chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain
Clinical narrative: immunization; severe headache in back of head; Dizziness/ Feeling of passing out; Neck pain; exhaustion; nausea; chills; This is a spontaneous report from a contactable other health care professional (patient). A 58-year-old non pregnant female patient (nurse) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in right arm on 27Oct2021 at 13:15 (at the age of 58 years) as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in right arm on 18Jan2021 at 14:15 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in right arm on 28Jan2021 as dose 2, single for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. On 27Oct2021 the patient experienced Dizziness/ Feeling of passing out, severe headache in back of head, neck pain, exhaustion, nausea, and chills. On   27Oct2021 at 13:15  patient reported booster. The events resulted in emergency room/department or urgent care. Tornadol, benadryl, ibprophen, fluids, all IV were taken as therapeutic measures for the events. The outcome of the events was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided  and plausible temporal association, the causality between BNT162B2 and Headache, Dizziness, Neck pain, Fatigue, Nausea, Chills  cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain
Clinical narrative: had covid; had covid; everything hurt; This is a spontaneous report from a contactable other HCP and a consumer or other non HCP. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR), via oral from Feb2020 to unknown date at 11mg daily for rheumatoid arthritis. The patient reported in Sep2021, she had covid, and was hospitalized for 2 days. Patient stated she was fully vaccinated. She missed 3 weeks of XELJANZ per MD instructions. She stated "everything hurt" in 2021 but was not able to differentiate between covid or rheumatoid arthritis related. She stated she is fine now, no specific date provided on improvement. MD aware. The outcome of events was recovered in 2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events Drug ineffective and Covid-19 and suspected drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: heart failure; This is a spontaneous report from a contactable consumer. 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 heart failure after received the pfizer covid shot on an unspecified date. Outcome of event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever that broke Friday night / Feverish again Saturday afternoon; Swollen lymph node in armpit of the arm that got the injection (left) on Saturday; This is a spontaneous report from a contactable consumer. This consumer reported for a 44-year-old female patient that:  A 44-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in left arm on 28Oct2021 11:00 as dose 3 (booster), single for COVID-19 immunisation. Medical history included asthma. Patient known allergies was unknown. The patient's concomitant medications were not reported. If other vaccine in four weeks and other medications in two weeks reported as unknown. If covid prior vaccination and if covid tested post vaccination reported as unknown. Patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on unspecified date as dose 1, single and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. On 29Oct2021 patient experienced fever that broke Friday night. Swollen lymph node in armpit of the arm that got the injection (left) on Saturday. Feverish again Saturday afternoon. It was unknown if patient received treatment for the events. Awareness Date: 30Oct2021. Outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Cough, Dizziness, Feeling hot
Clinical narrative: Allergy reaction; tightness of chest; cough; dizziness; high blood pressure; over heated; This is a spontaneous report from a contactable consumer or other non hcp.     A 47-years-old female Non pregnant patient received bnt162b2 (BNT162B2 PFIZER BIOTECH COVID19 MRNA SOLUTION FOR INJECTION (Batch/Lot Number: FF8839), dose 1 via an unspecified route of administration, administered in Arm Left on 09Oct2021 11:00 (Batch/Lot Number: FF8839) as dose 1, single for covid-19 immunisation. Medical history included hypertension, asthma, sleep apnoea syndrome, hypersensitivity, multiple allergies to environmental and medication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, The patient received within 2 weeks of vaccination have Allergies so took Allergy shots week. It was reported that the patient experienced on 09Oct2021 11:15 Allergy reaction, tightness of chest, cough, dizziness, high blood pressure, over heated with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure measurement. Case was assessed as non-serious no prolonged hospitalization. Therapeutic measures were 50 mg benadryl. Ice pack. Olmersartan 40 25mg taken as a result of allergy reaction (hypersensitivity), tightness of chest (chest discomfort), cough (cough), dizziness (dizziness), high blood pressure (hypertension), over heated (feeling hot).  Follow-up (03Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypertension
Clinical narrative: Allergy reaction; tightness of chest; cough; dizziness; high blood pressure; over heated; This is a spontaneous report from a contactable consumer or other non hcp.     A 47-years-old female Non pregnant patient received bnt162b2 (BNT162B2 PFIZER BIOTECH COVID19 MRNA SOLUTION FOR INJECTION (Batch/Lot Number: FF8839), dose 1 via an unspecified route of administration, administered in Arm Left on 09Oct2021 11:00 (Batch/Lot Number: FF8839) as dose 1, single for covid-19 immunisation. Medical history included hypertension, asthma, sleep apnoea syndrome, hypersensitivity, multiple allergies to environmental and medication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, The patient received within 2 weeks of vaccination have Allergies so took Allergy shots week. It was reported that the patient experienced on 09Oct2021 11:15 Allergy reaction, tightness of chest, cough, dizziness, high blood pressure, over heated with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure measurement. Case was assessed as non-serious no prolonged hospitalization. Therapeutic measures were 50 mg benadryl. Ice pack. Olmersartan 40 25mg taken as a result of allergy reaction (hypersensitivity), tightness of chest (chest discomfort), cough (cough), dizziness (dizziness), high blood pressure (hypertension), over heated (feeling hot).  Follow-up (03Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Nephrolithiasis, Sepsis
