chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Chills, Erythema, Headache
Clinical narrative: cellulitis; Erythema; pain; pruritus; sweeling; Fever; chills; headache; myalgias; This is a literature report for the following literature source(s): "COVID Arm: Delayed Hypersensitivity Reactions to SARS-CoV-2 Vaccines Misdiagnosed as Cellulitis.", Journal of Primary Care & Community Health, 2021; Vol:12, DOI:10.1177/21501327211024431.  A 44 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant), outcome "recovered", described as "cellulitis"; ERYTHEMA (non-serious), outcome "recovered", described as "Erythema"; PAIN (non-serious), outcome "recovered", described as "pain"; PRURITUS (non-serious), outcome "recovered", described as "pruritus"; SWELLING (non-serious), outcome "recovered", described as "sweeling"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered", described as "chills"; HEADACHE (non-serious), outcome "recovered", described as "headache"; MYALGIA (non-serious), outcome "recovered", described as "myalgias". The patient underwent the following laboratory tests and procedures: body temperature: fever. Therapeutic measures were taken as a result of cellulitis, erythema, pain, pruritus, swelling, pyrexia, chills, headache, myalgia.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "cellulitis and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: cellulitis; Erythema; pain; pruritus; sweeling; Fever; chills; headache; myalgias; This is a literature report for the following literature source(s): "COVID Arm: Delayed Hypersensitivity Reactions to SARS-CoV-2 Vaccines Misdiagnosed as Cellulitis.", Journal of Primary Care & Community Health, 2021; Vol:12, DOI:10.1177/21501327211024431.  A 44 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant), outcome "recovered", described as "cellulitis"; ERYTHEMA (non-serious), outcome "recovered", described as "Erythema"; PAIN (non-serious), outcome "recovered", described as "pain"; PRURITUS (non-serious), outcome "recovered", described as "pruritus"; SWELLING (non-serious), outcome "recovered", described as "sweeling"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered", described as "chills"; HEADACHE (non-serious), outcome "recovered", described as "headache"; MYALGIA (non-serious), outcome "recovered", described as "myalgias". The patient underwent the following laboratory tests and procedures: body temperature: fever. Therapeutic measures were taken as a result of cellulitis, erythema, pain, pruritus, swelling, pyrexia, chills, headache, myalgia.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "cellulitis and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Pruritus, Pyrexia, Somnolence
Clinical narrative: fever; sweating; I was itchy too right at the incision area; Fall asleep or unconscious at home; Fall asleep or unconscious at home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 (Lot number: Ew0177) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cardiovascular" (unspecified if ongoing); "Inactive TB" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Double joint" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing); "Muscle weakness" (unspecified if ongoing); "Mild hearing loss in my left ear" (unspecified if ongoing); "Severe ear infection in my left ear" (unspecified if ongoing); "Dermatitis" (unspecified if ongoing); "Otitis media" (unspecified if ongoing); "Sinus" (unspecified if ongoing); "Gait" (unspecified if ongoing); "Dry eye syndrome" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), SOMNOLENCE (non-serious) all with onset 14Jun2021, outcome "recovered" (2021) and all described as "Fall asleep or unconscious at home"; PYREXIA (non-serious) with onset 15Jun2021, outcome "recovered" (2021), described as "fever"; HYPERHIDROSIS (non-serious) with onset 15Jun2021, outcome "recovered" (2021), described as "sweating"; PRURITUS (non-serious) with onset 14Jun2021, outcome "recovered" (2021), described as "I was itchy too right at the incision area". Therapeutic measures were not taken as a result of loss of consciousness, somnolence, pyrexia, hyperhidrosis, pruritus.  Clinical Course: Patient have not received any other vaccine in four weeks, neither tested positive for COVID prior vaccination nor post vaccination.  No follow-up attempts are possible. No further information is expected  Follow-Up (14Feb2022): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis, Pain in extremity
Clinical narrative: Facial paralysis, this occurred with the booster too; on 03Dec2021 on my right arm. To this day, I am having a hard time lifting it and it still hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 (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 1, SINGLE, I did have facial paralysis when I received my first and second dose.), for Covid-19 Immunization, reaction(s): "facial paralysis"; Bnt162b2 (DOSE 2, SINGLE, I did have facial paralysis when I received my first and second dose.), for Covid-19 Immunization, reaction(s): "facial paralysis". The following information was reported: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "Facial paralysis, this occurred with the booster too"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "on 03Dec2021 on my right arm. To this day, I am having a hard time lifting it and it still hurts".