chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: UNK
Symptoms: Rhinorrhoea
Clinical narrative: got the vaccine from Pfizer vaccine in his runny nose was still there but it was better than before; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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. Vaccination history included: Moderna covid-19 vaccine (Dose 5 (Booster), Single), for COVID-19 immunization, reaction(s): "runny nose"; Moderna covid-19 vaccine (Dose 4 (Booster), Single), for COVID-19 immunization, reaction(s): "runny nose"; Moderna covid-19 vaccine (Dose 3 (Booster), Single), for COVID-19 immunization, reaction(s): "runny nose"; Moderna covid-19 vaccine (Dose 2, Single), for COVID-19 immunization, reaction(s): "runny nose"; Moderna covid-19 vaccine (Dose 1, Single), for COVID-19 immunization, reaction(s): "runny nose". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "got the vaccine from Pfizer vaccine in his runny nose was still there but it was better than before". Additional information:Caller said that Over the last several years, he had Moderna vaccines. He received all five based on my age. Recently, within three weeks, he got the Pfizer vaccine. While he was on the Moderna vaccine he continuously had a runny nose and everyone in the community did it as well then when he got the vaccine from Pfizer vaccine in his runny nose was still there but it was better than before. He knows that it takes two weeks for the Pfizer vaccine to work. He also had surgery, general week after week and all in his area have mental health problems and he always takes care of his health the covid 19 vaccine helped him immensely, also stated that without the pneumococcal shot, he would have been hospitalized a long time ago and with the third shot of the Morderna he was seriously sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: her husband died 4 years ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), in 2019 as dose number unknown, 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) with onset 2019, outcome "fatal", described as "her husband died 4 years ago". The patient date of death was 2019. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: The caller mentioned that her husband died 4 years ago and might have taken the vaccine and possibly in clinical trials at the time.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: her husband died 4 years ago
Sex: U
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: Rebound case caller had pneumonia multiple times; Rebound case caller had pneumonia multiple times; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "Rebound case caller had pneumonia multiple times".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: patient almost had a heart attack from Pfizer, and almost died; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2023NVX-US-000001337 (Novavax).  A male 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: MYOCARDIAL INFARCTION (medically significant, life threatening), outcome "unknown", described as "patient almost had a heart attack from Pfizer, and almost died". Clinical course: On 19Oct2023, it was reported that a patient started treatment on an unreported date with Pfizer BioNTech COVID-19 vaccine unspecified dose for COVID-19 vaccination. It was reported the patient almost had a heart attack from Pfizer, and almost died.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported event and suspect drug bnt162b2 omi xbb.1.5 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, FLUC3
Symptoms: Pain, Urticaria
Clinical narrative: Painful when touched; Raised, hard, warm red welt about 2 inches in diameter.; This spontaneous case was received on 26-Oct-2023 from Seqirus via Pfizer (reference number 202300315925) reported by other non-healthcare professional and concerned a patient of unknown age and gender.  The patient's medical history included allergy. The patient's concomitant medications included Shingrix (varicella zoster vaccine rgE (CHO)), received on 10-Sep-2023 for unknown indication.  On 30-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: right arm; dose, route of administration and indication: not reported). The batch number reported was 944484 (reported batch number was identified by Seqirus to be correct batch number).  On the same date, the patient was vaccinated with six non-company co-suspect Covid-19 vaccines: Covid-19 vaccine (Comirnaty bivalent; route of administration: intramuscular; anatomical location: left arm; dose and indication: not reported). The batch number reported was HD9876. Four Covid-19 vaccines (Pfizer; anatomical location: left arm; route of administration, dose and indication: not reported). The batch numbers reported were GH9703, FF8841, EW0102 and EPP6955. Covid-19 vaccine (Moderna; anatomical location: left arm; route of administration, dose and indication: not reported). The batch number reported was 066K21A.  On 01-Oct-2023, an unspecified amount of time after receiving Flucelvax Quadrivalent and 6 Covid-19 vaccines, the patient experienced red, hard, warm red welt about 2 inches in diameter. Painful to touch.  At the time of initial reporting, the patient was recovering from the events 'welts' and 'pain'.  The reporter did not provide a causality assessment.  Company comment: A patient of unknown age and gender was vaccinated with Flucelvax Quadrivalent and six non-company co-suspect Covid-19 vaccines on the same day. One day following vaccination, the patient experienced urticaria and pain. Although causality was confounded by six co-suspect Covid-19 vaccines, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for events pain and urticaria due to plausible temporal relationship.; Sender's Comments: A patient of unknown age and gender was vaccinated with Flucelvax Quadrivalent and six non-company co-suspect Covid-19 vaccines on the same day. One day following vaccination, the patient experienced urticaria and pain. Although causality was confounded by six co-suspect Covid-19 vaccines, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for events pain and urticaria due to plausible temporal relationship.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema
Clinical narrative: developed angioedema; This serious case was reported by a pharmacist via call center representative and described the occurrence of angioedema in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-AUG-2023, the patient received the 1st dose of Shingrix. On 19-AUG-2023, 1 days after receiving Shingrix, the patient experienced angioedema (Verbatim: developed angioedema) (serious criteria GSK medically significant). The outcome of the angioedema was resolved.   It was unknown if the reporter considered the angioedema to be related to Shingrix.     It was unknown if the company considered the angioedema to be related to Shingrix.   Additional Information: GSK receipt date: 31-OCT-2023 The health care professional (HCP) reported that the patient received her 1st dose of Shingrix and developed angioedema the following day.  The patient had recovered but had no information on how long the angioedema lasted.   No other information was known. The reporter consented to follow up.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: A dose of Pediarix that was exposed to a temperature of -0.5°C for 23 minutes was administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: A dose of Pediarix that was exposed to a temperature of -0.5°C for 23 minutes was administered to a patient.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date-31-OCT-2023 The healthcare provider called to inform that earlier on the day pf reporting, a dose of Pediarix that was exposed to a temperature of minus 0.5 degree C for 23 minutes was administered to a patient, which led to incorrect storage of error. Did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Pain in extremity
Clinical narrative: At most she experienced a headache or sore arm, but that's it.; At most she experienced a headache or sore arm, but that's it.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (At most she experienced a headache or sore arm, but that's it.) and HEADACHE (At most she experienced a headache or sore arm, but that's it.) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     Patient had no relevant medical history, allergy and COVID-19 diagnosis. Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 07-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (At most she experienced a headache or sore arm, but that's it.) and HEADACHE (At most she experienced a headache or sore arm, but that's it.). At the time of the report, PAIN IN EXTREMITY (At most she experienced a headache or sore arm, but that's it.) and HEADACHE (At most she experienced a headache or sore arm, but that's it.) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-748230, MOD-2023-748238.
Age: 76.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Headache, Rash
Clinical narrative: headache; rash/ she started breaking out/ she noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees, on her face but she noticed her joints had the rash too/ She said she noticed a rash on her thumb j; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and RASH (rash/ she started breaking out/ she noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees, on her face but she noticed her joints had the rash too/ She said she noticed a rash on her thumb j) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3915B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor. The patient had no allergy and no COVID-19 diagnosis.    On 11-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 16-Oct-2023, the patient experienced HEADACHE (headache) and RASH (rash/ she started breaking out/ she noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees, on her face but she noticed her joints had the rash too/ She said she noticed a rash on her thumb j). At the time of the report, HEADACHE (headache) and RASH (rash/ she started breaking out/ she noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees, on her face but she noticed her joints had the rash too/ She said she noticed a rash on her thumb j) had not resolved.            Concomitant medication not reported.   She got both the Spikevax and flu shot on 11 OCT 2023. She was not sure which flu shot she received but says that it was the senior flu shot for ages 65 and older. Initially everything was fine and that she only had a headache which was not a big deal. However, 4-5 days later, around 16 OCT 2023, she started breaking out. They had gone camping and she was in the woods, so she thought they were mosquito bites. But the rash didn't go away, and she started noticing more. She did not have any skin problems otherwise, neither does she have any allergies. She started looking up skin conditions online and from what she can tell, her rash looks like atrophic dermatitis or eczema. She never had a problem with other Moderna COVID-19 vaccines. At most she experienced a headache or sore arm, but that's it.  She noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees. She did not notice in on her face but noticed on joints. She noticed a rash on 2 Nov 2023 on her thumb joint.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748243, US-MODERNATX, INC.-MOD-2023-748238 (Patient Link).
