chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Red blood cell sedimentation rate decreased
Clinical narrative: CRP has been going up back in Jun 2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing), notes: She continues to experience arthritis.; "Diabetic" (unspecified if ongoing); "Multiple bleeding stomach polyps" (unspecified if ongoing), notes: multiple bleeding stomach polyps,; "Erythema Nodosum" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing), notes: She has Osteoporosis now and it was Osteopenia.; "Osteopenia" (unspecified if ongoing), notes: She has Osteoporosis now and it was Osteopenia. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jan2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: C-REACTIVE PROTEIN INCREASED (non-serious) with onset 2021, outcome "unknown", described as "CRP has been going up back in Jun 2021". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Second Dose: on the very end of it she had a slight reaction of like pins and needles but then it went away and she got rid of that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, The caller was fine with the first dose and there was no reaction), for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "not recovered", described as "Second Dose: on the very end of it she had a slight reaction of like pins and needles but then it went away and she got rid of that". Additional information: The Reporter received the booster dose, the third dose of the Pfizer covid 19 vaccine last September. After 2 days the caller started to feel like there are a million pins and needles internal, in her stomach and her body and she was in terrible shape. Can someone tell the caller what to do to counteract the reaction she is having? The reporter is feeling like millions of pins and needles coming out of her body- her eyes, nose, tongue, she can feel it in her chest and in her colon. The reporter went to her primary care provider to get a steroid injection. Usually if the caller has a reaction to something she gets a steroid injection. The reporter generally doesnt like to take the steroid injections. The reporter got a steroid injection yesterday against her doctor's better judgement. The reporter doctor didnt want to give it to her because it would work so hard against something. But the reporter has got to have some relief because she had 3 nights where she didnt sleep. The reporter lays down and it was like a million pins and needles coming out her head, it was so painful and powerful she would rub her head to make sure the pins werent actually there and its horrible. Right now the reporters eyes feel like theyre going to die from all the pins and needles. Does Pfizer know something the reporter can do to counteract this? This has happened really severe. The reporter got her booster dose on 23Sep2021. it was Pfizer because she asked for it. The reporter was fine with the first dose and there was no reaction. The second dose on the very end of it she had a slight reaction of like pins and needles but then it went away and she got rid of that. It did not completely get out of the reporters system because its been on and off. Last Thursday is when this attack started and she went 3 days without sleep because she couldnt lay down.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Dizziness, Hyperhidrosis, Mobility decreased, Pyrexia
Clinical narrative: dizzy; sweats / sweating; fever of 101f; felt like she could not get up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 08:30 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation; guanfacine (GUANFACINE) (Batch/Lot number: unknown). Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. Past drug history included: None known. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 17Dec2021, for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "dizzy"; HYPERHIDROSIS (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "sweats / sweating"; PYREXIA (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "fever of 101f"; MOBILITY DECREASED (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "felt like she could not get up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, hyperhidrosis, pyrexia, mobility decreased.  Additional information: Additional information: The fever lasted for several hours. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. No other vaccine in fourweeks. No treatment taken for the adverse events. No covid prior vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: dizzy; sweats / sweating; fever of 101f; felt like she could not get up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 08:30 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation; guanfacine (GUANFACINE) (Batch/Lot number: unknown). Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. Past drug history included: None known. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 17Dec2021, for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "dizzy"; HYPERHIDROSIS (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "sweats / sweating"; PYREXIA (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "fever of 101f"; MOBILITY DECREASED (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "felt like she could not get up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, hyperhidrosis, pyrexia, mobility decreased.  Additional information: Additional information: The fever lasted for several hours. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. No other vaccine in fourweeks. No treatment taken for the adverse events. No covid prior vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body height, Pain, Pyrexia
Clinical narrative: fever; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (148871). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Malig neoplm of upper-outerquadrant of right female breast" (unspecified if ongoing). Concomitant medication(s) included: IBRANCE taken for breast cancer female, start date: 19Aug2020. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: Patient reported missed doses due to receiving covid booster shot and was sick after and IBRANCE 75 MG TAB / Malig neoplasm of upper-outer quadrant of right female breast.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: neck started stiffening on both sides; pain; zero range of motion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2022 11:00 (Lot number: FK9896) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: XARELTO; JARDIANCE; LANTUS; OXYCODONE; EZETIMIBE BIOGARAN. Past drug history included: Statin drugs, reaction(s): "Allergy". The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 25Feb2022 12:00, outcome "not recovered", described as "neck started stiffening on both sides"; PAIN (non-serious) with onset 25Feb2022 12:00, outcome "not recovered", described as "pain"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 25Feb2022 12:00, outcome "not recovered", described as "zero range of motion". The events "neck started stiffening on both sides", "pain" and "zero range of motion" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of musculoskeletal stiffness, pain, joint range of motion decreased. Additional information: The patient was prescribed valium, steroid shot, 800 mg Tylenol, horse liniment on neck, muscle relaxers and pain medication. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity, Pain in extremity
Clinical narrative: arm started hurting; had a bad reaction; its getting worse all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, Dose 1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm started hurting"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had a bad reaction"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "its getting worse all the time".  Additional information: Reporter stated "about 6 weeks ago patient went to get the second covid shot and patient had a bad reaction patient still having a bad reaction. As soon as patient got the shot patient arm started hurting and it has not quit and its getting worse all the time."   Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "hysterectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional information: Patient stated I have had a complete hysterectomy I need to take the medication daily. Patient asked I am on 1.25 he's going to move me to 0.9mg this year. Does it matter if the prescription strength changes. Also patient stated how received covid vaccination and I had just minor reactions, tired that kind of stuff after the booster but it had been over 6 months after the original vaccination. So, I think that was part of the problem.  Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: felt pain in her kidney on the right side; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (002191). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2022 11:30 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, her 2nd dose of Pfizer Covid 19 vaccine on 18Jun2021), administration date: 18Jun2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, States she had her 1st dose of Pfizer Covid 19 vaccine on 28May2021), administration date: 28May2021, when the patient was 50 years old, for Covid-19 immunization. The following information was reported: RENAL PAIN (non-serious) with onset 02Mar2022 12:30, outcome "not recovered", described as "felt pain in her kidney on the right side".  Additional Information: She was very concerned because she had never had problems with her kidneys or pain in that area, she described that the pain was constant and not sharp and she was worried that her kidney function could be affected. Stated that she is worried about kidney function and wanted to get better. Stated that if there is anything that they can help her with then do so.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 19Jan2021 11:00 (Lot number: EL3302) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore at site".  Additional info: Patient received Dose 2 on 08Feb2021 and Dose 3 on 06Oct2021. Did not received any medication prior to Vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Body temperature abnormal, Chills, Headache
Clinical narrative: headache; upset stomach; muscle aches; neck pain; chills; temperature taken was 99.3 F; throat was now soar; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Feb2022 14:30 (Lot number: FK9895) at the age of 14 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0217, Route of Administration: Intramuscular), administration date: 09Jun2021, when the patient was 13 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0168, Route of Administration: Intramuscular), administration date: 19May2021, when the patient was 13 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 02Mar2022, outcome "unknown", described as "headache"; ABDOMINAL DISCOMFORT (non-serious) with onset 02Mar2022, outcome "unknown", described as "upset stomach"; MYALGIA (non-serious) with onset 02Mar2022, outcome "unknown", described as "muscle aches"; NECK PAIN (non-serious) with onset 02Mar2022, outcome "unknown", described as "neck pain"; CHILLS (non-serious) with onset 02Mar2022, outcome "unknown", described as "chills"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 02Mar2022, outcome "unknown", described as "temperature taken was 99.3 F"; OROPHARYNGEAL PAIN (non-serious) with onset 02Mar2022, outcome "unknown", described as "throat was now soar". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, abdominal discomfort, myalgia, neck pain, chills, body temperature abnormal, oropharyngeal pain.  Additional information:  None known allergies. No other vaccine in four weeks. The patient received other medications within 2 weeks birth control pills, topical acne. The Patient was received acetaminophen treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: headache; upset stomach; muscle aches; neck pain; chills; temperature taken was 99.3 F; throat was now soar; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Feb2022 14:30 (Lot number: FK9895) at the age of 14 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0217, Route of Administration: Intramuscular), administration date: 09Jun2021, when the patient was 13 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0168, Route of Administration: Intramuscular), administration date: 19May2021, when the patient was 13 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 02Mar2022, outcome "unknown", described as "headache"; ABDOMINAL DISCOMFORT (non-serious) with onset 02Mar2022, outcome "unknown", described as "upset stomach"; MYALGIA (non-serious) with onset 02Mar2022, outcome "unknown", described as "muscle aches"; NECK PAIN (non-serious) with onset 02Mar2022, outcome "unknown", described as "neck pain"; CHILLS (non-serious) with onset 02Mar2022, outcome "unknown", described as "chills"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 02Mar2022, outcome "unknown", described as "temperature taken was 99.3 F"; OROPHARYNGEAL PAIN (non-serious) with onset 02Mar2022, outcome "unknown", described as "throat was now soar". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, abdominal discomfort, myalgia, neck pain, chills, body temperature abnormal, oropharyngeal pain.  Additional information:  None known allergies. No other vaccine in four weeks. The patient received other medications within 2 weeks birth control pills, topical acne. The Patient was received acetaminophen treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Fear, Hypersomnia
Clinical narrative: Very tired; dizzy; Afraid to go down stairs; slept all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 27Feb2021 (Lot number: EN6202) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "underactive thyroid" (ongoing), notes: underactive thyroid; "mild high cholesterol" (ongoing), notes: mild high cholesterol. Concomitant medication(s) included: LEVOTHYROXIN taken for thyroid disorder (ongoing); ATORVASTATIN taken for blood cholesterol increased (ongoing). The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Very tired"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy"; FEAR (non-serious) with onset 2021, outcome "unknown", described as "Afraid to go down stairs"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "slept all day". Additional information: Patient received 2Nd Dose on 20Mar2021, in arm, via intramuscular, Batch/lot number:ER2613, 3rd Dose on 21Dec2021, in arm, via intramuscular, Batch/lot number: FE3594. Relevant tests and Specific relevant tests for Thromboembolic events with Thrombocytopenia were reported as none. The first covid-19 shot made patient very tired and dizzy. Slept all day after receiving shot. Received shot on Saturday and was afraid to go downstairs until Wednesday. The second shot and booster made patient very tired, that she slept all day the day after receiving shot. The booster made her arm quite achey and tender for about a week.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Tenderness
Clinical narrative: Very tired; I slept all day the day after receiving shot; The booster made my arm quite achey and tendor for about a week; The booster made my arm quite achey and tendor for about a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 21Dec2021 (Lot number: FE3594) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "thyroid function decreased" (ongoing), notes: thyroid function decreased; "mild high cholesterol" (ongoing), notes: mild high cholesterol. Concomitant medication(s) included: LEVOTHYROXIN taken for hypothyroidism (ongoing); ATORVASTATIN taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (Dose:1, Anatomical site of injection: arm, route of administration: intramuscular, Batch/lot number: EN6202, Vey tired), administration date: 27Feb2021, when the patient was 72 years old, for COVID-19 Immunization, reaction(s): "Tired", "Dizzy", "Afraid", "Slept all day"; Bnt162b2 (Dose:2, Anatomical site of injection: arm, route of administration: intramuscular, Batch/lot number:ER2613, Slept all day), administration date: 20Mar2021, when the patient was 72 years old, for COVID-19 Immunization, reaction(s): "Slept all day", "Tired". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Very tired"; FATIGUE (non-serious) with onset 22Dec2021, outcome "unknown", described as "I slept all day the day after receiving shot"; PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious), outcome "recovered" and all described as "The booster made my arm quite achey and tendor for about a week". No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: feeling run down; experienced fatigue/tiredness for 48 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: He has Type 2 diabetes.; "blood pressure" (unspecified if ongoing), notes: Takes medication for diabetes, cholesterol and blood pressure.; "cholesterol" (unspecified if ongoing), notes: Takes medication for diabetes, cholesterol and blood pressure. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACURER UNKNOWN), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "experienced fatigue/tiredness for 48 hours"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "feeling run down".  Additional information: Patient received his booster dose of Pfizer covid vaccine in Nov2021, He just told me about his experience this morning on 02Mar2022. He experienced fatigue/tiredness for 48 hours. He described it as just feeling run down. He said he felt good after that. No other adverse events. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Muscle spasms, Pain
Clinical narrative: two months with cramps in his legs he cannot even walk and go to school; He get cramps through the day on his legs; two months with cramps in his legs he cannot even walk and go to school; He get cramps through the day on his legs; he wakes up in the morning in pain he was too sleep in pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in hand left, administration date 08Jan2022 (Batch/Lot number: unknown) as dose 2, single and administered in hand left, administration date 18Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious), GAIT INABILITY (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "two months with cramps in his legs he cannot even walk and go to school; He get cramps through the day on his legs"; PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "he wakes up in the morning in pain he was too sleep in pain". Therapeutic measures were not taken as a result of muscle spasms, gait inability, pain. Additional Information: Patient had lab test but nothing shows up in his blood, nothing that, he is healthy, he was healthy, he used to play soccer he used to do karate and now he can do nothing he cannot even go to school.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2022 14:45 (Lot number: FK9895) at the age of 60 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (previous dose product: COVID 19, previous  dose brand: Pfizer, previous  dose lot number: EW0176, previous  dose lot unknown: False, previous  dose administration date: 09May2021 previous  dose dose number: 2, previous  dose vaccine location: Left arm), administration date: 09May2021, when the patient was 59 years old, for Covid-19 immunization; Bnt162b2 (previous dose product: COVID 19, previous  dose brand: Pfizer, previous  dose lot number: EW0162, previous  dose lot unknown: False, previous  dose administration date: 18Apr2021 previous  dose dose number: 1, previous  dose vaccine location: Left arm), administration date: 18Apr2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Mar2022 08:45, outcome "not recovered", described as "Felt strange morning after vaccine"; CHEST DISCOMFORT (non-serious) with onset 03Mar2022 08:45, outcome "not recovered", described as "heavy chest"; DIZZINESS (non-serious) with onset 03Mar2022 08:45, outcome "not recovered", described as "bit light headed / definitely feel light headed"; HEART RATE INCREASED (non-serious) with onset 03Mar2022 08:45, outcome "not recovered", described as "rate shot from 147 which is standard if not working too hard to 208 / heart rate jumps to 105 without much effort". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, chest discomfort, dizziness, heart rate increased. Additional information: The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient was not tested Covid-19 positive post vaccination. The patient had no known allergies. Follow-up attempts are completed. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: She mentioned that her son has been throwing up on and off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2022 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hard for him to breathe" (unspecified if ongoing), notes: He does not have asthma, but when he gets sick it is hard for him to breathe; "bad allergies" (unspecified if ongoing), notes: diagnosed for years; "he gets sick" (unspecified if ongoing), notes: when he gets sick it is hard for him to breathe. There were no concomitant medications. The following information was reported: VOMITING (non-serious) with onset Feb2022, outcome "not recovered", described as "She mentioned that her son has been throwing up on and off". Therapeutic measures were taken as a result of vomiting.  Additional information: Patient mother mentioned that her son has been throwing up on and off. She wanted to know if vomiting or throwing up is a commonly known side effect. She also wanted to if it is going to be permanent. Today he threw up twice and two days ago he threw up once. She is trying to figure out if it is normal. First dose Pfizer covid vaccine: 24Feb2022 in the afternoon. Thinks he received it in his right side, arm. She sees PF12ER and under that reads FK5618.Clarifies on Sunday he threw up four times and the next day he threw up once then was fine, then then two days later he throws up again, it is not every day. Unknown exact date of when he first threw up, but the first time he threw up, he only threw up once. Treatment: she usually gives him cough and asthma medicine. In Dec2021 two of her kids were positive for covid and some were negative. She was told to quarantine for two weeks and get retested. When they were retested, one was still positive, and everyone was negative and decided to get the covid vaccine. He does not have asthma, but when he gets sick it is hard for him to breathe so she gives him asthma medication. She has other children that have asthma.   Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Colonoscopy, Computerised tomogram head, Constipation, Electrocardiogram
Clinical narrative: after she received the initial dose, her ankle swelled.; wasn''t feeling the same; constipation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Jun2021 (Lot number: EN0168) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pericarditis" (unspecified if ongoing), notes: Verbatim: Pericarditis, Had pericarditis when she was 21 years old; "Blood cholesterol increased" (unspecified if ongoing), notes: Verbatim: High cholesterol, diagnosed maybe 3 years ago and she was put on a statin; "Chronic anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "chronic mastoiditis." (unspecified if ongoing). There were no concomitant medications. The following information was reported: JOINT SWELLING (non-serious) with onset 26Jun2021, outcome "not recovered", described as "after she received the initial dose, her ankle swelled."; FEELING ABNORMAL (non-serious) with onset Jun2021, outcome "not recovered", described as "wasn''t feeling the same"; CONSTIPATION (non-serious) with onset Jun2021, outcome "not recovered", described as "constipation". The events "after she received the initial dose, her ankle swelled.", "wasn''t feeling the same" and "constipation" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Joint swelling, Ultrasound scan
Clinical narrative: after she received the initial dose, her ankle swelled.; wasn''t feeling the same; constipation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Jun2021 (Lot number: EN0168) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pericarditis" (unspecified if ongoing), notes: Verbatim: Pericarditis, Had pericarditis when she was 21 years old; "Blood cholesterol increased" (unspecified if ongoing), notes: Verbatim: High cholesterol, diagnosed maybe 3 years ago and she was put on a statin; "Chronic anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "chronic mastoiditis." (unspecified if ongoing). There were no concomitant medications. The following information was reported: JOINT SWELLING (non-serious) with onset 26Jun2021, outcome "not recovered", described as "after she received the initial dose, her ankle swelled."; FEELING ABNORMAL (non-serious) with onset Jun2021, outcome "not recovered", described as "wasn''t feeling the same"; CONSTIPATION (non-serious) with onset Jun2021, outcome "not recovered", described as "constipation". The events "after she received the initial dose, her ankle swelled.", "wasn''t feeling the same" and "constipation" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Discouragement
Clinical narrative: Discouraged; Depressed; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: DISCOURAGEMENT (non-serious) with onset 2021, outcome "unknown", described as "discouraged"; DEPRESSED MOOD (non-serious) with onset 2021, outcome "unknown", described as "depressed".   Additional information: Patient reports per MD instruction was off xeljanz for 7 days when had covid booster shot in Sep2021. patient agrees with the statement "generally its been hard for me to cope with rheumatoid arthritis and sometimes I feel discouraged and/or depressed".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (1423231).  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2022 (Batch/Lot number: unknown) at the age of 40 years as dose number unknown, single for covid-19 immunisation; palbociclib (IBRANCE), since 24Feb2021 (Batch/Lot number: unknown) at 100 mg. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset 02Mar2022, outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Caller states her psoriasis has worsened ever since her first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Feb2021 (Lot number: EL9269) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "plaque psoriasis" (ongoing), notes: since she was 16 years old. There were no concomitant medications. The following information was reported: PSORIASIS (non-serious) with onset Feb2021, outcome "unknown", described as "Caller states her psoriasis has worsened ever since her first dose".  Additional information: The patient had the primary series of the Pfizer BioNTech Covid-19 Vaccine and then got a booster dose in Nov2021. Her psoriasis had worsened ever since her first dose and continues to worsen after her booster dose. She had psoriasis since she was 16 years old, but it was now much worse, very itchy, and she was experiencing gigantic spots on places she never had before, all up and down her legs, crawling up her arms, and four patches on her breasts. She did not take anything for her psoriasis, and she might be prescribed something from her dermatologist to treat it now that it had gotten so bad. Her primary care physician had instructed her not to get any more doses of Comirnaty. She reported that the extent of the psoriasis was itches so bad and it was hideous looking. There were no other products or investigation assessment.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Migraine, SARS-CoV-2 test
Clinical narrative: Chronic Cluster/ Migraine headaches everyday; Chronic Cluster/ Migraine headaches everyday; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Dec2020 13:00 (Lot number: EK9231) at the age of 29 years as dose 1, single, intramuscular, administered in arm right, administration date 20Jan2021 14:00 (Lot number: EL3246) as dose 2, signgle and intramuscular, administered in leg left, administration date 13Feb2022 10:30 (Lot number: FK9896) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: CT Contrast" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: EMGALITY [GALCANEZUMAB]; PREDNISONE; NORLYDA. The following information was reported: MIGRAINE (non-serious), CLUSTER HEADACHE (non-serious), outcome "not recovered" and all described as "Chronic Cluster/ Migraine headaches everyday". The event "chronic cluster/ migraine headaches everyday" and "chronic cluster/ migraine headaches everyday" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, cluster headache.  Additional Information: It was reported that that patient had Chronic Cluster/ Migraine headaches every day. 5-8 Times a Day for the past year. Headaches continue to get worse after getting Vaccinated. Started after my first vaccine. With slight headaches as time went by the headaches progressed with intensity. But after every Vaccine Dose the pain is simply unbearable. Medications and Botox are taken as treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient was tested for COVID-19. Prior the vaccination, the patient was not  tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Hypotrichosis, Skin burning sensation
Clinical narrative: My facial hair is not growing; my cheeks and around on my side 'burns'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Jan2022 (Lot number: 33075BD) at the age of 61 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "irregular heart beat and it's called PVCs" (unspecified if ongoing); "I have had a head injury" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPOTRICHOSIS (non-serious) with onset Jan2022, outcome "unknown", described as "My facial hair is not growing"; SKIN BURNING SENSATION (non-serious) with onset Jan2022, outcome "unknown", described as "my cheeks and around on my side 'burns'. Therapeutic measures were not taken as a result of hypotrichosis, skin burning sensation. Additional information: It was reported that patient had a side effect from booster, it's nothing major but it's kind of weird. The patient facial hair was not growing. The patient got the shot in Jan and was starting to notice it, so patient have never had real sick beard to begin with but in the last like 4 weeks, patient mean like cheeks, there's not hair growing on parts of patient cheeks and around on side 'burns' are (not clarified further, hence not captured). It's not bothering , it's just kind of weird. Consumer was informed about role of Pfizer drug safety. Consumer stated that doctor did lab work last month. It was all okay. Patient triglycerides were little high (Further clarification unknown hence not captured), it was the 'sign'. Date of adverse event: Consumer stated adverse event date was about 4 weeks ago(further clarification unknown). The patient did not receive any other vaccine prior to vaccination.  No follow-up attempts are possible. No further information is expected.