chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pharyngeal swelling
Clinical narrative: Little bit of swelling in my throat; it is still 'stiff'; This is a spontaneous report from a contactable consumer. This consumer (patient) reported.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an 13Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on Mar2021, the patient experienced little bit of swelling in throat and it is still stiff. The patient reported that the patient got the Pfizer vaccine yesterday. The reporter could tell after I left, the patient felt like a little swelling in throat. Is that normal. The patient took it yesterday and the patient had like a little bit of swelling in throat. It was yesterday (13Mar2021) when the patient took it, the patient stated that it is still 'stiff' a little bit and I was wondering is that normal or what is that. The outcome of the events were unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Temperature has gone up to 99.9, It is raising up again this afternoon like 99.5, It is not super high; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old male patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunization (age at vaccination: 56-years-old). Medical history included asthma from 2018 to an unknown date, and hypertension (last 30 years). Concomitant medications included atenolol and losartan taken for hypertension, budesonide, formoterol fumarate (SYMBICORT) taken for asthma from 2018 and ongoing. On 14Mar2021 the patient experienced temperature has gone up to 99.9, it is raising up again this afternoon like 99.5, it is not super high. The patient took the vaccine to prevent from Corona Virus pandemic. The patient had not received treatment for the event. On 14Mar2021 the patient underwent lab tests and procedures which included body temperature: 99.9 and 99.5 (Temperature has gone up to 99.9, It is raising up again this afternoon like 99.5, It is not super high). The outcome of the event was not recovered.  No follow-up attempts are possible. Information about lot/ batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: she had some "sharp pain" under the scapula and didn't know why.; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9262; Expiration Date: 31May2021) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200, Expiration Date: 30Jun2021) via an unspecified route of administration on 05Mar2021 at single dose for covid-19 immunisation. The patient had rabies vaccine (She had a very bad experience 4 years ago when she got a rabies vaccine, it was given at 45°, the nurse gave the injection cutaneously, after 5 min she was so in pain.). The patient experienced some "sharp pain" under the scapula and didn't know why on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out into hives; This is a spontaneous report from a contactable consumer (Patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: En6206) dose 2 via an unspecified route of administration, administered in right arm on 06Mar2021 at 13:30 (at the age of 23-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9267) via an unspecified route of administration, on 12Feb2021 09:30 AM at single dose for COVID-19 immunisation. The patient was not COVID prior vaccination and did not test COVID post vaccination. After receiving the second dose, on 07Mar2021 at 12:00 AM, the patient broke out into hives and had them since. The patient did not receive any treatment for the vent. The clinical outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Feeling abnormal, Headache
Clinical narrative: began having a fever of 101 degrees Fahrenheit; aches and chills; aches and chills; headache and all around feels horrible; headache and all around feels horrible; cough; scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in Left Arm on 10Mar2021 (age at the time of vaccination was 56 years) at 16:00 as dose 1, single for covid-19 immunisation. Medical history and family medical history relevant to AE(s) was reported as none. There were no concomitant medications. Additional Vaccines administered on same date of the pfizer suspect were reported as none. Prior Vaccinations (within 4 weeks) were reported as none. The reporter stated he had the Pfizer COVID Vaccine on 10Mar2021 which was Wednesday and then began having a fever of 101 degrees Fahrenheit, aches and chills, a headache and all around feels horrible, had a cough and scratchy throat and all of the listed symptoms began on Sunday 14Mar2021. The reporter stated all of the symptoms were ongoing but he believes he was turning a corner and these symptoms have improved and are starting to improve. The reporter clarified to state he still does have a fever but the chills and aches and pains are not as bad as they were an hour ago which was how long he was waiting on the phone for DSU. He stated he had not had any treatment for the reported symptoms. The reporter stated that he has not had his 2nd dose of the Pfizer COVID vaccine but it was scheduled. The AE(s) did not require a visit to Emergency Room. He just called the HCP and the HCP told him to take Ibuprofen or Tylenol for fever, aches and pains and to drink plenty of water. On 14Mar2021, the patient underwent lab tests and procedures which included body temperature: 101 degrees fahrenheit (began having a fever of 101 degrees Fahrenheit). This report is not related to a study or program. No investigation Assessment was reported. The outcome of the event began having a fever of 101 degrees Fahrenheit was not recovered. The outcome of the events headache and all around feels horrible, cough and scratchy throat was unknown. The outcome of the events aches and chills was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Throat irritation
Clinical narrative: began having a fever of 101 degrees Fahrenheit; aches and chills; aches and chills; headache and all around feels horrible; headache and all around feels horrible; cough; scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in Left Arm on 10Mar2021 (age at the time of vaccination was 56 years) at 16:00 as dose 1, single for covid-19 immunisation. Medical history and family medical history relevant to AE(s) was reported as none. There were no concomitant medications. Additional Vaccines administered on same date of the pfizer suspect were reported as none. Prior Vaccinations (within 4 weeks) were reported as none. The reporter stated he had the Pfizer COVID Vaccine on 10Mar2021 which was Wednesday and then began having a fever of 101 degrees Fahrenheit, aches and chills, a headache and all around feels horrible, had a cough and scratchy throat and all of the listed symptoms began on Sunday 14Mar2021. The reporter stated all of the symptoms were ongoing but he believes he was turning a corner and these symptoms have improved and are starting to improve. The reporter clarified to state he still does have a fever but the chills and aches and pains are not as bad as they were an hour ago which was how long he was waiting on the phone for DSU. He stated he had not had any treatment for the reported symptoms. The reporter stated that he has not had his 2nd dose of the Pfizer COVID vaccine but it was scheduled. The AE(s) did not require a visit to Emergency Room. He just called the HCP and the HCP told him to take Ibuprofen or Tylenol for fever, aches and pains and to drink plenty of water. On 14Mar2021, the patient underwent lab tests and procedures which included body temperature: 101 degrees fahrenheit (began having a fever of 101 degrees Fahrenheit). This report is not related to a study or program. No investigation Assessment was reported. The outcome of the event began having a fever of 101 degrees Fahrenheit was not recovered. The outcome of the events headache and all around feels horrible, cough and scratchy throat was unknown. The outcome of the events aches and chills was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain
Clinical narrative: I am hurting in between my breast like a type of soreness but yet sometimes I feel little pain is going between my two breasts; I am hurting in between my breast like a type of soreness but yet sometimes I feel little pain is going between my two breasts; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2) formulation solution for injection, unknown dose, via an unspecified route of administration on 14Mar2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, she got the COVID Vaccine (reporting before day) yesterday and it may be about an hour and half she been having, they are not actual chest pain, but she was hurting in between her breast like a type of soreness but yet sometimes she feels little pain was going between her two breasts. She doesn't know that was why she called you. In response to further probing, consumer stated, "You know what never mind. She just holds it out." And hung up abruptly. Consumer hung up the call abruptly, hence, product details (LOT#, expiration date, NDC# and UPC#) reporter type and other details were unknown. Limited information was available over the call. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot been obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Rash all over my body and it is really itchy; This is a spontaneous report from a contactable consumer or other non-HCP (Patient).  A 44-years-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6207 and expiration date was 31Jul2021) via an unspecified route of administration on 14Mar2021 (age at the time of vaccination was 44-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. Medical history was not reported. Concomitant medications included Lisinopril for an unspecified indication from an unspecified date. On 14Mar2021, the patient experienced Rash all over my body and it is really itchy. Additional Information: The consumer stated that she got a COVID shot today and had rash all over body and it was really itchy and she did not knew what to do. Vaccination date: The consumer stated that she got it 14Mar2021 and got the shot at 10 o clock this morning. Treatment: She I took some Benadryl to see if that would help but it did not helped. The clinical outcome of the event was Not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin disorder, Urticaria
Clinical narrative: Getting like a hives or rash all over my legs and my arms; It was like the bumps like the color of my skin; Getting like a hives or rash all over my legs and my arms; This is a spontaneous report from a contactable consumer. This 37-year-old female consumer (patient) that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199; Expiration Date: 30Jun2021; NDC number, UPC number: unknown), via an unspecified route of administration on 08Mar2021 (at the age of 37 years) as dose number unknow, single for covid-19 immunisation. Medical history included anxiety and panic attack. Concomitant medication(s) included escitalopram oxalate (LEXAPRO), once a day taken for anxiety, panic attack. No investigation assessment done. Consumer stated that she was not sure of her weight at the time of report but she thought she was 150, 155 pounds. She hadn't weigh in a while. She got her vaccine on 08th, Monday the 8th of this month. Two days ago, she started noticing that she got like a hives or rash all over her legs and her arms. It was like an over a week but it might be like 2-3 days ago, she started noticing that she got like a hives or rash all over her legs and rash like bumps, on her arms. It was kind of hives or rash on her arms or legs and they just felt like, they were getting worse at the time of report. She didn't notice it because when she first noticed it wasn't itchy at all. It was like the bumps like the color of her skin. They were not like inflamed or anything like that, not like red or anything. She just started feeling like bumps on her skin. She started noticing them like she wanted to say like Thursday or Friday. At the time of report, she still experiencing the events and it actually got more itchy. She was scratching her leg a minute ago and she realized they were coming out more. She took Benadryl (Batch/Lot number, NDC number, UPC number, Expiry date: Unknown) the other day like a day before but took the Benadryl on the day of report but it did not seem to be very helping. She did only took one. She took Benadryl but she thought it was supposed to take 2 but she only took one. The outcome of reaction/event at the time of last observation was not recovered/not resolved.  No follow-up attempts are possible. No further information is expected.   She did not know if it was just from the vaccine or what but she only know where else she had got them from. So she was calling for some advice.   The patient experienced getting like a hives or rash all over my legs and my arms (rash) (non-serious) on an unspecified date with outcome of not recovered , it was like the bumps like the color of my skin (skin disorder) (non-serious) on an unspecified date with outcome of unknown , getting like a hives or rash all over my legs and my arms (urticaria) (non-serious) on an unspecified date with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of getting like a hives or rash all over my legs and my arms (rash).
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: fever; didn't feel well; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever and did not feel well on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Dizziness, Feeling hot
Clinical narrative: headache; had a little fever and felt warm; had a little fever and felt warm; chills; felt light headedness; her blood pressure dropped; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from 01Feb2021 to an unknown date Verbatim: tested positive with the covid-19 virus on 01Feb2021. The patient's concomitant medications were not reported. On 10Mar2021, the patient experienced felt light headedness, her blood pressure dropped. on 11Mar2021, the patient experienced a little fever and felt warm, chills. on 12Mar2021, the patient experienced headache. It was reported that patient called in because she got her 1st dose of the vaccine on 10Mar2021. She said, a few minutes after her first dose, she felt light headedness and her blood pressure dropped. They waited like 10 minutes; she drank water then her blood pressure went back to normal. Thursday morning, 11Mar2021, she had a little fever and felt warm. She also had chills, but it just came and went vaguely and in a very short period of time only. She also started having a headache on Friday, 12Mar2021, and the headache just comes on and off. She wants to know if it was normal. She also said that she tested positive with the covid-19 virus on 01Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: dropped on an unspecified date, Sars-Cov-2 antibody test: positive on 01Feb2021. The outcome of the event headache was reported as not resolved. Outcome of event chills was reported as resolved on 11Mar2021. Outcome of the rest of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: headache; had a little fever and felt warm; had a little fever and felt warm; chills; felt light headedness; her blood pressure dropped; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from 01Feb2021 to an unknown date Verbatim: tested positive with the covid-19 virus on 01Feb2021. The patient's concomitant medications were not reported. On 10Mar2021, the patient experienced felt light headedness, her blood pressure dropped. on 11Mar2021, the patient experienced a little fever and felt warm, chills. on 12Mar2021, the patient experienced headache. It was reported that patient called in because she got her 1st dose of the vaccine on 10Mar2021. She said, a few minutes after her first dose, she felt light headedness and her blood pressure dropped. They waited like 10 minutes; she drank water then her blood pressure went back to normal. Thursday morning, 11Mar2021, she had a little fever and felt warm. She also had chills, but it just came and went vaguely and in a very short period of time only. She also started having a headache on Friday, 12Mar2021, and the headache just comes on and off. She wants to know if it was normal. She also said that she tested positive with the covid-19 virus on 01Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: dropped on an unspecified date, Sars-Cov-2 antibody test: positive on 01Feb2021. The outcome of the event headache was reported as not resolved. Outcome of event chills was reported as resolved on 11Mar2021. Outcome of the rest of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Low grade fever; muscle aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) as first dose for covid-19 immunisation. On an unspecified date, the patient experienced low grade fever, muscle aches and fatigue. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Glycosylated haemoglobin, Glycosylated haemoglobin increased, Pyrexia, Sensation of blood flow
Clinical narrative: side effect: A1C count and other blood works was high; Fever; Blood flow problems; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19 on an unspecified date in 2020, patient had covid last year. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced side effect: A1C count and other blood works was high, fever and blood flow problems. On an unspecified date, the patient underwent lab tests and procedures which included blood works (blood test), resulted as high and A1C count (glycosylated haemoglobin), resulted as high. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: He can hardly move and then his neck is hurting and he can hardly turn his head; He can hardly move and then his neck is hurting and he can hardly turn his head; The first time he felt in his knees and his shoulder and then in his hip and then that kind of went away and then he got it in his elbow and feet and his arm and his hand on his right side; The first time he felt in his knees and his shoulder and then in his hip and then that kind of went away and then he got it in his elbow and feet and his arm and his hand on his right side; his leg and his body was aching; Aches and pain got worse and joints were hurting and he had pain in his jaw; Aches and pain got worse and joints were hurting and he had pain in his jaw; This is a spontaneous report from a contactable and a non-contactable consumer. Both consumers (wife and daughter) reported for the patient that, A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), dose 2 via an unspecified route of administration on 12Mar2021 as dose 2, single for a covid-19 immunization indication. The patient medical history and concomitant medications were not reported. The patient experienced Aches and pain got worse and joints were hurting and he had pain in his jaw; Pain all over his body and the first time he felt in his knees and his shoulder and then in his hip and then that kind of went away and then he got it in his elbow and feet and his arm and his hand on his right side on an unspecified date of Mar2021 , He can hardly move and then his neck is hurting and he can hardly turn his head on 16Mar2021. For the treatment he received some anti-inflammatory drugs. Reporter stated, My Pharmacist told us to call you, my husband had his COVID second shot on Friday and he had symptoms in his leg and his body was aching, then he had to go to the hospital (Clarification unknown) then he gets out of the hospital and came home, the aches and pain got worse, and joints were hurting, and he had pain in his jaw. So we took him back to the hospital and they checked him and then they gave him some anti-inflammatory drug and send him home and today his arm, elbow and shoulder on his right side (incomplete sentence), he can hardly move and then his neck is hurting and he can hardly turn his head, so, she said that you should know that, I do not know why but anyways she thought you should know that. She told me to call you. Is there anything that we can do to lesser those pain because his neck is really hurting and. Reporter daughter stated that , He went to the ER twice. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: He can hardly move and then his neck is hurting and he can hardly turn his head; He can hardly move and then his neck is hurting and he can hardly turn his head; The first time he felt in his knees and his shoulder and then in his hip and then that kind of went away and then he got it in his elbow and feet and his arm and his hand on his right side; The first time he felt in his knees and his shoulder and then in his hip and then that kind of went away and then he got it in his elbow and feet and his arm and his hand on his right side; his leg and his body was aching; Aches and pain got worse and joints were hurting and he had pain in his jaw; Aches and pain got worse and joints were hurting and he had pain in his jaw; This is a spontaneous report from a contactable and a non-contactable consumer. Both consumers (wife and daughter) reported for the patient that, A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), dose 2 via an unspecified route of administration on 12Mar2021 as dose 2, single for a covid-19 immunization indication. The patient medical history and concomitant medications were not reported. The patient experienced Aches and pain got worse and joints were hurting and he had pain in his jaw; Pain all over his body and the first time he felt in his knees and his shoulder and then in his hip and then that kind of went away and then he got it in his elbow and feet and his arm and his hand on his right side on an unspecified date of Mar2021 , He can hardly move and then his neck is hurting and he can hardly turn his head on 16Mar2021. For the treatment he received some anti-inflammatory drugs. Reporter stated, My Pharmacist told us to call you, my husband had his COVID second shot on Friday and he had symptoms in his leg and his body was aching, then he had to go to the hospital (Clarification unknown) then he gets out of the hospital and came home, the aches and pain got worse, and joints were hurting, and he had pain in his jaw. So we took him back to the hospital and they checked him and then they gave him some anti-inflammatory drug and send him home and today his arm, elbow and shoulder on his right side (incomplete sentence), he can hardly move and then his neck is hurting and he can hardly turn his head, so, she said that you should know that, I do not know why but anyways she thought you should know that. She told me to call you. Is there anything that we can do to lesser those pain because his neck is really hurting and. Reporter daughter stated that , He went to the ER twice. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Sleep disorder
Clinical narrative: rash on her hands; disrupted her sleep; itching; This is a spontaneous report from a non-contactable consumer. This consumer reported for a female patient (daughter).   An adult female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unknown date in Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Feb2021, one week after receiving the vaccine patient developed a rash on her hands, that has disrupted her sleep ever since and itching. Patient took treatment with bendaryl to attempt to alleviate the itching with little success. The event itching was recovering and the outcome of rest other events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Pyrexia
Clinical narrative: Got very tired yesterday afterwork and ran a slight fever.; dehydrated; Got very tired yesterday afterwork and ran a slight fever.; This is a spontaneous report from a non-contactable consumer. A adult female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. On 17Mar2021 consumer stated I took second shot yesterday and I have had nothing extreme in way of symptoms. Got very tired yesterday after work and ran a slight fever. This morning felt like I got hit by a man truck. I did feel dehydrated but will follow their advice to take lots of fuel. I will try and rest up today. The patient was not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested. No further information is expected
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Epistaxis, Weight
Clinical narrative: Nose bleed; This is a spontaneous report from a contactable consumer. This 66-year-old male consumer (patient) reported that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 09Feb2021 at 12:15 (at the age of 66 years) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203, Expiry Date: not reported), via an unspecified route of administration in left arm on 02Mar2021 at 12:30 (at the age of 66 years) as dose 2, single for covid-19 immunisation. Medical history included pain and was a cancer patient. Regarding medical conditions, caller stated that he had something to do with his thyroid but that it was not relevant. Family medical history relevant to AE(s): Stated that he had a brother about 40 years ago who had nose bleeds. Stated that was how he knew how to stop his when it started bleeding. That brother currently lived in another location. Concomitant medication(s) included paracetamol (TYLENOL), took one, sometimes as needed taken for an unspecified indication, start and stop date were not reported; gabapentin, 300mg capsule, takes at night as needed taken for pain from an unspecified start date and ongoing (Started about a year ago. He mentioned that he did not take a lot of it, he did not take it every day). No investigation assessment done. Vaccination facility type was pharmacy and not military facility. Prior vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. About two weeks into the first vaccination he noticed something but didn't take it for much of anything. He got a nose bleed. On 03Mar2021 (the day after his second vaccination), he got another nose bleed. Never had that happened before. States he washes out his nose in the morning and cleans it out by blowing it and washing it. Stated that since his most recent nose bleed he hasn't been blowing as hard. Nose bleed had not happened again. It only happened those 2 times. Stated that he did not know to call to report until he went to his doctor appointment and mentioned it and they said he should call. His weight as 230, 235, 236. Caller added that his weight was less 3 years ago, that was only after he had an operation. Stated that he had labs done a day before; but they were just routine blood work. Caller did verify that his doctor appointment and blood work from 15Mar2021 were not for this particular event. It was a routine visit and he waited to mention that his nose bleeds until his appointment. No emergency room or physician office visit required. The outcome of event was recovered.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain, Pyrexia
Clinical narrative: Tireness; Body aches; Fever; Cough; This is a spontaneous report from a contactable consumer or other non health care professional. A patient 6th decade of unspecified gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number- Not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included breast cancer survival (Optional Information: Breast Cancer Survival) and Covid-19 from 2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date patient experienced tireness, body aches, fever and cough. It was reported that event took place 24 hours after use of product. The outcome of all the events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Lymphadenopathy
Clinical narrative: Two areas of bruising on her arm; Inflamed lymph nodes; Headache; This is a spontaneous report from a contactable consumer.   A 67-year-old female patient (mother) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in arm left on 05Mar2021 morning (Lot number was not reported, at the age of 66-year-old) as single dose for COVID-19 immunisation (COVID protection at hospital). Patient medical history included diabetes (diagnosed over 20-year-ago) and hypertension (has had for a long time) both are still ongoing. The patient's concomitant medications were not reported. It was reported that vaccine was not administered at military facility. Patient denied for any additional vaccines administered on same date of the Pfizer suspect and also denies for prior vaccinations (within 4 weeks). On 08Mar2021, the patient experienced headache which were on and off and are not consistent. The headaches lasted for 2 days. On 12Mar2021, the patient developed two areas of bruising on her arm and had inflamed lymph nodes. None of the AE require a visit to emergency room or physician office. The outcome of event for headache was recovered on 10Mar2021 whereas for remaining events it was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Swelling
Clinical narrative: swelling in the roof of her mouth, and it did go to her ears; swelling in the roof of her mouth, and it did go to her ears; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number: EN6198, Expiry date: unknown), via an unspecified route in the right arm on 25Feb2021 (age at vaccination: 73-year-old), as a single dose for covid-19 immunization. Medical history included she does have a problem with her throat with IV Dye, so she usually gets loaded up with Benadryl or whatever they use before she gets IV dye. The patient concomitant medications were not reported. Patient confirms that she had no other vaccines on the same day as the COVID Inoculation. On 25Feb2021, when patient got the vaccine, she waited the 15-minute timeframe, and during that time, she felt like a swelling in the roof of her mouth, but not in her throat, like she could breath and swallow. Patient reported that the swelling in the roof of her mouth did go to her ears, but it seemed gone by the time the patient went home. She asked her PCP if she could take Benadryl with the next dose, and he said it shouldn't hurt the vaccine, but the patient wants to make sure. Patient is wondering if she should take Benadryl the night before the second dose, or the morning before, is Benadryl okay to take with the product. The clinical outcome of the events was recovered/resolved completely that same day (25Feb2021), she even ate veggie soup with no problems with her throat.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypersensitivity, Pain in extremity, Vaccination site pain
Clinical narrative: allergies; cough; soreness in the arm; every time she touches the injection site, she feels the soreness more; This is a spontaneous report from a Pfizer-sponsored program. A Contactable consumer (patient) reported that a 80-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 80-year-old at the time of vaccination), on 18Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced allergies, cough, soreness in the arm because of the injection, every time she touches the injection site, she feels the soreness more. It was reported that she understands that sometimes this soreness comes and goes after injection. The outcomes of events (allergies, cough) were recovered on an unspecified date in 2021 and the outcomes of events (soreness in the arm, every time she touches the injection site, she feels the soreness more) were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: headache; pain in her arm; joint pain; This is a spontaneous report from a contactable consumer (patient).A 51-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Mar2021 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. On 13Mar2021, the patient experienced pain in her arm, on 14Mar2021, the patient had headache and on unknown date in Mar2021, patient had joint pain. It was reported that she got the first dose of the Pfizer covid on 13Mar2021 ( Saturday) and since that day she started having pain in her arm. Next day the arm pain was worse, and she had headache. Monday and Tuesday she had joint pain and she wonders how long this symptom will last since she was not like that before the vaccine. She mentions that she was a very active woman that does exercise every day. All that was left was the joint pain. The outcome of headache was unknown, and patient had not yet recovered from other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Neuralgia, Pain in extremity
Clinical narrative: her arthritis, which had flared up really bad /Severe attack of her arthritis; she began having pain going into her nerves and legs; she began having pain going into her nerves and legs; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number not reported) via an unspecified route of administration on 18Jan2021 as single dose for COVID-19 immunisation. Medical history included arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced a severe attack of arthritis in between doses and took Methylprednisolone for 6 days. Follow up the Caller mentioned that ten days after her 1st dose, she was having trouble with her arthritis, which had flared up really bad. She was not attributing this flare to the vaccine. She was prescribed with Methylprednisolone for 6 days. Her husband brought her a book on arthritis which mentioned that steroids are immunosuppressant and people getting vaccinated should avoid immunosuppressant. The caller reported that she took the 6 days of Methylprednisolone as recommended. Caller reported that she began having pain going into her nerves and legs. Caller stated that she didn't know that there could be a problem with having immunosuppression in the midst of all of this. Caller reported that the doctor prescribed the Methylprednisolone to get her out of this awful pain. Caller reported she finished the 6 day course and a week later went and got her second shot. Caller stated that she knows that you are supposed to get the second dose of the Covid-19 vaccine within 21 days and she couldn't help it that it was 22 days between the doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: little pain on her arm; sneezing; runny nose; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose on 07Mar2021, after the 1st dose she experienced little pain on her arm, sneezing and runny nose on an unspecified date in Mar2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Vaccination site pain
Clinical narrative: I have pain around the back of shoulder blade and injection site pain.; injection site pain; This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had pain around the back of shoulder blade and injection site pain. The patient wants to know can he get the second dose of the vaccine. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: arm got red; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient reported for herself). An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Mar2021, the patient experienced arm got red. Caller reported getting the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE on 06Mar2021, and reported had no side effects everything was fine, on 13Mar2021 (a week later) all of the sudden her arm got red, and it was still red, 5 days and it was still red. Patient was due for the next vaccine on 27Mar2021, was this normal. Was there here something can do to make a redness go away then. Caller stated when she got the injection on the 06Mar2021, it was red when she gave it to her, next day it was all  gone she had no side effects, she had no pain, no headaches, nothing, so she thought she was fine then the following week, exactly a week to a day that she got a vaccination, her arm got red and it has been 5 days and her arm was still red, it was less but it was still red. Should she take a second shot. Second dose refer to healthcare professional. No product quality complaint was reported. The outcome of the event was reported as not resolved.  No Follow-up attempts are Possible: information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Mentioned she did not have an allergic reaction, but her sister did to the first dose; This is a spontaneous report from a contactable consumer [patient's sister].  A female patient [reporter's sister] of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date after first dose of vaccination patient experienced allergy. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.