chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer covid vaccine on 23Jul2021 and tested positive on 28Jul2021; This is a spontaneous report from a contactable pharmacist. The pharmacist reported for a female patient. A patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Jul2021 (Batch/Lot number was not reported; Expiry date: Unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of the PFIZER COVID vaccine on 23Jul2021 and tested positive on 28Jul2021 (covid-19) (non-serious) on 28Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The clinical outcome of the event was unknown. The patient completed quarantine. The patient wanted to know if it was ok to proceed with 2nd dose tomorrow as it would be 21 days by tomorrow. The patient was asking if should go ahead with the 21 day scheduled second dose Pfizer Covid Vaccine. Should the patient delay receiving the second dose Pfizer Covid Vaccine based on the positive Covid test and if so, how long should the patient delay receiving the second dose Pfizer Covid Vaccine.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Heart rate, Heart rate increased, Lower respiratory tract infection
Clinical narrative: Inflammation chest; Heart palpitations; I am sleeping my heart start raising really bad; Burning up; This is a spontaneous report from a contactable consumer (patient).  A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Lot Number: EN6206) as single dose (at the age of 45) for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced inflammation chest on 09Aug2021, heart palpitations (mainly at night time) on 2021, 'i am sleeping my heart start raising really bad' on 2021, burning up on 2021. The patient underwent lab tests and procedures which included blood test: unknown results on 17Jun2021, heart rate: raising. It was reported that after the vaccine in March the patient had heart palpitations and more heart palpitations in June and currently has a heart monitor due to the palpitations. Has not received the second dose and does not know if she should get it.  It was reported patient had on another Heart monitor because the Cardiologist are saying the other one was not picking up any palpitations. States the other one kept going dead and she had to keep switching batteries. Just got the second heart monitor this past 09Aug. Last week she went to the doctor and they told her she has an Inflammation chest and she took Prednisone for 5 days. She took her last Prednisone on Sunday. Mentions again, she went to the Cardiologist and got a second monitor which is a 30 day monitor and it's more intense. Attempt made to slow caller to clarify details. Again mentions she had sent the Cardiologist a message about her palpitations and they said they didn't see any palpitations, which she guess it wouldn't since the batteries get dead all the time. She is going to wear this for 2 weeks. She works in healthcare remotely and is at home and has to have a medical form that she is supposed to return by 26Aug2021 and she has to have the vaccines done by 15 September or she won't have a job. Has a friend who is a Nurse Practitioner who told her not to get the second shot because she probably won't be here because of the bad reaction to the first one. That's what started the reaction, but it's like the cardiologist are saying it's not a reaction from the Pfizer shot, but she never had this until she received the first dose. After getting it she had to sit for 15 minutes and when she left the employee facility that's when they started. She walked to her car and her heart was beating fast and she was Burning up. The outcome of Heart palpitations was not recovered, of the other events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Inflammation chest; Heart palpitations; I am sleeping my heart start raising really bad; Burning up; This is a spontaneous report from a contactable consumer (patient).  A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Lot Number: EN6206) as single dose (at the age of 45) for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced inflammation chest on 09Aug2021, heart palpitations (mainly at night time) on 2021, 'i am sleeping my heart start raising really bad' on 2021, burning up on 2021. The patient underwent lab tests and procedures which included blood test: unknown results on 17Jun2021, heart rate: raising. It was reported that after the vaccine in March the patient had heart palpitations and more heart palpitations in June and currently has a heart monitor due to the palpitations. Has not received the second dose and does not know if she should get it.  It was reported patient had on another Heart monitor because the Cardiologist are saying the other one was not picking up any palpitations. States the other one kept going dead and she had to keep switching batteries. Just got the second heart monitor this past 09Aug. Last week she went to the doctor and they told her she has an Inflammation chest and she took Prednisone for 5 days. She took her last Prednisone on Sunday. Mentions again, she went to the Cardiologist and got a second monitor which is a 30 day monitor and it's more intense. Attempt made to slow caller to clarify details. Again mentions she had sent the Cardiologist a message about her palpitations and they said they didn't see any palpitations, which she guess it wouldn't since the batteries get dead all the time. She is going to wear this for 2 weeks. She works in healthcare remotely and is at home and has to have a medical form that she is supposed to return by 26Aug2021 and she has to have the vaccines done by 15 September or she won't have a job. Has a friend who is a Nurse Practitioner who told her not to get the second shot because she probably won't be here because of the bad reaction to the first one. That's what started the reaction, but it's like the cardiologist are saying it's not a reaction from the Pfizer shot, but she never had this until she received the first dose. After getting it she had to sit for 15 minutes and when she left the employee facility that's when they started. She walked to her car and her heart was beating fast and she was Burning up. The outcome of Heart palpitations was not recovered, of the other events was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chills, Fatigue, Headache
