chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: chills; vomiting/ throwing up/ puking; fever; diarrhea; stomach cramping; bone are sore; after the second shot he is feeling really sick.; arm is the worse; Has not eaten or been drinking for 2-3 days; This is a spontaneous report from a contactable consumer.   A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Sep2021 (at the age of 28-year-old) as dose 2, single for covid-19 immunisation. Medical history included asthma diagnosed at least 5 years ago from an unknown date and unknown if ongoing. Concomitant medication included ongoing fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) taken for asthma. On an unspecified date patient received first dose of BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Reporter states her son just got second Pfizer Covid vaccine on Tuesday, 07Sep 2021, and has been deathly ill since then, states he has been throwing up, fever chills, puking, diarrhea, stomach cramps states he was just brought by ambulance to the hospital, states he is in the ER, cannot hold anything down, he is really sick, just happened after he got second Covid, states his bones are sore, arm is the worse. Has not eaten or been drinking for 2-3 days, staff at hospital said they will probably give him fluids and give him a Covid test. As a therapeutic measures staff at hospital said they will probably give him fluids as a result of chills, vomiting/ throwing up ,fever, diarrhea stomach cramping, bone are sore has not eaten or been drinking for 2-3 days. Outcome of the events chills, fever, diarrhoea, vomiting, bones are sore was not recovered and outcome of the rest all the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pyrexia
Clinical narrative: Lost taste and smell 3 days after; Lost taste and smell 3 days after; Fever within the first 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 31Aug2021 at 09:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 31Aug2021 at 23:00, the patient experienced fever within the first 24 hours. On 03Sep2021, 3 days after vaccination, the patient had lost taste and smell. 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 fever, lost taste and smell 3 days after were resolved with sequelae on an unknown date in Sep2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: She had a urinary tract infection on 17Aug2021 for 7 days; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer (patient) reported.  A 71-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history includes Cancer and concomitant medications were not reported. On 17Aug2021, after the vaccination, the patient experienced a urinary tract infection for 7 days and was prescribed with cephalexin. Her primary care and oncologist recommended to get the 3rd dose of Pfizer's COVID vaccine on Monday, 13Sep2021. Caller is wondering if that may affect her 3rd dose. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Daily chest pain and shortness of breath that developed 2 days after receiving injection; Daily chest pain and shortness of breath that developed 2 days after receiving injection; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 04Sep2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient also reported to be healthy and in shape. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 06Sep2021, 2 days after receiving the injection, the patient developed daily chest pain and shortness of breath. 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. 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 daily chest pain and shortness of breath that developed 2 days after receiving injection were not resolved at the time of this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Vaginal spotting/bleeding; Abdominal cramping; This is a spontaneous report from a contactable other healthcare professional, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 08Sep2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), the patient have an intrauterine device (IUD) and did not have a menstruation cycle in three years, prior to IUD, the patient had oral contraceptives without menstruation for 25 years, and COVID-19 on an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and azithromycin (ZPAK); both from unknown dates for unknown indications and experienced allergy to antibiotic. On 10Sep2021 at 09:00, (also reported as three days after vaccination), the patient experienced abdominal cramping and had vaginal spotting/bleeding. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 09Sep2021, the patient underwent a binax test (COVID test) via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vaginal spotting/bleeding and abdominal cramping were recovering at the time of this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer, the patient. A 17-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 left arm on 05Aug2021 at 14:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy (reported as no medical history). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and unspecified hair skin and nails vitamins; all for unknown indications from unknown dates and unknown if ongoing. 