chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Hypoaesthesia, Muscle twitching, Oedema peripheral
Clinical narrative: He also reports his right leg and foot started swelling; He also reports his right leg and foot started swelling; Sweating; feels weird; Shaking; Later that day he states his left arm (injection arm) started twitching; he vomited; and his left pinky and ring fingers were numb; right leg blew up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0181), via an unspecified route of administration in left arm on 28May2021 as single dose for covid-19 immunization. The patient's medical history included alcohol use stated that all he does was drink some liquor and beer. No medications or surgeries. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient stated that after he received his first Pfizer COVID-19 vaccine dose on 28May2021, later that day he states his left arm (injection arm) started twitching, he vomited, and his left pinky and ring fingers were numb, and the patient felt nervous like he was shaking. On 14Jun2021, the patient also stated that he got the shot and the band aid that they cover the injection area with, it was branded in his arm and he got the shot 3 weeks ago and it looks like a band aid is on his arm. He thought it would be gone and it stayed. On an unknown date, the patient reported that his right leg and foot started swelling. The patient's right leg blew up. He reports the band aid to his injection site looks like it "burned" into his arm. He states his right/foot leg swelling and left arm twitching have continued and wants to know if this is a reported side effect. Now after he got the shot his arm has been twitching, he's sweating and vomiting all morning. His right leg blew up and he feels weird. He just doesn't feel like himself. Right after the shot, the patient felt like there's a bunch of fluid. It's ongoing, it has gone down a little bit. It's improved a little, very irritating when it does happen. He can't eat. It won't stay in his stomach and he can't hold water. It has improved but when it happens, he feels terrible. There was no emergency or physician room visit for the events. The clinical outcome for the events was unknown, the other events muscle twitching, and shaking was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Tremor, Vomiting
Clinical narrative: He also reports his right leg and foot started swelling; He also reports his right leg and foot started swelling; Sweating; feels weird; Shaking; Later that day he states his left arm (injection arm) started twitching; he vomited; and his left pinky and ring fingers were numb; right leg blew up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0181), via an unspecified route of administration in left arm on 28May2021 as single dose for covid-19 immunization. The patient's medical history included alcohol use stated that all he does was drink some liquor and beer. No medications or surgeries. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient stated that after he received his first Pfizer COVID-19 vaccine dose on 28May2021, later that day he states his left arm (injection arm) started twitching, he vomited, and his left pinky and ring fingers were numb, and the patient felt nervous like he was shaking. On 14Jun2021, the patient also stated that he got the shot and the band aid that they cover the injection area with, it was branded in his arm and he got the shot 3 weeks ago and it looks like a band aid is on his arm. He thought it would be gone and it stayed. On an unknown date, the patient reported that his right leg and foot started swelling. The patient's right leg blew up. He reports the band aid to his injection site looks like it "burned" into his arm. He states his right/foot leg swelling and left arm twitching have continued and wants to know if this is a reported side effect. Now after he got the shot his arm has been twitching, he's sweating and vomiting all morning. His right leg blew up and he feels weird. He just doesn't feel like himself. Right after the shot, the patient felt like there's a bunch of fluid. It's ongoing, it has gone down a little bit. It's improved a little, very irritating when it does happen. He can't eat. It won't stay in his stomach and he can't hold water. It has improved but when it happens, he feels terrible. There was no emergency or physician room visit for the events. The clinical outcome for the events was unknown, the other events muscle twitching, and shaking was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Bell's palsy, Blood test, Condition aggravated, Fatigue
