chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Heart rate increased, Hypoaesthesia, Nausea, Oropharyngeal pain
Clinical narrative: numbness; tingling in ankles and lower legs; Low grade fever; Nauseous; Major back tension; throat has gotten suddenly sore; not her face per se, but her throat, around her glands is swelling; difficulty swallowing, it is not blocked or anything, but is definitely not her normal; loss of feeling in lower calves and ankles; fast heartbeat; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported ) via an unspecified route of administration on 11Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection) via unknown route of administration as 1st dose, single dose for covid-19 immunization and experienced a little tiredness. Following the second dose she waited 30 minutes. Probably about 1 hour and 15 minutes later when she got home On 11Jun2021, the patient experienced numbness, tingling in ankles and lower legs, low grade fever, nauseous, major back tension, throat has gotten suddenly sore, not her face per se, but her throat, around her glands was swelling, difficulty swallowing, it was not blocked or anything, but was definitely not her normal, loss of feeling in lower calves and ankles, fast heartbeat. The events were considered as non serious. She didn't know if allergic reaction included swelling of the throat or face or just one. She was not too concerned about the fever or tension-like feeling throughout her back. The numbness in legs and swelling of the throat; she did not see side effects being any sort of loss of feeling in lower calves and ankles. She asked do you guys cover the cost of the emergency room visit. She mentioned when she goes to the emergency room and tells them; she has a fast heartbeat as well; did she submit that emergency room ticket to Pfizer or not. She mentioned the information sheet in front of her, asked was that who she should contact regarding emergency room cost coverage. She reported her dad was an attorney and she would just have him handle this. She did not need this in her life; she had no expectation of it being this bad considering the first one was maybe a little tiredness. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pharyngeal swelling, Pyrexia, Sensory loss, Tension
Clinical narrative: numbness; tingling in ankles and lower legs; Low grade fever; Nauseous; Major back tension; throat has gotten suddenly sore; not her face per se, but her throat, around her glands is swelling; difficulty swallowing, it is not blocked or anything, but is definitely not her normal; loss of feeling in lower calves and ankles; fast heartbeat; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported ) via an unspecified route of administration on 11Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection) via unknown route of administration as 1st dose, single dose for covid-19 immunization and experienced a little tiredness. Following the second dose she waited 30 minutes. Probably about 1 hour and 15 minutes later when she got home On 11Jun2021, the patient experienced numbness, tingling in ankles and lower legs, low grade fever, nauseous, major back tension, throat has gotten suddenly sore, not her face per se, but her throat, around her glands was swelling, difficulty swallowing, it was not blocked or anything, but was definitely not her normal, loss of feeling in lower calves and ankles, fast heartbeat. The events were considered as non serious. She didn't know if allergic reaction included swelling of the throat or face or just one. She was not too concerned about the fever or tension-like feeling throughout her back. The numbness in legs and swelling of the throat; she did not see side effects being any sort of loss of feeling in lower calves and ankles. She asked do you guys cover the cost of the emergency room visit. She mentioned when she goes to the emergency room and tells them; she has a fast heartbeat as well; did she submit that emergency room ticket to Pfizer or not. She mentioned the information sheet in front of her, asked was that who she should contact regarding emergency room cost coverage. She reported her dad was an attorney and she would just have him handle this. She did not need this in her life; she had no expectation of it being this bad considering the first one was maybe a little tiredness. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chest pain, Drug hypersensitivity, Feeling abnormal, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734) via an unspecified route of administration on 20May2021 (at the age of 52-years-old) as 2nd dose single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date in Apr 2021 for COVID-19 immunization. On unknown date (reported as after second dose), the patient had an allergic reaction on her skin and had to go to the emergency room. A week after her second dose (exact date unknown), the patient felt a pain in her chest and a rash next to the chest. Rash was a little better but the same rash she was on her body, she was now seeing on her fingers. On an unknown date, three weeks ago, went to the emergency room. Before she went to the emergency room patient went to urgent care and went twice and because she felt something like temperature and something coming up to her brain. Patient was treated with steroids and cortisone for rash. The treatment medication has affected her stomach, hairs falling out, and her skin was dry- clarifies the medication they gave her for the rash. Reporter seriousness for allergic reaction on her skin, rash on chest, pain in chest was unspecified. The outcome for all events was not