chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling, Oral discomfort
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Galderma (reference number: GL-041621-9614). A non-contactable 45-year-old female consumer (patient) reported that: A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as Dose 2, Single (age at vaccination:45-years-old) for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination includes administration of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as Dose 1, Single for Covid-19 immunisation, and on 21Jan2021 injected Restylane Kysse into lips. On 09Apr2021 the patient experienced severe swelling, pain and discomfort to upper and lower lips. Therapeutic measures were taken as a result of severe swelling, pain and discomfort to upper and lower lips includes administration of steroids and antihistamines. The outcome of the events was recovering(swelling improving but not resolved).    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number : Ew0169), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:30 as DOSE 2, SINGLE for covid-19 immunization.Medical history included hypertension and cosine-rash from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported.The patient previously took bnt162b2 for covid-19 immunization and experienced arthralgia, cosine and experienced rash.On an unspecified date the patient experienced extremely aching thumb, wrist and shoulder joints in both arms (pain in extremity), extremely aching thumb and wrist and shoulder joints in both arms (arthralgia) .The outcome of all the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Vertigo
Clinical narrative: Mild vertigo; Chills; low grade fever; Then 2 days of headache; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:15 (Age at Vaccination was 45years) as dose 2, single for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history was none. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 04Apr2021 15:15 (Age at Vaccination was 45years) as dose 1, single for COVID-19 immunisation and experienced Sore arm, pain on arm lead to unable to sleep and Vertigo. Patient did not received any other vaccine in four weeks and did not receive any other medications in two weeks prior COVID vaccination. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. She has no Known allergies. On 25Apr2021 18:00, the patient experienced mild vertigo, chills, low grade fever for 1 day, then 2 days of headache. The patient underwent lab tests and procedures which included fever: low on 25Apr2021. No therapeutic measures were taken as a result of events. The outcome of the events were recovered with sequelae (Recovered with lasting effects) on 2021.  No follow-up attempts are required. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Musculoskeletal chest pain, Myalgia, Vaccination site pain
Clinical narrative: Severe muscle pain; Severe joint pain; rib pain; pain at injection site(entire arm); severe fatigue(both shots); This is a spontaneous report from contactable consumer (patient). A 56-Year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Lot number: Ew0151) via an unspecified route of administration in right arm on 07Apr2021 at 15:00 (at the age of 56 years old) as dose 1, single for COVID-19 immunization. The patient medical history included high bp, generalized anxiety disorder, autoimmune history and allergic to sulfur. Concomitant medication included bisoprolol, lisinopril, alprazolam (XANAX), paracetamol (TYLENOL) all for an unknown indication from an unknown start date. Patient did not receive other vaccine in four weeks. On 07Apr2021 at 18:00 the patient had severe muscle and joint/rib pain, pain at injection site (entire arm) and severe fatigue (both shots). Patient did not have covid prior vaccination and not tested for covid post vaccination. Patient did not receive treatment for the events. The outcome of the events were not recovered. No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Condition aggravated, Fatigue, Lymph node pain
Clinical narrative: pain at injection site; intense pain in lymph node; fever 100-103 degrees- down to 99 with tylenol; severe fatigue; Severe muscle and joint/rib pain, pain at injection site (entire arm) 1st and 2nd shot- worse; Severe muscle and joint/rib pain, pain at injection site (entire arm) 1st and 2nd shot- worse; Severe muscle and joint/rib pain; Severe muscle and joint/rib pain; This is a spontaneous report from a contactable consumer (patient). This 56-year-old non-pregnant female (Not Hispanic Or Latino Caucasian) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0162) via an unspecified route of administration in left arm on 28Apr2021 at 10:30 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine reported as other. Medical history included High bp, generalized anxiety disorder, autoimmune history. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient concomitant medications included Bisoprolol, Lisinopril, Xanax for an unspecified indication and Tylenol for pyrexia, start and stop date were not reported. The patient had known allergies for sulfur. No covid prior vaccination. No covid tested post vaccination. The patient did not receive any other vaccines within four weeks. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Ew0151) on unspecified route in right arm on 07Apr2021 at 15:00 (at the age of 56-year-old) as DOSE 1, SINGLE for covid-19 immunization and on 07Apr2021 at 18:00 patient had severe muscle and joint/rib pain, joint/rib pain, pain at injection site and severe fatigue. On an unspecified date, after second dose patient experienced Severe muscle and joint/rib pain, pain at injection site (entire arm) 1st and 2nd shot- worse w/ 2nd dose, intense pain in lymph node (under arm), fever 100-103 degrees- down to 99 with Tylenol, severe fatigue. Treatment received for the event fever 100-103 degrees was Tylenol and for rest of the event patient did not receive any treatment. On an unknown date, patient underwent lab tests and procedures which included body temperature: 100-103 degrees- down to 99 with Tylenol. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: pain at injection site; intense pain in lymph node; fever 100-103 degrees- down to 99 with tylenol; severe fatigue; Severe muscle and joint/rib pain, pain at injection site (entire arm) 1st and 2nd shot- worse; Severe muscle and joint/rib pain, pain at injection site (entire arm) 1st and 2nd shot- worse; Severe muscle and joint/rib pain; Severe muscle and joint/rib pain; This is a spontaneous report from a contactable consumer (patient). This 56-year-old non-pregnant female (Not Hispanic Or Latino Caucasian) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0162) via an unspecified route of administration in left arm on 28Apr2021 at 10:30 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine reported as other. Medical history included High bp, generalized anxiety disorder, autoimmune history. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient concomitant medications included Bisoprolol, Lisinopril, Xanax for an unspecified indication and Tylenol for pyrexia, start and stop date were not reported. The patient had known allergies for sulfur. No covid prior vaccination. No covid tested post vaccination. The patient did not receive any other vaccines within four weeks. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Ew0151) on unspecified route in right arm on 07Apr2021 at 15:00 (at the age of 56-year-old) as DOSE 1, SINGLE for covid-19 immunization and on 07Apr2021 at 18:00 patient had severe muscle and joint/rib pain, joint/rib pain, pain at injection site and severe fatigue. On an unspecified date, after second dose patient experienced Severe muscle and joint/rib pain, pain at injection site (entire arm) 1st and 2nd shot- worse w/ 2nd dose, intense pain in lymph node (under arm), fever 100-103 degrees- down to 99 with Tylenol, severe fatigue. Treatment received for the event fever 100-103 degrees was Tylenol and for rest of the event patient did not receive any treatment. On an unknown date, patient underwent lab tests and procedures which included body temperature: 100-103 degrees- down to 99 with Tylenol. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other hcp (patient). A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 05May2021 at 09:00 (at the age of 43-years-old) as dose 1, single for covid-19 immunization. Patient had no known allergies. Medical history included covid-19. On 05May2021 at 16:30, patient experienced pain/body ache, fever, short of breath, swollen face and left arm and headache. Unknown if the patient received treatment. Patient received other medications in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: This is a spontaneous report from a contactable other hcp (patient). A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 05May2021 at 09:00 (at the age of 43-years-old) as dose 1, single for covid-19 immunization. Patient had no known allergies. Medical history included covid-19. On 05May2021 at 16:30, patient experienced pain/body ache, fever, short of breath, swollen face and left arm and headache. Unknown if the patient received treatment. Patient received other medications in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Nipple exudate bloody
Clinical narrative: L nipple discharge bloody; L nipple discharge bloody; This is a spontaneous report from a contactable physician.   A 61-years-old female (non-pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0162), via intramuscular, administered in Left arm on 18Apr2021 11:00 (at the age of 61-year-old) as dose 2, single for covid-19 immunisation ( Health Clinic/ Administration facility). The patient's medical history was none. The patient had no known drug allergies. The patient's concomitant medications were not reported. The patient had no covid prior vaccination. The patient had not been tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: ER8732), via intramuscular, administered in Left arm on 28Mar2021 11:00 (at the age of 61-year-old), as dose 1, single for covid-19 immunisation. On 27Apr2021, the patient had L nipple discharge bloody (breast discharge and nipple exudate bloody). The reporter assessed the case as non-serious. The patient underwent lab tests and procedures which included mammogram: mammogram, referral on an unspecified date. The events resulted in doctor or other health care professional office/clinic visit. The patient received treatment. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Tinnitus
Clinical narrative: vaccine does appear to have highly elevated the ringing. The second dose seemed to elevate it; my face and neck felt slightly inflamed, almost "puffy"; my face and neck felt slightly inflamed, almost "puffy"; This is a spontaneous report from a contactable consumer or other non hcp (patient) .  A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (Age at vaccination was 33 years) as dose 2, single for covid-19 immunisation. Medical history included alcoholism from an unknown date and unknown if ongoing. The patient did not have covid-19 prior to vaccination. The patient did not have any known allergy. The patient took Selective serotonin reuptake inhibitors (SSRI) in two weeks. The patient did not take other vaccine within four weeks. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8734 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 31Mar2021 at 16:30 hours (Age at vaccination was 33 years) as dose 1, single for COVID-19 immunization and few hours later he got a headache and some queasiness, the typical side effects. His ears began loudly ringing, which he attributed to the headache and immune response. The headache and nausea quickly faded, but his tinnitus remained highly elevated for weeks. His GP cleaned out his ears, which were heavily impacted with earwax, and that definitely helped. The patient experienced vaccine does appear to have highly elevated the ringing. the second dose seemed to elevate it, his face and neck felt slightly inflamed, almost puffy. The patient Seeing similar reports in group that does not appear to be populated by conspiracy theorists, anti-vaxxers or hypochondriancs. Patient think this was a real side effect and some guidance from Pfizer/CDC would be appreciated. The patient did not tested covid-19 post vaccination. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Chills; fever; swollen glands; nausea; lack of sleep; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number : EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 17:30 (at the age of 41-year-old) as DOSE 1, SINGLE for covid-19 immunization (Facility type vaccine : Hospital). The patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient did not have Covid prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included food allergy (Pineapple, kiwi, pecans) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 18Mar2021 01:00 AM Chills, fever, swollen glands, nausea and lack of sleep for 3 days after 1st vaccine and 2 days after 2nd vaccine. The patient did not receive any treatment for the events. The outcome of all the events was recovered 2021.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Headache, Nasopharyngitis, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 05May2021 at 16:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included several pneumonia cases back-to-back in childhood that required hospitalization and mainly affected the patient's left lung. The patient did not have any 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 vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 16:45 (at the age of 25-years old) as a single dose for COVID-19 immunisation and experienced soreness. The patient reported that it had been a little over 24 hours since her second dose. On 05May2021, on the day of the vaccination, the patient did not experience anything. The patient was actually really surprised at how little soreness she felt, in comparison to the first dose. However, today on 06May2021 at 09:45, the patient experienced what she could best describe as the typical signs that a heavy cold was fixing to knock one out in the coming days. The patient had ongoing moderate body aches, internal fever, a slight headache, and, what seemed unusual to her, slight chest pain. The patient felt it specifically on her left side, almost as if over the heart. There was also a slight intermittent ache in her left armpit. But specifically to the chest pain, the patient mainly felt it upon exhaling deeply. No other symptoms thus far to report at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, 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 the typical signs that a heavy cold is fixing to knock "you" out in the coming days, little soreness/moderate body aches, internal fever, slight headache, slight chest pain and slight intermittent ache in left armpit was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 05May2021 at 16:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included several pneumonia cases back-to-back in childhood that required hospitalization and mainly affected the patient's left lung. The patient did not have any 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 vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 16:45 (at the age of 25-years old) as a single dose for COVID-19 immunisation and experienced soreness. The patient reported that it had been a little over 24 hours since her second dose. On 05May2021, on the day of the vaccination, the patient did not experience anything. The patient was actually really surprised at how little soreness she felt, in comparison to the first dose. However, today on 06May2021 at 09:45, the patient experienced what she could best describe as the typical signs that a heavy cold was fixing to knock one out in the coming days. The patient had ongoing moderate body aches, internal fever, a slight headache, and, what seemed unusual to her, slight chest pain. The patient felt it specifically on her left side, almost as if over the heart. There was also a slight intermittent ache in her left armpit. But specifically to the chest pain, the patient mainly felt it upon exhaling deeply. No other symptoms thus far to report at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, 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 the typical signs that a heavy cold is fixing to knock "you" out in the coming days, little soreness/moderate body aches, internal fever, slight headache, slight chest pain and slight intermittent ache in left armpit was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Bladder disorder, Body temperature, Body temperature abnormal, Cystitis
