chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Somnolence
Clinical narrative: booster shot; soreness in the arm; little sleepy the next day.; 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 (Formulation: Solution for injection) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (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. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster shot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the arm"; SOMNOLENCE (non-serious), outcome "unknown", described as "little sleepy the next day.".  The lot number for bnt162b2 was not provided and will be requested during follow up. Additional information: I have received both shots and the booster shot. I had no reactions, just some soreness in the arm and a little sleepy the next day.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstrual disorder, Menstruation irregular
Clinical narrative: Dose number: 3; I am age 50 and have an IUD/I began having periods again.; I am age 50 and have an IUD/I began having periods again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 09:00 (Lot number: 320030BD) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; BUSPAR; VITAMIN D [COLECALCIFEROL]; CALCIUM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 17Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 07Apr2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "I am age 50 and have an IUD /  I began having periods again.", "I am age 50 and have an IUD /  I began having periods again.". The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "Dose number: 3"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I am age 50 and have an IUD/I began having periods again."; MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "I am age 50 and have an IUD/I began having periods again". Therapeutic measures were taken as a result of menstrual disorder, menstruation irregular.  Additional information: It was reported that, the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient had not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Poor quality product administered, Product temperature excursion issue
Clinical narrative: First dose: Second dose: Moderna; Received expired Adult Pfizer Covid Vaccine as Booster; First and Second dose: Moderna; Received expired Adult Pfizer Covid Vaccine as Booster; Caller clarifies this was the patient's booster dose.; ,06DEC2021 at 1513 and the patient received the Adult Pfizer Covid 19 Vaccine on 06DEC2021 at 1630, past the 6 hours of the Adult Pfizer Covid 19 Vaccine being at room temperature in a diluted vial; 06DEC2021 at 1513 and the patient received the Adult Pfizer Covid 19 Vaccine on 06DEC2021 at 1630, past the 6 hours of the Adult Pfizer Covid 19 Vaccine being at room temperature in a diluted vial; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 06Dec2021 16:30 (Lot number: FJ1620, Expiration Date: Feb2022) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. Vaccination history included: Moderna (Dose: 01), administration date: 03Apr2021, when the patient was 52 years old, for COVID-19 Immunization; Moderna (Dose: 02), administration date: 01May2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as "First dose: Second dose: Moderna; Received expired Adult Pfizer Covid Vaccine as Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as "First and Second dose: Moderna; Received expired Adult Pfizer Covid Vaccine as Booster"; IMMUNISATION (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as "Caller clarifies this was the patient's booster dose."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as ",06DEC2021 at 1513 and the patient received the Adult Pfizer Covid 19 Vaccine on 06DEC2021 at 1630, past the 6 hours of the Adult Pfizer Covid 19 Vaccine being at room temperature in a diluted vial"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as "06DEC2021 at 1513 and the patient received the Adult Pfizer Covid 19 Vaccine on 06DEC2021 at 1630, past the 6 hours of the Adult Pfizer Covid 19 Vaccine being at room temperature in a diluted vial".  No follow-up attempts are possible. No further information is expected.  Additional information: The reporter stated that event was not serious since it seems the patient was still stable at that time and did not cause any harm to the patient.   Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Testicular pain
Clinical narrative: Left testicular dull pain / Dull mild pain; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 (Lot number: 33026Bb) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mild gastritis" (unspecified if ongoing). Concomitant medication(s) included: HYOSCYAMINE; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0182, Location of injection: Arm Left), administration date: 12May2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Left testicular dull pain"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021, outcome "unknown", described as "booster"; TESTICULAR PAIN (non-serious) with onset 05Dec2021 04:45, outcome "not recovered", described as "Left testicular dull pain / Dull mild pain". Therapeutic measures were not taken as a result of testicular pain. 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. Since the vaccination, the patient has not been tested for COVID-19. It was reported that Left testicular dull pain after 2nd dose which was only experienced once after 2nd dose which lasted for few seconds and went away. And then nothing. After the 3rd booster dose it happened again. Dull mild pain that appears and goes away in few minutes. Follow-up attempts completed. No further information expected  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracting covid post 1st dose of the Pfizer Covid vaccine; contracting covid post 1st dose of the Pfizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 34-year-old male patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "contracting covid post 1st dose of the Pfizer Covid vaccine". Therapeutic measures were taken as a result of covid-19. Additional information: The reporter was looking for information about dosing a 34-year-old patient who acquired COVID-19 after the 1st dose of the Pfizer Covid vaccine on 23Aug2021 and received Regeneron treatment. The reporter stated how long could he wait between the first and second dose of the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) in 2021, and contracted COVID-19 on an unspecified date in 2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Myalgia, Pruritus
Clinical narrative: booster; itching all over body; Headache; muscle aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 10:00 (Lot number: 330308D) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm left, administration date 10Nov2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfa, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EN6199,, prev dose lot unknown=False,, prev dose administration date=025M, ar2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 25Mar2021, when the patient was 52 years old, for COVID-19 immunisation; Bnt162b2 (Prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EN5318,, prev dose lot unknown=False,, prev dose administration date=04M, ar2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 04Mar2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: PRURITUS (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "itching all over body"; IMMUNISATION (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "booster"; HEADACHE (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "Headache"; MYALGIA (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "muscle aches"; FATIGUE (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "fatigue". Therapeutic measures were not taken as a result of pruritus, immunisation, headache, myalgia, fatigue.  Additional Information: If other vaccine in four weeks was reported as yes and included Flu, other vaccine 4weeks vaccine date =10Nov2021, other vaccine 4weeks dose number=1, other vaccine 4weeks vaccine location=left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device time stamp: 07Dec2021  Follow-up attempts are completed. No further information is expected
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Fatigue, Immunisation, Lymphadenopathy
Clinical narrative: Sore; Swollen lymph under left arm; Back pain; Fatigue; Booster; No appetite at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 18:30 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (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 number: 2, lot unknown reason=Misplaced/discarded, administration time: 09:45 AM, Vaccine location: Left arm.), administration date: 25Apr2021, when the patient was 51 years old, for COVID-19 immunization; Covid-19 vaccine (dose number: 1, dose lot unknown reason=Misplaced/discarded, administration time: 09:45 AM, Vaccine location: Left arm.), administration date: 04Apr2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 18:30, outcome "unknown", described as "Booster"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "No appetite at all"; PAIN (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Sore"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Swollen lymph under left arm"; BACK PAIN (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Back pain"; FATIGUE (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of decreased appetite, pain, lymphadenopathy, back pain, fatigue.  Additional information: First week: sore. Swollen lymph under left arm. Back pain. Fatigue. Down and out. Second week: Fatigue. No appetite at all. Day 15: finally feel closer to normal, still fatigued at end of day and low appetite. Facility type vaccine was pharmacy or drug store, no other vaccine in four weeks, no other mediation in two weeks and no known allergies. Lot for third dose was unknown reason and reason was provided as misplaced/discarded.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Sore; Swollen lymph under left arm; Back pain; Fatigue; Booster; No appetite at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 18:30 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (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 number: 2, lot unknown reason=Misplaced/discarded, administration time: 09:45 AM, Vaccine location: Left arm.), administration date: 25Apr2021, when the patient was 51 years old, for COVID-19 immunization; Covid-19 vaccine (dose number: 1, dose lot unknown reason=Misplaced/discarded, administration time: 09:45 AM, Vaccine location: Left arm.), administration date: 04Apr2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 18:30, outcome "unknown", described as "Booster"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "No appetite at all"; PAIN (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Sore"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Swollen lymph under left arm"; BACK PAIN (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Back pain"; FATIGUE (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of decreased appetite, pain, lymphadenopathy, back pain, fatigue.  Additional information: First week: sore. Swollen lymph under left arm. Back pain. Fatigue. Down and out. Second week: Fatigue. No appetite at all. Day 15: finally feel closer to normal, still fatigued at end of day and low appetite. Facility type vaccine was pharmacy or drug store, no other vaccine in four weeks, no other mediation in two weeks and no known allergies. Lot for third dose was unknown reason and reason was provided as misplaced/discarded.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Scar inflammation, Skin irritation
Clinical narrative: small pox vaccine scar has become inflamed and slightly irritated; small pox vaccine scar has become inflamed and slightly irritated; Dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 11:00 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (dose number=2, product=COVID 19, brand=Pfizer, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=21Apr2021, administration time=06:00 PM, vaccine location=Left arm), administration date: 21Apr2021, when the patient was 24 years old, for Covid-19 immunization; Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=31Mar2021, administration time=09:00 AM, vaccine location=Left arm), administration date: 31Mar2021, when the patient was 24 years old, for Covid-19 immunization; Small pox vaccine (I received a small pox vaccine when I, was younger (previously lived in, Belarus).), for immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021 11:00, outcome "unknown", described as "Dose number=3"; SCAR INFLAMMATION (non-serious), SKIN IRRITATION (non-serious) all with onset 05Dec2021 15:00, outcome "recovering" and all described as "small pox vaccine scar has become inflamed and slightly irritated". Therapeutic measures were not taken as a result of scar inflammation, skin irritation.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Birth control medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Adverse Event resulted in none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Lymphadenopathy, Myalgia
Clinical narrative: COVID-19 Booster Dose; chills; muscle aches; headache; lymphadenopathy; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID-19 Booster Dose"; CHILLS (non-serious), outcome "unknown", described as "chills"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HEADACHE (non-serious), outcome "unknown", described as "headache"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymphadenopathy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Pain
Clinical narrative: Booster; Interchange of vaccine products; extremely sore and painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: current medical condition. Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Past drug history included: Johnson & johnson covid-19 vaccine for COVID-19 immunization, reaction(s): "did not get any antibodies", notes: dose 1. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "extremely sore and painful".  Additional information: Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the event pain. The causal relationship between the event pain and Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. No treatment information was received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pyrexia
Clinical narrative: booster; fever; exhaustion; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE , UNKNOWN MANUFACTURER.), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown", described as "exhaustion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Pruritus
Clinical narrative: Got Pfizer as booster; Consumer had Moderna Covid vaccine for first 2 initial doses. Got Pfizer as booster; Within 2 hours had face a head itching; From: (Name withheld) Reporter Name: (Name withheld) Reported by: Consumer Reporter Contact Information: (#) Patient Name: (#) Description of Event: Consumer had Moderna Covid vaccine for first 2 initial doses. Got Pfizer as booster when eligible because that's only one that was available in their area. Within 2 hours had face a head itching. Female. 35 years old. No underly( g health conditions Name of Product: Covid Vaccine Booster Awareness Date: 07Dec2021 Country of Occurrence: Event took place after use of product.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Immunisation, Malaise
Clinical narrative: Booster; a fever to 102.3; rigors; headache; malaise; myalgias; One episode of emesis; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Dec2021 (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 number unknown, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "a fever to 102.3"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "rigors"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "malaise"; MYALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "myalgias"; VOMITING (non-serious) with onset Dec2021, outcome "unknown", described as "One episode of emesis". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Approximately 13 hours after administration (captured as on an unspecified date in Dec2021), she experienced a fever to 102.3 (unit unspecified), rigors, headache, malaise, myalgias and one episode of emesis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Booster; a fever to 102.3; rigors; headache; malaise; myalgias; One episode of emesis; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Dec2021 (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 number unknown, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "a fever to 102.3"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "rigors"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "malaise"; MYALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "myalgias"; VOMITING (non-serious) with onset Dec2021, outcome "unknown", described as "One episode of emesis". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Approximately 13 hours after administration (captured as on an unspecified date in Dec2021), she experienced a fever to 102.3 (unit unspecified), rigors, headache, malaise, myalgias and one episode of emesis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Immunisation, Oestradiol, Oestradiol increased, Vitamin D decreased
Clinical narrative: sensitive estradiol went from a value of less than 2 (which it always is for years since being on an aromatase inhibitor) to a value of 5; vitamin D level dropped to 62 it's classically 79 or 80 also for years; Dose Number : 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 12:00 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "BC" (unspecified if ongoing). Concomitant medication(s) included: EXEMESTANE. Past drug history included: No., reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), when the patient was 62 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 12:00, outcome "unknown", described as "Dose Number : 3"; OESTRADIOL INCREASED (non-serious) with onset 02Dec2021 14:00, outcome "unknown", described as "sensitive estradiol went from a value of less than 2 (which it always is for years since being on an aromatase inhibitor) to a value of 5"; VITAMIN D DECREASED (non-serious) with onset 02Dec2021 14:00, outcome "unknown", described as "vitamin D level dropped to 62 it's classically 79 or 80 also for years". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oestradiol increased, vitamin d decreased.  Additional information: The patient regularly undergoes blood work because she was a breast cancer survivor, and was on aromatase inhibitor called exemestane. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Exemastane medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has 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: Swelling
Clinical narrative: booster dose; swollen on her neck or her arm comparable to the size of a baseball ball; swollen on her neck or her arm comparable to the size of a baseball ball; she is only seeing less inflammation as of today 07DEC2021; When will my daughter's lymph nodes return back to normal; had reaction and was very uncomfortable for the booster/ there was a reaction to this booster so badly; 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 38 year-old female patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, For the first two doses, we did not experience any adverse events".), for Covid-19 Immunization, reaction(s): "did not experience any adverse events"; Bnt162b2 (2nd dose, For the first two doses, we did not experience any adverse events".), for Covid-19 Immunization, reaction(s): "did not experience any adverse events". The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "booster dose"; SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Dec2021, outcome "unknown" and all described as "swollen on her neck or her arm comparable to the size of a baseball ball"; INFLAMMATION (non-serious) with onset Dec2021, outcome "recovering", described as "she is only seeing less inflammation as of today 07DEC2021"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "not recovered", described as "When will my daughter's lymph nodes return back to normal"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "had reaction and was very uncomfortable for the booster/ there was a reaction to this booster so badly".  Additional information: The Pfizer-BioNTech COVID-19 Vaccine is authorized for use as a single booster dose to individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19. Fever, headache, fatigue, and pain at the injection site were the most reported side effects, and overall, most side effects were mild to moderate. However, as with the two-shot or single-dose primary series, serious side effects are rare, but may occur. In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a booster dose included lymphadenopathy (5.2%), nausea (0.7%) and rash (0.3%). In an analysis of all unsolicited adverse events reported following the booster dose, through 1 month after the booster dose, in participants 18 through 55 years of age (N = 306), those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (n = 16, 5.2%), nausea (n = 2, 0.7%) and rash (n = 1, 0.3%)".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Immunisation
Clinical narrative: booster; blood sugar rose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization; Bnt162b2 (DOSE 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar rose". 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101741528 US-PFIZER INC-202101741528;US-PFIZER INC-202101742407 same vaccine, AE and different patient
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeling abnormal, Immunisation, Salivary hypersecretion, Somnolence
Clinical narrative: Third dose or booster shot: Just kind of out of it; Third dose or booster shot: trouble swallowing, difficulty swallowing; Third dose or booster shot: Began salivating quite a bit; Third dose or booster shot: Became more somnolent; Third dose or booster shot: Just kind of out of it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 13:30 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing), notes: Onset probably since she was a child of 7 or 8 years, but just undiagnosed at that point. She is paraplegic so he has to help her get in bed himself because she can't stand.; "High blood pressure" (ongoing), notes: Onset date unknown other than several decades back. Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing).Vaccination history included: Bnt162b2 (First dose: Date administered: Unknown, months ago he guessed. Lot/NDC/Expiry: Unknown, caller did not have CDC vaccine record card with them at time of the call.), for COVID-19 Immunization; Bnt162b2 (Second dose: Date administered: Unknown, months ago he guessed. Lot/NDC/Expiry: Unknown, caller did not have CDC vaccine record card with them at time of the call.), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", DYSPHAGIA (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021) and all described as "Third dose or booster shot: trouble swallowing, difficulty swallowing"; SALIVARY HYPERSECRETION (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "Third dose or booster shot: Began salivating quite a bit"; SOMNOLENCE (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "Third dose or booster shot: Became more somnolent"; FEELING ABNORMAL (non-serious) with onset 06Dec2021, outcome "recovered" (06Dec2021), described as "Third dose or booster shot: Just kind of out of it".The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Injection site pain, Nausea, Pain in extremity
Clinical narrative: booster; Pain at the injection site; Really very sore arm, it is still sore; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 10:00 (Lot number: FH8027) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE-1), for COVID-19 immunization; Bnt162b2 (DOSE-2), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 10:00, outcome "unknown", described as "booster"; INJECTION SITE PAIN (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Pain at the injection site"; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Really very sore arm, it is still sore"; NAUSEA (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "Nausea". Therapeutic measures were not taken as a result of injection site pain, pain in extremity, nausea.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain and swelling at the injection site.; Pain and swelling at the injection site.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Dec2021 10:45 (Lot number: FH8027) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP-6955, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 24Mar2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 01Mar2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 10:45, outcome "unknown", described as "booster"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 07Dec2021 05:30, outcome "recovering" and all described as "Pain and swelling at the injection site.". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain.  Additional information: reported seriousness was reported as non-serious. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination patient was not tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eyelids pruritus, Pruritus, Scab, Swelling of eyelid
Clinical narrative: Swollen Itchy Eye lids creating a crusty scab that burns; Swollen Itchy Eye lids creating a crusty scab that burns; Swollen Itchy Eye lids creating a crusty scab that burns; Swollen Itchy Eye lids creating a crusty scab that burns; Itchy scalp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 (Lot number: EW0177) at the age of 33 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient did not have COVID-19 prior to the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of the BNT162B2 vaccine. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EW0165, Location of injection: Arm Left), administration date: 11May2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: SWELLING OF EYELID (medically significant), EYELIDS PRURITUS (medically significant), EYE IRRITATION (non-serious), SCAB (non-serious) all with onset 01Jun2021, outcome "not recovered" and all described as "Swollen Itchy Eye lids creating a crusty scab that burns"; PRURITUS (non-serious) with onset 01Jun2021, outcome "not recovered", described as "Itchy scalp". The events "swollen itchy eye lids creating a crusty scab that burns" and "itchy scalp" were evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling of eyelid, eyelids pruritus, eye irritation, scab, pruritus. Clinical Course: Treatment included two doses of steroids and steroid creams. The patient was not tested for COVID-19 post vaccination.   Follow-up (17Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Headache, Pain
Clinical narrative: had a sore arm; severe headache; dizziness; feeling like he can't get oxygen; achy all over; dry cough; 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.  An 11- year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 07Dec2021 16:00 (Batch/Lot number: unknown) at the age of 11 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st Dose, Unknown Manufacturer.), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Dec2021, outcome "unknown", described as "had a sore arm"; HEADACHE (non-serious) with onset 08Dec2021, outcome "unknown", described as "severe headache"; DIZZINESS (non-serious) with onset 08Dec2021, outcome "unknown", described as "dizziness"; DYSPNOEA (non-serious) with onset 08Dec2021, outcome "recovered", described as "feeling like he can't get oxygen"; PAIN (non-serious) with onset 08Dec2021, outcome "unknown", described as "achy all over"; COUGH (non-serious) with onset 08Dec2021, outcome "unknown", described as "dry cough". Therapeutic measures were taken as a result of pain in extremity, headache.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; severe headache; dizziness; feeling like he can't get oxygen; achy all over; dry cough; 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.  An 11- year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 07Dec2021 16:00 (Batch/Lot number: unknown) at the age of 11 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st Dose, Unknown Manufacturer.), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Dec2021, outcome "unknown", described as "had a sore arm"; HEADACHE (non-serious) with onset 08Dec2021, outcome "unknown", described as "severe headache"; DIZZINESS (non-serious) with onset 08Dec2021, outcome "unknown", described as "dizziness"; DYSPNOEA (non-serious) with onset 08Dec2021, outcome "recovered", described as "feeling like he can't get oxygen"; PAIN (non-serious) with onset 08Dec2021, outcome "unknown", described as "achy all over"; COUGH (non-serious) with onset 08Dec2021, outcome "unknown", described as "dry cough". Therapeutic measures were taken as a result of pain in extremity, headache.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: booster; headache; nausea; chills; body aches; fatigue; This is a spontaneous report received from a contactable reporter (Other-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue".  Additional information: On day 2 after receiving Pfizer Covid booster, the patient experienced headache, nausea, chills, body aches and fatigue. The patient was still experiencing headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.