chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: unable to get out of bed; difficulty walking and has been having to use a walker; edema in legs; sever leg pain (muscle and joint pain)/had joint and muscle pain that affected her whole leg from her hip to her toes; sever leg pain (muscle and joint pain)/severe pain in her legs; sever leg pain (muscle and joint pain)/had joint and muscle pain that affected her whole leg from her hip to her toes; leg swelling/edema in her legs/calf and upper leg are still swollen; This is a spontaneous report received from a contactable consumer (Patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration, administered in right arm on 24Feb2021 (at the age of 78 years old) as a single dose for COVID-19 immunization. The patient's medical history included Diabetes and high blood pressure from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 78 years old) as a single dose for COVID-19 immunization. The patient had not visited emergency room or physician office due to the event. On 05Apr2021 the patient experienced sever leg pain, Muscle pain, leg swelling, edema in legs while on an unspecified date the patient was unable to get out of bed. On 12Apr2021 the patient experienced difficulty walking and has been having to use a walker. The reporter reported that the patient received both doses at (Redacted). The patient was not provided with any paperwork or information on who to call to report side effects when patient received her vaccine. Patient's husband received the vaccine at the medical center. The patient called the number that was listed on the papers. The reporter reported that patient's left ankle is back to normal in regards to the swelling. Patient's calf and upper leg are still swollen. The patient underwent lab tests and procedures which included Arthritis on an unspecified date. The outcome of the events of Joint pain, Leg pain, Muscle pain, Swelling of legs was recovering while for Movements abnormal was unknown and for Walking difficulty and edema in legs was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: Swelling on the face; Rashes, fine bumps on her face, neck, and arms; Itching on her right arm; Her arm was hurting form the vaccine; an allergic reaction; This is spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: ER8733, Expiry date: not reported) (age at the time of vaccination was 38 years), administered in Arm Left on 26Mar2021 at 10:15 as dose 1, single for COVID-19 immunization. The patient's medical history included anemic since Jan2021, Covid-19, allergies to penicillin. The patient's concomitant medication included Iron for anemic since Jan2021. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient reported that the patient had some allergic reactions after the first dose of the vaccine. On 26Mar2021, the patient had little bit of swelling on the face and rashes, fine bumps on her face, neck and arms, itching on her right arm. The patient was recommended by the facility when she went for her second dose last 16Apr2021 schedule for an allergy testing first. The patient should continue to get her second dose or not. The outcome of the event an allergic reactions was unknown and other events was recovered on 27Mar2021.  No follow-up attempts were needed. No further information was expected
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling on the face; Rashes, fine bumps on her face, neck, and arms; Itching on her right arm; Her arm was hurting form the vaccine; an allergic reaction; This is spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: ER8733, Expiry date: not reported) (age at the time of vaccination was 38 years), administered in Arm Left on 26Mar2021 at 10:15 as dose 1, single for COVID-19 immunization. The patient's medical history included anemic since Jan2021, Covid-19, allergies to penicillin. The patient's concomitant medication included Iron for anemic since Jan2021. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient reported that the patient had some allergic reactions after the first dose of the vaccine. On 26Mar2021, the patient had little bit of swelling on the face and rashes, fine bumps on her face, neck and arms, itching on her right arm. The patient was recommended by the facility when she went for her second dose last 16Apr2021 schedule for an allergy testing first. The patient should continue to get her second dose or not. The outcome of the event an allergic reactions was unknown and other events was recovered on 27Mar2021.  No follow-up attempts were needed. No further information was expected
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Pyrexia, Rash
Clinical narrative: rashes- one on her neck, right groin, and thigh.; Low grade fever; Rash was reported as worsened; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 26-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, Expiration date: unknown) via an unspecified route of administration on 01May2021 (at the age of 26 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration, administered in arm right on 02APR2021 (at the age of 26 years old) as dose 1, single for covid-19 immunization and experienced arm soreness and fatigue. On 01May2021 patient experienced fatigue and on 02May2021 rashes- one on her neck, right groin, and thigh; low grade fever and rashes in a few areas of her body, that seem to be progressed. The caller also had a low-grade fever, fatigue but it was fine. Today the caller woke up with 4 different rashes and still had a fever. The caller read that if you're allergic you may have a rash on the arm where she had the shot. The caller wants to know have her symptoms been reported and if everything was okay. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oral blood blister, Stomatitis
Clinical narrative: Mouth irritation; blood blister on the inside of my mouth; This is a spontaneous report from a contactable Consumer. This 65-year-old female Consumer (patient) reported for self via medical information team.  A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EN6199, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 03Mar2021 (65-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 100 mg once a day taken for an unspecified indication, and atorvastatin (ATORVASTATIN) 40 mg once a day taken for an unspecified indication. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Batch/lot number: EN6201, Expiry date: unknown) via an unspecified route of administration, on 10Feb2021 (age at vaccination: 65-years-old) as dose 1, single for COVID-19 immunization. It was reported that on an unspecified date in Mar2021, three weeks after the second dose patient developed a blood blister inside her mouth and mouth irritation. that she had the first dose of the Pfizer covid 19 vaccine on 10Feb2021 and the second dose on 3Mar2021. Reporter reported that three weeks after the second dose she developed a blood blister inside her mouth. reporter asked if other people have reported this and how long is it likely to last. she is going to her dentist. Reporter stated she saw a study on line that is looking at 1580 HCP who experienced mouth ulcers and blisters but she did not know which vaccine. weeks of the second vaccine, I started experiencing some mouth irritations, primarily the one I that am really the most concerned about is like a blood blister on the inside of my mouth and again it was like the 3rd week of Mar or so and it still has not gone away. I have an appointment with my dentist tomorrow, but I thought I should talk to you first and see if there are other people reporting this and you know what you think about it what I should tell the dentist potentially what I felt." Patient stated she was going to her dentist and no treatment has been taken for the events. The patient said she will go to the dentist tomorrow, if I could find out if there is any probable correlation between the vaccine you know blisters in my mouth." The patient not received any treatment for events. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Feeling abnormal, Rash, Skin reaction
Clinical narrative: the spots are dry; started to develop into what looked like a rash but the spots are more isolated; pinkish color spots on my stomach/Second dose: pinkish spots on his stomach/spots are on his stomach and around his waist line; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0172; expiration date: Aug2021) via an unspecified route of administration, administered in Arm Left on 24Apr2021 at the age of 31-year-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history included leukemia (from ages 3 years to 5 years). The patient's concomitant medications were not reported. Previously too first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0150) at Left Arm on 03Apr2021 (Early in the day) as dose, 1 single for covid-19 immunisation and reported felt gross, felt groggy on 03Apr2021. On 29Apr2021, after 5 days of vaccination, the patient experienced pinkish color spots on my stomach/second dose and around his waistline, started to develop into what looked like a rash, but the spots are more isolated, on 25Apr2021 felt terrible, the spots are dry on an unspecified date. It was reported that when he received the second Covid-19 vaccine he felt fine the day of. The next day he felt terrible. He received his second dose on 24Apr2021. Then on 29Apr2021, he started noticing pinkish spots on his stomach. It started to develop into what looked like a rash but the spots are more isolated. The spots are on his stomach and around his waistline. The spots haven't gone away and there are quite a few. The spots are not itching. He would say the spots are staying about the same. Some more have developed but mostly staying the same. It looks like the spots are dry but that could be from him being active and moving around or maybe is skin a little dry. Did not any AE require a visit to emergency room, physician office. No prior vaccinations (within 4 weeks). The outcome of event was felt terrible was unknown and rest all was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Rash
Clinical narrative: They woke up with chills and body aches; She has a small amount of rash; They woke up with chills and body aches; This is a spontaneous report received from a contactable consumer (Patient).  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as Dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient stated that she and her husband have received both Pfizer covid 19 vaccine doses. The patient stated that they didn't experience any adverse reaction after first dose. The patient's concomitant medications were not reported. The patient received second vaccine dose around 10 days ago (unspecified date) and had chills and body aches. The patient had a small amount of rash started the next day or the other day (unspecified date) and it was lingering. Outcome of event rash was not recovered and for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021524234 Same reporter/report type/product/event and different patients
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Nasal congestion, Pyrexia
Clinical narrative: the worst high fever; congestion; craziness in stomach; This is a spontaneous report from a contactable consumer or other non-healthcare professional (the patient). A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: not reported, expiry date: not reported ) via an unspecified route of administration on 20Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04May2021, the patient experienced worst high fever, congestion, craziness in stomach and he was scheduled to get the second dose 10May2021. He wants to know if he can still get the second dose and what lymphadenopathy is. The patient underwent lab tests which included high body temperature on 04May2021.The outcome of the events was 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: Fatigue, Nausea, Pain, Pharyngeal swelling, Pyrexia
Clinical narrative: My throat felt like it was swelling up; The next day I had a temperature; body aches; nauseaus; fatigue; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in Dec2020, single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced my throat felt like it was swelling up, the next day had a temperature, body aches, nauseaus and fatigue. She said that she had the first covid vaccine in December and had a reaction. She said that her throat felt like it was swelling up. No other reaction initially. The next day she had a temperature, body aches, nauseau, and fatigue. She was told because of her reaction. She asked that whether she should not get the second dose. She knew it was little late now but this virus was not going away. She was looking for input into how she should move forward. She asked that she could get another dose in the future. She was worried about the fall and the ever changing virus. Outcome of the events were unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: headaches; heaviness of the chest; stiffed neck; body aches; This is a spontaneous report from a contactable Nurse. This nurse (patient wife) reported for a patient (reporter husband) that:  A 67-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0165) via an unspecified route of administration on 29Apr2021 (At the age of 67 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included myocardial infarction from an unknown date and unknown if ongoing 5 years ago. Patient had previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ERW729) via an unspecified route of administration on 08Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient had experienced headaches. On 03May2021, the patient experienced heaviness of the chest, stiffed neck and body aches. He was rushed to ER for consultation She wants to know if there are reported cases such as stiffed neck and heaviness of the chest. Caller reported that the patient did go to the emergency room because he had a previous heart attack 5 years ago and the patient didn't want to take a chance. Caller reported that the emergency room staff performed complete testing and the patient's heart was ok. Caller reported that the patient has been in touch with his cardiologist and the cardiologist informed the patient that his heart was fine. At the time of reporting, the outcome of the events stiff neck, headache and body aches was not recovered and the event heaviness of the chest was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction, the symptoms have been debilitating; This is a spontaneous report from a regulatory authority. A contactable consumer (reporter daughter)  reported for an unspecified age female patient received bnt162b2, (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration on unknown date or covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was not reported. On an unknown date,patient experienced allergic reaction and on four weeks there was no improvement. Reporter stated that  we were on four weeks and she  not improved. The symptoms have been debilitating. if there was any information could you  guide us with, so far all of what the doctors have been prescribed has not helped her improve. The outcome of event was not recovered.  No follow-up attempts was needed
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin increased, Blood glucose, Blood glucose increased, Cough, Fatigue
Clinical narrative: slept the whole next day after the vaccine; Her fasting blood sugars were high; Her bilirubin was off, she believes slightly elevated 1.4 or 1.6.; cold like symptoms; cough; headache; stuffiness and running nose; really, really tired; stuffiness and running nose; not feeling like herself; sinus drainage; This is a spontaneous report from a contactable other health care professional (patient herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration in arm left on 16Apr2021 as dose 1 single (at the age of 47-year-old) for COVID-19 immunisation. The patient's medical history included Wolfe Parkinson white syndrome, adds this was a problem with electrical current in heart. She has had this a good ten or fifteen years, anxiety, this was occasional, off and on 15 or 20 years, diabetes mellitus, her mom and brother were diabetic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Ativan, when she flies. On 17Apr2021, slept the whole next day after the vaccine. On an unspecified date in Apr2021, the patient experienced her fasting blood sugars were high, her bilirubin was off and she believed slightly elevated 1.4 or 1.6. On an unspecified date 2021, the patient experienced cold like symptoms, cough, headache, stuffiness and running nose, was really, really tired, not feeling like herself and sinus drainage. It was reported that the cough and the headache began and then more stuffiness and drainage and stuff came a few days later. The cough was better and not as much as in the beginning. The stuffiness, running nose and good old fashion cold symptoms were lingering a little bit. It was reported that she could have slept the whole next day after the vaccine and she was really tired. It had gotten better. She states that since getting the vaccine she has not felt quite normal. It has not stopped her from doing anything, but she just has not felt like herself. That started right after and it was going on. It was reported that she went to the primary care physician visit because she did not feel like herself and for other events. The patient underwent lab tests and procedures on an unspecified date in Apr2021 which included blood bilirubin increased: elevated, her bilirubin was off, she believes slightly elevated 1.4 or 1.6, blood glucose: high, she found out her fasting blood sugars were 120 or 130, A1C, glycosylated haemoglobin: normal, A1C was high end of normal, haemoglobin: normal and on an unknown date rapid and regular SARS-COV-2 test: negative. Therapeutic measures were taken as a result of headache included Motrin, 600 mg, each pill was 200 mg. The outcome of the events was unknown.    Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Glycosylated haemoglobin, Haemoglobin, Headache, Nasal congestion
Clinical narrative: slept the whole next day after the vaccine; Her fasting blood sugars were high; Her bilirubin was off, she believes slightly elevated 1.4 or 1.6.; cold like symptoms; cough; headache; stuffiness and running nose; really, really tired; stuffiness and running nose; not feeling like herself; sinus drainage; This is a spontaneous report from a contactable other health care professional (patient herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration in arm left on 16Apr2021 as dose 1 single (at the age of 47-year-old) for COVID-19 immunisation. The patient's medical history included Wolfe Parkinson white syndrome, adds this was a problem with electrical current in heart. She has had this a good ten or fifteen years, anxiety, this was occasional, off and on 15 or 20 years, diabetes mellitus, her mom and brother were diabetic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Ativan, when she flies. On 17Apr2021, slept the whole next day after the vaccine. On an unspecified date in Apr2021, the patient experienced her fasting blood sugars were high, her bilirubin was off and she believed slightly elevated 1.4 or 1.6. On an unspecified date 2021, the patient experienced cold like symptoms, cough, headache, stuffiness and running nose, was really, really tired, not feeling like herself and sinus drainage. It was reported that the cough and the headache began and then more stuffiness and drainage and stuff came a few days later. The cough was better and not as much as in the beginning. The stuffiness, running nose and good old fashion cold symptoms were lingering a little bit. It was reported that she could have slept the whole next day after the vaccine and she was really tired. It had gotten better. She states that since getting the vaccine she has not felt quite normal. It has not stopped her from doing anything, but she just has not felt like herself. That started right after and it was going on. It was reported that she went to the primary care physician visit because she did not feel like herself and for other events. The patient underwent lab tests and procedures on an unspecified date in Apr2021 which included blood bilirubin increased: elevated, her bilirubin was off, she believes slightly elevated 1.4 or 1.6, blood glucose: high, she found out her fasting blood sugars were 120 or 130, A1C, glycosylated haemoglobin: normal, A1C was high end of normal, haemoglobin: normal and on an unknown date rapid and regular SARS-COV-2 test: negative. Therapeutic measures were taken as a result of headache included Motrin, 600 mg, each pill was 200 mg. The outcome of the events was unknown.    Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test, Sinus disorder, Somnolence
Clinical narrative: slept the whole next day after the vaccine; Her fasting blood sugars were high; Her bilirubin was off, she believes slightly elevated 1.4 or 1.6.; cold like symptoms; cough; headache; stuffiness and running nose; really, really tired; stuffiness and running nose; not feeling like herself; sinus drainage; This is a spontaneous report from a contactable other health care professional (patient herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration in arm left on 16Apr2021 as dose 1 single (at the age of 47-year-old) for COVID-19 immunisation. The patient's medical history included Wolfe Parkinson white syndrome, adds this was a problem with electrical current in heart. She has had this a good ten or fifteen years, anxiety, this was occasional, off and on 15 or 20 years, diabetes mellitus, her mom and brother were diabetic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Ativan, when she flies. On 17Apr2021, slept the whole next day after the vaccine. On an unspecified date in Apr2021, the patient experienced her fasting blood sugars were high, her bilirubin was off and she believed slightly elevated 1.4 or 1.6. On an unspecified date 2021, the patient experienced cold like symptoms, cough, headache, stuffiness and running nose, was really, really tired, not feeling like herself and sinus drainage. It was reported that the cough and the headache began and then more stuffiness and drainage and stuff came a few days later. The cough was better and not as much as in the beginning. The stuffiness, running nose and good old fashion cold symptoms were lingering a little bit. It was reported that she could have slept the whole next day after the vaccine and she was really tired. It had gotten better. She states that since getting the vaccine she has not felt quite normal. It has not stopped her from doing anything, but she just has not felt like herself. That started right after and it was going on. It was reported that she went to the primary care physician visit because she did not feel like herself and for other events. The patient underwent lab tests and procedures on an unspecified date in Apr2021 which included blood bilirubin increased: elevated, her bilirubin was off, she believes slightly elevated 1.4 or 1.6, blood glucose: high, she found out her fasting blood sugars were 120 or 130, A1C, glycosylated haemoglobin: normal, A1C was high end of normal, haemoglobin: normal and on an unknown date rapid and regular SARS-COV-2 test: negative. Therapeutic measures were taken as a result of headache included Motrin, 600 mg, each pill was 200 mg. The outcome of the events was unknown.    Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Pruritus, Tinnitus, Vaccination site rash
Clinical narrative: Headache; face started to flush and was warm; red rash in the shape of a square or triangle on the right arm; red rash that was itching on her arm.; ringing in her ears; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that,  A 72-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0167; Expiration Date: 31Aug2021) (at the age of 72 years old), dose 2 via an unspecified route of administration, administered in arm left on 06May2021 11:00 as dose 2, single for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: ER8731), dose 1 via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunisation. She thought that she had gained weight called as COVID fat. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine (Amlodipine) taken for blood pressure abnormal from an unspecified start date and ongoing. Patient received her second dose of vaccine on 06May 2021 and reported that on 06May2021 a few moments ago her face started to flush and was warm, had a ringing in her ears, and had a red rash in the shape of a square or triangle on the right arm (she received the vaccine in the left arm) appeared. She stated that she was starting to experience a headache on an unspecified date and also stated she was getting another rash on the back of her right arm. She was concerned she may be having a bad reaction to the vaccine and stated she was in no mood to pass away. No additional vaccines administered on same date of vaccine. There was no prior vaccination within four weeks. The outcome for the events of face started to flush and was warm, red rash that was itching on her arm and ringing in her ears was recovered on 06May2021. The outcome for the event of red rash in the shape of a square or triangle on the right arm was not recovered. The outcome for the event of headache was unknown.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Muscle tightness, Oropharyngeal discomfort, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore arm; felt puffy in the back of her throat; felt like pressure down on that Thyroid area; felt a little swollen; pinched my throat and went down to my thyroid, and lasted for 4 hours; tight around neck; harder to swallow; This spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program Support. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0158, Expiration date: 31Jul2021) on 06May2021 at 08:00, via an unspecified route of administration, in right arm as DOSE 1, single for covid-19 immunization (age at the time of vaccination: 60-year-old). Patient medical history included: Thyroid issue that gets checked every 2 year and a Fib ongoing for which she takes medication. Patient does not have any problems. She had a nodule, and it was checked every few years to make sure everything was good. Patient did not receive any vaccine on the same day when BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06May2021, after taking the first shot, at 11:00 the patient felt puffy in the back of her throat. She added by 11:00, she felt like pressure down on that Thyroid area. It felt a little swollen and pinched her throat, went down to her thyroid and lasted for 4 hours. She felt this kind like it was tight around neck, harder to swallow, a little full kind of pressure there, it moved from top of throat, moving down and was right there when her Thyroid was tested, and they injected something. Patient stated it felt like the same type of thing after she received the first dose Pfizer Covid Vaccine. It was not like she could not swallow. She has no problem breathing and she could eat. By 12:00 this was all gone. She also had sore arm for which she took Tylenol at 11:30. The outcome of the events (felt puffy in the back of her throat, felt like pressure down on that Thyroid area, felt a little swollen, pinched my throat and went down to my thyroid, and lasted for 4 hours, tight around neck, and harder to swallow was resolved on 06May2021 at 12:00. The outcome of the event sore arm was unknown.  The patient wanted to know if the side effect will be worse after second vaccine. She has not received second dose of Pfizer Covid-19 Vaccine and feels like she is not protected. She would like to know if she can safely complete the series, as she doesn't feel protected.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Throat irritation, Thyroid function test
Clinical narrative: Sore arm; felt puffy in the back of her throat; felt like pressure down on that Thyroid area; felt a little swollen; pinched my throat and went down to my thyroid, and lasted for 4 hours; tight around neck; harder to swallow; This spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program Support. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0158, Expiration date: 31Jul2021) on 06May2021 at 08:00, via an unspecified route of administration, in right arm as DOSE 1, single for covid-19 immunization (age at the time of vaccination: 60-year-old). Patient medical history included: Thyroid issue that gets checked every 2 year and a Fib ongoing for which she takes medication. Patient does not have any problems. She had a nodule, and it was checked every few years to make sure everything was good. Patient did not receive any vaccine on the same day when BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06May2021, after taking the first shot, at 11:00 the patient felt puffy in the back of her throat. She added by 11:00, she felt like pressure down on that Thyroid area. It felt a little swollen and pinched her throat, went down to her thyroid and lasted for 4 hours. She felt this kind like it was tight around neck, harder to swallow, a little full kind of pressure there, it moved from top of throat, moving down and was right there when her Thyroid was tested, and they injected something. Patient stated it felt like the same type of thing after she received the first dose Pfizer Covid Vaccine. It was not like she could not swallow. She has no problem breathing and she could eat. By 12:00 this was all gone. She also had sore arm for which she took Tylenol at 11:30. The outcome of the events (felt puffy in the back of her throat, felt like pressure down on that Thyroid area, felt a little swollen, pinched my throat and went down to my thyroid, and lasted for 4 hours, tight around neck, and harder to swallow was resolved on 06May2021 at 12:00. The outcome of the event sore arm was unknown.  The patient wanted to know if the side effect will be worse after second vaccine. She has not received second dose of Pfizer Covid-19 Vaccine and feels like she is not protected. She would like to know if she can safely complete the series, as she doesn't feel protected.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site discolouration, Vaccination site pain
Clinical narrative: There is also a very small raised blemish near the site of the injection; soreness in my left shoulder muscle; soreness in my left shoulder muscle; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient).  A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: not reported), via an unspecified route of administration on left arm on 04Mar2021 as dose 1, single for Covid 19 immunization. Medical history and concomitant medications were not reported. After first shot of covid vaccine, the patient was noticed with soreness in his left shoulder muscle. The area of soreness from the first shot was still there. It was mild and more noticeable when he extends his arm to its limits. There was also a very small, raised blemish near the site of the injection. The patient received both covid shots. The patient received second shot on 25Mar2021. There was no soreness from the second shot. Outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Muscle tightness, Pain in extremity
Clinical narrative: Ear is achy.; runny nose/nose is kind of runny; left arm is sore; Headache; very tired; muscle tension; This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on 03May2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first vaccine on Monday 03May2021 and wanted to ask a question about something she was experiencing. The patient had noticed especially yesterday my left ear started bothering me. My doctor looked at the ear there was no wax or infection. I received the vaccine on the same side. My left arm was sore, and ear was achy. I also have a runny nose with a headache. When I take Claritin, it goes away but when the medicine wear of it starts again. I also feel very tired. Caller clarified that she has allergies and got her first dose and next dose is due at the end of the month. The caller said that her left ear has been bothering her. She thought maybe that it was wax or maybe an infection in her ear. She said that she went to Instacare and the doctor there saw no wax build up or infection in her ear. It was bothering her. She said that they told her could be muscle tension that it could be causing her symptom. Caller said that her nose is kind of runny, but she feels better than she did. She said that she also had headaches along with it. Caller said that her ear aches and she forgot to ask the doctor if it could be a swollen gland. The outcome of the event runny nose/nose is kind of runny was recovering/resolving and outcome for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Ear is achy.; runny nose/nose is kind of runny; left arm is sore; Headache; very tired; muscle tension; This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on 03May2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first vaccine on Monday 03May2021 and wanted to ask a question about something she was experiencing. The patient had noticed especially yesterday my left ear started bothering me. My doctor looked at the ear there was no wax or infection. I received the vaccine on the same side. My left arm was sore, and ear was achy. I also have a runny nose with a headache. When I take Claritin, it goes away but when the medicine wear of it starts again. I also feel very tired. Caller clarified that she has allergies and got her first dose and next dose is due at the end of the month. The caller said that her left ear has been bothering her. She thought maybe that it was wax or maybe an infection in her ear. She said that she went to Instacare and the doctor there saw no wax build up or infection in her ear. It was bothering her. She said that they told her could be muscle tension that it could be causing her symptom. Caller said that her nose is kind of runny, but she feels better than she did. She said that she also had headaches along with it. Caller said that her ear aches and she forgot to ask the doctor if it could be a swollen gland. The outcome of the event runny nose/nose is kind of runny was recovering/resolving and outcome for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash and red spots around her body.; The caller gets these little red things on her skin that itch a lot; This is a spontaneous report received from a contactable Nurse. A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced rash and red spots around her body and the caller gets these little red things on her skin that itch a lot. It was reported that She received the first dose of the Pfizer COVID-19 vaccine 27Jan2021 and the second dose 22Feb2021. She recently been developing rash and red spots around her body. The red area was itchy. This occurred 6 weeks after she received the second shot. She wants to know if this a latent response to the Pfizer COVID-19 vaccine. She states Its not uncommon for me. I always have rash around my neck and on my body. Its the itchiness that keep coming back. I tried some home remedies. I don't like to take medications. I was glad at least I have the antibodies against covid-19 infection. Maybe this was all part of immune response. I just don't know if this was something I was going to have to live with for the rest of my life or would this go away. She received the 2 doses of the Pfizer Biontech vaccine, caller had her first dose on 27Jan-year not provided as caller was unwilling to complete report, and second dose on 17Feb-year not provided as caller was unwilling to complete report. The caller had a rash develop on her upper body, a red diffuse rash. It wasn't really bothersome. It didn't show up right away, maybe 4-6 weeks after the vaccine. The caller gets these little red things on her skin that itch a lot. The caller gets them mostly on her arms and legs. She has noticed the last couple of days she has noticed at night when the caller gets undressed to shower, she has noticed a rash under her breast to her waist, it doesn't itch. These bumps will finally dry up and go away but they keep reappearing. The caller was 80 years old now. She has an appointment later this month with her primary care doctor just for a routine visit. She hasn't had any life-threatening sort of thing, does not feel like she was in danger or anything. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Inappropriate schedule of product administration, Injection site pruritus
Clinical narrative: vaccines given in the same arm and at the same time/the area itched; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) via an unspecified route of administration administered in the arm on an unspecified date (Batch/Lot number was not reported) as a single dose for immunization and influenza vaccine (FLU), via an unspecified route of administration administered in the arm on an unspecified date (Batch/Lot number was not reported) at an unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The vaccines were given in the same arm and at the same time. The area itched. Outcome of the event was unknown.  Pfizer is marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report in situations where another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neuralgia, Vaccination site pain
Clinical narrative: Pain started in left arm near the injection; A very deep "joint" "nerve" pain; A very deep "joint" "nerve" pain; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 23Apr2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included secukinumab (COSENTYX) and methotrexate (MANUFACTURER UNKNOWN), both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 10:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 00:00, the day after receiving the 2nd vaccine, the patient experienced pain which started in left arm near the injection site. Since then the patient had pain that came and went in the arm. The patient described it as a very deep "joint" "nerve" pain. On an unknown date in 2021, day 13, the patient was concerned and the pain was continuing to increase but not get better. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain started in left arm near the injection site and a very deep "joint" "nerve" pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.