chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Headache, Lymphadenopathy, Peripheral swelling
Clinical narrative: The next day she felt completely exhausted and all symptoms were gone; felt burning up inside like she has a slight fever; back pain; elevated blood pressure; headache; whole body was like working everything; felt burning up inside like she has a slight fever; hands and feet were all ice cold; her arm where she received the shot is heavily swollen; Lymph nodes are swollen on the armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Oct2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization, reaction(s): "headache". The following information was reported: BACK PAIN (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "back pain"; BLOOD PRESSURE INCREASED (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "elevated blood pressure"; HEADACHE (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "headache"; FEELING ABNORMAL (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "whole body was like working everything"; BURNING SENSATION (non-serious), PYREXIA (non-serious) all with onset 22Oct2021, outcome "recovered" (23Oct2021) and all described as "felt burning up inside like she has a slight fever"; FEELING COLD (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "hands and feet were all ice cold"; FATIGUE (non-serious) with onset 23Oct2021, outcome "recovered" (23Oct2021), described as "The next day she felt completely exhausted and all symptoms were gone"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "her arm where she received the shot is heavily swollen"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "Lymph nodes are swollen on the armpit". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: The next day she felt completely exhausted and all symptoms were gone; felt burning up inside like she has a slight fever; back pain; elevated blood pressure; headache; whole body was like working everything; felt burning up inside like she has a slight fever; hands and feet were all ice cold; her arm where she received the shot is heavily swollen; Lymph nodes are swollen on the armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Oct2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization, reaction(s): "headache". The following information was reported: BACK PAIN (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "back pain"; BLOOD PRESSURE INCREASED (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "elevated blood pressure"; HEADACHE (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "headache"; FEELING ABNORMAL (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "whole body was like working everything"; BURNING SENSATION (non-serious), PYREXIA (non-serious) all with onset 22Oct2021, outcome "recovered" (23Oct2021) and all described as "felt burning up inside like she has a slight fever"; FEELING COLD (non-serious) with onset 22Oct2021, outcome "recovered" (23Oct2021), described as "hands and feet were all ice cold"; FATIGUE (non-serious) with onset 23Oct2021, outcome "recovered" (23Oct2021), described as "The next day she felt completely exhausted and all symptoms were gone"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "her arm where she received the shot is heavily swollen"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "Lymph nodes are swollen on the armpit". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Muscle spasms, Myalgia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 12:00 (Lot number: FC3183) at the age of 36 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hypoparathyroidism" (unspecified if ongoing), notes: I have hypoparathyroidism. I have had it stable for 10 years from taking prescription medicine. Concomitant medication(s) included: CALCITRIOL taken for hypoparathyroidism; CITRACAL D taken for hypoparathyroidism; MAGNESIUM. The following information was reported: MUSCLE SPASMS (non-serious) with onset 22Sep2021 21:00, outcome "not recovered", described as "have had consistent muscle spasms in multiple parts of my body: back, legs, arms, neck"; MYALGIA (non-serious) with onset 22Sep2021 21:00, outcome "not recovered", described as "muscle pains"; ILLNESS (non-serious) with onset 22Sep2021 21:00, outcome "not recovered", described as "general feelings of sickness"; MUSCLE SPASMS (non-serious) with onset 22Sep2021 21:00, outcome "not recovered", described as "Multiple spasms". The events "have had consistent muscle spasms in multiple parts of my body: back, legs, arms, neck", "muscle pains", "general feelings of sickness" and "multiple spasms" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle spasms, myalgia, illness, muscle spasms. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Frustration tolerance decreased, Headache, Hyperhidrosis, Mood altered
Clinical narrative: then the second day after getting it he woke up and was sweating; Neck pain; Headache dull; Muscle tension; felt really crampy for 3 days; Caller says he has never felt so crummy in his entire life; it is frustrating; affects his mood; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FF2587) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing), notes: he takes a blood pressure medication that he has taken for years that hadn't changed before this. The patient took concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious) with onset Nov2021, outcome "recovered", described as "felt really crampy for 3 days"; NECK PAIN (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Neck pain"; HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Headache dull"; MUSCLE TIGHTNESS (non-serious) with onset Nov2021, outcome "not recovered", described as "Muscle tension"; HYPERHIDROSIS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "then the second day after getting it he woke up and was sweating"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "Caller says he has never felt so crummy in his entire life"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset Nov2021, outcome "unknown", described as "it is frustrating"; MOOD ALTERED (non-serious) with onset 2021, outcome "unknown", described as "affects his mood". Therapeutic measures were not taken as a result of muscle spasms, neck pain, headache, muscle tightness, hyperhidrosis, feeling abnormal, frustration tolerance decreased, mood altered.  Additional information: The patient experiencing neck pain, dull headache, pain that travels from  neck to  left lower long area or region then  travels to his right neck like a muscle tension and then  travels to his right shoulder blade and his right side, had dull headache ever since.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Neck pain
Clinical narrative: then the second day after getting it he woke up and was sweating; Neck pain; Headache dull; Muscle tension; felt really crampy for 3 days; Caller says he has never felt so crummy in his entire life; it is frustrating; affects his mood; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FF2587) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing), notes: he takes a blood pressure medication that he has taken for years that hadn't changed before this. The patient took concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious) with onset Nov2021, outcome "recovered", described as "felt really crampy for 3 days"; NECK PAIN (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Neck pain"; HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "Headache dull"; MUSCLE TIGHTNESS (non-serious) with onset Nov2021, outcome "not recovered", described as "Muscle tension"; HYPERHIDROSIS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "then the second day after getting it he woke up and was sweating"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "Caller says he has never felt so crummy in his entire life"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset Nov2021, outcome "unknown", described as "it is frustrating"; MOOD ALTERED (non-serious) with onset 2021, outcome "unknown", described as "affects his mood". Therapeutic measures were not taken as a result of muscle spasms, neck pain, headache, muscle tightness, hyperhidrosis, feeling abnormal, frustration tolerance decreased, mood altered.  Additional information: The patient experiencing neck pain, dull headache, pain that travels from  neck to  left lower long area or region then  travels to his right neck like a muscle tension and then  travels to his right shoulder blade and his right side, had dull headache ever since.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Shooting pain in both arms, hands, legs and feet; Shooting pain in both arms, hands, legs and feet; Tingling and pin and needles sensations in both arms, hands, legs and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: Fc3182) at the age of 26 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. There were no concomitant medications. The following information was reported: PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 21Aug2021, outcome "not recovered" and all described as "Shooting pain in both arms, hands, legs and feet"; PARAESTHESIA (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Tingling and pin and needles sensations in both arms, hands, legs and feet". The events "shooting pain in both arms, hands, legs and feet", "shooting pain in both arms, hands, legs and feet" and "tingling and pin and needles sensations in both arms, hands, legs and feet" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain, pain in extremity, paraesthesia.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Body temperature, Chest X-ray, Chest discomfort
Clinical narrative: tight chest; Panic attacks; anxiety attacks; Rapid beating and pounding of the heart; Rapid beating and pounding of the heart; chills; loss of breath/difficulty to breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Nov2021 17:30 (Lot number: 3230BD) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), PALPITATIONS (non-serious) all with onset 28Nov2021 19:00, outcome "not recovered" and all described as "Rapid beating and pounding of the heart"; CHILLS (non-serious) with onset 28Nov2021 19:00, outcome "not recovered", described as "chills"; DYSPNOEA (non-serious) with onset 28Nov2021 19:00, outcome "not recovered", described as "loss of breath/difficulty to breath"; PANIC ATTACK (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Panic attacks"; ANXIETY (non-serious) with onset 06Dec2021, outcome "not recovered", described as "anxiety attacks"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "tight chest". The events "rapid beating and pounding of the heart", "rapid beating and pounding of the heart", "panic attacks" and "anxiety attacks" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, palpitations, chills, dyspnoea, panic attack.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 06Dec2021, the patient had the first panic attack. She complained of a rapid heartbeat, tight chest, difficulty to breath. The following 2 days she had two more panic attacks between 6pm and 7pm which resulted in a visit to the emergency room on 08Dec2021. They did an EKG and XR chest single view test. That day they diagnosed that what had given her was an anxiety and panic attack and they recommended seeking therapy at a family center. The patient was a healthy girl and she had never suffered from any depression or seizures before. We think as a family that the vaccine affected her nervous system to the point of causing these panic attacks. We now have a huge hospital bill that we cannot pay and my daughter has anxiety attacks at least once a week.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: tight chest; Panic attacks; anxiety attacks; Rapid beating and pounding of the heart; Rapid beating and pounding of the heart; chills; loss of breath/difficulty to breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Nov2021 17:30 (Lot number: 3230BD) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), PALPITATIONS (non-serious) all with onset 28Nov2021 19:00, outcome "not recovered" and all described as "Rapid beating and pounding of the heart"; CHILLS (non-serious) with onset 28Nov2021 19:00, outcome "not recovered", described as "chills"; DYSPNOEA (non-serious) with onset 28Nov2021 19:00, outcome "not recovered", described as "loss of breath/difficulty to breath"; PANIC ATTACK (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Panic attacks"; ANXIETY (non-serious) with onset 06Dec2021, outcome "not recovered", described as "anxiety attacks"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "tight chest". The events "rapid beating and pounding of the heart", "rapid beating and pounding of the heart", "panic attacks" and "anxiety attacks" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, palpitations, chills, dyspnoea, panic attack.