resolved. Follow-up attempts are needed. Further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration at arm right (upper) (at the age of 63-year-old) on 09Jun2021 as single dose for COVID-19 immunization. The patient medical history includes COVID-19 (indication because the caller had COVID-19 before prior to ever receiving the first dose Pfizer Covid vaccine and doesn't want to get Covid again). The patient's concomitant medications were not reported. On 09Jun2201, it was stated that the injection site was turning red began within two hours of getting home after receiving the first dose. The events were ongoing and it had worsened. On 10Jun2021 around 18:00, the patient began to experience having really bad swelling on the arm and the arm was really tender and had severe pain. The patient also stated the swelling on the arm had worsened. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unknown date, the patient had experienced heart palpitations since receiving the vaccine. He described them as similar to how his heart might feel after a long run or exercise, but he feels it while he was at rest.  The outcome of event was unknown.  Information about lot/batch number is requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus, Urticaria
Clinical narrative: I did feel like a sudden sharp pain in my arm like a burning pain; I did feel like a sudden sharp pain in my arm like a burning pain; My body started feeling itchy mainly like my lower leg, my thighs and now it's at my arms; feel a little small wheels like small little hives; This a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (Pfizer COVID Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date (NDC/UPC number: Unknown, Expiry Date: Unknown) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt like a sudden sharp pain in arm like a burning pain, body started feeling itchy mainly like lower leg and thighs, and hives. Consumer stated, "did not have card right now". Consumer stated, "had COVID vaccine, believed it was Thursday evening, initially patient was okay. After 15 minutes the patient felt like a sudden sharp pain in arm like a burning pain then it went away, but today at work, would be around 5'O clock 5:30 body started feeling itchy mainly like lower leg, thighs and now it was at arms and even like legs there was like a feel a little small wheels like small little hives. The patient wanted to know that whether it was a normal side effect". Consumer stated, "just calling to know if it was a normal side effect that other people had like reported because it just said it was genuine little bit, and wanted to know if it was something people have reported or not." Consumer was informed about Pfizer Medical information department and was provided with the number. Consumer was unwilling to complete the report, hence limited information was available over the call. Outcome of the events was unknown.  Information about the lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Electrocardiogram
Clinical narrative: It was a mild pain in his chest and when he was breathing; Fever; Had inflammation from the vaccine; His D-dimer was elevated; This is a spontaneous report from a contactable consumer. A 12-year-old male (same age at vaccination) patient (reporters son) received second dose of bnt162b2 (BNT162B2, Solution for injection, lot: EW0177) via unspecified route of administration on 08Jun2021 around 1 pm as single dose in upper arm for COVID-19 immunization. Medical history was not reported. concomitant medications reported was Children's Multivitamins. As per reporter, Well, it's a multivitamin, so it has a bunch in it. It's a Children's Multivitamins. The patient previously took first dose of bnt162b2 (Lot: EW0183) on 18May2021 at the age of year old in upper arm around 11:30. No prior Vaccinations (within 4 weeks) was reported. As per reported, reporter stated, I was calling I have the, I guess my son received the COVID Vaccination (captured as suspect) and I have the care sheet and it said to call if you had experienced a reaction, so I was calling to report the reaction that he had. Reporter stated, He has it wasn't (incomplete sentence) I guess it was a mild pain in his chest and when he was breathing. Reporter also stated, "You know what, he had a fever also I don't know if you wanted to add that. No, I guess I don't know if you want, the doctor at the ER said that he had inflammation from the vaccine that it was believe me I guess that was his conclusion. Reporter took him after the vaccine because the next day he was having problems we took him to the emergency room, and they did an ECG they did chest X-rays they did a CT scan and he had blood work. Result of Test included everything was normal except for his blood work, his D-dimer was elevated. Regarding weight reporter stated maybe 80 pounds. He got lab test after the vaccine. Before the vaccine he didn't get anything. Outcome of events was reported as recovering.   No follow-up attempts possible. No further information expected. Information on Lot/Batch number was available. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Pyrexia
