chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Migraine, SARS-CoV-2 test, Vertigo
Clinical narrative: Migraines; Head pressure; Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Jul2021 13:15 (Lot number: FA7485) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "unspecified goiter" (unspecified if ongoing); "anemic" (unspecified if ongoing); "tree nuts allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; ABC SPECTRUM [ASCORBIC ACID;BETACAROTENE;BIOTIN;BORON;CALCIUM;CALCIUM PANTOTHENATE;CHLORINE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PY; IBUPROFEN. Past drug history included: Zpak, reaction(s): "Known Allergy-Zpak". The following information was reported: MIGRAINE (non-serious) with onset 25Jul2021, outcome "not recovered", described as "Migraines"; HEAD DISCOMFORT (non-serious) with onset 25Jul2021, outcome "not recovered", described as "Head pressure"; VERTIGO (non-serious) with onset 25Jul2021, outcome "not recovered", described as "Vertigo". The events "migraines", "head pressure" and "vertigo" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, head discomfort, vertigo.  Additional Information: Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Treatment received for the adverse event was ibuprofen 800 mg. Prior to the vaccination, the patient was not 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. Patient has not medication, lab test or health problems since were than one year previous to vaccination. Device Date was 27Oct2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Muscle ache in his both arms where both dose vaccines injected; Muscle aches in the left arm where the shot was injected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Anatomical location: Arm Right), administration date: 29Mar2021, for COVID-19 Immunization, reaction(s): "unable to sleep on his right arm", "Muscle ache in his both arms where both dose vaccines injected". The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Muscle ache in his both arms where both dose vaccines injected"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Muscle aches in the left arm where the shot was injected". Therapeutic measures were taken as a result of myalgia, vaccination site pain. Additional Information: The patient stated that he had muscle aches in the left arm where the shot was injected but, it is not as prominent. He has massaged and took hot baths to try to relieve the aches but has not helped. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: super sore arm esp if lifiting or touching it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Oct2021 (Lot number: 301258A) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "super sore arm esp if lifiting or touching it".  Additional information: Patient has received dose 2 on 24Oct2021, at 10:45 AM, in left arm, with lot number Ff2590.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Weight decreased
Clinical narrative: nausea; weight loss; Bad things; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), reaction(s): "Covid-19 immunization"; Bnt162b2 (Dose 2), reaction(s): "Covid-19 immunizarion". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "weight loss"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Bad things".  Follow-up attempts completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysmenorrhoea, SARS-CoV-2 test
Clinical narrative: Intense, monthly, menstrual cramping and bloating; Intense, monthly, menstrual cramping and bloating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 (Lot number: EW0182) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: DYSMENORRHOEA (non-serious), ABDOMINAL DISTENSION (non-serious) all with onset 26Aug2021, outcome "not recovered" and all described as "Intense, monthly, menstrual cramping and bloating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysmenorrhoea, abdominal distension. Additional Information: Prior vaccinations within 4 weeks and other medications within 2 weeks were reported as none. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Since the booster shot, the ringing in his ears went away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 82 year-old male patient received bnt162b2 (BNT162B2), administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose: 19Mar2021 with lot number ER8727.), administration date: 19Mar2021, when the patient was 82 years old, for COVID-19 Immunization; Bnt162b2 (Second dose 09Apr2021 with lot number ER8729.), administration date: 09Apr2021, when the patient was 82 years old, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Oct2021, outcome "unknown", described as "Since the booster shot, the ringing in his ears went away". Additional information: The ringing stopped the next morning when patient woke up. Patient was on a blood pressure medicine, but dose not remember the name of it. Patient twin brother had multiple sclerosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: chest tightness; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the parent.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest tightness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: I noticed a small nodule under my left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) 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: NODULE (non-serious) with onset Apr2021, outcome "unknown", described as "I noticed a small nodule under my left arm". The event "i noticed a small nodule under my left arm" was evaluated at the physician office visit. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nasopharyngitis, Pyrexia, Swollen tongue
