chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm hurt at injection site for a few days; Metal taste in mouth for a couple of weeks; pains; felt kind of like he had a cold; asthma was real bad; Aches; Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 13:00 (Lot number: ER8727) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Asthma" (unspecified if ongoing), notes: Verbatim: Asthma, 11-12 years ago; "Verbatim: HIV positive", start date: 24Jan2001 (unspecified if ongoing), notes: Verbatim: HIV positive; "Verbatim: COPD" (unspecified if ongoing), notes: Verbatim: COPD. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 31Mar2021, outcome "recovering", described as "Aches"; BRONCHITIS (non-serious) with onset 31Mar2021, outcome "recovering", described as "Bronchitis"; VACCINATION SITE PAIN (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "Left arm hurt at injection site for a few days"; DYSGEUSIA (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "Metal taste in mouth for a couple of weeks"; PAIN (non-serious) with onset 31Mar2021, outcome "recovering", described as "pains"; NASOPHARYNGITIS (non-serious) with onset 31Mar2021, outcome "recovering", described as "felt kind of like he had a cold"; ASTHMA (non-serious) with onset 31Mar2021, outcome "recovering", described as "asthma was real bad". The events "bronchitis" and "asthma was real bad" were evaluated at the physician office visit. Therapeutic measures were taken as a result of bronchitis, asthma.  Additional details: Emergency Room? Yes Throwing up. 10Nov2021 went to (name). Placed IV and gave medication. One was to keep him from throwing up. He was more half asleep than he was awake. Treated and released. Physician Office?No. If the patient was hospitalized, how many days was the hospital stay? No. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination)? None or Unknown Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. COPD 4-5 years ago. Family Medical History Relevant to AE(s): Family is diabetic. Relevant Tests: Pancreas levels 600-700.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Dyspepsia, Fatigue, Headache
Clinical narrative: She has been having extensive headaches, nausea, and weakness in her body; Fatigue; Headache; digestive problems; Nausea; effects on her heart; started losing weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; DYSPEPSIA (non-serious) with onset 2021, outcome "unknown", described as "digestive problems"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "effects on her heart"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "started losing weight"; ASTHENIA (non-serious), outcome "unknown", described as "She has been having extensive headaches, nausea, and weakness in her body". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The reporter stated that he did research on it and found a college student that is 23 and almost the same thing happened her. No further details provided. The report was not related to a study or programme.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Weight, Weight decreased
Clinical narrative: She has been having extensive headaches, nausea, and weakness in her body; Fatigue; Headache; digestive problems; Nausea; effects on her heart; started losing weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; DYSPEPSIA (non-serious) with onset 2021, outcome "unknown", described as "digestive problems"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "effects on her heart"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "started losing weight"; ASTHENIA (non-serious), outcome "unknown", described as "She has been having extensive headaches, nausea, and weakness in her body". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The reporter stated that he did research on it and found a college student that is 23 and almost the same thing happened her. No further details provided. The report was not related to a study or programme.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: no severe fever reported; 4th Shot: Pfizer 27Aug; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Batch/Lot number: unknown) at the age of 25 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Sinopharm (Dose 1), administration date: 21Feb2021, when the patient was 25 years old, for COVID-19 immunisation; Sinopharm (Dose 2), administration date: 14Mar2021, when the patient was 25 years old, for COVID-19 immunisation, reaction(s): "Arm pain", "Fatigue", "Hotter Body"; Bnt162b2 (Dose 3), administration date: 25Jul2021, when the patient was 25 years old, for COVID-19 immunisation, reaction(s): "fever of 100.4", "Arm pain", "Fatigue", "Headache", "My heart raced". The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 27Aug2021, outcome "unknown", described as "4th Shot: Pfizer 27Aug"; PYREXIA (non-serious), outcome "unknown", described as "no severe fever reported".  Event Narrative: 1st Shot: Consumer got my first shot of (withheld) on 21Feb2021 and did not experience any side effects. 2nd Shot: Consumer got my second shot of (withheld) on 14Mar2021 and experienced arm pain, fatigue, and a hotter body (but my body temperature is normal). 3rd Shot: Consumer got another shot of Pfizer at 11:00 on 25Jul2021. Starting at 22:00 25Jul2021, Consumer developed a fever of 100.4, which lasted for about 24 hours. During this period, Consumer had severe arm pain, fatigue, headache, and her heart raced (her resting rate was usually 50-60 BPM but it reached 70-80 after the shot). 4th Shot: Pfizer 27Aug2021, no severe fever reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Widespread urticaria
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth
Clinical narrative: they've also experienced teeth sensitivity to hot and cold temperatures; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 59 year-old female patient 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: HYPERAESTHESIA TEETH (non-serious), outcome "unknown", described as "they've also experienced teeth sensitivity to hot and cold temperatures".  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-202101771853 Same reporter/drug, different patients.;US-PFIZER INC-202101767836 Same reporter/drug, different patients.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Feeling abnormal, Malaise, Mass, Swelling
Clinical narrative: feeling sick; i felt terrible; felt pain in my ampit; i had a big lump there; it felt like a swollen ballon; Raising my left arm whch was the site of the injection i felt pain in my ampit; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Dec2021 (Lot number: FD8448) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose dose number=2, unknown manufacturer), for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose dose number=1, unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "feeling sick"; FEELING ABNORMAL (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "i felt terrible"; AXILLARY PAIN (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "felt pain in my ampit"; MASS (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "i had a big lump there"; SWELLING (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "it felt like a swollen ballon"; VACCINATION SITE PAIN (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "Raising my left arm whch was the site of the injection i felt pain in my ampit". Therapeutic measures were not taken as a result of malaise, feeling abnormal, axillary pain, mass, swelling, vaccination site pain.  Additional information: Got the 3rd shot on saturday around 1pm. Got home and started feeling sick. The next day felt terrible and woke up monday feeling better but raising his left arm whch was the site of the injection he felt pain in armpit. He took a look and realized had a big lump there, showed it to his wife and took a picture of it. He touched it and it felt like a swollen balloon. He was still hoping the swelling or lump will go down. It's now 2.33pm on monday 13Dec2021 and yet it's still there. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient did not have any known allergies. The patient did not have covid prior vaccination. The patient was not covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feeling sick; i felt terrible; felt pain in my ampit; i had a big lump there; it felt like a swollen ballon; Raising my left arm whch was the site of the injection i felt pain in my ampit; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Dec2021 (Lot number: FD8448) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose dose number=2, unknown manufacturer), for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose dose number=1, unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "feeling sick"; FEELING ABNORMAL (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "i felt terrible"; AXILLARY PAIN (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "felt pain in my ampit"; MASS (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "i had a big lump there"; SWELLING (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "it felt like a swollen ballon"; VACCINATION SITE PAIN (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "Raising my left arm whch was the site of the injection i felt pain in my ampit". Therapeutic measures were not taken as a result of malaise, feeling abnormal, axillary pain, mass, swelling, vaccination site pain.  Additional information: Got the 3rd shot on saturday around 1pm. Got home and started feeling sick. The next day felt terrible and woke up monday feeling better but raising his left arm whch was the site of the injection he felt pain in armpit. He took a look and realized had a big lump there, showed it to his wife and took a picture of it. He touched it and it felt like a swollen balloon. He was still hoping the swelling or lump will go down. It's now 2.33pm on monday 13Dec2021 and yet it's still there. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient did not have any known allergies. The patient did not have covid prior vaccination. The patient was not covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling really good; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administration date 12Dec2021 13:30 (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: MALAISE (non-serious) with onset 13Dec2021, outcome "unknown", described as "not feeling really good".  Additional information: This is report 2 of 2.This report was not related to a study or programme. The Reporter was a Retired Registered Nurse who was also the patient's wife. The patient was administered Pfizer Covid-19 on 12Dec2021. Patient was not feeling really good today, but was not sick like reporter was; he didn't feel real good, but he didn't throw up.    Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Neck pain, Tinnitus
Clinical narrative: a constant high frequency ringing in my ear; getting regular headaches; Pain in my lower neck; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: TINNITUS (non-serious), outcome "not recovered", described as "a constant high frequency ringing in my ear"; HEADACHE (non-serious), outcome "unknown", described as "getting regular headaches"; NECK PAIN (non-serious), outcome "unknown", described as "Pain in my lower neck". Therapeutic measures were taken as a result of headache.  Additional Information: It was reported that, Customer Verbatim: Since getting the Covid 19 vaccine patient had a constant high frequency ringing in patients ear and getting regular headaches. It was stated that, Dates for High frequency pitch in ear; Ringing has been constant from the last, as patient don't know since patients first vaccine: (From: Unspecified To: Unspecified). Dates for Headache and dates for Pain in patients lower neck (From: Unspecified To: Unspecified). Patient stated regarding lot number, " patient can't read it very well, first one is FF2, looks like 593 and I really can't read the next one very well. The last four is 8762, patient don't know it's either KL or KI. Concern patient stated, ever since I got the COVID Vaccine, I have been getting this very high frequency pitch in my ear and I am also getting like a headache and like pain in my lower neck. Patient stated, I got about 6 minutes because I am going for another appointment. 2 hours I had been calling to see if you all to know or if there is another option I can do. Patient just received over the counter Advil. Patient already went to an ENT.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: had soreness in the arm and stuff; had things like headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had soreness in the arm and stuff"; HEADACHE (non-serious), outcome "unknown", described as "had things like headache". Additional Information: Reason for no lot number: of Comirnaty, Pfizer Covid-19 Vaccine: Other: She stated she does not have the details, but assuming it's the same as hers. Expiry Date of Comirnaty, Pfizer Covid-19 Vaccine is Unknown. This report is regarding the reporter's daughter. Caller stated on 18Nov2021 her and daughter got the booster for Covid, the Pfizer, administered at (pharmacy name) in (city name) on (place name). Caller explained they both, her and her daughter, received both of the Covid shots and had soreness in the arm and stuff, had things like headache. This was after the first two shots. She is concerned because both her and her daughter went in, and after the booster had side effect of soreness under the arm, and swelling. The under arm being swollen did not happen for the first two shots. Attempted to capture details regarding her daughter and she later stated she does not know if her daughter actually had the same experience. She was talking to her daughter and her daughter told her they can look it up today. Caller confirmed the other two doses received were the Pfizer Covid-19 Vaccine. Comirnaty, Pfizer Covid-19 Vaccine- Administered on 18Nov2021.Caller commented she thought the Covid booster, the one her and daughter received something was wrong with it. She is assuming her daughter's lot/exp of the covid-19 booster is the same as hers, but she is unable to provide any additional details. Caller then said all she knows is she had swelling under the arm. She stated she will let her daughter know and she can call and report these details on her own. There is a Product Complaint. Description of complaint is Caller reporting on Comirnaty, the Covid 19 booster Vaccination. She is concerned because both her and her daughter went in, and after the booster had side effect of soreness under the arm, and swelling. Caller commented she thought the Covid booster, the one her and daughter received something was wrong with 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-202101780739 same vaccine, different patient and AE.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Body mass index, Feeling abnormal, Investigation, SARS-CoV-2 antibody test
Clinical narrative: Felt a little crummy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Five brain surgeries" (unspecified if ongoing), notes: Five brain surgeries; "little pulmonary issue" (unspecified if ongoing), notes: little pulmonary issue. 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt a little crummy". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Batch/Lot number: unknown) at the age of 31 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 (dose 1, NDC/expiration: unknown, Lot: EW0173, Site: left arm), administration date: 07May2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (dose 2, NDC/expiration: unknown, Lot: EW0186, Site: left arm), administration date: 01Jun2021, when the patient was 31 years old, for COVID-19 Immunization, reaction(s): "Fever and chills for one day", "Fever and chills for one day". The following information was reported: HEAD DISCOMFORT (non-serious) with onset 12Dec2021, outcome "not recovered", described as "Pressure in head". Additional information: Patient stated he was calling about the Covid-19 vaccine, booster shot and got the vaccine last week. Patient stated it felt like a heavy pressure and it comes and goes and feels like a heavy pressure. The event did not result in Emergency Room or Physician Office. Family medical history was not provided. No relevant tests were reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Thyroid hormones decreased, Thyroid hormones test, Weight decreased
Clinical narrative: her thyroid hormone or TSH is dropping drastically; her thyroid hormone or TSH is dropping drastically; keeps losing weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID HORMONES DECREASED (non-serious), BLOOD THYROID STIMULATING HORMONE DECREASED (non-serious) all with onset 2021, outcome "unknown" and all described as "her thyroid hormone or TSH is dropping drastically"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "keeps losing weight". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller is a consumer reporting the caller's daughter received the Pfizer Covid Vaccine this past Spring 2021. The caller has been hearing that the Pfizer Covid Vaccine can effect thyroid. The caller would like to know if it is true that the Pfizer Covid Vaccine can effect thyroid? The caller's daughter has a thyroid issue the patient is just finding out about and the patient did not have the thyroid issue before receiving the Pfizer Covid Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lymph node pain, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: swell and pain in injection arm, after 24 hour pain in the lymph nodes underarm, left side; swell and pain in injection arm, after 24 hour pain in the lymph nodes underarm, left side; swell and pain in injection arm, after 24 hour pain in the lymph nodes underarm, left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 (Batch/Lot number: unknown) at the age of 66  as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sarcoidosis in remission," (unspecified if ongoing); "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE taken for immunisation, administration date 18Dec2021. Vaccination history included: Moderna (prev dose product=COVID 19,, prev dose brand=moderna,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the, time of report completion,, prev dose administration date=Mar2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: Mar2021, when the patient was 65 years old, for Covid-19 immunization; Moderna (prev dose product=COVID 19,, prev dose brand=moderna,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the, time of report completion,, prev dose administration date=Mar2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: Mar2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "swell and pain in injection arm, after 24 hour pain in the lymph nodes underarm, left side". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymph node pain, pain in extremity, peripheral swelling.  Additional information: patient does not had any known allergies. Patient did hot had COVID prior vaccination. The COVID was tested post vaccination reported as YES. Treatment received for the events included ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Myalgia, Pyrexia
Clinical narrative: cough; muscle pains; fever; 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 male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 2021, outcome "not recovered", described as "cough"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pains"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (27Dec2021), described as "fever".  Additional Information: The patient received booster dose of Pfizer Covid vaccine 21Dec2021, developed a cough, muscle pains, and fever. Stated that symptoms are what was given in the paper. Fever was resolved as of 27Dec2021, and the patient was "feeling better" but coughing continues. Further would like to know if he should get a Covid test. Potential AE recognized after caller disconnected. Transmitting potential duplicate AE.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A day after the Flu shot my left arm where I got the booster started hurting again like it did with the booster for at least a couple days; left injection site where I got the booster started to hurt; 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), administered in arm left, administration date 29Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster) single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 02Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown)), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Dec2021, outcome "unknown", described as "A day after the Flu shot my left arm where I got the booster started hurting again like it did with the booster for at least a couple days; left injection site where I got the booster started to hurt".   Additional information: Patient stated, patient was just want to report something really strange and got my booster (Unspecified Booster Shot) on 29Oct2021 of this year in patient left arm, on 02Dec2021 of this year patient got a Flu Shot (Unspecified Flu Shot) in my right arm, a day after the Flu shot patient left arm where patient got the booster started hurting again like it did with the booster for at least a couple days, are you understanding what patient was saying, yeah it's important because they told me at the pharmacy when patient was going to get the flu shot that it might hurt my arm so patient had it in my right arm because patient carry groceries with left, so patient got the flu shot in the right arm and then the booster in the left and after patient got the flu shot my left injection site where patient got the booster started to hurt like after patient got the booster (Further clarification unknown). Patient was just thought it was weird and wanted you to know. In response to further probing, patient stated, "I can hardly, I can't understand, you are talking too fast, 10 to 15 minutes, whatever is it goanna be you have to speak very slowly, I have really, it's nothing personal, I just have a hard time with accents so just speak slowly." Patient stated, "Is that what, I can't understand you, you know what I gave you what I needed to tell you." And hung up abruptly. Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default. Limited information was available over the call.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunology test
Clinical narrative: More headaches, they say it's normal to get more after COVID shot; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right (Lot number: EN6198, Expiration Date: 30Jun2021) at the age of 63 years as dose number unknown , 0.3 ml single. The patient's relevant medical history was not reported. Concomitant medication(s) included: XGEVA. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "More headaches, they say it's normal to get more after COVID shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information: Time of vaccination was 10:30 am .  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 antibody test
Clinical narrative: numbness on left side of face  and neck temporary 15 minutes; numbness on left side of face  and neck temporary 15 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Feb2021 13:00 (Lot number: EL1284) as dose 2, single and intramuscular, administration date 13Jan2021 13:00 (Lot number: EL1284) as dose 1, single for covid-19 immunisation. Family history included: "hypertension" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 03Feb2021 14:00, outcome "unknown" and all described as "numbness on left side of face  and neck temporary 15 minutes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, hypoaesthesia. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm pain; tired; This is a spontaneous report from a contactable consumer received from Pfizer Sponsored Program. A 70 years patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection (Batch/Lot number EN6198), intramuscular on 27FEB2021 13:00 as dose 1 single (At the age of 70 years) and dose 2 on 20MAR2021 13:00 (Batch/Lot number EP7534) for covid-19 immunisation. Medical history included anaphylactic reaction from ten years ago and never since (consumer had anaphylactic reaction in past to NSAID's and is wondering if she can take the Covid vaccine) and Gallbladder removal 5 years ago. The patient's concomitant medications were not reported. On an unspecified date, it was reported consumer had anaphylactic reaction in past to nsaid's and is wondering if she can take the covid vaccine. On an unspecified date the patient had experienced Arm pain and tired. No treatment was received. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was unknown. At the time of reporting, the outcome of the events Arm pain and tired were recovering.  Information on the lot/batch number has been requested.  Follow-up (25Mar2021): This is a Follow-up  spontaneous report received from a contactable consumer. This consumer reported in response to Non-HCP letter sent to consumer which included that: Updated information:  Patient Age at Time of Vaccination:70 Years. Suspect vaccine administration date, route of administration and batch no was added for dose 1 and dose 2. New events were added.  Follow-up attempts completed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted event "Circumstance or information capable of leading to medication error".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: I did not have any adverse events excepts sore arm; 1st dose 09Feb2021, 2nd dose 30Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Mar2021 12:45 (Batch/Lot number: EB8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure", start date: 2005 (ongoing), notes: Taking medication; "Allergies", start date: 1979 (ongoing), notes: got allergy shots + take medications; "arthroscopic surgery", start date: 27Jan2021 (unspecified if ongoing), notes: Left knee. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Time:1:30pm, Anatomical site of injection : left upper arm, Route of administration: Intramuscular, Batch/lot number: EL9267), administration date: 09Feb2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I did not have any adverse events excepts sore arm"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1st dose 09Feb2021, 2nd dose 30Mar2021". Relevant laboratory tests and procedures are available in the appropriate section.  Verbatim: Consumer was traveling to (City name) and she was in (City name). Consumer will not be able to get her second dose on 02Mar. Consumer would like to know if she can reschedule her appointment or if she gets the second dose in (City name) also asking if it's fine if she will get the second dose more than 3 weeks. Upon receiving further information, Consumer (Withheld), got the first dose of vaccine on 09Feb2021, and the second dose was scheduled on 02Mar2021. (Withheld) said she missed the second dose, and she was advised that she can get it within 6 weeks from her first dose. (Withheld) is trying to get an appointment and asking if she will start again from the first dose. Prior vaccination: None. Concomitant drugs: None. Anatomical location: Left upper arm.  Information about lot/batch number has been requested.  Followup#01 (09Apr2021): Upon receipt of follow-up information on 09Apr2021 this case is now considered valid. This is a follow-up spontaneous report from a contactable consumer. This 45-year-old male consumer (patient) reported in response to HCP letter sent via follow-up letter. Updated information included patient age, dose description, event details.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient. A female patient of an unspecified age received the second dose of the BNT162B2 (Pfizer COVID-19 vaccine, Lot/Batch number: EL9266, expiry: 31May2021) intramuscularly in deltoid right as dose 2, single for Covid-19 immunization on 22Feb2021 at 08:40 (2 hours prior to this report). Medical history and concomitant medications were not reported. The patient received the first dose of the BNT162B2 (Pfizer COVID-19 vaccine, Lot/Batch number: EN5318, expiry: 31May2021) intramuscularly in deltoid right (shoulder joint) on 01Feb2021 at 1:20PM as dose 1 single for Covid-19 immunization. It was reported that the second dose was inadvertently administered at her shoulder joint and not to her deltoid muscle on 22Feb2021 at 08:40 (instant). It was clarified upon follow-up that  reported medication error affected the patient with clinical consequences as the patient had shoulder pain requiring steroid treatment in an instant on 22Feb2021 08:40. Therapeutic measures were taken as a result of arthralgia: steroid treatment. It was reported that the events were evaluated at the physician office visit. The outcome of the event arthralgia was recovering. The reporter/pharmacist did not consider the Pfizer product to have had a causal effect to the events. Information on the Lot/Batch number has been requested. Follow-up (29Mar2021): This is spontaneous report received from a contactable Pharmacist. Updated information: suspect drug lot and expiration added. historical vaccine information updated (lot, expiry, route, vaccination date and time), event details (shoulder pain requiring steroid treatment added as event and coded "dose was inadvertently administered at her shoulder joint and not to her deltoid muscle" to inappropriate route of vaccine). This case is upgraded to serious IME. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender's Comments: Based on the information in the case report the causal relationship between the event Inappropriate route of vaccination, Shoulder pain, and suspect drug BNT162B2 can be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: body ached all over; slight headache; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 18Feb2021 (at the age of 63-years-old; Lot Number: EN6198) as dose 2, single for COVID-19 immunisation. Medical history included psoriasis on her skin, psoriatic arthritis, Mild COPD, herniated lumbar disc; all from an unknown date and unknown if ongoing. Patient has ongoing depression and anxiety, for both which she was treated. Concomitant medications included Effexor XR 225 mg and Lorazepam 2 mg twice daily. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 26Jan2021 10:30 (at the age of 63-years-old; Lot Number: EN5318) for COVID-19 immunization and experienced dull headache, chills, fatigue and slept though most of it. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 18Feb2021 15:00, the patient experienced body ached all over, slight headache and extreme fatigue for 48 hours. The events were considered as non-serious. The events were not treated. The outcome of the events was recovered on 20Feb2021 15:00.   Follow-up (PRD 29Mar2021): Follow-up attempts are completed. No further information is expected. The following information was also reflected on the narrative: non-pregnant and age at vaccination of suspect drug. Added age at vaccination and adverse events of the historical vaccine. Updated the dose description of suspect drug and captured stop date of events as 20Feb2021 15:00.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood test, Dizziness, Inappropriate schedule of product administration, Off label use
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 75-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200), intramuscular, administered in arm left, administration date 01Mar2021. Relevant medical history included: "Diabetic", start date: 2014 (ongoing), notes: onset: 7 years ago Doctor checkup every 3 months w/tests diabetes contracted with w/med approx. 1975.; "gallbladder surgery" (unspecified if ongoing); "hysterectomy", start date: 1973 (unspecified if ongoing). Family history included: "cancer lungs " (unspecified if ongoing), notes: Deceased; "multiple illnesses" (unspecified if ongoing), notes: age 84 deceased. Concomitant medication(s) included: TOUJEO taken for diabetes mellitus (ongoing); HUMALOG taken for diabetes mellitus; TYLENOL taken for sinus headache; AFRIN [OXYMETAZOLINE] taken for sinus disorder. She had received her first dose Bnt162b2 (Dose 1, Single; 09:20 AM; Batch/Lot: EL9261; Expiration date: May2021, Anatomical location: Left arm, Administration route: Intramuscular, administration date: 15Feb2021, for Covid-19 immunization. She received her second dose of Vaccine earlier than recommended (14 days instead of the recommended 19-42 days) which is Off-Label dosing. The patient experienced DIZZINESS (non-serious) with onset 02Mar2021, outcome "recovered" (05Mar2021), described as "extremely dizzy"; THIRST (non-serious) with onset 02Mar2021, outcome "recovered" (05Mar2021), described as "cotton ensided thirst". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, thirst. Additional information: Morning after second injection awake very thirsty and extremely dizzy. Mouth felt like it had cotton inside thirst and dizziness lasted 3 days. Dosser giving first injection entered date for second injection at 2 weeks instead of 3. not thinking that it was set at 2 weeks and went on and got second injection. The staff could not filled my paper original had me to prepare a second one they now the original date on my card.Follow-up (13Apr2021): This is a spontaneous follow-up report received from contactable consumer (patient). Updated information: Batch number, expiry date, route of administration was added for vaccine. Concomitant medications were added. Patient's medical history was added. Family history was added. New events (dizziness and thirst) was added. Laboratory test were added. No follow-up attempts are needed; information about lot/batch number cannot be obtained.