101.3. Clinical course: Per caller she received the Pfizer COVID-19 Vaccine Booster on 01Dec2021. Per caller, she experienced the common side effects muscle weakness, tiredness, achy joint, temperature 101.3. She felt much better today. She started voiding brown urine on 03Dec2021. Patient stated that she is well hydrated. Patient also reported having fever, chills, general measles, achiness in her knees and back especially. But on 03Dec2021, she was presented with like a 'brown ear end' (further not clarified) all day and she had not seen that as common side effect, so was not sure if it could be something more serious.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Measles, Muscular weakness, Otorrhoea
Clinical narrative: brown urine; 'brown ear end'; received the Pfizer Covid 19 Vaccine Booster on Wednesday 01Dec2021; General Measles; muscle weakness; tiredness; achy joint/achiness in knees; temperature 101.3/Fever; Chills; Achiness in back; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administered in arm left, administration date 01Dec2021 (Lot number: FD0809) at the age of 35 years as dose number unknown (booster), single for COVID-19 immunisation. Relevant medical history included: "Chronic migraine" (unspecified if ongoing). Concomitant medication included: EMGALITY [GALCANEZUMAB]. Vaccination history included: COVID-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021, outcome "unknown", described as "received the Pfizer Covid 19 Vaccine Booster on Wednesday 01Dec2021"; MEASLES (medically significant) with onset Dec2021, outcome "recovering", described as "General Measles"; MUSCULAR WEAKNESS (non-serious) with onset Dec2021, outcome "recovering", described as "muscle weakness"; FATIGUE (non-serious) with onset Dec2021, outcome "recovering", described as "tiredness"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "recovering", described as "achy joint/achiness in knees"; PYREXIA (non-serious) with onset Dec2021, outcome "recovering", described as "temperature 101.3/Fever"; CHROMATURIA (non-serious) with onset 03Dec2021, outcome "unknown", described as "brown urine"; CHILLS (non-serious) with onset Dec2021, outcome "recovering", described as "Chills"; BACK PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "Achiness in back"; OTORRHOEA (non-serious) with onset 03Dec2021, outcome "unknown", described as "'brown ear end'". The patient underwent the following laboratory tests and procedures: body temperature: (Dec2021) 101.3. Clinical course: Per caller she received the Pfizer COVID-19 Vaccine Booster on 01Dec2021. Per caller, she experienced the common side effects muscle weakness, tiredness, achy joint, temperature 101.3. She felt much better today. She started voiding brown urine on 03Dec2021. Patient stated that she is well hydrated. Patient also reported having fever, chills, general measles, achiness in her knees and back especially. But on 03Dec2021, she was presented with like a 'brown ear end' (further not clarified) all day and she had not seen that as common side effect, so was not sure if it could be something more serious.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: brown urine; 'brown ear end'; received the Pfizer Covid 19 Vaccine Booster on Wednesday 01Dec2021; General Measles; muscle weakness; tiredness; achy joint/achiness in knees; temperature 101.3/Fever; Chills; Achiness in back; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administered in arm left, administration date 01Dec2021 (Lot number: FD0809) at the age of 35 years as dose number unknown (booster), single for COVID-19 immunisation. Relevant medical history included: "Chronic migraine" (unspecified if ongoing). Concomitant medication included: EMGALITY [GALCANEZUMAB]. Vaccination history included: COVID-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021, outcome "unknown", described as "received the Pfizer Covid 19 Vaccine Booster on Wednesday 01Dec2021"; MEASLES (medically significant) with onset Dec2021, outcome "recovering", described as "General Measles"; MUSCULAR WEAKNESS (non-serious) with onset Dec2021, outcome "recovering", described as "muscle weakness"; FATIGUE (non-serious) with onset Dec2021, outcome "recovering", described as "tiredness"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "recovering", described as "achy joint/achiness in knees"; PYREXIA (non-serious) with onset Dec2021, outcome "recovering", described as "temperature 101.3/Fever"; CHROMATURIA (non-serious) with onset 03Dec2021, outcome "unknown", described as "brown urine"; CHILLS (non-serious) with onset Dec2021, outcome "recovering", described as "Chills"; BACK PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "Achiness in back"; OTORRHOEA (non-serious) with onset 03Dec2021, outcome "unknown", described as "'brown ear end'". The patient underwent the following laboratory tests and procedures: body temperature: (Dec2021) 101.3. Clinical course: Per caller she received the Pfizer COVID-19 Vaccine Booster on 01Dec2021. Per caller, she experienced the common side effects muscle weakness, tiredness, achy joint, temperature 101.3. She felt much better today. She started voiding brown urine on 03Dec2021. Patient stated that she is well hydrated. Patient also reported having fever, chills, general measles, achiness in her knees and back especially. But on 03Dec2021, she was presented with like a 'brown ear end' (further not clarified) all day and she had not seen that as common side effect, so was not sure if it could be something more serious.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion
Clinical narrative: Moderate pericardial effusion. Asymptomatic; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left, administration date 12Jan2021 10:00 (Lot number: EL1284) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no known allergies. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: EH9899, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), (administration date reported as "22Oct2020"), when the patient was 61 years old, for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. He had not been tested for COVID-19 since the vaccination. The following information was reported: PERICARDIAL EFFUSION (medically significant) with onset 01Feb2021 16:00, outcome "unknown", described as "Moderate pericardial effusion. Asymptomatic". The event "moderate pericardial effusion. asymptomatic" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pericardial effusion with antibiotic, NSAID, omeprazole, and colchicine.; Sender's Comments: Based on the currently available information the possibility of causal association between the event pericardial effusion and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available.  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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Antinuclear antibody, Antinuclear antibody positive, Aspartate aminotransferase
Clinical narrative: Positive ANA ab test result indicating autoimmune; Positive ANA ab test result indicating autoimmune; AST=224; ALT=492; Patient went to doctor for possible UTI, which was negative, follow up tests has been having increasing liver enzyme test since Jun. Most recent ALT=492;AST=224; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 12Apr2021 (Lot number: EP6955) at the age of 19 years as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose Lot number: EP6955,, Pev dose lot number: False), administration date: 22Mar2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), ANTINUCLEAR ANTIBODY POSITIVE (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "Positive ANA ab test result indicating autoimmune"; ASPARTATE AMINOTRANSFERASE INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "AST=224"; ALANINE AMINOTRANSFERASE INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "ALT=492"; HEPATIC ENZYME INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "Patient went to doctor for possible UTI, which was negative, follow up tests has been having increasing liver enzyme test since Jun. Most recent ALT=492;AST=224". The events "ast=224", "alt=492" and "patient went to doctor for possible uti, which was negative, follow up tests has been having increasing liver enzyme test since jun. most recent alt=492;ast=224" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: (01Jun2021) 492; antinuclear antibody: (04Dec2021) positive, notes: indicating autoimmune; aspartate aminotransferase: (01Jun2021) 224; hepatic enzyme: (01Jun2021) increasing; investigation: (01Jun2021) negative; sars-cov-2 test: (2021) unknown result, notes: COVID test type: Post vaccination: Blood test. Therapeutic measures were not taken as a result of autoimmune disorder, aspartate aminotransferase increased, alanine aminotransferase increased, hepatic enzyme increased, antinuclear antibody positive.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase increased, Autoimmune disorder, Hepatic enzyme, Hepatic enzyme increased, Investigation
Clinical narrative: Positive ANA ab test result indicating autoimmune; Positive ANA ab test result indicating autoimmune; AST=224; ALT=492; Patient went to doctor for possible UTI, which was negative, follow up tests has been having increasing liver enzyme test since Jun. Most recent ALT=492;AST=224; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 12Apr2021 (Lot number: EP6955) at the age of 19 years as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose Lot number: EP6955,, Pev dose lot number: False), administration date: 22Mar2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), ANTINUCLEAR ANTIBODY POSITIVE (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "Positive ANA ab test result indicating autoimmune"; ASPARTATE AMINOTRANSFERASE INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "AST=224"; ALANINE AMINOTRANSFERASE INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "ALT=492"; HEPATIC ENZYME INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "Patient went to doctor for possible UTI, which was negative, follow up tests has been having increasing liver enzyme test since Jun. Most recent ALT=492;AST=224". The events "ast=224", "alt=492" and "patient went to doctor for possible uti, which was negative, follow up tests has been having increasing liver enzyme test since jun. most recent alt=492;ast=224" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: (01Jun2021) 492; antinuclear antibody: (04Dec2021) positive, notes: indicating autoimmune; aspartate aminotransferase: (01Jun2021) 224; hepatic enzyme: (01Jun2021) increasing; investigation: (01Jun2021) negative; sars-cov-2 test: (2021) unknown result, notes: COVID test type: Post vaccination: Blood test. Therapeutic measures were not taken as a result of autoimmune disorder, aspartate aminotransferase increased, alanine aminotransferase increased, hepatic enzyme increased, antinuclear antibody positive.