Clinical narrative: back of his tongue was swelling; he can''t breathe; severe fever; severe cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization; Bnt162b2 (Dose:02), for COVID-19 immunization. The following information was reported: SWOLLEN TONGUE (non-serious) with onset Oct2021, outcome "unknown", described as "back of his tongue was swelling"; DYSPNOEA (non-serious) with onset Oct2021, outcome "unknown", described as "he can''t breathe"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "severe fever"; NASOPHARYNGITIS (non-serious) with onset Oct2021, outcome "unknown", described as "severe cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Sore body; fever of 100; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. This 41-Year-old female Other HCP reported that:  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration administered in arm left, administration date 26Oct2021 11:15 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. facility type vaccine: Workplace clinic. Relevant medical history included: "Dermatomyositis" (unspecified if ongoing), notes: Verbatim: Dermatomyositis. The patient's concomitant medications were not reported. If other vaccine in four weeks: No, other medications in two weeks: None. Past drug history included: None. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Don't have card on me), when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Don't have card on me, Location of injection: Arm Left), when the patient was 41 years old, for COVID-19 immunization. The following information was reported: PAIN with onset 27Oct2021 01:00, outcome "recovering", described as "Sore body"; PYREXIA with onset 27Oct2021 01:00, outcome "recovering", described as "fever of 100". Relevant laboratory tests and procedures are available in the appropriate section which included; Body temperature; 100 on 27Oct2021. Therapeutic measures were not taken as a result of pain.  Additional information: Most recent dose details: product; COVID 19, brand; Pfizer, brand unknown; False, lot unknown; True, lot unknown reason; Other, lot unknown reason other; Left vaccine card at my Pfizer office, administration date=26Oct2021, administration time; 11:15 AM, dose number; 3, vaccine location; Left arm.  Previous dose details: prev dose product; COVID 19, prev dose brand=Pfizer, prev dose brand unknown; False, prev dose lot unknown; True, prev dose lot unknown reason; Other, prev dose lot unknown reason other; Don't have card on me, prev dose dose number; 2, prev dose product; COVID 19, prev dose brand; Pfizer, prev dose brand unknown=False, prev dose lot unknown; True, prev dose lot unknown reason; Other, prev dose lot unknown reason other; Don't have card on me, prev dose dose number; 1, prev dose vaccine location; Left arm  Other vaccine same date details: other vaccine same date product; Pfizer, other vaccine same date vaccine date; 26Oct2021, other vaccine same date vaccine location; Left arm  Adverse event: Sore body, fever of 100, adverse event start date: 27Oct2021, adverse event start time: 01:00 AM, adverse event country: ae resulted in: None of the above, if patient recovered :Recovering, if treatment ae: No, if covid prior vaccination: No.  If covid tested post vaccination: No, known allergies: None, other medical history: Dermatomyositis.  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: Fall, Gait disturbance, Movement disorder
Clinical narrative: Every time the caller took the vaccine, all three times, the day of for 7 hours she can''t move or walk and she falls in the floor; Every time the caller took the vaccine, all three times, the day of for 7 hours she can''t move or walk and she falls in the floor; Every time the caller took the vaccine, all three times, the day of for 7 hours she can''t move or walk and she falls in the floor; 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 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (non-serious), GAIT DISTURBANCE (non-serious), FALL (non-serious), outcome "unknown" and all described as "Every time the caller took the vaccine, all three times, the day of for 7 hours she can''t move or walk and she falls in the floor".  Additional information included: The patient took it and then after midnight she fell in the floor and could not get up for 7-8 hours. It happened three times after the vaccines. The patient wanted to know if that was from the vaccine or if that had been reported by other people No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I still have headaches daily; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 16:45 (Lot number: 3101) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Apnea" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, single, Batch/Lot No: 3101 , Location of injection: Arm Left , Vaccine Administration Time: 16:45), administration date: 04Aug2021, when the patient was 42 years old, for Covid-19 Immunisation, reaction(s): "had only partial vision in my left eye", "my eyes begin to water 2 days later", "I started to have racing heart palpitations even while lying in bed", "major headaches", "Non arthritic ischemic optic neuropathy OS". The following information was reported: HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "I still have headaches daily". The