chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Off label use, Pain, Product use issue
Clinical narrative: fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: Headache; Mild fever; Lack of energy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248; Expiration date was not reported) on 19Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included Celiac disease and gluten allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). On 20Jan2021, the patient had headache, mild fever and lack of energy. The patient did not receive any treatment for the reported events. The outcome of the events, headache, mild fever and lack of energy, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Had some itching on my stomach and my back; I saw some hives after a shower; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 12Jan2021 as a single dose, for COVID-19 immunization, lot number: EL3302. Medical history and concomitant medications were not reported. Patient received the Pfizer COVID-19 vaccine on 12Jan2021 and after like 24 hours he/she had some itching on stomach and back that kind of lasted for about 2 and half to 3 days, patient saw some hives after a shower, 24 hours later but other than that, no rash, no anything, the hives went away with diphenhydramine hydrochloride (BENADRYL) (Intent: Treatment). Patient still has itching and the day before the report (reported as yesterday) and the day of the report (reported as today) it is back to where it was like when patient first had it like stomach and back is insanely itchy so patient does not know and he/ she has not changed any laundry detergent, soap like anything in patient's life is different other than that vaccine, patient had no itching or anything of that nature before vaccine. Patient knows that the people in his/her office that also got Pfizer COVID-19 Vaccine down at same time also had a few days of same symptoms of itching, there is went away, so patient is trying to figure out if this is related because patient is due for second one in a week from today. Patient had not recovered from itching and recovered on unknown date from hives.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: fever/Had temperature of 101; Chills; Lost my sense of taste; Body ache; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302, Expiration Date: 31Mar2021) at 0.3 mL single use in right deltoid on 21Jan2021 for COVID-19 immunisation. The first dose was on 31Dec2020 and experienced night sweat, even after her first dose they had not gone away. She had had night sweat every single night to the point she had to get her clothes off and change (refer to AER 2021111645). Medical history included factor V leiden, it's a blood clotting "supporter" (not clarified); asthma. Concomitant medication was not reported. Patient had temperature of 101, chills, lost her sense of taste and body ache in Jan2021. Patient received her second vaccine on the 21Jan2021 on Thursday and she had all the typical side effects startling on Friday with fever, chills, had a temperature of 101 and all the simple stuff and she lost her sense of taste on Saturday evening and it hadn't returned yet and she was trying to see if that was a possible side effect of the vaccine or what. When probed if the events had been worsened, improved or persisting, patient stated so improved for everything except one. So she got the sot on Thursday and it worsened meaning the fever started Thursday night, Friday all day she had a fever of 101, body ache and chills all that stuff but Saturday her fever went away but she lost her sense of taste on Saturday, so the fever and everything was OK. Patient had taken naproxen and ibuprofen. The outcome of events was reported as recovered in Jan2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Night sweat; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EH9899, Expiry Date 31Mar2021), via an unspecified route of administration on 31Dec2020 at 0.3 mL, single dose for COVID-19 immunisation. Patient age at vaccination was 35 years. Medical history included ongoing Factor V Leiden (it's a blood clotting supporter) and asthma. The patient's concomitant medications were not reported. The patient reported since she got her first vaccine on 31Dec2020 she had had night sweat every single night to the point she had to get her clothes off and change. The event had not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Abnormal faeces, Diarrhoea
Clinical narrative: I had a run to bathroom with chronic case of diarrhea and waste, the chemical was stink so badly that I had to open windows to get stink out; I had a run to bathroom with chronic case of diarrhea and waste, the chemical was stink so badly that I had to open windows to get stink out; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It told that they scheduled the patient for 13Feb2021 for the second dose. Consumer stated that the patient did his/her first dose and everything was good until last night (in Jan2021), just after midnight last night the patient had a run to the bathroom with a chronic case of diarrhea and the waste was so, the chemical was, stink so badly that the patient had to open the windows to get the stink out. Never had a problem like that ever. The patient wanted to know if he/she could stink from the dose of the vaccine that she/he got as side effects. The outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Insomnia, Lip swelling, Parosmia
Clinical narrative: had like sort of a hard time breathing; got really weird smell; lips and her tongue were all this kind of swelled and then like it was steamed; lips and her tongue were all this kind of swelled and then like it was steamed; her arm, both of her arms went numb; could not go to sleep; This is a spontaneous report from a contactable consume r(patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose (Lot # EL8982) for covid-19 immunisation. Medical history included stated, the only thing was got the susceptible to blood clots, had that gene so that is one of the reasons took the vaccine other than that did not take any meds. The patient didn't even take any blood thinners because did not need them." (not clarified further). No concomitant therapy included. The patient did not know if it is the vaccine but she got really weird smell and then her lips and her tongue were all this kind of swelled and then like it was steamed. The patient stated, "In the tongue and my lips, it was like when you get chilli on them and a distinct type of smell. " And then her arm, both of her arms went numb and she had like sort of a hard time breathing. Now, that it went away but she just waited and waited and it lasted almost in the most of the night and then she could not go to sleep but it was something she had never had before and it was very strange. She did not know if you have that kind of reaction from people or you know if it has come up but she thought she better report it because she had not had my second dose yet. She had to get the second dose on 09Feb. No treatments were received. Outcome of the events was recovering.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: had like sort of a hard time breathing; got really weird smell; lips and her tongue were all this kind of swelled and then like it was steamed; lips and her tongue were all this kind of swelled and then like it was steamed; her arm, both of her arms went numb; could not go to sleep; This is a spontaneous report from a contactable consume r(patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose (Lot # EL8982) for covid-19 immunisation. Medical history included stated, the only thing was got the susceptible to blood clots, had that gene so that is one of the reasons took the vaccine other than that did not take any meds. The patient didn't even take any blood thinners because did not need them." (not clarified further). No concomitant therapy included. The patient did not know if it is the vaccine but she got really weird smell and then her lips and her tongue were all this kind of swelled and then like it was steamed. The patient stated, "In the tongue and my lips, it was like when you get chilli on them and a distinct type of smell. " And then her arm, both of her arms went numb and she had like sort of a hard time breathing. Now, that it went away but she just waited and waited and it lasted almost in the most of the night and then she could not go to sleep but it was something she had never had before and it was very strange. She did not know if you have that kind of reaction from people or you know if it has come up but she thought she better report it because she had not had my second dose yet. She had to get the second dose on 09Feb. No treatments were received. Outcome of the events was recovering.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This is a spontaneous report from a contactable consumer (patient).  This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3302, Expiration Date May2021), via an unknown route, on 21Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included urinary tract infection for years. Relevant concomitant medications included apiaxaban (ELIQUIS). On 23Jan2021, the patient developed urinary tract infection (UTI). The patient stated ''I have urinary tract infection for years, so it's not something, it's not unusual". Therapeutic measures taken as result of the event included antibiotics. The patient had not recovered from the events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain assessment
Clinical narrative: On a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headache like I will give that a 2; This is a spontaneous report from a contactable consumer.  This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EE3247), via an unknown route, on 23Jan2021 (at 11:20) at a single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. Relevant concomitant medications included amlodipine. The patient stated, 'on a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headache like I will give that a 2' that night, the night I had got the injection". The outcome of the event was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash, Urticaria
Clinical narrative: allergic reaction; Rash kind of hives in upper chest and neck area; Rash kind of hives in upper chest and neck area; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL1284) , via an unspecified route of administration on 06Jan2021 at single dose on left arm for COVID-19 immunisation.  Medical history included blood pressure abnormal, cholesterol abnormal.  Concomitant medication included atorvastatin for cholesterol abnormal, warfarin sodium (COUMADIN).  The patient stated that, " I got very bad rash it kind of looks like hives in my upper chest and in my neck area but that was like maybe 11 days later (17Jan2021) and I went to urgent care and they gave me prescription for prednisone, which is cleared it up but then I saw my primary doctor on Monday the 18th and my primary doctor recommends that I should not get the second vaccine, which I have an appointment for on Thursday and I am very confused, I don't know this is the reaction from the Covid vaccine. I just I am very confused and I would like feedback if I could get some, did anybody recorded any kind of allergic reaction like 11 days later, I got the first one I am due for the second one. I went to urgent care and they prescribed me Prednisone and Zyrtec for 5 days." Therapeutic measures were taken as a result of the events. The outcome of the events was resolved on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe pain on my right arm and tiny bit of my shoulder sharp pains that lasts usually