chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis
Clinical narrative: Colitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 44 years 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: COLITIS (non-serious), outcome "unknown", described as "Colitis".  Additional information: Report not related to a study or programme. Pfizer COVID-19 vaccine manufacturer was unspecified. Reason for no lot number: of Pfizer COVID-19 vaccine: Caller unwilling to complete the report. Expiry Date of Pfizer COVID-19 vaccine not Provided. Investigation Assessment not Provided. Consumer says he would like to know if colitis could be a symptom from Pfizer vaccination, clarified to Pfizer COVID-19 vaccine. He says he looked it up and it said it was an inflammation of intestines, and he wants to know if it could be related in any way to the vaccine. Caller declines to complete a report at this time, and says that he got the vaccine at the (place withheld) and they said it was Pfizer.  Address: Caller declines to provide. Caller says he is kind of in a panic, and wants to know the medical stuff, he went to the hospital and read and googled it and it said something about it with the vaccine. No further details provided about going to a hospital. No further details captured, reported, or documented at this time.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Swelling
Clinical narrative: Swollen armpit; Hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 17:00 (Batch/Lot number: unknown) at the age of 32 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing), notes: known_allergies: Penicillin. Concomitant medication(s) included: TDAP taken for immunisation, administration date 09Aug2021; HEPLISAV B taken for immunisation, administration date 09Aug2021. The following information was reported: SWELLING (non-serious) with onset 23Aug2021, outcome "not recovered", described as "Swollen armpit"; ALOPECIA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "Hair loss". Therapeutic measures were not taken as a result of swelling, alopecia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No other medications the patient received within 2 weeks of vaccination.  Follow-up (14Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Fever; very sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adolescent male patient received bnt162b2 (BNT162B2) (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: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "very sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: On 10Sep2021 at 10:37 AM Est, about a possible side effect with their young child aged between 5-11 years. Child was in the Clinical study for the Covid vaccine at (name withheld) and got a fever and rash. Pfizer employee later clarifies that it was reported the child had got a fever and very sore arm, no rash. Pfizer employee was contacted through (withheld). Stated reporter does not provide her contact number or address in the message and he has not let her know any response or that he was providing this to Pfizer. States the message just asks how everything was going with him and informed him that she believes her child, (Name), got the vaccine because he developed a fever and a very sore arm the next day. He was to get the second dose on 22Sep2021. No further details provided.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: My daughter also had delayed rash reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) 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: RASH (non-serious) with onset 16Jul2021, outcome "not recovered", described as "My daughter also had delayed rash reaction". The event "my daughter also had delayed rash reaction" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional Information: Patient mother saying that her daughter also had delayed rash reaction. The worst of the rash lasted a month and still experiencing small areas of rash on arms. She was also still experiencing terrible fatigue and seeing a naturopathic doctor. The AE treatment was Supplements/homeopathic remedies. Patient had no Covid prior vaccination and tested post vaccination.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (18Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pruritus
Clinical narrative: 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. Other Case identifier(s): US-PFIZER INC-202101206085 (Pfizer).A female patient received bnt162b2 (BNT162B2), administration date 14Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: 2020 (unspecified if ongoing), notes: She is just getting over a case of Covid she had 12-13 months ago.; "asthma" (unspecified if ongoing), notes: she has asthma and allergies and does take allergy injections.; "allergies" (unspecified if ongoing), notes: she has asthma and allergies and does take allergy injections.; "short of breath" (unspecified if ongoing), notes: just went back to work after 13 months because she was short of breath.; "heart disease" (unspecified if ongoing), notes: She states she has asthma and heart disease. The patient's concomitant medications were not reported.The following information was reported: PRURITUS (non-serious) with onset 14Sep2021, outcome "unknown", described as "is having some itching"; DIZZINESS (non-serious) with onset 14Sep2021, outcome "recovered" (14Sep2021), described as "she got a little light headed"; FATIGUE (non-serious) with onset 14Sep2021, outcome "unknown", described as "fatigue".Additional information: The patient stated that she got itchy when she was at the vaccine and had to wait about 30 minutes as she got a little lightheaded too after taking the vaccine and fatigue. The patient stated the lightheadedness had gone away because she was laying down. The report not related to a study or programme. Investigation assessment not provided. It was reported that she had her 1st Pfizer Covid vaccine this morning and she is having some itching. Reporter was asking is it ok to itch, she knows not to scratch and asking is this a side effect. Report declines to make a report.This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: Cough; Fever; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 17:00 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZINC; VITAMIN C PLUS [ASCORBIC ACID]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, Lot unknown=True, Lot unknown reason=Not available/provided to reporter at the time of report completion, DOSE 1, SINGLE), for covid-19 immunization. The following information was reported: COUGH (non-serious) with onset 13Sep2021 13:00, outcome "unknown", described as "Cough"; PYREXIA (non-serious) with onset 13Sep2021 13:00, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 13Sep2021 13:00, outcome "unknown", described as "Chills". Therapeutic measures were not taken as a result of cough, pyrexia, chills.  Additional information: No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac disorder, Chest discomfort, Dyspnoea, Hypoaesthesia oral
Clinical narrative: lips rest of the day were tingling, kinda numb probably; lips rest of the day were tingling, kinda numb probably; swelled; joints ached next 5 days, specifically her fingers knee joints; twinge inside my heart that I never felt before; still having, this heaviness and trying to get a breath feeling in my chest; still having, this heaviness and trying to get a breath feeling in my chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Sep2021 (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: PARAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious), outcome "not recovered" and all described as "lips rest of the day were tingling, kinda numb probably"; SWELLING (non-serious), outcome "not recovered", described as "swelled"; ARTHRALGIA (non-serious), outcome "not recovered", described as "joints ached next 5 days, specifically her fingers knee joints"; CARDIAC DISORDER (non-serious), outcome "not recovered", described as "twinge inside my heart that I never felt before"; CHEST DISCOMFORT (non-serious), DYSPNOEA (non-serious), outcome "not recovered" and all described as "still having, this heaviness and trying to get a breath feeling in my chest".  Additional information: Caller received her first dose of the Pfizer Biontech covid 19 vaccine on 01Sep2021. Caller reported that her lips rest of the day were tingling, kinda numb probably swelled a little bit, kept wanting to bite her lip. Caller also reported that her joints ached next 5 days, specifically her fingers knee joints. Caller also reported a twinge inside her heart that she had never felt before. still had, that heaviness and trying to get a breath feeling in her chest. Noticed later that night and the next days and it still continued. Took 1st dose and experienced severe side effects that were not going away. Stated that she was scared to take the 2nd dose and was hoping Pfizer could help her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swelling
Clinical narrative: lips rest of the day were tingling, kinda numb probably; lips rest of the day were tingling, kinda numb probably; swelled; joints ached next 5 days, specifically her fingers knee joints; twinge inside my heart that I never felt before; still having, this heaviness and trying to get a breath feeling in my chest; still having, this heaviness and trying to get a breath feeling in my chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Sep2021 (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: PARAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious), outcome "not recovered" and all described as "lips rest of the day were tingling, kinda numb probably"; SWELLING (non-serious), outcome "not recovered", described as "swelled"; ARTHRALGIA (non-serious), outcome "not recovered", described as "joints ached next 5 days, specifically her fingers knee joints"; CARDIAC DISORDER (non-serious), outcome "not recovered", described as "twinge inside my heart that I never felt before"; CHEST DISCOMFORT (non-serious), DYSPNOEA (non-serious), outcome "not recovered" and all described as "still having, this heaviness and trying to get a breath feeling in my chest".  Additional information: Caller received her first dose of the Pfizer Biontech covid 19 vaccine on 01Sep2021. Caller reported that her lips rest of the day were tingling, kinda numb probably swelled a little bit, kept wanting to bite her lip. Caller also reported that her joints ached next 5 days, specifically her fingers knee joints. Caller also reported a twinge inside her heart that she had never felt before. still had, that heaviness and trying to get a breath feeling in her chest. Noticed later that night and the next days and it still continued. Took 1st dose and experienced severe side effects that were not going away. Stated that she was scared to take the 2nd dose and was hoping Pfizer could help her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: my arm is still swollen and really hard tough like a baseball and it still hard and it is little red and also it itches very bad; my arm is still swollen and really hard tough like a baseball and it still hard and it is little red and also it itches very bad; my arm is still swollen and really hard tough like a baseball and it still hard and it is little red and also it itches very bad; Started having pain in my arm; My fever got up to 101.6; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 11Sep2021 (Batch/Lot number: unknown) at the age of 60 years 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: PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset 11Sep2021, outcome "not recovered" and all described as "my arm is still swollen and really hard tough like a baseball and it still hard and it is little red and also it itches very bad"; PAIN IN EXTREMITY (non-serious) with onset 11Sep2021, outcome "unknown", described as "Started having pain in my arm"; PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "My fever got up to 101.6". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: my arm is still swollen and really hard tough like a baseball and it still hard and it is little red and also it itches very bad; my arm is still swollen and really hard tough like a baseball and it still hard and it is little red and also it itches very bad; my arm is still swollen and really hard tough like a baseball and it still hard and it is little red and also it itches very bad; Started having pain in my arm; My fever got up to 101.6; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 11Sep2021 (Batch/Lot number: unknown) at the age of 60 years 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: PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset 11Sep2021, outcome "not recovered" and all described as "my arm is still swollen and really hard tough like a baseball and it still hard and it is little red and also it itches very bad"; PAIN IN EXTREMITY (non-serious) with onset 11Sep2021, outcome "unknown", described as "Started having pain in my arm"; PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "My fever got up to 101.6". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis
Clinical narrative: made his arthritis worse; knees have been killing him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknwon, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "made his arthritis worse"; ARTHRALGIA (non-serious), outcome "unknown", described as "knees have been killing him".  The lot number for [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: The neighbor's daughter is kind of mad at the caller because caller accused them of getting her deathly sick / Coughed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 56 year-old 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, SINGLE), for Covid-19 immunization.  The following information was reported: COUGH (non-serious), outcome "unknown", described as "The neighbor's daughter is kind of mad at the caller because caller accused them of getting her deathly sick / Coughed".  Additional information: NDC number and Expiry Date of Pfizer Vaccine for Covid was unknown. The caller reported she picked up her neighbor and neighbor's daughter who both had taken both doses of Pfizer Vaccine they are fully vaccinated. Caller picked up both the neighbor and neighbor's daughter in her car to go pick up their vehicle. The neighbor coughed in caller's car spreading grassy oxide which caller believed to be an ingredient in the Pfizer Vaccine. She clarified that on 23Jun2021 she picked up her neighbor and her neighbor's daughter in her car to go get their car from the shop. While in caller's car the neighbor coughed, spreading grassy oxide which caller believed is an ingredient in the Pfizer Vaccine for Covid. Caller inhaled that grassy oxide that the neighbor coughed out in her car. Caller has the neighbor's Pfizer Vaccine for Covid information; but does not have the neighbor's daughter's Pfizer Vaccine for Covid information, the neighbor's daughter would not give caller that information like her Pfizer Vaccine for Covid Lots/NDCs/Expiry dates. The neighbor's daughter is kind of mad at the caller because caller accused them of getting her deathly sick . it happened because the very next day after she gave them a ride in her car she started having the massive headache and ever since then these things have been happening to her that never happened to her before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that 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: Alopecia, Pruritus, Skin disorder
Clinical narrative: severe hair loss; skin disorder; itching; This is a spontaneous report received from 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) (Batch/Lot number: unknown) as dose number unknown for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "severe hair loss"; SKIN DISORDER (non-serious), outcome "unknown", described as "skin disorder"; PRURITUS (non-serious), outcome "unknown", described as "itching".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hyperhidrosis, Pyrexia
Clinical narrative: breaking out into sweats; breaking out into sweats and fevers; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 09:30 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; MAGNESIUM; VITAMIN B12 [VITAMIN B12 NOS]; ZINC. Vaccination history included: Bnt162b2 (product: COVID 19, lot unknown: True, lot unknown reason: Misplaced/discarded, administration date: 23Aug2021, administration time: 11:30 AM, dose number: 1, vaccine location: Left arm), administration date: 23Aug2021, when the patient was 29 years old, for covid 19 immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 14Sep2021 01:00, outcome "not recovered", described as "breaking out into sweats"; PYREXIA (non-serious) with onset 14Sep2021 01:00, outcome "not recovered", described as "breaking out into sweats and fevers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hyperhidrosis, pyrexia.  Additional information: The patient was on day 4 and still breaking out into sweats and fevers every couple of hours. the patient did not tested covid post vaccination and covid prior vaccination was no.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: tightening on his chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 30 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 29 years 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: CHEST DISCOMFORT (non-serious) with onset 2021, outcome "recovering", described as "tightening on his chest".  Additional Information: caller reported that his son received the Pfizer Covid 19 vaccine and shortly after getting the 1st dose he had tightening in his chest. His son after getting the first dose of the vaccine of the Pfizer COVID Vaccine experienced tightening with his chest or tightening of his chest.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Inappropriate schedule of product administration, Injury, Monoplegia, Muscle spasms
Clinical narrative: Leg weakness & severe muscle spasms & mild leg paralysis leading to severe leg pain & several falls one resulting in fall onto concrete causing injuries & one causing a broken right arm
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Upper limb fracture, X-ray limb abnormal
Clinical narrative: Leg weakness & severe muscle spasms & mild leg paralysis leading to severe leg pain & several falls one resulting in fall onto concrete causing injuries & one causing a broken right arm
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Decreased appetite, Diarrhoea
Clinical narrative: Began with stomach ache and nausea at 9:00am the day after the shot. Diarrhea at 12pm. Gave Dramamine.  Vomiting at 1:30pm. Loss of appetite and weakness followed. Fever of 100.5 at 5pm. Gave Tylenol.  Fever of 101.7 at 6am on second day (2/16). Joint pain as well.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Began with stomach ache and nausea at 9:00am the day after the shot. Diarrhea at 12pm. Gave Dramamine.  Vomiting at 1:30pm. Loss of appetite and weakness followed. Fever of 100.5 at 5pm. Gave Tylenol.  Fever of 101.7 at 6am on second day (2/16). Joint pain as well.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pyrexia
Clinical narrative: freezing cold, bad headache, fever
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - A constant ringing in my left ear
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Haematology test, Hypertension
Clinical narrative: Pericarditis, severe chest pain, shortness of breath, fever, blood pressure spike
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Pericarditis, Pyrexia, X-ray
Clinical narrative: Pericarditis, severe chest pain, shortness of breath, fever, blood pressure spike
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Body temperature increased, Chest pain, Chills, Computerised tomogram thorax
Clinical narrative: chills, headache, temperature of 103.2 F, achy all over body more so on left side, ringing in ears, shortness of breath, nausea, brain fog, chest pains, swollen lymph nodes more so on left side, diarrhea, increase in blood pressure, rapid beating of heart, 5 days post booster I thought I was having a heart attack and went to ER
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: chills, headache, temperature of 103.2 F, achy all over body more so on left side, ringing in ears, shortness of breath, nausea, brain fog, chest pains, swollen lymph nodes more so on left side, diarrhea, increase in blood pressure, rapid beating of heart, 5 days post booster I thought I was having a heart attack and went to ER
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Lymphadenopathy, Nausea, Pain, Tinnitus
Clinical narrative: chills, headache, temperature of 103.2 F, achy all over body more so on left side, ringing in ears, shortness of breath, nausea, brain fog, chest pains, swollen lymph nodes more so on left side, diarrhea, increase in blood pressure, rapid beating of heart, 5 days post booster I thought I was having a heart attack and went to ER
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong vaccine formulation (ex. different manufacturer initial and booster).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: The area around the injection site was numb for about 1 week.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Computerised tomogram thorax abnormal, Decreased appetite, Dyspnoea
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/16/2021.  93 y/o with PMHx AFIB, CHF, HTN, HLD, Hypothyroid, Urinary Retention, CKD stage 3 presents to ER via EMS with c/o worsening generalized weakness and SOB.  Pt was initially diagnosed with Covid on 02/02/2022.  Per family pt is now unable to get OOB, has decreased appetite so brought to ED for evaluation.  Afebrile, Room air sat initially normal but dropped to 83%, O2 placed on 5L NC.  CT chest suspicious for multi-focal PNA.  Pt started on IV steroids and ABX.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Oxygen saturation decreased, Pneumonia, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/16/2021.  93 y/o with PMHx AFIB, CHF, HTN, HLD, Hypothyroid, Urinary Retention, CKD stage 3 presents to ER via EMS with c/o worsening generalized weakness and SOB.  Pt was initially diagnosed with Covid on 02/02/2022.  Per family pt is now unable to get OOB, has decreased appetite so brought to ED for evaluation.  Afebrile, Room air sat initially normal but dropped to 83%, O2 placed on 5L NC.  CT chest suspicious for multi-focal PNA.  Pt started on IV steroids and ABX.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Wrong dose of vaccine - too high.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong vaccine formulation (ex. different manufacturer initial and booster).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extremities)-Mild, Additional Details: Patient reported back for 2nd dose today. Her left arm, where she received the 1st dose on 1/25/2022, has been tingling since the 1st administration.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Malaise, Paraesthesia oral
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: pt alerted pharmacist not feeling well, feeling dizzy/faint,  I ( the pharmacist) instructd pt to stay >15 minutes, lay on floor, elevate feet, provided water.  patient then stated felt like tongue tingling, swelling, hard to swallow/talk, (similar reaction in past to sulfa when presented to er w/ anaphlaxis) administer 1 dose epipen 615 pm,, bp 165/134, 101 hr (620 pm,), paramedics called
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tachycardia, Throat tightness, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: pt alerted pharmacist not feeling well, feeling dizzy/faint,  I ( the pharmacist) instructd pt to stay >15 minutes, lay on floor, elevate feet, provided water.  patient then stated felt like tongue tingling, swelling, hard to swallow/talk, (similar reaction in past to sulfa when presented to er w/ anaphlaxis) administer 1 dose epipen 615 pm,, bp 165/134, 101 hr (620 pm,), paramedics called
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Severe insomnia
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide normal, COVID-19, Cardiac imaging procedure abnormal, Chest pain, Echocardiogram normal
Clinical narrative: Per patient report he developed chest pain and effort intolerance and underwent ED evaluation at Hospital  and understood he had vaccine induced myocarditis.  He reported multiple cardiac imaging studies demonstrating reduced LVEF.  He was treated with Entresto and had recovery of LV function.   When he was seen by Dr in Jan 2022 he had normal ECG, echocardiography LVEF but an elevated ST2 level.  Troponin and BNP were normal.  He had no clinical signs of heart failure at that time but did have mild pleural pericardial symptoms were treated with prednisone and colchicine.  On January 18, 2022 he had mild COVID-19 breakthrough infection with failure of vaccination.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram normal, Interleukin level increased, Myocarditis, Pericardial effusion
Clinical narrative: Per patient report he developed chest pain and effort intolerance and underwent ED evaluation at Hospital  and understood he had vaccine induced myocarditis.  He reported multiple cardiac imaging studies demonstrating reduced LVEF.  He was treated with Entresto and had recovery of LV function.   When he was seen by Dr in Jan 2022 he had normal ECG, echocardiography LVEF but an elevated ST2 level.  Troponin and BNP were normal.  He had no clinical signs of heart failure at that time but did have mild pleural pericardial symptoms were treated with prednisone and colchicine.  On January 18, 2022 he had mild COVID-19 breakthrough infection with failure of vaccination.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleural effusion, Troponin normal, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: Per patient report he developed chest pain and effort intolerance and underwent ED evaluation at Hospital  and understood he had vaccine induced myocarditis.  He reported multiple cardiac imaging studies demonstrating reduced LVEF.  He was treated with Entresto and had recovery of LV function.   When he was seen by Dr in Jan 2022 he had normal ECG, echocardiography LVEF but an elevated ST2 level.  Troponin and BNP were normal.  He had no clinical signs of heart failure at that time but did have mild pleural pericardial symptoms were treated with prednisone and colchicine.  On January 18, 2022 he had mild COVID-19 breakthrough infection with failure of vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Swelling of armpit which is painful.  Other symptoms were listed as possible side effects (chills, fatigue, pain in place of vax,strong headache)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling of armpit which is painful.  Other symptoms were listed as possible side effects (chills, fatigue, pain in place of vax,strong headache)
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Pruritus, Rash, Urticaria
Clinical narrative: 11 days after my booster shot, I developed a rash on my arms, chest, and scalp. Treated with Benadryl. On November 5th my eyes started to swell shut and itch severely so I presented to urgent care. Received oral prednisone course and treated with Benadryl. Swelling subsided however full body hives continued. Was administered prednisone shots in my arm which appeared to help for several days but hives returned. Hives are not localized and appear all over body. This report is being submitted on 2/16/22 while I am still experiencing full body hives and itchiness all over body. Benadryl has helped with treating itchiness however is only temporary. Best relief has been by taking 50mg Famotidine HCL every evening before bed. After 3 months of famotidine, the hives still present after running out of medication. We have been under assumption that something in my environment (exposure to dirty boxes @ a charity event) was causing the allergic reaction. As more extensive cases of uticaria following mRNA boosters have been reported, it is becoming a larger known issue which matches my symptoms and timeline. I am not anti-vax, I?m glad I got my three doses and am protected from COVID. I just need help finding out how to cure these hives and get my life back to normal. I cannot keep treating with Benadryl and being in a constant state of drowsiness or hives. Please help me!
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: 100F fever for around 18 hours or so. Typical fever symptoms such as pain in limbs and nausea. Generally disabling and had to call off school.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chest pain, Chills, Headache
Clinical narrative: ha/fever/chills/bodyaches/n/v; started developing a gradual onset of fevers and chills, throbbing headache, epigastric and right upper quadrant abdominal pain as well as a squeezing chest pain.  She has vomited several times.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 RNA, Vomiting
Clinical narrative: ha/fever/chills/bodyaches/n/v; started developing a gradual onset of fevers and chills, throbbing headache, epigastric and right upper quadrant abdominal pain as well as a squeezing chest pain.  She has vomited several times.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acoustic stimulation tests, Hypoacusis
Clinical narrative: Decreased hearing after first dose, but felt the decreased hearing was from a flight the next day. Increased hearing loss after second dose on 1/11/22. Went to ENT on 1/19 and no visual problems. on 1/21 went to Audiologist and Prednisone was recommended. This office placed her on Prednisone 20mg three times per day for 5 days w/o relief.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Blood test, COVID-19, Chest X-ray normal
Clinical narrative: After receiving the vaccine I had fatigue. I was in a lot of general pain especially in the joints. I also had arm pit pain. Those symptoms lasted for about 3 days. When I got covid it started with a mild cold, sore throat, a little bit of a dry cough, and post nasal drip. It started feeling like bronchitis, and I also had some skin rashes. Then I started having shortness of breath which brought me to the ER. My oxygen levels were okay, but I was a little dehydrated so the ER gave me a bag of saline. I was sick for a couple of weeks then it started to get a little bit better until it was gone. The fatigue lasted the longest all the way to the end. I got covid from my son who was also fully vaccinated. He got it at school. My husband had got it too but theirs were much more milder.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dehydration, Dyspnoea, Exposure to SARS-CoV-2, Exposure via direct contact
Clinical narrative: After receiving the vaccine I had fatigue. I was in a lot of general pain especially in the joints. I also had arm pit pain. Those symptoms lasted for about 3 days. When I got covid it started with a mild cold, sore throat, a little bit of a dry cough, and post nasal drip. It started feeling like bronchitis, and I also had some skin rashes. Then I started having shortness of breath which brought me to the ER. My oxygen levels were okay, but I was a little dehydrated so the ER gave me a bag of saline. I was sick for a couple of weeks then it started to get a little bit better until it was gone. The fatigue lasted the longest all the way to the end. I got covid from my son who was also fully vaccinated. He got it at school. My husband had got it too but theirs were much more milder.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nasopharyngitis, Oropharyngeal pain, Pain
Clinical narrative: After receiving the vaccine I had fatigue. I was in a lot of general pain especially in the joints. I also had arm pit pain. Those symptoms lasted for about 3 days. When I got covid it started with a mild cold, sore throat, a little bit of a dry cough, and post nasal drip. It started feeling like bronchitis, and I also had some skin rashes. Then I started having shortness of breath which brought me to the ER. My oxygen levels were okay, but I was a little dehydrated so the ER gave me a bag of saline. I was sick for a couple of weeks then it started to get a little bit better until it was gone. The fatigue lasted the longest all the way to the end. I got covid from my son who was also fully vaccinated. He got it at school. My husband had got it too but theirs were much more milder.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: After receiving the vaccine I had fatigue. I was in a lot of general pain especially in the joints. I also had arm pit pain. Those symptoms lasted for about 3 days. When I got covid it started with a mild cold, sore throat, a little bit of a dry cough, and post nasal drip. It started feeling like bronchitis, and I also had some skin rashes. Then I started having shortness of breath which brought me to the ER. My oxygen levels were okay, but I was a little dehydrated so the ER gave me a bag of saline. I was sick for a couple of weeks then it started to get a little bit better until it was gone. The fatigue lasted the longest all the way to the end. I got covid from my son who was also fully vaccinated. He got it at school. My husband had got it too but theirs were much more milder.
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Patient received second booster shot in error
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Limb discomfort
Clinical narrative: Veteran developed marked increase of his blood pressure (160/116) which eventually presented as chest pressure (5/10) that radiated to his left arm. He was sent to local emergency department to evaluate for possible acute MI.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization; fully vaccinated
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: About 2 minutes after vaccine given pt began to pass out with possible seizure. another 3 or 4  minutes later the same thing happened, pass out/ seizure.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given from vial opened 26 hours prior to admin.  Expired vaccine given.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2d vaccine; breakthrough case admission
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna as a 16 year old. Currently Moderna is only approved for patients 18 and older. No adverse reactions have been reported by patient.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Fatigue, Headache, Heart rate irregular
Clinical narrative: Five hours after injection, started experiencing body fatigue, followed by chills.  increasing through the night to the point where I was having convulsions and entire body shaking uncontrollably.  Shivering and could not stay warm under multiple blankets.  irregular heart rate (very high).  then around 6am woke up in a HOT fever, broke a sweat.  the entire next day body aches, extreme fatigue, and headache. currently experiencing random cold sweats at night when I wake up intermittently.  poor circulation and sweaty hands and feet / unknown if it is related
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Poor peripheral circulation, Pyrexia, Seizure
Clinical narrative: Five hours after injection, started experiencing body fatigue, followed by chills.  increasing through the night to the point where I was having convulsions and entire body shaking uncontrollably.  Shivering and could not stay warm under multiple blankets.  irregular heart rate (very high).  then around 6am woke up in a HOT fever, broke a sweat.  the entire next day body aches, extreme fatigue, and headache. currently experiencing random cold sweats at night when I wake up intermittently.  poor circulation and sweaty hands and feet / unknown if it is related
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: I started with itchy palms, then I had a red rash spread all over my body. Every day it got worse and started to burn and itch. The rash was not raised or blistered.  It would start on parts of my body then disappear within seconds, then spread to another part.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated, Dysgeusia, Dyspnoea, Lymphadenopathy
Clinical narrative: Shortness of breath, metallic taste in my mouth. Later developed prominent lymph nodes in lt axilla and neck which are still present. Had fever & body aches for 1 wk following each dose. Arthritis symptoms much more severe since vaccine, especially in rt hand which was virtually asymptomatic before vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Shortness of breath, metallic taste in my mouth. Later developed prominent lymph nodes in lt axilla and neck which are still present. Had fever & body aches for 1 wk following each dose. Arthritis symptoms much more severe since vaccine, especially in rt hand which was virtually asymptomatic before vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram thorax abnormal, Fatigue, Fibrin D dimer increased, Hysterectomy
Clinical narrative: The day after my 3rd dose had a fever, chills and fatigue. That lasted for 3 days. I took Motrin. So I had a laparoscopic hysterectomy on 12/14 then I was hospitalized on 12/23 for pulmonary embolism. I was hospitalized for 24 hours. I consulted with a physician they didn't know if the PE was related to the vaccine or not. Had follow up visit 01/02/2022 with pcp. They suggested that I follow up with hematologist. I have a past medical history of PE as well.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pyrexia
Clinical narrative: The day after my 3rd dose had a fever, chills and fatigue. That lasted for 3 days. I took Motrin. So I had a laparoscopic hysterectomy on 12/14 then I was hospitalized on 12/23 for pulmonary embolism. I was hospitalized for 24 hours. I consulted with a physician they didn't know if the PE was related to the vaccine or not. Had follow up visit 01/02/2022 with pcp. They suggested that I follow up with hematologist. I have a past medical history of PE as well.