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 06Dec2021, the patient had the first panic attack. She complained of a rapid heartbeat, tight chest, difficulty to breath. The following 2 days she had two more panic attacks between 6pm and 7pm which resulted in a visit to the emergency room on 08Dec2021. They did an EKG and XR chest single view test. That day they diagnosed that what had given her was an anxiety and panic attack and they recommended seeking therapy at a family center. The patient was a healthy girl and she had never suffered from any depression or seizures before. We think as a family that the vaccine affected her nervous system to the point of causing these panic attacks. We now have a huge hospital bill that we cannot pay and my daughter has anxiety attacks at least once a week.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Palpitations, Panic attack, Respiratory rate
Clinical narrative: tight chest; Panic attacks; anxiety attacks; Rapid beating and pounding of the heart; Rapid beating and pounding of the heart; chills; loss of breath/difficulty to breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Nov2021 17:30 (Lot number: 3230BD) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), PALPITATIONS (non-serious) all with onset 28Nov2021 19:00, outcome "not recovered" and all described as "Rapid beating and pounding of the heart"; CHILLS (non-serious) with onset 28Nov2021 19:00, outcome "not recovered", described as "chills"; DYSPNOEA (non-serious) with onset 28Nov2021 19:00, outcome "not recovered", described as "loss of breath/difficulty to breath"; PANIC ATTACK (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Panic attacks"; ANXIETY (non-serious) with onset 06Dec2021, outcome "not recovered", described as "anxiety attacks"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "tight chest". The events "rapid beating and pounding of the heart", "rapid beating and pounding of the heart", "panic attacks" and "anxiety attacks" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, palpitations, chills, dyspnoea, panic attack.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 06Dec2021, the patient had the first panic attack. She complained of a rapid heartbeat, tight chest, difficulty to breath. The following 2 days she had two more panic attacks between 6pm and 7pm which resulted in a visit to the emergency room on 08Dec2021. They did an EKG and XR chest single view test. That day they diagnosed that what had given her was an anxiety and panic attack and they recommended seeking therapy at a family center. The patient was a healthy girl and she had never suffered from any depression or seizures before. We think as a family that the vaccine affected her nervous system to the point of causing these panic attacks. We now have a huge hospital bill that we cannot pay and my daughter has anxiety attacks at least once a week.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 (Lot number: EL9269) at the age of 65 years as dose 1, single and administered in arm left, administration date 29Nov2021 (Lot number: FJ1611) as dose 3, (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; INSULIN taken for diabetes mellitus; SYNTHROID taken for thyroid disorder. The following information was reported: INSOMNIA (non-serious) with onset Feb2021, outcome "unknown", described as "Insomnia". Therapeutic measures were taken as a result of insomnia.  Additional information:Consumer stated, "Listen, the last two times when I take the Pfizer Vaccine. I started to experience insomnia. I could not sleep. I went to see a psychiatrist to get medication to sleep. Then, after taking medication for like 3 months I started back to get partial sleep. Now, I went to take booster yesterday."Second time, I had to go 3 weeks later to take it (Pfizer COVID-19 Vaccine) again and then after I finally could not sleep, the whole night I am awake. So, I had to get a medication to sleep but now yesterday I went to take the Booster and it happened again and then I could not sleep."  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: FLUC4, FLU4
Symptoms: Angina pectoris, Dizziness, Pallor, Skin discolouration, Yellow skin
Clinical narrative: Pain around heart; Skin went pale/yellow; Skin went pale/yellow; Under eyes were purple; Lightheaded/Dizzy; This spontaneous case was retrieved on 21-Feb-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2088100-1), reported by other healthcare professional and concerned a 29-year-old, male patient.  The patient's concurrent conditions included allergy to thimerosal (reported as 'thiomerosal'). The patient's concomitant medications were not reported. The patient's historical vaccine included hepatitis B vaccine (brand not specified) when the patient was a child after which the patient experienced unspecified adverse event.  On 01-Sep-2018, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; indication, dose, route of administration and anatomical location: not reported). The batch number reported was YF39708.  On the same day, after receiving Afluria Quadrivalent, the patient's skin became pale/yellow skin and under eyes were purple. Also, the patient experienced pain around heart and was lightheaded/dizzy.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The event of 'cardiac pain' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 29-year-old patient developed angina pectoris (reported as "pain around heart"), pallor, yellow skin, purple under eyes, and dizziness on the same day, after receiving the suspect product Afluria Quadrivalent. The patient's concomitant drugs were not provided. Due to lack of information regarding diagnostic findings causality for the event angina pectoris is unassessable. For the rest of the events causality is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 29-year-old patient developed angina pectoris (reported as "pain around heart"), pallor, yellow skin, purple under eyes, and dizziness on the same day, after receiving the suspect product Afluria Quadrivalent. The patient's concomitant drugs were not provided. Due to lack of information regarding diagnostic findings causality for the event angina pectoris is unassessable. For the rest of the events causality is assessed as possibly related, due to plausible temporal relationship.
Age: 29.0
Sex: M
Vaccine: FLUC4, FLU4
Symptoms: Angina pectoris, Dark circles under eyes, Dizziness, Pallor, Yellow skin
Clinical narrative: Pain around heart; Skin went pale/yellow; Skin went pale/yellow; Under eyes were purple; Lightheaded/Dizzy; This spontaneous case was retrieved on 21-Feb-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2088100-1), reported by other healthcare professional and concerned a 29-year-old, male patient.  The patient's concurrent conditions included allergy to thimerosal (reported as 'thiomerosal'). The patient's concomitant medications were not reported. The patient's historical vaccine included hepatitis B vaccine (brand not specified) when the patient was a child after which the patient experienced unspecified adverse event.  On 01-Sep-2018, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; indication, dose, route of administration and anatomical location: not reported). The batch number reported was YF39708.  On the same day, after receiving Afluria Quadrivalent, the patient's skin became pale/yellow skin and under eyes were purple. Also, the patient experienced pain around heart and was lightheaded/dizzy.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The event of 'cardiac pain' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 29-year-old patient developed angina pectoris (reported as "pain around heart"), pallor, yellow skin, purple under eyes, and dizziness on the same day, after receiving the suspect product Afluria Quadrivalent. The patient's concomitant drugs were not provided. Due to lack of information regarding diagnostic findings causality for the event angina pectoris is unassessable. For the rest of the events causality is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 29-year-old patient developed angina pectoris (reported as "pain around heart"), pallor, yellow skin, purple under eyes, and dizziness on the same day, after receiving the suspect product Afluria Quadrivalent. The patient's concomitant drugs were not provided. Due to lack of information regarding diagnostic findings causality for the event angina pectoris is unassessable. For the rest of the events causality is assessed as possibly related, due to plausible temporal relationship.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Insomnia, Pain in extremity
Clinical narrative: tired; since second vaccination I am awake at 3am every morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Mar2021 09:30 (Lot number: EN6198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: Apr1986 (ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVEMIR taken for diabetes mellitus (ongoing); NOVOLOG taken for diabetes mellitus (ongoing); LIPITOR taken for blood cholesterol increased (ongoing); INSULIN taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (dose 1, Time: 8:00, location: arm left, EL 9269), administration date: 12Feb2021, for Covid-19 immunisation. The following information was reported: SLEEP DISORDER (non-serious) with onset 06Mar2021 03:00, outcome "not recovered", described as "since second vaccination I am awake at 3am every morning"; FATIGUE (non-serious) with onset 10Mar2021 07:00, outcome "unknown", described as "tired". Therapeutic measures were taken as a result of sleep disorder, fatigue. Additional information: Coffee was taken for tired and slept when she was waking up. No follow-up attempts are possible. No further information is expected.  Follow-up (28Jul2021): The initial case was missing the following minimum criteria:the event cannot be assessed with the information provided (unspecified AE). Upon receipt of follow-up information on 28Jul2021, this case now contains all required information to be considered valid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Sleep disorder
Clinical narrative: tired; since second vaccination I am awake at 3am every morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Mar2021 09:30 (Lot number: EN6198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: Apr1986 (ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVEMIR taken for diabetes mellitus (ongoing); NOVOLOG taken for diabetes mellitus (ongoing); LIPITOR taken for blood cholesterol increased (ongoing); INSULIN taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (dose 1, Time: 8:00, location: arm left, EL 9269), administration date: 12Feb2021, for Covid-19 immunisation. The following information was reported: SLEEP DISORDER (non-serious) with onset 06Mar2021 03:00, outcome "not recovered", described as "since second vaccination I am awake at 3am every morning"; FATIGUE (non-serious) with onset 10Mar2021 07:00, outcome "unknown", described as "tired". Therapeutic measures were taken as a result of sleep disorder, fatigue. Additional information: Coffee was taken for tired and slept when she was waking up. No follow-up attempts are possible. No further information is expected.  Follow-up (28Jul2021): The initial case was missing the following minimum criteria:the event cannot be assessed with the information provided (unspecified AE). Upon receipt of follow-up information on 28Jul2021, this case now contains all required information to be considered valid.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Nausea
Clinical narrative: Debilitating vertigo to the point where I could not hold myself up; I was not able to keep my head up on my own for over 36 hours or eat or drink anything\I needed to grow adults to help me to and from the bathroom.; I would break out into a sweat; Vomit uncontrollably; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2022 09:45 (Lot number: Fk9729) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "drug allergy" (unspecified if ongoing), notes: unspecified product name. There were no concomitant medications. The following information was reported: VERTIGO with onset 13Feb2022 12:00, outcome "not recovered", described as "Debilitating vertigo to the point where I could not hold myself up"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES with onset 13Feb2022 12:00, outcome "not recovered", described as "I was not able to keep my head up on my own for over 36 hours or eat or drink anything\I needed to grow adults to help me to and from the bathroom."; HYPERHIDROSIS (non-serious) with onset 13Feb2022 12:00, outcome "not recovered", described as "I would break out into a sweat"; VOMITING (non-serious) with onset 13Feb2022 12:00, outcome "not recovered", described as "Vomit uncontrollably". The events "debilitating vertigo to the point where i could not hold myself up", "i was not able to keep my head up on my own for over 36 hours or eat or drink anything\i needed to grow adults to help me to and from the bathroom.", "i would break out into a sweat" and "vomit uncontrollably" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo, loss of personal independence in daily activities, hyperhidrosis, vomiting. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dizziness exertional, Dysstasia, Gait disturbance, Mobility decreased
Clinical narrative: Debilitating vertigo to the point where I could not hold myself up; I was not able to keep my head up on my own for over 36 hours or eat or drink anything\I needed to grow adults to help me to and from the bathroom.; I would break out into a sweat; Vomit uncontrollably; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2022 09:45 (Lot number: Fk9729) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "drug allergy" (unspecified if ongoing), notes: unspecified product name. There were no concomitant medications. The following information was reported: VERTIGO with onset 13Feb2022 12:00, outcome "not recovered", described as "Debilitating vertigo to the point where I could not hold myself up"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES with onset 13Feb2022 12:00, outcome "not recovered", described as "I was not able to keep my head up on my own for over 36 hours or eat or drink anything\I needed to grow adults to help me to and from the bathroom."; HYPERHIDROSIS (non-serious) with onset 13Feb2022 12:00, outcome "not recovered", described as "I would break out into a sweat"; VOMITING (non-serious) with onset 13Feb2022 12:00, outcome "not recovered", described as "Vomit uncontrollably". The events "debilitating vertigo to the point where i could not hold myself up", "i was not able to keep my head up on my own for over 36 hours or eat or drink anything\i needed to grow adults to help me to and from the bathroom.", "i would break out into a sweat" and "vomit uncontrollably" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo, loss of personal independence in daily activities, hyperhidrosis, vomiting. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Debilitating vertigo to the point where I could not hold myself up; I was not able to keep my head up on my own for over 36 hours or eat or drink anything\I needed to grow adults to help me to and from the bathroom.; I would break out into a sweat; Vomit uncontrollably; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2022 09:45 (Lot number: Fk9729) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "drug allergy" (unspecified if ongoing), notes: unspecified product name. There were no concomitant medications. The following information was reported: VERTIGO with onset 13Feb2022 12:00, outcome "not recovered", described as "Debilitating vertigo to the point where I could not hold myself up"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES with onset 13Feb2022 12:00, outcome "not recovered", described as "I was not able to keep my head up on my own for over 36 hours or eat or drink anything\I needed to grow adults to help me to and from the bathroom."; HYPERHIDROSIS (non-serious) with onset 13Feb2022 12:00, outcome "not recovered", described as "I would break out into a sweat"; VOMITING (non-serious) with onset 13Feb2022 12:00, outcome "not recovered", described as "Vomit uncontrollably". The events "debilitating vertigo to the point where i could not hold myself up", "i was not able to keep my head up on my own for over 36 hours or eat or drink anything\i needed to grow adults to help me to and from the bathroom.", "i would break out into a sweat" and "vomit uncontrollably" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo, loss of personal independence in daily activities, hyperhidrosis, vomiting. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of personal independence in daily activities, Vertigo, Vomiting
Clinical narrative: Debilitating vertigo to the point where I could not hold myself up; I was not able to keep my head up on my own for over 36 hours or eat or drink anything\I needed to grow adults to help me to and from the bathroom.; I would break out into a sweat; Vomit uncontrollably; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2022 09:45 (Lot number: Fk9729) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "drug allergy" (unspecified if ongoing), notes: unspecified product name. There were no concomitant medications. The following information was reported: VERTIGO with onset 13Feb2022 12:00, outcome "not recovered", described as "Debilitating vertigo to the point where I could not hold myself up"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES with onset 13Feb2022 12:00, outcome "not recovered", described as "I was not able to keep my head up on my own for over 36 hours or eat or drink anything\I needed to grow adults to help me to and from the bathroom."; HYPERHIDROSIS (non-serious) with onset 13Feb2022 12:00, outcome "not recovered", described as "I would break out into a sweat"; VOMITING (non-serious) with onset 13Feb2022 12:00, outcome "not recovered", described as "Vomit uncontrollably". The events "debilitating vertigo to the point where i could not hold myself up", "i was not able to keep my head up on my own for over 36 hours or eat or drink anything\i needed to grow adults to help me to and from the bathroom.", "i would break out into a sweat" and "vomit uncontrollably" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo, loss of personal independence in daily activities, hyperhidrosis, vomiting. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Rash pruritic, Vaccination site reaction
Clinical narrative: Rash. Numbness in fingers and burning
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Burning sensation, Hypoaesthesia, Rash
Clinical narrative: Rash. Numbness in fingers and burning
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adnexa uteri pain, Anorectal discomfort, Back pain, Haemorrhagic ovarian cyst, Ovarian cyst ruptured
Clinical narrative: I have another cyst and just got my 3rd pfizer covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2022 (Lot number: F18762) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "possible iodine allergy" (unspecified if ongoing); "PVC's" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Epinephrine for Numbing Medicine, reaction(s): "Known allergy: Reaction to numbing medicine with epinephrine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8735), administration date: 19May2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "I had a good sized ovarian cyst in my right ovary rupture", "burst and bled in my abdomen"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 28Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: OVARIAN CYST RUPTURED (medically significant) with onset Feb2022, outcome "not recovered", described as "I have another cyst and just got my 3rd pfizer covid-19 vaccine".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200301045 same patient/drug, different dose/event
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pelvic pain, Proctalgia, Vulvovaginal discomfort, Vulvovaginal pain
Clinical narrative: I have another cyst and just got my 3rd pfizer covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2022 (Lot number: F18762) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "possible iodine allergy" (unspecified if ongoing); "PVC's" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Epinephrine for Numbing Medicine, reaction(s): "Known allergy: Reaction to numbing medicine with epinephrine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8735), administration date: 19May2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "I had a good sized ovarian cyst in my right ovary rupture", "burst and bled in my abdomen"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 28Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: OVARIAN CYST RUPTURED (medically significant) with onset Feb2022, outcome "not recovered", described as "I have another cyst and just got my 3rd pfizer covid-19 vaccine".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200301045 same patient/drug, different dose/event
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ovarian cyst
Clinical narrative: I have another cyst and just got my 3rd pfizer covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2022 (Lot number: F18762) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "possible iodine allergy" (unspecified if ongoing); "PVC's" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Epinephrine for Numbing Medicine, reaction(s): "Known allergy: Reaction to numbing medicine with epinephrine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8735), administration date: 19May2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "I had a good sized ovarian cyst in my right ovary rupture", "burst and bled in my abdomen"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 28Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: OVARIAN CYST RUPTURED (medically significant) with onset Feb2022, outcome "not recovered", described as "I have another cyst and just got my 3rd pfizer covid-19 vaccine".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200301045 same patient/drug, different dose/event
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022; patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccines were placed in refrigerator on 13-Jan-2022. Expiration date placed on vial was12-Feb-2022.  No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter.