chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dermatitis contact, Diarrhoea, Dyspnoea, Oedema peripheral
Clinical narrative: Thrombosis; Palpitations; chest Discomfort; Oedema peripheral; Diarrhoea; Dyspnoea; weight Increased; Oxygen Saturation Decreased; Dermatitis Contact; This is a spontaneous report received from the Regulatory Authority. The regulatory authority report number is 18848208.   A contactable consumer reported for 41-year-old female patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; macitentan (OPSUMIT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; and treprostinil sodium (REMODULIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication included sildenafil citrate. The patient experienced palpitations, chest discomfort, thrombosis, oedema peripheral, diarrhoea, dyspnoea, weight increased, oxygen saturation decreased, dermatitis contact in Jan2021. The patient was admitted for the events. The action taken in response to the events for treprostinil and macitentan was unknown. Outcome of the events was unknown. The case was reported as serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (19Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Palpitations, Thrombosis, Weight
Clinical narrative: Thrombosis; Palpitations; chest Discomfort; Oedema peripheral; Diarrhoea; Dyspnoea; weight Increased; Oxygen Saturation Decreased; Dermatitis Contact; This is a spontaneous report received from the Regulatory Authority. The regulatory authority report number is 18848208.   A contactable consumer reported for 41-year-old female patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; macitentan (OPSUMIT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; and treprostinil sodium (REMODULIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication included sildenafil citrate. The patient experienced palpitations, chest discomfort, thrombosis, oedema peripheral, diarrhoea, dyspnoea, weight increased, oxygen saturation decreased, dermatitis contact in Jan2021. The patient was admitted for the events. The action taken in response to the events for treprostinil and macitentan was unknown. Outcome of the events was unknown. The case was reported as serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (19Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Thrombosis; Palpitations; chest Discomfort; Oedema peripheral; Diarrhoea; Dyspnoea; weight Increased; Oxygen Saturation Decreased; Dermatitis Contact; This is a spontaneous report received from the Regulatory Authority. The regulatory authority report number is 18848208.   A contactable consumer reported for 41-year-old female patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation; macitentan (OPSUMIT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; and treprostinil sodium (REMODULIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication included sildenafil citrate. The patient experienced palpitations, chest discomfort, thrombosis, oedema peripheral, diarrhoea, dyspnoea, weight increased, oxygen saturation decreased, dermatitis contact in Jan2021. The patient was admitted for the events. The action taken in response to the events for treprostinil and macitentan was unknown. Outcome of the events was unknown. The case was reported as serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (19Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol, Fatigue, Vaccination site pain
Clinical narrative: extreme tiredness; soreness in the injection spot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Lot number: EP7534, Expiration Date: 31Jul2021) as dose 1, single and administration date 06Apr2021 (Lot number: ER8734, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol was middle to middle high" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "extreme tiredness"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "soreness in the injection spot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, vaccination site pain.  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations after getting the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Medical Information Team for a Pfizer-sponsored program (159558).  A 35 year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation; escitalopram oxalate (LEXAPRO), oral (Batch/Lot number: unknown) till 2021 at 10 mg 1x/day for anxiety. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PALPITATIONS (non-serious) with onset 2021, outcome "recovering", described as "heart palpitations after getting the vaccine". The event "heart palpitations after getting the vaccine" was evaluated at the physician office visit. The action taken for escitalopram oxalate was dosage permanently withdrawn on 2021. Additional information: The patient recently started seeing the doctor that she worked for and reported feeling heart palpitations after getting Pfizer COVID vaccine. The patient had been taking Lexapro for about 7 years and has been off Lexapro since about two months ago, after getting the second dose of the vaccine. The reporter said it would have been during the last 5 months after vaccine, and the patient said with Lexapro the vaccine increased heart palpitations. The patient did say her heart palpitations were better after being off Lexapro. The reporter clarified that the patient is on Lexapro, and not Zoloft, and she didn't experience palpitations before taking the vaccine, so they wanted to know if they had reports of this before. The reporter was looking to see if reactions were reported with Zoloft since Pfizer manufactures Zoloft, which was another SSRI, and if reactions were reported with SSRIs.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electric shock sensation, Heavy menstrual bleeding, Lymphadenopathy, Nausea