Clinical narrative: It was a mild pain in his chest and when he was breathing; Fever; Had inflammation from the vaccine; His D-dimer was elevated; This is a spontaneous report from a contactable consumer. A 12-year-old male (same age at vaccination) patient (reporters son) received second dose of bnt162b2 (BNT162B2, Solution for injection, lot: EW0177) via unspecified route of administration on 08Jun2021 around 1 pm as single dose in upper arm for COVID-19 immunization. Medical history was not reported. concomitant medications reported was Children's Multivitamins. As per reporter, Well, it's a multivitamin, so it has a bunch in it. It's a Children's Multivitamins. The patient previously took first dose of bnt162b2 (Lot: EW0183) on 18May2021 at the age of year old in upper arm around 11:30. No prior Vaccinations (within 4 weeks) was reported. As per reported, reporter stated, I was calling I have the, I guess my son received the COVID Vaccination (captured as suspect) and I have the care sheet and it said to call if you had experienced a reaction, so I was calling to report the reaction that he had. Reporter stated, He has it wasn't (incomplete sentence) I guess it was a mild pain in his chest and when he was breathing. Reporter also stated, "You know what, he had a fever also I don't know if you wanted to add that. No, I guess I don't know if you want, the doctor at the ER said that he had inflammation from the vaccine that it was believe me I guess that was his conclusion. Reporter took him after the vaccine because the next day he was having problems we took him to the emergency room, and they did an ECG they did chest X-rays they did a CT scan and he had blood work. Result of Test included everything was normal except for his blood work, his D-dimer was elevated. Regarding weight reporter stated maybe 80 pounds. He got lab test after the vaccine. Before the vaccine he didn't get anything. Outcome of events was reported as recovering.   No follow-up attempts possible. No further information expected. Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site mass
Clinical narrative: it has been same but different of course they are little black and blue but not the same, the circles are round are still as dark; I have a very strange circles that goes around injection site; like a inner circle that the medium circle; looks like galaxies it looks like a moon and then around it there's a circle; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old female patient received BNT162B2(COMIRNATY, Formulation: solution for injection, Lot number: was not reported), via an unspecified route of administration on 27May2021 14:30, as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced it has been same but different of course they are little black and blue but not the same, the circles are round are still as dark and she have a very strange circles that goes around injection site; like a inner circle that the medium circle; looks like galaxies it looks like a moon and then around it there's a circle. It was reported as, she have a very strange circles that goes around injection site, it's not like the black and blue that's been happened, the needle went in very very fast and that was painful but she had circles around the injection site like a inner circle that the medium circle and it's still the same as of now almost 2 weeks. The consumer stated, she didn't receive treatment, because there's no pain it doesn't hurt. The outcome of the events were not recovered.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy, Scan
Clinical narrative: I still have a quite enlarged superior super clavicle glands on my shoulder blades on both sides and they are quite large; This is a spontaneous report from a contactable female consumer reported for herself. A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8737), via unspecified route, administered in left arm on 08Apr2021 (at the age of 69-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198), via unspecified route, administered in right arm on 05Mar2021 (at the age of 69-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications include Tramadol, Lyrica, Diclofenac, Arthrotec, Atorvastatin and Lipitor. No other vaccines were taken prior 4 weeks. On an unspecified date, after the vaccination, the patient experienced a quite enlarged superior super clavicle glands on her shoulder blades on both sides and they are quite large and enlarged lymph nodes. Consumer said even about 3 weeks after vaccination, still have a quite enlarged superior super clavicle glands on my shoulder blades on both sides and they are quite large and she have never had anything like that before and she went to her regular doctor and performed a scan with nothing abnormal, upon her reference in internet she found this happens in other women as a side effect of the vaccine. She was planning for an MRI because the first lab and the scan didn't show anything, and so doctor have ordered an MRI. Patient lab investigation data include blood test on unspecified date with results unknown and scan with results unknown. No treatment options were taken. The outcome of the event was not recovered.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Pain, Vomiting
Clinical narrative: body was aching; Diarrhoea; and I felt like I got to throw up but nothing was coming up; I was not feeling well; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunization. The pa-tient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot: Unknown) on 20May2021 via an unspecified route of administration for COVID-19 immunization. Patient stated, I got my second shot on Thursday but, On unknown date my body was aching and I got Diarrheas and I felt like I got to throw up but nothing was coming up and now since yesterday it as worse as today. Well that did not work for me because I was not feeling well. Reported that, I need to speak to somebody because this was not normal. I had my first shot on May 20th and then I had my second shot. Consumer was suggested to reach out to the nearest ER or call in case of urgency. The outcome of the events was reported as unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: sister woke up from sleep every hour with a fever; sister woke up from sleep every hour with a fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the sister woke up from sleep every hour with a fever. The outcome of event was unknown.  Follow-up attempts are possible. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Feeling abnormal, Heart rate increased, Illness