Clinical narrative: Sepsis; Had kidney stones; Have double vision problems; This is a spontaneous report from a contactable pharmacist. A 20-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on 30Aug2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   The patient experienced sepsis, had kidney stones, had double vision problems. The reporter a pharmacist, stated a mother called her on behalf of her 20-year-old daughter. The daughter got the first dose of the Pfizer covid 19 vaccines on 30Aug2021. Shortly after the vaccine, the daughter started to have double vision problems and has not had the second dose due to this problem. Mother stated the daughter school is requiring the second dose. The mother reported the daughter had kidney stones and sepsis and had a stent put in 10 days after the vaccine. Mother stated the daughter has not seen an eye doctor or other HCP for the double vision. Mother stated they did not ask about the double vision at the time of the kidney stones stating they did not think about the double vision. Mother reported the double vision was constant at first and is now random. The double vision started after the vaccine and before the kidney stones. Caller stated she reported AE in VAERS. The events sepsis and had kidney stones was considered as medically significant. Caller wanted to know if double vision has been reported. The outcome of all the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Sepsis, nephrolithiasis, double vision cannot be totally excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: 5 people in his church got Covid after being vaccinated with Pfizer; 5 people in his church got Covid after being vaccinated with Pfizer; This is a spontaneous report from contactable consumer or other non HCP a Pfizer sponsored program. A contactable consumer reported similar events for five patients. This is the second of five reports.   A 56-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration (Batch/Lot number was not reported) on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date it was reported that 5 people in his church got covid after being vaccinated with Pfizer. events reported as serious Medically Significant. The patient underwent lab tests and procedures which included sars-cov-2 test (5 people in his church got Covid after being vaccinated with Pfizer): unknown on unspecified date. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 5 people in his church got Covid after being vaccinated with Pfizer; 5 people in his church got Covid after being vaccinated with Pfizer; This is a spontaneous report from a contactable consumer or other non-health care professional via Pfizer sponsored program. A contactable consumer reported similar events for five patients under the same suspect product. This is third of five reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that 5 people in his church got COVID-19 after being vaccinated with Pfizer vaccine. The reporter asked if, after 6 months, he should get a booster dose, or how long should he wait. The reporter stated that he got his first 2 doses of the Pfizer Covid-19 vaccine on 01Apr2021 and 30Apr2021, respectively. He asked how effective those doses are after 6 months. He mentioned that he had temporary side effects after those doses but did not specify what they were. The patient asked whether he should wait to go to the dentist until he gets a booster. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 5 people in his church got Covid after being vaccinated with Pfizer; 5 people in his church got Covid after being vaccinated with Pfizer; This is a spontaneous report from a Pfizer sponsored program. A consumer reporting same event(s) under the same suspect product(s) for five patients. This is five of five reports.  A patient of an unspecified age and gender received an unknown dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number and Expiry date were not reported) via unspecified route of administration, on an unspecified date, as an unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter reported that 5 people in his church got Covid after being vaccinated with Pfizer. The patient asked whether he should wait to go to the dentist until he gets a booster. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She didn't feel well; This is a spontaneous report from a contactable consumer or other non hcp.   A 50-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. No medical history and no concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. It was reported that She did not feel well after her second dose either but only for 1 day. It was also reported that patient received her Pfizer COVID-19 booster on 26Oct2021. And today on 30Oct2021 she is finally feeling better. About 12 hours post booster dose, age felt fatigued, nauseous and had a headache. The outcome for the event did not feel well after her second dose was reported as resolved on an unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: tested positive for covid; Vaccination failure; This is a spontaneous report from a contactable consumer or other non hcp. The reporter has a remote colleague (Patient). A male patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 23Feb2021 as DOSE 1, SINGLE for covid-19 immunization, received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 17Mar2021 as DOSE 2, SINGLE for covid-19 immunization, and received