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Positive ANA ab test result indicating autoimmune; Positive ANA ab test result indicating autoimmune; AST=224; ALT=492; Patient went to doctor for possible UTI, which was negative, follow up tests has been having increasing liver enzyme test since Jun. Most recent ALT=492;AST=224; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 12Apr2021 (Lot number: EP6955) at the age of 19 years as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose Lot number: EP6955,, Pev dose lot number: False), administration date: 22Mar2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), ANTINUCLEAR ANTIBODY POSITIVE (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "Positive ANA ab test result indicating autoimmune"; ASPARTATE AMINOTRANSFERASE INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "AST=224"; ALANINE AMINOTRANSFERASE INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "ALT=492"; HEPATIC ENZYME INCREASED (medically significant) with onset 01Jun2021, outcome "not recovered", described as "Patient went to doctor for possible UTI, which was negative, follow up tests has been having increasing liver enzyme test since Jun. Most recent ALT=492;AST=224". The events "ast=224", "alt=492" and "patient went to doctor for possible uti, which was negative, follow up tests has been having increasing liver enzyme test since jun. most recent alt=492;ast=224" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: (01Jun2021) 492; antinuclear antibody: (04Dec2021) positive, notes: indicating autoimmune; aspartate aminotransferase: (01Jun2021) 224; hepatic enzyme: (01Jun2021) increasing; investigation: (01Jun2021) negative; sars-cov-2 test: (2021) unknown result, notes: COVID test type: Post vaccination: Blood test. Therapeutic measures were not taken as a result of autoimmune disorder, aspartate aminotransferase increased, alanine aminotransferase increased, hepatic enzyme increased, antinuclear antibody positive.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: His side effect are ''cold and cold''; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: 8020) at the age of 16 years as dose number unknown, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NASOPHARYNGITIS (hospitalization) with onset 2021, outcome "recovered" (2021), described as "His side effect are ''cold and cold''". The patient was hospitalized for nasopharyngitis (start date: 2021, discharge date: 2021).  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain in extremity, Peripheral swelling, Rash, Skin exfoliation
Clinical narrative: had pain and swelling in my left hand; had pain and swelling in my left hand/swollen rash covering my limbs.; It developed into hive rash on finger. Now it has developed into swollen hives on my scalp, ears, chest, arms, back, legs, and feet.; finger then started blistering up with open sores and peeling skin.; finger then started blistering up with open sores and peeling skin.; That then developed into a complete swollen rash covering my limbs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Sep2021 14:00 (Lot number: FD0809) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FD0808, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 03Sep2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "had pain and swelling in my left hand"; PERIPHERAL SWELLING (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "had pain and swelling in my left hand/swollen rash covering my limbs"; URTICARIA (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "It developed into hive rash on finger. Now it has developed into swollen hives on my scalp, ears, chest, arms, back, legs, and feet"; BLISTER (disability, medically significant), SKIN EXFOLIATION (disability, medically significant) all with onset 13Oct2021 01:00, outcome "not recovered" and all described as "finger then started blistering up with open sores and peeling skin."; RASH (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "That then developed into a complete swollen rash covering my limbs". The all the events were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of all events (antibiotic, steroid topical, 7 different).  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: had pain and swelling in my left hand; had pain and swelling in my left hand/swollen rash covering my limbs.; It developed into hive rash on finger. Now it has developed into swollen hives on my scalp, ears, chest, arms, back, legs, and feet.; finger then started blistering up with open sores and peeling skin.; finger then started blistering up with open sores and peeling skin.; That then developed into a complete swollen rash covering my limbs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Sep2021 14:00 (Lot number: FD0809) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FD0808, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 03Sep2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "had pain and swelling in my left hand"; PERIPHERAL SWELLING (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "had pain and swelling in my left hand/swollen rash covering my limbs"; URTICARIA (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "It developed into hive rash on finger. Now it has developed into swollen hives on my scalp, ears, chest, arms, back, legs, and feet"; BLISTER (disability, medically significant), SKIN EXFOLIATION (disability, medically significant) all with onset 13Oct2021 01:00, outcome "not recovered" and all described as "finger then started blistering up with open sores and peeling skin."; RASH (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "That then developed into a complete swollen rash covering my limbs". The all the events were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of all events (antibiotic, steroid topical, 7 different).  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune haemolytic anaemia, Blood test, Chronic lymphocytic leukaemia, Coagulation test