Clinical narrative: Menstrual bleeding; large golf ball size swollen gland under left arm; dizziness; nausea; electric shock feeling in head.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 15:30 (Lot number: FH8030) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 06Nov2021 23:00, outcome "not recovered", described as "Menstrual bleeding"; LYMPHADENOPATHY (non-serious) with onset 06Nov2021 23:00, outcome "not recovered", described as "large golf ball size swollen gland under left arm"; DIZZINESS (non-serious) with onset 06Nov2021 23:00, outcome "not recovered", described as "dizziness"; NAUSEA (non-serious) with onset 06Nov2021 23:00, outcome "not recovered", described as "nausea"; ELECTRIC SHOCK SENSATION (non-serious) with onset 06Nov2021 23:00, outcome "not recovered", described as "electric shock feeling in head.". Therapeutic measures were not taken as a result of heavy menstrual bleeding, lymphadenopathy, dizziness, nausea, electric shock sensation.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. Known allergy was reported as none. Patient did not receive any other medication within 2 weeks of vaccination. It was unknown if the patient received any other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Baseball/softball sized lymph node swelling in injection arm under armpit less than 48 hrs later.; Fever; body ache; exhaustion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Nov2021 at 16:45 PM (Lot number: FF2590) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bo, reaction(s): "Known allergies: Bo". The patient was diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 12Nov2021, outcome "not recovered", described as "Baseball/softball sized lymph node swelling in injection arm under armpit less than 48 hrs later."; PYREXIA (non-serious) with onset 12Nov2021, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset 12Nov2021, outcome "not recovered", described as "body ache"; FATIGUE (non-serious) with onset 12Nov2021, outcome "not recovered", described as "exhaustion". The events "baseball/softball sized lymph node swelling in injection arm under armpit less than 48 hrs later.", "fever", "body ache" and "exhaustion" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of lymphadenopathy, pyrexia, pain, fatigue included antiinflammatory medication.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administration date 10Apr2021 (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: Covid-19 vaccine (First dose covid-19 vaccine), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset May2021, outcome "unknown", described as "Stroke".  Clinical course: The caller is calling in regards to the Covid vaccine. She explains she took the first shot and then had the second one on 10Apr2021. Exactly, 28 days later, she  had a stroke. She is calling to ask if she needs to get the booster shot? The caller declines to complete a report at this time, stating she is seeking advice on whether or not to get the booster or not. She states she will call back and give her information at a later time, but she is concerned on whether she should get the booster as soon as possible. She clarifies further she is willing to give the information but not right now. She wants to find out if she should receive the booster or not. The caller states on Pfizer's website it says if anyone has had a severe reaction to the Moderna or Pfizer vaccine, any person should not get further vaccines, so she is assuming its recommending her to not get the booster?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Mobility decreased, Pain in extremity, Vaccination site eczema
Clinical narrative: heart rate jumped up pretty high; injection site was raised it is red, its hot, there are bumps on it, and it itches; injection site was raised it is red, its hot, there are bumps on it, and it itches; injection site was raised it is red, its hot, there are bumps on it, and it itches; injection site was raised it is red, its hot, there are bumps on it, and it itches; arm hurts and she can barely raise or move it at all; arm hurts and she can barely raise or move it at all; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 (Lot number: SH8030) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: ER8727), administration date: 24Apr2021, when the patient was 31 years old, for COVID-19 Immunization, reaction(s): "felt sick for a couple of days"; Bnt162b2 (Second dose, Lot: EW0168), administration date: 15May2021, when the patient was 31 years old, for COVID-19 Immunization, reaction(s): "felt sick for a couple of days". The following information was reported: HEART RATE INCREASED (non-serious) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "heart rate jumped up pretty high"; VACCINATION SITE ECZEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 16Nov2021, outcome "not recovered" and all described as "injection site was raised it is red, its hot, there are bumps on it, and it itches"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious) all with onset 16Nov2021, outcome "not recovered" and all described as "arm hurts and she can barely raise or move it at all". The events "heart rate jumped up pretty high", "injection site was raised it is red, its hot, there are bumps on it, and it itches", "injection site was raised it is red, its hot, there are bumps on it, and it itches", "injection site was raised it is red, its hot, there are bumps on it, and it itches", "injection site was raised it is red, its hot, there are bumps on it, and it itches", "arm hurts and she can barely raise or move it at all" and "arm hurts and she can barely raise or move it at all" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: time the vaccination was given: between 18: 00-19: 00. She called her primary care and has an appointment for tomorrow.