chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Nausea, Night sweats
Clinical narrative: chills; warm; headache; nausea; sweat last night; fever; This is a spontaneous report from a contactable Nurse reporting on herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number:unknown) via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. the patient experienced chills, warm, headache, nausea, started to sweat last night, may have fever on an unspecified date. The patient wanted to know about taking second dose. The outcome of events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; warm; headache; nausea; sweat last night; fever; This is a spontaneous report from a contactable Nurse reporting on herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number:unknown) via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. the patient experienced chills, warm, headache, nausea, started to sweat last night, may have fever on an unspecified date. The patient wanted to know about taking second dose. The outcome of events were unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Computerised tomogram, Movement disorder, X-ray
Clinical narrative: sharp pain through the chest; difficulty to move; chest tightness; This is a spontaneous report from a contactable consumer (patient himself) of 38-year-old non pregnant female patient received the first dose of BNT162B2 (Solution for injection, lot number: EL9262, Expiration date; unknown), in the right arm on 02Feb2021, 02:00 PM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not having known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on any other medications. On 05Feb2021 third day of vaccine patient experienced to had sharp pain through the chest and difficulty to move. Visited emergency room to done x ray and CT scans after this there was chest tightness already 5th day. The patient taking treatment Naproxen taken for all events. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Hurt a little bit after the 1st dose. Doubting if she had been vaccinated correctly.; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation.  The patient medical history was not reported and concomitant medications were not reported.  The patient experienced hurt a little bit after the 1st dose. doubting if she had been vaccinated correctly on an unspecified date. The caller mentioned that she received the first dose of the vaccine last thursday and was concerned because she did not feel anything and that the injection was too fast and did not hurt. She was expecting to have side effects because her son and granddaughters experienced chills and fevers after their shots. She was observing herself last friday and today and observed nothing but a little hurt in Feb 2021. She mentioned that the injection only slightly touched her skin and she didn't feel anything. She is worried and nervous because she doubts that she was properly vaccinated. She was scheduled to have her second dose on 25Feb2021.The outcome of event was unknown. Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a contactable consumer reported for a male patient (father) that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration from 08Feb201 to 08Feb2021 at single dose (dose number 1) for covid-19 immunisation. Patient's medical history and concomitant therapy was not reported. As per verbatim and Event Description the caller's father tested positive before getting the 2nd dose. The outcome of event was unknown.   Information on the Lot/Batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Localised infection
Clinical narrative: it was surgically removed 2 days ago it looks like the infected; This is a spontaneous report from a Pfizer-sponsored program. A contactable unspecified age of male consumer reported that for himself that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had a glass on his legs, and it was surgically removed 2 days ago it looks like the infected. The patient took antibiotics by his doctor. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Paraesthesia
Clinical narrative: Pain heightened; limbs she feels a little tingle/tingle in her face/face tingling; in her face, there is the warmth; This is a spontaneous report from a contactable consumer (patient).   A 38-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:01 (Batch/Lot Number: EN6281), at the age of 38-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included ongoing Low blood pressure, she has this about 8 months, ongoing impaired Gastroparesis,had this about 2 years and takes medication for it,  nerve damage in her stomach also, it is to stop abdominal cramping . Concomitant medications included amitriptyline taken for nerve injury, abdominal pain from 29Jan2021 and ongoing. The patient said she had a nerve damage before getting the COVID vaccine shot. She noticed that after getting the first dose of the vaccine the pain heightened, wanting to know if we have information regarding this. She feels the shot has exacerbated the feeling. In her limbs, she feels a little tingle and in her face, there is the warmth she associates with the nerve damage. She is wondering if this is this something we have seen happen. The caller confirms that the first dose was given at 9:01am. The tingling started about 5-10 minutes after the dose was given. It is basically in the face, that is where she notices it the most. The prior nerve damage is on her right side from the top of head to her hip. She explains that right now she mostly noticed in the face tingling and it is about the same since it started. In her legs, they was a little tingle when walking out, after the 15 minutes. This was in both legs and it is still there but she doesn't notice this as much since she has just been sitting there. The outcome of the events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: first dose of the Pfizer COVID-19 vaccine on 21Jan2021 However, she tested positive for COVID-19 on 01Feb2021; This is a spontaneous report from a contactable other Healthcare professional. This 31-years-old female female other Healthcare professional(patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of admin-istration on 21Jan2021 03:00 (Batch/Lot Number: EL9262) as single dose for covid-19 immunization.The patient's medical history  and concomitant medications were not reported.  She stated that she had the first round of the vaccine on 21Jan2021 and then she tested positive for COVID 01Feb2021. She is due to get her second dose tomorrow. She already has the appointment sched-uled for tomorrow and wants to know if it is safe for her to get. She read online that she should wait 90 days; somewhere else online she read to wait for 2 weeks. She contacted her PCP and the PCP does not know. The PCP directed the reporter to call us to get our opinion. She tried to do her own research online, but got no where. Caller also added, her testing positive from COVID, she does not believe it is from the vaccine. The patient underwent lab tests and procedures which in-cluded s COVIDars-cov-2 test: positive on 01Feb2021.  The outcome of the event was unknown
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: in between doses he tested positive for Covid-19; In between doses he tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). A 81-year-old-male patient received BNT162B2 (Pfizer-Biontech covid-19 vaccine, formulation: solution for injection, Batch/Lot number not provided) first dose via an unspecified route of administration on 26Jan2021 and the second dose on 17Feb2021 as single dose for COVID-19 immunization. On an unknown date, the patient underwent lab tests and procedures which included sars-cov-2 test: positive, he's almost done with quarantine, he also received an infusion for antibodies. The patient medical history and concomitant medications were not reported. The study excluded participants who had previous clinical or microbiological diagnosis of COVID-19 LAB-1457-5.0. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Vaccination site pain
Clinical narrative: she got up this morning her arm hurt; she had difficulty moving it; arm goes numb at injection site/it intermittently lost feeling; This is a spontaneous report from a contactable consumer (patient).  A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 10Feb2021 (Batch/Lot Number: E18982) as single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient reported that she got her first covid vaccination yesterday (10Feb2021) and when she got up this morning (11Feb2021), her arm hurt, she had difficulty moving it and it intermittently lost feeling and then it would come back. She has been icing it and she knows it is supposed to be kind of sore, but states every so often her arm goes numb where she got the injection and asked if it was normal. Therapeutic measures were taken as a result of arm goes numb at injection site/it intermittently lost feeling. The patient did not recover from arm goes numb at injection site/it intermittently lost feeling, while the outcome of the other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: if she can take the second dose after getting covid after first dose.; This is a spontaneous report from Pfizer-sponsored program. A contactable female patient of an unspecified age received of first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication were not reported. The patient observed that took covid vaccine the same time she had Covid. Inquiring if she can take the second dose after getting covid after first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive after first covid vaccine dose/Positive test for COVID/tested positive; testing positive after first covid vaccine dose/Positive test for COVID/tested positive; This is a spontaneous report.  A contactable nurse reported that a 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Expiration date: unknown), via an unspecified route of administration in left arm at the age of 73-year-year on 22Jan2021 at 11:30 am at a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, prostate cancer, and prediabetic. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were none. It was reported that the patient got the first dose on 22Jan2021. He is due for the second dose on the 12Feb2021 but last week he had positive test for COVID. He tested positive on 04Feb2021. The patient underwent lab tests and procedures which included PCR test on 04Feb2021: positive (PCR test done for positive COVID results). No treatment was given for the event positive test for COVID. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Patient felt culled and revise after shot; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Feb2021. The patient experienced tested positive for COVID (sars-cov-2 test positive), patient felt culled and revise after shot (feeling abnormal) (non-serious) on 02Feb2021. The outcome of events were unknown.   No follow up attempts are possible. Information about Lot and batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Paraesthesia, Pruritus, Urinary tract infection
