chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site pain, Paraesthesia, Tension headache
Clinical narrative: gallbladder and abdominal issues / abdominal problem; decrease in appetite; diarrhea; vomiting; sheer exhaustion; Throbbing on her face and back of her head; Throbbing on her face and back of her head; could not concentrate; discomfort on the side and back of the head; 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 female patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (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, single, doctor mentioned it might be a possible TIA (ministroke) or a complex migraine), administration date: 30Jan2021, for Covid-19 Immunization, reaction(s): "right side of the face and head she had a tingling feeling that travelled down"; Bnt162b2 (Dose 2, single), administration date: 2021, for Covid-19 Immunization, reaction(s): "sheer exhaustion". The following information was reported: FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "sheer exhaustion"; HEADACHE (non-serious), FACIAL PAIN (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "Throbbing on her face and back of her head"; DISTURBANCE IN ATTENTION (non-serious) with onset Jan2022, outcome "unknown", described as "could not concentrate"; HEAD DISCOMFORT (non-serious) with onset Jan2022, outcome "not recovered", described as "discomfort on the side and back of the head"; GALLBLADDER DISORDER (non-serious), outcome "unknown", described as "gallbladder and abdominal issues / abdominal problem"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decrease in appetite"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting". Therapeutic measures were taken as a result of fatigue, headache, facial pain, head discomfort.  Additional Information: The patient felt all those side effects again after receiving the booster dose on 29Dec2021. Within 3-4 days after booster, she had sheer exhaustion that was unbelievable, and it was 20Jan2022 now and she still felt the throbbing on her face and back of her head. She was scheduled for EEG of her Head to see what was wrong. With all the side affects her job was suffering, she could not concentrate for months, and these side effects never went away, there was always a discomfort on the side and back of the head. She took tylenol for it, but she wanted to stop that as she did not want to affect her Liver.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Diarrhoea, Disturbance in attention, Facial pain, Fatigue
Clinical narrative: gallbladder and abdominal issues / abdominal problem; decrease in appetite; diarrhea; vomiting; sheer exhaustion; Throbbing on her face and back of her head; Throbbing on her face and back of her head; could not concentrate; discomfort on the side and back of the head; 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 female patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (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, single, doctor mentioned it might be a possible TIA (ministroke) or a complex migraine), administration date: 30Jan2021, for Covid-19 Immunization, reaction(s): "right side of the face and head she had a tingling feeling that travelled down"; Bnt162b2 (Dose 2, single), administration date: 2021, for Covid-19 Immunization, reaction(s): "sheer exhaustion". The following information was reported: FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "sheer exhaustion"; HEADACHE (non-serious), FACIAL PAIN (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "Throbbing on her face and back of her head"; DISTURBANCE IN ATTENTION (non-serious) with onset Jan2022, outcome "unknown", described as "could not concentrate"; HEAD DISCOMFORT (non-serious) with onset Jan2022, outcome "not recovered", described as "discomfort on the side and back of the head"; GALLBLADDER DISORDER (non-serious), outcome "unknown", described as "gallbladder and abdominal issues / abdominal problem"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decrease in appetite"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting". Therapeutic measures were taken as a result of fatigue, headache, facial pain, head discomfort.  Additional Information: The patient felt all those side effects again after receiving the booster dose on 29Dec2021. Within 3-4 days after booster, she had sheer exhaustion that was unbelievable, and it was 20Jan2022 now and she still felt the throbbing on her face and back of her head. She was scheduled for EEG of her Head to see what was wrong. With all the side affects her job was suffering, she could not concentrate for months, and these side effects never went away, there was always a discomfort on the side and back of the head. She took tylenol for it, but she wanted to stop that as she did not want to affect her Liver.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gallbladder disorder, Head discomfort, Headache, Vomiting
