chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022; Temperature excursion occurred on 29-Nov-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29-Nov-2022), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis. No Medical History information was reported. On 02-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29-Nov-2022). On 02-Dec-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29-Nov-2022), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29-Nov-2022) and POOR-QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022, administered on 02-Dec-2022). Concomitant product use was not provided by the reporter. A total of 16 doses were administered, on 29-Nov-2022 (5), 30-Nov-2022 (4), 1-Dec-2022 (2), 2-Dec-2022 (2), 3-Dec-2022 (1), and 5-Dec-2022. It was unknown that the patient received any other vaccines on the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided. This case contains information for the 2nd of 2 patients who received vaccine on 02-Dec-2022. This case was linked to MODERNATX, INC.-MOD-2022-687688 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-687688:Same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia, Urinary tract infection
Clinical narrative: pneumonia; uti; still got flu; Initial information received on 14-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced pneumonia, uti and still got flu after receiving vaccine 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 suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Flu (Influenza).  On an unknown date, the patient developed serious events of pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed non-serious events of uti (urinary tract infection) and still got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, take of yourself & don't be embarrassed to wear a mask in crowded situations.. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (pneumonia, uti, still got flu).  At time of reporting, the outcome was Unknown for all events.; Sender's Comments: Sanofi company comment dated 20-Dec-2022: This case involves an unknown age and unknown gender patient who experienced pneumonia, uti and still got flu after receiving vaccine INFLUENZA VACCINE. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor, medical history, vaccination and lab investigations excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: pneumonia; Initial information received on 14-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp (non-healthcare provider)  This case involves an unknown age and unknown gender patient who experienced pneumonia after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient developed a serious pneumonia (unknown latency) following the administration of influenza vaccine.   It was reported "Product name was not provided. Since this is a public post assuming the consumer is referring to the Sanofi flu vaccine."  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event pneumonia.  Seriousness criteria: Medically significant; Sender's Comments: Sanofi company comment dated 19-Dec-2022: This case involves an unknown age and unknown gender patient who experienced pneumonia after receiving  influenza vaccine. Additional information regarding condition at the time of vaccination, medical history, concomitant medication and lab tests would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging head normal
Clinical narrative: Numbness to right lower lip, part of top lip, right side of tongue, right thumb and forefinger.
Age: 64.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Back pain, Muscle disorder, Spinal disorder
Clinical narrative: I started developing a lower back pain that does not go away and I cannot associate it with anything else. Thinking it could be renal pain, I consulted with an urologist while in vacation, but my kidneys are okay.  They suggested there is something to do with my muscles /spine in my lower back. The doctor prescribed me a temporary anti-inflammatories, muscle relaxant and pain medication and is helping . I cannot asure it is due to the COVID vaccine, but I can. It associate this lower back pain with anything else. I just wanted to reported
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient given Novavax vaccine following a second dose of J+J on 4/11/21. No adverse event noted.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nocturia, Urine output increased
Clinical narrative: PFizer Covid shots and booster: I took the first 2 shots in March and April 2021, and the booster in December 2021. It caused a severe case of frequent urination and nocturia. Then in 2022, after I stopped taking the vaccinations, the problem went away completely.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Moderna Bivalent COVID vaccine use for COVID-19 under Emergency Use Authorization (EUA): Worsening Tinnitus after COVID vaccine - Moderna-Bivalent
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Migraine
Clinical narrative: Long term headache/migraine after shingrix vaccine. going on four weeks now.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Erythema, Pruritus, Swelling
Clinical narrative: Diarrhea, swelling <50 mm, erythema 5cm round, intense pruritus, low grade fever 37.5
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Death
Clinical narrative: J & J Covid-19 Vaccine on 9/4/2021 and death occurred on 9/19/2021. Adverse events almost daily leading up to death.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Muscular weakness, SARS-CoV-2 test positive
