chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fear of death, Feeling abnormal, Hypersomnia, Near death experience, Vomiting
Clinical narrative: She started throwing up and it was consistent for 4 days/Throwing up consistently; She felt mellow like she was on a horse tranquilizer; She was asleep for 3 days and only woke up intermittently/Slept for three days; afraid of dying; She feels like she is going to die/Thought she was going to die; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration in right arm on 04May2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She had the first dose of the Pfizer COVID-19 vaccine on 04May2021 and At the first hour she felt mellow like she was on a horse tranquilizer. She went home and thought she would lay down for a while.  States she slept for three days from 04May2021 to 07May2021. She woke up intermittently, but she got the shot on Tuesday and woke up again on Friday. After that she was okay for 2 days. Again, on Sunday night she began throwing up and then threw up consistently for 4 days.  States she thought it wouldn't end. She thought she would die. She wanted to know what to do and if she should take the second shot. She is afraid to get the second shot and is afraid of dying. Her first shot was so severe she doesn't know what to do and it's time for her second shot but she is afraid. Her HCP lied to her and said her that reaction is unheard of. Its coincidence and what happened to her is not from the vaccine. However, many pharmacists had told her about reports of similar adverse reaction to hers. As response patient was referred to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events hypersomnia, vomiting were recovered and other events were unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Headache, Hypoaesthesia, Thrombosis
Clinical narrative: Stroke; she had blood clots on her brain; headache; her left leg was numb like it was asleep; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8736) in left arm via an unknown route of administration on 24Apr2021 at 10:10 (at the age 27-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8727) right arm, via an unknown route of administration on 31Mar2021 as single dose for covid-19 immunization and experienced no adverse event. On 14May2021 at around 07:00 or 08:00, the patient experienced stroke. The patient was hospitalized for stroke from 15May2021 to May2021. On an unknown date, the patient had blood clots on her brain, headache, her left leg was numb like it was asleep, blurry vision. It was reported that patient was recently got her vision back to where she can stand the light long enough to do the research and call around. The stroke happened on 14May2021 and patient went to the hospital on 15May2021 for 5 days because she thought it was just a headache. The patient cannot find the exact date she was discharged. The vision was the first thing that went, then headache started. When patient woke up early in the morning her left leg was numb like it was asleep. Patient used the restroom and did her morning routine, and when she sat back down had the worst headache of her life. They said she had blood clots on her brain. When patient got there, they couldn't stop it because it had already happened and the damage was done. It was reported that patient knew she was going to be travelling and would start working around children. Patient was exposed to a lot of people and thought at the time it was the best thing to go ahead and get the vaccine to go back to a new normal. Patient had bloodwork test and drew so much blood trying to figure out how but results showed unknown. The most common stroke was a blood clot on the brain. Everything matches from the blurry vision to the headaches. Patient declines to report on any of the people she read about, she is just calling to report on herself. The stroke was early because her aunt had a stroke literally the week before and her wake was in the morning. She was getting ready for that. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccines. Patient's lab test included blood work: unknown on an unspecified date. The outcome of the events was unknown.  PSCC Communication was as provided contact information for Pfizer Legal Department and report reference number to the caller. Caller declined to complete reports on the people she read about online.  Information on Lot/Batch number was available. Additional Information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Stroke; she had blood clots on her brain; headache; her left leg was numb like it was asleep; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8736) in left arm via an unknown route of administration on 24Apr2021 at 10:10 (at the age 27-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8727) right arm, via an unknown route of administration on 31Mar2021 as single dose for covid-19 immunization and experienced no adverse event. On 14May2021 at around 07:00 or 08:00, the patient experienced stroke. The patient was hospitalized for stroke from 15May2021 to May2021. On an unknown date, the patient had blood clots on her brain, headache, her left leg was numb like it was asleep, blurry vision. It was reported that patient was recently got her vision back to where she can stand the light long enough to do the research and call around. The stroke happened on 14May2021 and patient went to the hospital on 15May2021 for 5 days because she thought it was just a headache. The patient cannot find the exact date she was discharged. The vision was the first thing that went, then headache started. When patient woke up early in the morning her left leg was numb like it was asleep. Patient used the restroom and did her morning routine, and when she sat back down had the worst headache of her life. They said she had blood clots on her brain. When patient got there, they couldn't stop it because it had already happened and the damage was done. It was reported that patient knew she was going to be travelling and would start working around children. Patient was exposed to a lot of people and thought at the time it was the best thing to go ahead and get the vaccine to go back to a new normal. Patient had bloodwork test and drew so much blood trying to figure out how but results showed unknown. The most common stroke was a blood clot on the brain. Everything matches from the blurry vision to the headaches. Patient declines to report on any of the people she read about, she is just calling to report on herself. The stroke was early because her aunt had a stroke literally the week before and her wake was in the morning. She was getting ready for that. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccines. Patient's lab test included blood work: unknown on an unspecified date. The outcome of the events was unknown.  PSCC Communication was as provided contact information for Pfizer Legal Department and report reference number to the caller. Caller declined to complete reports on the people she read about online.  Information on Lot/Batch number was available. Additional Information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Neck pain, Paraesthesia oral, Taste disorder, Trismus
Clinical narrative: Her face drooping on one side/when brushing teeth water dribbled out of side of her mouth/ Bell's palsy; Her jaw locked up, when / she could not open her mouth wide enough to eat; Her tongue felt like it was burnt and her food tasted funny; Her tongue felt like it was burnt and her food tasted funny; Her neck hurt; This is a spontaneous report from a contactable consumer (Patient herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 (at 53-years age) as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26May2021 a week after the vaccination patient experienced her tongue felt like burnt and her food tasted funny, and face still felt funny, her neck hurt. On 29May2021 her jaw locked up, when brushing teeth water dribbled out of side of her mouth, she could not open her mouth wide enough to eat. On next day 30May2021 her son noticed that patient's face drooping on one side called 911. She thought she was having a stroke but at the hospital said she had Bell's Palsy. The doctor at the hospital stated it was one of the side effects of the shot. The patient started to take 60mg of Cymbalta and .37mg of Synthroid daily as a treatment to event. The outcome of the events was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Platelet count, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: Brain bleed; His platelets were only 9000; This is a spontaneous report from a contactable consumer reporting for her husband. A 63-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21May2021 14:00 (Batch/Lot Number: EW0172) as  single dose  for covid-19 immunisation (Age at vaccination 63 years) .  The patient medical history was not reported. Concomitant medications included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported.   On 23Apr2021 the patient received the first dose of BNT162B2 vaccine Lot # EW0169. The patient experienced brain bleed  on 30May2021 causing patient's death on an unknown date, and his platelets were only 9000  on 30May2021 with outcome of unknown.  The patient underwent lab tests and procedures which included platelet count: 9000   on 30May2021   , sars-cov-2 test: negative   on 29May2021  .   The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Reporter's comments: My husband was rushed to the ER one week after his 2nd vaccine.  He had a brain bleed, they couldn't operate because his platelets were only 9000.  He died!  I believe it was from the vaccine  Information about lot/batch number has been obtained. Additional information is requested.; Reported Cause(s) of Death: Brain bleed
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Intestinal ischaemia, SARS-CoV-2 test negative, Thrombosis
Clinical narrative: Incarcerated and ischemic bowel due to massive thrombosis of portal vein and SMV; Incarcerated and ischemic bowel due to massive thrombosis of portal vein and SMV; This is a spontaneous report from a contactable consumer.   A 59-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: ER8736) as single dose at the age of 59-year-old for COVID-19 immunisation.   Medical history included pre-myelofibrosis aspirin on daily baby. No known allergies. Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (BNT162B2), dose 1 on 02Apr2021 (Batch/Lot Number: ER2613) as single dose at the age of 59-year-old for COVID-19 immunisation.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced incarcerated and ischemic bowel due to massive thrombosis of portal vein and SMV (hospitalization, disability, life threatening) on 09May2021 with outcome of recovering. The adverse events resulted in any Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was hospitalized for the events for 26 days.  The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 24May2021 Nasal Swab. The treatment received for the adverse event was emergency bowel resection. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, SARS-CoV-2 test, Streptobacillus infection
Clinical narrative: she cut her hand open by accident a week after the first shot.; This is a spontaneous report from a contactable consumer or other non hcp (consumer).   A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9267) via an unspecified route of administration on 26Feb2021, left arm as 1st dose, single dose (at 39-years-old) for COVID-19 immunization. The patient's medical history included ankylosing spondylitis, Hashimoto disease, autoimmune disease. The patient's mom had a heart condition and they tested her and her heart was good. The patient's concomitant medication included tetanus vaccine on right arm. The patient previous vaccine included flu vaccine for immunization and experienced Guillain-Barre syndrome. She had a flu shot, she did get Guillain-Barre, so she was a little skeptical of the Covid shot, she was told it was safe. She did get Guillain-Barre, it was very mild, they thought she would be ok with this one. It was mentioned that the patient required emergency room and physician office and patient received vaccinations prior (within 4 weeks) to the first administration date of the suspect vaccine. On an unknown date in May-2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative and streptobacillus infection: negative. On an unknown date the patient cut her hand open by accident a week after the first shot. It was in between the first and second shot. She remembered she was pissed off because she cut her hand open and she asked if she was allowed to get it and they said better get it than not. She got it 04Mar2021 at the hospital because they had to stitch up her hand. She got it in her right arm because she cut her left. The outcome of event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Dyspnoea, Rash
Clinical narrative: Had a horrible rash her legs opened up in whelps; she really decompensated; Breathing problems; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 58-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0150), via an unspecified route of administration on 05Apr2021 as 2nd dose, single dose for covid-19 immunisation (age at vaccination was 58years). Medical history included Hashimoto's disease, hypopituitarism, Chronic pain, chronic severe calcification tendonitis, cortisol dependent and controlled emphysema. The patient previously took historical vaccine of first dose of bnt162b2 for covid-19 immunisation and experienced trouble Breathing; she took generic for crestor and experienced massive weight gain so she has stopped that now. She was taking CoQ10 to keep the muscle pain down from the statin but it couldn't get rid of it. Concomitant medications included cortisol hydrocortisone [CORTISOL [HYDROCORTISONE]] taken as 12.5 mg when wakes up, 5 mg at 1:00pm, 5 mg at 5:30 pm. Also as needed, when needed, levothyroxine(LEVOTHYROXINE) taken as 88 ug, 1x/day  (88 mcg once a day), metformin taken as 500 mg, 2x/day (twice a day), rosuvastatin calcium (CRESTOR) taken as 5 mg, diphenhydramine hydrochloride (BENADRYL) taken as needed, dhea(DHEA) taken as 5 mg, fish oil, magnesium (MAGNESIUM) taken as 800 mg, daily (800 mg a day), ascorbic acid (VIT C) taken as 100 mg, daily (100 mg a day), acetylcysteine (NAC [ACETYLCYSTEINE]) taken as 600 mg, 1x/day (600mg once a day), Nattokinase taken as 2000 UNK, 1x/day (2000 fu once a day), ubidecarenone (COQ-10) taken as 100 mg, ergocalciferol (VIT D) taken as 4000 iu a day.  The patient reported that 10 minutes after the second shot she had breathing problems and was in the emergency room and then 40 minutes after that, she really decompensated. The caller treated it herself because she kept her inhaler, epi pen, and benadryl on her. She is cortisol dependent and had to take an extra 20mg of cortisol. She also mentioned she had controlled Emphysema. She took her Ventolin inhaler and benadryl after the breathing problems started after the second dose, and then 40 minutes later she was on the road decompensating. The caller did a VSAFE report and gave details then. After the second shot, she had to take benadryl for a few days. After that, she had a horrible rash her legs opened up in whelps. The rash lasted a couple of weeks, it was the entire back of her legs. Whelps were everywhere on her legs, she put hydrocortisone cream on it and it knocked down the itching some. Therapeutic measures were taken as a result of breathing problems and had a horrible rash her legs opened up in whelps. The outcome of the events she really decompensated and breathing problem was unknown, and had a horrible rash her legs opened up in whelps the outcome was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Sinusitis
Clinical narrative: Asthma; Sinus; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) as first dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced asthma and sinus. The patient went to the doctor because of the events and was prescribed antibiotic Amox Clav 875 mg which she started taking last Saturday (29May2021) and had been taking it for 6 days and had finished with the antibiotics. Later she clarified that she has one dose left of antibiotics. The patient's next appointment for the second dose was 05Jun2021 (Saturday). Outcome of both the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes in his left arm pit; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration in Arm Left on 01Jun2021 (3 days ago) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient noticed swollen lymph nodes in his left arm pit. He did receive the injection in his left shoulder. He would like to know if that was a normal side effect from the vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: That after receiving the Covid vaccine in January that patient has been experiencing tinnitus; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date in Jan2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced that after receiving the COVID-19 vaccine in January that patient has been experiencing tinnitus. Employee offered to take her information and turn it into Pfizer, employee did not wish to be reached by Pfizer as she suggested that she already informed the CDC. Patient had reported the events on her own. The clinical outcome of the experienced that after receiving the COVID-19 vaccine in January that patient has been experiencing tinnitus was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: A week after the 1st dose, tested positive for COVID; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program COVAX US Support via medical information team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 30Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, tested positive for the COVID virus a week after the first dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia, Somnolence
Clinical narrative: Patient slept for about 16 hours a day; Severe fatigue; Vomiting; Nausea; Fever; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 15May2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing asthma (gotten better in the past year or so but had it almost her whole life investigation assessment: No) and cold. Concomitant medications were not reported. The patient's mother reported that on 16May2021, the patient (daughter) developed nausea and vomiting for about 12 hours and treated with dramamine and went away, completely resolved. She also had fever of up to 102 Fahrenheit for about 3 days that went away and also presents severe fatigue that lasted from 9 to 10 days that started on 18May2021 and was only improving now and wanted to know if that would that be an allergic reaction, when she presented fatigue the patient slept for about 16 hours a day. The hours that she was awake she was normal, she was nor weak. Caller wants to know what can they expect "fatigue wise" with the second dose and why do patients develop fatigue. She also wants to know if a "severe fatigue" could last several days. A higher incidence was reported with the second dose of the vaccine with adults and adolescents. No information on how long the fatigue would last. The outcome of the events nausea and vomiting was resolved on 16May2021 and fever was resolved on an unknown date. Outcome of the severe fatigue was recovering and for the event patient slept for about 16 hours a day, it was unknown.  Follow-up attempts are needed. Information on Lot/Batch number is requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient slept for about 16 hours a day; Severe fatigue; Vomiting; Nausea; Fever; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 15May2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing asthma (gotten better in the past year or so but had it almost her whole life investigation assessment: No) and cold. Concomitant medications were not reported. The patient's mother reported that on 16May2021, the patient (daughter) developed nausea and vomiting for about 12 hours and treated with dramamine and went away, completely resolved. She also had fever of up to 102 Fahrenheit for about 3 days that went away and also presents severe fatigue that lasted from 9 to 10 days that started on 18May2021 and was only improving now and wanted to know if that would that be an allergic reaction, when she presented fatigue the patient slept for about 16 hours a day. The hours that she was awake she was normal, she was nor weak. Caller wants to know what can they expect "fatigue wise" with the second dose and why do patients develop fatigue. She also wants to know if a "severe fatigue" could last several days. A higher incidence was reported with the second dose of the vaccine with adults and adolescents. No information on how long the fatigue would last. The outcome of the events nausea and vomiting was resolved on 16May2021 and fever was resolved on an unknown date. Outcome of the severe fatigue was recovering and for the event patient slept for about 16 hours a day, it was unknown.  Follow-up attempts are needed. Information on Lot/Batch number is requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Dizziness, Hypersensitivity, Incoherent
