chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: swollen/painful left axillary lymph nodes and cervical lymph nodes; swollen/painful left axillary lymph nodes and cervical lymph nodes; Max temp 101F 24 hrs after receiving vaccine; bruising at injection site; muscle soreness; general fatigue; moderate-severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 13:30 (Lot number: FF8841) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Reynaud's Syndrome" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; ADDERALL. Vaccination history included: Bnt162b2 (Dose 2, Single, Lot number: EL3246, Dose administration time: 09:45AM, vaccine location: Left arm), administration date: 19Jan2021, when the patient was 27 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Single, Lot number: EK9231, dose administration time: 09:45AM, vaccine location: Left arm), administration date: 29Dec2020, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 07Oct2021 17:00, outcome "recovering" and all described as "swollen/painful left axillary lymph nodes and cervical lymph nodes"; PYREXIA (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "Max temp 101F 24 hrs after receiving vaccine"; VACCINATION SITE BRUISING (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "bruising at injection site"; MYALGIA (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "muscle soreness"; FATIGUE (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "general fatigue"; HEADACHE (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "moderate-severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain, pyrexia, vaccination site bruising, myalgia, fatigue, headache.  Additional information: The patient received AE treatment as Tylenol. Patient did not have covid prior vaccination and covid was tested post vaccination. The patient underwent Nasal swab test (PCR test) on 26Jan2021, 29Jan2021, 12Jul2021 and 15Jul2021 and tested negative each time.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Polymerase chain reaction, Pyrexia, Vaccination site bruising
Clinical narrative: swollen/painful left axillary lymph nodes and cervical lymph nodes; swollen/painful left axillary lymph nodes and cervical lymph nodes; Max temp 101F 24 hrs after receiving vaccine; bruising at injection site; muscle soreness; general fatigue; moderate-severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 13:30 (Lot number: FF8841) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Reynaud's Syndrome" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; ADDERALL. Vaccination history included: Bnt162b2 (Dose 2, Single, Lot number: EL3246, Dose administration time: 09:45AM, vaccine location: Left arm), administration date: 19Jan2021, when the patient was 27 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Single, Lot number: EK9231, dose administration time: 09:45AM, vaccine location: Left arm), administration date: 29Dec2020, when the patient was 27 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 07Oct2021 17:00, outcome "recovering" and all described as "swollen/painful left axillary lymph nodes and cervical lymph nodes"; PYREXIA (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "Max temp 101F 24 hrs after receiving vaccine"; VACCINATION SITE BRUISING (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "bruising at injection site"; MYALGIA (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "muscle soreness"; FATIGUE (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "general fatigue"; HEADACHE (non-serious) with onset 07Oct2021 17:00, outcome "recovering", described as "moderate-severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain, pyrexia, vaccination site bruising, myalgia, fatigue, headache.  Additional information: The patient received AE treatment as Tylenol. Patient did not have covid prior vaccination and covid was tested post vaccination. The patient underwent Nasal swab test (PCR test) on 26Jan2021, 29Jan2021, 12Jul2021 and 15Jul2021 and tested negative each time.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Myalgia, Pain
Clinical narrative: very lethargic; Severe body aches; chills; headache; muscle soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 13:30 (Lot number: FF2587) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Spinal stenosis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: LETHARGY (non-serious) with onset 10Oct2021, outcome "recovered" (Oct2021), described as "very lethargic"; PAIN (non-serious) with onset 10Oct2021, outcome "recovered" (Oct2021), described as "Severe body aches"; CHILLS (non-serious) with onset 10Oct2021, outcome "recovered" (Oct2021), described as "chills"; HEADACHE (non-serious) with onset 10Oct2021, outcome "recovered" (Oct2021), described as "headache"; MYALGIA (non-serious) with onset 10Oct2021, outcome "recovered" (Oct2021), described as "muscle soreness". Therapeutic measures were not taken as a result of lethargy, pain, chills, headache, myalgia.  Additional Information: The patient was not diagnosed with COVID-19, Prior to vaccination and Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Reported seriousness was non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Dyspnoea
Clinical narrative: Shortness of breath on day of shot. Next 2 days I had chest pains by my heart/left breast. Shortness of breath persisted until day of this report 12/9/21
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea, Vomiting
Clinical narrative: Received first Covid vaccine on 11/12/2021.  On 11/17/2021 he had to stay home from school sick with nausea, stomach pains, nausea, vomiting, and diarrhea.  The same thing happened again today, 12/9/2021 and his second dose was 12/3/2021.  I?ll report separately for the incident related to his second vaccine dose.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Mechanical urticaria
Clinical narrative: Dermatographia started 2 weeks after 3rd booster shot.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Musculoskeletal stiffness, Pain
Clinical narrative: bursitis, aches, and stiffness relieved with Advil 200 mg x 2 tab
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic dissection, Arteriogram coronary abnormal, Surgery
Clinical narrative: Aortic dissection, type A
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Loss of personal independence in daily activities, Nausea, Vaccine positive rechallenge
Clinical narrative: Received 2nd Covid vaccine on 12/3/2021.  On 12/9/2021 around 5pm, he got sick with nausea, stomach pains, nausea, vomiting, and diarrhea and is staying home from school on 12/10/2021..  The same exact  thing happened at 5am on 11/17/2021 and he had to stay home from school because of it and his first vaccine dose was on 11/12/2021.   I reported separately for the incident related to his first vaccine dose.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Received 2nd Covid vaccine on 12/3/2021.  On 12/9/2021 around 5pm, he got sick with nausea, stomach pains, nausea, vomiting, and diarrhea and is staying home from school on 12/10/2021..  The same exact  thing happened at 5am on 11/17/2021 and he had to stay home from school because of it and his first vaccine dose was on 11/12/2021.   I reported separately for the incident related to his first vaccine dose.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Breast discharge, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: I had swollen lymph nodes and pain that radiated down my left arm. This was for 2 days. On the third day the pain and swelling were gone but my right breast leaked clear discharge.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Smear cervix
Clinical narrative: I had swollen lymph nodes and pain that radiated down my left arm. This was for 2 days. On the third day the pain and swelling were gone but my right breast leaked clear discharge.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Morning after second dose, started with complaints of tummy aches and nausea at breakfast shortly before 8 am. It was looking a bit better. She asked for food around 10 am. From 2 pm on fever of 101F and vomiting. Vomiting stopped after about an hour. Fever went on until 11 pm. No medication given after discussing with nurse on the phone, who assured this was a possible side effect and Tylenol should only be given after keeping solid food down. Continued with broth for dinner around 7 pm, some soda for electrolytes and a banana an hour before bed. Next day with no fever or complaints but slept for 2 hours during the day, which is uncommon. Third day after complete recovery with no fatigue. No side effects observed after the first shot.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Tenderness
Clinical narrative: Tenderness and swelling in the right armpit, beginning 1-2 days after receiving my COVID booster shot. Possibly swollen lymph nodes. The symptoms are still ongoing. No redness at the site.    Also experienced fatigue and chills for the first two days after vaccination, which has now ended.   I was asymptomatic after my first COVID dose in 04/2021 and had fatigue and chills after my second COVID dose 2 weeks after, but no lymph node swelling.  I also received an annual flu shot at the time I received my COVID booster, but have never had symptoms after a flu shot in the past.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sleep disorder, Urticaria
Clinical narrative: Hives, all over, coming & going throughout the day. Itchiness - woken up in middle of night. Appx. 10 days
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 16.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Incorrect dose administered
Clinical narrative: 12/09/2021 Patient age 16 was scheduled to receive a second dose of Pfizer (0.3ml). The client received a pediatric dose of Pfizer(0.2ml) administered by a nurse at approximately 5:38 p.m. The Physician on duty nurse was notified and gave an order to administer half of the full dose of Pfizer to the client. The patient's parent's were made known of the error and wanted to continue to give the patient the additional dose of Pfizer.  The client received an additional 0.15ml of the full dose of Pfizer completing his series. The patient was observed for 30 minutes by a nurse. EMT with no adverse effects noted.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Cardiac flutter, Heart rate increased, Palpitations
Clinical narrative: Periodic feelings of having a fast-beating, fluttering, or pounding in center of chest. It happens several times a day. Symptoms started about a week ago.  No problem with breathing or chest pain. Also having some joint pain in fingers
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Delayed menstrual period
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: I was tired the first night. The next day every single muscle and joint in my muscle ached  all night and all the next day. Even my skin hurts. I also have a headache, nausea, and I ran a fever of 101.7° all day. I was shivering in addition to having night sweats
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain of skin, Pyrexia
Clinical narrative: I was tired the first night. The next day every single muscle and joint in my muscle ached  all night and all the next day. Even my skin hurts. I also have a headache, nausea, and I ran a fever of 101.7° all day. I was shivering in addition to having night sweats
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: A few minutes after receiving a second vaccination of pfizer covid vaccine, the patient became pale, white and her eyes rolled back and she fainted. She was momentarily passed out (unconscious) for approximately one minute. She also urinated in the immunization booth. I attended to her care and I shook her arms and I called her name. The mom was there and she shook the patient(her daughter) which woke her up. I applied ice packs to the patient's forehead and arms and her sit in relaxed position. I had her remove her jacket as she was dizzy and sweating a lot. After 10 minutes of applying the ice packs her skin color came back and she was acting normal without anymore symptoms. I monitored the patient for 20 more minutes and the mom said she was fine and they left the pharmacy area.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Urinary incontinence
Clinical narrative: A few minutes after receiving a second vaccination of pfizer covid vaccine, the patient became pale, white and her eyes rolled back and she fainted. She was momentarily passed out (unconscious) for approximately one minute. She also urinated in the immunization booth. I attended to her care and I shook her arms and I called her name. The mom was there and she shook the patient(her daughter) which woke her up. I applied ice packs to the patient's forehead and arms and her sit in relaxed position. I had her remove her jacket as she was dizzy and sweating a lot. After 10 minutes of applying the ice packs her skin color came back and she was acting normal without anymore symptoms. I monitored the patient for 20 more minutes and the mom said she was fine and they left the pharmacy area.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chest pain, Dizziness, Dyspnoea, Inflammation
Clinical narrative: Chest pain, inflammation of chest wall, lightheadedness, short of breath, stabbing pain between shoulder blades, tingling on left side of body and face
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Chest pain, inflammation of chest wall, lightheadedness, short of breath, stabbing pain between shoulder blades, tingling on left side of body and face
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation with rvr
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Gingival bleeding
Clinical narrative: nosebleed of unusual length of time (about one hour), unusual bleeding of gums
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Chest X-ray, Chest discomfort, Computerised tomogram head, Dizziness
Clinical narrative: I waited at the vaccine site for 15 min as instructed. Apx 5 min after leaving I began to feel lip tingling and light headed. I continued to drive home. Upon artiving at my home my symptoms worsened. Lightheaded, chest heaviness, violent tremor, mild headache began. I called y md and was instructed to call EMS & go to ER.. I was evaluated by EMS and told I was tachcardic and hypertensive. I was taken to ER. And arrived apx 2 hours after I had received vaccine . I was given IV steroids snd benedryl and valium for shaking.  I was tested for and ruled out for stroke, MI , pulmonary embolism.  I improved, but continued to have episodes of symptoms.  I was kept for 2 days of observation testing and treatment. I was discharged on medrol pack and xanax for shaking. I was instructed not to receive 2nd covid shot.  After discharge I experienced symptoms for over 3 months. I was seen by my md , cardiology, pulmonology and allergy after discharge . They all agreed that I should not take additional covid vaccines.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Headache, Hypertension, Incomplete course of vaccination
Clinical narrative: I waited at the vaccine site for 15 min as instructed. Apx 5 min after leaving I began to feel lip tingling and light headed. I continued to drive home. Upon artiving at my home my symptoms worsened. Lightheaded, chest heaviness, violent tremor, mild headache began. I called y md and was instructed to call EMS & go to ER.. I was evaluated by EMS and told I was tachcardic and hypertensive. I was taken to ER. And arrived apx 2 hours after I had received vaccine . I was given IV steroids snd benedryl and valium for shaking.  I was tested for and ruled out for stroke, MI , pulmonary embolism.  I improved, but continued to have episodes of symptoms.  I was kept for 2 days of observation testing and treatment. I was discharged on medrol pack and xanax for shaking. I was instructed not to receive 2nd covid shot.  After discharge I experienced symptoms for over 3 months. I was seen by my md , cardiology, pulmonology and allergy after discharge . They all agreed that I should not take additional covid vaccines.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Paraesthesia oral, Pulmonary function test, SARS-CoV-2 test, Tachycardia
Clinical narrative: I waited at the vaccine site for 15 min as instructed. Apx 5 min after leaving I began to feel lip tingling and light headed. I continued to drive home. Upon artiving at my home my symptoms worsened. Lightheaded, chest heaviness, violent tremor, mild headache began. I called y md and was instructed to call EMS & go to ER.. I was evaluated by EMS and told I was tachcardic and hypertensive. I was taken to ER. And arrived apx 2 hours after I had received vaccine . I was given IV steroids snd benedryl and valium for shaking.  I was tested for and ruled out for stroke, MI , pulmonary embolism.  I improved, but continued to have episodes of symptoms.  I was kept for 2 days of observation testing and treatment. I was discharged on medrol pack and xanax for shaking. I was instructed not to receive 2nd covid shot.  After discharge I experienced symptoms for over 3 months. I was seen by my md , cardiology, pulmonology and allergy after discharge . They all agreed that I should not take additional covid vaccines.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I waited at the vaccine site for 15 min as instructed. Apx 5 min after leaving I began to feel lip tingling and light headed. I continued to drive home. Upon artiving at my home my symptoms worsened. Lightheaded, chest heaviness, violent tremor, mild headache began. I called y md and was instructed to call EMS & go to ER.. I was evaluated by EMS and told I was tachcardic and hypertensive. I was taken to ER. And arrived apx 2 hours after I had received vaccine . I was given IV steroids snd benedryl and valium for shaking.  I was tested for and ruled out for stroke, MI , pulmonary embolism.  I improved, but continued to have episodes of symptoms.  I was kept for 2 days of observation testing and treatment. I was discharged on medrol pack and xanax for shaking. I was instructed not to receive 2nd covid shot.  After discharge I experienced symptoms for over 3 months. I was seen by my md , cardiology, pulmonology and allergy after discharge . They all agreed that I should not take additional covid vaccines.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac discomfort, Cardiac flutter, Discomfort, Pain, Palpitations
Clinical narrative: To date... Heart Palpitations: SEP 13*, 16*, 21, 30; OCT 19, 31; NOV 4, 16 Stinging+Pressure sensation in heart area: NOV 21, 22, 25, 27; DEC 7 * denotes an odd quivery buildup to flutter Each occurrence lasted no longer than a few minutes. Pain/discomfort present but not excruciating.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Immunisation, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: didn't feel well; she started running a fever again/Continues to run a fever of 101; sore throat/spastic/tickle in throat; stuffy nose/stuffiness in the nose; Cough; She recieved the Pfizer Covid 19 Vaccine Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation; Bnt162b2 (Second dose), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "didn't feel well"; PYREXIA (non-serious), outcome "not recovered", described as "she started running a fever again/Continues to run a fever of 101"; OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "sore throat/spastic/tickle in throat"; NASAL CONGESTION (non-serious), outcome "recovered", described as "stuffy nose/stuffiness in the nose "; COUGH (non-serious), outcome "unknown", described as "Cough"; IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "She recieved the Pfizer Covid 19 Vaccine Booster". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: further stated that She received the Pfizer Covid 19 Vaccine Booster about 1-2 weeks ago. Per caller with the first shot his wife developed a fever (100, 101) and malaise. The second vaccine was a little worst. Per caller his wife didn't feel well for about two days, the fourth day she was fine with no fever. After a week she started running a fever again with a sore throat and stuffy nose (sore throat and stuffy nose has went away). Continues to run a fever of 101. Per caller there is a respiratory infection going around in their area. he figured she has caught the virus goin around but it continued. His wife has received a dose of prednisone, several rapid covid test that have all been negative. She just had a PCR test sent out, waiting for results. She has had a fever for a week running about 101.5 to 102 since she got shot booster. When she got the first 2 doses initially she got a fever, felt lousy and had malaise but this fever was higher than the previous fevers. With the first 2 she was just lousy the first 2 days then fine. After this booster it's been now 9 days later, has a fever, tickle in the throat and etcetera. It has been a good week or so and she has continued to have the fever.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: didn't feel well; she started running a fever again/Continues to run a fever of 101; sore throat/spastic/tickle in throat; stuffy nose/stuffiness in the nose; Cough; She recieved the Pfizer Covid 19 Vaccine Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation; Bnt162b2 (Second dose), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "didn't feel well"; PYREXIA (non-serious), outcome "not recovered", described as "she started running a fever again/Continues to run a fever of 101"; OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "sore throat/spastic/tickle in throat"; NASAL CONGESTION (non-serious), outcome "recovered", described as "stuffy nose/stuffiness in the nose "; COUGH (non-serious), outcome "unknown", described as "Cough"; IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "She recieved the Pfizer Covid 19 Vaccine Booster". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: further stated that She received the Pfizer Covid 19 Vaccine Booster about 1-2 weeks ago. Per caller with the first shot his wife developed a fever (100, 101) and malaise. The second vaccine was a little worst. Per caller his wife didn't feel well for about two days, the fourth day she was fine with no fever. After a week she started running a fever again with a sore throat and stuffy nose (sore throat and stuffy nose has went away). Continues to run a fever of 101. Per caller there is a respiratory infection going around in their area. he figured she has caught the virus goin around but it continued. His wife has received a dose of prednisone, several rapid covid test that have all been negative. She just had a PCR test sent out, waiting for results. She has had a fever for a week running about 101.5 to 102 since she got shot booster. When she got the first 2 doses initially she got a fever, felt lousy and had malaise but this fever was higher than the previous fevers. With the first 2 she was just lousy the first 2 days then fine. After this booster it's been now 9 days later, has a fever, tickle in the throat and etcetera. It has been a good week or so and she has continued to have the fever.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Drug interaction, Dysstasia, Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: I got high dose flu vaccine and at the same time I got a Covid (Covid-19 Vaccine); I couldn't stand; I couldn't walk; I couldn't get off the floor and I didn't know if I could; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization; Bnt162b2 (Dose no: 2), for COVID-19 immunization. The following information was reported: DRUG INTERACTION (non-serious), outcome unknown, described as I got high dose flu vaccine and at the same time I got a Covid (Covid-19 Vaccine); DYSSTASIA (non-serious), outcome unknown, described as I couldn't stand; GAIT DISTURBANCE (non-serious), outcome unknown, described as I couldn't walk; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome unknown, described as I couldn't get off the floor and I didn't know if I could. The events i got high dose flu vaccine and at the same time i got a covid (covid-19 vaccine), i couldn't stand, i couldn't walk and i couldn't get off the floor and i didn't know if i could were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dysstasia, gait disturbance, loss of personal independence in daily activities.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (29Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness to hands and feet; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness to hands and feet".  Additional information: The reporter was a pharmacist calling on behalf of a female patient who reported having numbness to hands and feet for the last couple of months after receiving the Pfizer Covid vaccine series, the patients doctors could not figure out what it was. The patients questioned that if she should have the booster dose since she has had these side effects. The reporter did not have any additional information about the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Injection site erythema, Poor quality product administered, Product storage error
Clinical narrative: She mentioned that they have a vaccine for more than 14 hours.; She mentioned that they have a vaccine for more than 14 hours.; small red bump on injection site; Booster; This is a spontaneous report received from contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A 38-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Oct2021 11:18 (Lot number: 032F21A) 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 (First dose), for COVID-19 immunisation; Bnt162b2 (Second dose), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 31Oct2021 11:18, outcome "unknown", described as "Booster"; PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "She mentioned that they have a vaccine for more than 14 hours."; INJECTION SITE ERYTHEMA (non-serious) with onset 02Nov2021, outcome "unknown", described as "small red bump on injection site". It was unknown if therapeutic measures were taken as a result of injection site erythema.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Rash/redness on arm; Rash/redness on arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 82 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) 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: RASH (non-serious), ERYTHEMA (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "Rash/redness on arm". It was unknown if therapeutic measures were taken as a result of rash, erythema.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other vaccine in four weeks was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: he experienced gasping for air; his heart beating rapidly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 08Jul2021 16:00 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to antibiotics" (unspecified if ongoing), notes: Caller is allergic to antibiotics; "sulfates" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "allergic to are tetracycline"; Amoxicillin, reaction(s): "allergic to are  amoxicillin"; Ampicillin, reaction(s): "allergic to are ampicillin"; Erythromycin, reaction(s): "allergic to are Erythromycin". The following information was reported: DYSPNOEA (non-serious) with onset 08Jul2021, outcome "recovered" (09Jul2021), described as "he experienced gasping for air"; HEART RATE INCREASED (non-serious) with onset 08Jul2021, outcome "recovered" (09Jul2021), described as "his heart beating rapidly". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: History: Patient was allergic to antibiotics. He states there was nothing he could take that he was not allergic to. He specified antibiotics he was allergic to were tetracycline, amoxicillin, ampicillin, Erythromycin and sulfates. Patient did not have allergy to Keflex and Cipro max. He did not have NDC/lot/expiration to provide for tetracycline, amoxicillin, ampicillin, erythromycin and sulfates. Patient had not taken any of these medications in decades due to being allergic to the medication. The patient on the way home after receiving the first dose Pfizer Covid Vaccine, 30 minutes after receiving the first dose Pfizer Covid Vaccine, the patient was gasping for air and heart was beating rapidly. Gasping for air got better the next day. Heart beating rapidly was kind of, it wasn't very severe, it was on and off and on and off. Gasping for air and Heart beating rapidly went away after a day (09Jul2021), the next day after receiving the first dose Pfizer Covid Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pigmentation disorder, Vaccination site bruising, Vaccination site pain
Clinical narrative: white circle appeared around the injection site.; There is no pigment in my arm in that 1/2" diameter circle.; The soreness is the same as a bruise; The soreness is the same as a bruise; Dizziness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; AZITHROMYCIN. Past drug history included: Albuterol, reaction(s): "Known allergies: Albuterol"; Penicillin, reaction(s): "Known allergies: Penicillin"; Duricef, reaction(s): "Known allergies: Duricef"; Steroids, reaction(s): "Known allergies: Steriods". The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "white circle appeared around the injection site."; PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "There is no pigment in my arm in that 1/2" diameter circle."; VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious), outcome "unknown" and all described as "The soreness is the same as a bruise"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Additional information: Patient was not pregnant at the time of vaccination. Patient was not patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient neither diagnosed with covid-19 prior to vaccination nor after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: white circle appeared around the injection site.; There is no pigment in my arm in that 1/2" diameter circle.; The soreness is the same as a bruise; The soreness is the same as a bruise; Dizziness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; AZITHROMYCIN. Past drug history included: Albuterol, reaction(s): "Known allergies: Albuterol"; Penicillin, reaction(s): "Known allergies: Penicillin"; Duricef, reaction(s): "Known allergies: Duricef"; Steroids, reaction(s): "Known allergies: Steriods". The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "white circle appeared around the injection site."; PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "There is no pigment in my arm in that 1/2" diameter circle."; VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious), outcome "unknown" and all described as "The soreness is the same as a bruise"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Additional information: Patient was not pregnant at the time of vaccination. Patient was not patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient neither diagnosed with covid-19 prior to vaccination nor after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Mobility decreased, Pain in extremity
Clinical narrative: very deep sharp pain in my bones; My hands was so painful, I could not raise my hand; My hands was so painful, I could not raise my hand; my left finger specially the big one is very painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: BONE PAIN (non-serious), outcome "not recovered", described as "very deep sharp pain in my bones"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "not recovered" and all described as "My hands was so painful, I could not raise my hand"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my left finger specially the big one is very painful".  Additional information: The patient experienced a very deep sharp pain in my bones inside my body. Her hands was so painful, she could not raise her hand. Her left hand, left finger specially the big one is very painful, it has not even gone. The reporter stated that she just want to report the Pfizer vaccine side effect that she had when she had the vaccine. The reporter stated just planning to go to the hospital because the pain has not stopped.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Hypersensitivity
Clinical narrative: I can't get the second dose; I had allergic reaction/ My reaction started probably little bit at after the 15 minute more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: Verbatim: Overweight; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes; "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: Fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "I can't get the second dose"; HYPERSENSITIVITY (non-serious) with onset 26Oct2021, outcome "unknown", described as "I had allergic reaction/ My reaction started probably little bit at after the 15 minute more". Therapeutic measures were not taken as a result of hypersensitivity.  Clinical Course: Consumer stated, "I need to know if I am allergic to the Covid19 Vaccine because I had allergic reaction. What kind of proof do I need to show the people in the future that I can't get the second dose and was informed about the role of Pfizer Drug Safety and about Pfizer Medical Information for the concern and was provided the contact, Option 3, Monday to Friday, 8am-20:00pm. Consumer confirmed the product as first dose of Pfizer Covid19 Vaccine LOT.  "I can't find my vaccine card. It is probably in the car or something. I don't know where it is. I don't have it on hand. Weight: "Weight I don't know. I am about 277 or something. Other Medical Conditions: "A lot of things is wrong with me those are just the major ones." (Further clarification unknown) "My reaction started probably little bit at after the 15 minute more. What do you want to know? "When clarified, consumer stated, "withheld pharmacy." No, I didn't have other shots this year and don't have any of the information. The pharmacy will have all that. I went home, and I just waited that it would go away. "The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Parosmia, Vaccination site bruising
Clinical narrative: she started smelling sulfa/she is experiencing phantom smells; booster dose; Bruise on left arm where she received the vaccine; Phantom smells was reported as worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 15Oct2021 10:15 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: Bnt162b2 (First dose), administration date: 12Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Second dose), administration date: 26Mar2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: PAROSMIA (non-serious) with onset 24Oct2021, outcome "not recovered", described as "she started smelling sulfa/she is experiencing phantom smells"; VACCINATION SITE BRUISING (non-serious) with onset 2021, outcome "not recovered", described as "Bruise on left arm where she received the vaccine"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "Phantom smells was reported as worsened"; IMMUNISATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "booster dose". Therapeutic measures were not taken as a result of parosmia, vaccination site bruising.  Additional information: A few days to a week after patient started smelling sulfa. Patient bought a new puppy and thought he was passing gas but noticed she was still smelling it when he wasn't in the room. Patient asked others around her if they smelled it and no one else did. Phantom Smell that is smelled like sulfur, that's what it is the smell that sounds like sulfur that comes and goes 100's of times a day. Patient wanted to report her side effects that she experienced after receiving her Pfizer COVID-19 vaccine, purple cap booster dose."The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Swelling face
Clinical narrative: Facial swelling with lip swelling, first dose; Facial swelling with lip swelling, first dose; Rash on leg, first dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SWELLING FACE (non-serious), LIP SWELLING (non-serious) all with onset 22Oct2021, outcome "recovered" (31Oct2021) and all described as "Facial swelling with lip swelling, first dose"; RASH (non-serious) with onset 22Oct2021, outcome "recovered" (31Oct2021), described as "Rash on leg, first dose.".  Additional information- Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Adverse event facial swelling with lip swelling on 22Oct2021 around 10:30AM or 11:00AM after first dose. Rash on leg around 1 PM after first dose. Relevant Tests were none. Caller asks that she was due to get her second dose, and she has heard the second dose was more intense. Patient did not visit any emergency room and physician office due to adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.