Clinical narrative: One week post Pfizer covid booster developed severe proximal muscle weakness in the legs, followed by severe covid infection one week later.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: infection-Medium, Additional Details: swabbed with 1 alcholol pad the area for infection and then admistered vaccine. pt states the area of injection was not swabbed properly and got an  infection. used new alcholol pad and used gloves and sterile needle
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Diluent Administered Instead of Vaccine-
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dark circles under eyes, Pain, Pallor, Pyrexia, Sensitive skin
Clinical narrative: Fever for three days despite having both Acetaminophen and ibuprofen alternating every three hours. Extreme sensitivity on skin to temperatures even lukewarm temperatures felt very hot. Body aches from head to toe pale skin dark circles under her eyes
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Temperature intolerance
Clinical narrative: Fever for three days despite having both Acetaminophen and ibuprofen alternating every three hours. Extreme sensitivity on skin to temperatures even lukewarm temperatures felt very hot. Body aches from head to toe pale skin dark circles under her eyes
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Dyspnoea, Electrocardiogram normal, X-ray normal
Clinical narrative: 3 days after receiving flu shot (listed as   FLU VACCINE 6MOS AND OLDER PRESERVATIVE FREE IM) in records, sudden onset of shortness of breath. Symptoms still present daily as of December 20,2022
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Headache, Productive cough, Rhinorrhoea
Clinical narrative: 12/13/22 I woke up with a headache, a runny nose and coughing up stuff. I have been very tired. I tested for COVID with a home test and it was positive. I had a telehealth with my doctor that same day. She gave me a prescription for PAXLOVID and had me take MUCINEX. I started taking it that day. I tested again on 12/19/2022 and it is still positive. Today my symptoms are gone except I am so tired.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 12/13/22 I woke up with a headache, a runny nose and coughing up stuff. I have been very tired. I tested for COVID with a home test and it was positive. I had a telehealth with my doctor that same day. She gave me a prescription for PAXLOVID and had me take MUCINEX. I started taking it that day. I tested again on 12/19/2022 and it is still positive. Today my symptoms are gone except I am so tired.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 9/24/21, 10/26/21. Positive on 12/19/22
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Health department has referred this case due to vaccination after limit administration date.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Constipation, Decreased appetite, Ear pain, Headache
Clinical narrative: fever, headache,ear aches, constipated, head cold, loss of appetite and no energy sick for 5 days getting slowly better
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: fever, headache,ear aches, constipated, head cold, loss of appetite and no energy sick for 5 days getting slowly better
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Referred by Health Department due to administration after limit date.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Pyrexia, Rash, Rash pruritic, Swelling face
Clinical narrative: Patient's mother contacted on 12/14/2022 to report her child experiencing symptoms of an adverse reaction. Patient's mom stated child had a fever approximately 24 hours after receiving Tdap, HPV, and Meningococcal along with redness and slight swelling to vaccination administration site on left arm. Mom reported that in the early morning of 12/14/22, the patient woke up with swelling and rash to face. Mother stated the rash was flat and itched tremendously per her child's report. Mom denied child having any other s/s related to anaphylaxis at that time. Mother was advised to follow up with PCP and administer Benadryl for rash and itching. On 12/19/22, followed up with mother regarding reaction. Mom states PCP just instructed her to watch child for further symptoms. Mom states swelling was gone by Thursday 12/15 and patient still has a few spots left from rash but it was mostly cleared up by Saturday, 12/17. She states child never developed any other symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vaccination site swelling
Clinical narrative: Patient's mother contacted on 12/14/2022 to report her child experiencing symptoms of an adverse reaction. Patient's mom stated child had a fever approximately 24 hours after receiving Tdap, HPV, and Meningococcal along with redness and slight swelling to vaccination administration site on left arm. Mom reported that in the early morning of 12/14/22, the patient woke up with swelling and rash to face. Mother stated the rash was flat and itched tremendously per her child's report. Mom denied child having any other s/s related to anaphylaxis at that time. Mother was advised to follow up with PCP and administer Benadryl for rash and itching. On 12/19/22, followed up with mother regarding reaction. Mom states PCP just instructed her to watch child for further symptoms. Mom states swelling was gone by Thursday 12/15 and patient still has a few spots left from rash but it was mostly cleared up by Saturday, 12/17. She states child never developed any other symptoms.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Decreased appetite, Headache, Lethargy, Myalgia
Clinical narrative: Lethargy, chills, lack of appetite, muscle pain, headaches.