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Rash, Rash papular, Rash pruritic
Clinical narrative: itchy, burning bumps began on my left hand and then my right; itchy, burning bumps began on my left hand and then my right; The rash is only on my hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy, burning bumps began on my left hand and then my right), BURNING SENSATION (itchy, burning bumps began on my left hand and then my right) and RASH (The rash is only on my hands) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030701) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 27-Oct-2023, the patient experienced PRURITUS (itchy, burning bumps began on my left hand and then my right), BURNING SENSATION (itchy, burning bumps began on my left hand and then my right) and RASH (The rash is only on my hands). At the time of the report, PRURITUS (itchy, burning bumps began on my left hand and then my right), BURNING SENSATION (itchy, burning bumps began on my left hand and then my right) and RASH (The rash is only on my hands) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported.   The next day after vaccination, raised, itchy, burning bumps began on my left hand and then my right. The rash was only on her hands. A week later the rash continued with small improvement on her left hand.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Condition aggravated, Cough
Clinical narrative: He presented on 1/31 with cough and dyspnea. He was diagnosed with COVID-19 Pneumonia and COPD exacerbation. His course has been complicated by atrial fibrillation with RVR and worsening hypoxemic respiratory failure. He required AirVo 60 liter flow and 80% FIO2. He improved and was on 10 liters NCO2 by 2/14. He is now back on AirVo. Patient died at 2201 on comfort care orders.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Fraction of inspired oxygen, Respiratory failure
Clinical narrative: He presented on 1/31 with cough and dyspnea. He was diagnosed with COVID-19 Pneumonia and COPD exacerbation. His course has been complicated by atrial fibrillation with RVR and worsening hypoxemic respiratory failure. He required AirVo 60 liter flow and 80% FIO2. He improved and was on 10 liters NCO2 by 2/14. He is now back on AirVo. Patient died at 2201 on comfort care orders.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Rash
Clinical narrative: Per mom- Patient was sent home from daycare with a temperature of 101 on 11/2/2023. On 11/3/2023, mom said pt had a rash on his stomach.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, COVID-19, Cough, Exposure to SARS-CoV-2
Clinical narrative: Admitted for Covid-19 and for atrial fibrillation with a rapid ventricular rate.   She presented to the emergency department, accompanied by her son, for congestion and nausea for the past day.  She has generalized weakness, nausea and coughing. He had an exposure to COVID-19 four days ago. Received dexamethasone and Covid-19 convalescent plasma. Respiratory status remained stable.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Respiratory tract congestion
Clinical narrative: Admitted for Covid-19 and for atrial fibrillation with a rapid ventricular rate.   She presented to the emergency department, accompanied by her son, for congestion and nausea for the past day.  She has generalized weakness, nausea and coughing. He had an exposure to COVID-19 four days ago. Received dexamethasone and Covid-19 convalescent plasma. Respiratory status remained stable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chills, Computerised tomogram abdomen abnormal, Cough, Device dislocation
Clinical narrative: Patient presented to the ER for worsening diarrhea, coughing, shortness of breath and chills x 1 week. Patient was treated with solu-medrol, pepcid, lovenox, antibiotics for Covid pneumonia. Patients respiratory status got worse and she had to be intubated. Patients kidney function worsened and nephrology was consulted. Patient was placed on a Bicarb drip. Patients condition worsened and she was transferred to another hospital on 12.4.21.  Patient received one dose of Tocilizumab. Patient required a tracheostomy and PEG tube placement on 12.16.21. Patient had an abdominal CT scan on 12.20.21 that revealed dislodgement of the PEG tube. Patient underwent PEG tube replacement on 12.21.21. Pt was transported back to hospital on 1.10.22. Patient was discharged to SNU on 1.14.22.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Endotracheal intubation, Gastrostomy, Medical device change
