chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Pain in extremity
Clinical narrative: sore in the arms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 24Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1, single for covid-19 immunization. Relevant medical history included: "arthritis" (ongoing). Family history included: "Ovarian cancer" (unspecified if ongoing), notes: mother; "mother died of Ovarian cancer" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE taken for arthritis. Vaccination history included: Flu shot (maybe in her 30s or 20s), for Immunization, reaction(s): "had a severe reaction". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore in the arms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any other vaccine within four weeks of Pfizer vaccine. The patient had Colonoscopy done in Jan2021 resulted negative. Her mother died of Ovarian cancer. Her mother had chemo induced diarrhea.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: Pins and needles in hands and feet. Burning in feet, legs, hands. Sharp pains/muscle jerks in legs.  Experienced same side effects in May following second dose of Pfizer
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood testosterone increased, Frustration tolerance decreased, Laboratory test, Menstruation irregular, Polycystic ovaries
Clinical narrative: Menstrual cycle irregularity consistently 25-40 days of cycles - endocrine believes now pcos started on metformin er. Frustrated to see this as I have always been regular 29 days
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, C-reactive protein increased, COVID-19, Discomfort
Clinical narrative: One day following vaccine injection, intense pain and stiffness arose in patient's left shoulder - not at site of injection but entire left shoulder. Symptoms consistent with SIRVA do not dissipate. Instead, pain and stiffness intensify and migrate over the following days/weeks/months to the neck, right shoulder, torso, lower back and hips. Symptoms are most intense in morning hours upon waking from restless and very uncomfortable sleep periods or other periods of inactivity.  It was extremely difficult to move while in bed or to get out of bed, extremely difficult to get dressed, bend over or down, difficult to run, often impossible to sneeze because patient was unable to sufficiently expand his lungs. Following a period of misdiagnosis, patient is diagnosed with polymyalgia rheumatica (PMR) and is prescribed 12.5mg/day of prednisone on 10/18/2021. Pain and stiffness in all areas improve substantially and prednisone dosage is tapered down to 10mg/day on 11/12/2021. Today (01/25/2021), patient continues to take 7.5mg/day.  Physical function equivalent to pre-vaccination has not been restored. Atop the immune suppression associated with prednisone use, patient was advised not to receive a vaccine booster. Despite careful attention to Covid precautions, he became symptomatic and tested positive for Covid on 01/22/2022.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Injection site pain, Joint stiffness, Loss of personal independence in daily activities, Lung disorder
Clinical narrative: One day following vaccine injection, intense pain and stiffness arose in patient's left shoulder - not at site of injection but entire left shoulder. Symptoms consistent with SIRVA do not dissipate. Instead, pain and stiffness intensify and migrate over the following days/weeks/months to the neck, right shoulder, torso, lower back and hips. Symptoms are most intense in morning hours upon waking from restless and very uncomfortable sleep periods or other periods of inactivity.  It was extremely difficult to move while in bed or to get out of bed, extremely difficult to get dressed, bend over or down, difficult to run, often impossible to sneeze because patient was unable to sufficiently expand his lungs. Following a period of misdiagnosis, patient is diagnosed with polymyalgia rheumatica (PMR) and is prescribed 12.5mg/day of prednisone on 10/18/2021. Pain and stiffness in all areas improve substantially and prednisone dosage is tapered down to 10mg/day on 11/12/2021. Today (01/25/2021), patient continues to take 7.5mg/day.  Physical function equivalent to pre-vaccination has not been restored. Atop the immune suppression associated with prednisone use, patient was advised not to receive a vaccine booster. Despite careful attention to Covid precautions, he became symptomatic and tested positive for Covid on 01/22/2022.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain, Polymyalgia rheumatica
Clinical narrative: One day following vaccine injection, intense pain and stiffness arose in patient's left shoulder - not at site of injection but entire left shoulder. Symptoms consistent with SIRVA do not dissipate. Instead, pain and stiffness intensify and migrate over the following days/weeks/months to the neck, right shoulder, torso, lower back and hips. Symptoms are most intense in morning hours upon waking from restless and very uncomfortable sleep periods or other periods of inactivity.  It was extremely difficult to move while in bed or to get out of bed, extremely difficult to get dressed, bend over or down, difficult to run, often impossible to sneeze because patient was unable to sufficiently expand his lungs. Following a period of misdiagnosis, patient is diagnosed with polymyalgia rheumatica (PMR) and is prescribed 12.5mg/day of prednisone on 10/18/2021. Pain and stiffness in all areas improve substantially and prednisone dosage is tapered down to 10mg/day on 11/12/2021. Today (01/25/2021), patient continues to take 7.5mg/day.  Physical function equivalent to pre-vaccination has not been restored. Atop the immune suppression associated with prednisone use, patient was advised not to receive a vaccine booster. Despite careful attention to Covid precautions, he became symptomatic and tested positive for Covid on 01/22/2022.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Restlessness, SARS-CoV-2 test positive, Shoulder injury related to vaccine administration