Clinical narrative: I have fast heartbeat, my heart is just beating fast; Feeling sick, It is not making me feel good right now; she said that she is feeling weird/ I didn't feel like this was normal, this is weird; Feels like falling over; I think she is experiencing dizziness; Don't feel like to go back to take the other one because this one is making me feel sick, it is not making me feel good, feel like I need to go to the emergency; This is a spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, (Batch/Lot Number: Unknown, Expiration date: Unknown), dose 1 via an unspecified route of administration on 12Jun2021 11:00 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Stated, she was calling was because she wants to know what to do after getting the first dose since she was feeling some adverse reactions, on 12Jun2021 at 11:00 she said that she was feeling weird and feels like falling over, so she think she was experiencing dizziness but she have not got any information from her because she refused to provide. Stated, Yes she have fast heartbeat, her heart was just beating fast and she start feeling sick but normally people say that the second dose was supposed to make her feel sick on 12Jun2021 at 11:00. Why was the first dose doing this? Can you just take one of them then she do not think she was going to take the second one then. Stated, No, she want to know if she can only take one, she do not feel like to go back to take the other one because this one was making her feel sick, it was not making her feel good right now on 12Jun2021 at 11:00. Right now she feel like she need to go to the emergency or something because she was not feeling good after she take this one. Again confirmed the name of the vaccine as Pfizer COVID 19 Vaccine. They will call then back and 'if she still don't feel' better she may be, then she should be calling, it feels like she have to go to the emergency. Stated, Yes go ahead if she can, she was feeling really dizzy right now, she hope it goes away, she so 'just pray' it goes away because she did not feel like this was normal, this was weird on 12Jun2021 at 11:00. Consumer was advised to visit the emergency room if not feeling well. Stated, "she do not have anything more, she don't feel, she don't have anything more, that was It. Outcome of the events are reported as unknown at this point of time.   Follow-up attempts are needed: Information about batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I have fast heartbeat, my heart is just beating fast; Feeling sick, It is not making me feel good right now; she said that she is feeling weird/ I didn't feel like this was normal, this is weird; Feels like falling over; I think she is experiencing dizziness; Don't feel like to go back to take the other one because this one is making me feel sick, it is not making me feel good, feel like I need to go to the emergency; This is a spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, (Batch/Lot Number: Unknown, Expiration date: Unknown), dose 1 via an unspecified route of administration on 12Jun2021 11:00 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Stated, she was calling was because she wants to know what to do after getting the first dose since she was feeling some adverse reactions, on 12Jun2021 at 11:00 she said that she was feeling weird and feels like falling over, so she think she was experiencing dizziness but she have not got any information from her because she refused to provide. Stated, Yes she have fast heartbeat, her heart was just beating fast and she start feeling sick but normally people say that the second dose was supposed to make her feel sick on 12Jun2021 at 11:00. Why was the first dose doing this? Can you just take one of them then she do not think she was going to take the second one then. Stated, No, she want to know if she can only take one, she do not feel like to go back to take the other one because this one was making her feel sick, it was not making her feel good right now on 12Jun2021 at 11:00. Right now she feel like she need to go to the emergency or something because she was not feeling good after she take this one. Again confirmed the name of the vaccine as Pfizer COVID 19 Vaccine. They will call then back and 'if she still don't feel' better she may be, then she should be calling, it feels like she have to go to the emergency. Stated, Yes go ahead if she can, she was feeling really dizzy right now, she hope it goes away, she so 'just pray' it goes away because she did not feel like this was normal, this was weird on 12Jun2021 at 11:00. Consumer was advised to visit the emergency room if not feeling well. Stated, "she do not have anything more, she don't feel, she don't have anything more, that was It. Outcome of the events are reported as unknown at this point of time.   Follow-up attempts are needed: Information about batch/ lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Chills, Headache
Clinical narrative: I went to the emergency room, I was diagnosed with bronchitis; I still have headache and chill eighteen days ago; I still have headache and chill eighteen days ago; This is a spontaneous report from a contactable consumer(Patient). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0177) (at age of 50-year-old) via an unspecified route of administration on 25May2021 as first dose, single dose for covid-19 immunization. Medical history included pulmonary embolism. Concomitant medications included apixaban (ELIQUIS) for thrombosis, escitalopram oxalate (LEXAPRO) for depression, buspirone hydrochloride (BUSPAR) for an unspecified indication. The patient did not receive any other vaccine with 4 weeks of vaccine administration. The patient went to emergency room after getting the vaccine on 25May2021 and was diagnosed with bronchitis. It was reported that the patient still had headache and chill from eighteen days. The patient stated that she got Bronchitis from the vaccine. As per response received, the patient should not get the vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason should be made by healthcare provider. The patient did not understand and trying to figure out if she supposed to get the next vaccine. Therapeutic measures were taken as prednisone 20 mg, twice a day. The outcome of the events was unknown. Information on batch/lot no. are available. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, Skin disorder
Clinical narrative: left me with some type of hardness on my skin; Muscle ache; Tiredness; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection, Batch/Lot Number: EW0179), via intramuscular route of administration, administered in Arm Right on 10May2021 as 1st dose, single dose for covid-19 immunisation. Patient received second dose via intramuscular route of administration, administered in arm right on 03Jun2021 (Lot number: EW0180) as single dose for covid-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine because patient was really skeptical about vaccine. The patient confirmed that he had taken both the shots. The patient's medical history and concomitant medications were not reported. The patient confirmed that he experienced side effects only after the first shot. The patient really quite got the alternative measures though but was really concerned about the vaccine that he received recently. On 11May2021 the patient experienced some type of hardness on skin, muscle ache, tiredness, arm pain. Patient was saying he was afraid for his life now. He wanted to know what was going on. Patient had been okay after the second dose, but wanted to know what could he do? He was quite careful for his life now. When probed if he was still experiencing the problem he stated, he was okay now. He thought the second time it was like some arm pain. He thought he had doubt after seeing all this stuff all over the news and talk this hard stuff and potentially putting the life in danger. He did not receive any treatment for the events, he just rested. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I think the second time it is like some Arm Pain; This is a spontaneous report from a contactable consumer (patient himself).   A 29-year-old male patient received 2nd dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection), via intramuscular route of administration, administered in arm right on 03Jun2021 (Lot number: EW0180) (at the age of 29-year-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection, Batch/Lot Number: EW0179), via intramuscular route of administration, administered in arm right on 10May2021 as 1st dose, single dose for covid-19 immunisation and experienced left me with some type of hardness on my skin, muscle ache, tiredness and arm pain. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine because patient was really skeptical about vaccine. The patient confirmed that he had taken both the shots. On an unspecified date, the patient reported that "I think the second time it is like some Arm Pain". He thought he had doubt after seeing all this stuff all over the news and talk this hard stuff and potentially putting the life in danger. He did not receive any treatment for the events, he just rested. At the time of reporting, the outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild soreness at the injection site; This is a spontaneous report from a contactable consumer (patient's parent).  A 14-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry date was not reported) as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry date was not reported) as single dose for covid-19 immunisation and expereinced mild soreness at the injection site. It was reported that the patient received the Pfizer vaccine yesterday afternoon (his second shot) and developed mild soreness at the injection site. Outcome of the event mild soreness at the injection site was reported as unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: that has a pink spot line under his armpit area and lymph node; he is in tremendous amount of pain; This is a spontaneous report from a contactable consumer (parent). A 14-years-old male patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose number single dose for covid-19 immunization. Medical history and concomitant medications were not reported. The reporter was wondering if he can get some advice here, about the covid vaccine. (Not further clarified whether pfizer vaccine or not hence not captured in tab) The patient had a pink spot line under his armpit area and lymph node, and he was in tremendous amount of pain. And should that be normal or that severe reaction for a reaction? The reporter stated his son was about 18 hour into his injection. He was sorry, He guess he was like 32 hours into it. Reporter was informed about the role of Pfizer Medical Information. So they were closed right now. Should they call emergency room or what then, he was not sure. Reporter was advised to call 911 or nearest physician in case of any emergency. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Movement disorder, Pain in extremity
Clinical narrative: Shoulder pain that started 3 weeks ago, hurts when I sleep and now my right fingers the bones are also hurting a little bit/ his shoulders on the joint are hurting; Shoulder pain that started 3 weeks ago, hurts when I sleep and now my right fingers the bones are also hurting a little bit/ He can barely move his arms and it hurts; Shoulder pain that started 3 weeks ago, hurts when I sleep and now my right fingers the bones are also hurting a little bit; Having a hard time moving his arms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 19Apr2021, as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included atorvastatin (has been taking this for years and it was recommended by his doctor). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 29Mar2021, as a single dose for COVID-19 immunization and no reaction on previous exposure to drug. The patient stated he had bilateral shoulder pain/ shoulders on the joint were hurting that started 3 weeks ago, hurts when he sleep and now his right fingers the bones were also hurting a little bit and asked was this a normal side effect. He stated he just went to (withheld) hospital a month ago where he got his first shot and three weeks later got his second shot and now his elbows, not his elbows, his shoulders started hurting. He stated he had a hard time moving his arms. He tried to call his doctor and his doctor was retiring. He was moving on and trying to get another doctor at (withheld). He stated he was taking Advil (Exp: Aug2022) and aspirin when it comes on. It went away but it came back. He wanted to know what to do. His doctor was telling him to get another doctor at (withheld). He was rubbing some cream on it and it went away and came back. The name of the cream was Therageist. He could barely move his arms and it hurts. He stated everything else was fine on his body. It was not getting worse, but it was not going away either. He stated he needed to call to make an appointment for a new doctor as (withheld) but he thought he will go to (withheld) instead to get in their system and fill out the paperwork. He stated he wanted to tell them his story. He stated he really just wanted to know when this will go away, as he thought it would go away after and has not. The adverse events did not require a visit to emergency room or physician office. There was a product complaint. Outcome of the event arthralgia was not recovered and for all other events, it was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Dyspnoea, Feeling jittery
Clinical narrative: weakness; aches; Jitteriness; shortness of breath; screaming headache for 4 days; sick to his stomach and not eating; sick to his stomach and not eating; not feeling well; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date, 2.5 weeks ago, as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, last Thursday, the patient experienced weakness, aches, jitteriness, shortness of breath, screaming headache for 4 days, sick to his stomach and not eating and overall, not feeling well. The patient called to ask about getting second shot, to know if his side effects are normal and how long are, they supposed to last, because he was told they could dissipate in a few days, but he was almost at 21 days now. On an unspecified date, Wednesday, it will be his recommended 21 days for second dose, but the patient was stuck in the middle on whether or not to get the second shot. The patient stated that he saw online that they were supposed to dissipate, and he was almost at the 21-day mark. He was confused on why he was still having these side effects. The patient was just an average Joe that got the vaccine, and he was feeling fine before shot. Investigation assessment was not provided. The outcome of all the events was unknown.  Information about lot/batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain
Clinical narrative: weakness; aches; Jitteriness; shortness of breath; screaming headache for 4 days; sick to his stomach and not eating; sick to his stomach and not eating; not feeling well; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date, 2.5 weeks ago, as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, last Thursday, the patient experienced weakness, aches, jitteriness, shortness of breath, screaming headache for 4 days, sick to his stomach and not eating and overall, not feeling well. The patient called to ask about getting second shot, to know if his side effects are normal and how long are, they supposed to last, because he was told they could dissipate in a few days, but he was almost at 21 days now. On an unspecified date, Wednesday, it will be his recommended 21 days for second dose, but the patient was stuck in the middle on whether or not to get the second shot. The patient stated that he saw online that they were supposed to dissipate, and he was almost at the 21-day mark. He was confused on why he was still having these side effects. The patient was just an average Joe that got the vaccine, and he was feeling fine before shot. Investigation assessment was not provided. The outcome of all the events was unknown.  Information about lot/batch number is requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur
Clinical narrative: heat murmur; This is a Spontaneous report from Pfizer sponsored. A contactable Consumer or other non-hcp (Patient) reported that a 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown and expiration date not reported) via an unspecified route of administration on 21Feb2021 (at the age of 54-years-old) as unknown, single dose for COVID-19 immunization. The patient's medical history included COVID-19 on an unspecified date in May2020. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced heat murmur and patient was asking that, was this a side effect of vaccine. The outcome of event was unknown.  Follow-up attempts are needed, information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: heaviness on my chest; shortness of breath; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team.  A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiration date was not provided), via an unspecified route of administration on 29May2021 as second dose single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. it was reported patient was always healthy. On an unspecified date, the patient experienced heaviness on my chest, shortness of breath. due to events patient was wondering about what my next plan of action should be because patient had no health insurance. Patient was scared and don't want to add anxiety to her symptoms. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Throat tightness
Clinical narrative: throat closed up; heart was racing; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-Biontech COVID-19 vaccine 3 weeks ago and upon getting home, her throat closed up and her heart was racing. Patient had to take a benadryl to get better. She wanted to know if she needs an epiphen for the 2nd dose or if she can still receive the 2nd dose after the side effects, she have experienced the side effect. Therapeutic measures were taken as a result of throat closed up and heart was racing. At the time of reporting, the outcome of events were unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable Nurse (patient). A 37-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine; solution for injection; Lot Number: EN6199), via an unspecified route of administration, on 08Mar2021, as 1st dose, single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that within the last week and a half, she had been experiencing arm pain and sensitivity at the injection site, on an unspecified date in 2021. She stated that she received one dose in each arm, in which both arms were experiencing pain. She did not have much arm pain after the first dose. On 29Mar2021, the patient received bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: ER8730), via an unspecified route of administration as 2nd dose, single dose, for Covid-19 immunization. The patient stated that she was calling about the Pfizer vaccine. she clarified she was referring to the Covid 19 vaccine. she stated she was just called because she received the Covid vaccine shot in March and she had suddenly in the last week in a half been feeling arm pain. Caller stated she got the shots in different arms but now she was having sensitivity in both sites where they put the vaccine. The patient asked if there was any more data collected on "keeping antibodies in her system." MI agent confirmed if caller is asking about the duration of protection in which caller answered yes. The patient also asked if there is a need for a booster dose (3rd dose) for the Pfizer Covid-19 vaccine. The patient was not recovered from the event arm pain after the first dose/ initial arm pain and outcome of She is having sensitivity in both sites was unknown.  Information on the lot/ batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Feeling hot, Pruritus, Rash erythematous
Clinical narrative: On 08Jun2021 she noticed red stripes on the back of both thighs and buttocks/ It's really, really red; feels warm or gets hot the red stripes will worsen/much worse when her body gets warm, like after exercise; maybe it's a little itchy in that area; Where the stripes are, the skin is rough, rougher than other parts of her skin/ rough skin is maybe like a half inch wide; This is a spontaneous report from a contactable consumer (patient, self-reported). A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7534 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 05Jun2021, as a single dose for COVID-19 immunization at clinic. The patient's medical history included hypothyroidism. Concomitant medications included levothyroxine for hypothyroidism. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 15May2021, as a single dose for COVID-19 immunization at clinic and no reaction on previous exposure to drug. Vaccine was not administered at this facility. The patient took Covid 19 vaccine due to social pressure because all of a sudden there were different rules for vaccinated and nonvaccinated people. She reported she was very healthy and believes she had a good immune system. She never got the flu vaccine and she never got the flu virus. The patient reported that on 08Jun2021, she noticed red stripes on the back of both thighs and buttocks and it's really, really red. She also mentioned that the red stripes on her thighs is "very pronounce". Whenever she exercises, feels warm or gets hot the red stripes will worsen and much worse when her body gets warm, like after exercise. She's asking if this were "burst blood vessels". Now it's starting to fade a little bit. Where the stripes were, the skin is rough, rougher than other parts of her skin. She could feel with her hand the rough skin was maybe like a half inch wide. It didn't hurt, it's just there and maybe it's a little itchy in that area. The adverse events did not require a visit to emergency room or physician office. Outcome of the events was not recovered.