about 10 minutes. Wednesday and progressively got worse, Thursday, Friday and Saturday the pain increased; Severe pain on my right arm and tiny bit of my shoulder sharp pains that lasts usually about 10 minutes. Wednesday and progressively got worse, Thursday, Friday and Saturday the pain increased; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration left arm on 19Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that "I had the Pfizer vaccine last Tuesday [unspecified date] and on my left arm and after 2 days I had the vaccine [unspecified date], I am having a severe pain on my right arm only, my right arm and tiny bit of my shoulder on right arm and the pain is steady but then I have sharp, very, very sharp pains that lasts usually about 10 minutes and then it goes away." The patient further clarified that "I had it Tuesday [unspecified date] and I had a little bit of pain in my right arm on Wednesday and progressively got worse, Thursday and Friday and Saturday [unspecified date] the pain increased. Thursday was less pain, Friday and Saturday the pain on the right arm has increased instead of decrease." The patient inquired if this was normal reaction to have just pain on the other side. The outcome of the event was not recovered.  The following information on the batch/lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, COVID-19, Chest X-ray normal, Chills
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm right on 20Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included diabetes from an unknown date and ongoing. The patient's concomitant medication included metformin.  The patient experienced COVID-19 on 27Jan2021 (she got all the symptoms: sinus, headache, body aches, pain, chills, joint pain, fever). The patient was admitted to emergency room due to the event. The patient underwent lab test and procedure which included blood test and chest X-ray both on an unspecified date and both resulted that "everything was good" values not provided, in Jan2021 body weight: between 114-115 lbs, but probably 110 (lost a lot of weight in the past two weeks because of the virus) and SARS-CoV-2 test (nasal swab): positive on 27Jan2021. Therapeutic measures were taken as result of COVID-19 and included treatment with benzonatate (lot: 7893614, dose: 100 mg; one pill a day), ivermectin (dose: 3 mg, 4 pills a day for 2 days, exp: 28Apr2021), prednisone (dose: 20 mg,  3 tablets once daily lot: 7893618 ), azithromycin (dose: 500 mg, for five days, lot: 7893308). Medications she was prescribed in the emergency room were helping a little bit. The patient outcome of the events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia, SARS-CoV-2 test positive, Weight decreased
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm right on 20Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included diabetes from an unknown date and ongoing. The patient's concomitant medication included metformin.  The patient experienced COVID-19 on 27Jan2021 (she got all the symptoms: sinus, headache, body aches, pain, chills, joint pain, fever). The patient was admitted to emergency room due to the event. The patient underwent lab test and procedure which included blood test and chest X-ray both on an unspecified date and both resulted that "everything was good" values not provided, in Jan2021 body weight: between 114-115 lbs, but probably 110 (lost a lot of weight in the past two weeks because of the virus) and SARS-CoV-2 test (nasal swab): positive on 27Jan2021. Therapeutic measures were taken as result of COVID-19 and included treatment with benzonatate (lot: 7893614, dose: 100 mg; one pill a day), ivermectin (dose: 3 mg, 4 pills a day for 2 days, exp: 28Apr2021), prednisone (dose: 20 mg,  3 tablets once daily lot: 7893618 ), azithromycin (dose: 500 mg, for five days, lot: 7893308). Medications she was prescribed in the emergency room were helping a little bit. The patient outcome of the events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm right on 20Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included diabetes from an unknown date and ongoing. The patient's concomitant medication included metformin.  The patient experienced COVID-19 on 27Jan2021 (she got all the symptoms: sinus, headache, body aches, pain, chills, joint pain, fever). The patient was admitted to emergency room due to the event. The patient underwent lab test and procedure which included blood test and chest X-ray both on an unspecified date and both resulted that "everything was good" values not provided, in Jan2021 body weight: between 114-115 lbs, but probably 110 (lost a lot of weight in the past two weeks because of the virus) and SARS-CoV-2 test (nasal swab): positive on 27Jan2021. Therapeutic measures were taken as result of COVID-19 and included treatment with benzonatate (lot: 7893614, dose: 100 mg; one pill a day), ivermectin (dose: 3 mg, 4 pills a day for 2 days, exp: 28Apr2021), prednisone (dose: 20 mg,  3 tablets once daily lot: 7893618 ), azithromycin (dose: 500 mg, for five days, lot: 7893308). Medications she was prescribed in the emergency room were helping a little bit. The patient outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Fatigue, Feeling abnormal, Lethargy
Clinical narrative: I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness/ same sensation in my arms, in arm that I got shot in and it came with hand weakness; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; Lethargy; Very tired; My heart kind of feel like it is pounding out from the chest like off and on throughout the day; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient got the vaccine on 17Jan2021 and she had been really brain fogged and on Tuesday and Wednesday she had a weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety and then Friday evening, patient had the same sensation in her arms, in arm that she got shot in and it lasted for about ten minutes and it came with hand weakness and then she had no muscle pain necessarily but lethargy, very tired and her heart kind of feel like it was pounding out from the chest like off and on throughout the day, events occurred on unknown date in Jan2021. Patient called the doctor and he said to wait but it is kind of there now, so she had an appointment on Wednesday. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Palpitations
Clinical narrative: I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness/ same sensation in my arms, in arm that I got shot in and it came with hand weakness; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; Lethargy; Very tired; My heart kind of feel like it is pounding out from the chest like off and on throughout the day; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient got the vaccine on 17Jan2021 and she had been really brain fogged and on Tuesday and Wednesday she had a weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety and then Friday evening, patient had the same sensation in her arms, in arm that she got shot in and it lasted for about ten minutes and it came with hand weakness and then she had no muscle pain necessarily but lethargy, very tired and her heart kind of feel like it was pounding out from the chest like off and on throughout the day, events occurred on unknown date in Jan2021. Patient called the doctor and he said to wait but it is kind of there now, so she had an appointment on Wednesday. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; When I woke up I could not step on my foot other than on toes; heel and the arch were so painful, I couldn't put any weight on them; Hobbling around my hip had a lot of pain throughout the day; My shoulder felt like somebody had pulled it out; Vaccination site pain; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; This is a spontaneous report from a contactable consumer (patient).  A 80-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL3248) for COVID-19 immunization on an unknown date in Jan2021 at single dose.  The patient medical history and concomitant medications were not reported. The morning after vaccination (unspecified date in 2021), when patient woke up could not step on foot other than on toes, the heel and the arch were so painful that couldn't put any weight on them and then was hobbling around hip had a lot of pain throughout the day.The patient was tired and wasn't quite him/her self, patient was just feeling like tired and a little bit weak-ish (all in 2021). Always in 2021, the patient's shoulder felt like somebody had pulled it out and patient had vaccination site pain.The next morning patient woke up and was fine, had nothing. So, patient thought was strange and was sure a reaction to the vaccine. The patient stated it was a weird reaction and thought was strange reaction to the vaccine and was wondering getting next shot (scheduled at the beginning of Feb2021) can expect the worst reaction; patient had first time such a strong reaction. The final outcome of the events was reported as unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; When I woke up I could not step on my foot other than on toes; heel and the arch were so painful, I couldn't put any weight on them; Hobbling around my hip had a lot of pain throughout the day; My shoulder felt like somebody had pulled it out; Vaccination site pain; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; This is a spontaneous report from a contactable consumer (patient).  A 80-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL3248) for COVID-19 immunization on an unknown date in Jan2021 at single dose.  The patient medical history and concomitant medications were not reported. The morning after vaccination (unspecified date in 2021), when patient woke up could not step on foot other than on toes, the heel and the arch were so painful that couldn't put any weight on them and then was hobbling around hip had a lot of pain throughout the day.The patient was tired and wasn't quite him/her self, patient was just feeling like tired and a little bit weak-ish (all in 2021). Always in 2021, the patient's shoulder felt like somebody had pulled it out and patient had vaccination site pain.The next morning patient woke up and was fine, had nothing. So, patient thought was strange and was sure a reaction to the vaccine. The patient stated it was a weird reaction and thought was strange reaction to the vaccine and was wondering getting next shot (scheduled at the beginning of Feb2021) can expect the worst reaction; patient had first time such a strong reaction. The final outcome of the events was reported as unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: I had been running a temperature, I am usually 97.6 it was 99.1; I started to not feel good; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 18Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history included thyroid cancer and they took her thyroid (as reported). Concomitant medication included levothyroxine sodium (LEVOXYL) as she had thyroid cancer and they took her thyroid. Patient stated that she had first of her vaccine on 18Jan2021 (a week before the report was last Monday) and she felt fine, just the injection site (no further clarified). Starting on 23Jan2021 (reported as Saturday) she started to not feel good and on 24Jan2021 (reported as Sunday yesterday) she had been running a temperature, it was only like she was usually 97.6 it was 99.1 and she took paracetamol (TYLENOL) and it took the temperature down but she was wondering, patient called her doctor and she thought that it was too far, too many days have passed since the vaccination to have symptoms. Second dose scheduled for 08Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Physical examination, Vaccination site mass
Clinical narrative: I have a bump or lump on my left elbow and that was the site where I received the vaccination and it is about a size of half of a golf ball; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL9263) on 24Jan2021 at single dose in left arm for COVID-19 immunization.  Medical history included enlarged prostate, high blood pressure and high cholesterol. Concomitant medication included alfuzosin for Enlarged prostate, finasteride for Enlarged prostate, amlodipine for High Blood Pressure and atorvastatin for High cholesterol.  Patient had a bump or lump on his left elbow and that was the site where he received the vaccination and it was about a size of half of a golf ball on an unknown date in 2021. Patient had unspecified physical lab test in Nov2020 (reported as two months before) with unknown result. The second dose of the vaccine is scheduled for 14Feb2021.The final outcome of the event was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: spine is really brothering me like anytime I turn my neck side to side or up and down like forward or backward when I shift my body from one side to the other; Tiredness; Headache; Chills; Muscle ache; Joint pain; have this pain/I wanted to tell what's going on with my spine after I received the Pfizer vaccine; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 23Jan2021 at single dose for covid-19 immunisation in hospital. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Batch/lot number: EH9899) on 04Jan2021 at single dose for covid-19 immunisation and experienced arm pain. patient got her second dose on 23rd and she had a typical stuff she talked about injection site, tiredness, headache. she had chills, muscle ache and she had lots of symptoms (not clarified) (Jan2021). that they mentioned and one that is of particularly continuing is joint pain, asked if it was going to be issue for some people, because for she her spine is. If she was going too fast. her biggest concern is her spine was really brothering her like anytime she turned her neck side to side or up and down like forward or backward when she shifts her body from one side to the other. she just wanted to make sure if this part is normal on part of the joint pain and that she was not missing anything. Patient further reported have this pain, she wanted to tell what's going on with her spine after she received the Pfizer vaccine. No Lab works. no treatment. Outcome of the events was unknown. Causality was yes.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal disorder, Spinal pain
Clinical narrative: spine is really brothering me like anytime I turn my neck side to side or up and down like forward or backward when I shift my body from one side to the other; Tiredness; Headache; Chills; Muscle ache; Joint pain; have this pain/I wanted to tell what's going on with my spine after I received the Pfizer vaccine; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 23Jan2021 at single dose for covid-19 immunisation in hospital. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Batch/lot number: EH9899) on 04Jan2021 at single dose for covid-19 immunisation and experienced arm pain. patient got her second dose on 23rd and she had a typical stuff she talked about injection site, tiredness, headache. she had chills, muscle ache and she had lots of symptoms (not clarified) (Jan2021). that they mentioned and one that is of particularly continuing is joint pain, asked if it was going to be issue for some people, because for she her spine is. If she was going too fast. her biggest concern is her spine was really brothering her like anytime she turned her neck side to side or up and down like forward or backward when she shifts her body from one side to the other. she just wanted to make sure if this part is normal on part of the joint pain and that she was not missing anything. Patient further reported have this pain, she wanted to tell what's going on with her spine after she received the Pfizer vaccine. No Lab works. no treatment. Outcome of the events was unknown. Causality was yes.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: diaphoretic; diarrhea; nausea; headache; oral temperature of 100.7; body aches; in the morning woke up with chills; This is a spontaneous report from a contactable other hcp.  A 30-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), intramuscular arm left single dose on 06Jan2021 14:00 for covid-19 immunisation. Medical history included sleep apnoea syndrome, chronic sinusitis. Concomitant medication included colesevelam. No other vaccine was received in four weeks.  The patient experienced in the morning woke up with chills on 07Jan2021 03:15, oral temperature of 100.7 on 07Jan2021 05:00, body aches on 07Jan2021 05:00, nausea on 07Jan2021 05:40, headache on 07Jan2021 05:40. On 07Jan2021 06:25 all described symptoms getting worse in severity. On 07Jan2021 06:35 patient took acetaminophen at recommended dose. Patient then had diarrhea on 07Jan2021 06:40. On 07Jan2021 07:00 all described symptoms were improving. On 07Jan2021 17:00 patient was diaphoretic with an oral temperature of 99.4 and only symptoms left were body aches. The patient underwent lab tests and procedures which included body temperature: 100.7 (05:00) and 99.4 (17:00) both on 07Jan2021. The events recovered in Jan2021; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519940 same patient/drug, different event separated with time
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: diaphoretic; diarrhea; nausea; headache; oral temperature of 100.7; body aches; in the morning woke up with chills; This is a spontaneous report from a contactable other hcp.  A 30-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), intramuscular arm left single dose on 06Jan2021 14:00 for covid-19 immunisation. Medical history included sleep apnoea syndrome, chronic sinusitis. Concomitant medication included colesevelam. No other vaccine was received in four weeks.  The patient experienced in the morning woke up with chills on 07Jan2021 03:15, oral temperature of 100.7 on 07Jan2021 05:00, body aches on 07Jan2021 05:00, nausea on 07Jan2021 05:40, headache on 07Jan2021 05:40. On 07Jan2021 06:25 all described symptoms getting worse in severity. On 07Jan2021 06:35 patient took acetaminophen at recommended dose. Patient then had diarrhea on 07Jan2021 06:40. On 07Jan2021 07:00 all described symptoms were improving. On 07Jan2021 17:00 patient was diaphoretic with an oral temperature of 99.4 and only symptoms left were body aches. The patient underwent lab tests and procedures which included body temperature: 100.7 (05:00) and 99.4 (17:00) both on 07Jan2021. The events recovered in Jan2021; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519940 same patient/drug, different event separated with time
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: First dose to muscle of left arm left muscle superbly sore; This is a spontaneous report from a contactable physician (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 21Dec2020 11:00 at single dose injection to muscle of left arm for Vaccination. There were no medication history and no concomitant medications. The patient had her first dose of Pfizer COVID-19 Vaccine she thought on 21Dec2020. She reported first dose of Pfizer COVID19 Vaccine to muscle of left arm, and out 1 hour after dose administered the patient experienced left muscle superbly sore probably onset about 12:00 noon on 21Dec2020 for about 3 days, when she recovered completely. The outcome of event was recovered on 24Dec2020. The physician considered Pfizer COVID19 Vaccine was related to the even.t First dose to muscle of left arm left muscle superbly sore.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: fatigue; sore arm; headache; This is a spontaneous report from a contactable Nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Patient had fatigue, a sore arm, and a headache following the first shot on unknown date. The outcome of the events was unknown. Information on the lot/Batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Moderate-severe pain in her large leg muscles; moderate pain in arm at injection site for a few days; This is a spontaneous report from a non-contactable nurse (patient) received via a Pfizer sales representative.  A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 and experienced moderate pain at injection site and fatigue. In Jan2021, the patient experienced moderate-severe pain in her large leg muscles for at least 24 hours and moderate pain in arm at injection site for a few days.  The patient outcome of the events was recovering.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: terrible pain; Initial information received on 27-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (reference number: US-SA-SAC20210204000817).  This case involves a patient (age and gender not reported) who experienced terrible pain (pain), while he/she received INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious terrible pain (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination site warmth
Clinical narrative: a bit of warmth at site; Initial information was received on 30-Jan-2021 regarding an unsolicited valid non-serious case from a consumer or other non-professional via media.  This case involves a patient (age and gender unspecified) who had a bit of warmth at site (vaccination site warmth), after patient received INFLUENZA VACCINE.  The patient had medical history of Influenza and almost died twice. At the time of event patient had ongoing COVID.  The patient had no other medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details not reported] for prophylactic vaccination between corona virus disease (COVID) vaccine.  On an unknown date, the patient developed a non-serious bit of warmth at site (vaccination site warmth) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, COVID sucked patient's strength like vampire also patient reported that, it is up to Individuals to decide if they can Live with guilt if they don't get Shots and give these sicknesses to somebody who never recovers.  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was reported as unknown for vaccination site warmth.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Malaise, Pneumonia
Clinical narrative: diagnosed with pnuemonia; covid; not feeling well; Initial information was received on 28-Jan-2021 regarding an unsolicited valid serious case received a consumer/non-hcp (healthcare professional).  This case involves a patient with unknown demography who experienced pneumonia (pneumonia), covid (covid-19) and was not feeling well (malaise), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date in December, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was not feeling well (malaise), (unknown latency) following the administration of INFLUENZA VACCINE  On an unknown date in January, the patient developed a serious pnuemonia (pneumonia), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date in January, the patient developed a non-serious covid (covid-19), (unknown latency), following the administration of INFLUENZA VACCINE.   It was reported that the patient will not get the vaccine yet, still too soon.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of all the events were unknown at the time of reporting.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case involves a patient with unknown demography who presented with pneumonia, covid-19 and malaise, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out predisposing etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.