chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Sadness; Congestion; Really bad diarrhea; Kidney pain; Dizziness; Cough; Headache; Thirst; Difficulty sleeping; Neck pain; I have burning in the back of my neck; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0191 Expiration date: unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 06Jun2021 11:00 (at the age of 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. patient did not received any other medication within 4 weak Prior to Vaccinations. The patient experienced neck pain, headache, thirst, depressed mood, cough, and difficulty sleeping on 06Jun2021, have burning in the back of the neck on Jun2021, Really bad diarrhea, Dizziness, kidney pain, on 07Jun2021, Sadness, Congestion on 08Jun2021.neck pain: Caller states neck pain was almost immediate after vaccine.She believes this pain resolved about a week later. when probed for the outcome, the caller explains she was okay right now. She feels she has recovered completely, Burning in the back of the neck started about two to three days after the vaccine, Headache: was almost immediate and resolved about maybe two weeks later, Thirst: Was almost immediate. She was drinking a lot of water.The thirst resolved maybe 2 weeks later. She has been hydrating on and off with Gatorade, Powerade and of course water, diarrhea: lasted about a week and a half, Cough: Was almost immediate. It was about maybe three hours after the vaccine, Dizziness: Resolved probably about two weeks later. The outcome of event Neck pain, Headache, Thirst, Sadness, Dizziness Recovered on Jun2021, outcome of burning in the back of my neck, recovered on 12Jun2021, while outcome of event Kidney pain, Congestion, Cough, Difficulty sleeping not recovered, outcome of other events was unknown     No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021820899 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Diarrhea; Headache; Fatigue; Nausea; This is a spontaneous report received from a non-contactable consumer (patient) via a Regulatory Authority. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on 25Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jun2021, patient experienced headache, fatigue, nausea, diarrhea on 29Jun2021. Patient did not provide any other personal information other than name. Patient reported the side effects and she was also calling because her doctors won't see her so she did not know what to do. Patient further stated that all of that started on Saturday such as the nausea, headache and all that had been every day. The running to the bathroom started last night and it had been all day today. It's like every day since after the shot. She just wanted to know if this was normal. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report from a non-contactable other HCP reporting for a patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported.  The patient experienced was hospitalized after receiving first COVID vaccine. Physician is okay with patient getting the second COVID shot. The patient and physician had no reason to believe that this was related to the COVID shot.  No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: Medical Evaluation Comment: This patient had fatigue after therapy with apixaban and COVID-19 vaccine. Considering the onset of event after starting vaccine; considered related to COVID-19 vaccine. Not related to apixaban. Pfizer comment: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported event cannot be excluded. Case will be reassessed upon receipt of additional information. 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: Hypersensitivity
Clinical narrative: she did get an awful reaction; This is a spontaneous report from a non-contactable Other Health Care Professional. A female patient of an unspecified age (70-74 year as per raw narrative) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced she get an awful reaction on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever; Extreme fatigue; Chills; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient experienced fever, extreme fatigue, chills on an unspecified date, one day after the vaccination which lasted for 24 hours. The outcome of the events was recovered.   Information on lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Fatigue, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: exhaustion/lowered endurance; sweats lasted for 5 weeks; fever; chills; severe inflammation; asthma worsen; hot, cold; pain; increased sleep; nightmares; This is a spontaneous report received from a contactable consumer (patient) reported for herself. This 44-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Patient was not pregnancy at time of vaccination. Medical history included lupus, asthma. Known allergies: latex, penicillin.  The patient's concomitant medications were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14May2021 05:00 PM, the patient experienced exhaustion, lowered endurance, fever, chills, severe inflammation, asthma worsen, hot, cold, pain, increased sleep, nightmares, sweats lasted for 5 weeks. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for events included injection. The outcome of events was recovered/resolved with sequel.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Inflammation, Nightmare, Pain, Pyrexia