Clinical narrative: One day following vaccine injection, intense pain and stiffness arose in patient's left shoulder - not at site of injection but entire left shoulder. Symptoms consistent with SIRVA do not dissipate. Instead, pain and stiffness intensify and migrate over the following days/weeks/months to the neck, right shoulder, torso, lower back and hips. Symptoms are most intense in morning hours upon waking from restless and very uncomfortable sleep periods or other periods of inactivity.  It was extremely difficult to move while in bed or to get out of bed, extremely difficult to get dressed, bend over or down, difficult to run, often impossible to sneeze because patient was unable to sufficiently expand his lungs. Following a period of misdiagnosis, patient is diagnosed with polymyalgia rheumatica (PMR) and is prescribed 12.5mg/day of prednisone on 10/18/2021. Pain and stiffness in all areas improve substantially and prednisone dosage is tapered down to 10mg/day on 11/12/2021. Today (01/25/2021), patient continues to take 7.5mg/day.  Physical function equivalent to pre-vaccination has not been restored. Atop the immune suppression associated with prednisone use, patient was advised not to receive a vaccine booster. Despite careful attention to Covid precautions, he became symptomatic and tested positive for Covid on 01/22/2022.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pruritus, Sleep disorder, Urticaria
Clinical narrative: After the Moderna booster shot, I have been itching all over my body, skull, arms, legs hands feet butt and beard non stop. Breaking into hives. Never experienced this in my entire life nor after the 1st or 2nd dose. Can't sleep, work nor enjoy my time with my kids because I'm constantly itching.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Swelling
Clinical narrative: Pt developed a lump in her arm which then became more raised, red & swollen.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: The same night I received the injection, I developed a pain under my left shoulder blade and could not lay flat. This lasted a little over a month. Then about 2 months later, when I was packing boxes to move, the shoulder pain returned.; it finally went away by August. Then I got a flu vaccine in the same left arm in November and the shoulder pain returned again, even worse and I could not lay down for a month. This time the shoulder pain was accompanied by pain that radiated down my arm and up to my neck. It cause all my fingers on my left hand to have numbness and tingling. I went to the Dr. who didn't do any tests and told me to exercise the arm. I did not do any of the exercises, but, then the numbness in the fingers and the shoulder pain gradually went away after about a month and a half. I feel that the covid vaccine first shot has sensitized my left arm to vaccines and will not get any vaccines in that arm in the future. I did take about 800 mg of ibuprofen and 500 mg Tylenol each day for a month from December to January. I am afraid that I will have even a worse shoulder/arm pain if I get another vaccine in the left arm.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache
Clinical narrative: I had Johnson and Johnson booster. A couple days after I noticed a small spot on my wrist. Then it slowly kept spreading and looked like a bruise on my left wrist ans into my fingers. Then a couple weeks later a spot started on my left wrist. The doctor I work with said that is a common symptom he has seen for the bruising on the hands. I did start getting  random sharp head pain and then goes away pretty fast this last week. Not sure if it is related. The bruising look on my hand is still there. Looks almost like burns but so far stopped spreading.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Hives, itching all over body, dermatographic urticaria
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Insomnia
Clinical narrative: SEVERE hot flashes for four days after receiving my Covid booster (3rd shot). They were so intense and frequent at night that I couldn't sleep at all. Worst on 2nd & 3rd days after injection, about 20x per night, lasting 5-10 min each. They happened during the day too, but the nighttime interference with my sleep for consecutive nights was terrible!  (Note: I am post-menopausal for over 10 yrs)
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dermatitis, Pain, Rash, Rash pruritic
Clinical narrative: 1/5/22:  full body aches, temperature 1/6/22: slight body ache  1/7/22: left armpit hurt for 2 days   Itchy rash 1/12/22 :  rash on right hip 1/13/22:  rash on left hip 1/14/22: rash on left and right forearms 1/15/22:   rash on the front of my left and right thighs 1/16/22- 1/26/22 present day: rash continues to spread on body.  right ankle, behind left & right knees, left & right upper arms,  scattered areas of bumps on lower legs.  new areas continue to pop up on forearms, and hips.  Dermatologist appt via telehealth diagnosed as Dermatitis.  recommended cerave lotion and prescribed Clobetasol Propionate.  zyrtech and benadryl also recommended but does not relieve the itching.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Pleuritic pain, Pulmonary embolism
Clinical narrative: Patient presented with sudden onset of pleuritic chest pain and elevated D dimer. Clinically suspect PE
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: one day after receiving the second dose of the modern vaccine I began to have intermittent pain in the heart
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: A couple of hours after my son got his 1st Pfizer covid vaccine, he had a breakout of hives on his chest, neck, back, chin, and thighs. The hives lasted for 3 days. We gave him Xyzal before bedtime, it helped him feel better.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Underdose
Clinical narrative: The patient should have received 0.5 ml as the second dose of the series, but the technician administering the vaccination drew up and injected 0.25 ml, the dose of a booster. The patient was contacted to notify them of the error. They reported they were experiencing general fatigue similar to their first dose but no other symptoms
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriogram coronary abnormal, Blood test, Coronary arterial stent insertion, Coronary artery occlusion, Dyspepsia
Clinical narrative: Extreme and sudden onset fatigue along with sudden sensation of cold hands and feet the day the Covid19 Pfizer/BioNTech booster shot (3rd dose) was administered. 16 days after receiving the booster shot suffered MAJOR heart attack. 100% blockage. Collapsed after having minor heart burn. Rushed to hospital for emergency coronary angiogram. Cardiac stent inserted.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myocardial infarction, Peripheral coldness, Syncope
Clinical narrative: Extreme and sudden onset fatigue along with sudden sensation of cold hands and feet the day the Covid19 Pfizer/BioNTech booster shot (3rd dose) was administered. 16 days after receiving the booster shot suffered MAJOR heart attack. 100% blockage. Collapsed after having minor heart burn. Rushed to hospital for emergency coronary angiogram. Cardiac stent inserted.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia
Clinical narrative: couldn't breathe very well; can't sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset Nov2021, outcome "not recovered", described as "couldn't breathe very well"; INSOMNIA (non-serious) with onset Nov2021, outcome "not recovered", described as "can't sleep".  Additional information: As the patient is the reporter, states that booster shot could not breath very well, patient could not sleep at night because of breathing disturbance and he did not have this problem with first and second dose. when the patient sleeps at night he can't slepp anymore because of this, later he struggled with his breath and this isn't good for his high blood pressure and thinks that he and his son had the same event. patient thinks that this began sometime this month or late November, he cannot remember. patient confirms that he is talking about the third dose of the Pfizer covid vaccine, he scared he will stop breathing when he sleeps so he is having a hard time sleeping. caller was really worried.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burns second degree
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: I have Hashimoto, Treatment: Consumer stated, "No. I do not have to, just I have the disease". The patient's concomitant medications were not reported. The following information was reported: BLISTER (non-serious) with onset 10Dec2021, outcome "unknown", described as "I have on my left shoulder, I have this blister. Might be, it look like a burned, like I burned by something, which like, which is 4.3 inches, like 6-7 centimeter long."; BURNS SECOND DEGREE (non-serious) with onset 10Dec2021, outcome "unknown", described as "Its a burn like, you know blister on it like 7 centimeter long, 3 inches may be 7-8 centimeter long and may be 1-2 centimeter wide". Therapeutic measures were taken as a result of blister, burns second degree. Additional information: Consumer stated, saying that, Pfizer has a deal that it doesn't matter what happen to us due to the vaccine is nothing we can do about. They don't treat us, they don't get of us and I said, you and I realize, no you are one of us, you are not one of them because they don't care about you either so, I will be frustrated (further not clarified) and I shouldn't be frustrated to you too. It's not your fault, you just work for them. I am just a bit frustrated, and I know, nothing I can do because of them, finding this and then they push us, they obligate us, it's mandate for us to have the vaccine, when they do not take any responsibility for anything so it's fair enough to be frustrated, alright that's all. Consumer was informed about Pfizer medical information department and contact number was provided. This follow-up is being submitted to notify that 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.