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 46-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown) via an unspecified route of administration in left arm on 01May2021 11:45 as dose 1, single (at the age of 46-year-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone (SPIRONOLACTONE) 25 mg per day taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. Patient had no COVID, prior vaccination. Patient was not tested for COVID, post vaccination. Patient had no known allergies. On 01May2021 13:45, the patient experienced facial flushing, entire body and face felt very hot, sweating profusely all over, runny nose, scratchy throat, temperature check showed 100.5, pelvic pain and pressure /extreme bloating, felt like bladder infection, couldn't empty bladder well at all, increased urinary urgency and frequency and increased urinary urgency and frequency. On 01May2021, the patient underwent lab tests and procedures which included body temperature: 100.5. Therapeutic measures were taken as a result of events felt like bladder infection, couldn't empty bladder well at all, increased urinary urgency and frequency, increased urinary urgency and frequency. The patient was treated with Cranberry extract pills (D mannose) for bladder. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Micturition urgency, Pelvic discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 46-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown) via an unspecified route of administration in left arm on 01May2021 11:45 as dose 1, single (at the age of 46-year-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone (SPIRONOLACTONE) 25 mg per day taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. Patient had no COVID, prior vaccination. Patient was not tested for COVID, post vaccination. Patient had no known allergies. On 01May2021 13:45, the patient experienced facial flushing, entire body and face felt very hot, sweating profusely all over, runny nose, scratchy throat, temperature check showed 100.5, pelvic pain and pressure /extreme bloating, felt like bladder infection, couldn't empty bladder well at all, increased urinary urgency and frequency and increased urinary urgency and frequency. On 01May2021, the patient underwent lab tests and procedures which included body temperature: 100.5. Therapeutic measures were taken as a result of events felt like bladder infection, couldn't empty bladder well at all, increased urinary urgency and frequency, increased urinary urgency and frequency. The patient was treated with Cranberry extract pills (D mannose) for bladder. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pelvic pain, Pollakiuria, Rhinorrhoea, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 46-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown) via an unspecified route of administration in left arm on 01May2021 11:45 as dose 1, single (at the age of 46-year-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone (SPIRONOLACTONE) 25 mg per day taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. Patient had no COVID, prior vaccination. Patient was not tested for COVID, post vaccination. Patient had no known allergies. On 01May2021 13:45, the patient experienced facial flushing, entire body and face felt very hot, sweating profusely all over, runny nose, scratchy throat, temperature check showed 100.5, pelvic pain and pressure /extreme bloating, felt like bladder infection, couldn't empty bladder well at all, increased urinary urgency and frequency and increased urinary urgency and frequency. On 01May2021, the patient underwent lab tests and procedures which included body temperature: 100.5. Therapeutic measures were taken as a result of events felt like bladder infection, couldn't empty bladder well at all, increased urinary urgency and frequency, increased urinary urgency and frequency. The patient was treated with Cranberry extract pills (D mannose) for bladder. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: chills; Fever; swollen glands; nausea; lack of sleep; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in left arm on 07Apr2021 as DOSE 2, SINGLE (at the age of 42-years-old) for COVID-19 immunization. The patient's concomitant medical history included pineapple allergy, kiwi allergy and pecans allergy. The patient's concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 16Mar2021 at 17:30 hours as DOSE 1, SINGLE (at the age of 41-years-old) for COVID-19 immunization and experienced chills, fever, swollen glands, nausea, and lack of sleep. The patient took no other medications in two weeks of Pfizer vaccine. The patient had no COVID prior vaccination and was not COVID tested post vaccination. On 09Apr2021, 2 days after second vaccine, the patient experienced chills, fever, swollen glands, nausea, and lack of sleep. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received no treatment for the events. The clinical outcome of the events was recovered on an unspecified date in 2021.No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysaesthesia, Fatigue, Headache, Paraesthesia
Clinical narrative: tinnitus; fatigue; frontal lobe pressure/bilateral pulsating headache; mild tingling in fingertips; paresthesias; dysesthesias; chest pain; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female (non-pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: 8731), via an unspecified route of administration, administered in Left arm on 16Apr2021 14:30 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation (in pharmacy). The patient's medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported and multi-vitamin, taken for an unspecified indication, start and stop date were not reported. The patient had no covid prior vaccination. The patient did not receive any other vaccine in four weeks. On 16Apr2021 15:00, few minutes after shot the patient experienced mild tingling in fingertips that I chalked up to regular vax stuff (tech also gave a bit high). On 17Apr2021 (Next Day), the patient experienced frontal lobe pressure, bilateral pulsating headache, tinnitus and fatigue. On an unspecified date in Apr2021, the patient had progressed