event "i still have headaches daily" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:No.List of any other medications the patient received within 2 weeks of vaccination:No.After receiving the first dose of vaccine my eyes begin to water 2 days later I started to have racing heart palpitations even while lying in bed and major headaches. On the 10th day I woke up and had only partial vision in my left eye. I then went to see a eye specialist. I had numerous tests and an mri. The heart palpitations went away after 2 weeks my vision returned after 1 month. I still have headaches daily.What treatment received for the adverse event: Eye drops pataday.Prior to vaccination, was the patient diagnosed with COVID-19:No.Since the vaccination, has the patient been tested for COVID-19:No.Did the patient provide information to you regarding the reported adverse event(s) with the use of the product: Yes.If yes above, do you consider the Pfizer product had a causal effect to the adverse event:Yes.Concomitant Drugs: Unknown.Relevant Test: Unknown.Specific relevant test for thromboembolic events with thrombocytopenia: Unknown.Seriousness Criteria: Not serious.Treatment: Did the event require the initiation of new medication/other treatment/Procedure: No.Pt presented 31Aug2021 complaining of headaches, tearing and loss of vision in 10 days after having first COVID vaccine we found dense superior VF defect OS on VF testing. we referred patient to retinal specialist who diagnosed Pt. with Non arthritic ischemic optic neuropathy OS. To my knowledge this pt had no risk factors systematically that would predispose her to this.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Vaccination site pain
Clinical narrative: he only got some pain on his arm where he got the injection; 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 56 year-old male patient received bnt162b2 (COMIRNATY), administered in arm, administration date 22May2021 (Lot number: EW0191) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 01May2021, when the patient was 56 years old, for Covid-19 Immunization, reaction(s): "he only got some pain on his arm where he got the injection", "it was a little red". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "he only got some pain on his arm where he got the injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient did not experience fever after dose 2 vaccination and he was tested negative 3 times and again tested negative last week.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Off label use, Product use issue
Clinical narrative: Chills; Other vaccine same date vaccine date 27Oct2021; Other vaccine same date vaccine date 27Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 11:45 (Lot number: EW0217) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 27Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Parathyroidism" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; CALCITRIOL; CITRACAL [CALCIUM CITRATE]; SYNTHROID. Vaccination history included: Bnt162b2 (Dose 1, lot number: EL3247, ), administration date: 01Feb2021, when the patient was 56 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, lot number: EL3247, ), administration date: 22Feb2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 27Oct2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 27Oct2021"; CHILLS (non-serious) with onset 28Oct2021 08:30, outcome "recovering", described as "Chills". Therapeutic measures were not taken as a result of chills.  Additional information: No other vaccine in four weeks. No covid prior vaccination and the patient had not covid tested post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: Brain fog; have the ringing in my ears and I never had this before so, I am wondering if, it''s from the vaccine/ They are a little worse maybe.; 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. Other Case identifier(s): US-PFIZER INC-202101482276 (pfizer).  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 17:40 (Lot number: FF8841) at the age of 37 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: TINNITUS (non-serious) with onset 20Oct2021, outcome "not recovered", described as "have the ringing in my ears and I never had this before so, I am wondering if, it''s from the vaccine/ They are a little worse maybe."; FEELING ABNORMAL (non-serious) with onset 24Oct2021, outcome "not recovered", described as "Brain fog". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Is report related to a study or programme- No. Consumer had a side effect after the first dose of the vaccine and scheduled for second dose in November at 4:00 and asking that Should consumer get the second dose or not. And stated that consumer was not received any vaccines. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Insomnia, Metamorphopsia, Photophobia, Sensory processing disorder
Clinical narrative: Brain fog; have the ringing in my ears and I never had this before so, I am wondering if, it''s from the vaccine/ They are a little worse maybe.; 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. Other Case identifier(s): US-PFIZER INC-202101482276 (pfizer).  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 17:40 (Lot number: FF8841) at the age of 37 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: TINNITUS (non-serious) with onset 20Oct2021, outcome "not recovered", described as "have the ringing in my ears and I never had this before so, I am wondering if, it''s from the vaccine/ They are a little worse maybe."; FEELING ABNORMAL (non-serious) with onset 24Oct2021, outcome "not recovered", described as "Brain fog". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Is report related to a study or programme- No. Consumer had a side effect after the first dose of the vaccine and scheduled for second dose in November at 4:00 and asking that Should consumer get the second dose or not. And stated that consumer was not received any vaccines. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Visual impairment
Clinical narrative: Brain fog; have the ringing in my ears and I never had this before so, I am wondering if, it''s from the vaccine/ They are a little worse maybe.; 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. Other Case identifier(s): US-PFIZER INC-202101482276 (pfizer).  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 17:40 (Lot number: FF8841) at the age of 37 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: TINNITUS (non-serious) with onset 20Oct2021, outcome "not recovered", described as "have the ringing in my ears and I never had this before so, I am wondering if, it''s from the vaccine/ They are a little worse maybe."; FEELING ABNORMAL (non-serious) with onset 24Oct2021, outcome "not recovered", described as "Brain fog". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Is report related to a study or programme- No. Consumer had a side effect after the first dose of the vaccine and scheduled for second dose in November at 4:00 and asking that Should consumer get the second dose or not. And stated that consumer was not received any vaccines. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal discharge, Vaginal disorder
Clinical narrative: vaginal discharge since then but more heavy about 2 1/2 weeks after first dosis; vaginal discharge since then but more heavy about 2 1/2 weeks after first dosis; vaginal discharge since then but more heavy about 2 1/2 weeks after first dosis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jun2021 (Lot number: EW0217) 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: VAGINAL DISCHARGE (non-serious), VAGINAL DISORDER (non-serious), VAGINAL DISCHARGE (non-serious) all with onset 13Jul2021, outcome "recovering" and all described as "vaginal discharge since then but more heavy about 2 1/2 weeks after first dosis". Therapeutic measures were not taken as a result of vaginal discharge, vaginal disorder, vaginal discharge.  Additional information: Patient did not receive any other vaccines within 4 weeks and any other medication within 2 weeks of the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest pain, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: dizzy; wobbly; can't walk across her floor without gasping for air; can't walk across her floor without gasping for air; Has chest pain upon exertion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 16Oct2021 (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: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; BALANCE DISORDER (non-serious), outcome "unknown", described as "wobbly"; GAIT DISTURBANCE (non-serious), DYSPNOEA (non-serious), outcome "unknown" and all described as "can't walk across her floor without gasping for air"; CHEST PAIN (non-serious), outcome "unknown", described as "Has chest pain upon exertion". Relevant laboratory tests and procedures included EKG normal, WBC,X-ray cleared.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (03Dec2021): 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: Gait disturbance, White blood cell count, X-ray
Clinical narrative: dizzy; wobbly; can't walk across her floor without gasping for air; can't walk across her floor without gasping for air; Has chest pain upon exertion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 16Oct2021 (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: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; BALANCE DISORDER (non-serious), outcome "unknown", described as "wobbly"; GAIT DISTURBANCE (non-serious), DYSPNOEA (non-serious), outcome "unknown" and all described as "can't walk across her floor without gasping for air"; CHEST PAIN (non-serious), outcome "unknown", described as "Has chest pain upon exertion". Relevant laboratory tests and procedures included EKG normal, WBC,X-ray cleared.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (03Dec2021): 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 13:00 (Lot number: EW) at the age of 43 years as dose 2, single and administered in arm left, administration date 28Mar2021 13:00 (Lot number: ER2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diverticulosis" (unspecified if ongoing). Concomitant medication(s) included: VIIBRYD; IRON; VITAMIN D [COLECALCIFEROL]. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), DIARRHOEA (non-serious), outcome "unknown" and all described as "Vaccine #1 and #2 had upset stomach and diarreha".  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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: under the arm where she received the injection, she noticed a swollen lymph node; 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 74 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 26Oct2021 (Lot number: FF2593) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation", start date: 2018 (unspecified if ongoing); "Mitral valve replacement", start date: 2016 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (LOT: EP7534 or EF7534. It's hard to tell , Injected into right arm), administration date: 24Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (LOT: Initially provides ER8727. Had to take it to a light to see it more clearly, it is written bad. Then clarifies lot number as ER8729., Injected into right arm), administration date: 15Apr2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 27Oct2021, outcome "recovering", described as "under the arm where she received the injection, she noticed a swollen lymph node". Therapeutic measures were taken as a result of lymphadenopathy.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Dry mouth, Somnolence
Clinical narrative: dizzy; weakness/feels so weak; feels sleepy all day long; Dry mouth; knocked him off balance; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101467586.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: 302030A) at the age of 69 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 (1st dose, first two shots that he took 6 or 7 months ago), administration date: 2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (2nd dose, first two shots that he took 6 or 7 months ago), administration date: 2021, when the patient was 69 years old, for Covid-19 immunization.  The following information was reported: ASTHENIA (non-serious) with onset 23Oct2021, outcome "not recovered", described as "weakness/feels so weak"; SOMNOLENCE (non-serious) with onset 23Oct2021, outcome "recovering", described as "feels sleepy all day long"; DRY MOUTH (non-serious) with onset 23Oct2021, outcome "recovering", described as "Dry mouth"; BALANCE DISORDER (non-serious) with onset 23Oct2021, outcome "recovering", described as "knocked him off balance"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy".  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Overdose, Product preparation error
Clinical narrative: 0.3mL of undiluted vaccine; 0.3mL of undiluted vaccine; She is currently reporting  warmness in her arm.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Oct2021 (Lot number: FF2589, Expiration Date: Dec2021) at the age of 66 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation; Bnt162b2 (Dose 2), for Covid-19 immunisation. The following information was reported: FEELING HOT (non-serious) with onset Oct2021, outcome "unknown", described as "She is currently reporting  warmness in her arm."; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 28Oct2021, outcome "unknown" and all described as "0.3mL of undiluted vaccine".  Additional information: Reporter was a contactable Nurse. Patient was administered the booster of the Pfizer covid 19 vaccine 0.3mL of undiluted vaccine today. Reporter was asking there anything they should do or look out for and asked for recommendation where to go from here. She was currently reporting warmness in her arm. In response, provided disclaimer and response from attached SRD - CDC ACIP Appendix A: No diluent, resulting in higher than authorized dose (i.e., 0.3 ml of undiluted vaccine administered); and Withheld (PHE) Phase I/II study different strengths. Reporter was given the number of medical information to answer her question and told her to speak drug and safety first and then go from there. Registered Nurse was informed about the role of Pfizer Drug Safety and informed about Pfizer Medical Information department and confirmed the number. Registered Nurse hung up the call abruptly so further probing could not be done. Hence, limited information was available over the call. Full details unable to be obtained as caller disconnected before transfer was complete. No voice contact with caller.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Gait disturbance, Limb discomfort, Pain, Pain in extremity
Clinical narrative: feet pain; It began with my legs feeling very heavy; I had a difficult time walking.; Troubles sleeping due to the pain, burning, tingling.; Troubles sleeping due to the pain, burning, tingling.; Troubles sleeping due to the pain, burning, tingling.; Troubles sleeping due to the pain, burning, tingling.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, single), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "feet pain"; LIMB DISCOMFORT (non-serious), outcome "recovering", described as "It began with my legs feeling very heavy"; GAIT DISTURBANCE (non-serious), outcome "recovering", described as "I had a difficult time walking."; BURNING SENSATION (non-serious), PAIN (non-serious), PARAESTHESIA (non-serious), SLEEP DISORDER (non-serious), outcome "unknown" and all described as "Troubles sleeping due to the pain, burning, tingling".  Additional information: Patient stated that I began to experience leg and feet pain after my 2nd dose. It began with my legs feeling very heavy, I had a difficult time walking. That feeling has mostly gone away but I continue to feel pain in my legs and feet. Troubles  sleeping due to the pain, burning, tingling. Random pains in my legs and feet At times my right foot falls asleep. I am an active individual. Now I can no longer exercise with constant struggles related to the pain.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: feet pain; It began with my legs feeling very heavy; I had a difficult time walking.; Troubles sleeping due to the pain, burning, tingling.; Troubles sleeping due to the pain, burning, tingling.; Troubles sleeping due to the pain, burning, tingling.; Troubles sleeping due to the pain, burning, tingling.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, single), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "feet pain"; LIMB DISCOMFORT (non-serious), outcome "recovering", described as "It began with my legs feeling very heavy"; GAIT DISTURBANCE (non-serious), outcome "recovering", described as "I had a difficult time walking."; BURNING SENSATION (non-serious), PAIN (non-serious), PARAESTHESIA (non-serious), SLEEP DISORDER (non-serious), outcome "unknown" and all described as "Troubles sleeping due to the pain, burning, tingling".  Additional information: Patient stated that I began to experience leg and feet pain after my 2nd dose. It began with my legs feeling very heavy, I had a difficult time walking. That feeling has mostly gone away but I continue to feel pain in my legs and feet. Troubles  sleeping due to the pain, burning, tingling. Random pains in my legs and feet At times my right foot falls asleep. I am an active individual. Now I can no longer exercise with constant struggles related to the pain.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product lot number issue
Clinical narrative: booster was different from the lot number with a combination of 2 letters and 4 numbers; very very sick; 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 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Sep2021 (Lot number: 30135BA, Expiration Date: 30Nov2021) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization; Bnt162b2 (2nd Dose), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "very very sick"; PRODUCT LOT NUMBER ISSUE (non-serious) with onset 28Sep2021, outcome "unknown", described as "booster was different from the lot number with a combination of 2 letters and 4 numbers".  Additional information: Caller was a consumer who received her booster dose of the Pfizer Biontech COVID19 vaccine on 28Sep2021. Caller said the lot number for her booster was different from the lot number with a combination of 2 letters and 4 numbers. Caller said the pharmacy was now giving the vaccine with lot number of 2 letters and 4 numbers. Caller said that she had a "very strong reaction" and was "very very sick" with the booster with different lot number and did not have a problem with her first two doses. Caller provided the lot number of 30135BA. Caller wants to know if the vaccine was indeed a Pfizer Biontech COVID19 vaccine and why does it have a different lot number. She said her question was she got a dose that has very different LOT number than all the LOT numbers being given including the ones they are giving now. She said it was a very different LOT, and she didn't have a problem with her first two doses and knows no one who got a dose a LOT other than with the two letter then four numbers combination. She said the combination of the fact that she had a very strong reaction to the booster and the fact the LOT was so different, makes her wonder if something was mislabeled as COVID-19 vaccine, she was the only person she knows who got that LOT, and she had such a strong reaction after it. She said no one can tell her why the LOT number for that dose was so different. She said the pharmacy was back to giving the LOTs with two letters and four numbers. She said her LOT for the booster dose was 30135BA, and no one can tell her why it was so different. She said she had such a bad reaction to it, she wants to talk to someone who can tell her why the LOT number was so different.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: no energy and head aches every sinse second shot; no energy and head aches every sinse second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Sep2021 14:00 (Lot number: 301308a) at the age of 73 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, SINGLE, Batch/Lot No: 301308a, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 30Aug2021, when the patient was 73 years old, for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), HEADACHE (non-serious) all with onset 25Sep2021, outcome "not recovered" and all described as "no energy and head aches every sinse second shot". The event "no energy and head aches every sinse second shot" and "no energy and head aches every sinse second shot" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of asthenia, headache. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Tonsillar lymph node within 12 hours of booster vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 (Lot number: FH8028) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; JANUMET; JARDIANCE; FENOFIBRATE. Vaccination history included: Bnt162b2 (lot number=EW0150, prev dose administration date=08Apr2021, prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 08Apr2021, for COVID-19 Immunization; Bnt162b2 (lot number=EN6208, prev dose lot unknown=False, prev dose administration date=17Mar2021, dose number=1, vaccine location=Left arm), administration date: 17Mar2021, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 27Oct2021 23:00, outcome "unknown", described as "Swollen Tonsillar lymph node within 12 hours of booster vaccine". It was unknown if therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Facility type Vaccine: Pharmacy or Drug Store. If other vaccine in four weeks: No. If COVID prior vaccination: No. If COVID tested post vaccination: No. No known allergies.   No follow-up attempts are possible. No further information is expected.