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: facial paralysis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, I did have facial paralysis when I received my first and second dose.), for COVID-19 Immunization, reaction(s): "facial paralysis". The following information was reported: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "facial paralysis".  Clinical course: Patient received booster on 03Dec2021 on right arm. To this day, patient had a hard time lifting it and it still hurts. Patient was wondering if someone could tell how long the side effects of the booster could last. Patient did have facial paralysis when received first and second dose. This occurred with the booster too, but not as bad as the first time. Patient was just hoping to receive some insight about how long can expect this side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart and slight obesity issues" (unspecified if ongoing); "Heart and slight obesity issues" (unspecified if ongoing); "breathing long haul effects from having COVID-19 a year ago", start date: 2021 (unspecified if ongoing); "breathing long haul effects from having COVID-19 a year ago", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of suspected covid-19. It was reported that patient had heart and slight obesity issues. Patient had been very impressed with Pfizer's Covid Vaccines, booster shots. Patient was having breathing long haul effects from having Covid-19 a year ago and felt protected. Unfortunately, patient developed Covid again. Patient was not hospitalized this time and was given drug Paxlovid. 5 days at home, patient feel better than patient had been in years. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: breast cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant), outcome "unknown", described as "breast cancer".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Fear, Hallucination, Insomnia, Tremor
Clinical narrative: hallucinations; I did not sleep for the rest of the night; tired; laid in bed borderline shaking; afraid someone was in my home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2022 11:00 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Bnt162b2 (Dose 2; arm left), administration date: 04Sep2021, when the patient was 20 years old, for Covid-19 immunization; Bnt162b2 (Dose 1; arm left), administration date: 05Aug2021, when the patient was 20 years old, for COVID-19 immunization. The following information was reported: HALLUCINATION (medically significant) with onset 11Feb2022, outcome "not recovered", described as "hallucinations"; INSOMNIA (non-serious) with onset 11Feb2022, outcome "not recovered", described as "I did not sleep for the rest of the night"; FATIGUE (non-serious) with onset 11Feb2022, outcome "not recovered", described as "tired"; TREMOR (non-serious) with onset 11Feb2022, outcome "not recovered", described as "laid in bed borderline shaking"; FEAR (non-serious) with onset 11Feb2022, outcome "not recovered", described as "afraid someone was in my home". A few hours after receiving booster the patient began to feel very tired. He drank roughly 120 ounces of water through the day to help minimize any side effects. When he went to sleep he woke up after a few hours and began to have hallucinations that someone was in his home. It took him about an hour to build the courage to do a walk through of the home to ensure than no one was there. He did not sleep for the rest of the night and laid in bed borderline shaking, afraid someone was in the home. He had never had any time of hallucinations before. He was a healthy individual, ate healthy and went to the gym three times a week. He had no history of anything even remotely close to this.Therapeutic measures were not taken as a result of hallucination, insomnia, fatigue, tremor, fear. The patient had not been tested for COVID-19 since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Macular hole, Visual impairment
Clinical narrative: my vision went wavy, got a wave to it and it turned out that I had a macular hole; my vision went wavy, got a wave to it and it turned out that I had a macular hole; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 (Lot number: EN6202) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RAPAFLO; CLONAZEPAM; ADDERALL. The following information was reported: MACULAR HOLE (medically significant), VISUAL IMPAIRMENT (non-serious) all with onset 2021, outcome "not recovered" and all described as "my vision went wavy, got a wave to it and it turned out that I had a macular hole".  Clinical Course: Consumer further stated, I had a, within a week of the first one my vision went wavy, got a wave to it and it turned out that I had a macular hole, I was going to say I didn't go to the eye doctor until after the second shot when It got worse but that's when they discovered that I had a Macular hole. Prior vaccination before 4 weeks: Consumer stated No. Consumer stated, I do not know the name of that but I also have another eye issue but I do not know the name of it in the other eye also from the shot and did not know the name of it. It's when retinol gel pull out' and get stuck and the happened after the second shot, The first and the second shot also then when I got the third shot it got much worse.  Follow-Up (15Feb2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Slit-lamp examination, Visual acuity tests, Visual field tests
Clinical narrative: Acute macular neuroretinopathy; This is a literature report for the following literature source(s): "Acute macular neuroretinopathy following Pfizer-BioNTech COVID-19 vaccination", Journal of Ophthalmology Case Reports, 21; Vol:24, DOI:10.1016/j.ajoc.2021.101200.  A 20 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "vaginal ring" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Etonogestrel/ethinyl estradiol for birth control, notes: only significant for use of etonogestrel/ethinyl estradiol 0.12-0.015 mg/24 hr vaginal ring for birth control. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: ACUTE MACULAR NEURORETINOPATHY (hospitalization, medically significant), outcome "recovered", described as "Acute macular neuroretinopathy". The event "acute macular neuroretinopathy" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: fundoscopy: unrevealing; unrevealing, with no hemorrhages, retinal vascular, notes: sheathing, retinal or choroidal lesions, and normal appearance of the optic nerve head; revealed hyporeflective foci typical for acute, notes: macular neuroretinopathy (AMN); intraocular pressure test: physiologic; ophthalmological examination: there was no relative afferent pupillary defect or, notes: dyschromatopsia; both eyes were white and quiet and there was no, notes: evidence of anterior chamber or vitreous inflammation; optical coherence tomography: demonstrated corresponding parafoveal foci of, notes: outer nuclear layer hyperreflectivity with granularity of the underlying ellipsoid (There are triangular dark lesions in the superior macula with corresponding bilateral focal ellipsoid zone loss worse in the right eye.); slit-lamp examination: unrevealing; visual acuity tests: 20/20, notes: in both eyes; remained 20/20, notes: in both eyes; visual field tests: confirmed the presence of bilateral paracentral, notes: scotomata; showed stable bilateral paracentral scotomata. Therapeutic measures were taken as a result of acute macular neuroretinopathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event Acute macular neuro-retinopathy 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 response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: pulmonary embolus; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Oct2021 (Lot number: FH8028) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies.  Concomitant medication(s) included: INFLUENZA VACCINE INACT SAG 4V (SEQIRUS FLUCELVAX; Lot number: 308523) taken for immunisation, administration date 01Nov2021. Vaccination history included: BNT162B2 (Dose 1; Lot number: EL1284 in the right arm), administration date: 29Dec2020, when the patient was 64 years old, for COVID-19 immunization; BNT162B2 (Dose 2; Lot number: EL3302 in the right arm), administration date: 19Jan2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant, life threatening) with onset 08Nov2021, outcome "recovered", described as "pulmonary embolus". The patient was hospitalized for pulmonary embolism (hospitalization duration: 3 day(s)). The event "pulmonary embolus" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) negative. Therapeutic measures were taken as a result of pulmonary embolism, which included heparin and then apixaban (ELIQUIS).; Sender's Comments: Based on the available information in the case, the causal association between the event pulmonary embolism 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 response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Pulmonary embolism
Clinical narrative: pulmonary embolus; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Oct2021 (Lot number: FH8028) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies.  Concomitant medication(s) included: INFLUENZA VACCINE INACT SAG 4V (SEQIRUS FLUCELVAX; Lot number: 308523) taken for immunisation, administration date 01Nov2021. Vaccination history included: BNT162B2 (Dose 1; Lot number: EL1284 in the right arm), administration date: 29Dec2020, when the patient was 64 years old, for COVID-19 immunization; BNT162B2 (Dose 2; Lot number: EL3302 in the right arm), administration date: 19Jan2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant, life threatening) with onset 08Nov2021, outcome "recovered", described as "pulmonary embolus". The patient was hospitalized for pulmonary embolism (hospitalization duration: 3 day(s)). The event "pulmonary embolus" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) negative. Therapeutic measures were taken as a result of pulmonary embolism, which included heparin and then apixaban (ELIQUIS).; Sender's Comments: Based on the available information in the case, the causal association between the event pulmonary embolism 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 response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Renal pain, SARS-CoV-2 test
Clinical narrative: my kidneys went from being in no pain to a 10/10 on the pain scale 1 week after receiving the vaccine/ pain dissipated down to an 8/10 after 3 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EN6206) at the age of 40 years as dose 2, single for covid-19 immunisation. Patient had an underlying disease. Relevant medical history included: "Polycystic kidney disease" (unspecified if ongoing); "Type II diabetes" (unspecified if ongoing). No covid prior vaccination. No other vaccine in four weeks. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Brand=Pfizer, Product=COVID 19), administration date: 20Feb2021, for COVID-19 immunization. He did not have an adverse reaction to the first vaccine.  The following information was reported: RENAL PAIN (disability) with onset 20Mar2021, outcome "not recovered", described as "my kidneys went from being in no pain to a 10/10 on the pain scale 1 week after receiving the vaccine/ pain dissipated down to an 8/10 after 3 months". One week after receiving his second dose of the vaccine his kidneys went from being in no pain to a 10 10 on the pain scale 1 week after receiving the vaccine. That pain dissipated down to an 8 10 after 3 months but never resolved. He was required to get the booster to continue attending school. 1 day after receiving the vaccine his pain was back to a 10+ to the point he was shaking from the pain. That had still not resolved 3 weeks later. Patient was covid tested post vaccination. The patient underwent the following laboratory tests and procedures: pain assessment: 10/10, notes: on the pain scale 1 week after receiving the vaccine; 8/10, notes: dissipated down to a 8/10 after 3 months but never resolved; sars-cov-2 test: negative, notes: Covid test type: Nasal Swab, post vaccination. Therapeutic measures were taken as a result of renal pain. Adverse event treatment: Nephrologist stated no treatment available.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Cyst, Investigation, Presyncope
Clinical narrative: felt like he was fainting; felt like his heart was coming out of his chest; a cyst in his neck on the left side; The caller received the vaccine in his left shoulder and there are 2 bumps that show up in the x-ray; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 (Lot number: 33030BD) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "gets sick from pollen" (unspecified if ongoing), notes: gets sick from pollen. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "felt like he was fainting"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "felt like his heart was coming out of his chest"; CYST (non-serious), outcome "unknown", described as "a cyst in his neck on the left side"; SWELLING (non-serious), outcome "unknown", described as "The caller received the vaccine in his left shoulder and there are 2 bumps that show up in the x-ray". The events "felt like he was fainting", "felt like his heart was coming out of his chest" and "a cyst in his neck on the left side" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; investigation: unknown results; x-ray: there are 2 bumps/ 2 small cysts. Clinical course: Clinical course: On Dec the patient had the second vaccine and can't really remember the day but it was in Dec. The patient had a really bad side effect, it didn't do that with the first one but the second one had him on the bed and felt like his heart was coming out of his chest and had to be taken to the hospital and the doctor said it was a side effect of the Covid 19 vaccine. The caller had to go to the emergency room.  The patient had the vaccine in his left shoulder and it created a cyst in his neck on the left side. They did an x-ray and it showed 2 small cysts, the said cysts but its called something else. Anytime the caller touches that part it was like he was going to faint. There was an artery on that side of the neck and the caller felt like he was fainting and it was really bad and he had to go to the hospital. They did an x-ray to his neck and blood work and a lot of tests.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, X-ray
Clinical narrative: felt like he was fainting; felt like his heart was coming out of his chest; a cyst in his neck on the left side; The caller received the vaccine in his left shoulder and there are 2 bumps that show up in the x-ray; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 (Lot number: 33030BD) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "gets sick from pollen" (unspecified if ongoing), notes: gets sick from pollen. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "felt like he was fainting"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "felt like his heart was coming out of his chest"; CYST (non-serious), outcome "unknown", described as "a cyst in his neck on the left side"; SWELLING (non-serious), outcome "unknown", described as "The caller received the vaccine in his left shoulder and there are 2 bumps that show up in the x-ray". The events "felt like he was fainting", "felt like his heart was coming out of his chest" and "a cyst in his neck on the left side" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; investigation: unknown results; x-ray: there are 2 bumps/ 2 small cysts. Clinical course: Clinical course: On Dec the patient had the second vaccine and can't really remember the day but it was in Dec. The patient had a really bad side effect, it didn't do that with the first one but the second one had him on the bed and felt like his heart was coming out of his chest and had to be taken to the hospital and the doctor said it was a side effect of the Covid 19 vaccine. The caller had to go to the emergency room.  The patient had the vaccine in his left shoulder and it created a cyst in his neck on the left side. They did an x-ray and it showed 2 small cysts, the said cysts but its called something else. Anytime the caller touches that part it was like he was going to faint. There was an artery on that side of the neck and the caller felt like he was fainting and it was really bad and he had to go to the hospital. They did an x-ray to his neck and blood work and a lot of tests.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid Pneumonia; tested positive for Covid; COVID-19; 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), administration date 04Jan2022 (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: Covid-19 vaccine (Primary immunization completed, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: COVID-19 PNEUMONIA (medically significant), outcome "unknown", described as "Covid Pneumonia"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "tested positive for Covid"; COVID-19 (medically significant), outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Jan2022) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got COVID; I got COVID; This is a spontaneous report received from a non-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, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Macular hole, Visual impairment
Clinical narrative: when It got worse but that's when they discovered that I had a Macular hole; my vision went wavy, got a wave to it and it turned out that I had a macular hole; when It got worse but that's when they discovered that I had a Macular hole; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8730) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RAPAFLO; CLONAZEPAM; ADDERALL. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, LOT#: "EN6202), administration date: 26Feb2021, when the patient was 63 years old, for COVID-19 Immunization, reaction(s): "The first one my vision went wavy, got a wave to it and it turned out that I had a macular hole", "The first one my vision went wavy, got a wave to it and it turned out that I had a macular hole". The following information was reported: MACULAR HOLE (medically significant), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "not recovered" and all described as "when It got worse but that's when they discovered that I had a Macular hole"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "my vision went wavy, got a wave to it and it turned out that I had a macular hole".  Clinical course: It was stated, "Sure, she just have some questions about filling in the form but sure, Well, she have to report adverse effects of the macular hole and some other things that she do not even know the name from the doctor. It was reported that, patient had a, within a week of the first one her vision went wavy, got a wave to it and it turned out that she had a macular hole, she was going to say she did not go to the eye doctor until after the second shot when It got worse but that was when they discovered that she had a macular hole. Consumer stated, She did not know the name of that but she also had another eye issue but she do not know the name of it in the other eye also from the shot and did not know the name of it. It was when 'retinol gel pull out' and get stuck and the happened after the second shot, The first and the second shot also then when she got the third shot it got much worse.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Brain natriuretic peptide, C-reactive protein, Cytomegalovirus test, Electrocardiogram
Clinical narrative: Nonspecific ST and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 11Feb2022, this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s): "CARDIOVASCULAR MANIFESTATIONS in ADOLESCENT MALES AFTER THE PFIZER COVID-19 VACCINE", Journal of Investigative Medicine, 2021; Vol:70, pgs:226, DOI:10.1136/jim-2022-WRMC.226; "CARDIOVASCULAR MANIFESTATIONS in ADOLESCENT MALES AFTER THE PFIZER COVID-19 VACCINE", Journal of Investigative Medicine, 2022; Vol:70, pgs:226, DOI:10.1136/jim-2022-WRMC.226.  A 16 year-old male 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: PERICARDITIS (medically significant), outcome "unknown", described as "Nonspecific ST and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6". The patient underwent the following laboratory tests and procedures: blood test: negative; brain natriuretic peptide: 53 pg/mL; c-reactive protein: 4.06 mg/dl; 4.06 mg/dl, notes: on admission; 1.45 mg/dl, notes: on discharge; cytomegalovirus test: negative; electrocardiogram: nonspecific st, notes: and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6; epstein-barr virus test: negative; influenza a virus test: negative; influenza b virus test: negative; investigation: negative; parvovirus b19 test: negative; polymerase chain reaction: negative; respiratory syncytial virus test: negative; troponin i: 4.76 ng/dL; 4.07 ng/dL, notes: on admission; 1.45 ng/dL, notes: on discharge.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Pericarditis" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200283445 same patient/article/drug and different event;US-PFIZER INC-202200283444 same drug/article and different patient/event
Sex: M
Vaccine: COVID19
Symptoms: Epstein-Barr virus test, Influenza A virus test, Influenza B virus test, Investigation, Parvovirus B19 test
Clinical narrative: Nonspecific ST and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 11Feb2022, this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s): "CARDIOVASCULAR MANIFESTATIONS in ADOLESCENT MALES AFTER THE PFIZER COVID-19 VACCINE", Journal of Investigative Medicine, 2021; Vol:70, pgs:226, DOI:10.1136/jim-2022-WRMC.226; "CARDIOVASCULAR MANIFESTATIONS in ADOLESCENT MALES AFTER THE PFIZER COVID-19 VACCINE", Journal of Investigative Medicine, 2022; Vol:70, pgs:226, DOI:10.1136/jim-2022-WRMC.226.  A 16 year-old male 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: PERICARDITIS (medically significant), outcome "unknown", described as "Nonspecific ST and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6". The patient underwent the following laboratory tests and procedures: blood test: negative; brain natriuretic peptide: 53 pg/mL; c-reactive protein: 4.06 mg/dl; 4.06 mg/dl, notes: on admission; 1.45 mg/dl, notes: on discharge; cytomegalovirus test: negative; electrocardiogram: nonspecific st, notes: and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6; epstein-barr virus test: negative; influenza a virus test: negative; influenza b virus test: negative; investigation: negative; parvovirus b19 test: negative; polymerase chain reaction: negative; respiratory syncytial virus test: negative; troponin i: 4.76 ng/dL; 4.07 ng/dL, notes: on admission; 1.45 ng/dL, notes: on discharge.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Pericarditis" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200283445 same patient/article/drug and different event;US-PFIZER INC-202200283444 same drug/article and different patient/event
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Polymerase chain reaction, Respiratory syncytial virus test, Troponin I
Clinical narrative: Nonspecific ST and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 11Feb2022, this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s): "CARDIOVASCULAR MANIFESTATIONS in ADOLESCENT MALES AFTER THE PFIZER COVID-19 VACCINE", Journal of Investigative Medicine, 2021; Vol:70, pgs:226, DOI:10.1136/jim-2022-WRMC.226; "CARDIOVASCULAR MANIFESTATIONS in ADOLESCENT MALES AFTER THE PFIZER COVID-19 VACCINE", Journal of Investigative Medicine, 2022; Vol:70, pgs:226, DOI:10.1136/jim-2022-WRMC.226.  A 16 year-old male 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: PERICARDITIS (medically significant), outcome "unknown", described as "Nonspecific ST and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6". The patient underwent the following laboratory tests and procedures: blood test: negative; brain natriuretic peptide: 53 pg/mL; c-reactive protein: 4.06 mg/dl; 4.06 mg/dl, notes: on admission; 1.45 mg/dl, notes: on discharge; cytomegalovirus test: negative; electrocardiogram: nonspecific st, notes: and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6; epstein-barr virus test: negative; influenza a virus test: negative; influenza b virus test: negative; investigation: negative; parvovirus b19 test: negative; polymerase chain reaction: negative; respiratory syncytial virus test: negative; troponin i: 4.76 ng/dL; 4.07 ng/dL, notes: on admission; 1.45 ng/dL, notes: on discharge.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Pericarditis" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200283445 same patient/article/drug and different event;US-PFIZER INC-202200283444 same drug/article and different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: after getting vaccinated she got the covid-19 virus and was rushed to the hospital; after getting vaccinated she got the covid-19 virus and was rushed to the hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a 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: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "after getting vaccinated she got the covid-19 virus and was rushed to the hospital".  Clinical course: Reporter Stated that his fiancee got vaccinated in the country where they visited and after getting vaccinated she got the covid-19 virus and was rushed to the hospital.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: I started releasing big blood clots for 5 days; my menstrual lasted 20 days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 12:00 (Lot number: Ff2590) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose details , Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number= Fc3184, Prev dose lot unknown=False, Prev dose administration date= 16Dec2021, Prev dose administration time= 03:00 PM, Prev dose dose number=1, Prev dose Vaccine location= Left arm), administration date: 16Dec2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "After my first vaccine my menstrual lasted 10 days". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "I started releasing big blood clots for 5 days"; OLIGOMENORRHOEA (non-serious), outcome "unknown", described as "my menstrual lasted 20 days". Therapeutic measures were taken as a result of heavy menstrual bleeding, oligomenorrhoea.  Additional information; covid prior vaccination, If covid not tested post vaccination, Not Known allergies. If other vaccine not in four weeks, Other medications not in two weeks. After my first vaccine my menstrual lasted 10 days. After my 2nd dose on the 23Dec2021 I started releasing big blood clots for 5 days my menstrual lasted20 days. Had to get prescribed medication so it could slow it down lost alot of blood.  No follow-up attempts are possible. No further information is expected