over the course of several days to full-body being symptomatic paresthesias/dysesthesias, headaches, chest pain, etc. 3 weeks on symptoms were worse, not better, and still evolving. The events resulted in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was tested for Covid post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: negative on 20Apr2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: tinnitus; fatigue; frontal lobe pressure/bilateral pulsating headache; mild tingling in fingertips; paresthesias; dysesthesias; chest pain; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female (non-pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: 8731), via an unspecified route of administration, administered in Left arm on 16Apr2021 14:30 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation (in pharmacy). The patient's medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported and multi-vitamin, taken for an unspecified indication, start and stop date were not reported. The patient had no covid prior vaccination. The patient did not receive any other vaccine in four weeks. On 16Apr2021 15:00, few minutes after shot the patient experienced mild tingling in fingertips that I chalked up to regular vax stuff (tech also gave a bit high). On 17Apr2021 (Next Day), the patient experienced frontal lobe pressure, bilateral pulsating headache, tinnitus and fatigue. On an unspecified date in Apr2021, the patient had progressed over the course of several days to full-body being symptomatic paresthesias/dysesthesias, headaches, chest pain, etc. 3 weeks on symptoms were worse, not better, and still evolving. The events resulted in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was tested for Covid post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: negative on 20Apr2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: This is a spontaneous report from a contactable Nurse (patient). A 56-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) that patient received within two weeks of vaccination included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; dipyridamole (METROPOLYN) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient was not tested with COVID-19. Four days after first vaccine, patient had outbreak of hsv1 on 10Apr2021. No treatment received for reported adverse event. Post vaccination, patient was not tested with COVID-19. The outcome of the event was resolving. No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Sensation of foreign body
Clinical narrative: Slightly thump in throat; Trouble swallowing; Slightly swollen glands in throat; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration in the arm left on 09Apr2021 at 16:30 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. Medical history included anxiety from 2021, hemorrhage after giving birth in 2018, blood transfusion in the year 2018 and DNC (uterine dilation and curettage) to address it. Concomitant medications included Prenatal vitamins (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) but day b4, vitamin d NOS (VITAMIN D) for an unknown indication received within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any known allergies, the patient reported that she never had any reaction to vaccines. On 09Apr2021 after 30 minutes of first dose vaccination, the patient experienced trouble swallowing, slightly swollen glands in throat. The patient reported as able to swallow with water. Called nurse and was not concerned because could breathe. The patient did not have rash and no other symptoms. Slept and next day, the patient experienced slightly thump in throat but subsided. 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. The clinical outcome of trouble swallowing and slightly swollen glands in throat were unknown. The clinical outcome of slightly thump in throat was recovered on an unknown date in 2021.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Fatigue, Feeling abnormal, Flushing
Clinical narrative: nausea; muscle aches; extreme fatigue; felt flushed; shaky; Always lightheaded/dizzy; Slept almost constantly for 4 straight days; Barely able to stay awake or get out of bed for over 2 weeks; vomiting; increased headaches; brain fog; loss of motor skills in my hands; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 12Apr2021 16:15 (at the age of 50-year-old) as dose 1, single for COVID-19 immunisation. Medical history included migraines due to traumatic brain injury (TBI) in 2014 unknown if ongoing and hypertention from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included valproate semisodium (DEPAKOTE), lamotrigine (LAMICTAL), oxybutynin (OXYTROL), lisinopril (LISINOPRIL) and varenicline tartrate (CHANTIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 12Apr2021 17:30, an hour after 1st dose, the patient felt flushed, shaky, and dizzy an hour after first dose. On 13Apr2021, about 12 hours after injection, patient had nausea, muscle aches and extreme fatigue. On unspecified date in 2021, patient slept almost constantly for 4 straight days and barely able to stay awake or get out of bed for over 2 weeks, always lightheaded, with bouts of nausea and vomiting, increased headaches, brain fog and loss of motor skills in her hands on unspecified date in 2021. Currently still battling fatigue and functioning for more than a few hours without falling back to sleep. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. At the time of this report, the outcome of event slept almost constantly for 4 straight days and barely able to stay awake or get out of bed for over 2 weeks were recovering and all other events were not recovered.  No follow-up attempts are required. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Motor dysfunction, Myalgia, Nausea
Clinical narrative: nausea; muscle aches; extreme fatigue; felt flushed; shaky; Always lightheaded/dizzy; Slept almost constantly for 4 straight days; Barely able to stay awake or get out of bed for over 2 weeks; vomiting; increased headaches; brain fog; loss of motor skills in my hands; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 12Apr2021 16:15 (at the age of 50-year-old) as dose 1, single for COVID-19 immunisation. Medical history included migraines due to traumatic brain injury (TBI) in 2014 unknown if ongoing and hypertention from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included valproate semisodium (DEPAKOTE), lamotrigine (LAMICTAL), oxybutynin (OXYTROL), lisinopril (LISINOPRIL) and varenicline tartrate (CHANTIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 12Apr2021 17:30, an hour after 1st dose, the patient felt flushed, shaky, and dizzy an hour after first dose. On 13Apr2021, about 12 hours after injection, patient had nausea, muscle aches and extreme fatigue. On unspecified date in 2021, patient slept almost constantly for 4 straight days and barely able to stay awake or get out of bed for over 2 weeks, always lightheaded, with bouts of nausea and vomiting, increased headaches, brain fog and loss of motor skills in her hands on unspecified date in 2021. Currently still battling fatigue and functioning for more than a few hours without falling back to sleep. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. At the time of this report, the outcome of event slept almost constantly for 4 straight days and barely able to stay awake or get out of bed for over 2 weeks were recovering and all other events were not recovered.  No follow-up attempts are required. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Vomiting
Clinical narrative: nausea; muscle aches; extreme fatigue; felt flushed; shaky; Always lightheaded/dizzy; Slept almost constantly for 4 straight days; Barely able to stay awake or get out of bed for over 2 weeks; vomiting; increased headaches; brain fog; loss of motor skills in my hands; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 12Apr2021 16:15 (at the age of 50-year-old) as dose 1, single for COVID-19 immunisation. Medical history included migraines due to traumatic brain injury (TBI) in 2014 unknown if ongoing and hypertention from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included valproate semisodium (DEPAKOTE), lamotrigine (LAMICTAL), oxybutynin (OXYTROL), lisinopril (LISINOPRIL) and varenicline tartrate (CHANTIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 12Apr2021 17:30, an hour after 1st dose, the patient felt flushed, shaky, and dizzy an hour after first dose. On 13Apr2021, about 12 hours after injection, patient had nausea, muscle aches and extreme fatigue. On unspecified date in 2021, patient slept almost constantly for 4 straight days and barely able to stay awake or get out of bed for over 2 weeks, always lightheaded, with bouts of nausea and vomiting, increased headaches, brain fog and loss of motor skills in her hands on unspecified date in 2021. Currently still battling fatigue and functioning for more than a few hours without falling back to sleep. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. At the time of this report, the outcome of event slept almost constantly for 4 straight days and barely able to stay awake or get out of bed for over 2 weeks were recovering and all other events were not recovered.  No follow-up attempts are required. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient herself). A 39-year-old (non-pregnant) female patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE (age at vaccination 39 years) for covid-19 immunisation. Medical history included herpes zoster from 2018 to an unknown date Previously had shingles in 2018. Patient had codeine allergies from unknown date and unknown if ongoing. Other medications in two weeks concomitant medications included fluoxetine hcl (FLUOXETINE HCL) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine for drug hypersensitivity. Patient had not diagnosed covid prior to vaccination and had not been covid tested post vaccination. On 06Apr2021 (1 week ) after 1st vaccine injection into left arm, patient experienced a bruise-colored but raised circular patch appear under my right arm (in armpit area). Patient did not received treatment for event. Adverse event resulted patient visited Doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vertigo
Clinical narrative: vertigo; Headache; chills; fever; body aches; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for herself.  A 64-years-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6205) via an unspecified route of administration, administered in Arm Left on 04Mar2021 (at 14:30) (age at the time of vaccination was 64-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Ciprofloxacin facial tingling, Azithromycin nausea, Erythromycin nausea and Levofloxacin nausea from an unspecified date. Concomitant medications included Metro (METRONIDAZOLE) topical gel 0.75% 1 daily and Yuvafem (ESTRADIOL). The patient had no other vaccines within 4 weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 09Apr2021 (at 07:00), the patient experienced vertigo, Headache, chills, fever and body aches. No treatment was received for the adverse events. Headache, chills, fever, body aches, began between 7 hours for headache and 12 hours later for the other symptoms. Resolved within 24 hours. Two weeks later, woke up with vertigo which lasted for 23 days, more severe at the onset diminishing over time. The clinical outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.