Clinical narrative: exhaustion/lowered endurance; sweats lasted for 5 weeks; fever; chills; severe inflammation; asthma worsen; hot, cold; pain; increased sleep; nightmares; This is a spontaneous report received from a contactable consumer (patient) reported for herself. This 44-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Patient was not pregnancy at time of vaccination. Medical history included lupus, asthma. Known allergies: latex, penicillin.  The patient's concomitant medications were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14May2021 05:00 PM, the patient experienced exhaustion, lowered endurance, fever, chills, severe inflammation, asthma worsen, hot, cold, pain, increased sleep, nightmares, sweats lasted for 5 weeks. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for events included injection. The outcome of events was recovered/resolved with sequel.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Epistaxis
Clinical narrative: nosebleeds, and they continued until about a week after the second shot. This was a different kind of nosebleed that sometimes get in dry win; nosebleeds, and they continued until about a week after the second shot. This was a different kind of nosebleed that sometimes get in dry win; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (Pfizer BioNTech), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) at the age of 68-years-old as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 12:30 (Batch/Lot Number: ewo175) at the age of 68-years-old as DOSE 2, SINGLE for covid-19 immunisation. The COVID-19 vaccine was administered in Pharmacy or Drug Store. Medical history included nosebleed, known allergies penicillin, Swiss cheese, sometimes latex; other medical history hypertension, overweight, otherwise pretty healthy for an old lady. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (LOSARTAN) ; levothyroxine sodium (LEVOTHYROXIN) ; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) ; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) ; colecalciferol (D3) ; tocopherol (E VITAMIN) and fish (as reported). Reported Event: 2 weeks  in Apr2021 after the first shot, the patient started getting nosebleeds, and they continued until about a week after the second shot. This was a different kind of nosebleed that she sometimes get in dry winter air. Much heavier (3 drops per 2 seconds...yes, she timed it), and it originated very close to the nostril, where winter bleeds never happened. She had 2 to 5 nosebleeds per day, and was able to stop them by applying pressure near the bottom of nose. If she sneezed, yawned, or entered the shower, it started again. Not enough space in the "Medications" space to add fish oil and sometimes a baby aspirin. But she quit taking the aspirin until a week after the nosebleeds stopped. The event was reported as non-serious. No treatment was received for event. No covid tested post vaccination. The event outcome was recovered on an unknown date. Since the vaccination, the patient has not been tested for COVID-19.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, Lymphadenopathy, Myocarditis
Clinical narrative: Myocarditis; Chest pain; high fever; Inflamed lymph nodes; This is a spontaneous report from a contactable other hcp.A male patient of 43 years old received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Jan2021 13:00 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included splenectomy from 1995 to an unknown date, mildly high cholesterol.He gets the Pneumovax because he is immunocompromised and gets kind of sick feeling. He gets it every 5 years and does get a fever afterwards; he got the Flu vaccine in Sep2020 or early Oct2020.he got the Flu vaccine in Sep2020 or early Oct2020.The patient's concomitant medications were not reported. Patient previously received the first dose of bnt162b2 on 05Jan2021 for covid-19 immunization. The patient experienced myocarditis in Mar2021 with outcome of recovered, high fever on 27Jan2021 with outcome of recovered, inflamed lymph nodes on 27Jan2021 with outcome of recovering, chest pain in Mar2021 with outcome of unknown. Stated that he received his 2nd dose on 26Jan2021 and had really inflamed lymph nodes and a very high fever. He didn't have chest pain until 4-6 weeks later; around Mar2021. Stated that his lymph nodes were really inflamed for about 2 months after the 2nd dose. They were so inflamed that he said he had a hard time turning his head. States that the other day he was saying that his lymph nodes were still inflamed. He had a very high fever for about 2 days. States this was concerning because they were told that if he had a high fever he would need antibiotics right away because of his splenectomy.  He was having chest pain every night when he laid down, but then it got severe, and normally he doesn't complain of anything. He went to the doctor the next day and had an EKG and blood work. Caller states that she doesn't remember the date this occurred, only that it was probably sometime in Mar2021. States that they weren't worried about anything on the EKG, and he had mildly high cholesterol. His doctor put him on Lipitor and Prilosec OTC, but now they are questioning whether he needs to be on them. Stated that about a month later it came out that myocarditis was a side effect of the vaccine. When they read the symptoms they realized that's what he had because every symptom matched, but at the time the doctor didn't know to be looking for that.Stated that the symptoms have gradually gone away. The patient underwent lab tests and procedures which included blood test: unknown, electrocardiogram: unknown. Therapeutic measures were taken as a result of myocarditis, chest pain. The causality between BNT162B2 and Inflamed lymph nodes,  high fever was related.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Myocarditis; Chest pain; high fever; Inflamed lymph nodes; This is a spontaneous report from a contactable other hcp.A male patient of 43 years old received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Jan2021 13:00 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included splenectomy from 1995 to an unknown date, mildly high cholesterol.He gets the Pneumovax because he is immunocompromised and gets kind of sick feeling. He gets it every 5 years and does get a fever afterwards; he got the Flu vaccine in Sep2020 or early Oct2020.he got the Flu vaccine in Sep2020 or early Oct2020.The patient's concomitant medications were not reported. Patient previously received the first dose of bnt162b2 on 05Jan2021 for covid-19 immunization. The patient experienced myocarditis in Mar2021 with outcome of recovered, high fever on 27Jan2021 with outcome of recovered, inflamed lymph nodes on 27Jan2021 with outcome of recovering, chest pain in Mar2021 with outcome of unknown. Stated that he received his 2nd dose on 26Jan2021 and had really inflamed lymph nodes and a very high fever. He didn't have chest pain until 4-6 weeks later; around Mar2021. Stated that his lymph nodes were really inflamed for about 2 months after the 2nd dose. They were so inflamed that he said he had a hard time turning his head. States that the other day he was saying that his lymph nodes were still inflamed. He had a very high fever for about 2 days. States this was concerning because they were told that if he had a high fever he would need antibiotics right away because of his splenectomy.  He was having chest pain every night when he laid down, but then it got severe, and normally he doesn't complain of anything. He went to the doctor the next day and had an EKG and blood work. Caller states that she doesn't remember the date this occurred, only that it was probably sometime in Mar2021. States that they weren't worried about anything on the EKG, and he had mildly high cholesterol. His doctor put him on Lipitor and Prilosec OTC, but now they are questioning whether he needs to be on them. Stated that about a month later it came out that myocarditis was a side effect of the vaccine. When they read the symptoms they realized that's what he had because every symptom matched, but at the time the doctor didn't know to be looking for that.Stated that the symptoms have gradually gone away. The patient underwent lab tests and procedures which included blood test: unknown, electrocardiogram: unknown. Therapeutic measures were taken as a result of myocarditis, chest pain. The causality between BNT162B2 and Inflamed lymph nodes,  high fever was related.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Hot flashes; This is a spontaneous report from a contactable consumer or other non healthcare professional. This is the first case out of two cases in which the reporter is reporting for herself. A 79-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration on 09Jan2021 as dose 1, single and received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she never had hot flashes like am having now, when are you going to tell the public about your adverse experiences with this shot. It is not safe, please get it out there, the people know what they are getting into and I had my 1st shot January and my 2nd shot in February and I have been having hot flashes and hot flashes and more hot flashes on Jan2021 and also my husband is having hot flashes from the shot and yes, the Covid vaccine gave me and my husband hot flashes. The outcome of the event was not recovered.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: hurting so bad shoulder across shoulder to neck; hurting so bad shoulder across shoulder to neck; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that an 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186) at the age of 80-years, via an unspecified route of administration, administered in left arm on 26Jun2021 at 10:10 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated that she was just calling to report her side effects from first Pfizer shot, she got her shot on Saturday and then on 28Jun2021 (Monday) it hurts so bad, 28Jun2021 (Monday) 29Jun2021 (Tuesday) and 30Jun2021 (today) she was hurting so bad her shoulder across her shoulder to her neck and she didn't know what could be to ease the pain, she would tell that she had tried heat, she have tried cold little wash cloth, she was taking paracetamol (TYLENOL) with codeine, she was taking the muscle relaxant (unspecified medication), rubbed it with this diclofenac sodium topical gel, she had rubbed it as per cream nothing does any good, patient wanted to know what she can do for. Consumer stated it was just severe pain from her shoulder. The adverse events occurred on 28Jun2021. Outcome of the events was not recovered/not resolved  Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Headache, SARS-CoV-2 test