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Loss of smell and of some taste. Tested positive for Covid-19 3 days later, but pharmacist said I should make the report in case it?s somehow related to the vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, COVID-19, Cardiac monitoring abnormal, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: I began to feel general fatigue, tiredness and congestion. As I was driving my eyes began to burn I got home and my rapid COVID-19 test was negative I had a fever of just under one hundred and one. My doctor scheduled a PCR tests January fifth or sixth 2022 which resulted in a positive. I had an infusion 01/12/2022 and at this point I was almost symptom free. Over the next few months I noticed breathlessness when climbing stairs and being awoke at night with a fast heartbeat. I scheduled an appointment with my doctor 09/19/2022 a dramatic increase in my blood pressure was noticed whereas before it was always on the normal to low side. I was diagnosed with stage 2 hypertension an ECG and heart monitor was ordered. Hypertension has not resolved my Tachycardia somewhat has. A prescription of losartan was ordered but not effective I am now on hydrochlorothiazide which is working.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Fatigue, Heart rate increased, Hypertension, Ischaemic cardiomyopathy
Clinical narrative: I began to feel general fatigue, tiredness and congestion. As I was driving my eyes began to burn I got home and my rapid COVID-19 test was negative I had a fever of just under one hundred and one. My doctor scheduled a PCR tests January fifth or sixth 2022 which resulted in a positive. I had an infusion 01/12/2022 and at this point I was almost symptom free. Over the next few months I noticed breathlessness when climbing stairs and being awoke at night with a fast heartbeat. I scheduled an appointment with my doctor 09/19/2022 a dramatic increase in my blood pressure was noticed whereas before it was always on the normal to low side. I was diagnosed with stage 2 hypertension an ECG and heart monitor was ordered. Hypertension has not resolved my Tachycardia somewhat has. A prescription of losartan was ordered but not effective I am now on hydrochlorothiazide which is working.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sleep disorder
Clinical narrative: I began to feel general fatigue, tiredness and congestion. As I was driving my eyes began to burn I got home and my rapid COVID-19 test was negative I had a fever of just under one hundred and one. My doctor scheduled a PCR tests January fifth or sixth 2022 which resulted in a positive. I had an infusion 01/12/2022 and at this point I was almost symptom free. Over the next few months I noticed breathlessness when climbing stairs and being awoke at night with a fast heartbeat. I scheduled an appointment with my doctor 09/19/2022 a dramatic increase in my blood pressure was noticed whereas before it was always on the normal to low side. I was diagnosed with stage 2 hypertension an ECG and heart monitor was ordered. Hypertension has not resolved my Tachycardia somewhat has. A prescription of losartan was ordered but not effective I am now on hydrochlorothiazide which is working.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: I began to feel general fatigue, tiredness and congestion. As I was driving my eyes began to burn I got home and my rapid COVID-19 test was negative I had a fever of just under one hundred and one. My doctor scheduled a PCR tests January fifth or sixth 2022 which resulted in a positive. I had an infusion 01/12/2022 and at this point I was almost symptom free. Over the next few months I noticed breathlessness when climbing stairs and being awoke at night with a fast heartbeat. I scheduled an appointment with my doctor 09/19/2022 a dramatic increase in my blood pressure was noticed whereas before it was always on the normal to low side. I was diagnosed with stage 2 hypertension an ECG and heart monitor was ordered. Hypertension has not resolved my Tachycardia somewhat has. A prescription of losartan was ordered but not effective I am now on hydrochlorothiazide which is working.
