chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: she still had a bruise on her left arm from that hematoma; rash; she still had a bruise on her left arm from that hematoma; 7 days after the first dose she got a big itchy rash, states it is called covid arm; 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 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMATOMA (non-serious) with onset 09Feb2021, outcome "recovered" (Mar2021), CONTUSION (non-serious), outcome "unknown" and all described as "she still had a bruise on her left arm from that hematoma"; RASH (non-serious), outcome "unknown", described as "rash"; RASH PRURITIC (non-serious) with onset Feb2021, outcome "unknown", described as "7 days after the first dose she got a big itchy rash, states it is called covid arm". The events "she still had a bruise on her left arm from that hematoma", "she still had a bruise on her left arm from that hematoma", "rash" and "7 days after the first dose she got a big itchy rash, states it is called covid arm" 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 haematoma, contusion, rash, rash pruritic.  Additional information: She thinks part of the issue is she is a tiny person and does not have muscle in her left arm. She thinks they nicked a blood vein when they gave her the first dose since she got a huge hematoma in her left arm that hurt. She does not think it was the vaccine but from the person that administered the vaccine. It got swelled up and got huge. Treatment: She put ice on it. 7 days after the first dose she got a big itchy rash, states it is called covid arm. When she went to go get the second dose she still had a bruise on her left arm from that hematoma that gradually went away.   Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated
Clinical narrative: increased joint inflation in my hands and my feet; increased joint inflation in my hands and my feet; accelerated my arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 16:15 (Lot number: ER8729) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "joint inflation in my hands and my feet" (unspecified if ongoing), notes: I have increased joint inflation in my hands and my feet.; "arthritis" (unspecified if ongoing), notes: It seems to have accelerated my arthritis. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0172, Administration time: 15:45 pm, Vaccine location: Left arm), administration date: 09Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 04May2021 07:00, outcome "not recovered" and all described as "increased joint inflation in my hands and my feet"; ARTHRITIS (non-serious) with onset 04May2021 07:00, outcome "not recovered", described as "accelerated my arthritis". The events "increased joint inflation in my hands and my feet", "increased joint inflation in my hands and my feet" and "accelerated my arthritis" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthritis, condition aggravated, arthritis.  Additional information: The patient did not have any known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had increased joint inflation in his hands and his feet. It seems to have accelerated his arthritis. He didn't have these symptoms until about a week after his second Pfizer dose. The case was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pain assessment, Vaccination site pain
Clinical narrative: Muscle and  joint aches; Muscle and  joint aches; headache; soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 10:00 (Lot number: BA30145) at the age of 71 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "HSVII" (unspecified if ongoing); "known_allergies: lactose" (unspecified if ongoing); "known_allergies: wheat intolerant" (unspecified if ongoing); "Depression" (ongoing); "Vt D Density" (ongoing), notes: Vitamin D Density; "Low Bone Density" (ongoing); "Mixed type lipidemic" (ongoing), notes: Mixed type lipidemic. Concomitant medication(s) included: FLUOXETINE; VIT D3 taken for bone density abnormal (ongoing); PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; PROZAC taken for depression (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date (dd-Mmm-yyyy): 06Jan2021, Pfizer/BioNTech COVID-19 Vaccine Details), administration date: 06Jan2021, when the patient was 71 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2nd , Date (dd-Mmm-yyyy): 29Jan2021, Pfizer/BioNTech COVID-19 Vaccine Details), administration date: 29Jan2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 28Sep2021 06:00, outcome "recovered" (29Sep2021) and all described as "Muscle and joint aches"; HEADACHE (non-serious) with onset 28Sep2021 06:00, outcome "recovered" (29Sep2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 28Sep2021 06:00, outcome "recovered" (29Sep2021), described as "soreness at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, arthralgia, headache, vaccination site pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Muscle & joint aches, headache, soreness at injection site, 8 on a scale of 1-10, 10. Prior to and since the vaccination, was the patient was not diagnosed with COVID-19. Patient received Booster (Pfizer covid vaccine) 29Sep2021 called 29Sep2021 to report she had indexes HA misled it pain 08/10 touch typical receiving 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Intermenstrual bleeding
Clinical narrative: The patient had a period with bleeding and really bad abdominal cramping; irritating breakthrough bleeding/ Menstrual bleeding; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 36 year-old female patient (wife) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jun2021 (Lot number: EW0191) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: Received 28May2021, lot EW0191, NDC and expiration date unknown.), administration date: 28May2021, when the patient was 36 years old, for COVID-19 immunisation. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "The patient had a period with bleeding and really bad abdominal cramping"; INTERMENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "recovered" (2021), described as "irritating breakthrough bleeding/ Menstrual bleeding".  Additional information includes The caller doesn't know what birth control the patient was on before that. Lot NDC and expiration date unknown for the birth control that the patient was on that experienced breakthrough bleeding. The caller didn't connect this until recently. The patient switched birth controls and it helped her side effects. The patient thought it may be the birth control she was originally on. The patient had a period with bleeding and really bad abdominal cramping, its not like the caller. The caller doesn't know what birth control the patient was on before that. Lot NDC and expiration date unknown for the birth control that the patient was on that experienced breakthrough bleeding.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: I am experiencing a little bit tightness on my chest; 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 28Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I am a asthmatic" (unspecified if ongoing), notes: I am a asthmatic. The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 28Sep2021, outcome "unknown", described as "I am experiencing a little bit tightness on my chest".  Additional information: The consumer stated this is a sort of tight just a little tight. Yes, I feel a little tightness here.   Follow-up attempts completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Pain, Rash, Urticaria
Clinical narrative: welts/whelps like beestings; rash; Very painful; Hurts to the bone; 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 54 year-old male patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Lot number: 56145BA) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing); "chicken pox" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Batch/lot number: FC3183, Expiry: Oct2021), administration date: 05Sep2021, when the patient was 54 years old, for Covid-19 immunization, reaction(s): "welts", "rash", "painful", "itching". The following information was reported: URTICARIA (non-serious) with onset 28Sep2021, outcome "not recovered", described as "welts/whelps like beestings"; RASH (non-serious) with onset 28Sep2021, outcome "not recovered", described as "rash"; PAIN (non-serious) with onset 28Sep2021, outcome "unknown", described as "Very painful"; BONE PAIN (non-serious) with onset 28Sep2021, outcome "unknown", described as "Hurts to the bone".  Additional information: The caller reported that after having his 2nd dose, 27Sep2021 he woke up with something similar but more like "bee stings. The rash remained present. Caller stated they were still welts, not red or anything like that, clear and they are only, not even the size of a dime. Like a clear bee sting. Very painful. Hurts to the bone. He stated he was on the phone with VAERS to report them as this was recommended to do by (withheld). While on the phone with VAERS he had more spots appear on his arm near the injection site, as well as one at the elbow and forearm. He wanted to know what was going on or if he should just go to the hospital. Caller was tearful during INT because he stated he cannot afford transportation to the hospital. If I call an ambulance they will send me a bill if they found out I'm homeless they refused to take me due to no insurance or money. Caller stated he does not to go through that embarrassment. He stated they will charge (withheld). The patient lost his job and lost his house because of it and he has been on the streets since then. He got the shot to be safe because he is out among homeless people and it just seems like it is all back-firing on him. He is 155 pounds to 160 pounds, he has lost a lost of weight. He has medications that are prescribed to him by a doctor but since he has been homeless he has not been able to see his doctor or afford to get his medications so he hasn't taken anything but maybe some pain reliever and that's it and that's just over the counter pain reliever. He doesn't do drugs or anything like that. He is exhausted.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia, Rash, Vaccination site rash
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# FC3183), in left arm, on Sep 24, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a vaccination site rash (large red rash on left arm), rash, onset Sep 2021, with outcome of unknown; fatigue (experienced little more tiredness than normal) and paresthesia (tingling in left hand), onset Sep 24, 2021, with outcome of unknown. Additional information: Patient stated, "I have a large red rash on my left arm where I received a shot on the left-side of my arm. I experienced little more tiredness than normal. I have tingling in my left hand, where  the Pfizer shot was given. I just wanted report what I have going on. I have this rash. I never had anything like this before." Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 100 degree fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 19:00 (Lot number: 301558A) 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 (2nd dose, Lot- EL9263), administration date: 28Jan2021, when the patient was 69 years old, for Covid-19 Immunization; Bnt162b2 (1st dose, Lot- EL3246), administration date: 07Jan2021, when the patient was 69 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 29Sep2021 16:30, outcome "not recovered", described as "100 degree fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated she had her booster AT 7PM yesterday, 28Sep2021, states she is 69 years old, was it okay, she took her temperature, feels like she has a fever, states she has a 100-degree fever, wants to know if it was okay to take Tylenol. felt like she got a fever this afternoon around 4:30. Stated she got the booster dose at pharmacy.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest X-ray, Chest discomfort, Fatigue, Heart rate
Clinical narrative: the first dose, she had a little soreness in her shoulder; felt like her chest was a little different; sleepy; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 (Lot number: EW0175) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Diagnosed years ago, has had since 2004 or 2005.; "Arthritis" (ongoing), notes: Diagnosed in 2018 or 2019; "Diabetes", start date: 2018 (ongoing), notes: Borderline in 2018, but started taking medication this year in 2021.; "immune system was weak" (unspecified if ongoing); "Swelling" (unspecified if ongoing); "Nerve pain in her joints" (unspecified if ongoing); "Mild pain" (unspecified if ongoing). Family history included: "Asthma" (unspecified if ongoing), notes: Grandmother had asthma. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); LOSARTAN taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); VITAMIN D [VITAMIN D NOS] taken for vitamin supplementation (ongoing); FOLIC ACID (ongoing); METHOTREXATE taken for arthritis (ongoing); GABAPENTIN taken for arthritis, neuralgia (ongoing); FUROSEMIDE taken for swelling (ongoing); CELEBREX taken for pain (ongoing). The following information was reported: ARTHRALGIA (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "the first dose, she had a little soreness in her shoulder"; CHEST DISCOMFORT (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "felt like her chest was a little different"; SOMNOLENCE (non-serious) with onset Aug2021, outcome "unknown", described as "sleepy"; FATIGUE (non-serious) with onset Aug2021, outcome "unknown", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence
Clinical narrative: the first dose, she had a little soreness in her shoulder; felt like her chest was a little different; sleepy; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 (Lot number: EW0175) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Diagnosed years ago, has had since 2004 or 2005.; "Arthritis" (ongoing), notes: Diagnosed in 2018 or 2019; "Diabetes", start date: 2018 (ongoing), notes: Borderline in 2018, but started taking medication this year in 2021.; "immune system was weak" (unspecified if ongoing); "Swelling" (unspecified if ongoing); "Nerve pain in her joints" (unspecified if ongoing); "Mild pain" (unspecified if ongoing). Family history included: "Asthma" (unspecified if ongoing), notes: Grandmother had asthma. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); LOSARTAN taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); VITAMIN D [VITAMIN D NOS] taken for vitamin supplementation (ongoing); FOLIC ACID (ongoing); METHOTREXATE taken for arthritis (ongoing); GABAPENTIN taken for arthritis, neuralgia (ongoing); FUROSEMIDE taken for swelling (ongoing); CELEBREX taken for pain (ongoing). The following information was reported: ARTHRALGIA (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "the first dose, she had a little soreness in her shoulder"; CHEST DISCOMFORT (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "felt like her chest was a little different"; SOMNOLENCE (non-serious) with onset Aug2021, outcome "unknown", described as "sleepy"; FATIGUE (non-serious) with onset Aug2021, outcome "unknown", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 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 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 10:30 (Lot number: FE3592) at the age of 72 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 (Dose: 1st, lot number: EN5318, Anatomical Location : Right Arm), administration date: 04Feb2021, when the patient was 71 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2nd, lot number:  EN6201 , Anatomical Location : Right Arm), administration date: 25Feb2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 28Sep2021 07:00, outcome "not recovered", described as "minor allergic reaction"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 28Sep2021 07:00, outcome "not recovered" and all described as "she has heat around the site and it is pink and swollen and itchy". Therapeutic measures were not taken as a result of hypersensitivity, vaccination site erythema, vaccination site swelling, vaccination site pruritus, vaccination site warmth. Additional information: Patient stated that she thought it was just a minor allergic reaction, but patient wanted to know if she should just take an antihistamine, or what she should do. Patient stated that it was not huge, but it had been almost 2 days now and it doesn't look like hives, and it is not spreading, and she had no headache. Patient considered it as a minor allergic reaction. Much later in the day, arm hurt a little, but it was later in the evening at 7:00 p.m. It was reported that patient had not visited to the emergency room or the physician office because of any AE. There were no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. Patient denied for any family medical history relevant to ae and for any relevant tests. Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Palpitations
Clinical narrative: Heart palpitation; she felt flushed in the face and neck and couldn't sit for 15 minutes; she felt kind of weird; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101448746 (Pfizer).  A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 64 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, Lot number: EN6203, expiry: Jun2021), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 Immunization.   The following information was reported: PALPITATIONS (non-serious) with onset Jun2021, outcome "recovering", described as "Heart palpitation"; FLUSHING (non-serious) with onset 24Mar2021, outcome "unknown", described as "she felt flushed in the face and neck and couldn't sit for 15 minutes"; FEELING ABNORMAL (non-serious) with onset 24Mar2021, outcome "recovered" (2021), described as "she felt kind of weird". The event "heart palpitation" was evaluated at the physician office visit.  Additional Information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller was calling on behalf of her sister who had the two doses of the Pfizer covid vaccine. The caller knows the third booster dose is coming up and the patient is refusing to get it because she can't see anything in the research about heart palpitations. The patient had heart palpitations and so on and is wondering if there is any research on this? This happened after the second dose. The patient had the vaccine in May and the summer was terrible, she has had heart monitors and that kind of thing. This information is third hand from the patient to the caller.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101295794 same reporter/product/event, different patient
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Maternal exposure during pregnancy, Nausea, Pain
Clinical narrative: Nausea; Chills; Body aches; Fever; Headache; pregnant and last menstrual date 19May2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 13:00 (Batch/Lot number: unknown) at the age of 38 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Date of last menstrual period: 19May2021. The patient was 19 weeks pregnant at the time of exposure to bnt162b2. The patient was 19 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Feb2022. There were no concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 29Sep2021 13:00, outcome "unknown", described as "pregnant and last menstrual date 19May2021"; NAUSEA (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Nausea"; CHILLS (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of nausea, chills, pain, pyrexia, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; Chills; Body aches; Fever; Headache; pregnant and last menstrual date 19May2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 13:00 (Batch/Lot number: unknown) at the age of 38 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Date of last menstrual period: 19May2021. The patient was 19 weeks pregnant at the time of exposure to bnt162b2. The patient was 19 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Feb2022. There were no concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 29Sep2021 13:00, outcome "unknown", described as "pregnant and last menstrual date 19May2021"; NAUSEA (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Nausea"; CHILLS (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 29Sep2021 23:00, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of nausea, chills, pain, pyrexia, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Vaccination site bruising, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Sep2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single. Family history included: "COVID-19", start date: 2021 (unspecified if ongoing), notes: I was not formally diagnosed with COVID but certain I contracted the virus as two members of my household were formally diagnosed. I lost my sense of taste and smell for greater than six months. I had the virus likely around Feb-Mar2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number FC3180,, dose number 1, vaccine location Right arm), administration date: 08Aug2021, when the patient was 48 years old, for COVID-19 Immunisation, reaction(s): "Submandibular glands swelled to size of plums", "Malaise", "fatigue", "nausea", "body aches", "persistent mild to moderate headache". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovering", described as "Submandibular glands swelled to size of plums"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "mild headache"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset Sep2021, outcome "recovering" and all described as "hurt with injection and bruised at site.". Therapeutic measures were not taken as a result of lymphadenopathy, pain, headache, vaccination site pain, vaccination site bruising. Additional information: Submandibular glands swelled to size of plums within two days, slowly resolving over the course of 30 days. This occurred again with dose two, but not as severe. Malaise, fatigue, nausea, body aches, persistent mild to moderate headache for one week for dose one; mild headache, body aches, and swollen glands dose two. Dose two (20Sep2021), hurt with injection and bruised at site. If treatment AE: No, Since the vaccination, patient not been tested for COVID-19, Patient was receive any other vaccines within 4 weeks prior to the COVID vaccine. Known Allergies: No. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Headache, Rash macular
Clinical narrative: tired; she had COVID arm, clarified as a big red blotch.; she had COVID arm, clarified as a big red blotch.; weakness; headache; 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 72 year-old female patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (Lot number: EL9262, Expiration Date: 31May2021) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose of the Pfizer COVID-19 vaccine: NDC: Unknown, Lot: EL1283, Expiry: 30Apr2021, Vaccine Facility: withheld), administration date: 19Jan2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "When she received the first dose of the vaccine she only had some pain in her arm". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; RASH MACULAR (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "she had COVID arm, clarified as a big red blotch."; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : With the second dose Pfizer COVID-19 vaccine, she had COVID arm, clarified as a big red blotch. She had weakness, headache, but had no nausea. She felt tired. This is going back 6 months, but she states these symptoms were not near as severe as what she had with the booster. Investigations were none. She stated that she didn't go to the doctor for her symptoms because she was reading about it and read that the symptoms normally pass.   Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: tired; she had COVID arm, clarified as a big red blotch.; she had COVID arm, clarified as a big red blotch.; weakness; headache; 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 72 year-old female patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (Lot number: EL9262, Expiration Date: 31May2021) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose of the Pfizer COVID-19 vaccine: NDC: Unknown, Lot: EL1283, Expiry: 30Apr2021, Vaccine Facility: withheld), administration date: 19Jan2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "When she received the first dose of the vaccine she only had some pain in her arm". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; RASH MACULAR (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "she had COVID arm, clarified as a big red blotch."; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : With the second dose Pfizer COVID-19 vaccine, she had COVID arm, clarified as a big red blotch. She had weakness, headache, but had no nausea. She felt tired. This is going back 6 months, but she states these symptoms were not near as severe as what she had with the booster. Investigations were none. She stated that she didn't go to the doctor for her symptoms because she was reading about it and read that the symptoms normally pass.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Ear haemorrhage, Pain in extremity, Pyrexia
Clinical narrative: Bleeding in right ear, not continuously bleeding; Arm was bruised, dark bruise, right arm; Arm soreness, right arm; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Sep2021 (Lot number: EW0150) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "stents placed", start date: Sep2021 (unspecified if ongoing), notes: was in hospital from 07Sep2021 to 20Sep2021 and had 3 stents placed; "stroke", start date: Sep2021 (unspecified if ongoing); "broke out in red hives" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergic to flu shot for Allergic to flu shot. The following information was reported: CONTUSION (non-serious) with onset 25Sep2021, outcome "not recovered", described as "Arm was bruised, dark bruise, right arm"; PAIN IN EXTREMITY (non-serious) with onset 25Sep2021, outcome "recovering", described as "Arm soreness, right arm"; PYREXIA (non-serious) with onset 25Sep2021, outcome "recovered" (2021), described as "Fever"; EAR HAEMORRHAGE (non-serious) with onset 26Sep2021, outcome "recovered" (26Sep2021), described as "Bleeding in right ear, not continuously bleeding".  Additional information: Patient stated she confirmed with her doctor that it would be alright for her to take the vaccine. She took the vaccine last Saturday. Patient stated she thought the blood thinner contributed to the extreme bruising. Patient did not know what blood thinner she was on, or an NDC, Lot number or expiration date. Patient wanted to get her doctor's approval because of her health issues and was allergic to the flu shot, so that played a part also. Her doctor told her it was alright to get the Covid vaccine. She just wanted Pfizer to know her experience for people that are in a similar situation, who take blood thinners.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever; chills; Muscle soreness; Sore arm; Swollen lymph gland on right side (size of orange half).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 14:15 (Lot number: 30145B7) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Second dose, No reactions for 1 & 2), for COVID-19 immunization, reaction(s): "No reactions for 1 & 2"; Bnt162b2 (First dose, No reactions for 1 & 2), for COVID-19 immunization, reaction(s): "No reactions for 1 & 2". The following information was reported: PYREXIA (non-serious) with onset 29Sep2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 29Sep2021, outcome "recovering", described as "chills"; MYALGIA (non-serious) with onset 29Sep2021, outcome "recovering", described as "Muscle soreness"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021, outcome "recovering", described as "Sore arm"; LYMPHADENOPATHY (non-serious) with onset 29Sep2021, outcome "recovering", described as "Swollen lymph gland on right side (size of orange half).". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, pain in extremity, lymphadenopathy.  Clinical Information:The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination,the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: sore arm (at site of injection); achy muscles; achy knees; general fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 09:15 (Lot number: EL0217) at the age of 34 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Sep2021 19:00, outcome "recovering", described as "sore arm (at site of injection)"; MYALGIA (non-serious) with onset 29Sep2021 19:00, outcome "recovering", described as "achy muscles"; ARTHRALGIA (non-serious) with onset 29Sep2021 19:00, outcome "recovering", described as "achy knees"; FATIGUE (non-serious) with onset 29Sep2021 19:00, outcome "recovering", described as "general fatigue". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, arthralgia, fatigue.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been not tested for COVID-19. Yes, the patient had been taking other vaccine in four weeks. Other vaccine 4 weeks details other vaccine 4 weeks product: Flu. The report was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Pain and swelling in right axillary; Pain and swelling in right axillary; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female nurse reported for self (not pregnant) not pregnant at time of vaccination received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 (Lot number: 301558A) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer, diabetes, hypothyroidism" (unspecified if ongoing); "Breast cancer, diabetes, hypothyroidism" (unspecified if ongoing); "Breast cancer, diabetes, hypothyroidism" (unspecified if ongoing). The patient's 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: AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 29Sep2021 20:00, outcome "recovering" and all described as "Pain and swelling in right axillary". Therapeutic measures were not taken as a result of axillary pain, swelling.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received other medications within 2 weeks of vaccination. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain, Pain in extremity, Pruritus, Vomiting
Clinical narrative: throwing up; sore arm/arm is sore; head is itching; pain/soreness; stomach hurts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent (patient's mother).  A male patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (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: VOMITING (non-serious), outcome "unknown", described as "throwing up"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm/arm is sore"; PRURITUS (non-serious), outcome "unknown", described as "head is itching"; PAIN (non-serious), outcome "unknown", described as "pain/soreness"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach hurts".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Extrasystoles, Heart rate, Heart rate normal
Clinical narrative: click palpitations; heart skipping a beat; take my breath away; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Sep2021 19:30 (Lot number: FC3180) at the age of 36 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 number=1, lot number=EW0187,, administration time=01:30 PM,, vaccine location=Left arm), administration date: 07Aug2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious) with onset Sep2021, outcome "unknown", described as "click palpitations"; EXTRASYSTOLES (non-serious) with onset Sep2021, outcome "unknown", described as "heart skipping a beat"; DYSPNOEA (non-serious) with onset Sep2021, outcome "unknown", described as "take my breath away". The events "click palpitations", "heart skipping a beat" and "take my breath away" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of palpitations, extrasystoles, dyspnoea.  Clinical course: Within a few days of the second vaccine, the patient began to develop around the click palpitations, heart skipping a beat, especially at rest or before going to sleep. It would actually take the breath away. Pulse and blood pressure (BP) were always good though.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, Since the vaccination. No known allergies and other medical history.  No follow-up attempts are possible. No further information is expected.