Clinical narrative: Pounding heart; Arm pain; Vomiting; Feeling unwell; Nausea; Injection site redness; Fever; Joint pain; Chills; Muscle pain/pain in calf muscle; Headache; Tiredness; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, administered via an unspecified route in left arm on 29Jul2021 15:00, at 46 years of age, (Batch/Lot Number: FA7485) as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jul2021 22:00 the patient experienced pounding heart, assessed as medically significant, arm pain, vomiting, feeling unwell, nausea, injection site redness, fever, joint pain, chills, muscle pain/pain in calf muscle, headache, tiredness and high blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on 29Jul2021 which included blood pressure measurement which was high. The patient didn't receive any treatment. At the time of the report the reported events were resolving.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: Pounding heart; Arm pain; Vomiting; Feeling unwell; Nausea; Injection site redness; Fever; Joint pain; Chills; Muscle pain/pain in calf muscle; Headache; Tiredness; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, administered via an unspecified route in left arm on 29Jul2021 15:00, at 46 years of age, (Batch/Lot Number: FA7485) as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jul2021 22:00 the patient experienced pounding heart, assessed as medically significant, arm pain, vomiting, feeling unwell, nausea, injection site redness, fever, joint pain, chills, muscle pain/pain in calf muscle, headache, tiredness and high blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on 29Jul2021 which included blood pressure measurement which was high. The patient didn't receive any treatment. At the time of the report the reported events were resolving.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Vaccination site erythema, Vomiting
Clinical narrative: Pounding heart; Arm pain; Vomiting; Feeling unwell; Nausea; Injection site redness; Fever; Joint pain; Chills; Muscle pain/pain in calf muscle; Headache; Tiredness; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, administered via an unspecified route in left arm on 29Jul2021 15:00, at 46 years of age, (Batch/Lot Number: FA7485) as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jul2021 22:00 the patient experienced pounding heart, assessed as medically significant, arm pain, vomiting, feeling unwell, nausea, injection site redness, fever, joint pain, chills, muscle pain/pain in calf muscle, headache, tiredness and high blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on 29Jul2021 which included blood pressure measurement which was high. The patient didn't receive any treatment. At the time of the report the reported events were resolving.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non healthcare professional. A 32 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of the vaccine on 24Jul2021 and was supposed to get his second dose but he tested positive for COVID-19. He asked if he could still get the second shot or if he needs to wait or start over. He stated that he tested positive, but has no symptoms and last year he also had Covid before he received his first dose. He tested positive for covid-19 leading to drug ineffective on 2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test on 2020 last year he also had Covid before he received first dose, sars-cov-2 test positive on 2021. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: numbing; tingly; This is a spontaneous report from a contactable Other HCP (patient).   A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 20Mar2021 at 18:00 (at the age of 55-years-old) as dose 1, single, and second dose via an unspecified route of administration, administered in right arm on 09Apr2021 (at the age of 55-years-old) as dose 2, single for covid-19 immunisation.  Medical history included COVID-19 and asthma (post-covid still a problem). The patient had no known allergies. The patient received unspecified consoncitant drugs in two weeks. The patient experienced within 10 minutes mild numbing from the injection site on her upper left arm to her cheekbone-only on the left. Another way of describing is her upper left chest and shoulder through the lower left quadrant of her face (as reported). The most significant symptom the patient first noticed initially was that the left side of her nose and upper lips felt numb and tingly, but no other part of her face. The same reaction occurred in the same area of her body, but on the right side when she received the second dose on 09Apr2021. The patient prepared by taking Benedryl for the second dose, as per advice from an infectious disease physician she consulted prior to receiving the vaccine, so she felt the second dose reaction seemed more mild. She also was prepared having gone through the first vaccine. MD's who attended to her when she initially reported the first side effect had never heard of it, while the pharmacist who delivered the second dose had many times. The events resulted in Emergency room/department or urgent care. The patient did not receive treatment for events (as reported). The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 02Jun2021. The outcome of events was recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pregnancy test
Clinical narrative: miscarriage; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 24Apr2021 11:00 (Batch/Lot Number: ER8736) age at vaccination of 30-years-old, as single dose, for covid-19 immunisation. Medical history was none. It was unknown if patient was pregnant and if she was pregnant at the time of vaccination.  There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Left arm on 29Mar2021 02:45 PM (Batch/Lot Number: ER8734) age at vaccination of 30-years-old, as single dose, for covid-19 immunisation.  The patient had a miscarriage on 07May2021, she found out that was pregnant on 27Apr2021. The patient believe that 2nd vaccine had something to do with miscarriage. The event was reported as serious (medically significant). Doctor visits were done and HCG testing 3 times (Unknown results). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from miscarriage on an unspecified date.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Severe muscle pain injection side of upper back between spine and shoulder blade; severe pain in injection side elbow and triceps; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 03Aug2021 at 11:45 (Batch/Lot Number: FA7485) as dose 1, single (at the age of 46-years-old) for Covid-19 immunisation. Medical history was reported as none. The patient had no Covid prior vaccination and had not tested post-vaccination. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. On 04Aug2021 04:30AM, the patient experienced severe muscle pain injection side of upper back between spine and shoulder blade. Also developed severe pain in injection side elbow and triceps-ongoing for 7 days. Therapeutic measures taken as a result of the events included muscle relaxer and anti-inflammatory. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Eating disorder
Clinical narrative: he hasn't eaten because he can't pass the food, he can't swallow; he hasn't eaten because he can't pass the food, he can't swallow; This is a spontaneous report from a contactable consumer (Patient's mother). A 12-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0183), via an unspecified route of administration on arm left on 09Aug2021 (Age at Vaccination: 12 Years) as dose 2, single for COVID-19 immunization. The reported verbatim indication was reported included to protect from Covid since they are going back to school. Patients Medical History (including any illness at time of vaccination) was reported as none. Family Medical History Relevant to Adverse events was reported as not applicable. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was reported as none. The patient Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0175), via an unspecified route of administration on arm left on 19Jul2021 (at the age of 12 Years) as dose 1, single for COVID-19 immunization. On 10Aug2021, the patient experienced he hasn't eaten because he can't pass the food, he can't swallow. On 12Aug2021, the patient experienced that he hasn't eaten. It was reported that patient received the second dose of the Pfizer Covid-19 vaccine on Monday, 09Aug. Now he feels his throat closed and he hasn't eaten because he can't pass the food, he can't swallow. The reporter reported that her son hadn't told her but he felt something like this with the first dose. With the 2nd dose he feels like food won't go through. Before, he was able to swallow but now he can't swallow. It has got-ten worse. On Tuesday he could swallow food but that night he felt it didn't go through. Yesterday he didn't eat. Today he has had only a little piece of donut with milk. The events has not resulted in Emergency Room or Physician Office visit. Relevant Tests was reported as none. The outcome of the events was not resolved.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Peripheral swelling, Throat tightness, Urticaria
Clinical narrative: Hives; Joint pain/joints hurt really bad; Swelling of hands/hands swelled; Throat tightening/Her throat was closing a little; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA6780), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jul2021 (at the age of 18years) as dose 1, single  for Covid-19 immunization. There were no medical history and concomitant medications. On 26Jul2021, the patient was admitted to the ER (emergency room) with hives, joint pain, swelling of hands, and throat tightening. The hives started 12 hours after the vaccine (as reported). She started to get bad, and the swelling started so she went in. The hives started on her neck. Her hands swelled, her joints hurt really bad, and she had hives over her whole body. Her throat was closing a little. She was prescribed antihistamines by the doctor. It took away the hives in 3 days. Didn't do imaging or tests, blood test was done, but they didn't give her the results everything else was normal. She would like to know if Pfizer recommends her to take the second dose of the Pfizer COVID-19 vaccine or should she take another COVID-19 vaccine. She stated that she never had an allergy before, and the doctor told her the vaccine would be the cause of her reaction and that this reaction would be "pretty rare". The doctor at the ER did not want to provide a recommendation and advised patient to call Pfizer. The outcome of event hives was recovered on 29Jul2021; outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, SARS-CoV-2 test