Age: 96.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood osmolarity decreased, COVID-19, Cough, Fall
Clinical narrative: Patient was seen in the ER s/p fall without injury, cough and hypotension.  Placed on observation status on the general ward with a Dx of Covid 19, hypotension, weakness and hypo-osmolality and hyponatremia
Age: 96.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyponatraemia, Hypotension
Clinical narrative: Patient was seen in the ER s/p fall without injury, cough and hypotension.  Placed on observation status on the general ward with a Dx of Covid 19, hypotension, weakness and hypo-osmolality and hyponatremia
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Vomiting
Clinical narrative: Very sick for five days following booster. Vomiting and rapid heartbeat.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient had already completed primary series and initial booster, so should have received bivalent vaccine for booster. Was administered monovalent vaccine instead in error. Will return in 2 months for bivalent booster dose.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated and boosted.  COVID breakthrough infection
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: At the moment the patient has not reported any adverse effects and after the administration the required time was observed where no adverse effect was presented.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Insomnia, Myalgia, Neuralgia
Clinical narrative: Nerve pain/muscle pain from upper shoulder to bicep. Painful during day and while trying to sleep. Lifting weights and stretching changes nothing.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Cough, Diarrhoea, Oropharyngeal pain, Pain
Clinical narrative: 12/16/2022, I started to have runny nose, sneezing, chills, achiness. The next day, I developed a sore throat, sinus pressure, coughing, diarrhea and I took a COVID-19 test and it was positive. I called into my doctor's answering service and it was not advised that I take PAXLOVID due to medications. I asked for an inhaler, but I have not needed it.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paranasal sinus discomfort, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: 12/16/2022, I started to have runny nose, sneezing, chills, achiness. The next day, I developed a sore throat, sinus pressure, coughing, diarrhea and I took a COVID-19 test and it was positive. I called into my doctor's answering service and it was not advised that I take PAXLOVID due to medications. I asked for an inhaler, but I have not needed it.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Age: 1.0
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. family contacted personally by PCP.
Age: 1.0
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. family contacted personally by PCP.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: I started to experience symptoms of a sore throat, congested nose, sneezing and constant coughing on 11/22/2022. I tested on 11/24/2022 and then went to urgent care to confirm the positive result. I was given a prescription for PAXLOVID which helped tremendously. I did still feel fatigued for about two weeks after testing positive.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sneezing
Clinical narrative: I started to experience symptoms of a sore throat, congested nose, sneezing and constant coughing on 11/22/2022. I tested on 11/24/2022 and then went to urgent care to confirm the positive result. I was given a prescription for PAXLOVID which helped tremendously. I did still feel fatigued for about two weeks after testing positive.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Chills, Dizziness, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: I started with body aches and chills on December 11th, 2-3 months after my vaccine. My heart rhythm was off beat, it felt like it was skipping beats. I felt dizzy and nausea and then it went away after a few hours. It came back on Tuesday and lasted a few hours, stronger this time. I felt fatigued for the entire week. I did not have shortness of breath though.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extrasystoles, Fatigue, Liver function test, Nausea, Pain
Clinical narrative: I started with body aches and chills on December 11th, 2-3 months after my vaccine. My heart rhythm was off beat, it felt like it was skipping beats. I felt dizzy and nausea and then it went away after a few hours. It came back on Tuesday and lasted a few hours, stronger this time. I felt fatigued for the entire week. I did not have shortness of breath though.
Age: 1.0
Sex: M
Vaccine: PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. family contacted personally by PCP.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Neuropathy peripheral
Clinical narrative: Sore joints and aggravated neuropathy
Age: 14.0
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. family contacted personally by PCP.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling on arm.
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Cough, Feeling abnormal, Headache, Rhinorrhoea
Clinical narrative: 12/07/2022 I felt like I had a cold coming on with post nasal drip, runny nose and feeling a little out of it. At 5:00PM, I took a home COVID test and it was positive. The next day my prominent symptom was a bad headache throughout the day. As the day progressed my nasal drip became more mucous. I called my doctor and she prescribed PAXLOVID and I began it on 12/9/2022. On 12/09/22, I continued to have congestion in my sinus, my headache was gone. I felt better with a little bit of a cough and congestion. I took another home COVID test on 12/13/22 and it was negative. I have recovered.
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sinus congestion, Upper-airway cough syndrome
Clinical narrative: 12/07/2022 I felt like I had a cold coming on with post nasal drip, runny nose and feeling a little out of it. At 5:00PM, I took a home COVID test and it was positive. The next day my prominent symptom was a bad headache throughout the day. As the day progressed my nasal drip became more mucous. I called my doctor and she prescribed PAXLOVID and I began it on 12/9/2022. On 12/09/22, I continued to have congestion in my sinus, my headache was gone. I felt better with a little bit of a cough and congestion. I took another home COVID test on 12/13/22 and it was negative. I have recovered.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Blood test abnormal, Blood uric acid increased, Condition aggravated, Gout
Clinical narrative: I have begun to have an increase in gout attacks and an increase in my blood pressure all after my COVID-19 vaccine shots. My doctor has prescribed daily medications for both gout and my high blood pressure.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Pentacel was ordered, pt was aministered only the DTaP-IPV components of the vaccine. It was not reconstituted with the Hib portion of the vaccine. Patient's mother advised to return for hib vaccine.
Age: 0.17
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. family contacted personally by PCP.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient requested Pfizer bivalent (confusion during data entry, tech believed to confirm moderna bivalent verbally), patient was given Moderna bivalent and patient asked if it was Pfizer after vaccine was already administered.  No adverse reaction reported at this time
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient inadvertently given monovalent Pfizer formulation instead of bivalent formulation at community event.  Pt. contacted.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, COVID-19, Death, Frequent bowel movements
Clinical narrative: PFIZER COVID VACCINE #3 GIVEN 10/12/21, LOT #FE3592; pt dx with COVID on 6/29/22 by PCP (Dr.) and was given Paxlovid; pt had worsening GI upset and was told to dc the medication; pt to ED on 6/30/22 with worsening weakness, malaise, frequent stools, poor po intake; O2 saturations in 80% on RA; O2 supplementation; Decadron and Remdesivir; dc'd Hospice in where she passed away
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Hypophagia, Malaise
Clinical narrative: PFIZER COVID VACCINE #3 GIVEN 10/12/21, LOT #FE3592; pt dx with COVID on 6/29/22 by PCP (Dr.) and was given Paxlovid; pt had worsening GI upset and was told to dc the medication; pt to ED on 6/30/22 with worsening weakness, malaise, frequent stools, poor po intake; O2 saturations in 80% on RA; O2 supplementation; Decadron and Remdesivir; dc'd Hospice in where she passed away
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash
Clinical narrative: Pt has experienced a local rash 11 days past vaccination date.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: LEFT ARM ERYTHEMA, WARM TO TOUCH, PRURITIS, PAIN, SWELLING
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt. inadvertently given Pfizer monovalent formulation instead of bivalent. at community event.  Pt. informed.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Staff member drew up 1.3 ml of normal saline dilutant into a syringe and then drew up 0.2ml of pure vaccine into the same syringe and then administered this 1.5ml dose into the child's LA.  Based on calculation it appears that the child received 3 times the normal amount of pure COVID 19 Pfizer Bivalent 5-11y vaccine.  Child is not experiencing any symptoms or side effects of this event.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt. inadvertently administered Pfizer monovalent formulation instead of bivalent at community event.  Pt. informed.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Atelectasis, Computerised tomogram thorax abnormal, Hypoxia, Pneumonia, Pyrexia
Clinical narrative: Fever, hypoxia
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt. inadvertently administered Pfizer monovalent vaccine instead of bivalent at a community event.  Pt. informed.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt. inadvertently administered Pfizer monovalent formulation instead of bivalent at a community event. Pt. informed.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary abnormal, Dyspnoea, Pulmonary embolism
Clinical narrative: Increasing shortness of breath resulting in diagnosis of multiple pulmonary emboli.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Pain at injection site. Worsened after 24 hours. Still sore after about 2 and a half months.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I had a scratchy throat and a bad headache. Everyone who had been to my brother's wedding was testing positive for COVID-19, so I took a home COVID-19 test, and it came back positive. I went to the local urgent care who confirmed my positive test result. They didn't prescribe any medication, they advised me to go home drink plenty of fluids and watch my oxygen.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Death, Increased bronchial secretion, Laboratory test abnormal
Clinical narrative: pt had a positive COVID test on 6/29/22;7/2/22 to ED with abnormal lab results and terminal respiratory secretions; given Scopolamine patch and Robinul; pt has fever and cough; family desires comfort measures (pt in end-stage Alzheimer's); 7/12/22 pt dc'd to Hospice where she passed away 3 days later
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Terminal state
Clinical narrative: pt had a positive COVID test on 6/29/22;7/2/22 to ED with abnormal lab results and terminal respiratory secretions; given Scopolamine patch and Robinul; pt has fever and cough; family desires comfort measures (pt in end-stage Alzheimer's); 7/12/22 pt dc'd to Hospice where she passed away 3 days later
Age: 0.33
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. family contacted personally by PCP.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given the wrong dose; he was given 0.2mL instead of the 0.3mL of the vaccine. Patient was informed to wait 15min due to this being his first dosing, that's when he stated that this was his second dose and had received the Janssen and Janssen vaccine for his first dose.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is 10 years of age. per vaccine biavalent she needs to be 12 yeaRS.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Ear pain, Headache, Influenza virus test negative, Oropharyngeal pain
Clinical narrative: The day after receiving the Pfizer Bivalent vaccine, I woke up and I was running a fever of 102.5. I was experiencing a lot of body ache and chills. As the day went on, I developed a very bad sore throat, earache and started to feel congested. By 11/21/2022, the congestion was worse and I was experiencing headaches and sinus pressure. I went to a walk in clinic and they tested me for Covid, Flu and Strep, which were all negative. They felt as though I had an upper respiratory infection. They prescribed me a Z-PAK and it did not help much. I contacted my doctor and he gave me a round of steroids and antibiotics. I followed up with him 12/13/2022 and I was feeling better at the appointment, but I could still tell that it was hanging on. He took me off one of my nasal sprays to help the drainage and I am supposed to keep him updated about my symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Paranasal sinus discomfort, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: The day after receiving the Pfizer Bivalent vaccine, I woke up and I was running a fever of 102.5. I was experiencing a lot of body ache and chills. As the day went on, I developed a very bad sore throat, earache and started to feel congested. By 11/21/2022, the congestion was worse and I was experiencing headaches and sinus pressure. I went to a walk in clinic and they tested me for Covid, Flu and Strep, which were all negative. They felt as though I had an upper respiratory infection. They prescribed me a Z-PAK and it did not help much. I contacted my doctor and he gave me a round of steroids and antibiotics. I followed up with him 12/13/2022 and I was feeling better at the appointment, but I could still tell that it was hanging on. He took me off one of my nasal sprays to help the drainage and I am supposed to keep him updated about my symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative, Upper respiratory tract infection
Clinical narrative: The day after receiving the Pfizer Bivalent vaccine, I woke up and I was running a fever of 102.5. I was experiencing a lot of body ache and chills. As the day went on, I developed a very bad sore throat, earache and started to feel congested. By 11/21/2022, the congestion was worse and I was experiencing headaches and sinus pressure. I went to a walk in clinic and they tested me for Covid, Flu and Strep, which were all negative. They felt as though I had an upper respiratory infection. They prescribed me a Z-PAK and it did not help much. I contacted my doctor and he gave me a round of steroids and antibiotics. I followed up with him 12/13/2022 and I was feeling better at the appointment, but I could still tell that it was hanging on. He took me off one of my nasal sprays to help the drainage and I am supposed to keep him updated about my symptoms.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: PATIENT ALREADY RECIEVED PFIZER BIVALENT VACCINE AND GOT ANOTHER DOSE
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: I've had a rash on the same arm as the shot.  It has appeared over the last two months.  It can be there for days or weeks.   No medical treatment, going to doctor next week.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 9/7/2022 Asymptomatic until testing. A PCR COVID-19 test through a local hospital. Doctor prescribed treating symptomatically and to rest. After the recommended period of isolation, cleared by doctor to return to normal.
Age: 0.33
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. family contacted personally by PCP.
Age: 0.5
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient received Prevnar20 (PCV20)and should have been given Prevnar13 (PCV13). Risk and legal involved. System smartset updated to remove PCV20 from selection options for peds. Updated by PCP on each patient impacted. family contacted personally by PCP.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Heart rate increased
Clinical narrative: Rapid Heart Rate the evening after the vaccination. I have since been diagnosed with Supraventricular Tachycardia (SVT) and have continuing problems with heart rate and occasional arrhythmia.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: Rapid Heart Rate the evening after the vaccination. I have since been diagnosed with Supraventricular Tachycardia (SVT) and have continuing problems with heart rate and occasional arrhythmia.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein increased, Gait inability, Inflammation
Clinical narrative: Extreme joint pain in ankles, knees, and wrists.  Inability to walk. Treatment -- 20mg Prednisone Outcome -- reduced inflammation and pain.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Extreme joint pain in ankles, knees, and wrists.  Inability to walk. Treatment -- 20mg Prednisone Outcome -- reduced inflammation and pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Postmenopausal haemorrhage, Ultrasound scan abnormal, Uterine dilation and curettage
Clinical narrative: Post menopausal bleeding
Age: 60.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Abnormal dreams, Arthralgia, COVID-19, Cough, Dyspnoea
Clinical narrative: 12/3/2022 About mid-day, I had a sore throat. I drank tea with honey and a shot of brandy and it did not help. In the evening I took NYQUIL when I went to bed. The next day, I had more of a sore throat that went away that evening. I was very fatigued and stayed in bed pretty much all day. It felt like I had a head cold. That night I had really strange dreams, it was very weird. On 12/5/22, I took a home COVID test and it was positive. I called my doctor's office and was prescribed PAXLOVID. I began taking it that afternoon. I took NYQUIL that night and had trouble breathing. I began having a runny nose. Around 2 in the morning, I was not having that much trouble breathing. I felt I was in a better place by 2 or 3 in the morning and was able to sleep for a while. On 12/6/22 I worked from home. That night, I slept better, but in the middle of the night I woke with real pain in the joints in my elbows. It felt like the worse arthritis. The next morning, they were still tender, but the pain had passed. 12/7/22, I was coughing, congestion and a runny nose with thick green mucous. By 12/8/22 I was feeling better and was a lot better by 12/9/22. 12/11/22 I took a home COVID test and it was negative. I was still coughing a little with thick mucous. I spoke to my doctor again and he put me on antibiotics which I have been taking and am now symptom free.
Age: 60.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Fatigue, Middle insomnia, Mucosal discolouration, Mucosal hypertrophy, Nasopharyngitis
Clinical narrative: 12/3/2022 About mid-day, I had a sore throat. I drank tea with honey and a shot of brandy and it did not help. In the evening I took NYQUIL when I went to bed. The next day, I had more of a sore throat that went away that evening. I was very fatigued and stayed in bed pretty much all day. It felt like I had a head cold. That night I had really strange dreams, it was very weird. On 12/5/22, I took a home COVID test and it was positive. I called my doctor's office and was prescribed PAXLOVID. I began taking it that afternoon. I took NYQUIL that night and had trouble breathing. I began having a runny nose. Around 2 in the morning, I was not having that much trouble breathing. I felt I was in a better place by 2 or 3 in the morning and was able to sleep for a while. On 12/6/22 I worked from home. That night, I slept better, but in the middle of the night I woke with real pain in the joints in my elbows. It felt like the worse arthritis. The next morning, they were still tender, but the pain had passed. 12/7/22, I was coughing, congestion and a runny nose with thick green mucous. By 12/8/22 I was feeling better and was a lot better by 12/9/22. 12/11/22 I took a home COVID test and it was negative. I was still coughing a little with thick mucous. I spoke to my doctor again and he put me on antibiotics which I have been taking and am now symptom free.
Age: 60.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: 12/3/2022 About mid-day, I had a sore throat. I drank tea with honey and a shot of brandy and it did not help. In the evening I took NYQUIL when I went to bed. The next day, I had more of a sore throat that went away that evening. I was very fatigued and stayed in bed pretty much all day. It felt like I had a head cold. That night I had really strange dreams, it was very weird. On 12/5/22, I took a home COVID test and it was positive. I called my doctor's office and was prescribed PAXLOVID. I began taking it that afternoon. I took NYQUIL that night and had trouble breathing. I began having a runny nose. Around 2 in the morning, I was not having that much trouble breathing. I felt I was in a better place by 2 or 3 in the morning and was able to sleep for a while. On 12/6/22 I worked from home. That night, I slept better, but in the middle of the night I woke with real pain in the joints in my elbows. It felt like the worse arthritis. The next morning, they were still tender, but the pain had passed. 12/7/22, I was coughing, congestion and a runny nose with thick green mucous. By 12/8/22 I was feeling better and was a lot better by 12/9/22. 12/11/22 I took a home COVID test and it was negative. I was still coughing a little with thick mucous. I spoke to my doctor again and he put me on antibiotics which I have been taking and am now symptom free.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation issue, Underdose
Clinical narrative: Staff member added 1.3 ml of normal saline dilutant to a vail of COVID 19 Pfizer 5-11y Bivalent that had 0.2ml of pure vaccine with drawn from it. Leaving 0.5ml of pure vaccine remaining in the vial.  Once the 1.3ml of dilutant was added this resulted in an over dilution of vaccine. The staff member then drew up 0.2ml of the diluted solution and administered the 0.2ml dose in the RA of the child. There have been now reported symptoms or side effects at this time.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchoscopy, COVID-19, Death, Endotracheal intubation, Hypoxia
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 12/7/21, LOT #076C21A; pt to hospital on 6/29/22 and found to be positive for COVID; respiratory failure; acute hypoxia; intubated; bronchoscopy; steroids; ABX; vasopressors; did not improve with tx; pt passed away in the hospital
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive, Treatment failure
Clinical narrative: MODERNA COVID VACCINE #3 GIVEN 12/7/21, LOT #076C21A; pt to hospital on 6/29/22 and found to be positive for COVID; respiratory failure; acute hypoxia; intubated; bronchoscopy; steroids; ABX; vasopressors; did not improve with tx; pt passed away in the hospital
Age: 1.42
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Nasal congestion, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, congestion, low fever, muscle pain. Fever gone in 24 hours. Nasal congestion continues after 1 week.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash under left arm near breast, non-itchy being treated with Clobetasol treatments started yesterday 12/19 with a 10-day prescription then a physician follows up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza A virus test negative, Influenza virus test negative, Oropharyngeal pain, Pain
Clinical narrative: I had a fever of 101F, chills, body aches, extreme sore throat. I went to the doctor they tested me for COVID-19, strep, influenza, RSV. All tests came back negative, I was advised to go home get plenty of rest, drink fluids and it should clear itself up. In a couple of days I was feeling much better.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: I had a fever of 101F, chills, body aches, extreme sore throat. I went to the doctor they tested me for COVID-19, strep, influenza, RSV. All tests came back negative, I was advised to go home get plenty of rest, drink fluids and it should clear itself up. In a couple of days I was feeling much better.