chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin haemorrhage
Clinical narrative: Caller states that the lady who just left her apartment is having the same issues as the caller.; sometimes when they scratch it will bleed.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Caller states that the lady who just left her apartment is having the same issues as the caller."; SKIN HAEMORRHAGE (non-serious), outcome "unknown", described as "sometimes when they scratch it will bleed.".  Additional Information: Number of covid vaccine was not provided. Reason for no lot number of covid vaccine: Caller unwilling to complete the report. Expiry date of covid vaccine was not provided. Caller states that she got the vaccine last February and got the second dose by 03Mar2021. She then got the booster dose in October.  Caller says that she started being itchy from the moment she got the vaccine. States that with the second dose she was itchy. States that the booster dose really set it off and she got a rash. States that a man at her gym and a lady who just left her apartment have the same problem. This report is concerning the lady who just left the caller's apartment. Caller states that she declines to provide further information on the man at her gym and the lady that she knows who have the same issues as her. States that she will ask the lady about it and that lady can call herself. Caller states that the lady is about the age of the caller and the caller states that she gave the lady some of her antihistamines she had left over.  States that it helped a little bit. Caller states that the lady is suffering like the caller. Caller states that sometimes when they scratch it will bleed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200473977 same product and event, different patient;US-PFIZER INC-202200474055 same product and event, different patient
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Burning sensation, Contusion, Pain, Pain in extremity
Clinical narrative: I received a deep pain in my inner thighs and on my lower left side of my stomach; I received a deep pain in my inner thighs and on my lower left side of my stomach; It was a burning and stinging sensation all the night of the vaccine; It was a burning and stinging sensation all the night of the vaccine; The next day I had large lumps underneath my skin which lasted for about 1 month; The lumps then turned to bruises that are still visible; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 12:45 (Lot number: FJ1614) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Chronic Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: PAIN IN EXTREMITY (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 14Jan2022 16:00, outcome "recovered with sequelae" and all described as "I received a deep pain in my inner thighs and on my lower left side of my stomach"; BURNING SENSATION (non-serious), PAIN (non-serious) all with onset 14Jan2022 16:00, outcome "recovered with sequelae" and all described as "It was a burning and stinging sensation all the night of the vaccine"; SKIN MASS (non-serious) with onset 14Jan2022 16:00, outcome "recovered with sequelae", described as "The next day I had large lumps underneath my skin which lasted for about 1 month"; CONTUSION (non-serious) with onset 14Jan2022 16:00, outcome "recovered with sequelae", described as "The lumps then turned to bruises that are still visible". The events "i received a deep pain in my inner thighs and on my lower left side of my stomach", "i received a deep pain in my inner thighs and on my lower left side of my stomach", "it was a burning and stinging sensation all the night of the vaccine", "it was a burning and stinging sensation all the night of the vaccine", "the next day i had large lumps underneath my skin which lasted for about 1 month" and "the lumps then turned to bruises that are still visible" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, abdominal pain upper, burning sensation, pain, skin mass, contusion.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient received ultrasounds treatment for the AE, Patient did not had Covid prior vaccination. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: I received a deep pain in my inner thighs and on my lower left side of my stomach; I received a deep pain in my inner thighs and on my lower left side of my stomach; It was a burning and stinging sensation all the night of the vaccine; It was a burning and stinging sensation all the night of the vaccine; The next day I had large lumps underneath my skin which lasted for about 1 month; The lumps then turned to bruises that are still visible; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 12:45 (Lot number: FJ1614) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Chronic Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: PAIN IN EXTREMITY (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 14Jan2022 16:00, outcome "recovered with sequelae" and all described as "I received a deep pain in my inner thighs and on my lower left side of my stomach"; BURNING SENSATION (non-serious), PAIN (non-serious) all with onset 14Jan2022 16:00, outcome "recovered with sequelae" and all described as "It was a burning and stinging sensation all the night of the vaccine"; SKIN MASS (non-serious) with onset 14Jan2022 16:00, outcome "recovered with sequelae", described as "The next day I had large lumps underneath my skin which lasted for about 1 month"; CONTUSION (non-serious) with onset 14Jan2022 16:00, outcome "recovered with sequelae", described as "The lumps then turned to bruises that are still visible". The events "i received a deep pain in my inner thighs and on my lower left side of my stomach", "i received a deep pain in my inner thighs and on my lower left side of my stomach", "it was a burning and stinging sensation all the night of the vaccine", "it was a burning and stinging sensation all the night of the vaccine", "the next day i had large lumps underneath my skin which lasted for about 1 month" and "the lumps then turned to bruises that are still visible" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, abdominal pain upper, burning sensation, pain, skin mass, contusion.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient received ultrasounds treatment for the AE, Patient did not had Covid prior vaccination. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, COVID-19, Pain, Pelvic pain
Clinical narrative: Extreme soreness/joint pain in my hips/pelvis area; It hurts to stand straight or walk, especially bending to put on shoes or get out of a laying position; Extreme soreness/joint pain in my hips/pelvis area; My underarms are also somehow sore but not to the same extent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2022 14:30 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "IUD" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR; PAXIL [PAROXETINE HYDROCHLORIDE]; TYLENOL; ACETAMINOPHEN. Past drug history included: Amoxicillin; Pencillin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 14:45 PM), administration date: 28Apr2021, when the patient was 21 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 14:30 PM), administration date: 07Apr2021, when the patient was 21 years old, for Covid-19 Immunization. The following information was reported: PELVIC PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 26Mar2022 09:00, outcome "not recovered" and all described as "Extreme soreness/joint pain in my hips/pelvis area"; PAIN (non-serious) with onset 26Mar2022 09:00, outcome "not recovered", described as "It hurts to stand straight or walk, especially bending to put on shoes or get out of a laying position"; AXILLARY PAIN (non-serious) with onset 26Mar2022 09:00, outcome "not recovered", described as "My underarms are also somehow sore but not to the same extent". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pelvic pain, pain, arthralgia, axillary pain.  Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Paxil and Buspar, may be Acetaminophen or Tylenol within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Gait disturbance, Headache, Nausea, Pain
Clinical narrative: Nausea; Headache; I have been in there ever since with severe pain; I am moving but with a lot of pain.; I already have some illnesses; I can barely get out of bed and barely walk.; the booster has had me in bed since the day I took it.; 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 10Mar2022 (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), for Covid-19 immunization; Bnt162b2 (DOSE 2), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "I have been in there ever since with severe pain; I am moving but with a lot of pain."; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I already have some illnesses; I can barely get out of bed and barely walk."; BEDRIDDEN (non-serious), outcome "unknown", described as "the booster has had me in bed since the day I took it.".  Additional information: It was reported that, patient was reporter. Patient had been in there ever since with severe pain; patient was moving but with a lot of pain. For next three- or four-months patient was feeling weak and tired all the time. What patient want to ask was, by on the 10Mar2022, patient took the Pfizer booster (later clarified as COVID-19 Vaccine) and patient had been in there ever since with severe pain and nausea and headache and patient wondering if this going to go away or was this react with something 'that patient already had' because patient already have some illnesses (Further not clarified). but patient was able to function now. Patient could barely get out of bed and barely walk and that was from Mar. Consumer was informed about Pfizer Medical information department. Patient was informed about the role of Pfizer Drug Safety. Patient stated, well, I want, I have a doctor 'appointment' but I did want to call you out and see this, If Is this, Am I only one whose having these symptoms or did he have been advised to 'bear' this symptom. Patient took the booster; patient took the two shots they didn't do me too bad, but the booster has had patient in bed since the day patient took it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200481511 Same patient, product, different dose and event
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chills, Malaise, Myalgia
Clinical narrative: 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 (COMIRNATY) (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: MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Slight fever"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Injection site swelling"; MALAISE (non-serious), outcome "unknown", described as "Feeling little unwell other than arm pain"; BLOOD PRESSURE MEASUREMENT (non-serious), PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown" and all described as "blood pressure, sinus pressure as well (voice not clear) that have been reoccurring". Additional information: Additional information: Consumer stated that have been experiencing some muscle pain, some chills, joint pain, slight fever, and injection site swelling, just feeling little unwell other than arm pain. They thought those are all the possible side effects that 'normally occur blood pressure, sinus pressure as well (voice not clear) that have been reoccurring'. And hung up the call abruptly. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Pyrexia, Vaccination site swelling
Clinical narrative: 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 (COMIRNATY) (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: MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Slight fever"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Injection site swelling"; MALAISE (non-serious), outcome "unknown", described as "Feeling little unwell other than arm pain"; BLOOD PRESSURE MEASUREMENT (non-serious), PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown" and all described as "blood pressure, sinus pressure as well (voice not clear) that have been reoccurring". Additional information: Additional information: Consumer stated that have been experiencing some muscle pain, some chills, joint pain, slight fever, and injection site swelling, just feeling little unwell other than arm pain. They thought those are all the possible side effects that 'normally occur blood pressure, sinus pressure as well (voice not clear) that have been reoccurring'. And hung up the call abruptly. 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
Clinical narrative: have noticed an unusual feeling in my right abdomen just below the ribs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's 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 ABNORMAL (non-serious), outcome "unknown", described as "have noticed an unusual feeling in my right abdomen just below the ribs".  Additional information: Serious: No. Patient did some online research and saw that some people had a possible side effect of kidney problems especially if like him they had a history of high blood pressure. Patient had received the 2 initial Pfizer COVID vaccines and the first booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysphonia, Nervousness, Tremor
Clinical narrative: severe anxiety; Caller states she was shaking uncontrollably even in her voice; Caller states she was shaking uncontrollably even in her voice; just weird shaking that started on the inside out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 (Lot number: ER8732, Expiration Date: Jul2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "leg cramps" (unspecified if ongoing); "Overweight" (unspecified if ongoing), notes: Medical Conditions: Caller states she is healthy just a little overweight. Concomitant medication(s) included: OLMESARTAN taken for blood pressure abnormal; KLOR-CON taken for muscle spasms. Vaccination history included: Bnt162b2 (Pfizer COVID-19 Vaccine 1st dose , Location: Left Upper Arm, Time: Between 4:30-5:00pm , Lot number: EN6199, Expiry: Jun2021, 1st dose aside from a sore arm which she expects to be normal.), administration date: 16Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "sore arm"; Flu (Caller states she gets the Flu shot every year with no reactions). The patient was not received any vaccine Prior Vaccinations (within 4 weeks). The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "severe anxiety"; NERVOUSNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "just weird shaking that started on the inside out"; DYSPHONIA (non-serious), outcome "unknown", TREMOR (non-serious) with onset 2021, outcome "recovered" (2021) and all described as "Caller states she was shaking uncontrollably even in her voice". The events "severe anxiety", "just weird shaking that started on the inside out", "caller states she was shaking uncontrollably even in her voice" and "caller states she was shaking uncontrollably even in her voice" were evaluated at the physician office visit. Therapeutic measures were taken as a result of anxiety, nervousness, dysphonia, tremor. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Fatigue, Lethargy, Myalgia, Pain in extremity
Clinical narrative: little arm soreness; Tiredness; some muscle and lower back pain; some muscle and lower back pain; lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: FD8448) at the age of 74 years as dose 3 (booster), single, administration date 20Feb2021 (Lot number: EL8982) as dose 2, single and administration date 30Jan2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart arrhythmia" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Polio survivor" (unspecified if ongoing); "Compromised lung function" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little arm soreness"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness"; MYALGIA (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "some muscle and lower back pain"; LETHARGY (non-serious), outcome "unknown", described as "lethargic".  Additional information: The patient had no family medical relevant history. The patient had no relevant test.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: little arm soreness; Tiredness; some muscle and lower back pain; some muscle and lower back pain; lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: FD8448) at the age of 74 years as dose 3 (booster), single, administration date 20Feb2021 (Lot number: EL8982) as dose 2, single and administration date 30Jan2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart arrhythmia" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Polio survivor" (unspecified if ongoing); "Compromised lung function" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little arm soreness"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness"; MYALGIA (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "some muscle and lower back pain"; LETHARGY (non-serious), outcome "unknown", described as "lethargic".  Additional information: The patient had no family medical relevant history. The patient had no relevant test.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Fatigue, Lethargy, Myalgia, Pain in extremity
Clinical narrative: Booster Vaccine #1: 26AUG2021; Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 (Lot number: FD8448) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Heart Arrhythmia" (unspecified if ongoing); "Polio Survivor" (unspecified if ongoing); "Compromised Lung Function" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (2nd dose, Lot: EL8982), administration date: 20Feb2021, when the patient was 74 years old, for Covid-19 Immunization, reaction(s): "Little arm sorness", "Tiredness"; Bnt162b2 (1st dose, Lot: EN5318), administration date: 30Jan2021, when the patient was 74 years old, for Covid-19 Immunization, reaction(s): "Little arm sorness", "Tiredness". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Aug2021, outcome "unknown", described as "Booster Vaccine #1: 26AUG2021"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Tiredness".  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Booster Vaccine #1: 26AUG2021; Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 (Lot number: FD8448) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Heart Arrhythmia" (unspecified if ongoing); "Polio Survivor" (unspecified if ongoing); "Compromised Lung Function" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (2nd dose, Lot: EL8982), administration date: 20Feb2021, when the patient was 74 years old, for Covid-19 Immunization, reaction(s): "Little arm sorness", "Tiredness"; Bnt162b2 (1st dose, Lot: EN5318), administration date: 30Jan2021, when the patient was 74 years old, for Covid-19 Immunization, reaction(s): "Little arm sorness", "Tiredness". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Aug2021, outcome "unknown", described as "Booster Vaccine #1: 26AUG2021"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Tiredness".  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm soreness; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single, administration date 20Feb2021 (Lot number: EL8982) as dose 2, single and administration date 30Jan2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing); "cancer survivor" (ongoing); "COPD" (ongoing); "afib" (ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: Just a little arm soreness and tiredness. The extreme tiredness where they were in bed for 3-4 days and the fever they did not have before (with previous shots).   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ear ringing and high pitched frequencies.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Mar2022 16:00 (Lot number: FK9729) at the age of 49 years as dose 3 (booster), single, administration date 15Apr2021 (Lot number: ER8731) as dose 2, single and administration date 18Mar2021 (Lot number: ER8727) 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: TINNITUS (non-serious) with onset 25Mar2021, outcome "not recovered", described as "Ear ringing and high pitched frequencies.". The event "ear ringing and high pitched frequencies." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 26May2021 (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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in the arm".  Additional information: Reporter was consumer that received 2 doses of vaccine outside of the country (in a country that had a different language). He does not have any documentation regarding the vaccination and states that when he visited the Doctors office, the doctor mentioned it is Pfizer COVID vaccine and that was all the information he has. (First dose on 26May2021 and Second dose on 16Jun2021). He has contacted (City Name Withheld) health department and was told to start the series of vaccination all over again. Reporter does not think this information was very Correct and he was concerned about starting the vaccination again which would sum up the total doses to 4-5 doses. He was concerned that the lack of paperwork would hinder him from travelling internationally and cause of that he has to start the vaccination series from the beginning. He stated that he showed normal symptoms after the vaccination such as pain in the arm.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: She feels she has no immunity; 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 88 year-old female patient received bnt162b2 (BNT162B2), administration date 21Jan2021 (Batch/Lot number: unknown) as dose 1, single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "fibromyalgia", start date: 1988 (ongoing), notes: States that she has had fibromyalgia since 1988 and has a diagnostic of COPD as well.; "COPD" (ongoing), notes: States that she has had fibromyalgia since 1988 and has a diagnostic of COPD as well. The patient's concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "She feels she has no immunity".  Additional information: Caller was an 88 year old female patient. Calls in regards to the Pfizer BioNTech COVID-19 vaccine. States that she had had three doses given outside of the recommended time frames but she cannot get her doctor to give her an order for a fourth dose. States that she had fibromyalgia since 1988 and had a diagnostic of COPD as well. Due to her age and illness she feels she was a high risk patient however, her doctor thinks that she does not need a fourth dose. She got her first dose of the Pfizer COVID-19 vaccine on 21Jan2021, her second dose on 15 or 16Feb2021 and her third dose by the end of Sep2021. According to her, she should have had her fourth dose two months ago, but she was still battling with her doctor to get the order for it. She feels she had no immunity. She was afraid to go out as everybody around her was sick. She states that the withheld administration wont permit her doctor to give her the order to get the fourth dose. She wants to write a letter asking for the fourth dose and asks for information that Pfizer may have on the recommended timing of the third dose and booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Breast tenderness, Computerised tomogram abdomen, Computerised tomogram pelvis, Hot flush
Clinical narrative: Menopause; Hot flashes; Breast tissue/It has been 7 months tissue is still swollen + tender; Breast tissue/It has been 7 months tissue is still swollen + tender; Night sweats; 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), intramuscular, administered in arm left, administration date 08Sep2021 (Lot number: F08448) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Allergies. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); CLARITIN [CLARITHROMYCIN] taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: AW0168), administration date: 18Aug2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "Both breast tissue under arms swelled", "Breast tissue/It has been 7 months tissue is still swollen + tender", "Menopause", "Hot flashes", "Night sweats". The following information was reported: MENOPAUSE (non-serious), outcome "unknown", described as "Menopause"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; BREAST SWELLING (non-serious), BREAST TENDERNESS (non-serious), outcome "not recovered" and all described as "Breast tissue/It has been 7 months tissue is still swollen + tender"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweats". The event "menopause" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient received first dose of Pfizer COVID vaccine within 5 to 7 minutes both breast tissue under arms swelled, also something happened with 2nd dose. It has been 7 months tissue was still swollen + tender, she had an mammogram + Ultrasound which are negative. Seen 2 breast specialist finally 2nd one said the COVID vaccine sent her into menopause, she having hot flashes, night sweats etc. Seen Gyn to C/O hormone testing. Waiting for results. This has been an horrible or deal for her, she never getting the booster shot. No specific relevant test for thromboembolic events with thrombocytopenia. Patient was taking fluticasone hydrochlorothiazide 25mg daily and claritin 10mg for allergies both orally. vaccination facility type: Hospital. No prior Vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Menopause, Night sweats, Ultrasound scan
Clinical narrative: Menopause; Hot flashes; Breast tissue/It has been 7 months tissue is still swollen + tender; Breast tissue/It has been 7 months tissue is still swollen + tender; Night sweats; 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), intramuscular, administered in arm left, administration date 08Sep2021 (Lot number: F08448) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Allergies. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); CLARITIN [CLARITHROMYCIN] taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: AW0168), administration date: 18Aug2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "Both breast tissue under arms swelled", "Breast tissue/It has been 7 months tissue is still swollen + tender", "Menopause", "Hot flashes", "Night sweats". The following information was reported: MENOPAUSE (non-serious), outcome "unknown", described as "Menopause"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; BREAST SWELLING (non-serious), BREAST TENDERNESS (non-serious), outcome "not recovered" and all described as "Breast tissue/It has been 7 months tissue is still swollen + tender"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweats". The event "menopause" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient received first dose of Pfizer COVID vaccine within 5 to 7 minutes both breast tissue under arms swelled, also something happened with 2nd dose. It has been 7 months tissue was still swollen + tender, she had an mammogram + Ultrasound which are negative. Seen 2 breast specialist finally 2nd one said the COVID vaccine sent her into menopause, she having hot flashes, night sweats etc. Seen Gyn to C/O hormone testing. Waiting for results. This has been an horrible or deal for her, she never getting the booster shot. No specific relevant test for thromboembolic events with thrombocytopenia. Patient was taking fluticasone hydrochlorothiazide 25mg daily and claritin 10mg for allergies both orally. vaccination facility type: Hospital. No prior Vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, SARS-CoV-2 test, Vaccination site mass, Vaccination site pain
Clinical narrative: raised lump formed at the injection site/ is sore and slightly itchy; raised lump formed at the injection site/ is sore and slightly itchy; raised lump formed at the injection site/ is sore and slightly itchy; 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 left, administration date 20Apr2021 12:00 (Lot number: EN0172) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 30Mar2021, when the patient was 43 years old, for Covid-19 Immunization.The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 04May2021 12:00, outcome "not recovered" and all described as "raised lump formed at the injection site/ is sore and slightly itchy". The event "raised lump formed at the injection site/ is sore and slightly itchy", "raised lump formed at the injection site/ is sore and slightly itchy" and "raised lump formed at the injection site/ is sore and slightly itchy" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, injection site pruritus.  Additional Information: It was reported that About 2 weeks after the 2nd vaccine, patient experienced a raised lump formed at the injection site. It's about 5mm and was sore and slightly itchy. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19, had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe leg pain since my Covid shot in Jan.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2022 (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: PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "severe leg pain since my Covid shot in Jan.".  Additional information: He had severe leg pain since Covid shot in Jan. I am 50yr old male. Please help. The pain was making him cry at night. Please tell what to do or tell Doctor what needs to be done. He was begging.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 01Sep2021 13:00 (Lot number: FC3182) at the age of 65 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: FATIGUE (non-serious) with onset 01Sep2021, outcome "unknown", described as "little fatigue".  Additional information: There were no any relevant tests.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Illness, Nausea
Clinical narrative: sick; very fatigued (has no energy to do anything); nausea; 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 (BNT162B2), administered in arm right, administration date 14Apr2021 (Lot number: ER8731) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure", start date: 2006 (ongoing); "thyroid issues Stated that the medication is working and he still has thyroid issues.", start date: 2006 (ongoing); "Diabetes Type II", start date: 2006 (ongoing). The patient took concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "sick"; FATIGUE (non-serious) with onset 14Apr2021, outcome "recovered" (15Apr2021), described as "very fatigued (has no energy to do anything)"; NAUSEA (non-serious) with onset 14Apr2021, outcome "unknown", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea.  Additional information: Caller stated that he got a couple of things about the vaccine. Stated that he took the first and second shot. Stated that the first one made him sick within a little over an hour after taking it and that he was sick for 4-5 days. Stated that he took the second shot 2.5-3 weeks later and got sick immediately after it. Stated that he had walked outside to his car and had nausea, did not feel good and was very fatigued. Stated that the nausea lasted a day or two but the no energy has been getting worst since. Stated that he took the second shot May2021. Stated that it is to the point that he has no energy to do anything. Stated that the timeframe of all this happening goes right up to the shot. Stated that the doctors do not know how to treat it. Wanted advice as to how to treat it or what to do. Stated that his bloodwork comes back normal and everything. Clarified that this is for the Pfizer vaccine. Stated that Pfizer made the vaccine and he is sure other people called. Stated that he wanted to know if they have any advice on what to do. Stated that he is getting worst and worst. Wanted to know what is going on.  No follow-up attempts are possible. No further information is expected.  Follow-up (28Mar2022): This is a follow up spontaneous report from a contactable consumer. This male consumer (patient) reported for himself that: Updated information: Reporter's address, RMH, vaccine administration date, lot number, outcome of the event and lab test captured.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: Got sick; Fever; Arm was so sore, couldn't even pick up arm; Arm was so sore, couldn't even pick up arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Dec2020 (Lot number: EK5730) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Dec2020, outcome "recovered", LIMB DISCOMFORT (non-serious) with onset 24Dec2020, outcome "unknown" and all described as "Arm was so sore, couldn't even pick up arm"; ILLNESS (non-serious), outcome "unknown", described as "Got sick"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: There were no any vaccines administered on same date with the Pfizer vaccine considered as suspect. There were no requirement to visit emergency Room or physician Office. There were no prior vaccinations within four weeks to the first administration date of the suspect vaccine. No, only other vaccinations caller has ever gotten were when was a young kid for measles, mumps and rubella. There were no any relevant tests done.   No follow-up attempts are possible. No further information is expected.