Clinical narrative: gallbladder and abdominal issues / abdominal problem; decrease in appetite; diarrhea; vomiting; sheer exhaustion; Throbbing on her face and back of her head; Throbbing on her face and back of her head; could not concentrate; discomfort on the side and back of the head; 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 female patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (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, single, doctor mentioned it might be a possible TIA (ministroke) or a complex migraine), administration date: 30Jan2021, for Covid-19 Immunization, reaction(s): "right side of the face and head she had a tingling feeling that travelled down"; Bnt162b2 (Dose 2, single), administration date: 2021, for Covid-19 Immunization, reaction(s): "sheer exhaustion". The following information was reported: FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "sheer exhaustion"; HEADACHE (non-serious), FACIAL PAIN (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "Throbbing on her face and back of her head"; DISTURBANCE IN ATTENTION (non-serious) with onset Jan2022, outcome "unknown", described as "could not concentrate"; HEAD DISCOMFORT (non-serious) with onset Jan2022, outcome "not recovered", described as "discomfort on the side and back of the head"; GALLBLADDER DISORDER (non-serious), outcome "unknown", described as "gallbladder and abdominal issues / abdominal problem"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decrease in appetite"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting". Therapeutic measures were taken as a result of fatigue, headache, facial pain, head discomfort.  Additional Information: The patient felt all those side effects again after receiving the booster dose on 29Dec2021. Within 3-4 days after booster, she had sheer exhaustion that was unbelievable, and it was 20Jan2022 now and she still felt the throbbing on her face and back of her head. She was scheduled for EEG of her Head to see what was wrong. With all the side affects her job was suffering, she could not concentrate for months, and these side effects never went away, there was always a discomfort on the side and back of the head. She took tylenol for it, but she wanted to stop that as she did not want to affect her Liver.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site rash, Pharyngeal swelling, Rash, Throat tightness
Clinical narrative: anaphylactic reactions; broke out in hives; having difficulty breathing; itchiness/closing of throat; itchiness/closing of throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 12:00 (Lot number: FL3209) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0177, Location of injection: Left arm, Vaccine Administration Time: 03:00 PM), administration date: 14May2021, when the patient was 12 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Left arm, Vaccine Administration Time: 10:00 AM), administration date: 04Jun2021, when the patient was 12 years old, for Covid-19 Immunization. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "anaphylactic reactions"; URTICARIA (hospitalization) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "broke out in hives"; DYSPNOEA (hospitalization) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "having difficulty breathing"; THROAT TIGHTNESS (hospitalization), PRURITUS (hospitalization) all with onset 09Jan2022 12:00, outcome "recovered" (Jan2022) and all described as "itchiness/closing of throat". The patient was hospitalized for anaphylactic reaction, urticaria, dyspnoea, throat tightness, pruritus (hospitalization duration: 3 day(s)). The events "anaphylactic reactions", "broke out in hives", "having difficulty breathing", "itchiness/closing of throat" and "itchiness/closing of throat" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction, urticaria, dyspnoea, throat tightness, pruritus with Epinephrine shot.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Injection site urticaria, Pruritus, Rash, Throat tightness
Clinical narrative: anaphylactic reactions; broke out in hives; having difficulty breathing; itchiness/closing of throat; itchiness/closing of throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 12:00 (Lot number: FL3209) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0177, Location of injection: Left arm, Vaccine Administration Time: 03:00 PM), administration date: 14May2021, when the patient was 12 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Left arm, Vaccine Administration Time: 10:00 AM), administration date: 04Jun2021, when the patient was 12 years old, for Covid-19 Immunization. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "anaphylactic reactions"; URTICARIA (hospitalization) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "broke out in hives"; DYSPNOEA (hospitalization) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "having difficulty breathing"; THROAT TIGHTNESS (hospitalization), PRURITUS (hospitalization) all with onset 09Jan2022 12:00, outcome "recovered" (Jan2022) and all described as "itchiness/closing of throat". The patient was hospitalized for anaphylactic reaction, urticaria, dyspnoea, throat tightness, pruritus (hospitalization duration: 3 day(s)). The events "anaphylactic reactions", "broke out in hives", "having difficulty breathing", "itchiness/closing of throat" and "itchiness/closing of throat" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction, urticaria, dyspnoea, throat tightness, pruritus with Epinephrine shot.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus, SARS-CoV-2 test, Throat tightness
Clinical narrative: anaphylactic reactions; broke out in hives; having difficulty breathing; itchiness/closing of throat; itchiness/closing of throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 12:00 (Lot number: FL3209) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0177, Location of injection: Left arm, Vaccine Administration Time: 03:00 PM), administration date: 14May2021, when the patient was 12 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Left arm, Vaccine Administration Time: 10:00 AM), administration date: 04Jun2021, when the patient was 12 years old, for Covid-19 Immunization. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "anaphylactic reactions"; URTICARIA (hospitalization) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "broke out in hives"; DYSPNOEA (hospitalization) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "having difficulty breathing"; THROAT TIGHTNESS (hospitalization), PRURITUS (hospitalization) all with onset 09Jan2022 12:00, outcome "recovered" (Jan2022) and all described as "itchiness/closing of throat". The patient was hospitalized for anaphylactic reaction, urticaria, dyspnoea, throat tightness, pruritus (hospitalization duration: 3 day(s)). The events "anaphylactic reactions", "broke out in hives", "having difficulty breathing", "itchiness/closing of throat" and "itchiness/closing of throat" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction, urticaria, dyspnoea, throat tightness, pruritus with Epinephrine shot.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: anaphylactic reactions; broke out in hives; having difficulty breathing; itchiness/closing of throat; itchiness/closing of throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 12:00 (Lot number: FL3209) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0177, Location of injection: Left arm, Vaccine Administration Time: 03:00 PM), administration date: 14May2021, when the patient was 12 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Left arm, Vaccine Administration Time: 10:00 AM), administration date: 04Jun2021, when the patient was 12 years old, for Covid-19 Immunization. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "anaphylactic reactions"; URTICARIA (hospitalization) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "broke out in hives"; DYSPNOEA (hospitalization) with onset 09Jan2022 12:00, outcome "recovered" (Jan2022), described as "having difficulty breathing"; THROAT TIGHTNESS (hospitalization), PRURITUS (hospitalization) all with onset 09Jan2022 12:00, outcome "recovered" (Jan2022) and all described as "itchiness/closing of throat". The patient was hospitalized for anaphylactic reaction, urticaria, dyspnoea, throat tightness, pruritus (hospitalization duration: 3 day(s)). The events "anaphylactic reactions", "broke out in hives", "having difficulty breathing", "itchiness/closing of throat" and "itchiness/closing of throat" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction, urticaria, dyspnoea, throat tightness, pruritus with Epinephrine shot.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Impaired driving ability, Impaired work ability, Inflammation, Laboratory test normal
Clinical narrative: 1st dose:27May2021, 2nd dose:11Apr2021; still have severe pain and inflammation in thigh.; medial meniscus tear; 2 weeks later severe inflammation is right medial thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 (Lot number: ER8729) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CORTISONE, start date: 22Apr2021, stop date: 22Apr2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208), administration date: 27Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (disability) with onset 06May2021, outcome "not recovered", described as "1st dose:27May2021, 2nd dose:11Apr2021"; PAIN IN EXTREMITY (disability) with onset 06May2021, outcome "not recovered", described as "still have severe pain and inflammation in thigh."; MENISCUS INJURY (disability) with onset 06May2021, outcome "not recovered", described as "medial meniscus tear"; INFLAMMATION (disability) with onset 06May2021, outcome "not recovered", described as "2 weeks later severe inflammation is right medial thigh". The events "still have severe pain and inflammation in thigh.", "medial meniscus tear" and "2 weeks later severe inflammation is right medial thigh" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: fine; magnetic resonance imaging: unknown result; ultrasound scan: nothing wrong with knee/leg. Therapeutic measures were taken as a result of inappropriate schedule of product administration, pain in extremity, meniscus injury, inflammation. The patient has no other vaccine in four weeks and no other medication in 2 weeks. The patient had confirmed medial meniscus tear. On 22Apr2021 received a cortisone injection in right knee. 2 weeks later severe inflammation is right medial thigh, still present. PT for 6 months, been to orthodpediest, physical med dr, rhuemalogist, immunologist, all blood work fine, except shows inflammation, no driving for 5 months, still have severe pain  and inflammation in thigh.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Meniscus injury, Pain in extremity, Peripheral swelling, Walking aid user
Clinical narrative: 1st dose:27May2021, 2nd dose:11Apr2021; still have severe pain and inflammation in thigh.; medial meniscus tear; 2 weeks later severe inflammation is right medial thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 (Lot number: ER8729) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CORTISONE, start date: 22Apr2021, stop date: 22Apr2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208), administration date: 27Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (disability) with onset 06May2021, outcome "not recovered", described as "1st dose:27May2021, 2nd dose:11Apr2021"; PAIN IN EXTREMITY (disability) with onset 06May2021, outcome "not recovered", described as "still have severe pain and inflammation in thigh."; MENISCUS INJURY (disability) with onset 06May2021, outcome "not recovered", described as "medial meniscus tear"; INFLAMMATION (disability) with onset 06May2021, outcome "not recovered", described as "2 weeks later severe inflammation is right medial thigh". The events "still have severe pain and inflammation in thigh.", "medial meniscus tear" and "2 weeks later severe inflammation is right medial thigh" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: fine; magnetic resonance imaging: unknown result; ultrasound scan: nothing wrong with knee/leg. Therapeutic measures were taken as a result of inappropriate schedule of product administration, pain in extremity, meniscus injury, inflammation. The patient has no other vaccine in four weeks and no other medication in 2 weeks. The patient had confirmed medial meniscus tear. On 22Apr2021 received a cortisone injection in right knee. 2 weeks later severe inflammation is right medial thigh, still present. PT for 6 months, been to orthodpediest, physical med dr, rhuemalogist, immunologist, all blood work fine, except shows inflammation, no driving for 5 months, still have severe pain  and inflammation in thigh.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray limb normal
Clinical narrative: 1st dose:27May2021, 2nd dose:11Apr2021; still have severe pain and inflammation in thigh.; medial meniscus tear; 2 weeks later severe inflammation is right medial thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 (Lot number: ER8729) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CORTISONE, start date: 22Apr2021, stop date: 22Apr2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208), administration date: 27Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (disability) with onset 06May2021, outcome "not recovered", described as "1st dose:27May2021, 2nd dose:11Apr2021"; PAIN IN EXTREMITY (disability) with onset 06May2021, outcome "not recovered", described as "still have severe pain and inflammation in thigh."; MENISCUS INJURY (disability) with onset 06May2021, outcome "not recovered", described as "medial meniscus tear"; INFLAMMATION (disability) with onset 06May2021, outcome "not recovered", described as "2 weeks later severe inflammation is right medial thigh". The events "still have severe pain and inflammation in thigh.", "medial meniscus tear" and "2 weeks later severe inflammation is right medial thigh" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: fine; magnetic resonance imaging: unknown result; ultrasound scan: nothing wrong with knee/leg. Therapeutic measures were taken as a result of inappropriate schedule of product administration, pain in extremity, meniscus injury, inflammation. The patient has no other vaccine in four weeks and no other medication in 2 weeks. The patient had confirmed medial meniscus tear. On 22Apr2021 received a cortisone injection in right knee. 2 weeks later severe inflammation is right medial thigh, still present. PT for 6 months, been to orthodpediest, physical med dr, rhuemalogist, immunologist, all blood work fine, except shows inflammation, no driving for 5 months, still have severe pain  and inflammation in thigh.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, Inflammation, Magnetic resonance imaging, Meniscus injury
Clinical narrative: 1st dose:27May2021, 2nd dose:11Apr2021; still have severe pain and inflammation in thigh.; medial meniscus tear; 2 weeks later severe inflammation is right medial thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 (Lot number: ER8729) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CORTISONE, start date: 22Apr2021, stop date: 22Apr2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208), administration date: 27Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (disability) with onset 06May2021, outcome "not recovered", described as "1st dose:27May2021, 2nd dose:11Apr2021"; PAIN IN EXTREMITY (disability) with onset 06May2021, outcome "not recovered", described as "still have severe pain and inflammation in thigh."; MENISCUS INJURY (disability) with onset 06May2021, outcome "not recovered", described as "medial meniscus tear"; INFLAMMATION (disability) with onset 06May2021, outcome "not recovered", described as "2 weeks later severe inflammation is right medial thigh". The events "still have severe pain and inflammation in thigh.", "medial meniscus tear" and "2 weeks later severe inflammation is right medial thigh" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: fine; magnetic resonance imaging: unknown result; ultrasound scan: nothing wrong with knee/leg. Therapeutic measures were taken as a result of inappropriate schedule of product administration, pain in extremity, meniscus injury, inflammation. The patient has no other vaccine in four weeks and no other medication in 2 weeks. The patient had confirmed medial meniscus tear. On 22Apr2021 received a cortisone injection in right knee. 2 weeks later severe inflammation is right medial thigh, still present. PT for 6 months, been to orthodpediest, physical med dr, rhuemalogist, immunologist, all blood work fine, except shows inflammation, no driving for 5 months, still have severe pain  and inflammation in thigh.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: 1st dose:27May2021, 2nd dose:11Apr2021; still have severe pain and inflammation in thigh.; medial meniscus tear; 2 weeks later severe inflammation is right medial thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 (Lot number: ER8729) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CORTISONE, start date: 22Apr2021, stop date: 22Apr2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208), administration date: 27Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (disability) with onset 06May2021, outcome "not recovered", described as "1st dose:27May2021, 2nd dose:11Apr2021"; PAIN IN EXTREMITY (disability) with onset 06May2021, outcome "not recovered", described as "still have severe pain and inflammation in thigh."; MENISCUS INJURY (disability) with onset 06May2021, outcome "not recovered", described as "medial meniscus tear"; INFLAMMATION (disability) with onset 06May2021, outcome "not recovered", described as "2 weeks later severe inflammation is right medial thigh". The events "still have severe pain and inflammation in thigh.", "medial meniscus tear" and "2 weeks later severe inflammation is right medial thigh" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: fine; magnetic resonance imaging: unknown result; ultrasound scan: nothing wrong with knee/leg. Therapeutic measures were taken as a result of inappropriate schedule of product administration, pain in extremity, meniscus injury, inflammation. The patient has no other vaccine in four weeks and no other medication in 2 weeks. The patient had confirmed medial meniscus tear. On 22Apr2021 received a cortisone injection in right knee. 2 weeks later severe inflammation is right medial thigh, still present. PT for 6 months, been to orthodpediest, physical med dr, rhuemalogist, immunologist, all blood work fine, except shows inflammation, no driving for 5 months, still have severe pain  and inflammation in thigh.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Balance disorder, Nausea, Vertigo
Clinical narrative: vestibular neuritis; chills; fever; involuntary shaking; Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 13:00 (Lot number: FJ1614) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, single;, Batch/Lot No: FA6780, Location of injection: Arm Left), administration date: 12Jun2021, for Covid-19 Immunization; Bnt162b2 (dose 1, single;, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 22May2021, for Covid-19 Immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 18Jan2022, outcome "not recovered", described as "vestibular neuritis"; CHILLS (non-serious) with onset 18Jan2022, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "fever"; TREMOR (non-serious) with onset 18Jan2022, outcome "not recovered", described as "involuntary shaking"; VERTIGO (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Vertigo". The events "vestibular neuritis", "chills", "fever", "involuntary shaking" and "vertigo" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vestibular neuronitis, chills, pyrexia, tremor, vertigo; patient was treated with Steroids.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Dysstasia, Gait inability, Headache, Impaired healing
Clinical narrative: vestibular neuritis; chills; fever; involuntary shaking; Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 13:00 (Lot number: FJ1614) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, single;, Batch/Lot No: FA6780, Location of injection: Arm Left), administration date: 12Jun2021, for Covid-19 Immunization; Bnt162b2 (dose 1, single;, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 22May2021, for Covid-19 Immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 18Jan2022, outcome "not recovered", described as "vestibular neuritis"; CHILLS (non-serious) with onset 18Jan2022, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "fever"; TREMOR (non-serious) with onset 18Jan2022, outcome "not recovered", described as "involuntary shaking"; VERTIGO (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Vertigo". The events "vestibular neuritis", "chills", "fever", "involuntary shaking" and "vertigo" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vestibular neuronitis, chills, pyrexia, tremor, vertigo; patient was treated with Steroids.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Neurological examination normal, Vertigo, Vestibular neuronitis
Clinical narrative: vestibular neuritis; chills; fever; involuntary shaking; Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 13:00 (Lot number: FJ1614) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, single;, Batch/Lot No: FA6780, Location of injection: Arm Left), administration date: 12Jun2021, for Covid-19 Immunization; Bnt162b2 (dose 1, single;, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 22May2021, for Covid-19 Immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 18Jan2022, outcome "not recovered", described as "vestibular neuritis"; CHILLS (non-serious) with onset 18Jan2022, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "fever"; TREMOR (non-serious) with onset 18Jan2022, outcome "not recovered", described as "involuntary shaking"; VERTIGO (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Vertigo". The events "vestibular neuritis", "chills", "fever", "involuntary shaking" and "vertigo" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vestibular neuronitis, chills, pyrexia, tremor, vertigo; patient was treated with Steroids.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Pyrexia, Tremor, Vertigo, Vestibular neuronitis
Clinical narrative: vestibular neuritis; chills; fever; involuntary shaking; Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 13:00 (Lot number: FJ1614) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, single;, Batch/Lot No: FA6780, Location of injection: Arm Left), administration date: 12Jun2021, for Covid-19 Immunization; Bnt162b2 (dose 1, single;, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 22May2021, for Covid-19 Immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 18Jan2022, outcome "not recovered", described as "vestibular neuritis"; CHILLS (non-serious) with onset 18Jan2022, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "fever"; TREMOR (non-serious) with onset 18Jan2022, outcome "not recovered", described as "involuntary shaking"; VERTIGO (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Vertigo". The events "vestibular neuritis", "chills", "fever", "involuntary shaking" and "vertigo" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vestibular neuronitis, chills, pyrexia, tremor, vertigo; patient was treated with Steroids.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyskinesia, Dysstasia, Inner ear inflammation, Nausea, Pyrexia
Clinical narrative: vestibular neuritis; chills; fever; involuntary shaking; Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 13:00 (Lot number: FJ1614) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, single;, Batch/Lot No: FA6780, Location of injection: Arm Left), administration date: 12Jun2021, for Covid-19 Immunization; Bnt162b2 (dose 1, single;, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 22May2021, for Covid-19 Immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 18Jan2022, outcome "not recovered", described as "vestibular neuritis"; CHILLS (non-serious) with onset 18Jan2022, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "fever"; TREMOR (non-serious) with onset 18Jan2022, outcome "not recovered", described as "involuntary shaking"; VERTIGO (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Vertigo". The events "vestibular neuritis", "chills", "fever", "involuntary shaking" and "vertigo" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vestibular neuronitis, chills, pyrexia, tremor, vertigo; patient was treated with Steroids.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: vestibular neuritis; chills; fever; involuntary shaking; Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 13:00 (Lot number: FJ1614) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, single;, Batch/Lot No: FA6780, Location of injection: Arm Left), administration date: 12Jun2021, for Covid-19 Immunization; Bnt162b2 (dose 1, single;, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 22May2021, for Covid-19 Immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant) with onset 18Jan2022, outcome "not recovered", described as "vestibular neuritis"; CHILLS (non-serious) with onset 18Jan2022, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "fever"; TREMOR (non-serious) with onset 18Jan2022, outcome "not recovered", described as "involuntary shaking"; VERTIGO (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Vertigo". The events "vestibular neuritis", "chills", "fever", "involuntary shaking" and "vertigo" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vestibular neuronitis, chills, pyrexia, tremor, vertigo; patient was treated with Steroids.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram normal, Atrioventricular block first degree, Blood test abnormal, Chest pain, Dyspnoea
Clinical narrative: Pericarditis/ light chest tightness and cough; This is a spontaneous report received from contactable reporter (consumer) from medical information team. The reporter is the patient.  A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 27Oct2021 16:00 (lot number: FF2593) at the age of 27-years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Epilepsy", start date: 1997 (ongoing), notes: Diagnosed with Epilepsy at 3-years-old. Concomitant medication included: KEPPRA [LEVETIRACETAM] taken for epilepsy (ongoing). Vaccination history included: BNT162B2 (lot number: EJ1686, administered in right arm at 11:30 as dose 1, single), administration date: 29Dec2020, when the patient was 26-years-old, for COVID-19 immunisation; BNT162B2 (lot number: EJ1686, administered in right arm at 11:30 as dose 2, single), administration date: 19Jan2021, when the patient was 26-years-old, for COVID-19 immunisation; and Flu shot, administration date: 2021, for Immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset Nov2021, outcome "recovering", described as "Pericarditis/ light chest tightness and cough." The patient was hospitalized for pericarditis (start date: 01Jan2022, discharge date: 02Jan2022, hospitalization duration: 1 day). The event "pericarditis/ light chest tightness and cough" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown result. Therapeutic measures were taken as a result of pericarditis. Clinical course: The patient was hospitalized for pericarditis after receiving the booster dose of Pfizer COVID-19 vaccine. When asked for the date of the adverse event, he mentioned that it became severe enough on 31Dec2021. It progressively increased. It probably started a month after the vaccine. It presented as light chest tightness and cough that progressively got worse until 31Dec2021. He is on medication for the next 3 months. The medication has helped, and the pericarditis was improving.  Family medical history relevant to the adverse event and additional vaccines administered on the same date as BNT162B2 were reported as none  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Electrocardiogram abnormal, Inflammation, Pericarditis
Clinical narrative: Pericarditis/ light chest tightness and cough; This is a spontaneous report received from contactable reporter (consumer) from medical information team. The reporter is the patient.  A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 27Oct2021 16:00 (lot number: FF2593) at the age of 27-years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Epilepsy", start date: 1997 (ongoing), notes: Diagnosed with Epilepsy at 3-years-old. Concomitant medication included: KEPPRA [LEVETIRACETAM] taken for epilepsy (ongoing). Vaccination history included: BNT162B2 (lot number: EJ1686, administered in right arm at 11:30 as dose 1, single), administration date: 29Dec2020, when the patient was 26-years-old, for COVID-19 immunisation; BNT162B2 (lot number: EJ1686, administered in right arm at 11:30 as dose 2, single), administration date: 19Jan2021, when the patient was 26-years-old, for COVID-19 immunisation; and Flu shot, administration date: 2021, for Immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset Nov2021, outcome "recovering", described as "Pericarditis/ light chest tightness and cough." The patient was hospitalized for pericarditis (start date: 01Jan2022, discharge date: 02Jan2022, hospitalization duration: 1 day). The event "pericarditis/ light chest tightness and cough" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown result. Therapeutic measures were taken as a result of pericarditis. Clinical course: The patient was hospitalized for pericarditis after receiving the booster dose of Pfizer COVID-19 vaccine. When asked for the date of the adverse event, he mentioned that it became severe enough on 31Dec2021. It progressively increased. It probably started a month after the vaccine. It presented as light chest tightness and cough that progressively got worse until 31Dec2021. He is on medication for the next 3 months. The medication has helped, and the pericarditis was improving.  Family medical history relevant to the adverse event and additional vaccines administered on the same date as BNT162B2 were reported as none  Follow-up attempts are completed. No further information is expected.