Clinical narrative: I had elevated level. I get feedback  term but it appeared that my liver that is been stressed.; Body aches in my legs and more over back; Body aches in my legs and more over back; Body aches in my legs and more over back; Prolonged headache for about 2 weeks; Fatigue of head; Sore arm at the injection site; At my second ER visit they told me I had something called the  bell's palsy; after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension; I have history of hypertension but it was under control prior to the taking vaccination."; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in Arm Right on 29May2021 14:00 as (At the age of 42-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. It was reported that patient had history of hypertension, but it was under control prior to the taking vaccination. Concomitant medication included hydrochlorothiazide taken at a dose of 50 mg once per day for hypertension; amlodipine taken at a dose of 5 mg once per day for High blood pressure. Patient did not take any vaccination 4 weeks prior to covid-19 vaccine. It was reported that patient have experienced side effects after taking the first covid vaccination and he visited the ER two times. Reportedly, after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension. He had a prolonged headache for about 2 weeks. Patient experienced fatigue of head, body aches in his legs and more over back. He had sore arm at the injection site and at his second ER visit they said that he had something called the bell's palsy. It was reported that when he went to ER they perform blood tests and COVID test which tested negative. It was reported that he visited his doctor, primary care physician, he ran another lab and he had elevated level. He got feedback term, but it appeared that his liver that was been stressed. It was reported that patient was not treated for liver, he was only treated for the hypertension, for the headache and body ache he was taking ibuprofen over the counter, ibuprofen and the hospital prescribed for the bell's palsy, there are three different medication here valacyclovir, its 1-gram tablet and he take 3 per day. Prednisone, its 20 mg tablet 3 times per day, Erythromycin. The patient underwent lab tests and procedures which included blood test, covid-19: negative, liver function test increased: elevated level on unspecified date. Reporter seriousness for the events was Unspecified. Patient did not got his vaccination card yet as he was not fully vaccinated. The outcome of events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypertension, Liver function test abnormal, Liver function test increased, Pain
Clinical narrative: I had elevated level. I get feedback  term but it appeared that my liver that is been stressed.; Body aches in my legs and more over back; Body aches in my legs and more over back; Body aches in my legs and more over back; Prolonged headache for about 2 weeks; Fatigue of head; Sore arm at the injection site; At my second ER visit they told me I had something called the  bell's palsy; after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension; I have history of hypertension but it was under control prior to the taking vaccination."; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in Arm Right on 29May2021 14:00 as (At the age of 42-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. It was reported that patient had history of hypertension, but it was under control prior to the taking vaccination. Concomitant medication included hydrochlorothiazide taken at a dose of 50 mg once per day for hypertension; amlodipine taken at a dose of 5 mg once per day for High blood pressure. Patient did not take any vaccination 4 weeks prior to covid-19 vaccine. It was reported that patient have experienced side effects after taking the first covid vaccination and he visited the ER two times. Reportedly, after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension. He had a prolonged headache for about 2 weeks. Patient experienced fatigue of head, body aches in his legs and more over back. He had sore arm at the injection site and at his second ER visit they said that he had something called the bell's palsy. It was reported that when he went to ER they perform blood tests and COVID test which tested negative. It was reported that he visited his doctor, primary care physician, he ran another lab and he had elevated level. He got feedback term, but it appeared that his liver that was been stressed. It was reported that patient was not treated for liver, he was only treated for the hypertension, for the headache and body ache he was taking ibuprofen over the counter, ibuprofen and the hospital prescribed for the bell's palsy, there are three different medication here valacyclovir, its 1-gram tablet and he take 3 per day. Prednisone, its 20 mg tablet 3 times per day, Erythromycin. The patient underwent lab tests and procedures which included blood test, covid-19: negative, liver function test increased: elevated level on unspecified date. Reporter seriousness for the events was Unspecified. Patient did not got his vaccination card yet as he was not fully vaccinated. The outcome of events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: I had elevated level. I get feedback  term but it appeared that my liver that is been stressed.; Body aches in my legs and more over back; Body