chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Bursitis, Pain, Sleep disorder
Clinical narrative: had arthritis in these areas; The pain interrupted his sleep; pain in his left hip, left arm, left lower back, feet and left shoulder; right arm/shoulder felt like bursitis; This is a spontaneous report from a contactable consumer (patient himself). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in right arm on an unspecified date (age at vaccination: 74 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was hypertension, blood cholesterol and arthritis.Concomitant medication included lisinopril taken for hypertension for over 10 years and was ongoing; simvastatin taken for blood cholesterol for over 10 years and was ongoing; famotidine taken for reflux from 2019 and ongoing. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 and the patient experienced low grade "flu", body aches and was sleeping a lot. On an unknown date, the patient experienced had arthritis in these areas, the pain interrupted his sleep. On an unknown date in Mar2021, the patient's right arm/shoulder felt like bursitis, pain in his left hip, left arm, left lower back, feet and left shoulder. It felt bad and achy. The event of arthritis was determined to be medically significant. His doctor had information where it could areas prone to arthritis. This started a couple days after getting the second dose. The patient took Aleve as treatment for the adverse events. If he did anything like driving the tractor and turning it became aggravated. He has been going to physical therapy for arthritis and was not had any problems in over 10 years. His doctor prescribed him steroids. He will see the doctor next Monday for a routine check-up. The adverse events did not require a visit to emergency room or physician's office. The patient did not receive any prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. The outcome of arthritis and sleep disorder was unknown; outcome of other events was not recovered.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Ventricular extrasystoles
Clinical narrative: also found to have high rate of PVCs a couple of days after her second Pfizer covid dose; This is a spontaneous report from a contactable other health care professional.   A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 01May2021 as dose 2 single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reported that patient had no covid prior vaccination and not tested covid post vaccination, no known allergies reported. Reported that patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received other medications within 2 weeks of vaccination. patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on unspecified date as dose 1 single for covid-19 immunisation. it was reported that after a couple of days of receiving second dose of covid vaccine, patient experienced very high rate of premature ventricular contractions PVCs - cardiologist found normal echocardiogram but 7-day cardiac ambulant EKG monitor showed PVCs at 6% of the time. patient biological parent (mother, 71yrs) was also found to have high rate of PVCs a couple of days after her second Pfizer covid dose. On 05May2021, the patient experienced also found to have high rate of PVCs a couple of days after her second pfizer covid dose. AE resulted in doctor or other healthcare professional office/clinic visit, no treatment received for events. device time stamp: 22Jun2021. The patient underwent lab tests and procedures which included echocardiogram resulted as normal, cardiac ambulant EKG monitor resulted as PVCs at 6% of the time (7-day cardiac ambulant EKG monitor showed PVCs at 6% of the time) on an unspecified date. The outcome of event was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: The event of Premature Ventricular systole is assessed as possibly related to the suspect product  BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's familial medical history. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Inappropriate schedule of product administration
Clinical narrative: female patient received the first dose on 08May2021 and second dose on 08May2021 for covid-19 immunisation; fatigue; hard time of breathing; This is a spontaneous report from contactable consumer. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0176) via an unspecified route of administration, administered in Arm Left on 08May2021 at 13:00 and second dose via an unspecified route of administration, administered in Arm Left on 08May2021 (Batch/Lot Number: EW0185) as single dose for covid-19 immunisation. The patient's relevant medical history included drug hypersensitivity from penicillin. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jun2021 at 12:30 PM, patient experienced fatigue and had a momentary hard time of breathing. Patient ended up laying down for about 15 minutes and was able to continue the day. AE resulted in congenital anomaly or birth defect. Patient did not received any treatment. The outcome of the events fatigue and hard time of breathing was recovered on 22Jun2021 and another event was unknown.   Information on Lot/Batch number was available. Additional information has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Dyspnoea, Fatigue, Lacrimation increased
Clinical narrative: Constant migraines ×4days; Body aches; Tiredness; Cough; Runny nose; Loss of voice; Blurry vision; Swelling to injection site; Watery eyes; Congestion; Sob; This is a spontaneous report from a contactable other health care professional.  A 42-years-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0175), via an unspecified route of administration, in left arm (at the age of 42-year-old) on 02Jun2021 16:00 at a dose number unknown, single as for covid-19 immunization. Medical history included Arthritis, Depression, Anxiety, PTSD, COVID-19. Concomitant medications included diclofenac taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021 20:00 the patient experienced constant migraines for 4days, body aches, tiredness, cough, runny nose, loss of voice, blurry vision, swelling to injection site, watery eyes, congestion, sob. The patient did not receive any treatment. The outcome of events was recovered with sequelae on an unspecified date in Jun2021. Information on Lot/Batch number was available. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nasal congestion, Pain, Rhinorrhoea, Vaccination site swelling
Clinical narrative: Constant migraines ×4days; Body aches; Tiredness; Cough; Runny nose; Loss of voice; Blurry vision; Swelling to injection site; Watery eyes; Congestion; Sob; This is a spontaneous report from a contactable other health care professional.  A 42-years-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0175), via an unspecified route of administration, in left arm (at the age of 42-year-old) on 02Jun2021 16:00 at a dose number unknown, single as for covid-19 immunization. Medical history included Arthritis, Depression, Anxiety, PTSD, COVID-19. Concomitant medications included diclofenac taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021 20:00 the patient experienced constant migraines for 4days, body aches, tiredness, cough, runny nose, loss of voice, blurry vision, swelling to injection site, watery eyes, congestion, sob. The patient did not receive any treatment. The outcome of events was recovered with sequelae on an unspecified date in Jun2021. Information on Lot/Batch number was available. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Constant migraines ×4days; Body aches; Tiredness; Cough; Runny nose; Loss of voice; Blurry vision; Swelling to injection site; Watery eyes; Congestion; Sob; This is a spontaneous report from a contactable other health care professional.  A 42-years-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0175), via an unspecified route of administration, in left arm (at the age of 42-year-old) on 02Jun2021 16:00 at a dose number unknown, single as for covid-19 immunization. Medical history included Arthritis, Depression, Anxiety, PTSD, COVID-19. Concomitant medications included diclofenac taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021 20:00 the patient experienced constant migraines for 4days, body aches, tiredness, cough, runny nose, loss of voice, blurry vision, swelling to injection site, watery eyes, congestion, sob. The patient did not receive any treatment. The outcome of events was recovered with sequelae on an unspecified date in Jun2021. Information on Lot/Batch number was available. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: had blood spew out of the injection site; This is a spontaneous report from a contactable consumer. This consumer reported for 3 patients. This is 1 of the 3 reports.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: E19126), via an unspecified route of administration on 23Jan2021 (at the age of 73-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Jan2021, after receiving the second dose of vaccine, the patient lost a lot of blood, there was excess bleeding at the injection site. He was the third patient that had blood spew out of the injection site. It was explained that the bleeding lasted about an hour, it was not a lot but shot right out of the puncture, where the jab was at the injection site. The clinical outcome of the event was resolved on 23Jan2021.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021760094 same reporter/product/event, different patient
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic
Clinical narrative: Allergic rash all over his body; This is a spontaneous report received from a contactable nurse (Parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0191), via intramuscular route of administration on 18Jun2021 at 19:00 (at the age of 12-year-old), as dose 1, single in right arm for COVID-19 immunisation. The patient's medical history was reported as none. Concomitant medications were not reported. On 21Jun2021, 2 days and 5 hours after the administration of first dose of vaccine, the patient experienced allergic rash all over body. The patient received vaccine on 18Jun2021, Friday and on 21Jun2021 night, he began to have rash, like an allergic rash all over the body. Patient never had this before and the reporter did not know if it was related to vaccine. Patient was taken to doctor at the urgent care, where he was prescribed with Prednisone 20 mg 1 tablet by mouth daily for 3 days and Benadryl 25 milligrams. Reporter attributed the events to vaccine because that was the only thing that was different since the rash broke out. Therapeutic measures were taken as a result of allergic rash all over body and no lab works were performed. Patient was due for his second dose on 09Jul2021. The clinical outcome of the event was unknown.; Sender's Comments: Based on known drug safety profile and close temporal association, the event of allergic rash is assessed as related to the product BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: He is be vomiting, ever since Saturday.; This is a spontaneous report received from a contactable consumer reported for patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter enquired that the new virus is out. The delta, could you tell what the signs and symptoms are there because reporter's nephew might have it because he is be vomiting ever since saturday, five days later. Reporter's nephew might have the strain because he has kept vomit ever since then so, need to contact somebody as soon as possible. Reporter stated you are pharmacist, let me ask you the same. What could have make him vomiting since saturday and he can't stop it. He has been vomiting since saturday he cannot hold anything on his stomach not even water. We tried soup we tried everything, to come to emergency room he vomit come around out there and he still doing the same thing, so what could have happen to him that made him vomit like this. Did you know anything that possibly happen to the person make them vomiting, while you being a pharmacist, you know medicine and you know lot of other stuff may be you may have some suggestions, It could be poisonous or what could it be could it be tummy ache or what. The outcome of event was unknown.  Information about batch/Lot number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Rash, Urticaria
Clinical narrative: Anaphylaxis; Rash; urticaria; This is a spontaneous report from a contactable Physician. This Physician reported in response to other health professional letter [sent to physician] via follow-up.  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via intramuscular in the right deltoid on 12Apr2021 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included history of previous allergies to PNC (penicillin), codeine, amitriptyline and latex. Patient received antihistamine for the treatment of allergies. Concomitant medications included trazodone, vitamin C (ascorbic acid), calcium citrate, linum usitatissimum seed (FLAXSEED), topiramate (TOPAMAX), zolmitriptan (ZOMIG), norethindrone (norethisterone), ethestradiol (desogestrel, ethinylestradiol (ETHISTREL)), esomeprazole sodium (NEXIUM), valaciclovir hydrochloride (VALTREX), linaclotide (LINZESS), cyanocobalamin (VITAMIN B12), and colecalciferol (VITAMIN D) all taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7534), via intramuscular in the left deltoid on 22Mar2021 (at the age of 61-years-old) as dose 1, single for covid-19 immunisation and on an unknown date in Mar2021 patient had rash/hives. The patient did not receive any recent vaccines, for any other conditions and for SARS-CoV2 other than Pfizer-BioNTech Covid-19 Vaccine, prior to the event being reported. On 13Apr2021, the patient experienced anaphylaxis with signs and symptoms rash and urticaria. First saw patient on 13Apr2021, 1 day after 2nd dose, she reported rash/hives since 1st dose in Mar. The patient required medical intervention with corticosteroids and antihistamine. It was reported that Pfizer product had a causal effect to the adverse event. The outcome of all the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Anaphylaxis, rash, urticaria and the suspect drug BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cataract, Dizziness, Nasopharyngitis, Weight increased
Clinical narrative: cataract; Flare up asthma; cold; dizzy; weight gain; This is a spontaneous report from non-contactable consumer (patient) by Pfizer. A  78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included ongoing severe asthma, high cholesterol, high blood pressure, inflammation, fluid around heart, depression, forgetfulness, headaches and reflux. Concomitant medications included omalizumab (XOLAIR), prednisone, montelukast, atorvastatin, azelastine (AZELASTINE HCL), albuterol sulfate, fluticasone propionate, salmeterol (WIXELA INHUB), hydrochlorothiazide, tiotropium bromide (SPIRIVA RESPIMAT), theophylline, amlodipine, pantoprazole all taken for an unspecified indication and start and stop date were not reported. On an unspecified date, the patient experienced cataract, flare up asthma, cold, dizzy and weight gain. The outcome of the reported events was unknown.  No further information was reported. Information on the lot/ batch number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: chest pain; difficulty breathing; This is a spontaneous report from a contactable nurse. A 20-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL9581), via intramuscular, administered in Arm Left on 18Feb2021 (at the age of 20-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number=EN9262) via intramuscular route of administration in left arm on 22Jan2021 as 1st dose, single for covid 19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021 03:00, Patient reported chest pain and difficulty breathing and reported to ED. He was given Benedryl and morphine and stated that he was fine four hours later. He followed up with his PCP. Therapeutic measures were taken as a result of chest pain (chest pain), difficulty breathing (dyspnoea). Treatment received for the adverse event was Benedryl and morphine. The outcome of the vents was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted event chest pain cannot be excluded based on a compatible temporal relation.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received first Pfizer vaccine 03Mar2021 days after that the patient tested positive for COVID-19; Patient received first Pfizer vaccine 03Mar2021 days after that the patient tested positive for COVID-19; This is a spontaneous report from a non-contactable other healthcare professional via regulatory authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Mar2021, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, and days after receiving the first dose of vaccine, the patient was tested positive for COVID-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive, on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eye swelling, Hypersensitivity, Pharyngeal swelling, Rash
Clinical narrative: allergic reaction; after the first dose she experienced puffy, swollen, and breaking out of the face. Caller states she also felt like her throat was swelling; after the first dose she experienced puffy, swollen, and breaking out of the face. Caller states she also felt like her throat was swelling; after the first dose she experienced puffy, swollen, and breaking out of the face. Caller states she also felt like her throat was swelling; her face broke out and eye swoll up, mainly one eye, but eyes were puffy; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number and expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 19Apr2021 at14:30 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. She did not receive any vaccination prior. On unspecified date, the patient experienced allergic reaction (hypersensitivity) after the first dose she experienced puffy, swollen, and breaking out of the face. caller states she also felt like her throat was swelling (pharyngeal swelling) (skin swelling) (rash) (eye swelling). The patient underwent lab tests and procedures which included blood pressure measurement as 143/111 on unknown date. The outcome of the events Hypersensitivity was recovered, and rest of the events were unknown.  Follow up needed; Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling
Clinical narrative: allergic reaction; after the first dose she experienced puffy, swollen, and breaking out of the face. Caller states she also felt like her throat was swelling; after the first dose she experienced puffy, swollen, and breaking out of the face. Caller states she also felt like her throat was swelling; after the first dose she experienced puffy, swollen, and breaking out of the face. Caller states she also felt like her throat was swelling; her face broke out and eye swoll up, mainly one eye, but eyes were puffy; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number and expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 19Apr2021 at14:30 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. She did not receive any vaccination prior. On unspecified date, the patient experienced allergic reaction (hypersensitivity) after the first dose she experienced puffy, swollen, and breaking out of the face. caller states she also felt like her throat was swelling (pharyngeal swelling) (skin swelling) (rash) (eye swelling). The patient underwent lab tests and procedures which included blood pressure measurement as 143/111 on unknown date. The outcome of the events Hypersensitivity was recovered, and rest of the events were unknown.  Follow up needed; Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Erection increased, Priapism
Clinical narrative: this condition causes him to have erections that last for long periods of time/preexisting condition has seemed to flare since having the dose; Low Flow Priapism/this condition causes him to have erections that last for long periods of time/preexisting condition has seemed to flare since having the dose; Low Flow Priapism; This is a spontaneous report from a contactable consumer (patient, self-reported). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jun2021, as a single dose for COVID-19 immunization. The patient's medical history included low flow priapism (I have a pre-existing condition called Low Flow Priapism). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0183 and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and no events reported. The patient reported that he received the 2nd dose of the Pfizer COVID19 vaccination on 11Jun2021. Since having the 2nd dose his "pre-existing condition has seemed to flare since having the dose." The patient reported having been previously diagnosed with "Low Flow Priapism." He states that on an unspecified date in Jun2021, this condition causes him to have erections that last for long periods of time, "generally speaking they can go anywhere to a day and sometimes become medical emergencies." Since having the 2nd dose of the vaccine, he stated that he has been having these concerns "quite often" which has not been the case in "some time." The patient advised after review of the prescribing information for Pfizer COVID19 vaccine he did not find information regarding prolonged erections or any data related to his diagnosis of Low Flow Priapism. Encouraged the patient to follow up with HCP to aid in medical decision making at this time based upon his condition and worsening symptoms also advised that all reported AEs were followed up on after being reported and studies remain ongoing. He was wondering, if you guys have heard of anything, anybody having the same issue flaring up after the COVID vaccine. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy testes, Fatigue, Granuloma annulare, Herpes zoster
Clinical narrative: patient had biopsies and the result was granuloma annulare possibly caused by vaccines.; initial fatigue for a couple of days; patient had shingles, patient thought to be caused by body's immune response to the shot. The rash from shingles never went away it has now spread over about 30% of body.; This is a spontaneous report from a contactable nurse (patient). A patient of an unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not provided), via an unspecified route of administration in an unspecified anatomical location on an unknown date, as single dose for COVID-19 immunization. The patient's medication history and concomitant medication were not reported. Patient was among the first nurses to receive the COVID vaccine in December/January. Other than the initial fatigue for a couple of days, patient had none of the bad side effects. On an unknown date in Feb2021, patient had shingles, patient thought to be caused by body's immune response to the shot. The rash from shingles never went away it has now spread over about 30% of body. Recently patient had biopsies on an unknown date and the result was granuloma annulare and possibly caused by vaccines. The patient underwent lab tests and procedures which included: biopsies: granuloma annulare and possibly caused by vaccines on an unknown date. Outcome of the event shingles was not resolved and outcome for other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event fatigue and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event Shingles, Granuloma annulare 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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hemiparesis, Hypertension, Inflammation, Insomnia
Clinical narrative: Baker's cyst under knee burst; Covid-19 vaccine inflamed her immune system; ordered an ultrasound of the caller's leg because they thought it was a DVT; Crazy leg problem; Tinnitus; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 14:00 (age at vaccination 50-years) (Batch/Lot Number: EW0153) as DOSE 1,SINGLE for covid-19 immunisation. Medical history included ongoing hypothyroidism (diagnose when she was 25 years old), ongoing diabetes insipidus (was diagnosed 9 years ago), ongoing autoimmune condition.  Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing (taking from when she was 25 years old, so 25 years ago); desmopressin taken for diabetes insipidus, start and stop date were not reported (started taking Desmopressin 9 years ago). Caller reported that she had seen 2 doctors and it seems like no one wants to report anything Caller reported that within 2 days of receiving the Covid-19 vaccine on 14Apr2021, she started getting a crazy leg problem on 16Apr2021.  Caller reported that her primary care doctor ordered an ultrasound of the caller's leg because they thought it was a DVT on 16Apr2012. Caller reported that the Covid-19 vaccine threw her immune system off. Caller reported that she began having fibromyalgia symptoms, but she did not have fibromyalgia. Caller reported that the Covid-19 vaccine caused inflammation.  Caller reported that the leg problem started in her right calf. she had fasciculations in her right calf, then her left calf. she then started getting internal vibrations or tremors.  Caller reported that it was now occurring in her left arm. Caller reported that she was going to see a rheumatologist. Covid-19 vaccine inflamed her immune system on 16Apr2021 and it happened 2 days after she received the vaccine. Caller reported that she was afraid to give the Covid-19 vaccine to her kid. Autoimmune conditions run in her family and stated that she didn't know how much testing had been done of the Covid-19 vaccine on people with autoimmune conditions. Regarding Crazy leg thing Caller reported that it went from her right leg to her left leg to her left arm.  Caller reported that it took forever to get to the rheumatologist and she was not even getting into them until 30Jun2021. She began experiencing tinnitus about 2 weeks after she received the Covid-19 vaccine (Apr2021). Patient did not receive second dose of Covid-19 vaccine Caller reported that after her reaction, her doctor instructed her to hold off on the second dose. Patient experienced baker's cyst under knee burst on an unspecified date. Outcome of the event Baker's cyst under knee burst and Covid-19 vaccine inflamed her immune system was unknown. Outcome of the other events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Ultrasound Doppler, Vibratory sense increased, Vision blurred
Clinical narrative: Baker's cyst under knee burst; Covid-19 vaccine inflamed her immune system; ordered an ultrasound of the caller's leg because they thought it was a DVT; Crazy leg problem; Tinnitus; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 14:00 (age at vaccination 50-years) (Batch/Lot Number: EW0153) as DOSE 1,SINGLE for covid-19 immunisation. Medical history included ongoing hypothyroidism (diagnose when she was 25 years old), ongoing diabetes insipidus (was diagnosed 9 years ago), ongoing autoimmune condition.  Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing (taking from when she was 25 years old, so 25 years ago); desmopressin taken for diabetes insipidus, start and stop date were not reported (started taking Desmopressin 9 years ago). Caller reported that she had seen 2 doctors and it seems like no one wants to report anything Caller reported that within 2 days of receiving the Covid-19 vaccine on 14Apr2021, she started getting a crazy leg problem on 16Apr2021.  Caller reported that her primary care doctor ordered an ultrasound of the caller's leg because they thought it was a DVT on 16Apr2012. Caller reported that the Covid-19 vaccine threw her immune system off. Caller reported that she began having fibromyalgia symptoms, but she did not have fibromyalgia. Caller reported that the Covid-19 vaccine caused inflammation.  Caller reported that the leg problem started in her right calf. she had fasciculations in her right calf, then her left calf. she then started getting internal vibrations or tremors.  Caller reported that it was now occurring in her left arm. Caller reported that she was going to see a rheumatologist. Covid-19 vaccine inflamed her immune system on 16Apr2021 and it happened 2 days after she received the vaccine. Caller reported that she was afraid to give the Covid-19 vaccine to her kid. Autoimmune conditions run in her family and stated that she didn't know how much testing had been done of the Covid-19 vaccine on people with autoimmune conditions. Regarding Crazy leg thing Caller reported that it went from her right leg to her left leg to her left arm.  Caller reported that it took forever to get to the rheumatologist and she was not even getting into them until 30Jun2021. She began experiencing tinnitus about 2 weeks after she received the Covid-19 vaccine (Apr2021). Patient did not receive second dose of Covid-19 vaccine Caller reported that after her reaction, her doctor instructed her to hold off on the second dose. Patient experienced baker's cyst under knee burst on an unspecified date. Outcome of the event Baker's cyst under knee burst and Covid-19 vaccine inflamed her immune system was unknown. Outcome of the other events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Herpes zoster, Malaise, Pharyngitis streptococcal
Clinical narrative: Messed up Afib; Not feeling good; It has been one thing after the another; Shingles; Strep throat; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2, second single dose via an unspecified route of administration on 28Apr2021 (Batch/Lot Number: EW0162) for covid-19 immunisation. The patient previously received first dose of bnt162b2 on an unspecified date (LOT number: EW0150). The patient's medical history and concomitant medications were not reported. The patient got second vaccination and still not feeling good and it had been one thing after the another and started off hours after the second vaccination. The patient got the shingles and then had strep throat and then there was congestion and it also messed up Afib. The patient mentioned it was almost like the symptoms from COVID. Outcome of the events was unknown.   Follow up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling abnormal, Hair disorder, Head discomfort
Clinical narrative: I have pressure over 180/ blood pressure was really high; my monthly period was been really strong for example in one period, I got like twice, if like I had two periods in one month; Head hurts; Body ache; Felt really bad; all the time I feel really nervous; sickness, of course for a week of sickness; I have headache like stains on my hair; I haven't been sleeping/ not able to sleep; I have headache like stains on my hair; I feel really bad since I got vaccinated, I don't know if there was any ingredient that mad me reaction; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry Date: unknown), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that the patient was not doing well and felt really bad since get vaccinated, the patient did not know if there was any ingredient that made her any reaction. It was reported that the patient experienced symptoms since the first dosage. The patient haven't been sleeping, had pressure over 180, headache like stains on her hair (further clarification required). The patient monthly period was been really strong for example in one period, patient got like twice, if like patient had two periods in one month and all the time patient felt really nervous. The patient cannot sleep a long ago, had the body ache and taken treatment with Advil that Ibuprofen, but still felt that. The patient was can't even stand sometimes, head hurts a lot. The patient husband stated that his wife felt ill, could not sleep and so not feeling well the problem was that we tried to take her to the emergency room then told that we shouldn't be taking her to the emergency room but on the computer to get the pills and they give to her but that's not because they told not to go back anymore. The patient felt sickness, of course for a week of sickness. It was stated that the patient was not able to sleep because her blood pressure was really high and she was not having any issue with her blood pressure. The patient received second dose of bnt162b2 on 19Apr2021. The clinical outcome for the event of body ache was not recovered and remaining all events outcome was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Illness, Insomnia, Malaise
Clinical narrative: I have pressure over 180/ blood pressure was really high; my monthly period was been really strong for example in one period, I got like twice, if like I had two periods in one month; Head hurts; Body ache; Felt really bad; all the time I feel really nervous; sickness, of course for a week of sickness; I have headache like stains on my hair; I haven't been sleeping/ not able to sleep; I have headache like stains on my hair; I feel really bad since I got vaccinated, I don't know if there was any ingredient that mad me reaction; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry Date: unknown), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that the patient was not doing well and felt really bad since get vaccinated, the patient did not know if there was any ingredient that made her any reaction. It was reported that the patient experienced symptoms since the first dosage. The patient haven't been sleeping, had pressure over 180, headache like stains on her hair (further clarification required). The patient monthly period was been really strong for example in one period, patient got like twice, if like patient had two periods in one month and all the time patient felt really nervous. The patient cannot sleep a long ago, had the body ache and taken treatment with Advil that Ibuprofen, but still felt that. The patient was can't even stand sometimes, head hurts a lot. The patient husband stated that his wife felt ill, could not sleep and so not feeling well the problem was that we tried to take her to the emergency room then told that we shouldn't be taking her to the emergency room but on the computer to get the pills and they give to her but that's not because they told not to go back anymore. The patient felt sickness, of course for a week of sickness. It was stated that the patient was not able to sleep because her blood pressure was really high and she was not having any issue with her blood pressure. The patient received second dose of bnt162b2 on 19Apr2021. The clinical outcome for the event of body ache was not recovered and remaining all events outcome was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain, Product formulation issue
Clinical narrative: I have pressure over 180/ blood pressure was really high; my monthly period was been really strong for example in one period, I got like twice, if like I had two periods in one month; Head hurts; Body ache; Felt really bad; all the time I feel really nervous; sickness, of course for a week of sickness; I have headache like stains on my hair; I haven't been sleeping/ not able to sleep; I have headache like stains on my hair; I feel really bad since I got vaccinated, I don't know if there was any ingredient that mad me reaction; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry Date: unknown), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that the patient was not doing well and felt really bad since get vaccinated, the patient did not know if there was any ingredient that made her any reaction. It was reported that the patient experienced symptoms since the first dosage. The patient haven't been sleeping, had pressure over 180, headache like stains on her hair (further clarification required). The patient monthly period was been really strong for example in one period, patient got like twice, if like patient had two periods in one month and all the time patient felt really nervous. The patient cannot sleep a long ago, had the body ache and taken treatment with Advil that Ibuprofen, but still felt that. The patient was can't even stand sometimes, head hurts a lot. The patient husband stated that his wife felt ill, could not sleep and so not feeling well the problem was that we tried to take her to the emergency room then told that we shouldn't be taking her to the emergency room but on the computer to get the pills and they give to her but that's not because they told not to go back anymore. The patient felt sickness, of course for a week of sickness. It was stated that the patient was not able to sleep because her blood pressure was really high and she was not having any issue with her blood pressure. The patient received second dose of bnt162b2 on 19Apr2021. The clinical outcome for the event of body ache was not recovered and remaining all events outcome was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.