chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 26Feb2021, when the patient was 63-year-old, for COVID-19 Immunisation; moderna (DOSE 2, SINGLE, Anatomical location: Left arm), administration date: 26Mar2021, when the patient was 63-year-old, for COVID-19 Immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 19Nov2021, when the patient was 64-year-old, for COVID-19 Immunisation; moderna (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 16Sep2022, when the patient was 65-year-old, for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) negative, notes: Two days after finishing my course of paxlovid, I tested negative and felt fine. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 15Nov2023 to 19Nov2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300413999 same patient, different drug and AE;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: have had both of my shots (COVID-19 Vaccine) when it first came into year when the corona virus was active/proved to be positive; have had both of my shots (COVID-19 Vaccine) when it first came into year when the corona virus was active/proved to be positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "have had both of my shots (COVID-19 Vaccine) when it first came into year when the corona virus was active/proved to be positive". The event "have had both of my shots (covid-19 vaccine) when it first came into year when the corona virus was active/proved to be positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: I should get a test for the Corona virus which I did and it proved to be positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Last week he got a cold and talked to his doctor and with all the information he gave him, doctor told him that he should get a test for the Corona virus which he did and it proved to be positive. he had both of his shots (COVID-19 Vaccine) when it first came into year when the corona virus was active. He did not have anything for 2 years until this time when he called his doctor. Doctor ordered him to take Paxlovid. he started the Paxlovid past Friday.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414024 same patient, different drug/event;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3(BOOSTER), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4(BOOSTER), Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 19Nov2023 to 24Nov2023. Clinical course: Patient had no Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414217 Same patient, different event/drug;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable consumer from product quality group. The reporter is the patient. A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulpha antibiotics" (unspecified if ongoing). Concomitant medication included: LEVOTHYROXINE (Manufacturer: Amneal), start date: May2000. Vaccination history included: bnt162b2 (Dose 5, location: Right arm, vaccine brand: Pfizer/BioNTech , Vaccine administration time: 01:00 PM), administration date: 28Sep2022, for COVID-19 immunization; bnt162b2 (Dose 4, location: Right arm, vaccine brand: Pfizer/BioNTech , Vaccine administration time: 01:00 PM, Vaccine lot number: EP4554), administration date: 12Apr2022, for COVID-19 immunization; bnt162b2 (Dose 3, location: Right arm, vaccine brand: Pfizer/BioNTech , Vaccine administration time: 01:00 PM, Vaccine lot number: 30145BA), administration date: 28Sep2021, for COVID-19 immunization; bnt162b2 (Dose 2, location: Right arm, vaccine brand: Pfizer/BioNTech , Vaccine administration time: 11:00 AM, Vaccine lot number: EN6205), administration date: 03Mar2021, for COVID-19 immunization; bnt162b2 (Dose 1, location: Left arm, vaccine brand: Pfizer/BioNTech, Vaccine administration time: 10:00 AM), administration date: 10Feb2021, for COVID-19 immunization. Patient received PAXLOVID tablet from 18Nov2023 to 22Nov2023 for treatment of COVID-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Outcome of the event was unknown.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: was exposed; then sx 24Nov2023, then 25Nov2023 positive test AG at home; was exposed; then sx 24Nov2023, then 25Nov2023 positive test AG at home; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 60-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Lot number: HF9275) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient didn't have covid prior vaccination. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 24Nov2023, outcome "recovering" and all described as "was exposed; then sx 24Nov2023, then 25Nov2023 positive test AG at home". The event "was exposed; then sx 24nov2023, then 25nov2023 positive test ag at home" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2023) Positive, notes: Covid test type post vaccination= Nasal Swab, Covid test name post vaccination= Binax Now Abbott. Therapeutic measures were taken as a result of covid-19, vaccination failure which included paxlovid. Clinical course: Patient's daughter with fatigue and COVID and patient was exposed, then sx 24Nov2023 moderate myalgias, rhinorrhea, chills and fevers then 25Nov2023 positive test AG at home, then paxlovid and sx resolved in 48 hours.