chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Mouth swelling, Paraesthesia oral, Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: 'localized' allergic reactions; throat and mouth were tingly and swelling; throat and mouth were tingly and swelling; throat and mouth were tingly and swelling; throat and mouth were tingly and swelling; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, COVAX US Support. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in left upper arm on 26Mar2021 (Batch/Lot Number: EP6955) (at the age of 42-years-old) as dose 1, single for COVID-19 immunisation. Vaccination facility type was pharmacy/drugstore. Medical history included asthma and allergy. Concomitant medications included budesonide (PULMICORT); albuterol [salbutamol] and verapamil, all for an unspecified indications, on unspecified dates; and loratadine (CLARITIN) for allergy on unspecified date. The patient reported that she got allergic reactions, a 'localized' allergic reactions when she got the first dose on 26Mar2021. The patient stated that at the pharmacy, they sent her in an ambulance to the hospital, and her reaction was her throat and mouth were tingly and swelling so they sent her in an ambulance to the hospital and ended up taking Benadryl. The patient is no longer experiencing the allergic reaction. The patient was not hospitalized, only stayed in an emergency room. The patient had no prior vaccination within 4 weeks. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Bad heart palpitations/I'm skipping a beat about every 15 seconds or as bad as every 5 seconds; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL9264 and expiration date were not reported), dose 1 via an unspecified route of administration, administered in right arm on an unspecified date in Apr2021 (at the age of 64 years) as dose 1, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included Light Emphysema and hyper inflated lung both from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications were not reported. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced bad heart palpitations on 05May2021 (one week after first shot). Reportedly, one week after first shot patient started having bad heart palpitations. Patient was skipping a beat about every 15 seconds or as bad as every 5 seconds. Since they seemed to improve slightly after 2 weeks or 3 weeks after first shot, patient went forward with second shot. They were not as bad for about a month and a half and then got worse again and have remained that way since. It was now more than three months after. Patient was skipping a beat about every 15 seconds or as bad as every 5 seconds. And his heart was beating very hard. Not necessarily fast, but very hard at times. Patient just went to cardiologist. He believed they are probably from the vaccine. He has patient on diltiazem 120 mg, calcium channel blockers. Patient had taken for 4 days, but no change. Event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with Covid-19. Since the vaccination, patient has not been tested for covid-19. Reportedly, patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0185 and expiration date were not reported), dose 1 via an unspecified route of administration, administered in left arm on 28May2021 as DOSE 2, SINGLE for covid-19 immunisation in Pharmacy or Drug Store. The patient took treatment for vaccination with Diltiazem 120 mg (calcium channel blocker) for the event. The outcome of the event was not recovered.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: fatigue; body aches; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0202) via an unspecified route of administration in the left arm on 06Aug2021 at 19:30 (at the age of 13-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Aug2021 at 15:00, the patient experienced fatigue and body aches. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events fatigue and body aches was unknown at the time of reporting.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Musculoskeletal chest pain, Productive cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Positive Covid test on August 7; Positive Covid test on August 7; Pain in back of right rib; Had sinus congestion. Nasal drip. Chest congestions with wet cough.; Had sinus congestion. Nasal drip. Chest congestions with wet cough.; Had sinus congestion. Nasal drip. Chest congestions with wet cough.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Lot Number: EN6202) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Lot Number: EN6207) as single dose, both at the age of 58-years-old for COVID-19 immunization. The patient had no other medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had positive Covid test on 07Aug2021. The patient had sinus congestion, nasal drip, chest congestions with wet cough, pain in back of right rib since 07Aug2021. The adverse event result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Jul2021; Covid test: positive on 07Aug2021. Outcome of the events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion, Vaccination failure
Clinical narrative: Positive Covid test on August 7; Positive Covid test on August 7; Pain in back of right rib; Had sinus congestion. Nasal drip. Chest congestions with wet cough.; Had sinus congestion. Nasal drip. Chest congestions with wet cough.; Had sinus congestion. Nasal drip. Chest congestions with wet cough.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Lot Number: EN6202) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Lot Number: EN6207) as single dose, both at the age of 58-years-old for COVID-19 immunization. The patient had no other medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had positive Covid test on 07Aug2021. The patient had sinus congestion, nasal drip, chest congestions with wet cough, pain in back of right rib since 07Aug2021. The adverse event result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Jul2021; Covid test: positive on 07Aug2021. Outcome of the events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Headache, Pain, Pyrexia, Somnolence