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: heart rate jumped up pretty high; injection site was raised it is red, its hot, there are bumps on it, and it itches; injection site was raised it is red, its hot, there are bumps on it, and it itches; injection site was raised it is red, its hot, there are bumps on it, and it itches; injection site was raised it is red, its hot, there are bumps on it, and it itches; arm hurts and she can barely raise or move it at all; arm hurts and she can barely raise or move it at all; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 (Lot number: SH8030) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: ER8727), administration date: 24Apr2021, when the patient was 31 years old, for COVID-19 Immunization, reaction(s): "felt sick for a couple of days"; Bnt162b2 (Second dose, Lot: EW0168), administration date: 15May2021, when the patient was 31 years old, for COVID-19 Immunization, reaction(s): "felt sick for a couple of days". The following information was reported: HEART RATE INCREASED (non-serious) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "heart rate jumped up pretty high"; VACCINATION SITE ECZEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 16Nov2021, outcome "not recovered" and all described as "injection site was raised it is red, its hot, there are bumps on it, and it itches"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious) all with onset 16Nov2021, outcome "not recovered" and all described as "arm hurts and she can barely raise or move it at all". The events "heart rate jumped up pretty high", "injection site was raised it is red, its hot, there are bumps on it, and it itches", "injection site was raised it is red, its hot, there are bumps on it, and it itches", "injection site was raised it is red, its hot, there are bumps on it, and it itches", "injection site was raised it is red, its hot, there are bumps on it, and it itches", "arm hurts and she can barely raise or move it at all" and "arm hurts and she can barely raise or move it at all" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: time the vaccination was given: between 18: 00-19: 00. She called her primary care and has an appointment for tomorrow.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itchy; Severe rash all over his body; Red especially in his arms, elbows, face, neck, ears, legs; This is a spontaneous report received from a contactable consumer (patient's mother) from the Medical Information Team. A 6-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, administration date 10Nov2021 14:00 (lot number: FK5127) at the age of 6 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medications included an unspecified flu nasal spray from 27Oct2021. The following information was reported: On 11Nov2021 08:00, the patient experienced severe rash all over his body and the patient was really itchy. The mother also noticed that the patient was red especially in his arms and elbows, then on a Monday (unspecified date in Nov2021), it started on his face and neck, and on a Tuesday (unspecified date in Nov2021), it was in his ears and legs too. The patient's mother started him on Zyrtec on Sunday night (unspecified date in Nov2021) and the doctor changed it to Allegra liquid 5mg once a day, so the patient does not get drowsy or sleepy to go to school during the day. Hydrocortisone 2.5% was used as needed for when the patient was very itchy on his elbow. The events were occurring more and more on the patient's body even with the medications. The mother was concerned for the patient, and his next shot was scheduled on 01Dec2021. The events resulted in emergency room visit and physician office visit. The outcome of the events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow-up.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Major heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 43 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 16Nov2021 10:02 (Lot number: FH8027) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, Lot Number: FF2593), administration date: 26Oct2021, when the patient was 43 years old, for COVID-19 immunization, reaction(s): "pain in his arm", "carpal tunnel". The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "Major heart attack". The patient was hospitalized for myocardial infarction (start date: 17Nov2021). The event "major heart attack" was evaluated at the emergency room visit.  Follow-up attempts completed. No further information expected
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Pain in extremity, Peripheral nerve injury
Clinical narrative: must have hit a nerve with the first dose; Pain in left arm/radiating pain; carpal tunnel; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), patient's wife.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Lot number: FF2593) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Reporter denied any other medications, medical conditions, labs, testing, or treatments for the patient relevant to the events. There were no concomitant medications. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Reporter referred to Pfizer Covid Vaccine as "Toxic Poison." The patient got the first dose in his left arm and had pain in his arm. Within 4 days, he had radiating pain. He let it go and then eventually was seen and was told it was carpal tunnel. He was given a brace and sent on his way. When he went back for the second dose he told the people at the site about the pain in his arm and they told him that they must have hit a nerve with the first dose. The patient went to a city run site on purpose for the vaccine because there was medical staff there.  The following information was reported: PERIPHERAL NERVE INJURY (medically significant) with onset 26Oct2021, outcome "unknown", described as "must have hit a nerve with the first dose"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "Pain in left arm/radiating pain"; CARPAL TUNNEL SYNDROME (non-serious) with onset 2021, outcome "unknown", described as "carpal tunnel". Therapeutic measures were taken as a result of carpal tunnel syndrome. Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Flushing, Throat irritation
Clinical narrative: dizzy; Itchy back of throat; tightness in chest; flush face; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient. A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:15 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; LAMICTAL; VYTORIN; TYLENOL. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin". The following information was reported: DIZZINESS (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "dizzy"; THROAT IRRITATION (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "Itchy back of throat"; CHEST DISCOMFORT (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "tightness in chest"; FLUSHING (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "flush face". The events "dizzy", "itchy back of throat", "tightness in chest" and "flush face" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness, throat irritation, chest discomfort, flushing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Immunisation, Peripheral swelling, Psoriasis