Clinical narrative: Patient presented to the ER for worsening diarrhea, coughing, shortness of breath and chills x 1 week. Patient was treated with solu-medrol, pepcid, lovenox, antibiotics for Covid pneumonia. Patients respiratory status got worse and she had to be intubated. Patients kidney function worsened and nephrology was consulted. Patient was placed on a Bicarb drip. Patients condition worsened and she was transferred to another hospital on 12.4.21.  Patient received one dose of Tocilizumab. Patient required a tracheostomy and PEG tube placement on 12.16.21. Patient had an abdominal CT scan on 12.20.21 that revealed dislodgement of the PEG tube. Patient underwent PEG tube replacement on 12.21.21. Pt was transported back to hospital on 1.10.22. Patient was discharged to SNU on 1.14.22.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Renal impairment, Respiratory distress, Tracheostomy
Clinical narrative: Patient presented to the ER for worsening diarrhea, coughing, shortness of breath and chills x 1 week. Patient was treated with solu-medrol, pepcid, lovenox, antibiotics for Covid pneumonia. Patients respiratory status got worse and she had to be intubated. Patients kidney function worsened and nephrology was consulted. Patient was placed on a Bicarb drip. Patients condition worsened and she was transferred to another hospital on 12.4.21.  Patient received one dose of Tocilizumab. Patient required a tracheostomy and PEG tube placement on 12.16.21. Patient had an abdominal CT scan on 12.20.21 that revealed dislodgement of the PEG tube. Patient underwent PEG tube replacement on 12.21.21. Pt was transported back to hospital on 1.10.22. Patient was discharged to SNU on 1.14.22.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram thorax abnormal, Fall, Rib fracture, SARS-CoV-2 test positive
Clinical narrative: Patient presented with c/o fall the morning of admission while trying to get out of bed. The pt is alert and oriented x 3. Per history from dtr, the pt tested (+) for COVID infection 2 weeks ago and had a negative test last week, however, she tested (+) on NAAT today. She was attempting to lean forward and open the door to the bathroom when she fell forward from a sitting position. She did not lose consciousness or feel dizzy. There are no visible injuries to her face, head or other parts of anatomy on exam. She is on 3l/min with SpO2 100%. She does not have O2 at home and still smokes 3 cig/day. In ER, CT chest showed subacute lateral right fourth and fifth rib fractures and she tested positive for Covid-19.I D consult requested from and she was started on Decadron inview of oxygen requirements.  Pain controlled with medications and weaned off from Oxygen. PT recommended post-acute therapy PT and OT. She was discharged home with home health services.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Nurse incorrectly administered Fluzone High Dose to patient. Nurse overrode alerts in our system about patient age in order to give.  Nurse was new to the area and unfamiliar with pulling from system. Nurse had come from another area with an system so supervisor was not aware that she needed additional training. Nurse stated she felt rushed because provider was ready to see patient and pulled rather than asking another nurse for help.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Dyspnoea, Hypophagia, Lethargy
Clinical narrative: Presents to the ED c/o SOB. Positive for Covid on day of admission 1/25/22. History is obtained from daughter at bedside. She says her mom has been feeling SOB for the past 5 days, along with lethargy and poor po intake. She has not been having any coughs, fevers, chills. She has supplemental O2 at home that she does not use. She has been vaccinated against COVIDx2. She was unable to come off of BIPAP. I did have a long discussion with the family. They would like to make the patient hospice and initate CMO. She has transferred and made CMO. Patient passed comfortably.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: Presents to the ED c/o SOB. Positive for Covid on day of admission 1/25/22. History is obtained from daughter at bedside. She says her mom has been feeling SOB for the past 5 days, along with lethargy and poor po intake. She has not been having any coughs, fevers, chills. She has supplemental O2 at home that she does not use. She has been vaccinated against COVIDx2. She was unable to come off of BIPAP. I did have a long discussion with the family. They would like to make the patient hospice and initate CMO. She has transferred and made CMO. Patient passed comfortably.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Dyspnoea, Fatigue
Clinical narrative: Presents with cough and shortness of breath since last 3-4 days.  Patient is vaccinated with COVID-19 J&J in April 2021, patient was in her usual health until about last week Friday, started having cough, shortness of breath, sore throat, generalized weakness and fatigue so came to the emergency room for further evaluation.  Patient was tested positive for COVID-19 at outside facility.  Patient is noted to be hypoxic requiring 2 L of oxygen, presently denies having acute chest pain, has been having yellow sputum on coughing
