chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lipids, Malaise
Clinical narrative: My chest is feeling like it's tightened itself; I am having a lot of trouble breathing; Headache; I am feeling little bit off; I don't feel well; This is a spontaneous report from a contactable consumer, the patient. A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 02Sep2021 (age at the time of vaccination 31-years-old), as a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date (age at the time of vaccination 31-years-old), as a single dose for COVID-19 immunization. On 02Sep2021, the patient experienced My chest is feeling like it's tightened itself, I am having a lot of trouble breathing, Headache, I am feeling little bit off, and I don't feel well. The patient took Excedrin for headache while patient did not receive any treatment for other events. The patient did not receive any other vaccine prior to 4 weeks of COVID Vaccine. The patient underwent lab tests and procedures which included blood cholesterol, blood glucose, blood iron and lipids which was great on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Tuberculin test
Clinical narrative: AWFUL ITCHY RASH AFTER 2ND SHOT; Severe all over the body rash; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old patient of unspecified gender received second dose of BNT162B2 (Pfizer-Biotech covid-19 vaccine, Solution for injection, Batch/lot number: FA7485) via an intramuscular route of administration, administrated into arm left on 07Aug2021 (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization at Pharmacy or Drug store. The patient medical history and concomitant were not reported. The patient previously took first dose of BNT162B2 (Pfizer-Biotech covid-19 vaccine, Solution for injection, Batch/lot number: FA7484) via an intramuscular route of administration, administrated into arm left on 17Jul2021 (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization and experienced arm soreness. On16Aug2021 the patient experienced awful itchy rash after 2nd shot, and 3weeks now all over the body. On 16 Jul2021 the patient underwent lab test and procedures which included TB Skin test, Tuberculin test and diagnosed with negative results on 19Jul2021 got read. Therapeutic measures were taken for the AE and treatment included with Zyrtec and Pepcid still no change after taken meds so on 14Sep2021 went to PRIVACY after patient tried self-care with everything didn't work so urgent care i go. Prednisone and hydroxyzine HCL have been given, when rash was getting somewhat better before taking these meds over and treated With Hazel, Equate, Triderma Psoriasis control, Ivarest Poison IVY itch cream, Eucerin Intensive repair lotion, Equate Baby oil gel, Equate 1% Hidrocortisone, hibiclens, olene zing cleaner, hydrocortisone cream 1%, hydrocortisone cream, Allergy, Lomalux eczema pill, Pepcid complete. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pruritus, Vaccination site inflammation
Clinical narrative: really tired; injection I got a big lump there; my arm hurts and it's itching; my arm hurts and it's itching; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 (age at the time of vaccination 64-years-old), as a single dose for covid-19 immunization. Medical history included, had allergic reactions, not to vaccines but to IV antibiotics, anaphylactic reaction, type 1 diabetes mellitus, and cardiac failure congestive, from an unknown date and unknown if ongoing. patient had a lot of underlying things. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization and experienced mild chill, little bit of body aches. Patient had her first dose of Pfizer Covid-19 Vaccine a month ago, and her second dose of Pfizer Covid-19 Vaccine a week ago today. After the first dose of Pfizer Covid-19 Vaccine she was fine, it doesn't matter, but she had a mild chill and a little bit of body aches for an hour and then she was good. After the second dose of Pfizer Covid-19 Vaccine she felt pretty good, just really tired at first, but no other symptoms for either first or second doses, not even arm pain. She has been feeling ok. On an unspecified date Aug2021, the patient experienced really tired, injection I got a big lump there, my arm hurts and it's itching. Caller's daughter is a nurse and said she hadn't heard of that with Pfizer Covid-19 Vaccine. Patient son was immunocompromised, and his physician ordered Covid antibody tests to see if it worked. It came back negative. was there any test that's recommended to see if it worked? Son was 30 years of age. He received both doses of product. Negative antibody test that the lab provides to see if you have been exposed to covid or have covid and created antibodies. Patient was told by the lab that it was not recommended. Special needs and immunocompromised patient, the antibody test came back negative. Patient sister had a different vaccine (Moderna) and she had a reaction "covid arm", rash red all the way down after the fact. Started yesterday out of the blue, day 6. Itching a bit. patient was allergic to everything, have had anaphylaxis to several important things. Symptom wise product seemed to be the best. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Follow-Up (11Oct2021): Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Really bad breaking out of her skin; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN (she does not have her card available at this time), Expiry Date: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 (about a month ago) (at the age of 63 years-old), as a single dose for COVID-19 immunization. The patient medical history (including any illness at time of vaccination) was none. No concomitant medications (other products) were reported. Family medical history relevant to adverse events was none. The report was not related to a study or programme. The vaccination facility type reported as grocery store. The vaccination facility address was unknown. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations was none. On an unspecified date in 2021, the day after she got the shot, patient experienced really bad breaking out of her skin (It has been about a month since she took the first covid vaccine). The patient was not visited to emergency room and physician office. No investigation assessment. No treatment was taken, she assumed that it would go away. It was reported that action taken with drug was unknown. Patient is due to receive the second vaccine, but she doesn't know if she should get it or not. Reporter (patient) questioned about the getting second vaccine. Reporter wants to know if there have been any reports of breaking out of the skin with the Pfizer COVID-19 vaccine. The outcome of event was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: body rash; had bumps all over; This is a spontaneous report from a contactable consumer (patient reporting for self). A 62-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Jul2021 at 12:00 (noon) as DOSE 1, SINGLE (at the age of 62-years-old) for covid-19 immunization. Medical history included vegetarian from an unknown date (She has been a vegetarian for 42 years). There were no concomitant medications. Patient did not take prior vaccination within 4 weeks. She got her first dose of the Pfizer COVID 19 vaccine. She has had a body rash since. She didn't know exactly when the rash started because it wasn't really itchy. She noticed it probably a week later. She had bumps all over. It went back in forth between improving and worsening both occurred on an unknown date in 2021. She wanted to know if rash had been reported in vegetarians, had bumps all over. Patient was wondering if there was something in the vaccine with extra protein that would cause a reaction in a vegetarian. She didn't have a prescribing doctor. Patient was scared for the second one because she didn't know if this was a reaction. She hasn't had any skin problems or rashes in her life and was pretty healthy. Events were not resulted in visiting of emergency or physician office. The outcome of the events was not recovered.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: loss of taste and sense of smell; loss of taste and sense of smell; This is a spontaneous report from a contactable other hcp.  A 14-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on 17Aug2021 (age at vaccination 14-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Aug2021, the patient experienced loss of taste and sense of smell. The patient was scheduled for 2nd dose of the vaccine on 07sep2021 whereas patient completed the ten days of quarantine. The clinical outcome of the event was unknown.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: some foods now taste like chemicals; Allergic reactions where none existed before/ new allergies keep popping up/ having allergies left and right, its like my body is in hyperactive state; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 29Sep2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient).  A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 10Feb2021 13:00 (Batch/Lot Number: EN5318) (at the age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history included polycythaemia vera from May2019 and ongoing, allergies: antihistamines, steroids, allergic to different meds, environmental allergy, and allergic to different foods (bananas taste like a weird sweet chemical and other food) from unknown dates and unknown if ongoing. Concomitant medications included probiotics and multivitamains  taken for an unspecifed indication, start and stop date were not reported.  Patient was not pregnant at time of vaccination. The vaccination was performed in a nursing home/ senior living facility. The patient had no prior vaccination received within 4 weeks prior to the COVID-19 vaccine. The patient previously took antihistamines and steroids and experienced allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19) intramuscular, administered in the left arm on 20Jan2021 11:00 (Batch/Lot Number: EL3249) (at the age of 50-years-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced nasal swab positive/ Covid test result: positive on 21Jan2021. On 28Mar2021, the patient experienced allergic reactions where none existed before/ new allergies keep popping up/ having allergies left and right, its like my body is in hyperactive state/ sudden onset of allergies On 29Mar2021, some foods now taste like chemicals. The patient reported within 4 weeks of 2nd dose of Pfizer vaccine, she had been having allergies left and right, its like her body was in hyperactive state. Even allergic to antihistamines, steroids and different meds and food. Allergist did not know what to do, she cannot take allergy shots, nothing. If she did not have allergic reactions to the food, different foods taste like chemical. Bananas taste like a weird sweet chemical and other food. The events were considered serious due to significant disability/ incapacity. The events required emergency room, physician's office visit, and treatment (had to see allergist, still had  no answers). The patient underwent nasal swab: positive on 21Jan2021 day after COVID 1st dose of vaccine. The outcome of the events was not recovered.  No Follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blister, Pain, Pruritus
Clinical narrative: get a sore; Pruritus; she has an ongoing blister that is filling up every time; weakness; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration in Deltoid Left on 02Sep2021 (age at the time of vaccination 55-years-old), as a 0.3 ml single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The Patient did not used other products. The Patient was not received other medications in two weeks. The patient was not received other vaccine in four weeks. The Patient was not diagnosed with COVID-19 prior vaccination and patient did not test COVID-19 post vaccination. It was mandatory patient taking COVID-19 vaccine. On 03Sep2021, the patient experienced pruritus, she has an ongoing blister that is filling up every time, weakness, and on an unspecified date get a sore. The caller has extensive side effects and has pictures of it. The caller was trying to report it online but decided to call and report it instead. The caller doesn't want to bust the blister on unspecified date she gets a sore. But the blister deflated yesterday and left drainage on the pillow. But if you leave it alone, it inflates again. The caller's body keeps feeding the blister water. The caller considers the event criteria as moderate seriousness. The Patient had not received treatment for events Pruritus, Ongoing blisters, weakness. The outcome for the events Pruritus, she has an ongoing blister that is filling up every time, weakness was not recovered, and event get a sore was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, Tendonitis
Clinical narrative: My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away.; My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away.; My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away.; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (age at the time of vaccination 54-years-old), as a single dose for covid-19 immunization. Medical history included glaucoma, allergy to Sulfa drugs, and COVID-19. There were no concomitant medications. The patient previously took historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 703-288), via an unspecified route of administration, administrated in Left arm on 06Jun2021 12:00 PM (age at the time of vaccination 54-years-old), as a single dose for covid-19 immunization and on 06Jun2021 06:00 PM patient experienced Weird Stinging sensation behind my right knee, high fever, and chills. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On an unspecified date, the patient experienced my second shot also had fever and chills, and greatly inflamed tendonitis in my elbow which also has yet to go away. On 28Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative, Nasal Swab. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: Muscle aches; Also ran a temperature and didn't feel good; Flu like symptoms; Also ran a temperature and didn't feel good; Muscle aches in his arm for 2-3 days, which kind of radiated up into his neck and back of head; This is a spontaneous report from a contactable consumer (parent). This is Report 3 of 3. A 20-years-old male patient received bnt162b2 ((PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Aug2021 12:00 (at the age of 20-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Neurofibromatosis (Verbatim: Neurofibromatosis, type 1 (von Recklinghausen's disease) diagnosed at 14 years old). There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0182) administered in left arm on 03Aug2021 11AM (at the age of 20-years-old) for covid-19 immunisation and patient experienced a dead arm in the injection arm, which was the right arm as reported. Could not lift arm because it hurt. Felt like was punched in the arm. Was continuous. It was reported that, second dose was administered a little over three weeks. On 26Aug2021, the patient experienced muscle aches in his arm for 2-3 days, which kind of radiated up into his neck and back of head. It was faded. Patient did break his arm in that area twice. Also ran a temperature and did not feel good. Felt Flu-ish or Flu-like symptoms on the same day. He never got sick. It was reported that all symptoms subsided in 48 hours. Outcome of events were recovered on an unspecified date in Aug2021.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye pruritus, Hypoaesthesia, Pain, Pruritus, Rash
Clinical narrative: is very painful; The numbness started on the right arm where I received the shot; The numbness started on the right arm where I received the shot , it started travelling to other parts of my body; I started having symptoms of rash; itchy skin and eyes; itchy skin and eyes; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced i started having symptoms of rash, itchy skin and eyes. On an 07Aug2021, the patient experienced is very painful, the numbness started on the right arm where i received the shot, it started travelling to other parts of my body. Reportedly, the patient received the first Pfizer Coved 19 shot 02Aug2021, less than a week later the patient started having symptoms of rash, itchy skin and eyes and then on the 5th day numbness, the numbness started on the right arm where the patient received the shot, it started traveling to other parts of the patient body and as of 5 weeks later, all numbness had not gone away and was located at 7 seven locations of the patient body and was very painful. The patient(s) General PC asked the patient to see the Neurologist. The patient needed help a little sooner than 27Sep. The outcome of the events I started having symptoms of rash, itchy skin and eyes was unknown. The outcome of the events is very painful, the numbness started on the right arm where i received the shot and it started travelling to other parts of my body and was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia
Clinical narrative: is very painful; The numbness started on the right arm where I received the shot; The numbness started on the right arm where I received the shot , it started travelling to other parts of my body; I started having symptoms of rash; itchy skin and eyes; itchy skin and eyes; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced i started having symptoms of rash, itchy skin and eyes. On an 07Aug2021, the patient experienced is very painful, the numbness started on the right arm where i received the shot, it started travelling to other parts of my body. Reportedly, the patient received the first Pfizer Coved 19 shot 02Aug2021, less than a week later the patient started having symptoms of rash, itchy skin and eyes and then on the 5th day numbness, the numbness started on the right arm where the patient received the shot, it started traveling to other parts of the patient body and as of 5 weeks later, all numbness had not gone away and was located at 7 seven locations of the patient body and was very painful. The patient(s) General PC asked the patient to see the Neurologist. The patient needed help a little sooner than 27Sep. The outcome of the events I started having symptoms of rash, itchy skin and eyes was unknown. The outcome of the events is very painful, the numbness started on the right arm where i received the shot and it started travelling to other parts of my body and was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: chills; body aches/ pain all over her body; congestion; sneezing; headache; ear pain; she has a lot of mucus; her throat hurts; This is a spontaneous report from a contactable consumer (parent). A 16-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 04Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on 07Aug2021 as dose 1, single for covid-19 immunisation. The caller reported that, the patient was supposed to get the second dose on 28Aug2021, however the patient received second dose until Saturday 04Sep2021. On Sunday (05Sep2021), the patient started having chills, body aches, pain all over her body, congestion, sneezing, headache and ear pain, she has a lot of mucus and her throat hurts. The caller took the patient to a clinic but came back because the waiting list was 2 hours. The outcome of all the events as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Sneezing
Clinical narrative: chills; body aches/ pain all over her body; congestion; sneezing; headache; ear pain; she has a lot of mucus; her throat hurts; This is a spontaneous report from a contactable consumer (parent). A 16-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 04Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on 07Aug2021 as dose 1, single for covid-19 immunisation. The caller reported that, the patient was supposed to get the second dose on 28Aug2021, however the patient received second dose until Saturday 04Sep2021. On Sunday (05Sep2021), the patient started having chills, body aches, pain all over her body, congestion, sneezing, headache and ear pain, she has a lot of mucus and her throat hurts. The caller took the patient to a clinic but came back because the waiting list was 2 hours. The outcome of all the events as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Renal pain, Tachycardia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient' medical history and concomitant medications not reported. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization and experienced high temperature/fevers. On an unspecified date, patient had discomfort in the right kidney and tachycardia. Reportedly, to date he continues to present these symptoms. He mentioned the pain in the kidney is frequent and greater; while tachycardias are also more frequent and particularly when he is in motion. The outcome of the events: not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high temperature fevers.; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown) via unknown route of administration on an unknown date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. After first dose of the vaccine, the patient developed high temperature fevers. The lab data included body temperature was high (high temperature fevers) on an unknown date. The outcome of the event was unknown.  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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nodule, Ocular hyperaemia, Swelling
Clinical narrative: develop 4 nodules with distinctive borders; swelling; redness under both eyes; lymphadenopathy bilateral jaw; This is a spontaneous report based on the information received by Pfizer from Facility (Reference Number: GL-082521-20503). This is a spontaneous report from a contactable physician. A 44-year-old female patient received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 2 via an unspecified route of administration on 05May2021 (at 44-years age) as dose 2, single for covid-19 immunisation and hyaluronic acid (RESTYLANE), via an unspecified route of administration from 09Jun2020 (Batch/Lot Number: 17327; Expiration Date: 31May2022) to an unspecified date, at 0.5 mL, via an unspecified route of administration from 31Jul2020 (Batch/Lot Number: 17327; Expiration Date: 31May2022) to an unspecified date, at 0.5 mL, via an unspecified route of administration from 02Mar2021 (Batch/Lot Number: 18439; Expiration Date: 31Mar2023) to an unspecified date, at 0.5 mL for an unspecified indication. Medical history included, had Versa to lips on 16Feb2021 with no issues. The patient's concomitant medications were not reported. Patient has not had any other vaccinations, illnesses, or dental procedures in the last 6-12 months. Patient previously received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on 14Apr2021 (at 44-years age) as dose 1, single for covid-19 immunisation. In Jun2021, patient reported that she started to develop 4 nodules with distinctive borders, swelling, redness under both eves, she lymphadenopathy bilateral jaw. HCP reported patient was seen in Urgent Care in the second week of August and prescribed 6 days prednisone taper. HCP reported the patient then presented to her on 17Aug2021 reporting no improvement with prednisone. HCP reported that she treated the patient with 900U hyaluronidase and Doxycycline. Nodules are 90% improved, still some swelling, redness and lymphadenopathy bilateral jaw but improving. She treated with another 600U hyaluronidase and another week of Doxycycline. Action taken for hyaluronic acid (RESTYLANE) was unknown. The outcome of the events was resolving.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Coordination abnormal, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: constantly dropping things; Pain in eyes; motor function was slightly impaired; Extremely tired/extremely exhausted; Pain in his body; Weak and brain fog; Weak and brain fog; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm left on 16Aug2021 at 16:00 (Lot Number: FC3181) as dose 2, single (at the age of 35 years old) for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 26Jul2021 at 04:00 PM (Lot number: FA7484) via intramuscular administered in left arm as dose 1 (at the age of 35 years old) for COVID-19 immunization. No other vaccine in two weeks and four weeks. No COVID prior vaccination and was not tested post vaccination. No known allergies. The patient experienced extremely tired still, pain in his body, weak, and brain fog on 16Aug2021 at 16:30. It was reported that after second (2nd) shot a month later (as reported), patient still wake up extremely exhausted. On 16Aug2021 at 18:00, reported that she constantly dropping things now which never happened before. Further reported that patient experienced pain in eyes, motor function was slightly impaired, stated playing basketball now his precision accuracy were way off on 16Aug2021 at 18:00. Asked on how much longer will that last. No treatment was provided. The outcome of the events was not recovered  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Motor dysfunction, Pain
Clinical narrative: constantly dropping things; Pain in eyes; motor function was slightly impaired; Extremely tired/extremely exhausted; Pain in his body; Weak and brain fog; Weak and brain fog; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm left on 16Aug2021 at 16:00 (Lot Number: FC3181) as dose 2, single (at the age of 35 years old) for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 26Jul2021 at 04:00 PM (Lot number: FA7484) via intramuscular administered in left arm as dose 1 (at the age of 35 years old) for COVID-19 immunization. No other vaccine in two weeks and four weeks. No COVID prior vaccination and was not tested post vaccination. No known allergies. The patient experienced extremely tired still, pain in his body, weak, and brain fog on 16Aug2021 at 16:30. It was reported that after second (2nd) shot a month later (as reported), patient still wake up extremely exhausted. On 16Aug2021 at 18:00, reported that she constantly dropping things now which never happened before. Further reported that patient experienced pain in eyes, motor function was slightly impaired, stated playing basketball now his precision accuracy were way off on 16Aug2021 at 18:00. Asked on how much longer will that last. No treatment was provided. The outcome of the events was not recovered  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Injection site irritation, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), on an unspecified date, single dose,  for COVID-19 immunization. The patient's  medical history and concomitant medications not reported. On an unknown date, patient wanted to know if coughing up from the lungs was natural. It started with a  runny nose and injection site irritation. "Was that common? Should I get the second one or was that going to put me in the hospital?" The outcome of event: unknown. Sender's comment: Reporter type could not be probed as consumer hung up the call abruptly, hence reporter type captured as consumer or non-healthcare professional by default. Follow-up (Oct 4, 2021): This is a spontaneous follow-up report. Phone answered by the consumer who stated she does not want to be contacted any further.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Maternal exposure during pregnancy, Myalgia, Pain in extremity
Clinical narrative: So, I am 34 weeks pregnant; arm hurt; When I touch it, it hurts. If I lay it hurts.; I feel like my body, like muscle pain; Flu; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 09Sep2021, patient took Pfizer vaccine, about a week ago. Patient was 34 weeks pregnant (further clarification unknown. Hence, tab not checked). On an unspecified date she reported, she did not had any side effect, it's just that her arm was hurting, and it two days and then it did stop. Her arm started hurting again and she felt like her body, like muscle pain, like she is getting a flu. When she touches it, it hurts. If she lay it hurts. Now she felt like she is coming down with the flu. The mother reported she became pregnant while taking bnt162b2. The mother was 34 Weeks pregnant at the onset of the event. The mother was due to deliver on 26Sep2021. Outcome of all the events was unknown.  No follow up attempts are needed. Information on batch/lot number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Dizziness, Feeling abnormal
Clinical narrative: lightheaded feeling; intense itching and crawling feeling; intense itching and crawling feeling; cold, headache developed; Chills; cold, headache developed; odd feeling; Throat got scratchy but did not close; Skin flushed; Allergic reaction; nausea; Joints ache; Cough; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years-old, intramuscular, administered in Arm Left on 14Sep2021 10:30 (Batch/Lot Number: FC3184) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 24Aug2021 10:30 (Batch/Lot Number: FC3184) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included ongoing hypothyroidism and high cholesterol from Nov2005, seasonal and sulfa allergies, pinched nerve on Aug2021, acid reflux from 1993, gastric sleeve from 2014, Gallbladder removal in 2013, Hysterectomy and appendectomy in Nov2005, has allergies to eggs, peanuts, tomatoes, wheat from Mar2019 and ongoing. The patient also had amoxicillin allergy. The patient had no family medical history. Concomitant medication included baclofen taken for pinched nerve, pain from 02Sep2021 and ongoing; omeprazole taken for acid reflux from 2006 and ongoing; citalopram taken for mood depression from 2009 and ongoing; ezetimibe taken for high cholesterol from 2015 and ongoing; amitriptyline taken for mood depression, neuropathy peripheral from 2009 and ongoing; levothyroxine sodium taken for hypothyroidism from 2005 and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergies from an unspecified start date and ongoing; naproxen taken for pinched nerve, pain from 02Sep2021 and ongoing. No other vaccine in four weeks. Within 5 min of getting the injection on 14Sep2021 10:35, he started with a lightheaded feeling, lips started itching which spread to whole body eye, palms, ears, everyplace intense, crazy itching and crawling feeling, cold, headache developed. She felt a chill or odd feeling wash over me a few times. It was 7pm and she still has itching and off/lightheaded feeling. She took 2 Benadryl and 2 Tylenol. She already had Zyrtec and Flonase in her system. She took Zyrtec the night before 25 mg Benedryl before shot, through the day she took 150 mg Benadryl. She also took Tylenol for headache that developed. Throat got scratchy but did not close. Skin on legs, arms, stomach flushed, no hives, had a little nausea (on 10:30), didn't vomit. Joints became achy within a few hours, stayed sore approximately 3 days. The patient has an allergic reaction, received multiple doses of Benadryl itched and coughed for 12 hours. Coughing started within an hour. The outcome of the event cough, chills, joints ache and allergic reaction was recovered while other events was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Formication, Headache, Hypersensitivity, Nasopharyngitis
Clinical narrative: lightheaded feeling; intense itching and crawling feeling; intense itching and crawling feeling; cold, headache developed; Chills; cold, headache developed; odd feeling; Throat got scratchy but did not close; Skin flushed; Allergic reaction; nausea; Joints ache; Cough; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years-old, intramuscular, administered in Arm Left on 14Sep2021 10:30 (Batch/Lot Number: FC3184) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 24Aug2021 10:30 (Batch/Lot Number: FC3184) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included ongoing hypothyroidism and high cholesterol from Nov2005, seasonal and sulfa allergies, pinched nerve on Aug2021, acid reflux from 1993, gastric sleeve from 2014, Gallbladder removal in 2013, Hysterectomy and appendectomy in Nov2005, has allergies to eggs, peanuts, tomatoes, wheat from Mar2019 and ongoing. The patient also had amoxicillin allergy. The patient had no family medical history. Concomitant medication included baclofen taken for pinched nerve, pain from 02Sep2021 and ongoing; omeprazole taken for acid reflux from 2006 and ongoing; citalopram taken for mood depression from 2009 and ongoing; ezetimibe taken for high cholesterol from 2015 and ongoing; amitriptyline taken for mood depression, neuropathy peripheral from 2009 and ongoing; levothyroxine sodium taken for hypothyroidism from 2005 and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergies from an unspecified start date and ongoing; naproxen taken for pinched nerve, pain from 02Sep2021 and ongoing. No other vaccine in four weeks. Within 5 min of getting the injection on 14Sep2021 10:35, he started with a lightheaded feeling, lips started itching which spread to whole body eye, palms, ears, everyplace intense, crazy itching and crawling feeling, cold, headache developed. She felt a chill or odd feeling wash over me a few times. It was 7pm and she still has itching and off/lightheaded feeling. She took 2 Benadryl and 2 Tylenol. She already had Zyrtec and Flonase in her system. She took Zyrtec the night before 25 mg Benedryl before shot, through the day she took 150 mg Benadryl. She also took Tylenol for headache that developed. Throat got scratchy but did not close. Skin on legs, arms, stomach flushed, no hives, had a little nausea (on 10:30), didn't vomit. Joints became achy within a few hours, stayed sore approximately 3 days. The patient has an allergic reaction, received multiple doses of Benadryl itched and coughed for 12 hours. Coughing started within an hour. The outcome of the event cough, chills, joints ache and allergic reaction was recovered while other events was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal discomfort, Pruritus
Clinical narrative: lightheaded feeling; intense itching and crawling feeling; intense itching and crawling feeling; cold, headache developed; Chills; cold, headache developed; odd feeling; Throat got scratchy but did not close; Skin flushed; Allergic reaction; nausea; Joints ache; Cough; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years-old, intramuscular, administered in Arm Left on 14Sep2021 10:30 (Batch/Lot Number: FC3184) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 24Aug2021 10:30 (Batch/Lot Number: FC3184) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included ongoing hypothyroidism and high cholesterol from Nov2005, seasonal and sulfa allergies, pinched nerve on Aug2021, acid reflux from 1993, gastric sleeve from 2014, Gallbladder removal in 2013, Hysterectomy and appendectomy in Nov2005, has allergies to eggs, peanuts, tomatoes, wheat from Mar2019 and ongoing. The patient also had amoxicillin allergy. The patient had no family medical history. Concomitant medication included baclofen taken for pinched nerve, pain from 02Sep2021 and ongoing; omeprazole taken for acid reflux from 2006 and ongoing; citalopram taken for mood depression from 2009 and ongoing; ezetimibe taken for high cholesterol from 2015 and ongoing; amitriptyline taken for mood depression, neuropathy peripheral from 2009 and ongoing; levothyroxine sodium taken for hypothyroidism from 2005 and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergies from an unspecified start date and ongoing; naproxen taken for pinched nerve, pain from 02Sep2021 and ongoing. No other vaccine in four weeks. Within 5 min of getting the injection on 14Sep2021 10:35, he started with a lightheaded feeling, lips started itching which spread to whole body eye, palms, ears, everyplace intense, crazy itching and crawling feeling, cold, headache developed. She felt a chill or odd feeling wash over me a few times. It was 7pm and she still has itching and off/lightheaded feeling. She took 2 Benadryl and 2 Tylenol. She already had Zyrtec and Flonase in her system. She took Zyrtec the night before 25 mg Benedryl before shot, through the day she took 150 mg Benadryl. She also took Tylenol for headache that developed. Throat got scratchy but did not close. Skin on legs, arms, stomach flushed, no hives, had a little nausea (on 10:30), didn't vomit. Joints became achy within a few hours, stayed sore approximately 3 days. The patient has an allergic reaction, received multiple doses of Benadryl itched and coughed for 12 hours. Coughing started within an hour. The outcome of the event cough, chills, joints ache and allergic reaction was recovered while other events was not recovered.    No follow-up attempts are needed. No further information is expected.