aches in my legs and more over back; Body aches in my legs and more over back; Prolonged headache for about 2 weeks; Fatigue of head; Sore arm at the injection site; At my second ER visit they told me I had something called the  bell's palsy; after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension; I have history of hypertension but it was under control prior to the taking vaccination."; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in Arm Right on 29May2021 14:00 as (At the age of 42-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. It was reported that patient had history of hypertension, but it was under control prior to the taking vaccination. Concomitant medication included hydrochlorothiazide taken at a dose of 50 mg once per day for hypertension; amlodipine taken at a dose of 5 mg once per day for High blood pressure. Patient did not take any vaccination 4 weeks prior to covid-19 vaccine. It was reported that patient have experienced side effects after taking the first covid vaccination and he visited the ER two times. Reportedly, after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension. He had a prolonged headache for about 2 weeks. Patient experienced fatigue of head, body aches in his legs and more over back. He had sore arm at the injection site and at his second ER visit they said that he had something called the bell's palsy. It was reported that when he went to ER they perform blood tests and COVID test which tested negative. It was reported that he visited his doctor, primary care physician, he ran another lab and he had elevated level. He got feedback term, but it appeared that his liver that was been stressed. It was reported that patient was not treated for liver, he was only treated for the hypertension, for the headache and body ache he was taking ibuprofen over the counter, ibuprofen and the hospital prescribed for the bell's palsy, there are three different medication here valacyclovir, its 1-gram tablet and he take 3 per day. Prednisone, its 20 mg tablet 3 times per day, Erythromycin. The patient underwent lab tests and procedures which included blood test, covid-19: negative, liver function test increased: elevated level on unspecified date. Reporter seriousness for the events was Unspecified. Patient did not got his vaccination card yet as he was not fully vaccinated. The outcome of events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Nausea and Significant Vomiting; Nausea and Significant Vomiting; Felt ill; This is a Spontaneous case report received from a contactable consumer. A 12-year-old female patient received first dose of BNT162B2 (Pfizer, Solution for injection) via an unspecified route of administration on an unspecified date (Lot number/NDC number/Expiry date: Unknown) (at age of vaccination) as single dose for Covid-19 immunization. Time the vaccination was given: afternoon. Anatomical location of vaccine: Unknown. The patient's medical history was not reported. Concomitant medications: Caller stated she knew the patient did take several medications because she had babysat her, but she did not know what they are. History of all previous immunization: none. On an unspecified date, the patient experienced nausea and significant vomiting and felt ill (afternoon). Caller was reporting what she heard about an adverse event in her daughter's friend with her first dose of the Pfizer Covid Vaccine in the newly approved age group, 12. Caller stated the patient had no other illness or notable cause for the nausea and vomiting. Caller stated the patient received the vaccine in the afternoon and then next morning she felt ill and then in the afternoon she had the nausea and vomiting. Caller stated dates were unknown, but she did know it was only on one occasion, she vomited a few times on that day and not any additional days. Caller stated she encouraged the girl's parents to call the number and she was hoping they would report it. Adverse event details: Provide the time of onset of AE(s): Morning. Treatment was unknown. Outcome of the events was recovered on an unspecified date. Communication: Caller provided with Report Reference Number.  Information about the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Diarrhoea, Ultrasound scan, Ultrasound testes
