chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Immunisation, Off label use
Clinical narrative: experienced most of these same symptoms after being inoculated three times with your vaccine; experienced most of these same symptoms after being inoculated three times with your vaccine; Debilitating fatigue; Extreme chills; Headaches; Joint pain; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Contracted covid", start date: Dec2020 (unspecified if ongoing), notes: contracted covid last December. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Debilitating fatigue), for Covid-19 immunization, reaction(s): "Debilitating fatigue"; Bnt162b2 (DOSE: 1, Extreme chills), for Covid-19 immunization, reaction(s): "Extreme chills"; Bnt162b2 (DOSE: 1, Headaches), for Covid-19 immunization, reaction(s): "Headaches"; Bnt162b2 (DOSE: 1), for Covid-19 immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE: 1, Loss of taste and smell for 3 weeks), for Covid-19 immunization, reaction(s): "Loss of taste and smell", "Loss of taste and smell"; Bnt162b2 (DOSE: 2, Debilitating fatigue), for Covid-19 immunization, reaction(s): "Debilitating fatigue"; Bnt162b2 (DOSE: 2, Extreme chills), for Covid-19 immunization, reaction(s): "Extreme chills"; Bnt162b2 (DOSE: 2, Headaches), for Covid-19 immunization, reaction(s): "Headaches"; Bnt162b2 (DOSE: 2), for Covid-19 immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE: 2, Loss of taste and smell for 3 weeks), for Covid-19 immunization, reaction(s): "Loss of taste and smell", "Loss of taste and smell". The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "experienced most of these same symptoms after being inoculated three times with your vaccine"; FATIGUE (non-serious), outcome "unknown", described as "Debilitating fatigue"; CHILLS (non-serious), outcome "unknown", described as "Extreme chills"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Loss of taste and smell".  Additional information: patient who, having contracted Covid last December and experienced symptoms of debilitating fatigue, extreme chills, headaches, joint pain, loss of taste and smell for 3 weeks, has experienced most of these same symptoms after being inoculated three times with your vaccine. Each time I have gotten the vaccine, the side effects have gotten worse. I hate to think that if I have to get a booster twice a year, I will have to experience more severe side effects.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Echocardiogram, Ejection fraction, Electrocardiogram, Fatigue
Clinical narrative: nonradiating chest pain/ Myocarditis; 1 day of fatigue and arm soreness after vaccination; 1 day of fatigue and arm soreness after vaccination; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 26Nov2021, this case now contains all required information to be considered valid. This is a literature report.  A previously healthy 19-year-old man presented with sudden onset of severe, nonradiating chest pain 3 days after receiving a second dose of a messenger RNA (mRNA) SARS-CoV-2 vaccine. He noted 1 day of fatigue and arm soreness after vaccination, which resolved before the onset of chest pain. There was no associated dyspnea, nausea, or vomiting. Work-up included a negative SARS-CoV-2 polymerase chain reaction test result, electrocardiography with diffuse ST-segment elevation, and high-sensitivity cardiac troponin T level of 1029 pg/mL (reference range, 0 to 19 pg/mL). A transthoracic echocardiogram showed left ventricular systolic function within normal range (ejection fraction of 58%), with no regional wall motion abnormalities and no pericardial effusion. He was admitted and received ibuprofen and colchicine. His pain resolved by the following morning. Troponin T levels peaked the day after presentation at 1273 pg/mL; repeated measure of troponin T level 1 month later was within normal range (10 pg/mL). Echocardiography done 4 days after presentation was normal, with an ejection fraction of 67%. Three months after presentation, the patient was asymptomatic. A 7-day ambulatory rhythm monitor showed 25 isolated ventricular ectopic beats. An exercise stress test was normal. A cardiac magnetic resonance image (MRI) showed a small area of subepicardial late gadolinium enhancement but no definite signs of active myocardial inflammation.; Sender's Comments: Based on the currently available information the possibility of causal association between the event myocarditis and the suspect drug BNT162B2  cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Magnetic resonance imaging heart, Myocarditis, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: nonradiating chest pain/ Myocarditis; 1 day of fatigue and arm soreness after vaccination; 1 day of fatigue and arm soreness after vaccination; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 26Nov2021, this case now contains all required information to be considered valid. This is a literature report.  A previously healthy 19-year-old man presented with sudden onset of severe, nonradiating chest pain 3 days after receiving a second dose of a messenger RNA (mRNA) SARS-CoV-2 vaccine. He noted 1 day of fatigue and arm soreness after vaccination, which resolved before the onset of chest pain. There was no associated dyspnea, nausea, or vomiting. Work-up included a negative SARS-CoV-2 polymerase chain reaction test result, electrocardiography with diffuse ST-segment elevation, and high-sensitivity cardiac troponin T level of 1029 pg/mL (reference range, 0 to 19 pg/mL). A transthoracic echocardiogram showed left ventricular systolic function within normal range (ejection fraction of 58%), with no regional wall motion abnormalities and no pericardial effusion. He was admitted and received ibuprofen and colchicine. His pain resolved by the following morning. Troponin T levels peaked the day after presentation at 1273 pg/mL; repeated measure of troponin T level 1 month later was within normal range (10 pg/mL). Echocardiography done 4 days after presentation was normal, with an ejection fraction of 67%. Three months after presentation, the patient was asymptomatic. A 7-day ambulatory rhythm monitor showed 25 isolated ventricular ectopic beats. An exercise stress test was normal. A cardiac magnetic resonance image (MRI) showed a small area of subepicardial late gadolinium enhancement but no definite signs of active myocardial inflammation.; Sender's Comments: Based on the currently available information the possibility of causal association between the event myocarditis and the suspect drug BNT162B2  cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Troponin T
Clinical narrative: nonradiating chest pain/ Myocarditis; 1 day of fatigue and arm soreness after vaccination; 1 day of fatigue and arm soreness after vaccination; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 26Nov2021, this case now contains all required information to be considered valid. This is a literature report.  A previously healthy 19-year-old man presented with sudden onset of severe, nonradiating chest pain 3 days after receiving a second dose of a messenger RNA (mRNA) SARS-CoV-2 vaccine. He noted 1 day of fatigue and arm soreness after vaccination, which resolved before the onset of chest pain. There was no associated dyspnea, nausea, or vomiting. Work-up included a negative SARS-CoV-2 polymerase chain reaction test result, electrocardiography with diffuse ST-segment elevation, and high-sensitivity cardiac troponin T level of 1029 pg/mL (reference range, 0 to 19 pg/mL). A transthoracic echocardiogram showed left ventricular systolic function within normal range (ejection fraction of 58%), with no regional wall motion abnormalities and no pericardial effusion. He was admitted and received ibuprofen and colchicine. His pain resolved by the following morning. Troponin T levels peaked the day after presentation at 1273 pg/mL; repeated measure of troponin T level 1 month later was within normal range (10 pg/mL). Echocardiography done 4 days after presentation was normal, with an ejection fraction of 67%. Three months after presentation, the patient was asymptomatic. A 7-day ambulatory rhythm monitor showed 25 isolated ventricular ectopic beats. An exercise stress test was normal. A cardiac magnetic resonance image (MRI) showed a small area of subepicardial late gadolinium enhancement but no definite signs of active myocardial inflammation.; Sender's Comments: Based on the currently available information the possibility of causal association between the event myocarditis and the suspect drug BNT162B2  cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Lymph node swollen/'supraclavicular' lymph nodes swollen; I just want to report that I had a side effects from COVID booster; 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 female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 14Oct2021 (Lot number: FF2590) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, The LOT# was LOX EN6198.), administration date: 26Feb2021, when the patient was 65 years old, for COVID-19 immunization; Bnt162b2 (2d dose, LOT# was EN6207.), administration date: 19Mar2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "I just want to report that I had a side effects from COVID booster"; LYMPHADENOPATHY (non-serious) with onset 17Oct2021, outcome "unknown", described as "Lymph node swollen/'supraclavicular' lymph nodes swollen". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Expiry date of COVID-19 Vaccine: unknown. Patient History and Investigation Assessment: No. Anatomical site of vaccine administration: Reporter stated, "It was high on the left shoulder." It was reported as patient was not taken any vaccination 4 weeks prior to the COVID 19 Vaccine.  Follow-Up (24Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Immunisation, Skin discolouration, Temperature perception test abnormal
Clinical narrative: receiving Covid-19 booster; bilateral chilling of the  hands with whitening of the skin and purple discoloration; bilateral chilling of the  hands with whitening of the skin and purple discoloration; Patient measured temperature of hands at 93 degrees F; This is a spontaneous report received from a contactable Consumer or other non HCP.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Food allergies" (unspecified if ongoing); "allergic to cold" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, Unknown dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "receiving Covid-19 booster"; FEELING COLD (non-serious), SKIN DISCOLORATION (non-serious), outcome "recovered" and all described as "bilateral chilling of the  hands with whitening of the skin and purple discoloration"; TEMPERATURE PERCEPTION TEST ABNORMAL (non-serious), outcome "recovered", described as "Patient measured temperature of hands at 93 degrees F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling cold, skin discoloration, temperature perception test abnormal. Additional information: About 12 hours after receiving Covid-19 booster patient experienced bilateral chilling of the hands with whitening of the skin and purple discoloration. This occurred after ice was applied to the injection site which was described as feeling like there was a bullet in the arm. Patient measured temperature of hands at 93 degrees F. After applying gloves and a heating pad the hands returned to normal about 2 hours later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Immunisation, Swelling
Clinical narrative: Swelling; lump under the left armpit; dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 19:30 (Lot number: 301458A) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALEVE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9263, Location of injection: Arm Left, Vaccine Administration Time: 03:00 AM), administration date: 08Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 04:00 AM), administration date: 18Jan2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 19:30, outcome "unknown", described as "dose number = 3"; SWELLING (non-serious) with onset 19Nov2021 14:00, outcome "not recovered", described as "Swelling"; AXILLARY MASS (non-serious) with onset 19Nov2021 14:00, outcome "not recovered", described as "lump under the left armpit". Therapeutic measures were not taken as a result of swelling, axillary mass.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Pfizer booster shot; A lot of nausea; Fatigue; headache; I have hot and cold,; chills; sweating; dizziness; waking up at night and not being able to sleep; heart palpitation; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FD0809) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was none. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster shot"; NAUSEA (non-serious), outcome "recovering", described as "A lot of nausea"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "recovering", described as "I have hot and cold,"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; DIZZINESS (non-serious), outcome "recovering", described as "dizziness"; SLEEP DISORDER (non-serious), outcome "unknown", described as "waking up at night and not being able to sleep"; PALPITATIONS (non-serious), outcome "recovering", described as "heart palpitation".  Additional information included: The patient neither had any medical history nor received any concomitant medications. The patient stated that she had the Pfizer booster shot. She had the 4 vaccinations. The patient had got the first shot, the second shot and 8 months after that she had Covid booster just 5 days ago. Most of the times the symptoms go away in 2 to 3 days. But she was having some different symptoms now still hanging on her day 5. The patient was kind of wondering if she was feeling was kind of normal. The patient was feeling hot and cold, not totally chills but cold one moment and hot the next and sweating, dizziness, waking up at night and not being able to sleep due to this nausea. She got a lot of nausea, comes and goes. She did have a little bit of heart palpitation. The patient had a home self-test twice to see if she has Covid, but it came out negative (further clarification unknown about the tests). The patient received Tylenol as treatment.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Immunisation, Nausea, Palpitations, Sleep disorder
Clinical narrative: Pfizer booster shot; A lot of nausea; Fatigue; headache; I have hot and cold,; chills; sweating; dizziness; waking up at night and not being able to sleep; heart palpitation; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FD0809) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was none. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster shot"; NAUSEA (non-serious), outcome "recovering", described as "A lot of nausea"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "recovering", described as "I have hot and cold,"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; DIZZINESS (non-serious), outcome "recovering", described as "dizziness"; SLEEP DISORDER (non-serious), outcome "unknown", described as "waking up at night and not being able to sleep"; PALPITATIONS (non-serious), outcome "recovering", described as "heart palpitation".  Additional information included: The patient neither had any medical history nor received any concomitant medications. The patient stated that she had the Pfizer booster shot. She had the 4 vaccinations. The patient had got the first shot, the second shot and 8 months after that she had Covid booster just 5 days ago. Most of the times the symptoms go away in 2 to 3 days. But she was having some different symptoms now still hanging on her day 5. The patient was kind of wondering if she was feeling was kind of normal. The patient was feeling hot and cold, not totally chills but cold one moment and hot the next and sweating, dizziness, waking up at night and not being able to sleep due to this nausea. She got a lot of nausea, comes and goes. She did have a little bit of heart palpitation. The patient had a home self-test twice to see if she has Covid, but it came out negative (further clarification unknown about the tests). The patient received Tylenol as treatment.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling cold, Feeling hot, Hyperhidrosis, Insomnia
Clinical narrative: Pfizer booster shot; A lot of nausea; Fatigue; headache; I have hot and cold,; chills; sweating; dizziness; waking up at night and not being able to sleep; heart palpitation; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FD0809) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was none. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster shot"; NAUSEA (non-serious), outcome "recovering", described as "A lot of nausea"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "recovering", described as "I have hot and cold,"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; DIZZINESS (non-serious), outcome "recovering", described as "dizziness"; SLEEP DISORDER (non-serious), outcome "unknown", described as "waking up at night and not being able to sleep"; PALPITATIONS (non-serious), outcome "recovering", described as "heart palpitation".  Additional information included: The patient neither had any medical history nor received any concomitant medications. The patient stated that she had the Pfizer booster shot. She had the 4 vaccinations. The patient had got the first shot, the second shot and 8 months after that she had Covid booster just 5 days ago. Most of the times the symptoms go away in 2 to 3 days. But she was having some different symptoms now still hanging on her day 5. The patient was kind of wondering if she was feeling was kind of normal. The patient was feeling hot and cold, not totally chills but cold one moment and hot the next and sweating, dizziness, waking up at night and not being able to sleep due to this nausea. She got a lot of nausea, comes and goes. She did have a little bit of heart palpitation. The patient had a home self-test twice to see if she has Covid, but it came out negative (further clarification unknown about the tests). The patient received Tylenol as treatment.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: Pfizer booster shot; A lot of nausea; Fatigue; headache; I have hot and cold,; chills; sweating; dizziness; waking up at night and not being able to sleep; heart palpitation; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FD0809) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was none. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization; Bnt162b2 (Second dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster shot"; NAUSEA (non-serious), outcome "recovering", described as "A lot of nausea"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "recovering", described as "I have hot and cold,"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; DIZZINESS (non-serious), outcome "recovering", described as "dizziness"; SLEEP DISORDER (non-serious), outcome "unknown", described as "waking up at night and not being able to sleep"; PALPITATIONS (non-serious), outcome "recovering", described as "heart palpitation".  Additional information included: The patient neither had any medical history nor received any concomitant medications. The patient stated that she had the Pfizer booster shot. She had the 4 vaccinations. The patient had got the first shot, the second shot and 8 months after that she had Covid booster just 5 days ago. Most of the times the symptoms go away in 2 to 3 days. But she was having some different symptoms now still hanging on her day 5. The patient was kind of wondering if she was feeling was kind of normal. The patient was feeling hot and cold, not totally chills but cold one moment and hot the next and sweating, dizziness, waking up at night and not being able to sleep due to this nausea. She got a lot of nausea, comes and goes. She did have a little bit of heart palpitation. The patient had a home self-test twice to see if she has Covid, but it came out negative (further clarification unknown about the tests). The patient received Tylenol as treatment.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: booster; her skin is red, tender and warm in the arm area in where she had the shot; her skin is red, tender and warm in the arm area in where she had the shot; her skin is red, tender and warm in the arm area in where she had the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "her skin is red, tender and warm in the arm area in where she had the shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Musculoskeletal stiffness
Clinical narrative: Covid booster; I'm experiencing a headache; whole body stiffness; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), 30 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First dose, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Seccond dose, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Covid booster"; HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "I'm experiencing a headache"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Nov2021, outcome "not recovered", described as "whole body stiffness"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "not recovered", described as "joint pain".  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: Event took place after use of product. After receiving the Covid booster on 22Nov2021, several hours afterwards and continuing to now, I'm experiencing a headache and whole body stiffness and joint pain.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Immunisation
Clinical narrative: Booster; The patient got COVID (Coronavirus Disease) booster and got sicker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENBREL. Vaccination history included: Covid-19 vaccine (Dose 1 Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2 Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; ILLNESS (non-serious), outcome "unknown", described as "The patient got COVID (Coronavirus Disease) booster and got sicker". Therapeutic measures were not taken as a result of illness.  Additional information: Feeling really bad/ not feeling well/ got sicker than a dog. The patient thought that booster was less medicine and it would not be horrible but it was not like that. The patient was feeling really bad and not feeling well. The reporter declined consent for follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick; This is a spontaneous report received from a contactable reporter(s) (Nurse). A patient (no qualifiers provided) received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (hospitalization), outcome "unknown", described as "got sick". It was reported that the Nurse's patient had a reaction and was sent to the hospital. It was reported that the patient went back to their job and got sick.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event illness cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic myelomonocytic leukaemia, Condition aggravated, Deafness
Clinical narrative: complete hearing loss in right ear and diminished hearing in the left; diagnosed with leukemia; very rare form of leukemia, CMML.; had issues with her hearing before, but it was completely gone after the doses of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 21Feb2021 (Lot number: EL9269) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "issues with her hearing" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, 31Jan2021, Lot-EN5318 or EM5318- states it is hard to tell), administration date: 31Jan2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: CHRONIC MYELOMONOCYTIC LEUKAEMIA (medically significant) with onset Mar2021, outcome "not recovered", described as "diagnosed with leukemia; very rare form of leukemia, CMML."; DEAFNESS (medically significant) with onset Apr2021, outcome "not recovered", described as "complete hearing loss in right ear and diminished hearing in the left"; CONDITION AGGRAVATED (medically significant) with onset Feb2021, outcome "not recovered", described as "had issues with her hearing before, but it was completely gone after the doses of the vaccine". The events "diagnosed with leukemia; very rare form of leukemia, cmml.", "complete hearing loss in right ear and diminished hearing in the left" and "had issues with her hearing before, but it was completely gone after the doses of the vaccine" were evaluated at the physician office visit with ear specialists and the cancer doctor. Clinical course: she has a loss of hearing that occurred after she got the second shot in Feb2021. Complete hearing loss in her right ear occurred toward the end of Apr2021. Hearing was very diminished in her left ear. Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Loss of consciousness
Clinical narrative: Passed out; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 81 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Mar2021 10:10 (Lot number: ER2613) at the age of 81 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "allergies toward caffeine" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing); "sore knee" (unspecified if ongoing); "injection in her eye" (unspecified if ongoing). Concomitant medication(s) included: SUPARTZ taken for arthralgia, start date: 15Feb2021, stop date: 15Feb2021; EYLEA taken for eye disorder. Past drug history included: Codeine, reaction(s): "allergies"; Eylea. Vaccination history included: Bnt162b2 (dose 1 (lot number: EN6202), in the upper left arm), administration date: 25Feb2021, when the patient was 81 years old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 18Mar2021, outcome "recovered", described as "Passed out". The patient underwent the following laboratory tests and procedures: computerised tomogram: clear. The patient was wondering abut the booster shot. She states she had a problem with the original second shot she received. She states with the second shot received on 19Mar2021, she passed out that evening. She received her second shot two weeks after the first one, but it's more involved than that. On 15Feb2021, she had an injection for a sore knee. She clarifies the name of the drug is Supartz FX and it was a series of 4 injections. She had one injection before the 2 shots and then after the two shots, she had two more. After the Supartz FX, she had an injection in her eye called Eylea. The caller clarifies she has no NDC, Lot or expiry date for the Supartz FX or the Eylea. So, she had a series of shots in a very short time. The patient clarified that the day she passed out was 18Mar2021 and she wanted to report that. Also, she wanted to know how safe it is to get the booster shot. Her doctor recommended her getting the moderna shot because it wasn't strong as Pfizer but according to all of the information that has come out, it says to stick to the same drug. The patient wanted to know how safe it is for her to get the booster shot. She is inclined to skip it because she is afraid of Pfizer but as she stated earlier, her doctor suggested she get the Moderna. However, according to the research that has come out, it says to not to mix the shots, so she is confused by that. The caller clarifies it took about 24 hours for her to recover from passing out. However, she did not go to the doctor or emergency room.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Dizziness, Headache, Loss of personal independence in daily activities
Clinical narrative: arm blew up; excruciating pain throughout her body; hurts from head; sinus infection; bronchitis; nauseous; dizzy; lost another 15 pounds; cough; temperature spikes; get sicker; vomit; unable to do anything; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (PFIZER BIOTECH VACCINE), administered in arm right, administration date 26Aug2021 12:00 (Lot number: FC3182) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "chronic pelvic pain" (unspecified if ongoing); "Ehler's Danlos Syndrome" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "allergies to Bee Stings" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Allergy to antibiotic" (unspecified if ongoing). Concomitant medication(s) included: GEODON [ZIPRASIDONE HYDROCHLORIDE]; ZOLOFT; HYDROMORPHONE; KLONOPIN; FIORICET. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Pfizer, Dose Number: 1, Batch/Lot No: FC3180, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), for Covid-19 immunisation. The following information was reported: After her 2nd shot her arm blew up. The patient ended up at Urgent Care the next day but they told her that it was normal. By the next day the patient started having an excruciating pain throughout her body. She was a chronic pain patient due to Ehler's Danlos  and Endometriosis but this was nothing she had ever experienced. Every day it got worse and nothing helps but she was already on enough pain medication but none of it touches this type of pain. It elt like she have live wires instead of veins and it hurts from her head, with constant headaches down to her toes and everywhere in between. About a month ago the patient started to get sicker. It started with a sinus infection and bronchitis but then she started getting dizzy and nauseous and the patient was unable to do anything but lay here and vomit. The world was spinning in her head but her stomach was telling her she was starving. The patient had lost another 15 pounds in the last 4 weeks and she was down to 100 pounds. The patient was having temperature spikes for no reason. She still have a horrible cough. No one knows what was. The event onset date was reported as 26Aug2021 at 18:00, outcome "not recovered". The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. No treatment was received for the events. Covid nasal swab PCR test on 27Oct2021 was negative.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: arm blew up; excruciating pain throughout her body; hurts from head; sinus infection; bronchitis; nauseous; dizzy; lost another 15 pounds; cough; temperature spikes; get sicker; vomit; unable to do anything; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (PFIZER BIOTECH VACCINE), administered in arm right, administration date 26Aug2021 12:00 (Lot number: FC3182) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "chronic pelvic pain" (unspecified if ongoing); "Ehler's Danlos Syndrome" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "allergies to Bee Stings" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Allergy to antibiotic" (unspecified if ongoing). Concomitant medication(s) included: GEODON [ZIPRASIDONE HYDROCHLORIDE]; ZOLOFT; HYDROMORPHONE; KLONOPIN; FIORICET. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Pfizer, Dose Number: 1, Batch/Lot No: FC3180, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), for Covid-19 immunisation. The following information was reported: After her 2nd shot her arm blew up. The patient ended up at Urgent Care the next day but they told her that it was normal. By the next day the patient started having an excruciating pain throughout her body. She was a chronic pain patient due to Ehler's Danlos  and Endometriosis but this was nothing she had ever experienced. Every day it got worse and nothing helps but she was already on enough pain medication but none of it touches this type of pain. It elt like she have live wires instead of veins and it hurts from her head, with constant headaches down to her toes and everywhere in between. About a month ago the patient started to get sicker. It started with a sinus infection and bronchitis but then she started getting dizzy and nauseous and the patient was unable to do anything but lay here and vomit. The world was spinning in her head but her stomach was telling her she was starving. The patient had lost another 15 pounds in the last 4 weeks and she was down to 100 pounds. The patient was having temperature spikes for no reason. She still have a horrible cough. No one knows what was. The event onset date was reported as 26Aug2021 at 18:00, outcome "not recovered". The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. No treatment was received for the events. Covid nasal swab PCR test on 27Oct2021 was negative.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinusitis, Vomiting, Weight decreased
Clinical narrative: arm blew up; excruciating pain throughout her body; hurts from head; sinus infection; bronchitis; nauseous; dizzy; lost another 15 pounds; cough; temperature spikes; get sicker; vomit; unable to do anything; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (PFIZER BIOTECH VACCINE), administered in arm right, administration date 26Aug2021 12:00 (Lot number: FC3182) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "chronic pelvic pain" (unspecified if ongoing); "Ehler's Danlos Syndrome" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "allergies to Bee Stings" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Allergy to antibiotic" (unspecified if ongoing). Concomitant medication(s) included: GEODON [ZIPRASIDONE HYDROCHLORIDE]; ZOLOFT; HYDROMORPHONE; KLONOPIN; FIORICET. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Pfizer, Dose Number: 1, Batch/Lot No: FC3180, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), for Covid-19 immunisation. The following information was reported: After her 2nd shot her arm blew up. The patient ended up at Urgent Care the next day but they told her that it was normal. By the next day the patient started having an excruciating pain throughout her body. She was a chronic pain patient due to Ehler's Danlos  and Endometriosis but this was nothing she had ever experienced. Every day it got worse and nothing helps but she was already on enough pain medication but none of it touches this type of pain. It elt like she have live wires instead of veins and it hurts from her head, with constant headaches down to her toes and everywhere in between. About a month ago the patient started to get sicker. It started with a sinus infection and bronchitis but then she started getting dizzy and nauseous and the patient was unable to do anything but lay here and vomit. The world was spinning in her head but her stomach was telling her she was starving. The patient had lost another 15 pounds in the last 4 weeks and she was down to 100 pounds. The patient was having temperature spikes for no reason. She still have a horrible cough. No one knows what was. The event onset date was reported as 26Aug2021 at 18:00, outcome "not recovered". The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. No treatment was received for the events. Covid nasal swab PCR test on 27Oct2021 was negative.  Follow-up attempts are completed. No further information is expected.