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 left arm on 15Jul2021 at 14:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 06Aug2021 at 00:00, the patient got a headache afterwards (which the patient was aware that it was common) but only since getting the second dose and that headache had been persistent for over a month now. The patient had to take medication for it every single day and also reported that she never had frequent headaches before this. The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported event and included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Joint range of motion decreased, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: fever; headache; body aches; colds; he can't even move his arm; This is a spontaneous report received from a contactable consumer (patient) via Team. A 62-year-old male patient received BNT162B2 (COMIRNATYsolution for injection; lot number and expiry date were not reported) via unspecified route of administration, on 12Aug2021, dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had a very hard time after his first dose further described as he can't even move his arm, fever, headache, body aches and colds. He's getting ready for his 2nd dose and he would like to know what to expect on the 2nd dose. The outcome of the events was unknown at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: 2 weeks after the vaccine his osteoporosis disappeared; 2 weeks after the vaccine his osteoporosis disappeared; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 79-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included osteoporosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, patient experienced 2 weeks after the vaccine his osteoporosis disappeared and wondered if you already knew this. The clinical outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Myalgia
Clinical narrative: muscle aches; over did not feel well; joint aches; headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 09Sep2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reports that he received his first dose of the Pfizer Biontech covid 19 vaccine around 10:15-10:30 yesterday. Last night (on 09Sep2021)  he experienced muscle aches, joint aches, headache and over did not feel well. Patient seeking information about how long these side effects typically last. The outcome of the events was unknown.  Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhoids, Herpes zoster, Proctalgia, Vulvovaginal pain
Clinical narrative: My doctor diagnosed me with Shingles on 10Sep21.; Have seen doctor 3 times since beginning of August for pain the anal and virginial area.; Have seen doctor 3 times since beginning of August for pain the anal and virginial area.; hemorrhoids; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 37-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 23Apr2021 12:00 (at the age of 37-years-old) (Batch/Lot Number: EW0176) as dose 2, single for covid-19 immunisation. Medical history included high blood pressure, seasonal allergies and chronic heartburn. The patient previously experienced known allergies: Penicillin. Concomitant medications included dexlansoprazole (DEXILANT) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (at the age of 37-years-old) (lot number: ER8734, vaccine location: Left arm) on 02Apr2021 12:00 PM for covid-19 immunisation. The patient stated that her doctor diagnosed her with Shingles on 10Sep2021. She have seen doctor 3 times since beginning of August for pain the anal and virginial area. After reviewing her complaints and attempting to treat for hemorrhoids and discussing with another doctor who recently treated a female patient with the same symptoms who was test for Shingles and tested positive. The patient stated that her personal symptoms onset began the last week in June. The patient received medications for the treatment of the events. The patient did not had prolonged hospitalization for the events. The patient visited physician office and emergency room regarding the treatment for the events. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Nausea
Clinical narrative: High blood pressure; felt dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced felt dizzy, nausea on 2021, high blood pressure on an unspecified date. Reported as, She has felt dizzy, nausea and not the same since her 1st dose. She saw her primary and cardiologist for her High blood pressure since and the primary doctor said that if she was not comfortable that she should not get it and wait 6 months before starting over. Her cardiologist however gave an opposite opinion. since her 1st dose of the vaccine, she still has some side effects, she does not feel the same. Outcome of the events were not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Platelet disorder
Clinical narrative: a platelet problem; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer was interested in the ingredient of the Pfizer COVID19 vaccine since she has a platelet problem, and she has seen patients die from the vaccine from the 1st and 2nd dose. Consumer wanted to know what in the ingredient was causing this. The outcome of the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Her sister is also diabetic.; nausea; vomiting; diarrhea; dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 08Sep2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, vomiting, diarrhoea and dizziness on an unspecified date. She was also diabetic on an unspecified date. She would like to know if these are known side effects of the first dose of the vaccine and how long they may last. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest X-ray, Computerised tomogram, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Cardiomegaly without typical pulmonary edema; Had shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 13Aug2021 at 15:30 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included diagnosis (dx) with glioblastoma 62 days after COVID hospitalization in Oct2020 and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. On 01Feb2021, the patient underwent COVID-19 test via nasal swab and the result was negative.  