Clinical narrative: severe stomach pains; diarrhea; This is a spontaneous report from a contactable consumer (patient himself). A 59-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm right on 08Jun2021 15:30 (Batch/Lot Number: EW0180) (at the age of 59-year-old) as unknown, single dose for covid-19 immunisation. Medical history included asthma (the patient was diagnosed 10-15 years ago). It takes certain things to bring on asthma attacks, like a cat will do it. patient tries to avoid certain things. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No adverse event prior vaccinations. The patient stated that, he was wondering if anyone else reported side effects 2 and a half days after receiving the COVID shot. Patient reports that he got the shot on Tuesday afternoon (08Jun2021), the next two days was nothing, the patient was fine when he woke up on Friday morning (11Jun2021, 5:00) with severe stomach pains and he has had diarrhea for 4 days. Patient reports that, the diarrhea was starting to clear up a little bit, but still going to the bathroom and still had pretty severe stomach pains, in his lower stomach. The stomach pains were ongoing, they were not as often. They were still as strong, they were less, verified then as persisting. Patient reports that, he had gone to the bathroom like 17 times since like Friday, 11Jun2021. That was totally unusual, he was a day guy. Patient states that, it was clearing up and he was starting to return to regular stools. The patient went to work and was unsure how he got through the day. He tried to hide holding his belly, he has been in bed all weekend. The patient reports that, he got a physical a month ago and his annual physical was ok and a bunch of blood tests and they were fine. The patient states after physical he was signed up a bunch of tests to see if he had a risk for aneurysms. The patient reported that "sonograms and stuff" and that he did have a test down around my belly and such he had received 6 or 7 tests ultrasounds on different parts of the body looking for certain blockages and stuff but he had not received the results yet. He also shared that he didn't get the flu shot and declined the shingles shot at his last physcial, about a month and half ago. The patient confirms he received all tests occurred prior to receiving the COVID 19 vaccine. The outcome of the events severe stomach pains was not resolved and diarrhea was resolving.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Dizziness, Heart rate increased
Clinical narrative: She read in the Fact sheet that this could be a severe allergic reaction; shivering; temp was up; pale; dizzy; elevated heart rate; weakness; muscle ache pains; Woke up in the middle of the night; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer (patient).  A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 08Jun2021 (at the age of 20-yearsr-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on Jun2021, the patient experienced woke up in the middle of the night with shivering, temp was up, was pale, dizzy, elevated heart rate, weakness, muscle ache pains trying to calm down, but trying to get to relax from shaking/shivering. She read in the Fact sheet that this could be a sever allergic reaction and was wondering if she should received the second dose of the vaccine. As noted in the Fact Sheet for Recipients, should not get the Pfizer-BioNTech COVID-19 Vaccine if the patient had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the events were unknown.   Information regarding Lot/Batch number has been requested
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Myalgia, Pallor, Sleep disorder
Clinical narrative: She read in the Fact sheet that this could be a severe allergic reaction; shivering; temp was up; pale; dizzy; elevated heart rate; weakness; muscle ache pains; Woke up in the middle of the night; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer (patient).  A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 08Jun2021 (at the age of 20-yearsr-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on Jun2021, the patient experienced woke up in the middle of the night with shivering, temp was up, was pale, dizzy, elevated heart rate, weakness, muscle ache pains trying to calm down, but trying to get to relax from shaking/shivering. She read in the Fact sheet that this could be a sever allergic reaction and was wondering if she should received the second dose of the vaccine. As noted in the Fact Sheet for Recipients, should not get the Pfizer-BioNTech COVID-19 Vaccine if the patient had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the events were unknown.   Information regarding Lot/Batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Fatigue, Headache, Laboratory test
Clinical narrative: severe headaches; nauseous for 24 hours a day basically; throwing up periodically; now worse and worse and worse/progressively getting worse; I'm exhausted, no energy whatsoever; I'm exhausted, no energy whatsoever; I've lost about thirty pounds in the last month; This is a spontaneous report from a non-contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 26Feb2021 as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 Immunization and the patient had no reaction on exposure to vaccine. The patient reported, she had been progressively getting worse. Had been to the doctor and they aren't sure what's going on with it. She has experienced severe headaches, nauseous for 24 hours a day basically, throwing up periodically and now worse and worse and worse, exhausted, no energy whatsoever, lost about thirty pounds in the last month. She had various tests and they haven't been able to figure it out. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting, Weight decreased