Clinical narrative: After I read out the signs of severe allergic reaction. Caller mentioned her daughter had some but not all of them; her lips turned blue; light headache; incoherent; This is a spontaneous report from a contactable consumer (patient's father) reported for his daughter via medical information team.  A 14-year-old female patient BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number, and expiration date: Unknown), via an unspecified route of administration on an unknown date (at the age of 14-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She received the first dose of the Pfizer COVID-19 vaccine three weeks ago and was due to receive the second dose next day. She had a severe reaction to the first dose. she had the first COVID-19 vaccine dose, she had a pretty severe reaction to it, that passed after 15, 20 minutes but just want to make sure that still get the second shot which was scheduled for tomorrow. Reporter stated, patient got her first shot for the first fifteen minutes, her lips turned blue, she got really light headache, become slightly incoherent, then after about 15, 30 minutes those symptoms went away, and she was ok. Reporter wants to know whether she could get her second dose and asked what the signs of a severe allergic reaction are. Consumer read out the signs of severe allergic reaction and mentioned her daughter had some but not all of them. Reporter did not specify any seriousness. The outcome of the events was resolved.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pain in extremity
Clinical narrative: pain in the arm; anxious; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced pain in the arm, anxious. It was reported that a local Pharmacist recommended to take 220 mg of Aleve, an NSAID, for any pain in the arm. She was asking if it was okay that she took Aleve since they usually recommend Tylenol for Moderna COVID shots. They noted that she was fine and only took the medicine because she was anxious and wanted to take it just in case. They were asking if this could weaken the shot or the vaccine. Reporter stated, She just had a question she got Pfizer vaccine (Unspecified vaccine) the first dose today and she is doing fine. Reported that one of her friend recommended that she take an Aleve to help with any arm pain or anything like that and then the local pharmacist said that they don't recommend to take Aleve, just take Tylenol. If she took an Aleve is that a problem or not. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Malaise, Pain, Pyrexia
Clinical narrative: sick; pain in shoulder; the place where they did injection is little bit swollen and feel pain; the place where they did injection is little bit swollen and feel pain; pain was getting stronger; fever; not feeling well; This is a spontaneous report received from a contactable consumer (patient) via a Medical Information Team. A 54-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0179) via an unspecified route of administration on 04Jun2021 as 2nd, dose single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EW0172) received three weeks ago, on an unspecified date for COVID-19 immunization and experienced little bit pain. It was reported that, the patient received the Pfizer Covid vaccine second dose yesterday (04Jun2021) and today (05Jun2021) he felt sick and pain in shoulder. The place where they did injection was little bit swollen and feel pain in Jun2021. Before he received three weeks was okay was no problem, but this time it was kind of bothering him, the pain was getting stronger and fever in Jun2021. The patient was not feeling well in Jun2021, and he do not want to be bothered and was not feeling well right now. The outcome of the events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: sick; pain in shoulder; the place where they did injection is little bit swollen and feel pain; the place where they did injection is little bit swollen and feel pain; pain was getting stronger; fever; not feeling well; This is a spontaneous report received from a contactable consumer (patient) via a Medical Information Team. A 54-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0179) via an unspecified route of administration on 04Jun2021 as 2nd, dose single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EW0172) received three weeks ago, on an unspecified date for COVID-19 immunization and experienced little bit pain. It was reported that, the patient received the Pfizer Covid vaccine second dose yesterday (04Jun2021) and today (05Jun2021) he felt sick and pain in shoulder. The place where they did injection was little bit swollen and feel pain in Jun2021. Before he received three weeks was okay was no problem, but this time it was kind of bothering him, the pain was getting stronger and fever in Jun2021. The patient was not feeling well in Jun2021, and he do not want to be bothered and was not feeling well right now. The outcome of the events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19, MEN
Symptoms: Facial pain, Headache
Clinical narrative: had a headache afterwards; the side of his face was hurting; This is a spontaneous report from a contactable consumer (patient's grandmother). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 1st dose, via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunization and received meningococcal vaccine (MENINGOCOCCAL VACCINE) (formulation, lot number unknown and expiration unknown) via unspecified route of administration, on an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported.  Patient took received the Pfizer BioNTech COVID vaccine and had got the meningococcal vaccine 10 days ago. Had headache after the vaccine and the side of his face was hurting but she was alright at the time of reporting. After got his Pfizer shot and the nurse did asked reporter have patient had any vaccine in time of 14 days, she told her yes but it haven't been 14 days it's just been 10 days. Reporter thought it was the last of his shot that the one for cancer, meningococcal vaccine. The outcome of the event was recovered.  Information on the batch/lot number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Constant cough; This is a spontaneous report from a contactable consumer. This contactable 15-years-old male consumer (patient) reported himself that he received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was mentioned that the patient was not diagnosed with covid-19 prior to vaccination and did not get tested for covid-19 since vaccination. The device date was 05Jun2021. On an unknown date patient reported that he had constant cough. The outcome of event was unknown.  Information about lot number/batch number could be requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Gastrointestinal disorder, Illness, Insomnia, SARS-CoV-1 test negative
Clinical narrative: First experienced chest pressure and insomnia a few days after.  Then, GI flare up.  I was so sick I couldn't keep fluids down and ended up in the ER.  I started to feel better week 3, then had to get; First experienced chest pressure and insomnia a few days after.  Then, GI flare up.  I was so sick I couldn't keep fluids down and ended up in the ER.  I started to feel better week 3, then had to get; First experienced chest pressure and insomnia a few days after.  Then, GI flare up.  I was so sick I couldn't keep fluids down and ended up in the ER.  I started to feel better week 3, then had to get; First experienced chest pressure and insomnia a few days after.  Then, GI flare up.  I was so sick I couldn't keep fluids down and ended up in the ER.  I started to feel better week 3, then had to get; This is a spontaneous report from a contactable consumer (patient herself). A 35-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in right arm on 15Apr2021 10:30 as 1st dose, single dose for COVID-19 immunization. Patient was 35-years-old and was not pregnant at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient was allergic to cephalexin, mucinex, nasonex. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has been tested for COVID-19, since the vaccination. On 28Apr2021, patient first experienced chest pressure and insomnia a few days after vaccination. Then, GI flare up. She was so sick she could not keep fluids down and ended up in the ER. She started to feel better week 3, then had to get her second dose. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Patient received all sorts of stomach medications for the adverse events. Device Date was reported as 05Jun2021. The lab tests and procedures included nasal swab test on 06May2021 with result as negative. The outcome of the event was not recovered.   Information about lot batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hot flush, Malaise
Clinical narrative: feeling very hot & flushed, very uncomfortable; feeling very hot & flushed, very uncomfortable; feeling very hot & flushed, very uncomfortable; hot flashes; This is a spontaneous report from a contactable consumer or other non-health care professional. A 50-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 28May2021 20:15 as 1st dose, single dose for COVID-19 immunization. Medical history included thyroid disorder, high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, lisinopril taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks. The patient was not had Covid prior vaccination, and the test was not performed post vaccination. 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 has not been tested for COVID-19, since the vaccination. On 29May2021 08:00 am, the patient reported that in 8 days since received vaccine I have been feeling very hot & flushed, very uncomfortable. It is warm out but even at night when 50s or 60s, still feel like I need a/c running. I am of the age to have hot flashes but never had them prior to this shot and this hot feeling has been rather continuous over the last 8 days, starting right after the shot, with no sign of slowing down. The events were assessed as non-serious. Treatment was received for the events. The patient had no known allergies. The outcome of the events was reported as not recovered.   Information about lot/batch number has been requested.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: I felt fine other than a sore arm and applied essential oils to my feet and immediately felt nauseated and dizzy; I felt fine other than a sore arm and applied essential oils to my feet and immediately felt nauseated and dizzy; I felt fine other than a sore arm and applied essential oils to my feet and immediately felt nauseated and dizzy; This is a spontaneous report from a contactable consumer. A 52-years-old patient of an unspecified gender received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; lot number: EW0171), via an unspecified route of administration, administered in Arm Right on 15May2021 13:00 as 1st dose, single for covid-19 immunisation. Medical history included Chronic pain, bilateral mastectomy. Patient known allergies to nystatin. The patient's concomitant medications was post op Pain medication, essential oils. On 16May2021 14:00 the patient reported I felt fine other than a sore arm and applied essential oils to my feet and immediately felt nauseated and dizzy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any treatment for event. The outcome of the events were recovered.    Follow-up attempts are needed. Further information is expected
