chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Shoulder pain; headache; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Sep2021 14:00 (Lot number: FF8841) at the age of 47 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Gall bladder removed" (unspecified if ongoing); "bicuspid" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 28Sep2021. The following information was reported: ARTHRALGIA (non-serious) with onset 30Sep2021 23:15, outcome "recovering", described as "Shoulder pain"; HEADACHE (non-serious) with onset 30Sep2021 23:15, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 30Sep2021 23:15, outcome "recovering", described as "tiredness". Therapeutic measures were not taken as a result of arthralgia, headache, fatigue.  Additional information: The patient had received other vaccine Flu vaccine in 4 weeks on 28Sep2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: I have had a chronic dry cough that started 3 days after my second shot. I cough all the time.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 12:00 (Lot number: Ew0172) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=Er8730, lot unknown=False, administration date=04May2021, administration time=02:30 PM, dose number=1, vaccine location=Left arm), administration date: 04May2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 29Jun2021 12:00, outcome "not recovered", described as "I have had a chronic dry cough that started 3 days after my second shot. I cough all the time.". The event "i have had a chronic dry cough that started 3 days after my second shot. i cough all the time." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of cough. Additional information: No other vaccine in four weeks and no other medications in two weeks. No treatment. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: achiness of her joints and muscles; Her arm was also sore; low grade fever; tired and so forth; headache; achiness of her joints and muscles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for Covid-19 immunization, reaction(s): "Tired", "sore arm". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "low grade fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "achiness of her joints and muscles"; FATIGUE (non-serious), outcome "recovered", described as "tired and so forth"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Her arm was also sore"; HEADACHE (non-serious), outcome "recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, myalgia, arthralgia, fatigue, pain in extremity, headache.  Additional information:The next day Patient had a low grade fever with achiness of joints and muscles. Patient was unsure which of the 2 may have been sore. Patient also was tired and so forth.Arm was also sore. Patient states it seems that after booster dose having very similar symptoms was hoping the immune system is working as strongly as it was working before hand. After 1st vaccine the caller notes having a sore arm and not much else, maybe tired. The 2nd vaccine hit much harder, sore for several days, headache that night and low grade fevers. Patient had not taken any medication due to side effects and noted that coffee worked. Patient reports having achiness for several days after the vaccine, also notes that sore arm was not as bad as the first injection and last night arm was very sore.They had been so careful for 1.5 years and just hearing about breakthrough cases.Patient is hoping that the vaccine is working as efficiently as expected despite taking 2 Advil prior to the injection for a headache Patient was developing prior to the vaccine administration. Patient did not take Advil before her 1st and second doses and she is having similar reaction this time around as she was after her 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: achiness of her joints and muscles; Her arm was also sore; low grade fever; tired and so forth; headache; achiness of her joints and muscles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for Covid-19 immunization, reaction(s): "Tired", "sore arm". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "low grade fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "achiness of her joints and muscles"; FATIGUE (non-serious), outcome "recovered", described as "tired and so forth"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Her arm was also sore"; HEADACHE (non-serious), outcome "recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, myalgia, arthralgia, fatigue, pain in extremity, headache.  Additional information:The next day Patient had a low grade fever with achiness of joints and muscles. Patient was unsure which of the 2 may have been sore. Patient also was tired and so forth.Arm was also sore. Patient states it seems that after booster dose having very similar symptoms was hoping the immune system is working as strongly as it was working before hand. After 1st vaccine the caller notes having a sore arm and not much else, maybe tired. The 2nd vaccine hit much harder, sore for several days, headache that night and low grade fevers. Patient had not taken any medication due to side effects and noted that coffee worked. Patient reports having achiness for several days after the vaccine, also notes that sore arm was not as bad as the first injection and last night arm was very sore.They had been so careful for 1.5 years and just hearing about breakthrough cases.Patient is hoping that the vaccine is working as efficiently as expected despite taking 2 Advil prior to the injection for a headache Patient was developing prior to the vaccine administration. Patient did not take Advil before her 1st and second doses and she is having similar reaction this time around as she was after her 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heart rate, Heart rate increased, Lymphadenopathy, Myalgia
Clinical narrative: I have a mosquito bite looking lump at the injection site that I did not have previously; my left armpit is very swollen; Rapid heart rate; Weak; Muscle tenderness; My lymph nodes also started to swell in my left under arm on this day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Sep2021 13:45 (Lot number: FF8841) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA; SLYND; BACTRIM; MAGNESIUM OXIDE. Past drug history included: Azithromycin, reaction(s): "known allergies: Azithromycin"; Vancomycin, reaction(s): "known allergies: Vancomycin". Vaccination history included: Bnt162b2 (Dose 2, Batch number=EL3248, Administration date: 01Feb202, Administration time: 07:00 AM, Location: Left arm), administration date: 01Feb2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Batch: EL3248, Administration date: 12Jan2021,, Administration time=07:00 AM, location=Left arm), administration date: 12Jan2021, when the patient was 33 years old, for Covid-19 immunization; Diphtheria vaccination, reaction(s): "Known allergies: Diphtheria vaccination". The following information was reported: VACCINATION SITE MASS (non-serious), outcome "recovering", described as "I have a mosquito bite looking lump at the injection site that I did not have previously"; SWELLING (non-serious), outcome "recovering", described as "my left armpit is very swollen"; HEART RATE INCREASED (non-serious) with onset 02Oct2021, outcome "recovering", described as "Rapid heart rate"; ASTHENIA (non-serious) with onset 01Oct2021 06:00, outcome "recovering", described as "Weak"; MYALGIA (non-serious) with onset 01Oct2021 06:00, outcome "recovering", described as "Muscle tenderness"; LYMPHADENOPATHY (non-serious) with onset 01Oct2021 06:00, outcome "recovering", described as "My lymph nodes also started to swell in my left under arm on this day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass, swelling. Therapeutic measures were taken as a result of heart rate increased, asthenia, myalgia, lymphadenopathy.  Additional information: Patient was not received any other vaccine four weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. Ae treatment: I visited the Pfizer clinic  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site mass
Clinical narrative: I have a mosquito bite looking lump at the injection site that I did not have previously; my left armpit is very swollen; Rapid heart rate; Weak; Muscle tenderness; My lymph nodes also started to swell in my left under arm on this day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Sep2021 13:45 (Lot number: FF8841) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA; SLYND; BACTRIM; MAGNESIUM OXIDE. Past drug history included: Azithromycin, reaction(s): "known allergies: Azithromycin"; Vancomycin, reaction(s): "known allergies: Vancomycin". Vaccination history included: Bnt162b2 (Dose 2, Batch number=EL3248, Administration date: 01Feb202, Administration time: 07:00 AM, Location: Left arm), administration date: 01Feb2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Batch: EL3248, Administration date: 12Jan2021,, Administration time=07:00 AM, location=Left arm), administration date: 12Jan2021, when the patient was 33 years old, for Covid-19 immunization; Diphtheria vaccination, reaction(s): "Known allergies: Diphtheria vaccination". The following information was reported: VACCINATION SITE MASS (non-serious), outcome "recovering", described as "I have a mosquito bite looking lump at the injection site that I did not have previously"; SWELLING (non-serious), outcome "recovering", described as "my left armpit is very swollen"; HEART RATE INCREASED (non-serious) with onset 02Oct2021, outcome "recovering", described as "Rapid heart rate"; ASTHENIA (non-serious) with onset 01Oct2021 06:00, outcome "recovering", described as "Weak"; MYALGIA (non-serious) with onset 01Oct2021 06:00, outcome "recovering", described as "Muscle tenderness"; LYMPHADENOPATHY (non-serious) with onset 01Oct2021 06:00, outcome "recovering", described as "My lymph nodes also started to swell in my left under arm on this day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site mass, swelling. Therapeutic measures were taken as a result of heart rate increased, asthenia, myalgia, lymphadenopathy.  Additional information: Patient was not received any other vaccine four weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. Ae treatment: I visited the Pfizer clinic  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Chills; Shortness of breath; Extreme fatigue; Loss of appetite; Frequent urination (q 20-30 minutes); Cold sweats; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 12:45 (Lot number: FF8839) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Mar2021, when the patient was 78 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 20Feb2021, when the patient was 78 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Chills"; DYSPNOEA (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Shortness of breath"; FATIGUE (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Extreme fatigue"; DECREASED APPETITE (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Loss of appetite"; POLLAKIURIA (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Frequent urination (q 20-30 minutes)"; COLD SWEAT (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Cold sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, dyspnoea, fatigue, decreased appetite, pollakiuria, cold sweat. Additional information: No other vaccine was given in four weeks. The patient did not have Covid prior to vaccination. Covid tested was performed post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, SARS-CoV-2 test
Clinical narrative: Chills; Shortness of breath; Extreme fatigue; Loss of appetite; Frequent urination (q 20-30 minutes); Cold sweats; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 12:45 (Lot number: FF8839) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Mar2021, when the patient was 78 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 20Feb2021, when the patient was 78 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Chills"; DYSPNOEA (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Shortness of breath"; FATIGUE (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Extreme fatigue"; DECREASED APPETITE (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Loss of appetite"; POLLAKIURIA (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Frequent urination (q 20-30 minutes)"; COLD SWEAT (non-serious) with onset 29Sep2021 23:00, outcome "recovered" (2021), described as "Cold sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, dyspnoea, fatigue, decreased appetite, pollakiuria, cold sweat. Additional information: No other vaccine was given in four weeks. The patient did not have Covid prior to vaccination. Covid tested was performed post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Night sweats, Pyrexia
Clinical narrative: extremely high fever of 103 degrees,; night sweating; Sweating, sweating a lot; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 14:00 (Lot number: 30145BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single, Lot number: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 24Mar2021, when the patient was 65 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, single, Lot number: EN6200, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 03Mar2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 29Sep2021 04:00, outcome "recovered" (02Oct2021), described as "extremely high fever of 103 degrees,"; NIGHT SWEATS (non-serious) with onset 29Sep2021 04:00, outcome "recovered" (02Oct2021), described as "night sweating"; HYPERHIDROSIS (non-serious) with onset 29Sep2021 04:00, outcome "recovered" (01Oct2021), described as "Sweating, sweating a lot"; CHILLS (non-serious) with onset 29Sep2021 04:00, outcome "recovered" (01Oct2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The most recent facility for COVID-19 vaccine administration was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had a reaction after the booster shot, 14 hours after he got the booster shot, he had a very extremely high fever of 103 degrees, chills and sweating, sweating a lot and that lasted for 2 days and then it went down to 102.7 on the third day. So he had a very high adverse reaction with fever, chills and sweating, he sweat so much he couldn't believe it, but feel better later. He did not smoke or do anything, and he had a very hard reaction with booster shot. She had no lab test done, she haven't been to the doctor. Patient was not experiencing any problems afterwards. No Investigation Assessment. The adverse reactions started at 4 am 04:00 on the 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Limb discomfort
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 19:00 (Lot number: 40135BA) at the age of 36 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2, Lot Number: EH9889), administration date: 18Jan2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Lot number: EK4176), administration date: 22Dec2020, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Fever of over 102.00 degrees"; CHILLS (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Body aches"; ARTHRALGIA (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Joint pain"; HEADACHE (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Headaches"; VACCINATION SITE LYMPHADENOPATHY (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Large swollen lymph node under armpit of injection site"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Very sore arm"; LIMB DISCOMFORT (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Could not lift arm or support weight". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, arthralgia, headache, vaccination site lymphadenopathy, pain in extremity, and limb discomfort. Additional Information: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 19:00 (Lot number: 40135BA) at the age of 36 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2, Lot Number: EH9889), administration date: 18Jan2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Lot number: EK4176), administration date: 22Dec2020, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Fever of over 102.00 degrees"; CHILLS (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Body aches"; ARTHRALGIA (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Joint pain"; HEADACHE (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Headaches"; VACCINATION SITE LYMPHADENOPATHY (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Large swollen lymph node under armpit of injection site"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Very sore arm"; LIMB DISCOMFORT (non-serious) with onset 02Oct2021 05:00, outcome "recovering", described as "Could not lift arm or support weight". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, arthralgia, headache, vaccination site lymphadenopathy, pain in extremity, and limb discomfort. Additional Information: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Headache, Pyrexia
Clinical narrative: Fever; headache; chills; cough; chest discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 15:45 (Lot number: 30145BA) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "chills"; COUGH (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "cough"; CHEST DISCOMFORT (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "chest discomfort". The events "fever", "headache", "cough" and "chest discomfort" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache, chills, cough, chest discomfort.  No follow-up attempts are possible. No further information is expected.  Additional information: Fever, headache, chills, cough, chest discomfort. All lasting now 5 days. The vaccine was administered in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies. The patient had no other medical history. The patient received imaging as treatment for the adverse events. The device date was 03Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; headache; chills; cough; chest discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 15:45 (Lot number: 30145BA) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "chills"; COUGH (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "cough"; CHEST DISCOMFORT (non-serious) with onset 29Sep2021 20:00, outcome "not recovered", described as "chest discomfort". The events "fever", "headache", "cough" and "chest discomfort" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache, chills, cough, chest discomfort.  No follow-up attempts are possible. No further information is expected.  Additional information: Fever, headache, chills, cough, chest discomfort. All lasting now 5 days. The vaccine was administered in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies. The patient had no other medical history. The patient received imaging as treatment for the adverse events. The device date was 03Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gingival swelling, Headache, Menstruation delayed
Clinical narrative: No Menstrual yet (late); Vertigo; Dizziness; Headache; Tongue and gum swelling; gum swelling; Fever; Fever blisters in my mouth; Tiredness; Injection site pain (only w/the 1st doze); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 15:00 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "No Menstrual yet (late)"; VERTIGO (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Dizziness"; HEADACHE (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Headache"; SWOLLEN TONGUE (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Tongue and gum swelling"; GINGIVAL SWELLING (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "gum swelling"; PYREXIA (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Fever"; ORAL HERPES (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Fever blisters in my mouth"; FATIGUE (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Injection site pain (only w/the 1st doze)". Therapeutic measures were not taken as a result of menstruation delayed, vertigo, dizziness, headache, swollen tongue, gingival swelling, pyrexia, oral herpes, fatigue, vaccination site pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101303886 same reporter/patient/product, different dose/event.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia, Swollen tongue, Vaccination site pain, Vertigo
Clinical narrative: No Menstrual yet (late); Vertigo; Dizziness; Headache; Tongue and gum swelling; gum swelling; Fever; Fever blisters in my mouth; Tiredness; Injection site pain (only w/the 1st doze); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 15:00 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "No Menstrual yet (late)"; VERTIGO (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Dizziness"; HEADACHE (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Headache"; SWOLLEN TONGUE (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Tongue and gum swelling"; GINGIVAL SWELLING (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "gum swelling"; PYREXIA (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Fever"; ORAL HERPES (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Fever blisters in my mouth"; FATIGUE (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Injection site pain (only w/the 1st doze)". Therapeutic measures were not taken as a result of menstruation delayed, vertigo, dizziness, headache, swollen tongue, gingival swelling, pyrexia, oral herpes, fatigue, vaccination site pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101303886 same reporter/patient/product, different dose/event.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: 24 hrs later low grade fever 99.6; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 16:00 (Lot number: FF8841) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; ATORVASTATIN. Past drug history included: Sulfur, reaction(s): "known allergies: sulfur"; Relafen, reaction(s): "known allergies: relafen"; Flagyl, reaction(s): "known allergies: Flagyl". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 13Feb2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 8982, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Jan2021, when the patient was 77 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 03Oct2021 16:00, outcome "recovering", described as "24 hrs later low grade fever 99.6"; HEADACHE (non-serious) with onset 03Oct2021 16:00, outcome "recovering", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache. Additional information- It was reported that patient did not suffer from covid prior to vaccination and did not undergo covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: pain and swelling in below arm pit of arm shot was given; pain and swelling in below arm pit of arm shot was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 10:30 (Lot number: FF2587) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; PEPCID [FAMOTIDINE]; TRAZODONE; LIPITOR. Past drug history included: Morphine, reaction(s): "drug allergy"; Lisiniprol, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 05Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 12Feb2021, for Covid-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 02Oct2021 13:00, outcome "recovering" and all described as "pain and swelling in below arm pit of arm shot was given". Therapeutic measures were not taken as a result of axillary pain, swelling.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Erythema, Headache, Insomnia, Muscle tightness
Clinical narrative: Visible swelling noted; redness about 2 inches x 1 inch oval; Headache day after injection with myalgias esp hips and lower back; Headache day after injection with myalgias esp hips and lower back; Headache day after injection with myalgias esp hips and lower back; Left deltoid tightening felt immediately; Could not sleep on left side; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 09:15 (Lot number: EW0185) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CELEXA [CELECOXIB]; VITAMIN B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer, prev dose lot number=EL1284,, prev dose dose number=1, prev dose vaccine location: Left Arm), administration date: 30Dec2020, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer, prev dose lot number=EL9262,, prev dose dose number=2, prev dose vaccine location: Left Arm), administration date: 20Jan2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 01Oct2021 09:15, outcome "recovering", described as "Left deltoid tightening felt immediately"; SWELLING (non-serious) with onset 03Oct2021 09:15, outcome "recovering", described as "Visible swelling noted"; ERYTHEMA (non-serious) with onset 03Oct2021 09:15, outcome "recovering", described as "redness about 2 inches x 1 inch oval"; HEADACHE (non-serious), MYALGIA (non-serious), BACK PAIN (non-serious) all with onset 01Oct2021 09:15, outcome "recovering" and all described as "Headache day after injection with myalgias esp hips and lower back"; INSOMNIA (non-serious) with onset 01Oct2021, outcome "recovering", described as "Could not sleep on left side". Therapeutic measures were not taken as a result of muscle tightness, swelling, erythema, insomnia. Therapeutic measures were taken as a result of headache, myalgia, back pain.  Additional information: Left deltoid tightening felt immediately which was dissipated over the next few hours and then increased over the following 12-18 hours.  Patient could not lift elbow above shoulder level. Visible swelling noted 2 days after followed by redness about 2 inches x 1 inch oval. Headache day after injection with myalgias esp hips and lower back which was resolved with Aleve 400 mg. Headache improved 48h after injection.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Swelling
Clinical narrative: Visible swelling noted; redness about 2 inches x 1 inch oval; Headache day after injection with myalgias esp hips and lower back; Headache day after injection with myalgias esp hips and lower back; Headache day after injection with myalgias esp hips and lower back; Left deltoid tightening felt immediately; Could not sleep on left side; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 09:15 (Lot number: EW0185) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CELEXA [CELECOXIB]; VITAMIN B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer, prev dose lot number=EL1284,, prev dose dose number=1, prev dose vaccine location: Left Arm), administration date: 30Dec2020, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer, prev dose lot number=EL9262,, prev dose dose number=2, prev dose vaccine location: Left Arm), administration date: 20Jan2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 01Oct2021 09:15, outcome "recovering", described as "Left deltoid tightening felt immediately"; SWELLING (non-serious) with onset 03Oct2021 09:15, outcome "recovering", described as "Visible swelling noted"; ERYTHEMA (non-serious) with onset 03Oct2021 09:15, outcome "recovering", described as "redness about 2 inches x 1 inch oval"; HEADACHE (non-serious), MYALGIA (non-serious), BACK PAIN (non-serious) all with onset 01Oct2021 09:15, outcome "recovering" and all described as "Headache day after injection with myalgias esp hips and lower back"; INSOMNIA (non-serious) with onset 01Oct2021, outcome "recovering", described as "Could not sleep on left side". Therapeutic measures were not taken as a result of muscle tightness, swelling, erythema, insomnia. Therapeutic measures were taken as a result of headache, myalgia, back pain.  Additional information: Left deltoid tightening felt immediately which was dissipated over the next few hours and then increased over the following 12-18 hours.  Patient could not lift elbow above shoulder level. Visible swelling noted 2 days after followed by redness about 2 inches x 1 inch oval. Headache day after injection with myalgias esp hips and lower back which was resolved with Aleve 400 mg. Headache improved 48h after injection.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: headache; fever; chills; nausea; muscle and joint pain; muscle and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization, reaction(s): "Arthralgia", "Chills", "Fatigue", "Headache", "Myalgia", "Nausea", "Vomiting". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "unknown" and all described as "muscle and joint pain".  Additional information: 16hrs following administration of booster dose for COVID-19, the patient experienced headache, fever, chills, nausea, muscle and joint pain. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; fever; chills; nausea; muscle and joint pain; muscle and joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 immunization; Bnt162b2 (Dose:2), for Covid-19 immunization, reaction(s): "Arthralgia", "Chills", "Fatigue", "Headache", "Myalgia", "Nausea", "Vomiting". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "unknown" and all described as "muscle and joint pain".  Additional information: 16hrs following administration of booster dose for COVID-19, the patient experienced headache, fever, chills, nausea, muscle and joint pain. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.