Clinical narrative: severe headaches; nauseous for 24 hours a day basically; throwing up periodically; now worse and worse and worse/progressively getting worse; I'm exhausted, no energy whatsoever; I'm exhausted, no energy whatsoever; I've lost about thirty pounds in the last month; This is a spontaneous report from a non-contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 26Feb2021 as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 Immunization and the patient had no reaction on exposure to vaccine. The patient reported, she had been progressively getting worse. Had been to the doctor and they aren't sure what's going on with it. She has experienced severe headaches, nauseous for 24 hours a day basically, throwing up periodically and now worse and worse and worse, exhausted, no energy whatsoever, lost about thirty pounds in the last month. She had various tests and they haven't been able to figure it out. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: very tired; headache; Arm was very sore; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in arm left in the morning on 04Jun2021 as a single dose for COVID-19 immunisation. Medical history included stage 3 chronic kidney disease from May2021 and was ongoing; High blood pressure diagnosed at the end of Feb2021 or beginning of Mar2021 and was ongoing; High cholesterol diagnosed at the end of Feb2021 or beginning of Mar2021 and was ongoing; Acid reflux from unspecified date in 2021 was ongoing and acid reflux diagnosed at the end of Feb2021 or beginning of Mar2021; pneumonia from on an unknown date in Jan2021. He reported that he was in the hospital the first week of Jan2021, on 07Jan2021 or 08Jan2021 the time, he didn't know that it shut down his immune system and his kidneys took a bigger hit than they already had, and he had pneumonia. He reported that he was in the hospital for a good 8 or 9 days and shortly after he was discharged and after that he started the medications for blood pressure, cholesterol, and acid reflux. He reported that the biggest thing was that he had to wait until his doctor cleared him to get the Covid-19 vaccine as he has some other medical issues and once his doctor said to get the Covid-19 vaccine, he got it. Concomitant medications included amlodipine besilate (Film-coated tablet) taken 10 mg once daily for blood pressure from 2021 and ongoing; atorvastatin taken 20mg once daily for Cholesterol abnormal from 2021 and was ongoing; pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40) taken 40mg once daily for acid reflux from an unspecified start date and was ongoing. The patient's arm was very sore on 04Jun2021. The patient was very tired on 05Jun2021 and had headache on 05Jun2021. The outcome of the events was recovered on an unknown date in Jun2021.   Follow up activities has been raised.
Sex: F
Vaccine: COVID19
Symptoms: Lyme disease, Pain
Clinical narrative: started developing terrible pain; concerned about Lyme's diseases; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age reported for herself that she received second dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration as single dose for COVID-19 immunization. Medical history reported was ongoing rheumatoid arthritis. Concomitant medications reported was tofacitinib citrate (XELJANZ XR) for rheumatoid arthritis. Patient previously took first dose of bnt162b2 on an unspecified date for COVID-19 immunization. Xeljanz XR 11mg tablets, she was taking Xeljanz XR and was off of it for 3.5 weeks when got her covid shot, during that time she was in great pain because of the arthritis. Caller clarified she was Off of Xeljanz XR for a week, she had the covid shot, and then she stayed off Xeljanz XR for 1 more week and then went back on it. The Same thing happened with the second shot, she went off of Xeljanz XR for the second covid shot and was then only back on the Xeljanz XR for a short period of time because she started developing terrible pain, which she dealt with and took Advil to managed. Now with being told to go off the Xeljanz XR for 5 days, she has already started the Doxycycline and was said to go back on Xeljanz XR in 5 days. They added Zithromax 250mg once a day. Caller asked was that too much medication at one time. Caller explained that she was prescribed the Doxycycline and Zithromax because she was bitten by a tick, and so they are concerned about Lyme's diseases. Caller stated that she was practically in tick heaven. Outcome of the events was unknown.  No follow-up attempts possible. No further information expected. Information about Lot/batch number is requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia, Sleep terror, Somnolence