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: has been having difficulty talking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPEECH DISORDER (non-serious) with onset Jul2021, outcome "unknown", described as "has been having difficulty talking".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: mild cough; I was told individual was not feeling well morning of 12Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization.   Relevant medical history included: "overweight (not sure how much)" (unspecified if ongoing), notes: overweight (not sure how much); "Allergies: potentially gluten" (unspecified if ongoing), notes: Known Allergies: potentially gluten. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, Primary Immunization series complete but unknown manufacturer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization.  The following information was reported: MALAISE (non-serious) with onset 12Dec2021, outcome "unknown", described as "I was told individual was not feeling well morning of 12Dec2021"; COUGH (non-serious), outcome "unknown", described as "mild cough".  Additional information: Do not know when he started developing a mild cough. was in early 20s - probably between 21 and 23-years-old. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Therapeutic response unexpected
Clinical narrative: The day after receiving the third dose; The day after receiving the third dose of the vaccine, the patient's chronic post-partum inflammatory arthritis dissipated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Dec2021 13:00 (Lot number: FJ8757) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic post-partum inflammatory arthritis" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9265, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 24Feb2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 03Feb2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021 08:00, outcome "unknown", described as "The day after receiving the third dose"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 12Dec2021 08:00, outcome "unknown", described as "The day after receiving the third dose of the vaccine, the patient's chronic post-partum inflammatory arthritis dissipated". Therapeutic measures were not taken as a result of immunisation, therapeutic response unexpected. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had the two Pfizer vaccines and the Pfizer booster and had no problem with any of those other than my arm hurting that's it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Brain aneurysm", start date: 2020 (unspecified if ongoing), notes: Brain aneurysm; "Quadruple heart bypass" (unspecified if ongoing), notes: Quadruple heart bypass. Family history included: "My dad committed suicide" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had the two Pfizer vaccines and the Pfizer booster and had no problem with any of those other than my arm hurting that's it.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Fever; chills; body aches; headache; loss of appetite; overall un wellness; diarrhea; received third dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Dec2021 16:00 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Right, Vaccine Administration Time: 14:00), administration date: 12Feb2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 16:00, outcome "unknown", described as "received third dose"; PYREXIA (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "headache"; DECREASED APPETITE (non-serious) with onset 14Dec2021 22:00, outcome "recovered" (17Dec2021), described as "loss of appetite"; MALAISE (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "overall un wellness"; DIARRHOEA (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, headache, decreased appetite, malaise, diarrhoea.  Additional information: The seriousness of the case was reported as non-serious. The patient did not receive any other vaccine in four weeks and did not receive any other medication in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Malaise, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; headache; loss of appetite; overall un wellness; diarrhea; received third dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Dec2021 16:00 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Right, Vaccine Administration Time: 14:00), administration date: 12Feb2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 16:00, outcome "unknown", described as "received third dose"; PYREXIA (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "headache"; DECREASED APPETITE (non-serious) with onset 14Dec2021 22:00, outcome "recovered" (17Dec2021), described as "loss of appetite"; MALAISE (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "overall un wellness"; DIARRHOEA (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, headache, decreased appetite, malaise, diarrhoea.  Additional information: The seriousness of the case was reported as non-serious. The patient did not receive any other vaccine in four weeks and did not receive any other medication in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination : Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 1), for COVID-19 immunization, reaction(s): "Prior to vaccination, was the patient diagnosed with COVID-19?: Yes", "Prior to vaccination, was the patient diagnosed with COVID-19?: Yes". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Dec2021, outcome "recovered" (Dec2021), described as "sore arm"; HEADACHE (non-serious) with onset 11Dec2021, outcome "recovered" (Dec2021), described as "headache"; FATIGUE (non-serious) with onset 11Dec2021, outcome "recovered" (Dec2021), described as "fatigue". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue.  Additional information: It was unknown if the patient was received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Pyrexia, Tooth extraction
Clinical narrative: Wisdom tooth extraction; fever; hypersensitivity; strange feelings in his spine and his back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: EP7533) at the age of 17 years as dose 1, single and administered in arm right, administration date 21Apr2021 (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TOOTH EXTRACTION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Wisdom tooth extraction"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "hypersensitivity"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "strange feelings in his spine and his back". Therapeutic measures were taken as a result of tooth extraction.  Additional information: The reporter states that her son has already the first and second dose of the Pfizer Biontech COVID-19 vaccine. He just got his wisdom teeth extracted and is on methylpredniso-lone. The reporter didn't mention the date. Last week her son underwent wisdom tooth extraction and now her son is requiring Methylprednisolone. The reporter questions is if her son should wait to get the booster dose after this procedure. The reporter is reporting this because the extraction happened after the COVID vaccine. The reporter clarified that her son had the last vaccine back in Apr and he had his wisdom teeth taken out last week. The caller wants her son to get the booster and is wondering if the medication he's on will lessen the effects of the booster. The reporter stated that her son has a hypersensitivity to vaccines. He has strong reactions to them but not anything that makes him go to the doctor. He is just hypersensitive which is really weird. He is not looking forward to the booster because it will put him in bed for at least 24 hours. just with the COVID vaccine and he just had the same reaction to both. He's the kind of person that when he's going to have a fever he feels it coming on. That's what the caller meant by hypersensitivity. He had strange feelings in his spine and his back; just weird reactions to it.  The vaccination facility type: It was a place called in withheld. It was a technical college where withheld had a full service vaccination thing going on.  No follow-up attempts are possible. No further information is expected.  Follow-Up (04Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Swelling, Tooth extraction
Clinical narrative: swelled up everywhere that I had any injury; teeth have been pulled; gums all swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: El00177) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stroke" (unspecified if ongoing), notes: Other medical history: Stroke, brain bleed, arthritis and severe ruined disc; "brain bleed" (unspecified if ongoing), notes: Other medical history: Stroke, brain bleed, arthritis and severe ruined disc; "arthritis" (unspecified if ongoing), notes: Other medical history: Stroke, brain bleed, arthritis and severe ruined disc; "severe ruined disc" (unspecified if ongoing), notes: Other medical history: Stroke, brain bleed, arthritis and severe ruined disc. The patient's concomitant medications were not reported. Past drug history included: Remeron, reaction(s): "allergy", notes: Known allergies: Remeron, clonidine, doxycycline; Clonidine, reaction(s): "allergy", notes: Known allergies: Remeron, clonidine, doxycycline; Doxycycline, reaction(s): "allergy", notes: Known allergies: Remeron, clonidine, doxycycline. The following information was reported: SWELLING (non-serious) with onset 20May2021, outcome "not recovered", described as "swelled up everywhere that I had any injury"; TOOTH EXTRACTION (non-serious) with onset 20May2021, outcome "not recovered", described as "teeth have been pulled"; GINGIVAL SWELLING (non-serious) with onset 20May2021, outcome "not recovered", described as "gums all swelled up"; CEREBRAL HAEMORRHAGE (non-serious), outcome "recovered", described as "I have a brain bleed". The events "swelled up everywhere that i had any injury", "teeth have been pulled" and "gums all swelled up" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of swelling, tooth extraction, gingival swelling which included pain medicine.  Additional information: She did not receive any other vaccines in four weeks. Her reaction was that she had swelled up everywhere that she had any injury. her teeth have been pulled and her gums all swelled up. Prior to vaccination, she was not diagnosed with covid-19. She was not tested positive post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Immunisation
Clinical narrative: booster; her booster dose a month ago but was exposed to the virus from her coworker; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: REMICADE taken for crohn's disease. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose number Unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 2021, outcome "unknown", described as "her booster dose a month ago but was exposed to the virus from her coworker".  Additional information: The reporter wanted to know if there is any data or studies done to people who are taking immunosuppressant drugs and were fully vaccinated with the vaccine as she cannot find any data about this. She stated that her daughter takes Remicade, a monoclonal antibody, every 4 weeks for her Crohn's disease and she (daughter) received her booster dose a month ago but was exposed to the virus from her coworker. Her (caller) main concern is, even with the booster, that the monoclonal antibody her daughter is taking will make her more likely to be infected after an exposure. Response: Provided the disclaimer. Spoke from General Drug Interactions (v12.0): Ongoing Phase 1/2/3 Trials, Adolescents and Adults Aged =12 Years. Use of the following medications was prohibited and defined as exclusion criteria during the phase 1/2/3 study:3,4. Receipt of medications intended to prevent COVID-19. Treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Systemic corticosteroids administered short term (<14 days) for treatment of an acute illness had to be discontinued for at least 28 days before study intervention administration. Clarified to the caller that since this a on going clinical trial, no further information found.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Headache, Immunisation, Oropharyngeal pain
Clinical narrative: Dose Number: 3; stomach ache; sore throat; headache; cough; lung pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Vaccine Administration Time: 03:00 PM), for COVID-19 immunization; Bnt162b2 (Dose Number: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "Dose Number: 3"; ABDOMINAL PAIN UPPER (non-serious) with onset 23Dec2021, outcome "not recovered", described as "stomach ache"; OROPHARYNGEAL PAIN (non-serious) with onset 23Dec2021, outcome "not recovered", described as "sore throat"; HEADACHE (non-serious) with onset 23Dec2021, outcome "not recovered", described as "headache"; COUGH (non-serious) with onset 23Dec2021, outcome "not recovered", described as "cough"; PULMONARY PAIN (n on-serious) with onset 23Dec2021, outcome "not recovered", described as "lung pain". It was unknown if therapeutic measures were taken as a result of abdominal pain upper, oropharyngeal pain, headache, cough, pulmonary pain.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: Dose Number: 3; stomach ache; sore throat; headache; cough; lung pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Vaccine Administration Time: 03:00 PM), for COVID-19 immunization; Bnt162b2 (Dose Number: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "Dose Number: 3"; ABDOMINAL PAIN UPPER (non-serious) with onset 23Dec2021, outcome "not recovered", described as "stomach ache"; OROPHARYNGEAL PAIN (non-serious) with onset 23Dec2021, outcome "not recovered", described as "sore throat"; HEADACHE (non-serious) with onset 23Dec2021, outcome "not recovered", described as "headache"; COUGH (non-serious) with onset 23Dec2021, outcome "not recovered", described as "cough"; PULMONARY PAIN (n on-serious) with onset 23Dec2021, outcome "not recovered", described as "lung pain". It was unknown if therapeutic measures were taken as a result of abdominal pain upper, oropharyngeal pain, headache, cough, pulmonary pain.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Swelling
Clinical narrative: dose number:3; Just more swelling and pain with the third dose; Just more swelling and pain with the third dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 11:45 (Lot number: FF8841) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 30Apr2021, when the patient was 42 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 20May2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 11:45, outcome "unknown", described as "dose number:3"; SWELLING (non-serious), PAIN (non-serious) all with onset 27Dec2021, outcome "recovering" and all described as "Just more swelling and pain with the third dose". Therapeutic measures were not taken as a result of swelling, pain.  Additional information: This case assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medication within 2 weeks of vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Disease progression, Obsessive-compulsive disorder
Clinical narrative: he started displaying OCD symptoms that had previously resolved; he started displaying OCD symptoms that had previously resolved; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Dec2021 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (ongoing), notes: Verbatim: Autism, Diagnosed at 3 years old.; "OCD" (unspecified if ongoing), notes: They had gotten rid of it years ago with therapy and he started doing it again. There were no concomitant medications.  The following information was reported: OBSESSIVE-COMPULSIVE DISORDER (non-serious), DISEASE PROGRESSION (non-serious) all with onset 27Dec2021, outcome "not recovered" and all described as "he started displaying OCD symptoms that had previously resolved".  Additional information: Mother, calling on behalf of son, aged 12, received his first dose of the adult formulation of the Pfizer BioNTech Covid 19 vaccine on 18Dec2021.Her son has autism.Two days after receiving the vaccine he started displaying OCD symptoms that had previously resolved.She stated for example that during their walks he has started backstepping. It took approximately 2 hours to complete a 45 minute walk.He is still displaying symptoms of OCD a little bit. patient (reporter son) that: Updated information: Patient history: Autism (From: Unspecified To: Ongoing), Additional Information for Other Conditions: Diagnosed at 3 years old. She reported that on Monday, he started to do OCD stuff that he had previously gotten rid of. He was back stepping when they went for a walk at the park and started doing that again. They had gotten rid of it years ago with therapy and he started doing it again. She said that she does not know of it is temporary, but she is praying to God it was not permanent. She said that she was just stating it because people with autism have slightly different chemistry and thinks they are more susceptible to have stuff happen.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I didn't have this reaction with the first two doses, just a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, 0.3 ml single and (Batch/Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I didn't had this reaction with the first two doses, just a little tired".  Additional information: The reporter stated Something happened, the patient didn't have this reaction with the first two doses, just a little tired but nothing happened to her eye.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches".  Additional Information: I received my Booster vaccine, I cannot get rid of these headaches. Clinical Trial Information (provide if caller indicated they are enrolled in a Pfizer Clinical Trial - remove if not applicable): not provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.