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Oropharyngeal pain, SARS-CoV-2 test positive, Sputum discoloured
Clinical narrative: Presents with cough and shortness of breath since last 3-4 days.  Patient is vaccinated with COVID-19 J&J in April 2021, patient was in her usual health until about last week Friday, started having cough, shortness of breath, sore throat, generalized weakness and fatigue so came to the emergency room for further evaluation.  Patient was tested positive for COVID-19 at outside facility.  Patient is noted to be hypoxic requiring 2 L of oxygen, presently denies having acute chest pain, has been having yellow sputum on coughing
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus
Clinical narrative: About an hour after vaccination, She started itching on thigh and then the itching spread to the torso and bilateral upper and lower extremities. No rash, No hives. She self medicated with Benadryl and the itching resolved by that night.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient complained of "normal, typical" soreness in left deltoid area the day after receiving Afluria Influenza vaccine. However, the soreness continued. Patient reported the persistent soreness on 11/3/23. She stated the affected area bothers her when she moves her arm in certain directions. She reports normal range of motion of shoulder. Denies any numbness/tingling to left arm. Denies any swelling to left deltoid area. She describes left deltoid as a muscular soreness equivalent to what one would feel after working out.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Nurse incorrectly administered Fluzone High Dose to patient. Nurse overrode alerts in our system about patient age in order to give. Nurse was new to the area and unfamiliar with pulling from system. Nurse had come from another area with an system so supervisor was not aware that she needed additional training. Nurse stated she felt rushed because provider was ready to see patient and pulled rather than asking another nurse for help.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, COVID-19, Diarrhoea, Hypoxia
Clinical narrative: Presented to hospital w/ 2 day history of diarrhea and worsening weakness. AKI and elevated trop on admission. Covid positive on admission. Covid-19 infection  diarrhea predominant w/o acute respiratory failure, hypoxic on pneumonia
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test positive, Troponin increased
Clinical narrative: Presented to hospital w/ 2 day history of diarrhea and worsening weakness. AKI and elevated trop on admission. Covid positive on admission. Covid-19 infection  diarrhea predominant w/o acute respiratory failure, hypoxic on pneumonia
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site warmth, Pain
Clinical narrative: Patient complained of "normal, typical" soreness in right deltoid area the day after receiving Afluria Influenza vaccine. However, the soreness continued and spread throughout right upper arm/right deltoid area. Patient reported the persistent soreness on 11/6/23. She stated the affected area bothers her when she moves her arm  and is tender to touch. Denies any numbness/tingling to right arm. Denies any swelling to right deltoid area, but states it feels warm to her (skin warmth was not detected on exam).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, COVID-19 pneumonia, Cough, Dyspnoea, Fatigue
Clinical narrative: Presented with fatigue, myalgies, cough and dyspnea ; patient was diagnosed with sepsis due to COVID pneumonia ,  And treated with  remdesivir  and dexamethasone ; patient initially  required 15 O2 for adequate oxygenation ,   and was also seen by Pulmonary  and Critical Care  Service  ; patient had 1 episode of atrial flutter which has resolved by discharge ,   and no further intervention needed per Cardiology . By discharge, patient was breathing much better , has  Much  Less  Cough , and down to 1 L oxygen  to maintain  adequate oxygenation  with ambulation .
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Sepsis
Clinical narrative: Presented with fatigue, myalgies, cough and dyspnea ; patient was diagnosed with sepsis due to COVID pneumonia ,  And treated with  remdesivir  and dexamethasone ; patient initially  required 15 O2 for adequate oxygenation ,   and was also seen by Pulmonary  and Critical Care  Service  ; patient had 1 episode of atrial flutter which has resolved by discharge ,   and no further intervention needed per Cardiology . By discharge, patient was breathing much better , has  Much  Less  Cough , and down to 1 L oxygen  to maintain  adequate oxygenation  with ambulation .
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Presented with cough and SOB. The patient completed 5 days of remdesivir. She completed a 14 day course of intravenous meropenem. She completed intravenous dexamethasone and nearly completed the subsequent oral taper with only a few more doses planned post-hospitalization as below. The patient also completed 18/21 days of isolation from the date of diagnosis.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Metastases to lung
Clinical narrative: Admitted to the hospital on 2/1/2022 with c/o cough, worsening SOB, please refer to H & P for details  Immunocompromised patient admitted for pneumonia due to COVID-19.  Seen by, Infectious Disease and completed course of IV remdesivir, and will complete course of steroid and empiric antibiotic at home.  No secondary bacterial infection/pneumonia.  Suspected lung metastasis, patient already established with Oncology and will be following up with Dr.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site reaction, Injection site vesicles, Injection site warmth, Myalgia, Pain
Clinical narrative: Muscle very sore the evening of and more so the next morning (11/3/23), then 11/4/23, it was very itchy and there were multiple vesicles at the site.  Very red, hard, itchy and many vesicles.  They were scratched and popped, then scabbed over.  Scabby, itchy, dull ache still present as of 11/7/23.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Scab
Clinical narrative: Muscle very sore the evening of and more so the next morning (11/3/23), then 11/4/23, it was very itchy and there were multiple vesicles at the site.  Very red, hard, itchy and many vesicles.  They were scratched and popped, then scabbed over.  Scabby, itchy, dull ache still present as of 11/7/23.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Chills, Constipation, Fibrin D dimer increased
Clinical narrative: Patient also was diagnosed with COVID-19 infection with a positive test.  Patient did have elevated inflammatory markers and D-dimer.  Therefore, he was placed on Solu-Medrol steroids and Zithromax antibiotic. Presented with abdominal pain, fevers, chills, constipation. Found to have SBO and ileus post hip replacement along with Covid.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hip arthroplasty, Inflammatory marker increased, Postoperative ileus, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient also was diagnosed with COVID-19 infection with a positive test.  Patient did have elevated inflammatory markers and D-dimer.  Therefore, he was placed on Solu-Medrol steroids and Zithromax antibiotic. Presented with abdominal pain, fevers, chills, constipation. Found to have SBO and ileus post hip replacement along with Covid.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Small intestinal obstruction
Clinical narrative: Patient also was diagnosed with COVID-19 infection with a positive test.  Patient did have elevated inflammatory markers and D-dimer.  Therefore, he was placed on Solu-Medrol steroids and Zithromax antibiotic. Presented with abdominal pain, fevers, chills, constipation. Found to have SBO and ileus post hip replacement along with Covid.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acute respiratory failure, COVID-19 pneumonia, Cough, Hypoxia
Clinical narrative: Admitted for Covid-19 PNA and acute hypoxemic resp failure. Presented with hypoxia, congestion, cough, abdominal pain, nausea, vomiting. She was treated with dexamethasone, remdesivir, tocilizumab, oxygen support, and prone positioning. She improved gradually with treatment and was stable for discharge home on day 8. She required oxygen supplement 2L with exertion on discharge.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Prone position, Respiratory tract congestion, Vomiting
Clinical narrative: Admitted for Covid-19 PNA and acute hypoxemic resp failure. Presented with hypoxia, congestion, cough, abdominal pain, nausea, vomiting. She was treated with dexamethasone, remdesivir, tocilizumab, oxygen support, and prone positioning. She improved gradually with treatment and was stable for discharge home on day 8. She required oxygen supplement 2L with exertion on discharge.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Hypoxia, Malaise, Nasal congestion
Clinical narrative: Presented to hospital with a eight day history of nasal congestion, malaise and cough. "Was found to be covid positive". In the Emergency Room patient found to have SpO2 >92% on RA, but hypoxic to 87-88% while ambulating. Admitted to Medicine and started on decadron. The following morning walking oximetry test completed which showed no supplemental oxygen requirement at rest or with exertion. Patient discharged clinically stable and with strict return precautions.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Walking distance test normal
Clinical narrative: Presented to hospital with a eight day history of nasal congestion, malaise and cough. "Was found to be covid positive". In the Emergency Room patient found to have SpO2 >92% on RA, but hypoxic to 87-88% while ambulating. Admitted to Medicine and started on decadron. The following morning walking oximetry test completed which showed no supplemental oxygen requirement at rest or with exertion. Patient discharged clinically stable and with strict return precautions.
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Ear pain, Headache, Neck pain, Pharyngeal swelling, Throat tightness
Clinical narrative: Patient stated he had a bad reaction to the shingrix and did not want to get the second shot in the series. He stated that his throat was swollen and closed on the right side. All reactions were on the right side. He also said he had an ear ache, headache and sore neck.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus, Rash, Skin warm, Tenderness
Clinical narrative: Per the patient: A few hours after I received the flu vaccination, I noticed I had a few itchy spots on my legs. I did not think anything of it, and I left work around 3:30 p.m. I was getting ready to go to the movies and I had become extremely itchy. I noticed my face started to feel warm and I just kept an eye on it. The movie I saw started at 7:30 and while I was in there, my entire body started itching and my lips became very tender to touch and swollen. I took 3 Benadryl and went to sleep. The next morning, I was covered in a rash, and I was still itching. I was seen by Urgent Care, and they gave me a shot of steroids. The physician also sent in a prescription for Prednisone to take for the next week.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Neurological symptom
Clinical narrative: Caused stroke symptoms and now I can?t walk
Age: 72.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: She got her vaccine, her arm was warm to touch which turned into hot to touch about a day later.  She had swelling, tenderness, painful, very itchy arm at the injection site.  She put some itching lotion on it, Pramoxine 1% lotion, which did not help her symptoms, just a little bit.  The only thing that helped relieve her symptoms was an ice pack.  It is not itching this morning.  She took Tylenol.  She saw her doctor yesterday and she told her to put the ice pack on it and to take Tylenol.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: ***VACCINATION IS ACTUALLY THE PNEUMONIA  PREVNAR 23*** When I called down there on 10/26/23-one of the nurse told me to go to an urgent care and tell them to check it out and show them what was going on, and I did that and they end up telling me it was cellulitis from the injection. They told me that if I had to be billed, they would send the bill to the clinic. Starting on Tuesday night my arm started to ache and swelled up the size of  a baseball, my left arm, triceps area. The next day it was red and swelled on the upper part of my arm with redness down to my elbow. It appeared to have fluid there hanging from my arm in my skin. By Thursday it remained red and rash looking and aching. Medication was given for the symptoms of cellulitis. I went to (urgent care)
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Diarrhoea, Myalgia
Clinical narrative: following day had muscle aches. Then day after with muscle aches and loose stools for multiple days
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure congestive, Condition aggravated, Pleural effusion, SARS-CoV-2 test positive
Clinical narrative: Hospitalization for acute CHF exacerbation and bilateral pleural effusions, elevated troponins, tested covid positive on admission day, 10/24/2023 on dates 10/24/2023- 10/27/2023. Treated with vitamin C 1,000 mg PO daily,  zinc 50 mg PO daily.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Hospitalization for acute CHF exacerbation and bilateral pleural effusions, elevated troponins, tested covid positive on admission day, 10/24/2023 on dates 10/24/2023- 10/27/2023. Treated with vitamin C 1,000 mg PO daily,  zinc 50 mg PO daily.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Cough, Decreased activity, Diarrhoea, Gastrointestinal disorder, Insomnia
Clinical narrative: Mom states that babys is not sleeping a lot of congestion , coughing , Body pain mom states that she use to be very active and since they put the last vaccine she changes .  Gi symptoms, diarrhea and vomiting x 1 day, continues with soft stools x 4 times a day (watery)- mom attributes to vaccine received
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Pain, Respiratory tract congestion, Vomiting
Clinical narrative: Mom states that babys is not sleeping a lot of congestion , coughing , Body pain mom states that she use to be very active and since they put the last vaccine she changes .  Gi symptoms, diarrhea and vomiting x 1 day, continues with soft stools x 4 times a day (watery)- mom attributes to vaccine received
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Magnetic resonance imaging, Pain
Clinical narrative: on-call provider received a call from patient that she received a flu vaccine in the office 10/24/23.  She reports that starting about 3 days after the vaccine she developed severe pain in the left shoulder.  She thought it was worse than what she had experienced with previous vaccines- but kept thinking she would give it another day and it would go away.  The pain continues.  She reports continued pain that does not respond to 800mg Ibuprofen, OTC tylenol, biofreeze. She denies any localized swelling, skin color changes/bruising/erythema, denies any heat or warmth to the joint, denies fevers.    She reports limited ROM, pain with any movement.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia
Clinical narrative: Hospitalization for acute hypoxemic respiratory failure with pneumonia secondary to COVID-19 on dates 10/28/2023- 11/3/2023. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 58.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Blood test, Cardiac operation, Catheterisation cardiac, Chest discomfort, Coronary arterial stent insertion
Clinical narrative: He got his vaccine while he was receiving chemo treatment.  He started that Friday night around 11:00 he started having chest pressure and a pounding heart beat.  After that he started vomiting and sweating.  His wife called 911 and they did an EKG and found that he was having a heart attack and he had a stent placed in the right coronary artery.  He was in CCU and yesterday he went back to the cath lab again and to have another sent put on the left anterior descending artery and was discharged last night.  He is taking now 6 more medications than he was taking before the vaccine.  He does not have a history of heart disease and never had any problems with his heart prior to the vaccine.  He had cataract surgery 4 years ago and was tested for cardiac issues with an EKG and everything was normal at that time.  He started chemotherapy in March of this year and he is getting it every 3 weeks and has had no problems, and his heart has had no issues until the vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Electrocardiogram abnormal, Hyperhidrosis, Intensive care, Myocardial infarction, Palpitations
Clinical narrative: He got his vaccine while he was receiving chemo treatment.  He started that Friday night around 11:00 he started having chest pressure and a pounding heart beat.  After that he started vomiting and sweating.  His wife called 911 and they did an EKG and found that he was having a heart attack and he had a stent placed in the right coronary artery.  He was in CCU and yesterday he went back to the cath lab again and to have another sent put on the left anterior descending artery and was discharged last night.  He is taking now 6 more medications than he was taking before the vaccine.  He does not have a history of heart disease and never had any problems with his heart prior to the vaccine.  He had cataract surgery 4 years ago and was tested for cardiac issues with an EKG and everything was normal at that time.  He started chemotherapy in March of this year and he is getting it every 3 weeks and has had no problems, and his heart has had no issues until the vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Vomiting
Clinical narrative: He got his vaccine while he was receiving chemo treatment.  He started that Friday night around 11:00 he started having chest pressure and a pounding heart beat.  After that he started vomiting and sweating.  His wife called 911 and they did an EKG and found that he was having a heart attack and he had a stent placed in the right coronary artery.  He was in CCU and yesterday he went back to the cath lab again and to have another sent put on the left anterior descending artery and was discharged last night.  He is taking now 6 more medications than he was taking before the vaccine.  He does not have a history of heart disease and never had any problems with his heart prior to the vaccine.  He had cataract surgery 4 years ago and was tested for cardiac issues with an EKG and everything was normal at that time.  He started chemotherapy in March of this year and he is getting it every 3 weeks and has had no problems, and his heart has had no issues until the vaccine.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Rash
Clinical narrative: FEVER (102.1), CHILLS, FELT LIKE I WAS HIT BY A TRUCK (SEVERE MUSCLE ACHES), FATIGUE, ALL OVER RASH AND ITCHINESS WITH LITTLE BUMPS. I TOOK 2 EXTRA STRENGTH EXCEDRIN AT MIDNIGHT  WITHOUT MUCH EFFECT THEN TOOK NYQUIL THREE HOURS LATER AT 3AM (I STILL HAVE RASH AND ITCHINESS BUT EVERYTHING ELSE BETTER)
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash pruritic
Clinical narrative: FEVER (102.1), CHILLS, FELT LIKE I WAS HIT BY A TRUCK (SEVERE MUSCLE ACHES), FATIGUE, ALL OVER RASH AND ITCHINESS WITH LITTLE BUMPS. I TOOK 2 EXTRA STRENGTH EXCEDRIN AT MIDNIGHT  WITHOUT MUCH EFFECT THEN TOOK NYQUIL THREE HOURS LATER AT 3AM (I STILL HAVE RASH AND ITCHINESS BUT EVERYTHING ELSE BETTER)
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given the full vial, containing 3 doses, diluted. No adverse reaction noted. Unable to make contact with parent at this time.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine was administered below deltoid tissue in left arm.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High dose given
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received rotavirus vaccine at 6 months of age when child did not qualify for the vaccine. Child had never received a dose of rotavirus and was too old to receive it for the first time. Rotavirus should only be given to child before 15 weeks old. No symptoms or sign.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Urticaria
Clinical narrative: welts, redness at injection site
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: 07 November 2023 influenza vaccine recipient reported she has concerns of shoulder injury related to vaccine administration (SIRVA). She was vaccinated 31 October 2023 with vaccine provided by a work-related occupational health program. She states pain/soreness developed approximately ninety minutes after vaccination. She thought it was typical post vaccination pain/soreness. However, her pain/soreness and now decreased range of motion are causing her concern. She will seek guidance from Healthcare Occupational Health for next steps.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Injury associated with device, Occupational exposure to product
Clinical narrative: After immunizing the patient, I was trying to put the cap back on the syringe before putting it on the red bin then the needle slid and poke me in the left middle finger.  I told the Pharmacist on duty right away.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: MY HEART BEAT IS OUT OF RHYTHM  SINCE RECEVING THE JANSSEN COVID 19 IMMUNIZATION.