Clinical narrative: Itchiness; Diagnosed with UTI; Tingly; Chills; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer sponsored program. A 79-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration and unspecified date as an single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Due for the 2nd shot tomorrow. Patient diagnosed with urinary tract infection, itchiness after the 1st dose, little sore on the first day, little itchy and tingly all over with some chills. Patient second Pfizer COVID vaccine tomorrow on 09Feb2021. She is just diagnosed with a light case of UTI with a temperature of 97F and no fever. Cephalexin given as a treatment for UTI. The patient underwent lab tests and procedures which included body temperature was 97 Fahrenheit. On an unspecified date, the events were resolved and outcome of the event UTI was unknown.  Information about batch/lot number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: sore and achy all over; headache; sore arm at injection site; soreness and achiness progressed; This is a spontaneous report from a contactable consumer. A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:45 at single dose for covid-19 immunization. The patient medical history was not reported. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via an unspecified route of administration, administered in Arm Right on 21Jan2021 09:45 at single dose for covid-19 immunization. Concomitant medications included loratadine (ALAVERT) taken for an unspecified indication and melaleuca multivitamins/minerals. As per adverse event description, on 11Feb2021 18:00, sore and achy all over, headache, sore arm at injection site, but not right away, it took until the evening the same day as the 2nd injection. The soreness and achiness progressed a bit more from the evening into the morning, today. I felt nothing at all after the first injection. The patient did not received treatment. Upon follow up, it was confirmed that he mentioned that he noticed the onset on 11Feb2021 at around 6 pm, the start of it, but then felt the symptoms increase into the night and then more so the next morning on 12Feb2021. The outcome of events not recovered.  No follow-up attempts are possible. No further information was provided.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: fever; chills; headache; nausea; dizziness; This is a spontaneous report from a contactable nurse, the patient (reported in response to the HCP letter sent in cross reference case). A 55 years old female patient received the second dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine; Lot number: EK9231) intramuscularly on left arm on 19Jan2021 at 08:00 as a single dose for COVID-19 immunization in a hospital. Medical history included asthma, pericarditis, angina, hypertension and ulcerative colitis. Family medical history included diabetes, hypertension and cardiac stroke. Concomitant medication included Motrin 600 mg PO (per oral) on 30Dec2020 started in day2 of 1st vaccine and continued to present. Historical vaccine included first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine; Lot number: EH9899 on right arm on 29Dec2020 at 08:20) which led to headache, nausea, dryness, body ache to present on 29Dec2020 at 08:20 and received Panic injection at x 6 days. Both the doses were 21 days apart. On 19Jan2021 at 08:00, patient had intermittent headache, nausea, dizziness continuous present. Fever and chills x 2days. Covid 19 vaccine cause headache on day 2 and continued intermittent 1x to present. Also associated with nausea and dizziness. Patient was not admitted to hospital. Patient was unable to watch for few days. Taking pain meds to manage headache. Other than going to work, home is lied feeling unwell. Outcome of the events was not recovered. There is a reasonable possibility that the event is related to suspect product (EK9231).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder aches; This is a spontaneous report received from a contactable consumer (Patient) as part of Pfizer-sponsored program. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route on 08Feb2021 as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date, next day of vaccination, the patient experienced shoulder aches and wanted to take Ibuprofen. The Outcome of event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive covid test after vaccine; This is a spontaneous report from a Pfizer Sponsored program . An unspecified age of male patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 25Jan2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that on 25Jan2021 was first dose of covid vaccine, had positive covid test on 31Jan2021, second dose is scheduled for 15Feb2021. He is wondering if it is okay to receive the second dose of the vaccine. Read ISI, cold transfer to Drug and Safety, long hold time, AE`/PCOM for positive covid test after vaccine faxed to Pfizer CEP 2191  Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Pain in extremity, Weight
Clinical narrative: Sore arm for a day after; This is a spontaneous report from a Contactable Consumer (patient's wife). A 50-year-old male patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 27Jan2021 at single dose for covid-19 immunization. Her husband takes no medications. He has no medical history or conditions. He has no allergies at all. It was reported that She thought she would report some side effects after one shot of the Pfizer COVID19 Vaccine. It is strange. She didn't read the symptoms until seven days out. Then she saw some have reported a lot less. After the shot, that night she had swelling in her upper chest. She thinks it was lymph nodes in the breast and chest area on the side she got the shot. The next day her arm that she got the vaccine in got very large. Then, she doesn't know if it was related, two days later she had itching on both of her feet. It was the tops of her feet and only for a couple of days. She is not counting that. Day five after the shot has been the main problem. Her arm pits started itching like crazy. It was severe itching and swelling in her arm pits. The itching lasted for three to four days. The lymph nodes in her arm are still swollen. It was five days after the shot. It is both arm pits. The night of the shot she had a lot of neck pain and she thinks it was probably the lymph nodes in the back of her neck. That has lasted and is slowly diminishing. Height six-foot one inch or six foot two inches. Weight 225 to 230 pounds. He is not obese, but a big guy. There was an agency for assisted living for people that need help. They were giving it and had extra doses. This guy in charge at the assisted living house offered it to caller and caller's husband because her and her husband run a behavior health counseling. He offered it to them as healthcare professionals. Her husband got it at the same time and didn't even have a sore arm. Caller clarified that he did have a sore arm for a day after. It didn't swell up. The outcome of the event was "Unknown".  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Mucosal dryness
Clinical narrative: Dry mouth; mucosal dryness in mouth; This is a spontaneous report from a Contactable pharmacist. A unspecified  age female patient received the first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration date unknown), via an unspecified route of administration, on 16Jan2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient experienced Dry mouth, mucosal dryness in their mouths. The outcome of event was unknown.  Information on the lot/ batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130811 same reporter/ drug ,different event/patient
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: had platelet count of 116,000; This is a spontaneous report from a contactable physician (patient). This report was received via a Pfizer sales representative. A 62-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient has no underlying conditions and has no current medications. The patient had platelet count of 116,000 on 08Feb2021 with outcome of unknown. The patient was scheduled for a surgical procedure on 17Mar2021. In the course of pre op labs, 08Feb2021, had platelet count of 116,000. This is 3 weeks after having first COVID 19 vaccine. No history of platelet disorders; have always had normal count of 180,000 - 200,000. Concerned about the possibility of there being a connection between vaccine and platelet dropping having had the second vaccine prior to surgical procedure. The patient received dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; cough; colds; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration on 21Jan2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant were not reported. Patient stated on 23Jan2021 patient got colds and cough, tested positive for COVID-19 on 26Jan2021 after getting the first dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoacusis, Hypoaesthesia, Restless legs syndrome
Clinical narrative: Restless legs; Reaction with her legs; Burning of my legs/my legs feels like they are hot; I am having a sort of numbness feeling in my legs/I am experiencing a sort of numbnessin my legs, in my legs in the muscles; hard of hearing; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: EL8982) both as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced restless, reaction with her legs, burning of legs/ legs feels like they are hot, sort of numbness feeling in legs/ legs in the muscles, hard of hearing. Therapeutic measures were taken because of restless legs which included over the counter drugs. Patient's lab data was not reported. Outcome of the events was not reported.   When requested for probing, Reporter stated, "No." Further probing could not be done as reporter don't want to share further information. Hence, limited information was available over the call.  Follow-up activities have been completed and no further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Gait disturbance, Pain in extremity, Pruritus
Clinical narrative: My arm is pretty warm and itched quite a lot; My arm is pretty warm and itched quite a lot; My knees have bothered me, my legs have bothered me quite a bit; My knees have bothered me, my legs have bothered me quite a bit; It is hard for me to walk since I got the shot; This is a spontaneous report from a contactable 89-year-old female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EM9809, Expiration date: 30Jun2021), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunization. The patient relevant medical history included diabetes mellitus. Concomitant medications were not reported. On an unknown date, the patient experienced her arm was pretty warm and itched quite a lot, her knees have bothered her, and her legs have bothered her quite a bit. It was hard for her to walk since she got the shot. It reacts a little bit in the arm of older people. The patient did not take treatment for the events. The outcome of the events was unknown.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Condition aggravated, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Failing health since vaccine; she does not want to eat; She slept probably five hours during the day; She got up and she does not want to eat, she took a nap, she changed chairs and she took a nap; Her health has declined each day; She has more fatigue every day; In constant pain; Lost 20 LBS.; became weak and lightheaded; became weak and lightheaded; her immune system began to shut down; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 26Mar2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 04Feb2021 at 12:30 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. Medical history included ongoing diabetes, arthritis and thyroid, all three for 10 plus years; and bladder. Concomitant medication included ongoing methotrexate and meloxicam taken for arthritis; metformin taken for diabetes; mirabegron taken for bladder; and levothyroxine taken for thyroid, all from an unspecified start date and ongoing. The patient received the vaccine on 04Feb2021 (reported as last Thursday afternoon) and everyday since then her health has declined each day. She has more fatigue every day and lightheaded. Her immune system began to shut down (several blood draws taken). She just wanted little afternoon nap. On Saturday, she wanted to do very little 'aero' (word not clear), very little just the minimum. She get up, she had a little breakfast, and as I live near a little pond, she watched the water and birds. And then yesterday, she slept probably five hours during the day and today that is all she has done, she got up and she does not want to eat, she took a nap, she changed chairs and she took a nap. She is now in her bedroom and taking another nap and this is not my mother. The patient was still alive but in failing health since the vaccine. The patient is now bedridden, lost 20 pounds (lbs) and was in constant pain. The patient was fine, walking and even dancing prior to vaccine.  The outcome of the events "Her health has declined each day" was not recovered while unknown for the other events. The patient died from vaccine on 15Mar2021. The autopsy was not done.  Follow-Up (02Apr2021): Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Failing health since vaccine
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: General physical health deterioration, Immune system disorder, Pain, Somnolence, Weight decreased
Clinical narrative: Failing health since vaccine; she does not want to eat; She slept probably five hours during the day; She got up and she does not want to eat, she took a nap, she changed chairs and she took a nap; Her health has declined each day; She has more fatigue every day; In constant pain; Lost 20 LBS.; became weak and lightheaded; became weak and lightheaded; her immune system began to shut down; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 26Mar2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 04Feb2021 at 12:30 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. Medical history included ongoing diabetes, arthritis and thyroid, all three for 10 plus years; and bladder. Concomitant medication included ongoing methotrexate and meloxicam taken for arthritis; metformin taken for diabetes; mirabegron taken for bladder; and levothyroxine taken for thyroid, all from an unspecified start date and ongoing. The patient received the vaccine on 04Feb2021 (reported as last Thursday afternoon) and everyday since then her health has declined each day. She has more fatigue every day and lightheaded. Her immune system began to shut down (several blood draws taken). She just wanted little afternoon nap. On Saturday, she wanted to do very little 'aero' (word not clear), very little just the minimum. She get up, she had a little breakfast, and as I live near a little pond, she watched the water and birds. And then yesterday, she slept probably five hours during the day and today that is all she has done, she got up and she does not want to eat, she took a nap, she changed chairs and she took a nap. She is now in her bedroom and taking another nap and this is not my mother. The patient was still alive but in failing health since the vaccine. The patient is now bedridden, lost 20 pounds (lbs) and was in constant pain. The patient was fine, walking and even dancing prior to vaccine.  The outcome of the events "Her health has declined each day" was not recovered while unknown for the other events. The patient died from vaccine on 15Mar2021. The autopsy was not done.  Follow-Up (02Apr2021): Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Failing health since vaccine