Clinical narrative: Body aches; fever; sleepiness; headaches; vivid dreams; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Aug2021 at 09:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple personality disorder, depression and COVID-19. The patient was allergic to latex and opiates. Prior to the vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Jul2021 at 09:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Aug2021 at 16:00, the patient experienced body aches, fever, sleepiness, headaches and vivid dreams. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, fever, sleepiness, headaches and vivid dreams were recovering at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Rash, SARS-CoV-2 test
Clinical narrative: Swollen ankles; All over body rash; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0178), via an unspecified route of administration on arm right on 23May2021 12:00 PM (Age at Vaccination: 49 years) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history included Known allergies to Codeine, Morphine, Laytex, Tree pollen (seasonal allery). Prior to the vaccination, the patient was not diagnosed with COVID-19. device timestamp was reported as 08Aug2021. Since the vaccination, the patient has been tested for COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient Concomitant medications received within 2 weeks of vaccination included Chlorthalidone, Colestipol taken for unspecified indication, start and stop dates was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8731), via an unspecified route of administration on arm right on 29Apr2021 01:00 PM (at the age of 48 years) as dose 1, single for COVID-19 immunization. On an unspecified date in Jun2021, the patient experienced All over body rash and swollen ankles that appeared week 2 after dose 2 of vaccine given, symptoms lasted one week. The lab tests included SARS-CoV-2 test (Nasal Swab): negative on 09Jun2021. Treatment received for the adverse event was reported as no. The outcome of events was resolved on Jun2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Chills, Dyspnoea, Fatigue, Haemoglobin
Clinical narrative: had several small pulmonary embolisms in lungs; blood clots in lungs; severely anemic (hemoglobin of 5%); flu-like side effects; muscle tension through neck; fever; fatigue; increased resting heart rate; immune system went into overdrive; shortness of breath; chills; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0180) via an unspecified route of administration into left arm on 01Jun2021 17:00 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation. Medical history included ulcerative proctitis, ulcerative colitis from 2016 and iron deficiency anaemia. Patient was not pregnant. Concomitant medications included minocycline (MINOCYCLINE) and sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0182) via an unspecified route of administration into left arm on 11May2021 at 05:00 PM (at the age of 31-year-old) for COVID-19 immunization and experienced no adverse effect. On 02Jun2021 patient had several small pulmonary embolisms in lungs, blood clots in lungs, was severely anemic (hemoglobin of 5%), had flu-like side effects, muscle tension through neck, fever, fatigue, increased resting heart rate, immune system went into overdrive, shortness of breath and chills. The events resulted in emergency room visit. The events were reported as serious, hospitalization for 7 days and patient was treated with blood transfusions as well as intravenous and oral blood thinners. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 26Jun2021 and negative on 31Jul2021. Outcome of events was recovered with sequelae on Jun2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Immune system disorder, Influenza like illness, Muscle tightness
Clinical narrative: had several small pulmonary embolisms in lungs; blood clots in lungs; severely anemic (hemoglobin of 5%); flu-like side effects; muscle tension through neck; fever; fatigue; increased resting heart rate; immune system went into overdrive; shortness of breath; chills; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0180) via an unspecified route of administration into left arm on 01Jun2021 17:00 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation. Medical history included ulcerative proctitis, ulcerative colitis from 2016 and iron deficiency anaemia. Patient was not pregnant. Concomitant medications included minocycline (MINOCYCLINE) and sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0182) via an unspecified route of administration into left arm on 11May2021 at 05:00 PM (at the age of 31-year-old) for COVID-19 immunization and experienced no adverse effect. On 02Jun2021 patient had several small pulmonary embolisms in lungs, blood clots in lungs, was severely anemic (hemoglobin of 5%), had flu-like side effects, muscle tension through neck, fever, fatigue, increased resting heart rate, immune system went into overdrive, shortness of breath and chills. The events resulted in emergency room visit. The events were reported as serious, hospitalization for 7 days and patient was treated with blood transfusions as well as intravenous and oral blood thinners. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 26Jun2021 and negative on 31Jul2021. Outcome of events was recovered with sequelae on Jun2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary thrombosis, Pyrexia, SARS-CoV-2 test
Clinical narrative: had several small pulmonary embolisms in lungs; blood clots in lungs; severely anemic (hemoglobin of 5%); flu-like side effects; muscle tension through neck; fever; fatigue; increased resting heart rate; immune system went into overdrive; shortness of breath; chills; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0180) via an unspecified route of administration into left arm on 01Jun2021 17:00 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation. Medical history included ulcerative proctitis, ulcerative colitis from 2016 and iron deficiency anaemia. Patient was not pregnant. Concomitant medications included minocycline (MINOCYCLINE) and sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0182) via an unspecified route of administration into left arm on 11May2021 at 05:00 PM (at the age of 31-year-old) for COVID-19 immunization and experienced no adverse effect. On 02Jun2021 patient had several small pulmonary embolisms in lungs, blood clots in lungs, was severely anemic (hemoglobin of 5%), had flu-like side effects, muscle tension through neck, fever, fatigue, increased resting heart rate, immune system went into overdrive, shortness of breath and chills. The events resulted in emergency room visit. The events were reported as serious, hospitalization for 7 days and patient was treated with blood transfusions as well as intravenous and oral blood thinners. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 26Jun2021 and negative on 31Jul2021. Outcome of events was recovered with sequelae on Jun2021.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure, Drug ineffective, Haemoglobin, Haemoglobin decreased
Clinical narrative: kidney failure; Heart failure; respiratory failure; High fever; 6.7 hemoglobin blood poisoning due to kidney function failure; 6.7 hemoglobin blood poisoning; Since the vaccination, the patient had been tested for COVID-19/ Test Nasal swab, Result Positive; Since the vaccination, the patient had been tested for COVID-19/ Test Nasal swab, Result Positive; This is a spontaneous report from a contactable consumer (patient). This 70-year-old-male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the arm right on 15Jun2021 at 19:00 as DOSE 1, SINGLE for COVID-19 immunization. There was no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 24Jun2021, the patient experienced high fever, heart failure, kidney failure, respiratory failure, blood transfusion 6.7 hemoglobin blood poisoning due to kidney function failure 1 month in hospital. The duration of hospitalization was 20 days, no hospitalization prolonged. Events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Therapeutic measures were taken as a result of 6.7 hemoglobin blood poisoning due to kidney function failure. Unknown if treatment received for high fever, heart failure, kidney failure, respiratory failure. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Lab data included nasal swab was positive in 2021, hemoglobin was 6.7 on 24Jun2021. Outcome of events "Since the vaccination, the patient had been tested for COVID-19/ Test Nasal swab, Result Positive" was unknown, while of the other events was not recovered.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Renal failure, Respiratory failure, SARS-CoV-2 test, Sepsis
Clinical narrative: kidney failure; Heart failure; respiratory failure; High fever; 6.7 hemoglobin blood poisoning due to kidney function failure; 6.7 hemoglobin blood poisoning; Since the vaccination, the patient had been tested for COVID-19/ Test Nasal swab, Result Positive; Since the vaccination, the patient had been tested for COVID-19/ Test Nasal swab, Result Positive; This is a spontaneous report from a contactable consumer (patient). This 70-year-old-male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the arm right on 15Jun2021 at 19:00 as DOSE 1, SINGLE for COVID-19 immunization. There was no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 24Jun2021, the patient experienced high fever, heart failure, kidney failure, respiratory failure, blood transfusion 6.7 hemoglobin blood poisoning due to kidney function failure 1 month in hospital. The duration of hospitalization was 20 days, no hospitalization prolonged. Events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Therapeutic measures were taken as a result of 6.7 hemoglobin blood poisoning due to kidney function failure. Unknown if treatment received for high fever, heart failure, kidney failure, respiratory failure. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Lab data included nasal swab was positive in 2021, hemoglobin was 6.7 on 24Jun2021. Outcome of events "Since the vaccination, the patient had been tested for COVID-19/ Test Nasal swab, Result Positive" was unknown, while of the other events was not recovered.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: Patient failed to wake in the morning. Suspected heart inflammation.; This is a spontaneous report from a non-contactable consumer. An adult male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. There was no other vaccine in four weeks. The patient failed to wake in the morning on 02Aug2021. suspected heart inflammation. The patient died on 02Aug2021. death cause was heart Inflammation. It was unknown if treatment was received. Case was reported serious due to Results in death. It was not reported if an autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Heart Inflammation
Sex: F
Vaccine: COVID19
Symptoms: Foetal death
Clinical narrative: Patient lost baby 4 weeks prior to estimated date of birth. Emergency c section.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was pregnant at the time of vaccination was reported. Due date of pregnancy was 30Aug2021, gestation period of 12 weeks [unspecified]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, patient lost baby 4 weeks prior to estimated date of birth. Emergency c section. Adverse event resulted in Emergency room/department or urgent care, hospitalization, Congenital anomaly or birth defect. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101016957 Mother case/Fetal case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Insomnia, Pain
Clinical narrative: Headache; body aches; chills; stomach mildly upset; unable to sleep due to foregoing; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in left arm on 06Aug2021 at 09:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in left arm on 15Jul2021 at 15:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 06Aug2021 at 18:00, the patient experienced headache, body aches, chills, stomach mildly upset and was unable to sleep due to foregoing. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, chills, stomach mildly upset and was unable to sleep due to foregoing were recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Congenital anomaly, Maternal exposure during pregnancy
Clinical narrative: Congenital anomaly or birth defect; Patient lost baby 4 weeks prior to estimated date of birth. Emergency c section.; This is a spontaneous report from a non contactable consumer (parent) or other non HCP. This consumer (patients mother) reported for patient.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. On an unspecified date, the patient experienced congenital anomaly or birth defect, patient lost baby 4 weeks prior to estimated date of birth. emergency c section. Events resulted in Emergency room/department or urgent care. Events were considered as serious (hospitalization, congenital anomaly). The clinical outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101016416 Mother case/Fetal case
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID Positive 07Aug2021; COVID Positive 07Aug2021; This is a spontaneous report from a contactable physician. This physician reported for a 93-year-old female patient.  A 93-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date in 2021 (at the age of 93-year-old) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history includes Cardiac valve disease from unknown onset to unknown ongoing, Chronic obstructive pulmonary disease from unknown onset to unknown ongoing, Diabetes mellitus from unknown onset to unknown ongoing, Hypertension from unknown onset to unknown ongoing and Chronic kidney disease from unknown onset to unknown ongoing. The concomitant medications were not reported. Patient past drug events include codeine induced drug hypersensitivity on an unspecified date. Prior to vaccination, the patient was diagnosed with COVID-19 was unknown. On 07Aug2021, after the vaccination, the patient experienced covid positive in SARS-CoV-2 test, which caused hospitalization but not prolonged. Patient received treatment with Decadron and Oxygen. Since the vaccination, the patient had been tested for COVID-19.  The patient underwent lab test and procedure includes SARS-CoV 2 RT PCR test positive nasal swab on 07Aug2021. The outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Digestive enzyme abnormal, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional ( patient). A 75-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not report-ed), via an unspecified route of administration (at the age of 75-years), on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included ongoing Dercums. I am 75 years, have a rare disease, Dercums, for info if unaware see Dr. research doc, it is progressive with no cure. It was a doozie Last winter I sent an email to the CDC about your shot as this virus would send those of us with DD straight to heaven, we are so compromised. Nice note back, stating they were comfortable with the Pfizer shot.90% of us wanted the shot. The patient concomitant medications were not reported. On an unspecified date, the patient stated that after getting the first shot was great, arm got sore, no swelling or side effects. Except I felt great, many of my other problems stopped. weakness, pain, brain fogs, digestive. Lasted just over 2 weeks then poof. Others but not enough for (withheld). But she was interested. Second shot just fine but the good stuff didn't come back. No more room, those with strong immunity. Did not get sick from shot. The 2 I know of that got the virus before the shot was available. they are both lucky to be alive, however, both have now got the Delta strain. Both very sick. Enter the reason I call (withheld). You know the old saying out of the horses mouth to get answers. I want answers you can not give probably. How much protection will we have against Delta, are you thinking about a booster, what added things do we look for in Delta anything diff. This is info I wanted to take back to the people who are really scared, and a heads up to all. I will move on to the shot, glad-ly fill in any further questions as needed. Took almost a year. To get it and I had to go to the hospital for that. Let me say because of this DD I keep my immune system pretty strong with herbs and fruits. The clinical outcome for the events was reported as recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101017357 same reporter/drug, different patient/AE
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional ( patient). A 75-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not report-ed), via an unspecified route of administration (at the age of 75-years), on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included ongoing Dercums. I am 75 years, have a rare disease, Dercums, for info if unaware see Dr. research doc, it is progressive with no cure. It was a doozie Last winter I sent an email to the CDC about your shot as this virus would send those of us with DD straight to heaven, we are so compromised. Nice note back, stating they were comfortable with the Pfizer shot.90% of us wanted the shot. The patient concomitant medications were not reported. On an unspecified date, the patient stated that after getting the first shot was great, arm got sore, no swelling or side effects. Except I felt great, many of my other problems stopped. weakness, pain, brain fogs, digestive. Lasted just over 2 weeks then poof. Others but not enough for (withheld). But she was interested. Second shot just fine but the good stuff didn't come back. No more room, those with strong immunity. Did not get sick from shot. The 2 I know of that got the virus before the shot was available. they are both lucky to be alive, however, both have now got the Delta strain. Both very sick. Enter the reason I call (withheld). You know the old saying out of the horses mouth to get answers. I want answers you can not give probably. How much protection will we have against Delta, are you thinking about a booster, what added things do we look for in Delta anything diff. This is info I wanted to take back to the people who are really scared, and a heads up to all. I will move on to the shot, glad-ly fill in any further questions as needed. Took almost a year. To get it and I had to go to the hospital for that. Let me say because of this DD I keep my immune system pretty strong with herbs and fruits. The clinical outcome for the events was reported as recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101017357 same reporter/drug, different patient/AE
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test
Clinical narrative: Both have now got the Delta strain, both very sick; Both have now got the Delta strain, both very sick; Both have now got the Delta strain, both very sick; This is a spontaneous report from a contactable consumer reported for a patient. This is one of two reports (No. 1 got Delta strain). A patient of an unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included virus (covid-19) and DD (Dercum's disease) both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated for the patient as "I am 75yrs, have a rare disease, DERCUMS, it is progressive with no cure. it's a doozie. Last winter I sent an email to the CDC about your shot as this virus would send those of us with DD straight to heaven, we were so compromised. Nice note back, stating they were comfortable with the Pfizer shot. 90% of us wanted the shot. The 2 I know of that got the virus before the shot was available, they were both lucky to be alive, however, Both have now got the Delta strain, both very sick". The patient underwent lab tests and procedures which included sars-cov-2 test: got the delta strain on an unknown date. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101017357 Same reporter/events/product, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: both have now got the Delta strain; both have now got the Delta strain; both very sick; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter said that the 2 I know of that got the virus before the shot was available, they are both lucky to be alive, however, both have now got the Delta strain, both very sick on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: got the delta strain on an unspecified date. The outcome of all the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101017243 same reporter/drug, different patient/AE;US-PFIZER INC-202101017356 Same reporter/events/product, different patients
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Vasculitic rash
Clinical narrative: Vascular rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 22-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 04Aug2021 (Batch/Lot Number: FA6780, Expiry date was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. No other vaccine was taken within four weeks prior to the first administration date of COVID vaccine. On an unspecified date, the patient experienced vascular rash. Consumer wanted to report a side effect from the shot and confirmed the name of the product name as Pfizer COVID-19 vaccine. When probed for the side effects experienced, consumer stated, It was a vascular rash. The patient took Benadryl for the reported event.  The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea; Nausea; Had episode of severe vomiting; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484, Expiry Date: unknown) via an intramuscularly administered in arm on 26Jul2021 at 18:30 (at the age of 15-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive prior vaccination within 4 weeks. Reporter stated that patient received the first dose of the Pfizer vaccine about 2 weeks ago on wednesday and had an episode of severe vomiting on unspecified date in 2021. On 03Aug2021, he had diarrhea and nausea. On an unspecified date in 2021, he had another episode of vomiting. Later, there was an improvement compared to first vomiting episode. He took a Zofran. The reporter wanted to know if anyone else reported the same. For second dose due date, reporter did not know, it was most likely that he/she might not give it to the patient, but was not confirmed. Regarding causality, reporter thought a possibility but did not know for sure as reporter was not a vaccine professional. Reporter did not know about any laboratory test performed on patient or not. Therapeutic measures were taken for severe vomiting, diarrhea and nausea with zofran. The outcome of the event vomiting was recovering and other events outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Diabetic ketoacidosis, Malaise, Type 1 diabetes mellitus
Clinical narrative: type 1 diabetes/ ended up in the ICU; Diabetic ketoacidosis; got very ill and he looked liked a skeleton; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Jun2021 (Batch/Lot Number: EW0180) as DOSE 1, SINGLE; and dose 2 via an unspecified route of administration, administered in Arm Right on 25Jun2021 (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Family history of diabetes. The patient's concomitant medications were not reported. Her son went into the ICU on 28Jul2021. It was stated that her son, got the Pfizer Covid vaccine in 03Jun2021 and on 25Jun2021 and a month later he ended up in the ICU and she highly suspects it was the vaccine that caused this. Calling so that she can report that now he has Type 1 Diabetes and has to be on insulin. He was a perfectly fine and healthy child. He had Diabetic ketoacidosis and ended up on insulin and ended (withheld)  hospital. They were at  and he got very ill and he looked liked a skeleton. They transferred him to Dr. (withheld) hospital and then was transferred to (withheld) ICU.  He was discharged on 30Jul2021. Went into diabetic ketoacidosis on the 28th and they did blood work and all that stuff. They started him on insulin on that same evening to bring down his blood sugar. It was at 688 and when he started on the insulin, little by little it brought the blood sugar down. Not sure what insulin was given in hospital in the IV and unable to provide NDC, Lot, or expiry, but thinks it's the same as what's given since he has been using at home, but not really sure. He now is taking Novolog for meals, fast release, and it's based on his carb input. It depends on how much he is eating right now, so he takes about 7 units in a pen. When it's very high he ends up getting up to 10 units. He uses Lantus for the evening/bedtime , a slow release, which he uses once daily. When he started on the insulins it started bringing the blood sugar down and the next day he saw the nurse practitioner and they were not sure that day about his diagnosis, which one he had. They fully diagnosed him with Type 1 diabetes on this past Tuesday, 03Aug2021. The event type 1 diabetes/ ended up in the ICU was assessed as life-threatening. The patient was hospitalized for the events from 28Jul2021 to 30Jul2021. The patient had lab data: blood sugar of 688 on 28Jul2021. The outcome of the event Type 1 diabetes was not recovered, while recovering for the other events. The patient received treatment for the events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear pain, Hypoaesthesia, Nausea, Ocular hyperaemia
Clinical narrative: leg pain like squeezing rubber bands around leg; vertigo; Nausea; Red left eye; Left ear pain; Left side of face numb; Severe leg burning starts; This is a spontaneous report from a contactable consumer (patient).   This 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number ER8734), via an unknown route administered administered at left arm, on 05May2021 13:15 (at the age of 50-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EA0170), on 14Apr2021 (at the age of 50-year-old) at single dose for COVID-19 immunisation and developed severe burning in legs on 14Apr2021 and flu like symptoms on 15Apr2021. Relevant medical history included latex allergy and hypothyroidism. Relevant concomitant medications included levothyroxine sodium (SYNTHROID) for hypothyroidism and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 05May2021 at 13:45 (1/2 hour after second vaccine) left side of face numb completely numb for about 20 minutes, severe leg burning started at midnight. On 09May2021, she woke up with red left eye and left ear pain. On 09May2021, the patient nausea. On 09May2021 (at 20:00), the patient had vertigo. On 10May2021, appointment with physician and no bacterial infection in ear was determined, advise again of leg heat and left face numbness. On 13May2021, leg burning turned to leg pain like squeezing rubber bands around leg, left face numbness increased. The events required physician office visit, but no treatments were given. The patient had not recovered from  the events.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: leg pain like squeezing rubber bands around leg; vertigo; Nausea; Red left eye; Left ear pain; Left side of face numb; Severe leg burning starts; This is a spontaneous report from a contactable consumer (patient).   This 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number ER8734), via an unknown route administered administered at left arm, on 05May2021 13:15 (at the age of 50-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EA0170), on 14Apr2021 (at the age of 50-year-old) at single dose for COVID-19 immunisation and developed severe burning in legs on 14Apr2021 and flu like symptoms on 15Apr2021. Relevant medical history included latex allergy and hypothyroidism. Relevant concomitant medications included levothyroxine sodium (SYNTHROID) for hypothyroidism and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 05May2021 at 13:45 (1/2 hour after second vaccine) left side of face numb completely numb for about 20 minutes, severe leg burning started at midnight. On 09May2021, she woke up with red left eye and left ear pain. On 09May2021, the patient nausea. On 09May2021 (at 20:00), the patient had vertigo. On 10May2021, appointment with physician and no bacterial infection in ear was determined, advise again of leg heat and left face numbness. On 13May2021, leg burning turned to leg pain like squeezing rubber bands around leg, left face numbness increased. The events required physician office visit, but no treatments were given. The patient had not recovered from  the events.  No follow-up attempts are needed. No further information is expected.