Concomitant medications included losartan (MANUFACTURER UNKNOWN), pregabalin (LYRICA) and levetiracetam (KEPPRA); all from unknown date for unknown indication and unknown if ongoing. The patient previously received  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm on 16Jul2021 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. On 14Aug2021 at 13:00, the patient experienced cardiomegaly without typical pulmonary edema. The patient had computed tomography (CT) and chest X-rays before first shot and after second shot. The patient's daughter noticed that the patient had shortness of breath and the patient did not had the issue all year. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included CT and chest X- ray. Since the vaccination, the patient had not been tested for COVID-19 (also reported as yes). The clinical outcome of the events cardiomegaly without typical pulmonary edema and had shortness of breath was unknown at the time of the report.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Headache, Platelet count, Platelet count decreased
Clinical narrative: Fever; Chills; headache; adverse events after getting the third dose of the Pfizer BioNtech covid-19 Vaccine; adverse events after getting the third dose of the Pfizer BioNtech covid-19 Vaccine; a low platelet count; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on 08Sep2021 (at the age of 69-years-old) as dose 3, single for COVID-19 immunization. Medical history included ongoing low immune system. Patient had 1st and 2nd dose of BNT162B2 on an unspecified date for COVID-19 immunization and after 2nd dose patient had fever, chills and headache. The patient's concomitant medications were not reported. On 08Sep2021, the patient experienced fever, chills, headache, adverse events after getting the third dose of the pfizer biontech COVID-19 vaccine. On an unspecified date in Sep2021, experienced a low platelet count. Patient had COVID-19 Vaccine on Wednesday morning 08Sep2021, and later that night, she started experiencing chills, (woke up with chills), yesterday experienced headache and fever with body temperature of 101F, she took a number medications (Tylenol, Ibuprofen and aceterin) as therapeutic measure for the events fever chills and headache. Patient was fine for the rest of last night. Earlier, she got a body temperature of 99.1F and it went back to 100F with a bit of headache. The patient underwent lab tests and procedures on an unspecified date in Sep2021 which included body temperature: 101 fahrenheit, body temperature: 99.1 fahrenheit, body temperature: 100 fahrenheit and platelet count: low on an unspecified date. She was seeing a hematologist because she has a low platelet count. The outcome of event chills was recovered on an unspecified date in Sep2021 and all other events was reported as unknown.   Information on lot number has been requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; headache; adverse events after getting the third dose of the Pfizer BioNtech covid-19 Vaccine; adverse events after getting the third dose of the Pfizer BioNtech covid-19 Vaccine; a low platelet count; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on 08Sep2021 (at the age of 69-years-old) as dose 3, single for COVID-19 immunization. Medical history included ongoing low immune system. Patient had 1st and 2nd dose of BNT162B2 on an unspecified date for COVID-19 immunization and after 2nd dose patient had fever, chills and headache. The patient's concomitant medications were not reported. On 08Sep2021, the patient experienced fever, chills, headache, adverse events after getting the third dose of the pfizer biontech COVID-19 vaccine. On an unspecified date in Sep2021, experienced a low platelet count. Patient had COVID-19 Vaccine on Wednesday morning 08Sep2021, and later that night, she started experiencing chills, (woke up with chills), yesterday experienced headache and fever with body temperature of 101F, she took a number medications (Tylenol, Ibuprofen and aceterin) as therapeutic measure for the events fever chills and headache. Patient was fine for the rest of last night. Earlier, she got a body temperature of 99.1F and it went back to 100F with a bit of headache. The patient underwent lab tests and procedures on an unspecified date in Sep2021 which included body temperature: 101 fahrenheit, body temperature: 99.1 fahrenheit, body temperature: 100 fahrenheit and platelet count: low on an unspecified date. She was seeing a hematologist because she has a low platelet count. The outcome of event chills was recovered on an unspecified date in Sep2021 and all other events was reported as unknown.   Information on lot number has been requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Body temperature, Chills, Headache
Clinical narrative: Fever; Chills; headache; adverse events after getting the third dose of the Pfizer BioNtech covid-19 Vaccine; adverse events after getting the third dose of the Pfizer BioNtech covid-19 Vaccine; a low platelet count; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on 08Sep2021 (at the age of 69-years-old) as dose 3, single for COVID-19 immunization. Medical history included ongoing low immune system. Patient had 1st and 2nd dose of BNT162B2 on an unspecified date for COVID-19 immunization and after 2nd dose patient had fever, chills and headache. The patient's concomitant medications were not reported. On 08Sep2021, the patient experienced fever, chills, headache, adverse events after getting the third dose of the pfizer biontech COVID-19 vaccine. On an unspecified date in Sep2021, experienced a low platelet count. Patient had COVID-19 Vaccine on Wednesday morning 08Sep2021, and later that night, she started experiencing chills, (woke up with chills), yesterday experienced headache and fever with body temperature of 101F, she took a number medications (Tylenol, Ibuprofen and aceterin) as therapeutic measure for the events fever chills and headache. Patient was fine for the rest of last night. Earlier, she got a body temperature of 99.1F and it went back to 100F with a bit of headache. The patient underwent lab tests and procedures on an unspecified date in Sep2021 which included body temperature: 101 fahrenheit, body temperature: 99.1 fahrenheit, body temperature: 100 fahrenheit and platelet count: low on an unspecified date. She was seeing a hematologist because she has a low platelet count. The outcome of event chills was recovered on an unspecified date in Sep2021 and all other events was reported as unknown.   Information on lot number has been requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Off label use, Platelet count, Pyrexia
Clinical narrative: Fever; Chills; headache; adverse events after getting the third dose of the Pfizer BioNtech covid-19 Vaccine; adverse events after getting the third dose of the Pfizer BioNtech covid-19 Vaccine; a low platelet count; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on 08Sep2021 (at the age of 69-years-old) as dose 3, single for COVID-19 immunization. Medical history included ongoing low immune system. Patient had 1st and 2nd dose of BNT162B2 on an unspecified date for COVID-19 immunization and after 2nd dose patient had fever, chills and headache. The patient's concomitant medications were not reported. On 08Sep2021, the patient experienced fever, chills, headache, adverse events after getting the third dose of the pfizer biontech COVID-19 vaccine. On an unspecified date in Sep2021, experienced a low platelet count. Patient had COVID-19 Vaccine on Wednesday morning 08Sep2021, and later that night, she started experiencing chills, (woke up with chills), yesterday experienced headache and fever with body temperature of 101F, she took a number medications (Tylenol, Ibuprofen and aceterin) as therapeutic measure for the events fever chills and headache. Patient was fine for the rest of last night. Earlier, she got a body temperature of 99.1F and it went back to 100F with a bit of headache. The patient underwent lab tests and procedures on an unspecified date in Sep2021 which included body temperature: 101 fahrenheit, body temperature: 99.1 fahrenheit, body temperature: 100 fahrenheit and platelet count: low on an unspecified date. She was seeing a hematologist because she has a low platelet count. The outcome of event chills was recovered on an unspecified date in Sep2021 and all other events was reported as unknown.   Information on lot number has been requested during follow up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tremor
Clinical narrative: hey am or shaking can't sign anything lymph nodes under the arms are all swollen; hey am or shaking can't sign anything lymph nodes under the arms are all swollen; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: hfc3182), via an unspecified route of administration on 03Sep2021 (at the age of 77 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. On 03Sep2021 patient experienced shaking can't sign anything lymph nodes under the arms are all swollen. The outcome of events was unknown.  No follow-up attempts are Possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Hypoaesthesia, Pain in extremity, Vaccination site pain
Clinical narrative: the pain from his injection elbow to his shoulder; numbness and tightness that goes from shoulders to chest; numbness and tightness that goes from shoulders to chest; experience arm pain in the injection arm; experience arm pain in the injection arm; This is a spontaneous report from a contactable consumer (patient, self-reported). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm, on 20Aug2021 (age at vaccination: 44 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 20Aug2021, at evening, he started to experience arm pain in the injection arm. The following day he stated the arm was still sore and had not stopped hurting since but reports that "some days the pain was not so bad." He described that on an unspecified date the pain from his injection elbow to his shoulder and then numbness and tightness that goes from shoulders to chest. He was calling to report his side effects. Outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Caller states she reported side effects form first  dose of the  Pfizer covid 19 vaccine./she is also allergic to a lot of foods that may not have set well in my system; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient 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 DOSE 1, SINGLE for covid-19 immunisation. Medical history included she is also allergic to a lot of foods that may not have set well in my system. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced caller states she reported side effects form first dose of the pfizer covid 19 vaccine/she is also allergic to a lot of foods that may not have set well in my system. The outcome of event unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: died the beginning of this month because of blood clots because of vaccine.; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable consumer reported for a patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 experienced died the beginning of this month because of blood clots because of vaccine on an unspecified date. The patient died in Sep2021. It was not reported if an autopsy was performed.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: died the beginning of this month because of blood clots because of vaccine.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Irregular heart rate up to 180bpm in a resting state.; Lightheaded/Dizziness; palpitations; drop in blood pressure 80/60 sometimes unreadable.; diaphoretic; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 35 years on 02Jun2021 12:00 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included penicillin allergy, no other medical history. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 in 2021 (reported as other vaccine in 4weeks) at age of 35 years for covid-19 immunisation. The patient experienced Irregular heart rate up to 180bpm in a resting state. Lightheaded, dizziness, palpitations, diaphoretic, drop in blood pressure 80/60 sometimes unreadable, started since 03Jun2021 13:00, resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalization for 7 days, received treatment of Adenosine, Cardizem, Metroprolol. No COVID prior vaccination. COVID test post vaccination (Nasal Swab) on 04Jun2021 was negative. The outcome of the events was recovering.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Palpitations, SARS-CoV-2 test
Clinical narrative: Irregular heart rate up to 180bpm in a resting state.; Lightheaded/Dizziness; palpitations; drop in blood pressure 80/60 sometimes unreadable.; diaphoretic; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 35 years on 02Jun2021 12:00 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included penicillin allergy, no other medical history. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 in 2021 (reported as other vaccine in 4weeks) at age of 35 years for covid-19 immunisation. The patient experienced Irregular heart rate up to 180bpm in a resting state. Lightheaded, dizziness, palpitations, diaphoretic, drop in blood pressure 80/60 sometimes unreadable, started since 03Jun2021 13:00, resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalization for 7 days, received treatment of Adenosine, Cardizem, Metroprolol. No COVID prior vaccination. COVID test post vaccination (Nasal Swab) on 04Jun2021 was negative. The outcome of the events was recovering.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain, Pain in extremity, Somnolence
Clinical narrative: Very drowsy sleepy; Muscle pain; Severe pain in the neck on right side; Severe pain in the shoulder on right side; The pain started to migrate over next couple days over to his right arm from his triceps to his biceps where it is now; This is a spontaneous report from a contactable 27-year-old male consumer reported for himself received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on 27Aug2021 (at the age of 27-year-old) (2 weeks ago from Friday(10Sep2021)) as SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Aug2021 (2 weeks ago from Friday (10Sep2021)), about an hour or 2 hrs after the vaccine he had got very drowsy sleepy and had muscle pain. In Aug2021 (that Friday into Monday), he woke up with severe pain in the neck and shoulder on right side, opposite injection site on left side. He took Tylenol to try and relieve but it didn't do much. Also the pain started to migrate over next couple days over to his right arm from his triceps to his biceps where it was now. It was been like that for over a week and a half. Some days not so bad and other days wake in pain to the point of tears, bad. Stating he was a heavy guy over 400 pounds. He was taking 3 Advil 200mg each about every 6 hours, which was helping. He states he does forget it sometimes and states, it was slow onset that builds then he has to take the Advil. The reporter considered the events as non-serious. The outcome of the event very drowsy sleepy was unknown whereas other events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Joint lock, Muscle spasms, Pain
Clinical narrative: Muscle cramps in calves, feet, thumbs; Thumbs lock up; Extremely painful; The patient received both doses on 10Aug2021; This is a spontaneous report from a contactable consumer (patient). This 44-year-old non-pregnant female consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Aug2021 at 10:00 (Lot number and expiry date: not reported, at the age of 44 years) as single dose and she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm (left shoulder) on 10Aug2021 (Lot Number, Expiry Date: not reported, at the age of 44 years) as single dose for COVID-19 immunisation. Medical history included orthoarthritis and COVID-19 (from an unknown date and unknown if ongoing). There were no concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications that the patient received within 2 weeks of vaccination. The patient received both doses on 10Aug2021 (inappropriate schedule of vaccine administered). On 16Aug2021, the patient experienced muscle cramps in calves, feet, thumbs similar to a 'charlie horse' and extremely painful. Every time, she stretched she would get one at least in one of her calves. Thumbs lock up a lot too. Hospitalization was not prolonged. Treatment was not received. The adverse event result in following Doctor or other healthcare professional office/clinic visit. Location of injection for vaccine received same date: Pfizer was left shoulder. It was reported that reason for batch/lot is Unknown was misplaced/discarded. Device Date was 10Sep2021. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Rash