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Sleep disorder, Vitreous floaters
Clinical narrative: Numbness; tingling; moderate to severe pain in right hand; It wakes me up at night, it's so bad; Visual disturbances (floaters in left eye constantly).; This is a spontaneous report from a contactable Nurse (reporting for herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 2nd dose, via an unspecified route of administration administered in Arm Right 23May2021 at 12:00 pm, as single dose for covid-19 immunization (at the age of 63-years-old). The patient medical history was not reported. The patient was not patient diagnosed with COVID-19 prior to vaccination and since vaccination has not been tested positive for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); trazodone (TRAZODONE) and hydrocodone bitartrate, paracetamol (NORCO) all were taken for an unspecified indication and start and stop date were not reported. patient previously experienced allergy while taking codeine, Ativan and augmentin bambini. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on 2May2021 at 12:00 pm, as single dose for covid-19 immunization. Caller stated that after receiving second dose of vaccine on 26May2021 08:00 am the patient experienced numbness, tingling, and moderate to severe pain in right hand. it wakes me up at night, it was so bad. visual disturbances (floaters in left eye constantly). Patient visited to the emergency room/department or urgent care for the events. The outcome of the events was not recovered.  Information lot/batch number is requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: left arm deltoid injection site with red circular rash with well defined border; There was general swelling (puffy/boggy) of upper arm centered around the injection site that extended under the rash 4 inches in diameter with diffuse/tapered border.; The injection site was very tender to palpation w/ pain raising or using arm.; This is a spontaneous report from contactable consumer (patient). A 13-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 03Jun2021 at 10:30 as 2nd dose, single dose for COVID-19 immunization. Medical history included appendectomy in Feb2019, otherwise healthy boy. Patient previously took Amoxicillin and experienced full body rash. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the patient received within 2 weeks of vaccination. On 05Oct2020, patient had been tested for COVID-19 via Nasal Swab and resulted negative. Prior to vaccination, patient was not diagnosed with COVID-19. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 13May2021 at 09:15 AM as 1st dose, single dose for COVID-19 immunization. It was reported that, patient experienced on left arm deltoid injection site with red circular rash with well defined border that was not raised and about 2 inches in diameter. Does not itch. There was general swelling (puffy/boggy) of upper arm centered around the injection site that extended under the rash 4 inches in diameter with diffuse/tapered border. The injection site was very tender to palpation w/ pain raising or using arm. This was only a day following the 2nd injection (On 04Jun2021 at 14:00).  No treatment was received for the adverse events. Since the vaccination, the patient had been tested for COVID-19 via Nasal Swab. On 07Mar2021, patient tested COVID-19 and resulted negative. The device date was 05Jun2021. The outcome of the events was recovering.  Information about batch/ lot number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, SARS-CoV-2 test, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: My arm at the injection site turned hot and red. It was shining and burning and had a lump the size of a golf ball.; My arm at the injection site turned hot and red. It was shining and burning and had a lump the size of a golf ball.; My arm at the injection site turned hot and red. It was shining and burning and had a lump the size of a golf ball./Arm continues to have aump the size of a dime; It was shining and burning and had a lump the size of a golf ball.; This is a spontaneous report from a contactable other hcp (patient). A 35-years-old female patient (non-pregnant) received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 21May2021 05:30 (at the age of 35-years-old) as single dose for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing Verbatim: Hashimotos Thyroiditis complete thyroid removal, food allergy from an unknown date and unknown if ongoing Chocolate , allergy to plants from an unknown date and unknown if ongoing pine Tress, dust allergy from an unknown date and unknown if ongoing Dust, seasonal allergy from an unknown date and unknown if ongoing Grass, covid-19 from an unknown date and unknown if ongoing, thyroidectomy from an unknown date and unknown if ongoing  Verbatim: Hashimotos Thyroiditis complete thyroid removal. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination.  The patient was diagnosed with COVID-19 prior to vaccination. The patient stated "My arm at the injection site turned hot and red. It was shining and burning and had a lump the size of a golf ball (on an unspecified date)." Arm continues to have aump the size of a dime but no pain on an unspecified date. Since the vaccination, has the patient been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Jun2021 Nasal swab. Device date was 05Jun2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested