chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Inflammatory marker test, Influenza like illness, Migraine, Pain
Clinical narrative: Gastrointestinal issues, migraines, fever and flu like symptoms, heart issues/palpitations, head fog, body aches, breathing issues, elevated inflammation and white blood cell count
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pulmonary function test, Pyrexia, Respiratory symptom, White blood cell count abnormal
Clinical narrative: Gastrointestinal issues, migraines, fever and flu like symptoms, heart issues/palpitations, head fog, body aches, breathing issues, elevated inflammation and white blood cell count
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Gastrointestinal issues, migraines, fever and flu like symptoms, heart issues/palpitations, head fog, body aches, breathing issues, elevated inflammation and white blood cell count
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Nausea, Skin warm
Clinical narrative: Pt was disoriented, extremely nauseous and  feeling warm form head to toe.  It started around 6:08pm  It passed within 20 minutes.  EMS checked her out and BP, pulse and BS was fine  She walked out of store just fine and drove home.  I called pt later around 7:15pm, she was still nauseous but otherwise feeling much better
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Pyrexia, Retching
Clinical narrative: 103 fever, vomiting, dry heaves, coughing, severely tired, loss of appetite, all symptoms lasted for 4 days
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 103 fever, vomiting, dry heaves, coughing, severely tired, loss of appetite, all symptoms lasted for 4 days
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac fibrillation, Dyspnoea, Palpitations
Clinical narrative: Extreme palpitations/fibrillation accompanied by blood pressure 190 over 90 and breathlessness
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Blood pressure increased, Chills, Fatigue
Clinical narrative: Right leg went numb right after injection, same happened with the first dose. Arm and shoulder pain that goes up to neck on right side, and wraps around to armpit. No swelling at this time. 24 hours after injection I felt extremely sick with a fever, chills, nausea, migraine, excessive thirst, and extreme fatigue. Slightly elevated blood pressure occurred as well.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Malaise, Migraine, Nausea, Neck pain
Clinical narrative: Right leg went numb right after injection, same happened with the first dose. Arm and shoulder pain that goes up to neck on right side, and wraps around to armpit. No swelling at this time. 24 hours after injection I felt extremely sick with a fever, chills, nausea, migraine, excessive thirst, and extreme fatigue. Slightly elevated blood pressure occurred as well.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Thirst
Clinical narrative: Right leg went numb right after injection, same happened with the first dose. Arm and shoulder pain that goes up to neck on right side, and wraps around to armpit. No swelling at this time. 24 hours after injection I felt extremely sick with a fever, chills, nausea, migraine, excessive thirst, and extreme fatigue. Slightly elevated blood pressure occurred as well.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Shoulder articular/muscular pain, at one time the pain diffused to the hands and then stopped, continuing just in the shoulder. Then it diffused to the neck and continue until this date.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient stated that he woke up on 2-23-22  and adjusted his pillow with his left arm and began having shooting pain that radiated up and down his left arm and neck. He said that one day later his arm  became numb and he rubbed it with green alcohol.  He stated that his arm is no longer numb, but stings when he moves it up and down, but doesn't hurt at rest. He has not gone for  medical attention at this time.  He said he is going to wait to see if pain improves.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chillblains, Dermatologic examination
Clinical narrative: I developed Chilblain like lesions on all my fingers at the nail growth plate in early January.     They have slowly gotten worse.   I never had this before and doctors can't find a reason.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Initially, the day after in the evening, the beginning of fatigue and nausea along with a minor headache. Day 3 was the worse with all 3 of these.  These all seemed to correct themselves.  About a week later, I started noticing: continued fatigue here and there but now also  heart palpitations, brain fog (remembering things, words, stumbling over words), worsening internal vibrations to shakiness (jitters) developing in toes and legs, abdomen, vaginal area, rear end, and head area along with eye twitching and vision issues and not feeling like myself/anxious. Vibrations were not as bad before and not moving around. Lastly, a couple of strange bumps on my skin - arm, chest area - allergic reaction?  Though this many weeks later, the bumps remain.  These symptoms are similar to my experience to 2nd dose.  See past filing.  That would be helpful.  I can't believe I'm back to this again.  Much had improved and now I'm taking a step backwards again.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash, Tremor, Visual impairment
Clinical narrative: Initially, the day after in the evening, the beginning of fatigue and nausea along with a minor headache. Day 3 was the worse with all 3 of these.  These all seemed to correct themselves.  About a week later, I started noticing: continued fatigue here and there but now also  heart palpitations, brain fog (remembering things, words, stumbling over words), worsening internal vibrations to shakiness (jitters) developing in toes and legs, abdomen, vaginal area, rear end, and head area along with eye twitching and vision issues and not feeling like myself/anxious. Vibrations were not as bad before and not moving around. Lastly, a couple of strange bumps on my skin - arm, chest area - allergic reaction?  Though this many weeks later, the bumps remain.  These symptoms are similar to my experience to 2nd dose.  See past filing.  That would be helpful.  I can't believe I'm back to this again.  Much had improved and now I'm taking a step backwards again.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Discomfort, Hypersensitivity, Pruritus, Rash
Clinical narrative: I've developed serious itchy skin/hives starting 12 days after I received my moderna booster shot. My hives started on Feb 2nd. After a few days, I followed up with an urgent care as I thought it was a rash or random allergic reaction to something I ate. They prescribed me an oral steroid 6 day pack. After I finished the steroids, I went back, as nothing had changed. They then prescribed an additional stronger steroid, which also did not change anything. This has been the 25th day of having hives consecutively. I did not have hives on February 21st, which happened to be the day that I had a lot of symptoms of covid-19 and had tested positive. The itching is extremely uncomfortable and the hives pop up all over my body, including feet, thighs, arms, back, stomach, face, neck.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Urticaria
Clinical narrative: I've developed serious itchy skin/hives starting 12 days after I received my moderna booster shot. My hives started on Feb 2nd. After a few days, I followed up with an urgent care as I thought it was a rash or random allergic reaction to something I ate. They prescribed me an oral steroid 6 day pack. After I finished the steroids, I went back, as nothing had changed. They then prescribed an additional stronger steroid, which also did not change anything. This has been the 25th day of having hives consecutively. I did not have hives on February 21st, which happened to be the day that I had a lot of symptoms of covid-19 and had tested positive. The itching is extremely uncomfortable and the hives pop up all over my body, including feet, thighs, arms, back, stomach, face, neck.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Lip swelling, Swelling, Swelling face
Clinical narrative: Wife came in yesterday and said that her husband got the moderna booster at around 12pm and he started to have symptoms at 9pm that same day. He had swelling of the chin, face, lips and neck, sob, diff breathing, and numbness started from the right face to the left face. She took him to the urgent care and now he is all better and back to normal. Apologized to the wife that happened to her husband but she was fine she just wanted to let us know. She also said he got 2 moderna vaccines and he was fine just the 3rd dose he got really bad reactions. put in database and vaers
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Left shoulder hurted every single day, each time I reached for something, it had pain on the joint of my shoulder that lasted from 10-30 seconds. It had never hurted before until the Covid-19 shot.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: anaphylaxis, shortness of breath, stridor given benadryl, duoneb by ems ed visit pending completion of treatment
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient got first dose of moderna vaccine series on 2/5/22. The patient got her second dose on 2/26/22.  This is only a 21-day wait and not the 28-day wait recommended , and thus is a medication error.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Sever Chest pain, shortness of breath, difficulty breathing
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: I don't have the lot information.  My BP skyrocketed after I got the vaccine.  I ended up in the emergency room 59 days after the vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever, chills, body aches, dizziness, headache. localized erythema, pain, and swelling at injection site
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, dizziness, headache. localized erythema, pain, and swelling at injection site
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza like illness, Injection site pain, Nausea
Clinical narrative: Flu like symptoms, soreness in injection site, body aches, headache, vomiting, diarrhea, nausea
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Flu like symptoms, soreness in injection site, body aches, headache, vomiting, diarrhea, nausea
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test
Clinical narrative: severe swelling in hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "exposed to Covid 19" (unspecified if ongoing), notes: was given the Regeneron infusion. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1, Starting with the first dose she experienced a side effect of severe swelling in hands and feet), administration date: 28Dec2020, for COVID-19 Immunization, reaction(s): "Starting with the first dose she experienced a side effect of severe swelling in hands and feet", "Starting with the first dose she experienced a side effect of severe swelling in hands and feet". The following information was reported: PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2021, outcome "not recovered" and all described as "severe swelling in hands and feet"; EXPOSURE TO SARS-COV-2 (non-serious) with onset Aug2021, outcome "unknown", described as "exposed to Covid 19". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reason for no lot number: of Pfizer covid vaccine: Caller unwilling to complete the report Expiry Date of Pfizer covid vaccine: Not Provided. Reporter stated that the patient is currently 68 years old but she was 67 when she received her vaccines. Reporter stated that her sister was in a nursing home in (with held) and she was her sisters power of attorney and she lived in (with held). She relays that her sister received the first dose of the Pfizer Covid 19 vaccine on 28DEC2020 and the second dose in Jan2021. Starting with the first dose she experienced a side effect of severe swelling in hands and feet, to the point that she was unable to bend her fingers and could not place her feet in wide slippers. She has never experienced this prior. The reaction stayed for weeks and after a long time it went away. In Aug2021 she was exposed to Covid 19 and she was given the Regeneron infusion. Now there have been cases of the new Covid 29 variant in her nursing home and they would like to give her a booster dose. Her sister refuses. The reporter stated that since she is the POA she has to make the decision if she should get a booster or not? She would like to know if this side effect of the hands and feet swelling has been reported and if she can safely get a booster dose after that reaction. Response was given per PI section 4 Contraindications. This report was not related to a study or programme. Caller was unwilling to complete the report expiry date of Pfizer covid vaccine. Investigation Assessment: Not Provided.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: In pain a lot. Sometimes on steroids. After the shots pain goes away for sometime; 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, single for covid-19 immunisation. Relevant medical history included: "have very bad joint pain" (unspecified if ongoing); "In pain a lot" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "In pain a lot. Sometimes on steroids. After the shots pain goes away for sometime".  Additional Information: The patient noted a good side effect to the covid vaccine. The patient had very bad joint pain. Lower leg circulation problem. In pain a lot. Sometimes on steroids. After the shots pain went away for sometime.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: her arm is hurting at the site of the injection; the child has a little discomfort in the arm (which he is aware can happen) and continues to complain of a sore arm; the child has a little discomfort in the arm (which he is aware can happen) and continues to complain of a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 17:30 (Batch/Lot number: unknown) at the age of 5 years as dose number unknown (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LIMB DISCOMFORT (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Jan2022, outcome "unknown" and all described as "the child has a little discomfort in the arm (which he is aware can happen) and continues to complain of a sore arm"; VACCINATION SITE PAIN (non-serious) with onset 13Jan2022, outcome "not recovered", described as "her arm is hurting at the site of the injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter would like to know if it was okay to give Tylenol to the child.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: had a similar reaction / swollen armpit up to her collarbone on the side of the vaccine; their doctor drained their lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "had a similar reaction / swollen armpit up to her collarbone on the side of the vaccine"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "their doctor drained their lymph node".  Additional information: Report 2 of 2 on female that had similar reaction. Caller stated she was calling because she has side effects and when she got it middle of last year, the vaccine, they told her from where she got it to go to a website with the CDC and report her issue, so she has been doing that. Stated that somebody else said to contact Pfizer and see if there was anything else she should be doing, that she may have to go to the doctor. During report caller stated she was talking to someone that had a similar reaction with the vaccine and their doctor drained their lymph node so she didn't know if that was something she needed to do or if Pfizer had doctors she would go see. Caller relays she was not sure which vaccine they had and thinks that she or her doctor made a report about it already. No further details provided.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Panic attack
Clinical narrative: diarrhea; patient experiencing panic attack in the past but believe this is attributed to existing anxiety issue, believe some of these happened after vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Auto immune disease" (unspecified if ongoing); "Panic attack" (unspecified if ongoing), notes: Patient experiencing panic attack in the past; "Allergy to grass" (unspecified if ongoing), notes: May have an allergy to grass but not 100% sure. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; PANIC ATTACK (non-serious), outcome "unknown", described as "patient experiencing panic attack in the past but believe this is attributed to existing anxiety issue, believe some of these happened after vaccination".  Additional information: As a note as well, sometime in Apr/May/Jun the patient believe of 2021, had started using anxiety medication that had to switch away from (to a different medication) since was giving a side effect of diarrhea, the event onset date should be May or June. As a note, there have been reports of experiencing panic attack in the past but believe this is attributed to existing anxiety issue. There has been at least one time where has experienced them more than usual in a time period (believe was under stress when occurred).   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: Coughing; Congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US006845 (Privacy).  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Coughing"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Congestion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Omicron after holiday with very mild flu-like symptoms; got Omicron after Christmas with very mild flu-like symptoms; This is a spontaneous report received from contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), in Aug2021 (Batch/) as first single dose for covid-19 immunization. Relevant medical history included: asthma from an unspecified date. The patient's concomitant medications were not reported. The patient got Omicron after holiday with very mild flu-like symptoms, on an unspecified date, noted as after holiday. Details were as follows: Patient got the 1st dose of the Pfizer vaccine in Aug2021. 10 days later, he started experiencing swelling around the neck. The symptoms came and went. Patient went to the doctor in September, who said that he had not seen a reaction like that before and suggested ibuprofen (ADVIL). The swelling kept coming and going. Nine days straight, and it was still swollen all day. The patient got Omicron after holiday with very mild flu-like symptoms. The clinical outcome of got Omicron after holiday with very mild flu-like symptoms was unknown.   The lot number for BNT162B2  was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site for a day or two; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 11Jan2021 14:00 (Lot number: EL3249) at the age of 44 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) with onset Jan2021, outcome "recovered" (2021), described as "Soreness at injection site for a day or two". Additional information: The patient did not receive prior vaccination and had no relevant tests. She had no family medical history relevant to AE. The patient received dose 2 (Lot number: EM9810) on 01Feb2021 and dose 3 (Lot number: 33130BA) on 14Dec2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: diarrhea; had experienced day-long nausea/vomitting after receiving the vaccine, I believe after the first dose.; had experienced day-long nausea/vomitting after receiving the vaccine, I believe after the first dose.; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200149332 (Pfizer).  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), NAUSEA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "had experienced day-long nausea/vomitting after receiving the vaccine, I believe after the first dose."; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhoea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Hypersensitivity
Clinical narrative: I have Asthma; Very serious allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 Immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "I have Asthma"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Very serious allergic reaction".  Additional information: Patient want to know about the side effects, allergic side effects because patient had asthma. No death, no hospitalization but very serious allergic reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Biopsy, Laboratory test
Clinical narrative: Hair loss; Alopecia areata; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Apr2021 (Lot number: ew0153) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "eczema" (unspecified if ongoing); "hypo thyroid" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT. The following information was reported: ALOPECIA (non-serious) with onset May2021, outcome "recovered with sequelae", described as "Hair loss"; ALOPECIA AREATA (non-serious) with onset May2021, outcome "recovered with sequelae", described as "Alopecia areata". The events "hair loss" and "alopecia areata" were 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 alopecia, alopecia areata.  Additional information: The patient receive any other medications within 2 weeks of vaccination includes tiro sent 25 mcg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: I developed Alopecia areata; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Unknown, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: ALOPECIA AREATA (non-serious), outcome "unknown", described as "I developed Alopecia areata".  Additional Information: Customer Verbatim was reported as "I am a physician, convinced that I have an adverse reaction to vaccine booster. I developed Alopecia areata. Please help me with samples of Xeljanz."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Headache
Clinical narrative: Lost eyesight in one of her eyes; She developed severe headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), via an unspecified route of adminiatration, on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "Lost eyesight in one of her eyes"; HEADACHE (non-serious), outcome "unknown", described as "She developed severe headache". Additional information: The patient cannot perform her doctor duties and was out of the profession.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash; Urticaria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date May2021 (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 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand_unknown=False,, prev dose lot number=UNK,, prev dose lot unknown=False,, prev dose administration date=May2021, prev dose dose number=1), administration date: May2021, for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset Jun2021, outcome "not recovered", described as "Rash"; URTICARIA (non-serious) with onset Jun2021, outcome "not recovered", described as "Urticaria". Therapeutic measures were taken as a result of rash, urticaria. Additional information: treatment was Prednisone. Rash, Urticaria lasting since 2 weeks post injection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Overdose, Pain in extremity, Product preparation error
Clinical narrative: after 3 patients were administered with the Pfizer COVID-19 Vaccine Orange Cap undiluted resulting in a higher than authorized dose; after 3 patients were administered with the Pfizer COVID-19 Vaccine Orange Cap undiluted resulting in a higher than authorized dose; Headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 9 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FL0007, Expiration Date: Jun2022) at the age of 9 years as dose 1 (tris), 0.2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), outcome "unknown" and all described as "after 3 patients were administered with the Pfizer COVID-19 Vaccine Orange Cap undiluted resulting in a higher than authorized dose"; HEADACHE (non-serious) with onset 08Feb2022, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 08Feb2022, outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of headache, pain in extremity. Clinical course: Caller was on the line after 3 patients were administered with the Pfizer COVID-19 Vaccine Orange Cap undiluted, resulting in a higher than authorized dose. The 3 patients involved were a 10 years old male and two 9 years old females. Each one of them received 0.2 mL of the undiluted Pfizer COVID-19 Vaccine Orange Cap. For the 10 years old male and one of the 9 years old female, the administered dose was the second dose, but for the other 9 years old female, it was the first dose. For the patient with the first dose, there was additional concern because they're going on a cruise on March. Caller wanted to know what were the typical concerns, what information could be given to the patients, and if we had any post-market information regarding other administration errors. Caller wanted to know what would the total amount of doses per vial be.  For one of the 9 years old female, it was the first dose. Caller wanted information on the recommended way of spacing the second dose of the Pfizer COVID-19 Vaccine. Relatedness of drug to reaction(s)/event(s): Reaction assessed: administered doses that were undiluted, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Caller states she had 3 patients that received undiluted pediatric dose of Pfizer Covid vaccine. Caller states she followed up with patient (initial) and they reported no adverse reactions last night and this morning the patient had a headache and sore arm so mom gave her 2 and a half Tylenol chewables at 5am and sent her to school. With regards to this initial report, caller reported there were three pediatric patients who received an undiluted dose of the Pfizer Pediatric COVID Vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: heart is "pounding"; resting heart rate was anywhere from the high 70's BPM to 100 BPM Just lying in bed; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) 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 1), for COVID-19 immunization, reaction(s): "no symptom"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "no symptom".  The following information was reported: HEART RATE INCREASED (non-serious) with onset 23Nov2021, outcome "unknown", described as "resting heart rate was anywhere from the high 70's BPM to 100 BPM Just lying in bed"; PALPITATIONS (non-serious), outcome "unknown", described as "heart is "pounding"". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got 3rd vaccine on 23Nov2021, starting that night and for a few days after that, resting heart rate was anywhere from the high 70's BPM to 100 BPM, just lying in bed, it was 100 BPM. (patient had virtually no symptoms with the first 2 shots). Now, even with slight activity, BPM goes over 90 and patient's resting heart rate is anywhere from 60 to 80+. This was not the case before 3rd shot. It feels like heart is "pounding" even when resting.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Ascites, Pancreatitis, Pleural effusion, Splenic vein thrombosis
Clinical narrative: pancreatitis; developed bilateral pleural effusions; ascites; splenic vein blood clot; This is a spontaneous report received from contactable reporter(s) (Physician).  An adolescent male patient received bnt162b2 (BNT162B2), administration date 15Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "kidney stone" (unspecified if ongoing), notes: Other medical history: kidney stone; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose number: 2), for Covid-19 immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose number: 1), for Covid-19 immunization. The following information was reported: PANCREATITIS (hospitalization) with onset 17Jan2022, outcome "unknown", described as "pancreatitis"; PLEURAL EFFUSION (hospitalization) with onset 17Jan2022, outcome "unknown", described as "developed bilateral pleural effusions"; ASCITES (hospitalization) with onset 17Jan2022, outcome "unknown", described as "ascites"; SPLENIC VEIN THROMBOSIS (hospitalization) with onset 17Jan2022, outcome "unknown", described as "splenic vein blood clot". The events "pancreatitis", "developed bilateral pleural effusions", "ascites" and "splenic vein blood clot" were evaluated at the emergency room visit. Clinical course: 17Jan diagnosed with pancreatitis at ER. developed bilateral pleural effusions, ascites with a splenic vein blood clot. Adverse event resulted in Emergency room/department or urgent care, Hospitalization. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site mass
Clinical narrative: feeling a lump in his armpit while taking a shower./ lump was in the arm where he received the vaccine.; He also stated feeling a sore muscle around the area of the lump; 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 31-year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Feb2022 (Lot number: FK9729) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose #1, Lot: EW0169, Unknown manufacturer), administration date: 30Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose #2, Lot: EW0186, Expiration: 31Aug2021, Unknown manufacturer), administration date: 21May2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 06Feb2022, outcome "not recovered", described as "feeling a lump in his armpit while taking a shower./ lump was in the arm where he received the vaccine."; MYALGIA (non-serious) with onset Feb2022, outcome "not recovered", described as "He also stated feeling a sore muscle around the area of the lump". Additional information included: The next morning after vaccination on 06Feb2022, feeling a lump in his armpit while taking a shower. He also stated feeling a sore muscle around the area of the lump and that said lump was in the arm where he received the vaccine. He woke up with a lump in his armpit. He looked it up on internet and it said something about lymph nodes. He got a small lump in his armpit in the same arm he got the shot in. It is like a little ball. The patient still got it feels like a sore muscle. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blepharitis, Finger deformity, Pain in extremity, Psoriatic arthropathy, Uveitis
Clinical narrative: Psoriatic arthritis; Uveitis; Blepharitis; Deformation in fingers; Finger pain/fingers hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4257369-00.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administration date Feb2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous since 2019 (ongoing) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis"; UVEITIS (medically significant), outcome "not recovered", described as "Uveitis"; BLEPHARITIS (non-serious), outcome "not recovered", described as "Blepharitis"; FINGER DEFORMITY (non-serious), outcome "not recovered", described as "Deformation in fingers"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Finger pain/fingers hurts". The events "psoriatic arthritis", "uveitis", "blepharitis", "deformation in fingers" and "finger pain/fingers hurts" were evaluated at the physician office visit. The action taken for risankizumab was unknown. Clinical course: As of 27Jan2022 Patient was on Skyrizi and until first covid shot in Feb, it was doing wondered for all those conditions. After each vaccine, everything flared, but then patient came due for the next Skyrizi shot and everything, except the Psoriatic Arthritis, settled. Patient as of 27Jan2022 seeing even more deformation in fingers and they hurt so badly that typing hurt. Just that little bit of hitting of the keys sent spikes of pain into fingers. Patient had to change out all plush towels to the thinnest could find, ditto or wash cloths. It hurt too much to get into the cracks and crevices with the thick ones. Patient list of accommodations went on and on. Patient working with a pain doc who was also a functional doc to see if she can get pain under control. Patient knew that patient should see, but patient scared was going to suggest the addition of Plaquenil or Methotrexate and patient was leery of those two drugs. The reporter's causality for the event(s) of psoriatic arthritis, uveitis, blepharitis, deformation in fingers and finger pain/fingers hurts was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia, Headache, Nausea
Clinical narrative: blood in stool; diarrhea/ flair ups diarrhea; nausea; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4097881-00 (AbbVie).  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for non-infectious intermediate posterior and panuveitis, moderate to severe chronic plaque psoriasis, moderate to severe ulcerative colitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1 ), administration date: 01Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Ulcerative colitis aggravated", "Blood in stool", "Flare ups increased to once a week", "got sick", "nauseous", "diarrhea", "sore arm on covid vaccine shot", "upset stomach", "headache", "Fever", "Flair ups diarrhea"; Bnt162b2 (dose 2 ), administration date: 01Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Nausea ", "Headache", "Diarrhea". The following information was reported: HAEMATOCHEZIA (medically significant), outcome "not recovered", described as "blood in stool"; DIARRHOEA (medically significant) with onset 2021, outcome "recovered" (2021), described as "diarrhea/ flair ups diarrhea"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache". Booster and second vaccinations caused nausea, headache and diarrhea resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. The action taken for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of flare ups increased to once a week, sore arm on covid vaccine shot, got sick with diarrhea and nauseous onset in 2021, flair ups diarrhea and blood in stool unknown onset, got sick with diarrhea and nauseous onset in 2021, first vaccine caused upset stomach, headache and fever onset in Mar2021, first vaccine caused upset stomach, headache and fever onset in Mar2021, first vaccine caused upset stomach, headache and fever onset in March 2021, booster and second vaccinations caused nausea, headache and diarrhea onset in 2021, and flair ups diarrhea and blood in stool unknown onset was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.