Clinical narrative: Psoriatic arthritis more intense; extremely tired; swelling of legs feet; extreme pain in joints; psoriasis which became much more severe; dose received: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: 320308D) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "flu like symptoms"; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 12May2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "administration date=15Mar2021/ dose administration date=12May2021". No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 29Oct2021, outcome "unknown", described as "dose received: 3"; PSORIATIC ARTHROPATHY (medically significant) with onset 30Oct2021, outcome "recovering", described as "Psoriatic arthritis more intense"; FATIGUE (non-serious) with onset 30Oct2021, outcome "recovering", described as "extremely tired"; PERIPHERAL SWELLING (non-serious) with onset 30Oct2021, outcome "recovering", described as "swelling of legs feet"; ARTHRALGIA (non-serious) with onset 30Oct2021, outcome "recovering", described as "extreme pain in joints"; PSORIASIS (non-serious) with onset 30Oct2021, outcome "recovering", described as "psoriasis which became much more severe". The events "psoriatic arthritis more intense", "extremely tired", "swelling of legs feet", "extreme pain in joints" and "psoriasis which became much more severe" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of psoriatic arthropathy, fatigue, peripheral swelling, arthralgia, psoriasis. These events finally calm down 18Nov2021 and Outcome was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis more intense; extremely tired; swelling of legs feet; extreme pain in joints; psoriasis which became much more severe; dose received: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: 320308D) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "flu like symptoms"; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 12May2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "administration date=15Mar2021/ dose administration date=12May2021". No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 29Oct2021, outcome "unknown", described as "dose received: 3"; PSORIATIC ARTHROPATHY (medically significant) with onset 30Oct2021, outcome "recovering", described as "Psoriatic arthritis more intense"; FATIGUE (non-serious) with onset 30Oct2021, outcome "recovering", described as "extremely tired"; PERIPHERAL SWELLING (non-serious) with onset 30Oct2021, outcome "recovering", described as "swelling of legs feet"; ARTHRALGIA (non-serious) with onset 30Oct2021, outcome "recovering", described as "extreme pain in joints"; PSORIASIS (non-serious) with onset 30Oct2021, outcome "recovering", described as "psoriasis which became much more severe". The events "psoriatic arthritis more intense", "extremely tired", "swelling of legs feet", "extreme pain in joints" and "psoriasis which became much more severe" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of psoriatic arthropathy, fatigue, peripheral swelling, arthralgia, psoriasis. These events finally calm down 18Nov2021 and Outcome was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Breast tenderness, Chest discomfort, Fatigue
Clinical narrative: feel like I am going to die any minute. It's like someone injected poison in my body; feel sick; Breast pain and tenderness; going on the menopause; severe fatigue; can not even get out of the couch; Its feels like someone hit me in the chest; Breast pain and tenderness; severe joint ache; severe headache; 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), administration date 10Oct2021 (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: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feel like I am going to die any minute. It's like someone injected poison in my body"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "feel sick"; BREAST PAIN (non-serious), BREAST TENDERNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "Breast pain and tenderness"; MENOPAUSE (non-serious) with onset 2021, outcome "unknown", described as "going on the menopause"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "severe fatigue"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "can not even get out of the couch"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Its feels like someone hit me in the chest"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "severe joint ache"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "severe headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Loss of personal independence in daily activities, Malaise, Menopause
Clinical narrative: feel like I am going to die any minute. It's like someone injected poison in my body; feel sick; Breast pain and tenderness; going on the menopause; severe fatigue; can not even get out of the couch; Its feels like someone hit me in the chest; Breast pain and tenderness; severe joint ache; severe headache; 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), administration date 10Oct2021 (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: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feel like I am going to die any minute. It's like someone injected poison in my body"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "feel sick"; BREAST PAIN (non-serious), BREAST TENDERNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "Breast pain and tenderness"; MENOPAUSE (non-serious) with onset 2021, outcome "unknown", described as "going on the menopause"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "severe fatigue"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "can not even get out of the couch"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Its feels like someone hit me in the chest"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "severe joint ache"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "severe headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was tested positive for COVID-19; was tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "was tested positive for COVID-19". A female individual who received 2 doses of the Pfizer-BioNTech COVID-19 vaccine was tested positive for COVID-19. This was 6 month after Dose 2. Her symptoms included fever (99 F), sore throat, and tiredness. She still had her taste and smell.  The patient underwent the following laboratory tests and procedures: body temperature: (Nov2021) 99 Fahrenheit; sars-cov-2 test: (Nov2021) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Drug ineffective, Suspected COVID-19
Clinical narrative: Second one isn't going to be as effective anymore; Second one isn't going to be as effective anymore; She is still dealing with the anxiety; 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 32 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: she has been on anxiety medication Lorazepam for about two months prior to receiving her first Pfizer Covid 19 Vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Anxiety", "Concentration impaired", "Vertigo" like dizziness/ super dizzy", "Slurred speech like her brain couldn't catch up with her words", "Syllable stumbling", "Shortness of breathe", "Foggy feeling in head", "Weird feeling", "pain in arm", "Arms tingling", "Fever", "Fainting", ""Vertigo" like dizziness". The patient thought maybe she was just anxious about the side effects with the new vaccine because she was hesitant to receive it. Now she is going on her third week because her second vaccine is on the 26Nov2021 is the second one and she is still dealing with the anxiety, her medication is not working even the PRN. Per patient even her doctors are confused how come the medicine just stopped working. It was reported the second one isn't going to be as effective anymore.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Second one isn't going to be as effective anymore"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "She is still dealing with the anxiety".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: First vaccine :Heavy period with clots; First vaccine :Heavy period with clots; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (medically significant), HEAVY MENSTRUAL BLEEDING (medically significant) all with onset 10Oct2021, outcome "not recovered" and all described as "First vaccine :Heavy period with clots". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative. Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Oropharyngeal pain, Pruritus
Clinical narrative: Right arm and leg pruritus; he was feeling hot; throat pain; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 9- year-old male patient received Bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Nov2021 14:29 (Lot number: FK5127) at the age of 9 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "known allergies: peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: pruritus (medically significant) with onset 17Nov2021 14:45, outcome "unknown", described as "Right arm and leg pruritus"; feeling hot (medically significant) with onset 17Nov2021 14:45, outcome "unknown", described as "he was feeling hot"; oropharyngeal pain (medically significant) with onset 17Nov2021 14:45, outcome "unknown", described as "throat pain"; dizziness (medically significant) with onset 17Nov2021 14:45, outcome "unknown", described as "dizziness". The events "right arm and leg pruritus", "he was feeling hot", "throat pain" and "dizziness" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pruritus, feeling hot, oropharyngeal pain, dizziness. Events details was reported as follow: The patient was vaccinated Pfizer-BionTech COVID-19 Vaccine at 14:29 17Nov2021. Around 14:40 the observation nurse noted that the patient was fanning himself. The patient complained that he was feeling hot, Right arm and leg pruritus, new "throat pain" and dizziness. The observation nurse and POD lead then called 9-1-1 at 14:45 and initiated the anaphylaxis protocol. An epipen JR was administered (Lot #LFN341) IM to right thigh at 14:51 and at 14:57 0.4ml of Diphenhydramine (lot # 080008) was administered IM to R Deltoid by Nurse withheld. EMS arrived at 14:58 and hand off occurred to the EMS crew at 14:59. Transport to the ER occured at 15:05.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As per available information, the causal association between the reported events 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Feeling hot, Headache, Night sweats
Clinical narrative: maybe has covid/she and her son experienced the same kind of symptoms; maybe has covid/she and her son experienced the same kind of symptoms; Bad night sweats; tremors; low grade fever; headache; Fatigue; was hot; 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 female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "maybe has covid/she and her son experienced the same kind of symptoms"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Bad night sweats"; TREMOR (non-serious), outcome "unknown", described as "tremors"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; FEELING HOT (non-serious), outcome "unknown", described as "was hot".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101619284 same reporter /product, different patient, similar events
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19, Tremor
Clinical narrative: maybe has covid/she and her son experienced the same kind of symptoms; maybe has covid/she and her son experienced the same kind of symptoms; Bad night sweats; tremors; low grade fever; headache; Fatigue; was hot; 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 female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "maybe has covid/she and her son experienced the same kind of symptoms"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Bad night sweats"; TREMOR (non-serious), outcome "unknown", described as "tremors"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; FEELING HOT (non-serious), outcome "unknown", described as "was hot".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101619284 same reporter /product, different patient, similar events