Clinical narrative: Have heat in my back like there was an electric heating pad turned on high; This is a spontaneous report from a contactable consumer. An elderly female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EM9810) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Pre-diabetes and asthma. The patient's concomitant medications were not reported. The patient previously took sulfur and experienced allergies. The patient received first dose of  bnt162b2 for covid-19 immunization on an unspecified date (Batch/lot number not reported). The patient started to have heat in my back like there was an electric heating pad turned on high on 23Feb2021. It was reported as; Two days after second dose, started to have heat in my back like there was an electric heating pad turned on high. Now it's five months later and still experience this every day all day long. The event was reported as serious-medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08May2021. Outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Neuropathy peripheral, Pain in extremity
Clinical narrative: One week later the pain in both feet returned and has not left; One week later the pain in both feet returned and has not left; headache; neck ache; fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulaytion:Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history included Covid. She received the Pfizer shot 3 months after Covid. No concomitant medications were reported. Historical vaccination included the patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and had muscle aches and tired. One week after 1st. shot, she started with neuropathy in both feet. Before second shot, they were a little better. When she received the 2nd shot she did mention her concern about her feet. They said that they had heard about hands not feet. The 2nd shot, she had headache, neck ache and fatigue. One week later the pain in both feet returned and had not left. Her last shot was in June. She wanted to know thoughts from Pfizer on that. The outcome of event "pain in both feet returned and had not left" was not recovered while the outcome of other events was unknown.  Information about Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a program. A contactable male consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date Mar2021 as dose 1, single and second dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date 2021, patient tested positive for COVID-19 and wants to know what recommendations to follow. The patient underwent lab tests and procedures which included SARS-CoV-2 test, tested positive on an unspecified date of 2021. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, Pericarditis
Clinical narrative: This is a spontaneous report received from a contactable Physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 32-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 15Apr2021 (at 32 years old, not pregnant) (Batch/Lot Number: EW0153) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included TRI-SPRINTEC. The patient experienced suspected myocarditis or pericarditis, chest pain all on 20Apr2021 with outcome of not recovered. Treatment given for all events was colchicine. No covid prior vaccination. Not covid tested post vaccination.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events myocarditis and pericarditis and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Motor dysfunction, Multiple sclerosis
Clinical narrative: Multiple Sclerosis; hands didn't work too well; This is a spontaneous report received from a contactable consumer (patient) and a consumer from a Pfizer sponsored program. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 24Mar2021 at 09:05 (Batch/lot number: ER8727; Expiration Date: Unknown) at the age of 62-year-old as single dose since the patient had Multiple Sclerosis and didn't want COVID. Medical history included ongoing multiple Sclerosis from 24Dec1982, ongoing asthma from 2007. Prior Vaccinations (within 4 weeks), other vaccinations was not received. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Investigation assessment was none. Concomitant medication included fingolimod hydrochloride (GILENYA). The patient previously received Hepatitis B vaccine and experienced extreme itching on back, but no rash. The patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 03Mar2021 in the morning (Lot number: EN6202) at the age of 62-year-old as single dose for COVID-19 immunization. On 15Jul2021, the patient had an antibody test but did not have any antibodies. On an unspecified date, the patient hands didn't work too well and had Multiple Sclerosis and taken immunosuppressants. The patient wanted to know if she were to stop the Gilenya, would those antibody cells be re-activated and whether she needed to receive a booster dose of the Pfizer-Biontech Covid19 vaccine. The patient was at her doctors office and they chose to do that test. Doctor mentioned there was some problems and other patients tested negative for antibodies after their COVID-19 Vaccines. The patient wanted to known how long it takes for the booster shot to give her antibodies. The patient didn't get sick after her COVID-19 Vaccines. Caller states she called the company who manufactures her medication, and they suggested if she were to stop her medication for two weeks with her doctor's guidance, she may be able to get an additional dose of the Pfizer BioNTech Covid-19 Vaccine during that time and develop an immune response. The events did not required a visit to emergency room and physician office. Nobody can tell her how many days it takes to develop antibodies after the third shot. She discussed this information with transfer agent. Relevant tests was none. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: she couldn't breathe; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PFIZER-BIONTECH COVID-19 VACCINE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to know since the Pfizer shot is an mRNA vaccine but the Johnson and Johnson one is not, what are the chances that it would be safe for a person to switch over after an allergic reaction to the 1st dose of the Pfizer covid vaccine. The patient had an allergic reaction to the first Pfizer covid shot. She was fine until 4 hours later when she could not breathe. Had to use her rescue inhaler for asthma and took 3 puffs. It took 20 minutes for her to be able to breathe. 20 minutes afterwards, again she could not breathe again, she was arching her back trying to breathe. She took 1 Benadryl 25 mg and put Vicks vapor rub under her nose. 20 mins later that started to help. She felt like 'a fish on the sidewalk' gasping for air. She took a 2nd Benadryl. Called her primary care who sent her to an allergist. The 1st allergist refused to see her, and the other said there's nothing they can do more than her primary care could do for her. Primary care sent her back to allergist. No one wants to be responsible for her. She went to the pharmacy today to get 2nd shot, pharmacist said they do not think she could get it, and also confirmed with a 2nd pharmacist. She did not receive the 2nd dose. Outcome of the events was unknown.   Information on lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Overdose, Pharyngeal mass, Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: Swollen nodules in throat; Swollen nodules in throat; administration date=29Mar2021, dose number=1  29Mar2021, number=2; administration date=29Mar2021, dose number=1  29Mar2021, number=2; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old (also the age at time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Mar2021 (Batch/Lot Number: EN6208) as DOSE 1 and on 29Mar2021 (Batch/Lot Number: ER8732) as DOSE 2, both given via an unspecified route of administration administered in arm right,  SINGLE for COVID-19 immunization.  Medical history included none. Concomitant medications were not reported.  On 21Apr2021, the patient had swollen nodules in throat. The patient had negative nasal swab on 30Jul2021. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events of swollen nodules in throat. Outcome of the events of swollen nodules in throat was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Left side of face is swollen and has hives/Left arm has small hives scattered and left leg has hives scattered; Left side of face is swollen; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 10Aug2021 at 13:00 (lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included tachycardia and bipolar disorder both from an unknown date. There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 10Aug2021 at 18:15, the patient's left side of face is swollen and has hives. The patient's left arm has small hives scattered and left leg has hives scattered. The patient received allergy medication as treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Impulse-control disorder, Mobility decreased
Clinical narrative: felt a different impulse; lift side shoulder blade to fingers and left hand (mobility issue),; felt like fluctuation bacterial something was moving at a rapid rate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included stroke in 2020 (reported a year from this report) and left side mobility problems from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After the first dose the patient reported that she felt like fluctuation bacterial something was moving at a rapid rate, lift side shoulder blade to fingers and left hand (mobility issue), pinkly goes wild and felt a different impulse. The patient did not have to go to the emergency room. The patient wanted to get the second dose but the site near her said its been too long pass the window now she needs to take the first dose again. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Pericarditis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 55-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm at the age of 55 years old on 11Feb2021 11:00 (Batch/Lot Number: EN6201) as dose 2, single for covid-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EK9231) on 21Jan2021 at 11:00 AM administered at left arm for COVID-19 Immunization. No reaction reported. The patient also took amoxicillin and experienced allergies. On 28Jun2021, the patient experienced pericarditis and it was a possible diagnosis at an ER visit that ruled out any life-threatening events. SED rate test with value of 75 confirmed pericarditis on 22Jul2021. Echocardiogram, EKG, electrocardiogram, chest XR were done and all indicate healthy heart. Prednisone was prescribed after 22Jul2021. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Oestradiol, SARS-CoV-2 test
Clinical narrative: no mensural cycle for 4 months. Estradiol levels normal and not in menopause; This is a spontaneous report from a non-contactable consumer (the patient). A 51-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, on an unspecified date in May2021 (at the age of 51-year-old), as single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On an unknown date in May2021, the patient has no mensural cycle for 4 months. Estradiol levels normal and not in menopause. The patient underwent tab tests and procedure which included the Estradiol was normal on an unknown date in 2021 and COVID-19/Nasal swab test and result was negative on an unknown date in Jun2021. Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received for event. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Lymphadenopathy, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Started period when I wasn't due/went almost 2 months without a period; swollen lymph nodes by groin; Was regular, every 26 days prior to Covid vaccine; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 45-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 12:00 as dose 2, single for COVID-19 immunization and first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm right on 12Mar2021 12:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient experienced period when she wasn't due and went almost 2 months without a period leading to menstrual disorder on 06Apr2021 with outcome of not recovered , swollen lymph nodes by groin on 06Apr2021 with outcome of not recovered , was regular, every 26 days prior to covid vaccine with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test on Nasal Swab. No treatment was received by patient for events. The outcome of the events was reported as not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: had a sore arm; and a fever that didn't go over 99.9F yesterday; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Aug2021 (at the age of 39-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Aug2021, the patient experienced had a sore arm, and a fever that didn't go over 99.9f yesterday. The patient underwent lab tests and procedures which included body temperature: fever that didn't go over 99.9f yesterday fahrenheit on 11Aug2021 fever that didn't go over 99.9F yesterday. The outcome of the events were unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Chest pain, Heart rate, Investigation
Clinical narrative: he was not feeling well; chest pain; anxiety; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 30Jul2021 (batch/lot number: EW0181) at 40 years old as DOSE 1, SINGLE for COVID-19 immunization. The patient had no medical history, no concomitant medications, and had no prior vaccinations. The patient experienced chest pain and anxiety on 03Aug2021 and was not feeling well on an unspecified date. The patient reported that 4 days after his first dose, on 03Aug2021, he started having chest pain and anxiety. He went to the ER and they checked his cardiovascular system and said everything was fine. He continued having chest pain and went back to the ED and had another check-up and did tests for acid reflux, results were unknown. He had pulse oximeter and a BP cuff at home, these have been normal. The patient went to the ED for a 3rd visit and did not stay since it was too crowded. The ED has provided a F/U appt in 4 weeks. Patient asked if other people had these same symptoms after getting the Pfizer COVID vaccine. The patient further stated that he had been experiencing constant chest pain, which comes and goes from taking the Pfizer Vaccine. He tried to see if reports of chest pain from getting the vaccine have been received. Therapeutic measures were taken as a result of chest pain and anxiety which included administration of ibuprofen (MOTRIN) and alprazolam (XANAX) and these did not work. Patient does not have the lot numbers of these medications. He was about to talk to the representative about this thing to healthcare person from Pfizer because he was not feeling well since an unknown date. So, he needed to talk to them. The outcome of the events was unknown. It was reported that the patient was scheduled for the second shot on 20Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oxygen saturation
Clinical narrative: he was not feeling well; chest pain; anxiety; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 30Jul2021 (batch/lot number: EW0181) at 40 years old as DOSE 1, SINGLE for COVID-19 immunization. The patient had no medical history, no concomitant medications, and had no prior vaccinations. The patient experienced chest pain and anxiety on 03Aug2021 and was not feeling well on an unspecified date. The patient reported that 4 days after his first dose, on 03Aug2021, he started having chest pain and anxiety. He went to the ER and they checked his cardiovascular system and said everything was fine. He continued having chest pain and went back to the ED and had another check-up and did tests for acid reflux, results were unknown. He had pulse oximeter and a BP cuff at home, these have been normal. The patient went to the ED for a 3rd visit and did not stay since it was too crowded. The ED has provided a F/U appt in 4 weeks. Patient asked if other people had these same symptoms after getting the Pfizer COVID vaccine. The patient further stated that he had been experiencing constant chest pain, which comes and goes from taking the Pfizer Vaccine. He tried to see if reports of chest pain from getting the vaccine have been received. Therapeutic measures were taken as a result of chest pain and anxiety which included administration of ibuprofen (MOTRIN) and alprazolam (XANAX) and these did not work. Patient does not have the lot numbers of these medications. He was about to talk to the representative about this thing to healthcare person from Pfizer because he was not feeling well since an unknown date. So, he needed to talk to them. The outcome of the events was unknown. It was reported that the patient was scheduled for the second shot on 20Aug2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported that a 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jul2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient tested positive for Covid in 2021 and reported as Non-Serious. The patient received the antibody infusion on 03Aug2021. Reporter asking guidance on administering the second dose of the Pfizer Covid 19 Vaccine. The patient also reported as 52-year-old/female. The outcome of the event was unknown.  Information about lot/batch number has been requested. Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: no taste or smell; no taste or smell; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Aug2021 as dose number unknown, single for covid-19 immunisation. No relevant medical history and concomitant medications were reported. On an unspecified date in 2021, the patient experienced no taste or smell. Patient question if it was normal. The outcome of the events no taste or smell was unknown.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.