Clinical narrative: knock him back deafness rash; knock him back deafness rash; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: 50fc3182) via an unspecified route of administration on 03Sep2021 (at the age of 57-years-old) as dose 1 single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Sep2021, the patient experienced knock him back deafness rash. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood test, Myalgia, Rhabdomyolysis
Clinical narrative: my cpk levels had spiked to 2300; Rhabdomyolysis; abdomen muscles were very sore and hurting terrible; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Aug2021 16:00 (at the age of 37-years-old) (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included none. Concomitant medications included diclofenac (VOLTAREN [DICLOFENAC]); and amlodipine besilate (NORVASC). After a day or two after vaccination on 21Aug2021, it was reported that the abdomen muscles were very sore and hurting terrible. The patient went to the doctor and described what was going on, they took blood tests and found that the cpk levels had spiked to 2300. The patient was sent to the emergency room and put on iv's, he had to stay in the hospital overnight on iv's as they monitored his cpk levels. They began to go down and he was released after 24 hours. The was diagnosed with Rhabdomyolysis. The patient was hospitalized for my cpk levels had spiked to 2300, and Rhabdomyolysis from 21Aug2021 to 22Aug2021, both assessed as Life-threatening. The patient underwent lab tests and procedures which included blood creatine phosphokinase: increased on 21Aug2021 cpk levels had spiked to 2300, blood test: unknown results on 21Aug2021, sars-cov-2 test: negative on 10Sep2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. The patient did not have COVID prior vaccination. The patient was covid tested post vaccination, nasal swab on 10Sep2021, negative.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: my cpk levels had spiked to 2300; Rhabdomyolysis; abdomen muscles were very sore and hurting terrible; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Aug2021 16:00 (at the age of 37-years-old) (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included none. Concomitant medications included diclofenac (VOLTAREN [DICLOFENAC]); and amlodipine besilate (NORVASC). After a day or two after vaccination on 21Aug2021, it was reported that the abdomen muscles were very sore and hurting terrible. The patient went to the doctor and described what was going on, they took blood tests and found that the cpk levels had spiked to 2300. The patient was sent to the emergency room and put on iv's, he had to stay in the hospital overnight on iv's as they monitored his cpk levels. They began to go down and he was released after 24 hours. The was diagnosed with Rhabdomyolysis. The patient was hospitalized for my cpk levels had spiked to 2300, and Rhabdomyolysis from 21Aug2021 to 22Aug2021, both assessed as Life-threatening. The patient underwent lab tests and procedures which included blood creatine phosphokinase: increased on 21Aug2021 cpk levels had spiked to 2300, blood test: unknown results on 21Aug2021, sars-cov-2 test: negative on 10Sep2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. The patient did not have COVID prior vaccination. The patient was covid tested post vaccination, nasal swab on 10Sep2021, negative.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a non-contactable consumer(patient) or other non hcp. A 60-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number:FC3180) via an unspecified route of administration, administered in Arm Left on 20Aug2021(at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Darvon (dextropropoxyphene hydrochloride) and experienced allergy. The historical vaccine included bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: FA6780) via an unspecified route of administration, administered in Arm Left in Jul2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination has not been tested for COVID-19. The patient experienced shingles on 03Sep2021. Adverse event result in emergency room/department or urgent care. Therapeutic measures included Valacyclovir. Treatment received for the adverse event: prescription for Valacyclovir. The event outcome was reported as recovering  No follow -up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Nausea
Clinical narrative: Nausea; Confusion; Fatigue; Lightheaded/ dizziness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 27Aug2021 at 17:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, peripheral neuropathy, fatigue and penicillin allergy. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. Concomitant medications included unspecified medications for an unknown indication from on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PA7485) via an unspecified route of administration in the left arm on 06Aug2021 at 17:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021 at 16:00 the patient experienced nausea, confusion, fatigue, lightheadedness and dizziness. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events nausea, confusion, fatigue, lightheadedness and dizziness were not recovered at the time of this report.