third dose of  bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 02Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's medical history and concomitant medication was not reported. On 29Oct2021 the patient was reported about Comirnaty. The patient tested positive for covid after having the first, second and booster dose of the covid vaccine. The patient's height/ weight/ DOB/ age were unknown. On 29Oct2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive. On an unknown date he had a positive antigen test at home, sars-cov-2 test: positive. The outcome of the event was reported as unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID; contracted COVID; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: was not reported, Expiration Date: was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date in Feb2021, as dose 2, single for COVID-19 immunization and the patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: was not reported, Expiration Date: was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date in Jan2021, as dose 1, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient stated, she received her first dose of the vaccine in Jan2021 and her second dose in Feb2021. The patient mentioned that she contracted COVID-19 in Aug2021. The patient asked if she is allowed to take a booster dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Pain
Clinical narrative: could barely walk; headache; body aches; feeling a little tired; she got really bad chills and was in bed and was shaking the whole bed,teeth were chattering; barley even speak; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Nov2021 around noon (at the age of 68-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included fibromyalgia. There were no concomitant medications. She has a recent physical and she was perfect for her age, all her bloodwork and everything. Historical vaccine the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm in Jan2021 around 8am  as dose 1, single patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm in Mar2021 around 8am as dose 2, single for COVID-19 immunization and experienced tired for both doses. The patient did not receive any other vaccine prior vaccinations within 4 weeks. The patient did not have any adverse events following prior vaccinations. The patient received her booster dose of the Pfizer COVID-19 vaccine on Monday 1Nov2021, she had experienced the same side effects with the first two doses and that is 10 hours after she received the shot she started feeling a little tired and as the night progressed she got chills and it started shaking the bed, the patient stated that her husband put an electric blanket on her and her teeth were chattering. She states that in the morning (02Nov2021) she woke up with such a severe headache and body aches she could barely walk herself (02Nov2021) to from the bedroom to the bathroom. And then yesterday she could barely even speak (01Nov2021). She is calling today because it seems with every shot the symptoms are worse, since it looks like and we going to have to keep getting these boosters she doesn't want to have to feel this bad after each one. she got her booster 2 days ago and for the 3rd time she got, she doesn't want to say a reaction, but pretty severe symptoms to the vaccine to the point she had to call her doctor, she didn't know what to do. She states that her fear is the booster every year, does she have to go through this nightmare. The patient had visited for Physician Office for events but did not require Emergency Room for the events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: could barely walk; headache; body aches; feeling a little tired; she got really bad chills and was in bed and was shaking the whole bed,teeth were chattering; barley even speak; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Nov2021 around noon (at the age of 68-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included fibromyalgia. There were no concomitant medications. She has a recent physical and she was perfect for her age, all her bloodwork and everything. Historical vaccine the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm in Jan2021 around 8am  as dose 1, single patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm in Mar2021 around 8am as dose 2, single for COVID-19 immunization and experienced tired for both doses. The patient did not receive any other vaccine prior vaccinations within 4 weeks. The patient did not have any adverse events following prior vaccinations. The patient received her booster dose of the Pfizer COVID-19 vaccine on Monday 1Nov2021, she had experienced the same side effects with the first two doses and that is 10 hours after she received the shot she started feeling a little tired and as the night progressed she got chills and it started shaking the bed, the patient stated that her husband put an electric blanket on her and her teeth were chattering. She states that in the morning (02Nov2021) she woke up with such a severe headache and body aches she could barely walk herself (02Nov2021) to from the bedroom to the bathroom. And then yesterday she could barely even speak (01Nov2021). She is calling today because it seems with every shot the symptoms are worse, since it looks like and we going to have to keep getting these boosters she doesn't want to have to feel this bad after each one. she got her booster 2 days ago and for the 3rd time she got, she doesn't want to say a reaction, but pretty severe symptoms to the vaccine to the point she had to call her doctor, she didn't know what to do. She states that her fear is the booster every year, does she have to go through this nightmare. The patient had visited for Physician Office for events but did not require Emergency Room for the events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: She had a nephew who died, 15 years old after getting the vaccine, the Pfizer COVID vaccine; This is a spontaneous report from a Pfizer sponsored program by a Non-contactable consumer. A 15-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. She had a nephew who died, 15 years old after getting the vaccine, the Pfizer COVID vaccine. Outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: She had a nephew who died, 15 years old after getting the vaccine, the Pfizer COVID vaccine