Clinical narrative: I dropped a considerable amount of weight; headaches; weakness; diarrhea; experience stomach pains; This is a spontaneous report from a contactable consumer (patient). An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25May2021 10:00 AM (Lot Number: ER8735) as dose 2, single (at age of 18-years-old) for covid-19 immunisation. No pregnancy at time of vaccination. Medical history included covid-19 prior to vaccination. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0179) on 04May2021 11:00 (at age of 17-years-old) in Arm Right for COVID-19 immunisation. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced Drug allergy. On 27May2021 07:00, the second day after receiving the shot, she began to experience stomach pains. On 28May2021 (the third day after the shot) the that symptom increased in strength and transitioned into severe diarrhea. In addition, she also began to suffer from headaches and weakness. She dropped a considerable amount of weight, approximately 10 pounds well experiencing the diarrhea. The events were not received treatment. Since the vaccination, the patient had been tested for COVID-19 included rapid test: negative (nasal Swab) on 28May2021. No Hospitalization Prolonged. Outcome of the events was not recovered/not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: I dropped a considerable amount of weight; headaches; weakness; diarrhea; experience stomach pains; This is a spontaneous report from a contactable consumer (patient). An 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25May2021 10:00 AM (Lot Number: ER8735) as dose 2, single (at age of 18-years-old) for covid-19 immunisation. No pregnancy at time of vaccination. Medical history included covid-19 prior to vaccination. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0179) on 04May2021 11:00 (at age of 17-years-old) in Arm Right for COVID-19 immunisation. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced Drug allergy. On 27May2021 07:00, the second day after receiving the shot, she began to experience stomach pains. On 28May2021 (the third day after the shot) the that symptom increased in strength and transitioned into severe diarrhea. In addition, she also began to suffer from headaches and weakness. She dropped a considerable amount of weight, approximately 10 pounds well experiencing the diarrhea. The events were not received treatment. Since the vaccination, the patient had been tested for COVID-19 included rapid test: negative (nasal Swab) on 28May2021. No Hospitalization Prolonged. Outcome of the events was not recovered/not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was killing her; This is a spontaneous report from a contactable consumer or other non health professional (patient). This report is for the first dose. A 36-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection; Lot Number: EW0167; Expiration Date: 31Aug2021) via an unspecified route of administration in left arm on 16May2021 at 16:00 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccinations (within 4 weeks). On 16May2021, the patient reported that her arm was killing her. Her arm was killing her and took maybe like 2 hours prior from getting it which happened fast but went away within a day and a half. No treatment was given for the event. The outcome of the event was resolved on 17May2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Liver disorder, SARS-CoV-2 test
Clinical narrative: she got this transplant, she, she caught the, the virus/liver transplant; She caught the, the virus.; She had got the shot three months prior.She caught the, the virus.; This is a spontaneous report   from a non-contactable Other HCP. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had a liver transplant, she caught the virus/liver transplant. She had got the shot three months prior. She got this transplant, she, she caught the, the virus. The patient underwent lab tests and procedures which included sars-cov-2 test: positive.  Outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events "Liver disorder, COVID-19 " and the suspect drug BNT162B2 cannot be 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 re-sponse, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: seeing spots/seeing blue lines and weird shapes/seeing some funny shapes and colors like in the sky; blurred vision; This is a spontaneous report from a contactable consumer (patient father). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0169), dose 1 via an unspecified route of administration in right arm on 27Apr2021 (at the age of 33-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included Down's syndrome. It was reported also that patient handicapped. Concomitant medication included lisinopril (LISINOPRIL) taken for blood pressure, start and stop date were not reported. It was reported that reporter wife and son both got both doses of the Pfizer BioNTech Covid 19 vaccine. Both have been having issues with eyes, seeing spots. The patient was seeing blue lines and weird shapes, but had a hard time communicating that due to a handicap, but showed physical signs of seeing things.  Went to eye doctor today, and they gave him new glasses.  Eye doctor said he can't get into specifics, but he knew of people that were experiencing blurred visions, fuzzy visions, and "eyes not working properly" .  Said it was temporary, but no time frame given. His wife and son got the Pfizer shot, both on the same day, second one back to back. They had their card stamped and left. The reporter stated also that his son was handicap with down syndrome and he went to a day program that was a group home. He was going there every day back in 2019 and they shut it down due to regulations. They said everyone had to wear a mask and face shield if they open up and everybody was getting full vaccinations, so they the needed the shot. They both have the exact same day, exact same pretty much one after other, Pfizer COVID shot and they like a week later started to have some reactions to it and they had the second shot. The patient had second dose of bnt162b2 (Lot Number: EW0176), via an unspecified route of administration on 18May2021.  The outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Loss of personal independence in daily activities, Myalgia
Clinical narrative: He had the flu; could not climb up these stairs; Muscle ache; This is a spontaneous report from a Pfizer Covid Vaccine Hesitancy Dialogue Program via a non-contactable other HCP reported. A male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unknown date at an unknown dose at single dose (dose number unknown, single) for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. It was reported that the patient could not climb up these stairs on unspecified date. The patient who worked there at doctor, could not climb up these stairs. The patient had muscle ache and reported like he had the flu on unspecified date. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Chest pain; the racing of the heart/palpitations; This is a spontaneous report received from a contactable consumer (patient) via a team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and experienced chest pain, racing heart, and elevated blood pressure. Patient had some concerns about the Pfizer COVID-19 vaccine. Patient stated that he usually never gets sick with and had flu every 5 to 7 years. Patient stated that he usually gets sick for no longer thang 3 days and have not had any flu or common flu for 9 years and normally does not get sick. Patient stated that he would be last person who would need vaccine and took vaccine to protect everyone as he works for a utility and had to go to multiple homes. It was reported that on an unspecified date, the racing of the heart/palpitations and chest pain which patient experienced after first dose, had become more persistent after second dose and symptoms comes and goes but more persistent now. Patient did not have any other symptoms like fever or sore arm. Patient stated that he booked appointed with cardiologist. Patient stated that he had some financial issue and had an insurance highly deductible and must pay huge amount out of his pocket. Patient wanted to know if Pfizer supports the medical bills and received response that the program is a program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. For more information about the program regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19". Patient stated that he had a co-worker who got vaccine and ended up having same issue. The outcome of the events was unknown.   Information about batch/Lot number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm just got a little swollen; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), via an unspecified route of administration in arm left on 21May2021 (at the age of 48-year-old) as single dose for COVID-19 immunisation. The family medical history relevant to AE(s) included cholesterol, high blood pressure and diabetes, really high on his dads' side of the family. The patient's medical history (including any illness at time of vaccination) included ongoing high blood pressure, he had high blood pressure for years, ongoing high cholesterol, he was diagnosed with high cholesterol about 2, maybe 3 years ago and pneumonia, the patient had pneumonia shots and never had any problems. The patient's concomitant medications included lisinopril, 12.5 mg, once daily, for blood pressure and atorvastatin, 40 mg, once daily, for cholesterol. Historical vaccine included Flu shots (FLU VACCINE VII), via an unspecified route of administration on an unspecified date as dose number unknown, single for an unspecified indication (the patient had flu shots). Prior vaccinations (within 4 weeks) were reported as none. The AE(s) following prior vaccinations were reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. It was reported that, the caller was a consumer called in regard to the Pfizer COVID-19 vaccine. Stated that, he had been seeing his doctor for about 3 weeks now and his doctor did not know what to do, so he advised the caller to contact Pfizer. The caller stated that, he got his first dose of the COVID-19 vaccine back on 21May2021 and then 3 weeks later, he came in on 11Jun2021 and got the number two shot. Stated that, the caller was unable to provide the NDC number or expiry date of the COVID-19 vaccine. Stated that, when the patient got the first shot, his arm just got a little swollen on 22May2021, but it was not red. Stated that, his arm did not show any signs of infection or anything, so it was just swollen and after a couple days everything was fine. The AE require a visit to emergency room was reported as no and physician office was reported as yes. The reporter seriousness for the event was reported as unspecified. The outcome of the event was recovered on an unspecified date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Peripheral swelling