Clinical narrative: Chronic lymphocytic leukemia; Autoimmune hemolytic anemia; Coughing; Feeling sick all over/Malaise; Sneezing; Runny nose; Pain and swelling in her left elbow; Pain and swelling in her left elbow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 (Lot number: EW0202) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Family Medical History was None. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot: EW0167, Location: Left arm), administration date: 17May2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant) with onset Nov2021, outcome "not recovered", described as "Chronic lymphocytic leukemia"; AUTOIMMUNE HAEMOLYTIC ANAEMIA (medically significant) with onset Nov2021, outcome "not recovered", described as "Autoimmune hemolytic anemia"; COUGH (non-serious) with onset Jul2021, outcome "not recovered", described as "Coughing"; MALAISE (non-serious) with onset Jul2021, outcome "not recovered", described as "Feeling sick all over/Malaise"; SNEEZING (non-serious) with onset Jul2021, outcome "not recovered", described as "Sneezing"; RHINORRHOEA (non-serious) with onset Jul2021, outcome "not recovered", described as "Runny nose"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset Jul2021, outcome "not recovered" and all described as "Pain and swelling in her left elbow". The events "chronic lymphocytic leukemia", "autoimmune hemolytic anemia", "pain and swelling in her left elbow" and "pain and swelling in her left elbow" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: coagulation test: (2021) negative; blood test: (2021) unknown result; (Oct2021) unknown result; x-ray: (2021) unknown result. Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, autoimmune haemolytic anaemia, cough, malaise, sneezing, rhinorrhoea, arthralgia, joint swelling. In Jul2021, she coughing and was feeling really sick all over, was sneezing and had a runny nose. She didn't have a fever; she just had malaise for 6-7 days. Then the following week she had 3 days with the same symptoms. After all that, she ended up going to the doctor for pain and swelling that showed up overnight in her left elbow. She was then sent to a Hematology/Oncology doctor in Oct2021 and diagnosed in Nov2021 with Chronic lymphocytic leukemia and autoimmune hemolytic anemia. On 01Dec2021, she went to MD withheld and is now being treated. States that she is not saying that the vaccines had anything to do with all this, but she wants to report this to Pfizer because of how quickly her health deteriorated after her 2nd vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Joint swelling, Malaise, Rhinorrhoea, Sneezing
Clinical narrative: Chronic lymphocytic leukemia; Autoimmune hemolytic anemia; Coughing; Feeling sick all over/Malaise; Sneezing; Runny nose; Pain and swelling in her left elbow; Pain and swelling in her left elbow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 (Lot number: EW0202) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Family Medical History was None. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot: EW0167, Location: Left arm), administration date: 17May2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant) with onset Nov2021, outcome "not recovered", described as "Chronic lymphocytic leukemia"; AUTOIMMUNE HAEMOLYTIC ANAEMIA (medically significant) with onset Nov2021, outcome "not recovered", described as "Autoimmune hemolytic anemia"; COUGH (non-serious) with onset Jul2021, outcome "not recovered", described as "Coughing"; MALAISE (non-serious) with onset Jul2021, outcome "not recovered", described as "Feeling sick all over/Malaise"; SNEEZING (non-serious) with onset Jul2021, outcome "not recovered", described as "Sneezing"; RHINORRHOEA (non-serious) with onset Jul2021, outcome "not recovered", described as "Runny nose"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset Jul2021, outcome "not recovered" and all described as "Pain and swelling in her left elbow". The events "chronic lymphocytic leukemia", "autoimmune hemolytic anemia", "pain and swelling in her left elbow" and "pain and swelling in her left elbow" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: coagulation test: (2021) negative; blood test: (2021) unknown result; (Oct2021) unknown result; x-ray: (2021) unknown result. Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, autoimmune haemolytic anaemia, cough, malaise, sneezing, rhinorrhoea, arthralgia, joint swelling. In Jul2021, she coughing and was feeling really sick all over, was sneezing and had a runny nose. She didn't have a fever; she just had malaise for 6-7 days. Then the following week she had 3 days with the same symptoms. After all that, she ended up going to the doctor for pain and swelling that showed up overnight in her left elbow. She was then sent to a Hematology/Oncology doctor in Oct2021 and diagnosed in Nov2021 with Chronic lymphocytic leukemia and autoimmune hemolytic anemia. On 01Dec2021, she went to MD withheld and is now being treated. States that she is not saying that the vaccines had anything to do with all this, but she wants to report this to Pfizer because of how quickly her health deteriorated after her 2nd vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Chronic lymphocytic leukemia; Autoimmune hemolytic anemia; Coughing; Feeling sick all over/Malaise; Sneezing; Runny nose; Pain and swelling in her left elbow; Pain and swelling in her left elbow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 (Lot number: EW0202) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Family Medical History was None. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot: EW0167, Location: Left arm), administration date: 17May2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant) with onset Nov2021, outcome "not recovered", described as "Chronic lymphocytic leukemia"; AUTOIMMUNE HAEMOLYTIC ANAEMIA (medically significant) with onset Nov2021, outcome "not recovered", described as "Autoimmune hemolytic anemia"; COUGH (non-serious) with onset Jul2021, outcome "not recovered", described as "Coughing"; MALAISE (non-serious) with onset Jul2021, outcome "not recovered", described as "Feeling sick all over/Malaise"; SNEEZING (non-serious) with onset Jul2021, outcome "not recovered", described as "Sneezing"; RHINORRHOEA (non-serious) with onset Jul2021, outcome "not recovered", described as "Runny nose"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset Jul2021, outcome "not recovered" and all described as "Pain and swelling in her left elbow". The events "chronic lymphocytic leukemia", "autoimmune hemolytic anemia", "pain and swelling in her left elbow" and "pain and swelling in her left elbow" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: coagulation test: (2021) negative; blood test: (2021) unknown result; (Oct2021) unknown result; x-ray: (2021) unknown result. Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, autoimmune haemolytic anaemia, cough, malaise, sneezing, rhinorrhoea, arthralgia, joint swelling. In Jul2021, she coughing and was feeling really sick all over, was sneezing and had a runny nose. She didn't have a fever; she just had malaise for 6-7 days. Then the following week she had 3 days with the same symptoms. After all that, she ended up going to the doctor for pain and swelling that showed up overnight in her left elbow. She was then sent to a Hematology/Oncology doctor in Oct2021 and diagnosed in Nov2021 with Chronic lymphocytic leukemia and autoimmune hemolytic anemia. On 01Dec2021, she went to MD withheld and is now being treated. States that she is not saying that the vaccines had anything to do with all this, but she wants to report this to Pfizer because of how quickly her health deteriorated after her 2nd vaccine.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: First dose on 21Mar2021, second dose on 05Apr2021; heart pain; Headache; Pain in my chest like left side of my chest; My body started to ache; My arm aching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; CONCERTA; FINASTERIDE. Vaccination history included: Bnt162b2 (first dose), administration date: 21Mar2021, when the patient was 18 years old, for COVID-19 immunization, reaction(s): "little swelling in the arm". The following information was reported: ANGINA PECTORIS (medically significant) with onset Apr2021, outcome "unknown", described as "heart pain"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache"; CHEST PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Pain in my chest like left side of my chest"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "My body started to ache"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "My arm aching"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Apr2021, outcome "unknown", described as "First dose on 21Mar2021, second dose on 05Apr2021". Therapeutic measures were not taken as a result of angina pectoris, headache, chest pain, pain, pain in extremity.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose on 21Mar2021, second dose on 05Apr2021; heart pain; Headache; Pain in my chest like left side of my chest; My body started to ache; My arm aching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; CONCERTA; FINASTERIDE. Vaccination history included: Bnt162b2 (first dose), administration date: 21Mar2021, when the patient was 18 years old, for COVID-19 immunization, reaction(s): "little swelling in the arm". The following information was reported: ANGINA PECTORIS (medically significant) with onset Apr2021, outcome "unknown", described as "heart pain"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache"; CHEST PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Pain in my chest like left side of my chest"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "My body started to ache"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "My arm aching"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Apr2021, outcome "unknown", described as "First dose on 21Mar2021, second dose on 05Apr2021". Therapeutic measures were not taken as a result of angina pectoris, headache, chest pain, pain, pain in extremity.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: gave her cousin cancer and disconnected.; This is a spontaneous report received from a non-contactable Consumer for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "gave her cousin cancer and disconnected". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Hypertension, Inappropriate schedule of product administration, Photophobia
Clinical narrative: severe headache; unexceptional eye contact to light; high blood pressure; upset stomach; First dose on 25Apr2021, second dose on 10May2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10May2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "heart patient" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 25Apr2021, for COVID-19 Immunization, reaction(s): "Extremely fatigued", "Headache". The following information was reported: HEADACHE (hospitalization) with onset 10May2021, outcome "unknown", described as "severe headache"; PHOTOPHOBIA (non-serious), outcome "unknown", described as "unexceptional eye contact to light"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "upset stomach"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10May2021, outcome "unknown", described as "First dose on 25Apr2021, second dose on 10May2021". In the evening of 10May2021, patient began to suffer a severe headache and he ended up at withheld. They kept overnight and kept a close eye on me, patient was a heart patient. The patient was hospitalized for headache (start date: 10May2021, discharge date: 11May2021, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of headache. Patient did not receive anything for pain until 2 a.m. of 10May2021. Patient was given Naproxin and was sent home with a prescription for the same. Patient continued to remain at home on 12May2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.