Clinical narrative: Fever; Dizziness; Headache; Night terrors; Slept all day; This is a spontaneous report received from a contactable consumer (Patient's mother). A 13-year-old male patient (reporter son) received BNT162B2 (PFIZER-BONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182) dose 2 via an unspecified route of administration on 11Jun2021 16:30 (at the age of 13-year-old) as single dose for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder). The patient's concomitant medications were not reported. No prior vaccines (4 weeks), no other medical conditions. Reporter Stated, he did not have any other medical conditions besides ADHD. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BONTECH COVID-19 VACCINE, Lot number: EW0182) received on 21May2021 at 2:00 PM, administered in left arm via IM (intramuscular) route, and experienced night terrors and fever. On an unspecified date in Jun2021, the patient experienced fever, dizziness, headache, night terrors and slept all day. The patient, on Friday afternoon at 16:30 received his second Pfizer vaccination and he had the most he had common obviously he had the fever the next day, the dizziness, the headache, slept all day, he had the fever all day, around 6:30, he had a really bad night terror and he also had that with the first injection too. Reporter stated, she thought that he just had it with the first injection and that was gonna be it but she didn't think that he was gonna have the same results with the second injection cause he had it with the first one but he had it a really bad night terrors with the second one as well so he's pediatrician wanted her to report it again with the second one because his pediatrician hadn't been seeing that with any other children. She did not know if any other parents had been reporting these. When Probed if the patient was still experiencing these problems, reporter stated that, the symptoms were improved he did not have them since. Reporter Stated, she gave him paracetamol (TYLENOL) for the fever and the headache. It was 200 mg. The outcome of events was reported as recovering.   Follow-up attempts are needed. Further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Illness, Influenza like illness, Menstrual disorder
Clinical narrative: Fever; Back pain; Sick; like the flu, a bad flu; could not get up; body looked like somebody hit her, like she had a crash , had body pain; body was very heavy; She now has her period.; This is spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a 42-year-old female patient received second dose of BNT162B2 (Pfizer Covid 19 vaccine, Solution for Injection, Batch/lot number: ER8729, Expiration date: Unknown), via an unspecified route on right shoulder on 13Apr2021 at around 16:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer Covid 19 vaccine, Solution for Injection, LOT: ER8727, Expiration date: Unknown) on 23Mar2021 at around 16:00, on right shoulder, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Family history included diabetes (mother) and high cholesterol (husband) and prostate cancer (Father-in-law). She received the vaccine at like 2:00pm or 3:00pm. Initially reported as around 2:00 or 3:00pm; but when time of administration later queried reported she thinks they were both at the same time, like 3:00 or 4:00pm, thinks it was around 4:00pm By 9:00pm that day, her body looked like somebody hit her, like she had a crash on 13Apr2021. After the vaccine, she was sick for one day on 13Apr2021. She had a fever, and was like the flu, a bad flu on 14Apr2021 and she could not get up on 13Apr2021. Was like fever, body pain, and couldn't get up, she was very sick. After 24 hours, it was like nothing happened. On 13Apr2021, the back pain was a lot and on an unspecified date in 2021, her body was very heavy but had no headaches. She preferred being in bed. She had a fever at night, like at midnight. She didn't take any medicine. The next day, around 3:00pm, she took Tylenol and at about 7:00pm, it was like nothing happened, like she didn't receive the shot. It was very crazy. Like 24 hours after, she didn't feel anything. She thinks this was normal. The fever started in the middle of the night, around midnight, 3:00am. She does not remember she was in bed. The fever came and would go out and would come and go again. Was only for one night. On an unspecified date in 2021, She now has her period. The clinical outcome of the event was didn't feel anything after 24 hours (13Apr2021) and thinks this is normal, at about 19:00 on 14Apr2021 it was like nothing happened, like she didn't receive the shot, fever, she was sick, like the flu, a bad flu, body looked like somebody hit her, like she had a crash, had body pain was recovered on 14Apr2021 and events back pain, couldn't get up, body was very heavy, She now has her period was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain, Pyrexia
Clinical narrative: Fever; Back pain; Sick; like the flu, a bad flu; could not get up; body looked like somebody hit her, like she had a crash , had body pain; body was very heavy; She now has her period.; This is spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a 42-year-old female patient received second dose of BNT162B2 (Pfizer Covid 19 vaccine, Solution for Injection, Batch/lot number: ER8729, Expiration date: Unknown), via an unspecified route on right shoulder on 13Apr2021 at around 16:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer Covid 19 vaccine, Solution for Injection, LOT: ER8727, Expiration date: Unknown) on 23Mar2021 at around 16:00, on right shoulder, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Family history included diabetes (mother) and high cholesterol (husband) and prostate cancer (Father-in-law). She received the vaccine at like 2:00pm or 3:00pm. Initially reported as around 2:00 or 3:00pm; but when time of administration later queried reported she thinks they were both at the same time, like 3:00 or 4:00pm, thinks it was around 4:00pm By 9:00pm that day, her body looked like somebody hit her, like she had a crash on 13Apr2021. After the vaccine, she was sick for one day on 13Apr2021. She had a fever, and was like the flu, a bad flu on 14Apr2021 and she could not get up on 13Apr2021. Was like fever, body pain, and couldn't get up, she was very sick. After 24 hours, it was like nothing happened. On 13Apr2021, the back pain was a lot and on an unspecified date in 2021, her body was very heavy but had no headaches. She preferred being in bed. She had a fever at night, like at midnight. She didn't take any medicine. The next day, around 3:00pm, she took Tylenol and at about 7:00pm, it was like nothing happened, like she didn't receive the shot. It was very crazy. Like 24 hours after, she didn't feel anything. She thinks this was normal. The fever started in the middle of the night, around midnight, 3:00am. She does not remember she was in bed. The fever came and would go out and would come and go again. Was only for one night. On an unspecified date in 2021, She now has her period. The clinical outcome of the event was didn't feel anything after 24 hours (13Apr2021) and thinks this is normal, at about 19:00 on 14Apr2021 it was like nothing happened, like she didn't receive the shot, fever, she was sick, like the flu, a bad flu, body looked like somebody hit her, like she had a crash, had body pain was recovered on 14Apr2021 and events back pain, couldn't get up, body was very heavy, She now has her period was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood test, Impaired work ability, Loss of consciousness, Memory impairment
Clinical narrative: Can't stay awake and she is falling asleep; keeps forgetting things; She literally can't work, can't stay awake and she is falling asleep.; Passed out; Memory loss; This is a spontaneous report from a contactable consumer (patient). A 31-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 09Jun2021at 15:00 (age at vaccination was 31 years) as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization and no reaction on previous exposure to first vaccine. It was reported that patient was calling about the covid vaccine. She talked to someone earlier and is trying to figure out the next steps. She was having side effects. On 10Jun2021 at 10:00am, patient was literally could not work, could not stay awake and she was falling asleep then on an unspecified date in Jun2021 the patient experienced memory loss and was passed out in her car and visited the ER and she choose to go home, later she could not stay awake and on 10Jun2021 at 10:00am, she kept forgetting things and scheduled to visit a neurologist. Patient stated that she has never had this before, until last Thursday. Patient had blood test she clarified that it was inconclusive. Patient was taking covid vaccine because of her job she works with kids. Patient stated reason for no lot number of covid vaccine was other. Patient initially stated she has her vaccination card but not with her and then stated she does not know where she put them. The outcome of the events passed out, memory loss was unknown and outcome of the other events was not recovered.  Information about batch/lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Can't stay awake and she is falling asleep; keeps forgetting things; She literally can't work, can't stay awake and she is falling asleep.; Passed out; Memory loss; This is a spontaneous report from a contactable consumer (patient). A 31-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 09Jun2021at 15:00 (age at vaccination was 31 years) as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization and no reaction on previous exposure to first vaccine. It was reported that patient was calling about the covid vaccine. She talked to someone earlier and is trying to figure out the next steps. She was having side effects. On 10Jun2021 at 10:00am, patient was literally could not work, could not stay awake and she was falling asleep then on an unspecified date in Jun2021 the patient experienced memory loss and was passed out in her car and visited the ER and she choose to go home, later she could not stay awake and on 10Jun2021 at 10:00am, she kept forgetting things and scheduled to visit a neurologist. Patient stated that she has never had this before, until last Thursday. Patient had blood test she clarified that it was inconclusive. Patient was taking covid vaccine because of her job she works with kids. Patient stated reason for no lot number of covid vaccine was other. Patient initially stated she has her vaccination card but not with her and then stated she does not know where she put them. The outcome of the events passed out, memory loss was unknown and outcome of the other events was not recovered.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Tinnitus
Clinical narrative: Head ringing; Faint ringing in both his ears; This is a spontaneous report from a contactable consumer (patient, reported himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 02Jun2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications, investigation assessment and other products were not reported. Patient previously took chemo treatment 2 years ago which caused head ringing, but it did not last longer. The patient stated that he looked at all the sheets and he did not have any of the side effects listed on the sheets. On an unknown date in Jun2021, he had a bit of head ringing and might be a day or two later he started to hear little bit of faint ringing in both of his ears, especially if things were quiet. He did not know if this was due to bit damp weather but the only thing, he had different in the last few weeks was getting his first vaccine. The patient stated that it was just weird, and he feels the chemo was all out of his system by now a year and a half later. The outcome of both the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces soft, Nausea, Pollakiuria
Clinical narrative: feeling a sense of nausea; diarrhea, system is flushed out; stool is soft and at one point, it was a little soupy; he is urinating a lot also; This is a spontaneous report from a contactable male consumer (patient) reported for himself. A male patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: unknown), via unspecified route, administered on unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient's medical history include muscular dystrophy and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date and no other details available except patient showed no reactions. On unspecified date, after the vaccination, the patient experienced feeling a sense of nausea, diarrhoea- system flushed out, soft stool and at one point, it was a little soupy and lot of urination. He received the second shot last Tuesday and felt nauseous. before and after taking the shot, he was advised to increase fluid intake, so he has been drinking a lot of water and some Gatorade. The patient stated that he had going to the bathroom a lot, it was not uncontrollable diarrhoea, but he was going to the bathroom and his system flushes out. He was little concerned and felt nausea because this happened before. he stayed in on Wednesday and Thursday, he didn't do much of anything. Then went to the gym on Friday. His doctor told him it could possibly be the fluids that he was drinking, so that might may take him to the bathroom even more. Patient said when he goes to the bathroom, it's like his system consistently flushes out. His stool was soft and at one point, it was a little soupy. Normally, he doesn't go the bathroom every day. Now, he was going to the bathroom and he was urinating a lot also. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Pain in extremity
Clinical narrative: little pain in his arm and it was warm, gained pain in his legs; little pain in his arm and it was warm; Friday night the caller had a reoccurrence and had a terrible pain in his left knee and radiated in his leg; This is a spontaneous report from a contactable consumer or other non HCP (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing arthritis in his right knee. The patient's concomitant medications were not reported. It was reported that, the patient was calling about the covid 19 vaccine. The patient got his first shot and had no problem. The next day, the patient had a little pain in his arm, and it was warm. Late in the day, the patient gained pain in his legs, his legs aren't good to start with. It was an uncomfortable night and then the patient was back to himself the next day as far as his legs go. The patient asked can side effects occur 8 to 9 days after the shot. Friday night the patient had a reoccurrence and had a terrible pain in his left knee and radiated in his leg. The caller has arthritis in his right knee already. The next day, the pain was gone. Sunday, the patient was cooking, and he had pain in his right knee. The pain was so bad that the caller had to stop cooking and put a heating pad on it. The pain was manageable. The patient wants to know about this because he gets his second shot next week, especially if it was a result of the first shot. The outcome of the events was not recovered.   Information on the lot/batch number has been requested. The patient received the treatment for the knee pain.