chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chills, Feeling abnormal, Immunisation
Clinical narrative: feels like dead weight; aching has grown to the left side of my neck; aching has grown to the left side of my neck and past my arm pit into my left breast; Mouth sores; Covid-19 booster vaccine received; Chills; body aches specifically near spine/slight aches under my left arm pit.; Received my shot on my left arm so soreness; Last night had slight aches under my left arm pit/This morning just woke up with greater soreness in left arm pit, feels like dead weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-years-old patient received third dose of bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Relevant medical history included: "exercise induced asthma" (unspecified if ongoing), notes: Verbatim: exercise induced asthma; "adult acne" (unspecified if ongoing), notes: Verbatim: adult acne; "vertigo" (unspecified if ongoing), notes: Verbatim: vertigo. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Covid-19 booster vaccine received"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "body aches specifically near spine/slight aches under my left arm pit."; ORAL PAIN (non-serious) with onset 05Dec2021, outcome "unknown", described as "Mouth sores"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Received my shot on my left arm so soreness"; AXILLARY PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Last night had slight aches under my left arm pit/This morning just woke up with greater soreness in left arm pit, feels like dead weight"; FEELING ABNORMAL (non-serious) with onset 06Dec2021, outcome "unknown", described as "feels like dead weight"; NECK PAIN (non-serious) with onset 06Dec2021, outcome "unknown", described as "aching has grown to the left side of my neck"; BREAST PAIN (non-serious) with onset 06Dec2021, outcome "unknown", described as "aching has grown to the left side of my neck and past my arm pit into my left breast".  Additional Information: Folks were adding a new symptom to COVID booster AE. Last night, the patient had slight aches under her left arm pit. She received shot on her left arm, so soreness by the shot which was different from the aches under her arm pit now. This morning just, she woke up with greater soreness in left arm pit, feels like dead weight. The aching had grown to the left side of her neck and past arm pit into her left breast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Oral pain, Pain, Pain in extremity
Clinical narrative: feels like dead weight; aching has grown to the left side of my neck; aching has grown to the left side of my neck and past my arm pit into my left breast; Mouth sores; Covid-19 booster vaccine received; Chills; body aches specifically near spine/slight aches under my left arm pit.; Received my shot on my left arm so soreness; Last night had slight aches under my left arm pit/This morning just woke up with greater soreness in left arm pit, feels like dead weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-years-old patient received third dose of bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Relevant medical history included: "exercise induced asthma" (unspecified if ongoing), notes: Verbatim: exercise induced asthma; "adult acne" (unspecified if ongoing), notes: Verbatim: adult acne; "vertigo" (unspecified if ongoing), notes: Verbatim: vertigo. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Covid-19 booster vaccine received"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "body aches specifically near spine/slight aches under my left arm pit."; ORAL PAIN (non-serious) with onset 05Dec2021, outcome "unknown", described as "Mouth sores"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Received my shot on my left arm so soreness"; AXILLARY PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Last night had slight aches under my left arm pit/This morning just woke up with greater soreness in left arm pit, feels like dead weight"; FEELING ABNORMAL (non-serious) with onset 06Dec2021, outcome "unknown", described as "feels like dead weight"; NECK PAIN (non-serious) with onset 06Dec2021, outcome "unknown", described as "aching has grown to the left side of my neck"; BREAST PAIN (non-serious) with onset 06Dec2021, outcome "unknown", described as "aching has grown to the left side of my neck and past my arm pit into my left breast".  Additional Information: Folks were adding a new symptom to COVID booster AE. Last night, the patient had slight aches under her left arm pit. She received shot on her left arm, so soreness by the shot which was different from the aches under her arm pit now. This morning just, she woke up with greater soreness in left arm pit, feels like dead weight. The aching had grown to the left side of her neck and past arm pit into her left breast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Immunisation
Clinical narrative: Fast Heart Beat; 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 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 12:30 (Lot number: FH8027) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ep7533, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Apr2021, when the patient was 22 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Mar2021, when the patient was 22 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose Number 3"; HEART RATE INCREASED (non-serious) with onset 04Dec2021 07:00, outcome "recovering", described as "Fast Heart Beat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, heart rate increased.  Additional information: Patient was administered with most recent COVID-19 vaccine in Hospital. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as yes Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. known allergies and other medical history were reported as yes  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Immunisation
Clinical narrative: booster; She is very sick right now; Very severe headache; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A female patient received bnt162b2 (BNT162B2), administration date 04Dec2021 (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 (Manufacturer Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "unknown", described as "booster"; ILLNESS (non-serious) with onset Dec2021, outcome "not recovered", described as "She is very sick right now"; HEADACHE (non-serious) with onset Dec2021, outcome "not recovered", described as "Very severe headache"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "Chills".  Additional information: The reporter reported for daughter, she had a vaccine on Saturday for the booster, Pfizer and she was very sick right now and had a very severe headache and chills and the reporter wanted to know what to do for her. Reporter stated she needed somebody now, the reporter cannot wait. Reporter stated cannot understand the word she is says.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Body temperature, Fatigue, Immunisation
Clinical narrative: Left axillary pain-same side as the injection; Fever; Pain at the injection site; Myalgias; Arthralgias; Moderate fatigue; I received my booster vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, solution for injection), administration date 03Dec2021 (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: 2), administration date: 09Mar2021, for COVID-19 immunization, reaction(s): "lymphadenopathy", "pain in my left axilla (injection in left arm) with extension into the lateral aspect of my left breast", "pain in my left axilla (injection in left arm) with extension into the lateral aspect of my left breast", "pain in my left axilla (injection in left arm) with extension into the lateral aspect of my left breast"; Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "I received my booster vaccine"; VACCINATION SITE PAIN (non-serious) with onset 03Dec2021, outcome "recovering", described as "Pain at the injection site"; MYALGIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Myalgias"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Arthralgias"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Moderate fatigue"; PYREXIA (non-serious) with onset 04Dec2021, outcome "recovered" (06Dec2021), described as "Fever"; AXILLARY PAIN (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Left axillary pain-same side as the injection". In responded to acetaminophen returned to normal. Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Left axillary pain-same side as the injection; Fever; Pain at the injection site; Myalgias; Arthralgias; Moderate fatigue; I received my booster vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, solution for injection), administration date 03Dec2021 (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: 2), administration date: 09Mar2021, for COVID-19 immunization, reaction(s): "lymphadenopathy", "pain in my left axilla (injection in left arm) with extension into the lateral aspect of my left breast", "pain in my left axilla (injection in left arm) with extension into the lateral aspect of my left breast", "pain in my left axilla (injection in left arm) with extension into the lateral aspect of my left breast"; Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "I received my booster vaccine"; VACCINATION SITE PAIN (non-serious) with onset 03Dec2021, outcome "recovering", described as "Pain at the injection site"; MYALGIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Myalgias"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Arthralgias"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Moderate fatigue"; PYREXIA (non-serious) with onset 04Dec2021, outcome "recovered" (06Dec2021), described as "Fever"; AXILLARY PAIN (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Left axillary pain-same side as the injection". In responded to acetaminophen returned to normal. Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A patient (no qualifiers provided) 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: Covid-19 vaccine (First dose, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Second dose, unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "Pain in armpit after receiving booster shot".  Additional Information: It was reported that the patient had pain in armpit after receiving booster shot. No similar pain in previous shots. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Immunisation, Peripheral swelling
Clinical narrative: swollen under left arm pit; dizziness; diarrhea; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 15:15 (Lot number: FH8027) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimotos thyroid" (unspecified if ongoing); "Sulpha allergy" (unspecified if ongoing); "soy allergy" (unspecified if ongoing); "eggs allergy" (unspecified if ongoing); "wheat allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; PANTOPRAZOLE; PROZAC; LOSARTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0161, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 46 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: er8727, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 46 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 15:15, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious) with onset 04Dec2021 09:00, outcome "not recovered", described as "swollen under left arm pit"; DIZZINESS (non-serious) with onset 04Dec2021 09:00, outcome "not recovered", described as "dizziness"; DIARRHOEA (non-serious) with onset 04Dec2021 09:00, outcome "not recovered", described as "diarrhea". Therapeutic measures were not taken as a result of peripheral swelling, dizziness, diarrhoea.  Additional information: The case assessed as non-serious by the reporter. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Limb discomfort, Pain in extremity
Clinical narrative: booster; arm feels sore and hard/right arm is still sore; arm feels sore and hard/right arm feels hard; headache; fatigue; stated that his right arm still feels numb by the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. Other Case identifier(s): US-PFIZER INC-202101733053 (Pfizer).  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 (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 (Manufacture unspecified), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "not recovered", described as "arm feels sore and hard/right arm is still sore"; LIMB DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "arm feels sore and hard/right arm feels hard"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "fatigue"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset Dec2021, outcome "not recovered", described as "stated that his right arm still feels numb by the injection site".  Additional Context: Caller reported that her brother's arm feels sore and hard, has a headache that comes and goes and was more prominent at night and was feeling fatigue. Caller also wanted to know how long the side effects usually last. Caller reported that her brother got booster dose of Covid 19 vaccine last Thursday but his arm was still sore and feels hard. Was experiencing a headache. Stated that it was sore and hard. Stated that it still feels numb by injection site. Was for his right arm. Was curious if other reports from booster of arm being sore for 3-4 days. Mentioned that she had hers and her arm was sore for 3-4 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia
Clinical narrative: booster; arm feels sore and hard/right arm is still sore; arm feels sore and hard/right arm feels hard; headache; fatigue; stated that his right arm still feels numb by the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. Other Case identifier(s): US-PFIZER INC-202101733053 (Pfizer).  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 (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 (Manufacture unspecified), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "not recovered", described as "arm feels sore and hard/right arm is still sore"; LIMB DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "arm feels sore and hard/right arm feels hard"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "fatigue"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset Dec2021, outcome "not recovered", described as "stated that his right arm still feels numb by the injection site".  Additional Context: Caller reported that her brother's arm feels sore and hard, has a headache that comes and goes and was more prominent at night and was feeling fatigue. Caller also wanted to know how long the side effects usually last. Caller reported that her brother got booster dose of Covid 19 vaccine last Thursday but his arm was still sore and feels hard. Was experiencing a headache. Stated that it was sore and hard. Stated that it still feels numb by injection site. Was for his right arm. Was curious if other reports from booster of arm being sore for 3-4 days. Mentioned that she had hers and her arm was sore for 3-4 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Immunisation, Interchange of vaccine products
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 (Batch/Lot number: unknown) at the age of 61 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:1, Manufacture unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacture unknown), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 05Dec2021, outcome "unknown", described as "received Pfizer booster shot"; VACCINATION SITE PAIN (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Injection site pain that started to radiate to back and neck on the left side."; HEADACHE (non-serious) with onset 06Dec2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 06Dec2021, outcome "unknown", described as "left side pain"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "tired".  Additional information: No underlaying condition or other medications. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Off label use, Pain, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 (Batch/Lot number: unknown) at the age of 61 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:1, Manufacture unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacture unknown), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 05Dec2021, outcome "unknown", described as "received Pfizer booster shot"; VACCINATION SITE PAIN (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Injection site pain that started to radiate to back and neck on the left side."; HEADACHE (non-serious) with onset 06Dec2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 06Dec2021, outcome "unknown", described as "left side pain"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "tired".  Additional information: No underlaying condition or other medications. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Malaise
Clinical narrative: Booster; We not feeling great; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; lenvatinib mesilate (LENVIMA) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; MALAISE (non-serious), outcome "unknown", described as "We not feeling great". The action taken for lenvatinib mesilate was unknown.  Additional information: This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-104219), for bnt162b2. Initial Report: Reporter spoke with patient wife who stated "We not feeling great, because we just had the covid-19 booster shot". No further information was provided. Prescribing HCP Diagnosis on enrollment form Lenvima 12mg.  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-202101732774 Same reporter/drug/event for different patients
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Malaise
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. Patient also takes Lenvima (lenvatinib mesilate) 12mg. The patient's medical history included liver cell carcinoma. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. The patient reported immunization/booster, and malaise/not feeling great; both with outcome of unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected. Additional information: Prescribing HCP diagnosis on enrollment form is liver cell carcinoma for Lenvima 12mg. Sender's comments: Linked report(s): US-PFIZER INC-202101732726 same reporter/drug/event for different patients.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pyrexia
Clinical narrative: Booster; Curious how much may have been related to the change in  vaccine type for me (Moderna to Pfizer); Curious how much may have been related to the change in  vaccine type for me (Moderna to Pfizer); Got a bit feverish 24 hours after the  booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received third dose of bnt162b2 (BNT162B2), administration date Dec2021 (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: MODERNA (Dose No: 1), for Covid-19 immunization; MODERNA (Dose No: 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Curious how much may have been related to the change in vaccine type for me (MODERNA to PFIZER)"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Got a bit feverish 24 hours after the booster".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: booster; Pain around the injection site on the left arm, which was the site of administration.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Dec2021 11:00 (Lot number: FJ8762) at the age of 29 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 Number: 2, Batch/Lot No: EW0171), administration date: 26Apr2021, when the patient was 28 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150), administration date: 05Apr2021, when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 11:00, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021 11:00, outcome "not recovered", described as "Pain around the injection site on the left arm, which was the site of administration.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information:  No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Psychotic disorder
Clinical narrative: brain is fried; she's in a psych ward going insane/ psychotic break/ mental breakdown; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient's husband.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (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: BRAIN INJURY (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "brain is fried"; PSYCHOTIC DISORDER (hospitalization) with onset 2021, outcome "unknown", described as "she's in a psych ward going insane/ psychotic break/ mental breakdown".  Caller states that his wife had a psychotic break after receiving the both doses of the vaccine and that he has a written statement from a doctor confirming her mental breakdown was a direct result of receiving the Pfizer BioNTech Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Heart rate, Heart rate increased, Hypertension
Clinical narrative: dose 3; collapsed on floor and was seizing; went unconscious for brief few seconds; chest pain; elevated pulse (90s); high BP (156/86); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 09:30 (Lot number: 7534) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). Patient had no COVID prior vaccination. There were no concomitant medications in two weeks and no other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 8028, Location of injection: Arm Left, Vaccine Administration Time: 09:45 AM), administration date: 16Mar2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: 8732, Location of injection: Arm Left, Vaccine Administration Time: 02:45 PM), administration date: 13Apr2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 02Dec2021 09:30, outcome "unknown", described as "dose 3"; SEIZURE (medically significant) with onset 02Dec2021, outcome "not recovered", described as "collapsed on floor and was seizing"; LOSS OF CONSCIOUSNESS (medically significant) with onset 02Dec2021, outcome "recovered" (02Dec2021), described as "went unconscious for brief few seconds"; CHEST PAIN (non-serious) with onset 02Dec2021, outcome "not recovered", described as "chest pain"; HEART RATE INCREASED (non-serious) with onset 02Dec2021, outcome "not recovered", described as "elevated pulse (90s)"; HYPERTENSION (non-serious) with onset 02Dec2021, outcome "not recovered", described as "high BP (156/86)". It was reported that approximately 4-5 hours after booster, patient collapsed on the floor and was seizing. Patient's wife, a registered RN, was able to revive him and place him in a chair. After being placed in a chair, the patient went unconscious for a brief few seconds. Since then, patient had chest pain, elevated pulse (90s) and high BP (156/86). Patient was in excellent condition prior to event and his pulse was normally in mid to upper 50s. Therapeutic measures were not taken as a result of seizure, loss of consciousness, chest pain, heart rate increased, hypertension. Patient was not COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Loss of consciousness, Seizure
Clinical narrative: dose 3; collapsed on floor and was seizing; went unconscious for brief few seconds; chest pain; elevated pulse (90s); high BP (156/86); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 09:30 (Lot number: 7534) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). Patient had no COVID prior vaccination. There were no concomitant medications in two weeks and no other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 8028, Location of injection: Arm Left, Vaccine Administration Time: 09:45 AM), administration date: 16Mar2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: 8732, Location of injection: Arm Left, Vaccine Administration Time: 02:45 PM), administration date: 13Apr2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 02Dec2021 09:30, outcome "unknown", described as "dose 3"; SEIZURE (medically significant) with onset 02Dec2021, outcome "not recovered", described as "collapsed on floor and was seizing"; LOSS OF CONSCIOUSNESS (medically significant) with onset 02Dec2021, outcome "recovered" (02Dec2021), described as "went unconscious for brief few seconds"; CHEST PAIN (non-serious) with onset 02Dec2021, outcome "not recovered", described as "chest pain"; HEART RATE INCREASED (non-serious) with onset 02Dec2021, outcome "not recovered", described as "elevated pulse (90s)"; HYPERTENSION (non-serious) with onset 02Dec2021, outcome "not recovered", described as "high BP (156/86)". It was reported that approximately 4-5 hours after booster, patient collapsed on the floor and was seizing. Patient's wife, a registered RN, was able to revive him and place him in a chair. After being placed in a chair, the patient went unconscious for a brief few seconds. Since then, patient had chest pain, elevated pulse (90s) and high BP (156/86). Patient was in excellent condition prior to event and his pulse was normally in mid to upper 50s. Therapeutic measures were not taken as a result of seizure, loss of consciousness, chest pain, heart rate increased, hypertension. Patient was not COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Epistaxis, HLA marker study, Inflammation, Migraine
Clinical narrative: migraine headache; difficulty breathing / I was able to breath in but not out; nose bleeds; acute inflammation in entire body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 10:15 (Lot number: FF2590) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "genetic marker HLA-B27 positive" (unspecified if ongoing); "history of ankloysing spondinitis" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Past drug history included: Mesalamine, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 22Sep2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: MIGRAINE (hospitalization) with onset 23Oct2021, outcome "recovering", described as "migraine headache"; DYSPNOEA (hospitalization) with onset 23Oct2021, outcome "recovering", described as "difficulty breathing / I was able to breath in but not out"; EPISTAXIS (hospitalization) with onset 23Oct2021, outcome "recovering", described as "nose bleeds"; INFLAMMATION (hospitalization) with onset 23Oct2021, outcome "recovering", described as "acute inflammation in entire body". The patient was hospitalized for migraine, dyspnoea, epistaxis, inflammation (start date: 29Oct2021, discharge date: 03Nov2021, hospitalization duration: 5 day(s)). The events "migraine headache", "difficulty breathing / i was able to breath in but not out", "nose bleeds" and "acute inflammation in entire body" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: hla marker study: (unspecified date) positive; sars-cov-2 test: (30Oct2021) negative, notes: covid test type post vaccination=Blood test, covid test name post vaccination=Hospital did it. Therapeutic measures were taken as a result of migraine, dyspnoea, epistaxis, inflammation which included antibiotics.  Clinical course: Within 1 week after 2nd dose, she had migraine headache, difficulty breathing, nose bleeds. She was able to breath in but not out. Ended up in hospital 29Oct-03Nov with acute inflammation in entire body.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: migraine headache; difficulty breathing / I was able to breath in but not out; nose bleeds; acute inflammation in entire body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 10:15 (Lot number: FF2590) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "genetic marker HLA-B27 positive" (unspecified if ongoing); "history of ankloysing spondinitis" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Past drug history included: Mesalamine, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 22Sep2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: MIGRAINE (hospitalization) with onset 23Oct2021, outcome "recovering", described as "migraine headache"; DYSPNOEA (hospitalization) with onset 23Oct2021, outcome "recovering", described as "difficulty breathing / I was able to breath in but not out"; EPISTAXIS (hospitalization) with onset 23Oct2021, outcome "recovering", described as "nose bleeds"; INFLAMMATION (hospitalization) with onset 23Oct2021, outcome "recovering", described as "acute inflammation in entire body". The patient was hospitalized for migraine, dyspnoea, epistaxis, inflammation (start date: 29Oct2021, discharge date: 03Nov2021, hospitalization duration: 5 day(s)). The events "migraine headache", "difficulty breathing / i was able to breath in but not out", "nose bleeds" and "acute inflammation in entire body" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: hla marker study: (unspecified date) positive; sars-cov-2 test: (30Oct2021) negative, notes: covid test type post vaccination=Blood test, covid test name post vaccination=Hospital did it. Therapeutic measures were taken as a result of migraine, dyspnoea, epistaxis, inflammation which included antibiotics.  Clinical course: Within 1 week after 2nd dose, she had migraine headache, difficulty breathing, nose bleeds. She was able to breath in but not out. Ended up in hospital 29Oct-03Nov with acute inflammation in entire body.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Postmenopausal haemorrhage
Clinical narrative: I am age 50 and have an IUD /  I began having periods again.; The first time, it started within a couple of weeks (late April) and stopped again in late July; 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 07Apr2021 11:00 (Lot number: EW0158) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IUD" (ongoing), notes: I am age 50 and have an IUD. Concomitant medication(s) included: METOPROLOL; BUSPAR; VITAMIN D; CALCIUM. Vaccination history included: Bnt162b2 (1st dose, lot number: EN6204,  administration time: 11:00 AM, vaccine location: Left arm), administration date: 17Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 19Apr2021 12:00, outcome "recovered" (Jul2021), described as "I am age 50 and have an IUD /  I began having periods again."; MENSTRUATION IRREGULAR (non-serious) with onset 19Apr2021 12:00, outcome "recovered" (Jul2021), described as "The first time, it started within a couple of weeks (late April) and stopped again in late July". The events were evaluated at the physician office visit. Therapeutic measures were taken as a result of postmenopausal haemorrhage, menstruation irregular. No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Facial hives appeared within 15 minutes after administration of vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 at 15:00 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), intramuscular, administered in arm right, administration date 07Dec2021 (Lot number: KA92R). Relevant medical history included: "allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 07Dec2021 at 15:15, outcome "recovered" (Dec2021), described as "Facial hives appeared within 15 minutes after administration of vaccines". Therapeutic measures were taken as a result of urticaria and include Benadryl.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  event urticaria and the suspect drug BNT162B2 cannot be excluded.