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Immunisation, Joint swelling, Lymphadenopathy
Clinical narrative: Fever; Body aches; Headache for 72 hours; Swelling and redness at injection site; Swelling and redness at injection site; A lot of swelling in underarm lymph nodes; A lot of swelling in left shoulder; Underarm extremely painful; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable other healthcare professional, the patient. A 53-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease. The patient had known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via intramuscular route of administration in the left arm on 23Dec2020 at 07:00 (at the age of 52-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on an unknown date (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 29Oct2021 at 22:00, the patient experienced fever, body aches and headache for 72 hours, swelling and redness at injection site, a lot of swelling in underarm lymph nodes, left shoulder and underarm extremely painful. 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 taken as a result of swelling at injection site, a lot of swelling in underarm lymph nodes, left shoulder which included treatment with ice for underarm and ibuprofen (MANUFACTURER UNKNOWN) for the swelling. The clinical outcome of the events fever, body aches and headache was resolved on 01Nov2021 at 22:00 whereas swelling and redness at injection site, a lot of swelling in underarm lymph nodes, left shoulder and underarm extremely painful were not resolved at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Fever; Body aches; Headache for 72 hours; Swelling and redness at injection site; Swelling and redness at injection site; A lot of swelling in underarm lymph nodes; A lot of swelling in left shoulder; Underarm extremely painful; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable other healthcare professional, the patient. A 53-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease. The patient had known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via intramuscular route of administration in the left arm on 23Dec2020 at 07:00 (at the age of 52-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on an unknown date (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 29Oct2021 at 22:00, the patient experienced fever, body aches and headache for 72 hours, swelling and redness at injection site, a lot of swelling in underarm lymph nodes, left shoulder and underarm extremely painful. 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 taken as a result of swelling at injection site, a lot of swelling in underarm lymph nodes, left shoulder which included treatment with ice for underarm and ibuprofen (MANUFACTURER UNKNOWN) for the swelling. The clinical outcome of the events fever, body aches and headache was resolved on 01Nov2021 at 22:00 whereas swelling and redness at injection site, a lot of swelling in underarm lymph nodes, left shoulder and underarm extremely painful were not resolved at the time of this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Night sweats, Pain, Pyrexia
Clinical narrative: Body aches; Chills; Nausea; Fever; Injection site pain; Major night sweats/  Woke up 4 time and had to change clothes throughout the night due to being Soaked in own sweat.; Major night sweats/  Woke up 4 time and had to change clothes throughout the night due to being Soaked in own sweat.; The patient received third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 01Nov2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar II and penicillin allergy. The patient was diagnosed with COVID-19, prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC) and lamotrigine (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 29-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Apr2021 at 10:00 (at the age of 29-years-old); as single dose for COVID-19 immunisation. On 02Nov2021, the patient experienced body aches, chills, nausea, fever, injection site pain and major night sweats. The patient woke up 4 times and had to change clothes throughout the night due to being soaked in own sweat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, chills, nausea, fever, injection site pain, major night sweats woke up 4 times and had to change clothes throughout the night due to being soaked in own sweat were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: Body aches; Chills; Nausea; Fever; Injection site pain; Major night sweats/  Woke up 4 time and had to change clothes throughout the night due to being Soaked in own sweat.; Major night sweats/  Woke up 4 time and had to change clothes throughout the night due to being Soaked in own sweat.; The patient received third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 01Nov2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar II and penicillin allergy. The patient was diagnosed with COVID-19, prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC) and lamotrigine (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 29-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Apr2021 at 10:00 (at the age of 29-years-old); as single dose for COVID-19 immunisation. On 02Nov2021, the patient experienced body aches, chills, nausea, fever, injection site pain and major night sweats. The patient woke up 4 times and had to change clothes throughout the night due to being soaked in own sweat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, chills, nausea, fever, injection site pain, major night sweats woke up 4 times and had to change clothes throughout the night due to being soaked in own sweat were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain, Pyrexia
Clinical narrative: The patient received the third/booster dose of BNT162b2; Soreness; Headache; Fever; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the arm on 03Nov2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via an unspecified route of administration on an unknown date in Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9581) via an unspecified route of administration on an unknown date in Feb2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021, the patient experienced headache, fever, fatigue and soreness. The events did not result in doctor 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 headache, fever, fatigue and soreness were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Derealisation, Disorientation, Dizziness, Headache, Interchange of vaccine products
Clinical narrative: A sudden feeling of extreme disorientation, time distortion; Dizziness/ a general feeling of wooziness; Sense of unreality that lasted about 3-4 hours; I still have a slight headache; The patient received JANSSEN on 12Mar2021 and BNT162B2 on 29Oct2021; The patient received JANSSEN on 12Mar2021 and BNT162B2 on 29Oct2021; The patient received the booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the left arm on 29Oct2021 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergy to cane sugar. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included cyanocobalamin (B12), iron (MANUFACTURER UNKNOWN), hyaluronic acid (MANUFACTURER UNKNOWN), probiotics nos (MANUFACTURER UNKNOWN) and fish oil (OMEGA 3); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) for an unknown indication from an unknown date and experienced drug allergy and received first dose of jnj 78436735(JANSSEN COVID-19 VACCINE, Lot Number: 1805025) via an unspecified route of administration on 12Mar2021 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. On 03Nov2021 at 16:15, the patient experienced a sudden feeling of extreme disorientation, time distortion, dizziness, sense of unreality that lasted about 3-4 hours. The patient still had a slight headache and a general feeling of wooziness. The events resulted in 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 sense of unreality was resolved on 03Nov2021 (lasted about 3-4 hours) and of the sudden feeling of extreme disorientation, time distortion, dizziness, and still have a slight headache, general feeling of wooziness was resolved with lasting effects on unknown date of Nov2021 at the time of this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Myalgia, Vaccination site pain
Clinical narrative: Muscle ache at injection sight; Muscle ache at injection sight; Fatigue; Short term chills; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the left arm on 03Nov2021 at 09:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other medications within two weeks of vaccination which were not specified, for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 21Mar2021 at 11:15 (at the age of 65-years-old) as single dose for COVID-19 immunisation and also second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 17Apr2021 at 10:00 (at the age of 65-years-old) as single dose for COVID-19 immunisation. On 03Nov2021 at 22:00, the patient experienced muscle ache at injection site, fatigue and short term chills. 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 muscle ache at injection site, fatigue and short term chills was resolving at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: Very sore joints. Both knees and wrists; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30B0BA) via an unspecified route of administration in the left arm on 17Sep2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 27Aug2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021, the patient experienced very sore joints, both knees and wrists. The patient never had pain like this in her joints before but it was constant and all the time. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 03Nov2021, the patient underwent polymerase chain reaction (PCR) test via nasal swab and the result was negative. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event very sore joints, both knees and wrists was not resolved at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: "My" first menstruation cycle that occurred following the 2 week requirement to be considered fully vaccinated began almost 2 weeks early / "My" period is always on time, never early; This is the first time "I" have had a period last >7 days/ or have had non stop bleeding; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 20Sep2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. 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 vaccination. Concomitant medications included esomeprazole sodium (NEXIUM), over the counter (OTC), for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 30Aug2021 at 13:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 21Oct2021 at 12:00, the patient experienced her first menstruation cycle that began almost 2 weeks early following the 2-week requirement for being considered fully vaccinated; her period was always on time, never early, not once in her life, but her menstruation had not stopped ever since; some days were lighter than others, but some had required a tampon. This was the first time she had a period that lasted more than 7 days, or had non-stop bleeding. The patient felt it was very disturbing since this possibility was "NEVER" explained to her. She would have opted out if she had known. The events did not result in doctor 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 first menstruation cycle that began almost 2 weeks early following the 2-week requirement for being considered fully vaccinated; her period was always on time, never early, period that lasted more than 7 days, or had non-stop bleeding was not resolved at the time of this report.