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug bnt162b2 omi xbb.1.5 and reported events covid 19 and vaccination failure cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Lot number: HD9835) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "shellfish" (unspecified if ongoing); "multiple pollens" (unspecified if ongoing); "Premature Atrial Contractions (13%)" (unspecified if ongoing); "severe obstructive sleep apnea (using CPAP)" (unspecified if ongoing); "lymphedema cause multiple episodes of sepsis" (unspecified if ongoing); "obesity" (unspecified if ongoing); "lymphedema cause multiple episodes of sepsis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: GH9694), administration date: 16Sep2022, when the patient was 69-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 4, Batch/Lot No: FK9729), administration date: 06May2022, when the patient was 69-year-old, for COVID-19 Immunization; moderna (Dose Number: 3, Batch/Lot No: 035C21A), administration date: 26Oct2021, when the patient was 68-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205), administration date: 01Mar2021, when the patient was 68-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EN9581), administration date: 08Feb2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash in the legs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Nov2023 as dose 1, single (Batch/Lot number: unknown) 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 28Nov2023, outcome "unknown", described as "rash in the legs". Additional information: Caller mentioned she and her husband got the Pfizer COVID-19 Vaccine today in the morning and now she has rash in the legs. She wanted to know more information about this. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Product administered to patient of inappropriate age, Underdose
Clinical narrative: heart problems; gave a pediatric 5-11 year old covid dose to an adult; gave a pediatric 5-11 year old covid dose to an adult; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTURER UNKNOWN (where X=1, 2, or number unknown)), for COVID-19 immunisation. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), UNDERDOSE (non-serious) all with onset 24Nov2023 and all described as "gave a pediatric 5-11 year old covid dose to an adult."; CARDIAC DISORDER (non-serious), described as "heart problems". Therapeutic measures were taken as a result of cardiac disorder.  Additional information: HCP stated that a staff member gave a pediatric 5-11 year old covid dose to an adult. States when a colleague followed up with the patient, the patient mentioned she had 'such a hard time with the first shot and the booster' and is getting the shots because she has heart problems. HCP stated the doctor was ok that the patient received a lower dose. Caller thinking maybe the pediatric dose will be safer for her given her past experience with previous shots.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on my legs after receiving the vaccine this morning; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Nov2023 as dose 1, single (Batch/Lot number: unknown) 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 28Nov2023, outcome "unknown", described as "rash on my legs after receiving the vaccine this morning". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: the next day I was really tired; Kinda lethargic; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 27Nov2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP), Program ID. The reporter is the patient.  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LETHARGY (non-serious) with onset 07Oct2023, outcome "recovered", described as "Kinda lethargic"; FATIGUE (non-serious) with onset 07Oct2023, outcome "recovered", described as "the next day I was really tired". Therapeutic measures were not taken as a result of fatigue, lethargy.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted a terrible case of Covid; contracted a terrible case of Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for COVID-19 treatment, notes: patient used Paxlovid during a prior infection, with great results. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "contracted a terrible case of Covid". The patient was extremely disappointed in the latest Covid vaccine. Despite being fully vaccinated, the patient contracted a terrible case of Covid. She/he was now on day-12 of severe illness. The patient used Paxlovid during a prior infection, with great results, but was lulled into a false sense of security since was vaccinated just 5 weeks before the report. The patient missed the Paxlovid window this time because thought she/he would be protected from the vaccine. It did not work.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My wife died from the side effects of COVID-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "My wife died from the side effects of COVID-19 vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: My wife died from the side effects of COVID-19 vaccine
Sex: F
Vaccine: COVID19
Symptoms: Hypothyroidism
Clinical narrative: hypothyroidism; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOTHYROIDISM (medically significant) with onset 2023, outcome "unknown". Clinical course: Made her felt better about Pfizer seeing she was debating whether she should have Moderna since she got hyper hypothyroidism after Pfizer. She did not know if it was related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Impaired work ability, Influenza
Clinical narrative: worst flu illness; Initial information received on 23-Nov-2023 regarding an unsolicited valid social media non-serious case received from patient.  This case involves an unknown age and gender patient who had worst flu illness after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for flu (Influenza immunization). Information on the batch number was requested.  On an unknown date the patient had worst flu illness (influenza like illness) (unknown latency) following the administration of influenza vaccine.  Reportedly, Patient's first flu shot was about 25 years ago, 2 weeks later I came down with the worst flu illness in my life. Missed work for a week. About 25 years later, now for my annual physical, Nurse comes in and gives me a flu shot I didn't ask for and should have refused. About a month later came down so sick couldn't work for days.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (worst flu illness).  At time of reporting, the outcome was Unknown for the event worst flu illness.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient received fluzone HD QIV, and then 4 weeks later they accidentally administered another dose of fluzone HD QIV with no reported adverse event; Initial information received on 17-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent], and then 4 weeks later they accidentally administered another dose of fluzone HD QIV with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, dosage, expiry date, formulation- not reported) via unknown route in unknown administration site for Immunization,  then 4 weeks later they accidentally administered another dose of fluzone HD QIV with no reported adverse event (extra dose administered) (latency- same day). Information on the batch number was requested.  Reportedly, The pharmacist reports that a patient received FLUZONE HD QIV, and then 4 weeks later they accidentally administered another dose of FLUZONE HD QIV. The pharmacist asks if there is anything that they need to have the patient look out for?   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Pyrexia, Skin induration
Clinical narrative: patient came into clinic 11/30/23 with erythemic area measuring 4.5 inches x 2.5 inches. Area hard and warm to touch. Patient states that day 1 she had a local reaction butthe last 24 hours it has worsened. Fever today. Patient also states that she felt a warm sensation on day 1 down her right leg liek someone was pouring warm water on her, States that she is worried about an MS flare. She did contact her neurologist and they suggested benadryl and allegra. Did not feel this was working so she came in to be seen. Doxycycline was ordered for cellulitis
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: patient came into clinic 11/30/23 with erythemic area measuring 4.5 inches x 2.5 inches. Area hard and warm to touch. Patient states that day 1 she had a local reaction butthe last 24 hours it has worsened. Fever today. Patient also states that she felt a warm sensation on day 1 down her right leg liek someone was pouring warm water on her, States that she is worried about an MS flare. She did contact her neurologist and they suggested benadryl and allegra. Did not feel this was working so she came in to be seen. Doxycycline was ordered for cellulitis
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Diarrhoea, Syncope
Clinical narrative: Patient fainted morning after receiving RSV vaccine. She fainted briefly and then experienced diarrhea / stomach pain
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC15
Symptoms: Injection site reaction
Clinical narrative: Localized allergic reaction, bilateral anterior thighs
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Colonoscopy normal, Decreased appetite, Endoscopy normal, Erythema
Clinical narrative: Very sore arm lasting over a week with redness. Fatigue set in and has since just increased, noticed that I wasn't able to complete tasks as easier as before. Loss of appetite and all hunger cues.  Had to set a timer to remember to eat because I had no hunger and almost repulsed by food. Changes to menstrual cycle, early or late in timing, heavier than before and much thicker.  More symptoms after my second dose came.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal bacterial overgrowth, Heavy menstrual bleeding, Laboratory test abnormal, Loss of personal independence in daily activities
Clinical narrative: Very sore arm lasting over a week with redness. Fatigue set in and has since just increased, noticed that I wasn't able to complete tasks as easier as before. Loss of appetite and all hunger cues.  Had to set a timer to remember to eat because I had no hunger and almost repulsed by food. Changes to menstrual cycle, early or late in timing, heavier than before and much thicker.  More symptoms after my second dose came.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Pain in extremity, Ultrasound scan vagina normal
Clinical narrative: Very sore arm lasting over a week with redness. Fatigue set in and has since just increased, noticed that I wasn't able to complete tasks as easier as before. Loss of appetite and all hunger cues.  Had to set a timer to remember to eat because I had no hunger and almost repulsed by food. Changes to menstrual cycle, early or late in timing, heavier than before and much thicker.  More symptoms after my second dose came.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Chest discomfort, Nausea, Rash, Swelling
Clinical narrative: pt called today stating swelling, rash on left arm ,chest tightness and nausea
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: PT STATES A MONTH POST-VACCINATION HE DEVELOPED PAIN IN HIS SHOULDER.  I RECOMMENDED HE VISIT HIS PHYSICIAN BEFORE ADDITIONAL VACCINATION
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient is complaining of muscle soreness at the injection site more than a month later.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: Extreme fatigue, muscle soreness, lack of appetite, headache
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Angiotensin II receptor type 1 antibody positive, Antinuclear antibody positive, Arthralgia, Asthenia, Biopsy lip normal
Clinical narrative: Just like with the first dose I had long lasting arm pain and redness. I still had fatigue, changes in menstrual cycle, and appetite changes from the first dose of Moderna. Following this dose I had extreme Diarrhea, that was beyond what could be justified considering I didn't have an appetite and was losing weight prior due to not being able to eat much. Heart Palpitations started occasionally, I would describe them as very noticeable heart beats. I was able to catch what was happening on my smart watch ecg. My endurance for my usually walking or daily activities was less seemed out of breath or could have been from the fatigue from the initial vaccine. My migraines got substantially worse in frequency and intensity and no longer responded to treatment that had previously been successful. I caught covid in January shortly after the vaccine and recovered fine and then all of a sudden March 17, 2022  all symptoms worsened massively. I had chest pain, shortness of breath, tachycardia, POTS-like, MCAS-like, allergic type reactions to things I hadnt been allergic to before, diarrhea, no appetite, repulsed by foods, fatigue, light headedness, weak, shaky, body tremors, foreheah and leg numbness and tingling, worsening migraines that were non responsive to normal successful medications, joint pain, stiffness. The list goes on.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, COVID-19, Cardiac monitoring, Chest pain, Colonoscopy normal
Clinical narrative: Just like with the first dose I had long lasting arm pain and redness. I still had fatigue, changes in menstrual cycle, and appetite changes from the first dose of Moderna. Following this dose I had extreme Diarrhea, that was beyond what could be justified considering I didn't have an appetite and was losing weight prior due to not being able to eat much. Heart Palpitations started occasionally, I would describe them as very noticeable heart beats. I was able to catch what was happening on my smart watch ecg. My endurance for my usually walking or daily activities was less seemed out of breath or could have been from the fatigue from the initial vaccine. My migraines got substantially worse in frequency and intensity and no longer responded to treatment that had previously been successful. I caught covid in January shortly after the vaccine and recovered fine and then all of a sudden March 17, 2022  all symptoms worsened massively. I had chest pain, shortness of breath, tachycardia, POTS-like, MCAS-like, allergic type reactions to things I hadnt been allergic to before, diarrhea, no appetite, repulsed by foods, fatigue, light headedness, weak, shaky, body tremors, foreheah and leg numbness and tingling, worsening migraines that were non responsive to normal successful medications, joint pain, stiffness. The list goes on.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Decreased appetite, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Just like with the first dose I had long lasting arm pain and redness. I still had fatigue, changes in menstrual cycle, and appetite changes from the first dose of Moderna. Following this dose I had extreme Diarrhea, that was beyond what could be justified considering I didn't have an appetite and was losing weight prior due to not being able to eat much. Heart Palpitations started occasionally, I would describe them as very noticeable heart beats. I was able to catch what was happening on my smart watch ecg. My endurance for my usually walking or daily activities was less seemed out of breath or could have been from the fatigue from the initial vaccine. My migraines got substantially worse in frequency and intensity and no longer responded to treatment that had previously been successful. I caught covid in January shortly after the vaccine and recovered fine and then all of a sudden March 17, 2022  all symptoms worsened massively. I had chest pain, shortness of breath, tachycardia, POTS-like, MCAS-like, allergic type reactions to things I hadnt been allergic to before, diarrhea, no appetite, repulsed by foods, fatigue, light headedness, weak, shaky, body tremors, foreheah and leg numbness and tingling, worsening migraines that were non responsive to normal successful medications, joint pain, stiffness. The list goes on.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory abnormal, Endoscopy normal, Erythema
Clinical narrative: Just like with the first dose I had long lasting arm pain and redness. I still had fatigue, changes in menstrual cycle, and appetite changes from the first dose of Moderna. Following this dose I had extreme Diarrhea, that was beyond what could be justified considering I didn't have an appetite and was losing weight prior due to not being able to eat much. Heart Palpitations started occasionally, I would describe them as very noticeable heart beats. I was able to catch what was happening on my smart watch ecg. My endurance for my usually walking or daily activities was less seemed out of breath or could have been from the fatigue from the initial vaccine. My migraines got substantially worse in frequency and intensity and no longer responded to treatment that had previously been successful. I caught covid in January shortly after the vaccine and recovered fine and then all of a sudden March 17, 2022  all symptoms worsened massively. I had chest pain, shortness of breath, tachycardia, POTS-like, MCAS-like, allergic type reactions to things I hadnt been allergic to before, diarrhea, no appetite, repulsed by foods, fatigue, light headedness, weak, shaky, body tremors, foreheah and leg numbness and tingling, worsening migraines that were non responsive to normal successful medications, joint pain, stiffness. The list goes on.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Food aversion, Hydrogen breath test abnormal, Hypersensitivity
Clinical narrative: Just like with the first dose I had long lasting arm pain and redness. I still had fatigue, changes in menstrual cycle, and appetite changes from the first dose of Moderna. Following this dose I had extreme Diarrhea, that was beyond what could be justified considering I didn't have an appetite and was losing weight prior due to not being able to eat much. Heart Palpitations started occasionally, I would describe them as very noticeable heart beats. I was able to catch what was happening on my smart watch ecg. My endurance for my usually walking or daily activities was less seemed out of breath or could have been from the fatigue from the initial vaccine. My migraines got substantially worse in frequency and intensity and no longer responded to treatment that had previously been successful. I caught covid in January shortly after the vaccine and recovered fine and then all of a sudden March 17, 2022  all symptoms worsened massively. I had chest pain, shortness of breath, tachycardia, POTS-like, MCAS-like, allergic type reactions to things I hadnt been allergic to before, diarrhea, no appetite, repulsed by foods, fatigue, light headedness, weak, shaky, body tremors, foreheah and leg numbness and tingling, worsening migraines that were non responsive to normal successful medications, joint pain, stiffness. The list goes on.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immune system disorder, Loss of personal independence in daily activities, Loss of therapeutic response, Magnetic resonance imaging head
Clinical narrative: Just like with the first dose I had long lasting arm pain and redness. I still had fatigue, changes in menstrual cycle, and appetite changes from the first dose of Moderna. Following this dose I had extreme Diarrhea, that was beyond what could be justified considering I didn't have an appetite and was losing weight prior due to not being able to eat much. Heart Palpitations started occasionally, I would describe them as very noticeable heart beats. I was able to catch what was happening on my smart watch ecg. My endurance for my usually walking or daily activities was less seemed out of breath or could have been from the fatigue from the initial vaccine. My migraines got substantially worse in frequency and intensity and no longer responded to treatment that had previously been successful. I caught covid in January shortly after the vaccine and recovered fine and then all of a sudden March 17, 2022  all symptoms worsened massively. I had chest pain, shortness of breath, tachycardia, POTS-like, MCAS-like, allergic type reactions to things I hadnt been allergic to before, diarrhea, no appetite, repulsed by foods, fatigue, light headedness, weak, shaky, body tremors, foreheah and leg numbness and tingling, worsening migraines that were non responsive to normal successful medications, joint pain, stiffness. The list goes on.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Menstrual disorder, Migraine, Musculoskeletal stiffness, Nervous system disorder
Clinical narrative: Just like with the first dose I had long lasting arm pain and redness. I still had fatigue, changes in menstrual cycle, and appetite changes from the first dose of Moderna. Following this dose I had extreme Diarrhea, that was beyond what could be justified considering I didn't have an appetite and was losing weight prior due to not being able to eat much. Heart Palpitations started occasionally, I would describe them as very noticeable heart beats. I was able to catch what was happening on my smart watch ecg. My endurance for my usually walking or daily activities was less seemed out of breath or could have been from the fatigue from the initial vaccine. My migraines got substantially worse in frequency and intensity and no longer responded to treatment that had previously been successful. I caught covid in January shortly after the vaccine and recovered fine and then all of a sudden March 17, 2022  all symptoms worsened massively. I had chest pain, shortness of breath, tachycardia, POTS-like, MCAS-like, allergic type reactions to things I hadnt been allergic to before, diarrhea, no appetite, repulsed by foods, fatigue, light headedness, weak, shaky, body tremors, foreheah and leg numbness and tingling, worsening migraines that were non responsive to normal successful medications, joint pain, stiffness. The list goes on.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain in extremity, Palpitations, Paraesthesia, Serum ferritin decreased
Clinical narrative: Just like with the first dose I had long lasting arm pain and redness. I still had fatigue, changes in menstrual cycle, and appetite changes from the first dose of Moderna. Following this dose I had extreme Diarrhea, that was beyond what could be justified considering I didn't have an appetite and was losing weight prior due to not being able to eat much. Heart Palpitations started occasionally, I would describe them as very noticeable heart beats. I was able to catch what was happening on my smart watch ecg. My endurance for my usually walking or daily activities was less seemed out of breath or could have been from the fatigue from the initial vaccine. My migraines got substantially worse in frequency and intensity and no longer responded to treatment that had previously been successful. I caught covid in January shortly after the vaccine and recovered fine and then all of a sudden March 17, 2022  all symptoms worsened massively. I had chest pain, shortness of breath, tachycardia, POTS-like, MCAS-like, allergic type reactions to things I hadnt been allergic to before, diarrhea, no appetite, repulsed by foods, fatigue, light headedness, weak, shaky, body tremors, foreheah and leg numbness and tingling, worsening migraines that were non responsive to normal successful medications, joint pain, stiffness. The list goes on.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tremor, Ultrasound scan vagina normal, Ultrasound thyroid normal, Weight decreased
Clinical narrative: Just like with the first dose I had long lasting arm pain and redness. I still had fatigue, changes in menstrual cycle, and appetite changes from the first dose of Moderna. Following this dose I had extreme Diarrhea, that was beyond what could be justified considering I didn't have an appetite and was losing weight prior due to not being able to eat much. Heart Palpitations started occasionally, I would describe them as very noticeable heart beats. I was able to catch what was happening on my smart watch ecg. My endurance for my usually walking or daily activities was less seemed out of breath or could have been from the fatigue from the initial vaccine. My migraines got substantially worse in frequency and intensity and no longer responded to treatment that had previously been successful. I caught covid in January shortly after the vaccine and recovered fine and then all of a sudden March 17, 2022  all symptoms worsened massively. I had chest pain, shortness of breath, tachycardia, POTS-like, MCAS-like, allergic type reactions to things I hadnt been allergic to before, diarrhea, no appetite, repulsed by foods, fatigue, light headedness, weak, shaky, body tremors, foreheah and leg numbness and tingling, worsening migraines that were non responsive to normal successful medications, joint pain, stiffness. The list goes on.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received .5ml of vaccine instead of .25 ml .  There is .5ml in the vial and I drew up that amount.  I realized I gave the incorrect dose immediately after giving the vaccine.  Patient had no signs or symptoms of a reaction.  I made our Nurse Manager aware, as well as Dr. aware.  Mom aware also.  No further action was needed.
Age: 84.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Pain in extremity
Clinical narrative: Patient described her arm as sore for a day. Patient did not seek medical help or advise.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Seizure
Clinical narrative: Vaccine given 10/20/2023. Patient had an unprovoked seizure 11/28/23.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient recieved Abrysvo injection on november 1, 2023. The next following day patient called due to she noted the injection site was red and slightly swollen. We advised patient that the injection site reaction was possible  but should be completely resolved by day 7 and to report if this was not the case. Patient returned on November 8, 2023 to let us know that on day 7, the site was unchanged so she went to go see her physician. Her physician administered a steroid injection. Patient reports that symptoms got better after the steroid injection.
Age: 1.33
Sex: F
Vaccine: FLU4, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site warmth
Clinical narrative: 1 WEEK AFTER VACCINES GIVEN MOM STATES SHE STARTED WITH REDNESS,HOT,HARD ON LEFT THIGH; ABOUT THE SIZE OF PEA. THE NEXT DAY IT WAS BIGGER ABOUT THE SIZE OF A QUARTER. SHE WENT TO THE ER THE NEXT DAY AND THE DX AS INFECTION AND SHE WAS STARTED ON KEFLEX. SHE WAS SEEN IN THE OFFICE ON 11/27 AND DR. STS " APPEARS TO BE RESOVING"
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Catheterisation cardiac, Chest pain, Heart rate increased
Clinical narrative: patient had rapid heart rate 130-140 resting less than 24 hours after receiving both vaccines. He also experienced chest pains and later had to get a heart cath
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Asthenia, Dizziness, Ear pain, Nausea
Clinical narrative: Patient felt somewhat lightheaded shortly after vaccine administration but able to walk without difficulty, later in evening at home became considerably lightheaded, weak and nauseous.  She had to sit on the floor a while then was assisted by husband to bed.  The lightheadedness and nausea was gone the next morning but she had aching across the top of her shoulders and noticed a faint yellow discoloration in the center of her chest.  She also had skin tenderness or sensitivity on underside of forearms.  The skin sensitivity lasted about 2 weeks.  She continues to have aching in the left shoulder and pain from that shoulder to her ear if she coughs.  The pain in the shoulder precipitated by coughing subsides immediately afterward.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain of skin, Sensitive skin, Skin discolouration
Clinical narrative: Patient felt somewhat lightheaded shortly after vaccine administration but able to walk without difficulty, later in evening at home became considerably lightheaded, weak and nauseous.  She had to sit on the floor a while then was assisted by husband to bed.  The lightheadedness and nausea was gone the next morning but she had aching across the top of her shoulders and noticed a faint yellow discoloration in the center of her chest.  She also had skin tenderness or sensitivity on underside of forearms.  The skin sensitivity lasted about 2 weeks.  She continues to have aching in the left shoulder and pain from that shoulder to her ear if she coughs.  The pain in the shoulder precipitated by coughing subsides immediately afterward.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a dose of Comirnaty on 11/30/23. The Beyond Use Date (BUD)  assigned to the box that the syringe came from was 11/29/23. Patient received vaccine after the beyond use date. Patient has reported no issues as of this time.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Feeling abnormal, Premature delivery, Premature labour, Vaginal discharge
Clinical narrative: 35 weeks, 6 days pregnant at time of vaccine Due date was Nov 10, 2023. Delivery date was early. He was healthy and 7 lbs 5 oz.  I noticed excess discharge starting the morning after the vaccine and was feeling ?weird? up until I went into labor days later.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted after administration of the second dose of gardasil. She awoke quickly and sat for 5 more minutes before standing and leaving
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Throat irritation, Throat tightness
Clinical narrative: AFTER RECEIVING TWINRIX, PATIENT SAID HE FELT DIZZY AND THAT HIS THROAT WAS THIGHTING. AFTER AWHILE, HE SAID HIS THROAT FELT ITCHY. I ADVISED HIM TO TO CONTINUE TO STAY SEATED UNTIL HE WAS NO LONGER DIZZY. HE SAID HE WOULD GO TO EMERGENCY ROOM  IF HE FELT THAT WAS NEEDED. HE LEFT AFTER AN HOUR. I CALLED HIM ON SUNDAY TO FOLLOW UP ON HOW HE WAS DOING, BUT HE DID NOT RETURN MY CALL.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Other Relevant HX: Other: ANAPHYLAXIS
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms:  10002218:ANAPHYLAXIS;  Narrative:  Other Relevant HxL   Other:  ANAPHYLAXIS
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Death
Clinical narrative: Reported Symptoms:  10011906:DEATH;   Narrative:  Medical Support Assistant called patients home on 10/11/2023 to inquire if patient was coming in for his scheduled appointment that day for COVID vaccine.  Patients daughter answered the phone and reported that patient had passed away on 10-8-23. Other Relevant HX: Other:  DEATH
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, Asthenia, COVID-19, Cough
Clinical narrative: Reported Symptoms: 10013573:DIZZINES; 10042772:SYNCOPE; Narrative: Patient presented with weakness, nonproductive cough, myalgia, loss of taste/smell, and orthostatic hypotension with positive COVID test a day prior to presentation. Electrolyte abnormalities corrected and fluids given. Patient did not qualify for remdesivir or dexamethasone treatment. Improved within a day and discharged home. Other Relevant HX: Other: