chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Hyperhidrosis, Hypoaesthesia, Immunisation
Clinical narrative: body aches; chills; subsequent sweats; my left arm and upper back felt numb; aches in my middle back; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 17:30 (Lot number: FJ8757) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "allergies" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Allergies: aspirin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 17Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Feb2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 03Dec2021 20:30, outcome "unknown", described as "my left arm and upper back felt numb"; BACK PAIN (non-serious) with onset 03Dec2021 20:30, outcome "unknown", described as "aches in my middle back"; PAIN (non-serious) with onset 04Dec2021 02:30, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 04Dec2021 02:30, outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious) with onset 04Dec2021 02:30, outcome "unknown", described as "subsequent sweats"; IMMUNISATION (non-serious) with onset 03Dec2021 17:30, outcome "unknown", described as "Dose number 3". Therapeutic measures were taken as a result of hypoaesthesia, back pain, pain, chills, hyperhidrosis.  Additional information: The patient didn't receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to the vaccination. The patient was not tested with Covid-19 since vaccination. Immediately after shot was administered, the patient left arm ad upper back felt numb. Over the course of about three hours, the patient began to develop aches in her middle back. Approximately 10 hours after the shot, the patient woke with body aches and chills. The patient took Advil and was able to fall back to sleep but the chills and subsequent sweats continued all night.  No follow-up attempts were possible. No further information was expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; chills; subsequent sweats; my left arm and upper back felt numb; aches in my middle back; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 17:30 (Lot number: FJ8757) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "allergies" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Allergies: aspirin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 17Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Feb2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 03Dec2021 20:30, outcome "unknown", described as "my left arm and upper back felt numb"; BACK PAIN (non-serious) with onset 03Dec2021 20:30, outcome "unknown", described as "aches in my middle back"; PAIN (non-serious) with onset 04Dec2021 02:30, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 04Dec2021 02:30, outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious) with onset 04Dec2021 02:30, outcome "unknown", described as "subsequent sweats"; IMMUNISATION (non-serious) with onset 03Dec2021 17:30, outcome "unknown", described as "Dose number 3". Therapeutic measures were taken as a result of hypoaesthesia, back pain, pain, chills, hyperhidrosis.  Additional information: The patient didn't receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to the vaccination. The patient was not tested with Covid-19 since vaccination. Immediately after shot was administered, the patient left arm ad upper back felt numb. Over the course of about three hours, the patient began to develop aches in her middle back. Approximately 10 hours after the shot, the patient woke with body aches and chills. The patient took Advil and was able to fall back to sleep but the chills and subsequent sweats continued all night.  No follow-up attempts were possible. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pyrexia
Clinical narrative: mild fever; chills; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49 year-old male patient received bnt162b2 (COMIRNATY), administration date 02Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "mild high cholesterol" (unspecified if ongoing), notes: mild high cholesterol for which he takes Lipitor. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (2nd dose, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 04Dec2021, outcome "recovered" (04Dec2021), described as "mild fever"; CHILLS (non-serious) with onset 04Dec2021, outcome "recovered" (04Dec2021), described as "chills".  Additional information : It was reported that Patient received booster on the afternoon of 02Dec2021 and started experiencing events while sleeping in the early morning of 04Dec2021 and the symptoms were transient and resolved within a few hours.Event took place after use of product. The patient was taking Lipitor for mild high cholesterol.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: booster; Little arm pain like a flu shot; my arm was really bad I could hardly lift it; I was having diarrhea; joints ache really bad; I was flaming at night ''top and turning''; I just couldn''t get any sleep; my lower back hurts so bad; I got a headache; muscle aches; I could hardly walk a few steps; The itching started first on the palm of my hands and spread to my arms, my belly; fully down the right side of my body and its now in my right calf; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 10:00 (Lot number: FG3527, Expiration Date: 28Feb2022) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bipolar disorder" (unspecified if ongoing), notes: Verbatim: Bipolar disorder; "Thyroid cancer", start date: 1997 (ongoing); "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; SYNTHROID; OMEPRAZOLE taken for gastrooesophageal reflux disease; XANAX taken for sleep disorder; NEURONTIN. Vaccination history included: Flu shot, administration date: Oct2021, when the patient was 66 years old; Bnt162b2 (First dose), administration date: 2020, when the patient was 66 years old, for COVID-19 immunization, reaction(s): "little arm pain"; Bnt162b2 (Second dose), administration date: 2020, when the patient was 66 years old, for COVID-19 immunization, reaction(s): "little arm pain". The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "booster"; LIMB DISCOMFORT (non-serious) with onset 02Dec2021, outcome "unknown", described as "Little arm pain like a flu shot; my arm was really bad I could hardly lift it"; DIARRHOEA (non-serious) with onset 02Dec2021, outcome "unknown", described as "I was having diarrhea"; ARTHRALGIA (non-serious) with onset 02Dec2021, outcome "unknown", described as "joints ache really bad"; FEELING ABNORMAL (non-serious) with onset 02Dec2021, outcome "unknown", described as "I was flaming at night ''top and turning''"; INSOMNIA (non-serious) with onset 02Dec2021, outcome "unknown", described as "I just couldn''t get any sleep"; BACK PAIN (non-serious) with onset 02Dec2021, outcome "unknown", described as "my lower back hurts so bad"; HEADACHE (non-serious) with onset 02Dec2021, outcome "not recovered", described as "I got a headache"; MYALGIA (non-serious) with onset 02Dec2021, outcome "unknown", described as "muscle aches"; GAIT DISTURBANCE (non-serious) with onset 02Dec2021, outcome "unknown", described as "I could hardly walk a few steps"; PRURITUS (non-serious) with onset 02Dec2021, outcome "unknown", described as "The itching started first on the palm of my hands and spread to my arms, my belly; fully down the right side of my body and its now in my right calf". Therapeutic measures were taken as a result of pruritus.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Neck pain, Pain, Pyrexia
Clinical narrative: her booster shot; low grade fever; body aches; body aches, especially in the neck; swollen lymph nodes in her neck; swollen lymph nodes in her neck and in her right arm (the same arm the shot was given).; 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 42 year-old 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, experienced multiple symptoms after her booster shot that she did not experience with her first two doses of the same vaccine.), for COVID-19 Immunization, reaction(s): "symptoms after her booster shot that she did not experience with her first two doses of the same vaccine."; Bnt162b2 (Dose:2, experienced multiple symptoms after her booster shot that she did not experience with her first two doses of the same vaccine.), for COVID-19 Immunization, reaction(s): "with her first two doses of the same vaccine.". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "her booster shot"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; NECK PAIN (non-serious), outcome "unknown", described as "body aches, especially in the neck"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes in her neck"; VACCINATION SITE LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes in her neck and in her right arm (the same arm the shot was given)."  Additional information: it was reported that the patient experienced multiple symptoms after her booster shot that she did not experience with her first two doses of the same vaccine. Symptoms experienced after booster included a low grade fever, body aches, especially in the neck, and swollen lymph nodes in her neck and in her right arm (the same arm the shot was given). The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: her booster shot; low grade fever; body aches; body aches, especially in the neck; swollen lymph nodes in her neck; swollen lymph nodes in her neck and in her right arm (the same arm the shot was given).; 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 42 year-old 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, experienced multiple symptoms after her booster shot that she did not experience with her first two doses of the same vaccine.), for COVID-19 Immunization, reaction(s): "symptoms after her booster shot that she did not experience with her first two doses of the same vaccine."; Bnt162b2 (Dose:2, experienced multiple symptoms after her booster shot that she did not experience with her first two doses of the same vaccine.), for COVID-19 Immunization, reaction(s): "with her first two doses of the same vaccine.". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "her booster shot"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; NECK PAIN (non-serious), outcome "unknown", described as "body aches, especially in the neck"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes in her neck"; VACCINATION SITE LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes in her neck and in her right arm (the same arm the shot was given)."  Additional information: it was reported that the patient experienced multiple symptoms after her booster shot that she did not experience with her first two doses of the same vaccine. Symptoms experienced after booster included a low grade fever, body aches, especially in the neck, and swollen lymph nodes in her neck and in her right arm (the same arm the shot was given). The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Tenderness
Clinical narrative: some mild soreness in the arm/a tender, sore spot in my right underarm/it is still mildly sore; some mild soreness in the arm/a tender, sore spot in my right underarm/it is still mildly sore; I had my Covid vaccine booster shot; A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 14:30 (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 03Dec2021 14:30, outcome "unknown", described as "I had my Covid vaccine booster shot"; PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "some mild soreness in the arm/a tender, sore spot in my right underarm/it is still mildly sore". Therapeutic measures were taken as a result of pain in extremity, tenderness.  Additional Information: Patient took two Aleve for mild soreness in the arm.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Malaise, Pain in extremity
Clinical narrative: I have been wants about my heart, taken left and right and middle and bottom and top and right and bottom and I never had chest pain before that.; I felt like the  sharp pain go up my arm across my shoulder and went to my heart and I was since then, I have been getting like these sharp pain in my heart constant.; I am not feeling well; I feel extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Lot number: Unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (medically significant), outcome "unknown", described as "I have been wants about my heart, taken left and right and middle and bottom and top and right and bottom and I never had chest pain before that."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I felt like the  sharp pain go up my arm across my shoulder and went to my heart and I was since then, I have been getting like these sharp pain in my heart constant."; MALAISE (non-serious), outcome "unknown", described as "I am not feeling well"; FATIGUE (non-serious), outcome "unknown", described as "I feel extremely tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Urticaria
Clinical narrative: I have had allergic reaction to wear my lips and face hands and feet; break out in hives; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Sep2021 14:00 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications (also reported as Other medications in two weeks: None). The following information was reported: DRUG HYPERSENSITIVITY (medically significant, disability) with onset 17Sep2021, outcome "not recovered", described as "I have had allergic reaction to wear my lips and face hands and feet"; URTICARIA (medically significant, disability) with onset 17Sep2021, outcome "not recovered", described as "break out in hives". The events "i have had allergic reaction to wear my lips and face hands and feet" and "break out in hives" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hypersensitivity, urticaria which is Steroid shot an EpiPen was given to the patient and Benadryl.  Additional information: The patient had no covid prior vaccination and not covid tested post vaccination. No other vaccine in four weeks. It was added that the events last anywhere from an hour to two hours and they reoccur throughout the whole day. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Coma, Immunisation, Mobility decreased, Pain
Clinical narrative: felt comatose; I spiked a 103.3 fever; I was barely able to move; body was aching; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 18:00 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Apr2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 23Mar2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 02Dec2021 18:00, outcome "unknown", described as "Booster"; COMA (medically significant) with onset 02Dec2021 20:00, outcome "recovering", described as "felt comatose"; PYREXIA (non-serious) with onset 02Dec2021 20:00, outcome "recovering", described as "I spiked a 103.3 fever"; MOBILITY DECREASED (non-serious) with onset 02Dec2021 20:00, outcome "recovering", described as "I was barely able to move"; PAIN (non-serious) with onset 02Dec2021 20:00, outcome "recovering", described as "body was aching". The patient underwent the following laboratory tests and procedures: body temperature: (02Dec2021) 103.3. Therapeutic measures were not taken as a result of coma, pyrexia, mobility decreased, pain. The clinical course was reported as follows: "spiked a 103.3 fever and felt comatose. I was barely able to move and my body was aching so badly I had to call for help. The fever last 24 hours without relief but my symptoms took a full 3 days to get back to normal overall". The patient had no covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt comatose; I spiked a 103.3 fever; I was barely able to move; body was aching; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 18:00 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Apr2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 23Mar2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 02Dec2021 18:00, outcome "unknown", described as "Booster"; COMA (medically significant) with onset 02Dec2021 20:00, outcome "recovering", described as "felt comatose"; PYREXIA (non-serious) with onset 02Dec2021 20:00, outcome "recovering", described as "I spiked a 103.3 fever"; MOBILITY DECREASED (non-serious) with onset 02Dec2021 20:00, outcome "recovering", described as "I was barely able to move"; PAIN (non-serious) with onset 02Dec2021 20:00, outcome "recovering", described as "body was aching". The patient underwent the following laboratory tests and procedures: body temperature: (02Dec2021) 103.3. Therapeutic measures were not taken as a result of coma, pyrexia, mobility decreased, pain. The clinical course was reported as follows: "spiked a 103.3 fever and felt comatose. I was barely able to move and my body was aching so badly I had to call for help. The fever last 24 hours without relief but my symptoms took a full 3 days to get back to normal overall". The patient had no covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Immunisation, Menstrual disorder
Clinical narrative: headache / My headaches were severe; arm and muscle soreness; arm and muscle soreness; extreme fatigue; cramps; cramps, and started menstruating mid cycle; Pain went from left arm up through neck and back; Pain went from left arm up through neck and back; Pain went from left arm up through neck and back; Dose number: 3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 14:00 (Lot number: 330308D) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 11Nov2021. Vaccination history included: Bnt162b2 (dose 2, lot number: ER8731), administration date: 13Apr2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (dose 1, lot number: ER8727, Vaccine location: Left arm), administration date: 22Mar2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 14:00, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "headache / My headaches were severe"; PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset 03Dec2021 20:00, outcome "recovering" and all described as "arm and muscle soreness"; FATIGUE (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "extreme fatigue"; MUSCLE SPASMS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "cramps"; MENSTRUAL DISORDER (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "cramps, and started menstruating mid cycle"; VACCINATION SITE PAIN (non-serious), NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 03Dec2021 20:00, outcome "recovering" and all described as "Pain went from left arm up through neck and back". Therapeutic measures were taken as a result of headache. Therapeutic measures were not taken as a result of pain in extremity, myalgia, fatigue, muscle spasms, menstrual disorder, vaccination site pain, neck pain, back pain.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: headache / My headaches were severe; arm and muscle soreness; arm and muscle soreness; extreme fatigue; cramps; cramps, and started menstruating mid cycle; Pain went from left arm up through neck and back; Pain went from left arm up through neck and back; Pain went from left arm up through neck and back; Dose number: 3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 14:00 (Lot number: 330308D) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 11Nov2021. Vaccination history included: Bnt162b2 (dose 2, lot number: ER8731), administration date: 13Apr2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (dose 1, lot number: ER8727, Vaccine location: Left arm), administration date: 22Mar2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 14:00, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "headache / My headaches were severe"; PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset 03Dec2021 20:00, outcome "recovering" and all described as "arm and muscle soreness"; FATIGUE (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "extreme fatigue"; MUSCLE SPASMS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "cramps"; MENSTRUAL DISORDER (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "cramps, and started menstruating mid cycle"; VACCINATION SITE PAIN (non-serious), NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 03Dec2021 20:00, outcome "recovering" and all described as "Pain went from left arm up through neck and back". Therapeutic measures were taken as a result of headache. Therapeutic measures were not taken as a result of pain in extremity, myalgia, fatigue, muscle spasms, menstrual disorder, vaccination site pain, neck pain, back pain.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood chloride, Blood chloride increased, Blood glucose, Blood glucose increased, Brain natriuretic peptide
Clinical narrative: palpitations; fever; Sinus Tachycardia; high chloride 108; high glucose; myocarditis; 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 36 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EL9266, Expiration Date: 31May2021) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single; Lot: EL9266 and Expiry: 31May2021; administered in arm), administration date: 16Mar2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; PALPITATIONS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "palpitations"; PYREXIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "fever"; SINUS TACHYCARDIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "Sinus Tachycardia"; BLOOD CHLORIDE INCREASED (non-serious) with onset 08Apr2021, outcome "unknown", described as "high chloride 108"; BLOOD GLUCOSE INCREASED (non-serious) with onset 08Apr2021, outcome "unknown", described as "high glucose". The events "palpitations" and "fever" were evaluated at the emergency room visit. Course of events: He got both doses of Pfizer vaccine and developed palpitations, fever, and went to the ER. EKG was completed and showed Sinus Tachycardia, a heart rate of 123 bpm with an incomplete bundle branch block, an abnormal EKG; it is possible that patient developed myocarditis relative to the Pfizer Covid-19 Vaccine.  The patient underwent the following laboratory tests and procedures: blood chloride: (08Apr2021) 108, notes: high; blood glucose: (08Apr2021) high, notes: Glucose; brain natriuretic peptide: (unspecified date) unknown result; electrocardiogram: (unspecified date) abnormal; (Oct2020) unknown result; (08Apr2021) ventricular rate 123 bpm, notes: ECG abnormal; (08Apr2021) atrial rate 123 bpm, notes: ECG abnormal; (08Apr2021) p-r interval 152 ms, notes: ECG abnormal; (08Apr2021) qrs duration 94 ms, notes: ECG abnormal; (08Apr2021) qt 320 ms, notes: ECG abnormal; (08Apr2021) qtc 458 ms, notes: ECG abnormal; (08Apr2021) p axis 40 degrees, notes: ECG abnormal; (08Apr2021) r axis 15 degrees, notes: ECG abnormal; (08Apr2021) t axis 21 degrees, notes: ECG abnormal; (08Apr2021) sinus tachycardia, notes: ECG abnormal; (08Apr2021) incomplete right bundle branch block, notes: ECG abnormal; full blood count: (unspecified date) unknown result; heart rate: (unspecified date) 123 bpm; troponin: (unspecified date) unknown result; x-ray: (08Apr2021) no acute pulmonary abnormality.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Full blood count, Heart rate, Myocarditis, Palpitations
Clinical narrative: palpitations; fever; Sinus Tachycardia; high chloride 108; high glucose; myocarditis; 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 36 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EL9266, Expiration Date: 31May2021) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single; Lot: EL9266 and Expiry: 31May2021; administered in arm), administration date: 16Mar2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; PALPITATIONS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "palpitations"; PYREXIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "fever"; SINUS TACHYCARDIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "Sinus Tachycardia"; BLOOD CHLORIDE INCREASED (non-serious) with onset 08Apr2021, outcome "unknown", described as "high chloride 108"; BLOOD GLUCOSE INCREASED (non-serious) with onset 08Apr2021, outcome "unknown", described as "high glucose". The events "palpitations" and "fever" were evaluated at the emergency room visit. Course of events: He got both doses of Pfizer vaccine and developed palpitations, fever, and went to the ER. EKG was completed and showed Sinus Tachycardia, a heart rate of 123 bpm with an incomplete bundle branch block, an abnormal EKG; it is possible that patient developed myocarditis relative to the Pfizer Covid-19 Vaccine.  The patient underwent the following laboratory tests and procedures: blood chloride: (08Apr2021) 108, notes: high; blood glucose: (08Apr2021) high, notes: Glucose; brain natriuretic peptide: (unspecified date) unknown result; electrocardiogram: (unspecified date) abnormal; (Oct2020) unknown result; (08Apr2021) ventricular rate 123 bpm, notes: ECG abnormal; (08Apr2021) atrial rate 123 bpm, notes: ECG abnormal; (08Apr2021) p-r interval 152 ms, notes: ECG abnormal; (08Apr2021) qrs duration 94 ms, notes: ECG abnormal; (08Apr2021) qt 320 ms, notes: ECG abnormal; (08Apr2021) qtc 458 ms, notes: ECG abnormal; (08Apr2021) p axis 40 degrees, notes: ECG abnormal; (08Apr2021) r axis 15 degrees, notes: ECG abnormal; (08Apr2021) t axis 21 degrees, notes: ECG abnormal; (08Apr2021) sinus tachycardia, notes: ECG abnormal; (08Apr2021) incomplete right bundle branch block, notes: ECG abnormal; full blood count: (unspecified date) unknown result; heart rate: (unspecified date) 123 bpm; troponin: (unspecified date) unknown result; x-ray: (08Apr2021) no acute pulmonary abnormality.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sinus tachycardia, Troponin, X-ray
Clinical narrative: palpitations; fever; Sinus Tachycardia; high chloride 108; high glucose; myocarditis; 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 36 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EL9266, Expiration Date: 31May2021) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single; Lot: EL9266 and Expiry: 31May2021; administered in arm), administration date: 16Mar2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; PALPITATIONS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "palpitations"; PYREXIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "fever"; SINUS TACHYCARDIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "Sinus Tachycardia"; BLOOD CHLORIDE INCREASED (non-serious) with onset 08Apr2021, outcome "unknown", described as "high chloride 108"; BLOOD GLUCOSE INCREASED (non-serious) with onset 08Apr2021, outcome "unknown", described as "high glucose". The events "palpitations" and "fever" were evaluated at the emergency room visit. Course of events: He got both doses of Pfizer vaccine and developed palpitations, fever, and went to the ER. EKG was completed and showed Sinus Tachycardia, a heart rate of 123 bpm with an incomplete bundle branch block, an abnormal EKG; it is possible that patient developed myocarditis relative to the Pfizer Covid-19 Vaccine.  The patient underwent the following laboratory tests and procedures: blood chloride: (08Apr2021) 108, notes: high; blood glucose: (08Apr2021) high, notes: Glucose; brain natriuretic peptide: (unspecified date) unknown result; electrocardiogram: (unspecified date) abnormal; (Oct2020) unknown result; (08Apr2021) ventricular rate 123 bpm, notes: ECG abnormal; (08Apr2021) atrial rate 123 bpm, notes: ECG abnormal; (08Apr2021) p-r interval 152 ms, notes: ECG abnormal; (08Apr2021) qrs duration 94 ms, notes: ECG abnormal; (08Apr2021) qt 320 ms, notes: ECG abnormal; (08Apr2021) qtc 458 ms, notes: ECG abnormal; (08Apr2021) p axis 40 degrees, notes: ECG abnormal; (08Apr2021) r axis 15 degrees, notes: ECG abnormal; (08Apr2021) t axis 21 degrees, notes: ECG abnormal; (08Apr2021) sinus tachycardia, notes: ECG abnormal; (08Apr2021) incomplete right bundle branch block, notes: ECG abnormal; full blood count: (unspecified date) unknown result; heart rate: (unspecified date) 123 bpm; troponin: (unspecified date) unknown result; x-ray: (08Apr2021) no acute pulmonary abnormality.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Cough, Dyspnoea, SARS-CoV-2 test
Clinical narrative: burning in mouth; joint pains; cough; SOB; tongue swelling; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: FE3590) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; LIPITOR. Past drug history included: Iodine, reaction(s): "known allergies: Iodine", notes: known allergies: Iodine. The following information was reported: BURNING SENSATION (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "burning in mouth"; ARTHRALGIA (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "joint pains"; COUGH (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "cough"; DYSPNOEA (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "SOB"; SWOLLEN TONGUE (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "tongue swelling". The events "burning in mouth", "joint pains", "cough", "sob" and "tongue swelling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of burning sensation, arthralgia, cough, dyspnoea, swollen tongue. No other vaccine in four weeks. No Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: burning in mouth; joint pains; cough; SOB; tongue swelling; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: FE3590) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; LIPITOR. Past drug history included: Iodine, reaction(s): "known allergies: Iodine", notes: known allergies: Iodine. The following information was reported: BURNING SENSATION (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "burning in mouth"; ARTHRALGIA (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "joint pains"; COUGH (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "cough"; DYSPNOEA (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "SOB"; SWOLLEN TONGUE (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "tongue swelling". The events "burning in mouth", "joint pains", "cough", "sob" and "tongue swelling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of burning sensation, arthralgia, cough, dyspnoea, swollen tongue. No other vaccine in four weeks. No Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Drug eruption, Feeling hot, Immunisation, Pain, Pain in extremity
Clinical narrative: developed what almost looks like a Niacin rash; rash on her chest and upper neck - the area is red and warm; rash on her chest and upper neck - the area is red and warm; body aches; body aches are mostly upper body, in the upper arms; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: 33130BA) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Inflammatory arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "mild crohn''s colitis" (unspecified if ongoing); "Neuralgia" (unspecified if ongoing); "autoimmune disorder" (unspecified if ongoing); "Overweight" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 27Nov2021; ENBREL taken for autoimmune disorder, overweight. Past drug history included: Niacin, reaction(s): "rash". Vaccination history included: Bnt162b2 (Dose:1, lot EP6955), administration date: 21Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, lot ER8737), administration date: 11Apr2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; DRUG ERUPTION (non-serious) with onset 05Dec2021, outcome "not recovered", described as "developed what almost looks like a Niacin rash"; RASH ERYTHEMATOUS (non-serious), FEELING HOT (non-serious) all with onset 05Dec2021, outcome "not recovered" and all described as "rash on her chest and upper neck - the area is red and warm"; PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 04Dec2021, outcome "recovering", described as "body aches are mostly upper body, in the upper arms". Therapeutic measures were taken as a result of drug eruption, rash erythematous, feeling hot.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: developed what almost looks like a Niacin rash; rash on her chest and upper neck - the area is red and warm; rash on her chest and upper neck - the area is red and warm; body aches; body aches are mostly upper body, in the upper arms; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: 33130BA) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Inflammatory arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "mild crohn''s colitis" (unspecified if ongoing); "Neuralgia" (unspecified if ongoing); "autoimmune disorder" (unspecified if ongoing); "Overweight" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 27Nov2021; ENBREL taken for autoimmune disorder, overweight. Past drug history included: Niacin, reaction(s): "rash". Vaccination history included: Bnt162b2 (Dose:1, lot EP6955), administration date: 21Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, lot ER8737), administration date: 11Apr2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; DRUG ERUPTION (non-serious) with onset 05Dec2021, outcome "not recovered", described as "developed what almost looks like a Niacin rash"; RASH ERYTHEMATOUS (non-serious), FEELING HOT (non-serious) all with onset 05Dec2021, outcome "not recovered" and all described as "rash on her chest and upper neck - the area is red and warm"; PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 04Dec2021, outcome "recovering", described as "body aches are mostly upper body, in the upper arms". Therapeutic measures were taken as a result of drug eruption, rash erythematous, feeling hot.