Clinical narrative: I got my first vaccine,I had pain on side of my head, one side; swelling on arm, it was paining me for days; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0186) via an unspecified route of administration, administered in arm left on 26May2021 as single dose for COVID-19 immunization. Medical history included thyroidectomy from 2016 to an unknown date. Concomitant medications were not reported. The patient stated I I had a thyroid surgery I am not on medication. It's no medical history I have I only had a surgery in throat I had in 2016 and my thyroid hormones are no more I am not on medication. The patient stated i got my first vaccine, i had pain on side of my head, one side, swelling on arm, it was paining me for days and after 2 weeks she did not feel any pain on May2021. Therapeutic measures were taken with Tylenol, strength 800mg, took two tablets as a result of event I got my first vaccine, I had pain on side of my head, one side.  The patient underwent lab tests and procedures which included blood test: unknown (I am not diabetic). The outcome of events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Death, Headache
Clinical narrative: Ended up passing away about seven days after she received the second shot of the vaccine; Extreme headache; This is a spontaneous report from a non-contactable consumer. A female patient (reporter's mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), for covid-19 immunisation. Patient actually took both of the vaccines and she experienced extreme headache after she received her second vaccine and she ended up passing away, she ended up passing away about seven days after she received the second shot of the vaccine. The outcome of headache was unknown, while other event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ended up passing away about seven days after she received the second shot of the vaccine
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity, Vaccination site bruising, Vaccination site erythema
Clinical narrative: Headache; arm was killing me like, even under my armpit it was hurting, my fingers were hurting like my whole arm was in pain; injection site itches and it is red and it is  bruise and it is swollen; injection site itches and it is red and it is  bruise and it is swollen; injection site itches and it is red and it is  bruise and it is swollen; injection site itches and it is red and it is  bruise and it is swollen; I am writhing; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Jun2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Jan2021, the patient experienced a mild headache. On an unspecified date in Jun2021 (The next day), patient's arm was killing like, even under armpit it was hurting, fingers were hurting like whole arm was in pain. Patient's arm had been hurting; it was also swollen and hot to touch and it was red and patient had been taking Ibuprofen (Treatment) for it, it was kind of help to subside the pain. It was reported that the patient experienced the injection site itches and it was red, bruise and swollen. Patient was writhing. Patient wanted to know if the patient should still get second dose even though patient was getting this type of reaction. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Headache; arm was killing me like, even under my armpit it was hurting, my fingers were hurting like my whole arm was in pain; injection site itches and it is red and it is  bruise and it is swollen; injection site itches and it is red and it is  bruise and it is swollen; injection site itches and it is red and it is  bruise and it is swollen; injection site itches and it is red and it is  bruise and it is swollen; I am writhing; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Jun2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Jan2021, the patient experienced a mild headache. On an unspecified date in Jun2021 (The next day), patient's arm was killing like, even under armpit it was hurting, fingers were hurting like whole arm was in pain. Patient's arm had been hurting; it was also swollen and hot to touch and it was red and patient had been taking Ibuprofen (Treatment) for it, it was kind of help to subside the pain. It was reported that the patient experienced the injection site itches and it was red, bruise and swollen. Patient was writhing. Patient wanted to know if the patient should still get second dose even though patient was getting this type of reaction. The outcome of the events was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm following the vaccine; This is a spontaneous report from a contactable consumer (patient wife reporting for her husband) via Pfizer sponsored program. Report 2 of 2 which is for the caller calling about her husband. A 69-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm (as reported) on 29Jun2021 as dose 1, single (at the age of 69-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The wife called to report that she had a sore arm that was swollen at the injection site after her Pfizer Covid-19 Vaccine at which time she also reported her husband had a sore arm following his vaccine. She and her husband had their first vaccine yesterday (29Jun2021) and she was not aware about whatever the purpose of calling here was but she had a sore arm, sore and swollen arm at the injection site. Her husband also had a sore arm. They were senior citizens. She confirmed that she and her husband both received the Pfizer Covid-19 Vaccine yesterday (29Jun2021) and are now both experiencing sore arms. She stated they were fine, she guessed they wanted her to register that they had the shot.  She did not know, she called like they said. The outcome of the event was unknown.     Additional information has been requested. Information about lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: first dose: pain in the arm; first dose: headache; This is a spontaneous report from a contactable consumer or other non hcp. A 32-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16May2021 (Batch/Lot Number: EW0167; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. The patient experienced first dose: pain in the arm on 16May2021, first dose: headache on 16May2021The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Electric shock sensation, Joint swelling, Limb discomfort, Pain
Clinical narrative: I only had pain like in the body ache; I started feeling something under my knee, in front of my leg under the knee, something like electric in my leg in front;  something like swelling but not swelling; On Tuesday morning, felt something on her leg under the knee, swelling and like a bruise of someone who had an injection; When I bent or when I run to in here there is like something inside, it is swelling but something is inside like it shocks me; Have an electric shock in that area when try to bend the leg.; This is a spontaneous report received from a contactable consumer (Patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EZ0196), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Jun2021 (at the age of 58-year-old) as single dose for COVID-19 immunisation. Medical history included surgery in throat in 2016 (Not on medication. It was no medical history. She only had a surgery in throat in 2016 and her thyroid hormones are no more). The patient's concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0186), Solution for injection, via an unspecified route of administration, administered in left arm on 26May2021 as single dose for COVID-19 immunisation. On 22Jun2021, the patient experienced pain like in the body, she started feeling something under her knee, in front of her leg under the knee, something like electric in her leg in front; something like swelling but not swelling, on Tuesday morning, felt something on her leg under the knee, swelling and like a bruise of someone who had an injection, when she bent or when she run to in here there was like something inside, it was swelling but something was inside like it shock her, had an electric shock in that area when try to bend the leg. Patient got the 2nd dose on Sunday, 20Jun2021 on the same arm (left arm), she felt body aches. On Tuesday morning, felt something on her leg under the knee, swelling and like a bruise of someone who had an injection, 'she had an electric shock in that area when she tried to bend the leg'. She had been putting ice on it. Every day, it got more and more stuff which felt like when remove glue from something, that was what she felt on the inside. The outcome of events was not recovered.  No follow-up attempts are possible. No expected further information.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Furuncle, Illness, Malaise, Muscular weakness
Clinical narrative: I have the vaccine got the night, yesterday and I get sick; I have my veins on my leg popped out, in case  in my veins, lot of boils.; I have my veins on my leg popped out, in case  in my veins, lot of boils.; one side like my legs, just don't have the power; I am tired already and I don't feel well; I had lot of bones feel bad in my neck; I am tired already and I don't feel well; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Solution for injection; Lot Number: EW0187, Expiration date: 31Aug2021) via an unspecified route of administration on 29Jun2021 as a dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had got the vaccine the night yesterday and got sick. She had her veins on leg popped out in case as lot of boils. "Popped out, out, you know when your veins gets bigger, this is popped off. When your veins get bigger and make a boils in there. You know what is a boils, like one little ball." She had a concern, why she had that? Is it going to worse or is it going to be disappear or what is going to do that to me? I need to know why, first place. Second place, if its not danger. Third place, if its going to be disappear. Patient stated that she don't want and no other get problems with the vaccine. The patient stated, "No, I am not. I am tired already. I am tired already and I don't feel well." and hung up the call, hence limited information available over the call." The patient further stated that she had pain in left leg and feel like, she was going to one side like her legs, just don't have the power. Additional information included that patient reported that she had yesterday, the Pfizer BioNTech covid-19 and today a very bad plug, in veins, pop off and had lot of bones feel bad in my neck. She wants to know what I can do? If its bad or is going away or what happen and also she had pain in my leg. Like in my left leg and I feel like, I am going to one side like my legs, just don't have the power. Therapeutic measures were not reported. Clinical outcome of the event was unknown.