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Capillary fragility, Death, Hypersomnia, Hypophagia, Laboratory test abnormal
Clinical narrative: Failing health since vaccine; she does not want to eat; She slept probably five hours during the day; She got up and she does not want to eat, she took a nap, she changed chairs and she took a nap; Her health has declined each day; She has more fatigue every day; In constant pain; Lost 20 LBS.; became weak and lightheaded; became weak and lightheaded; her immune system began to shut down; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 26Mar2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 04Feb2021 at 12:30 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. Medical history included ongoing diabetes, arthritis and thyroid, all three for 10 plus years; and bladder. Concomitant medication included ongoing methotrexate and meloxicam taken for arthritis; metformin taken for diabetes; mirabegron taken for bladder; and levothyroxine taken for thyroid, all from an unspecified start date and ongoing. The patient received the vaccine on 04Feb2021 (reported as last Thursday afternoon) and everyday since then her health has declined each day. She has more fatigue every day and lightheaded. Her immune system began to shut down (several blood draws taken). She just wanted little afternoon nap. On Saturday, she wanted to do very little 'aero' (word not clear), very little just the minimum. She get up, she had a little breakfast, and as I live near a little pond, she watched the water and birds. And then yesterday, she slept probably five hours during the day and today that is all she has done, she got up and she does not want to eat, she took a nap, she changed chairs and she took a nap. She is now in her bedroom and taking another nap and this is not my mother. The patient was still alive but in failing health since the vaccine. The patient is now bedridden, lost 20 pounds (lbs) and was in constant pain. The patient was fine, walking and even dancing prior to vaccine.  The outcome of the events "Her health has declined each day" was not recovered while unknown for the other events. The patient died from vaccine on 15Mar2021. The autopsy was not done.  Follow-Up (02Apr2021): Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Failing health since vaccine
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Stomatitis, Tongue geographic
Clinical narrative: Failing health since vaccine; she does not want to eat; She slept probably five hours during the day; She got up and she does not want to eat, she took a nap, she changed chairs and she took a nap; Her health has declined each day; She has more fatigue every day; In constant pain; Lost 20 LBS.; became weak and lightheaded; became weak and lightheaded; her immune system began to shut down; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 26Mar2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 04Feb2021 at 12:30 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. Medical history included ongoing diabetes, arthritis and thyroid, all three for 10 plus years; and bladder. Concomitant medication included ongoing methotrexate and meloxicam taken for arthritis; metformin taken for diabetes; mirabegron taken for bladder; and levothyroxine taken for thyroid, all from an unspecified start date and ongoing. The patient received the vaccine on 04Feb2021 (reported as last Thursday afternoon) and everyday since then her health has declined each day. She has more fatigue every day and lightheaded. Her immune system began to shut down (several blood draws taken). She just wanted little afternoon nap. On Saturday, she wanted to do very little 'aero' (word not clear), very little just the minimum. She get up, she had a little breakfast, and as I live near a little pond, she watched the water and birds. And then yesterday, she slept probably five hours during the day and today that is all she has done, she got up and she does not want to eat, she took a nap, she changed chairs and she took a nap. She is now in her bedroom and taking another nap and this is not my mother. The patient was still alive but in failing health since the vaccine. The patient is now bedridden, lost 20 pounds (lbs) and was in constant pain. The patient was fine, walking and even dancing prior to vaccine.  The outcome of the events "Her health has declined each day" was not recovered while unknown for the other events. The patient died from vaccine on 15Mar2021. The autopsy was not done.  Follow-Up (02Apr2021): Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Failing health since vaccine
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: fatigue; Muscle aches; headache; sore throat; chills; low grade fever; This is a spontaneous report from a contactable consumer. A 47-year-old female consumer received second dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: EM9810) via an unspecified route of administration on Left arm on 09Feb2021 at 04:00 PM for COVID-19 immunization. Medical history included uterine tumors. Patient had no known allergies. Concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, lot number: EL3247 at 04:00 PM on Left arm) and experienced muscle ache on injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 10Feb2021 at 06:00 AM, patient experienced muscle aches, headache, sore throat, chills, low grade fever and fatigue. No treatment was provided for the events. Outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue; Muscle aches; headache; sore throat; chills; low grade fever; This is a spontaneous report from a contactable consumer. A 47-year-old female consumer received second dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: EM9810) via an unspecified route of administration on Left arm on 09Feb2021 at 04:00 PM for COVID-19 immunization. Medical history included uterine tumors. Patient had no known allergies. Concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, lot number: EL3247 at 04:00 PM on Left arm) and experienced muscle ache on injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 10Feb2021 at 06:00 AM, patient experienced muscle aches, headache, sore throat, chills, low grade fever and fatigue. No treatment was provided for the events. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Got Corona virus vaccine and I came up positive; This is a spontaneous report from a contactable consumer reported for an unspecified age of female patient (mom) that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9265), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was no reported. Concomitant medications included dexamethasone and azithromycin. On 08Feb2021, she came up positive. The patient did not take treatment for the event. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: after receiving their vaccine, they have contracted the Covid-19 infection; after receiving their vaccine, they have contracted the Covid-19 infection; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving their vaccine, the patient experienced contracted with the covid-19 infection an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: they have contracted the covid-19 infection. Caller wanted to know whether they get the 2nd dose of the vaccine? How long should they wait before getting it and is there a recommended interval? Can they get the vaccine if they still have symptoms? Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (COMIRNATY) on an unspecified date, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Vaccination site pain, Vaccination site warmth
Clinical narrative: Fatigue; soreness at injection site; warmth at injection site; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 07Feb2021 14:15 (at the age of 68-years-old) as single dose for COVID-19 immunization. The patient medical history included Hypertension, Atrial fibrillation, Mitral Valve Prolapse. No known allergies. The patient concomitant medications included Lisinopril, Metoprolol, Eliquis, Calcium, Biotin. On 08Feb2021 09:00 AM patient experienced fatigue, soreness at injection site, warmth at injection site, diarrhea. No other vaccine in four weeks. No COVID tested post vaccination. No COVID prior vaccination. No treatment received. The outcome of the event was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Product odour abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EM9809), via unspecified route of administration on left arm on 03Feb2021 08:30 (at the age of 56-year-old) at single dose for Covid-19 immunization administered at Workplace clinic. The patient medical history included Atrial tachycardia and Meniere's disease. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EK4176), via unspecified route of administration on left arm on 19Jan2021 15:00 (at the age of 56-year-old) at single dose for Covid-19 immunization. Concomitant medication include Metoprolol, Pantoprazole, Crestor and Famotidine. Past drug events include Pyridium and Cleocin and experienced Allergy. The patient experienced, chemical taste and odor for 1st vaccine, right after administration for a minute or so 2nd vaccine, 30-45 minutes after which lasted at least 5 minutes on 09Feb2021 09:15. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: fever of 103.8; headache; Chills; achy muscles; nausea; weak; dizzy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9267; expiry date: unknown), via an unspecified route of administration on 18Feb2021 at 15:15 (at the age of 67-years-old) on Right arm at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No Allergies to medications, food, or other products. The patient previously took first dose of BNT162B2 (lot number: EL0142) on 28Jan2021 at 03:45 PM (at the age of 67-years-old) on Right arm for COVID-19 immunisation. It was reported that the patient had experienced chills, fever of 103.8, headache, nausea, achy muscles, dizzy weak on 20Feb2021 at 07:00. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. Outcome of all the events was recovering.