chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Nightmare, Pain, Pain in extremity, Palpitations
Clinical narrative: She got her vaccine, around 9:30 Friday night she did not feel as if she would make it to bed as she felt so tired.  She went to bed, her heart rate was kind of all over the place all night long.  She wears a smart watch to monitor her heart rate, and she felt lousy when she got up.  She felt faint standing in the kitche at one point and had to sit down.  She got herself into the family room (she was alone at this time), she felt as if her heart was racing, and found out later in the day and checked the smart watch and believes at a time that she felt faint her heart rate got down to 54.  At the time that she was sitting in the family room it jumped up to 105.  She did not feel very well on Saturday.  Looking The next day she was feeling better, was able to move around the house, kept busy.  Monday night she had another terrible night, nightmare, got her feet tangled up in her bed, and has bunions on her feet, and had rested her feet together and woke up with tingling and burning pain in her feet.  She sat with her legs over the bed, she called for her husband.  It went away, she felt nauseaous and took a Lorazepam to help with the stress and nausea.  Every day she has gotten gradually better, but she don't feels particularly sharp.  She feels kind of achy, stretching twice a day and in touch with her massage therapist to get a message, and feels like she has been run over by a truck.    She did call her doctor and she was told to hydrate as much possible, she should report it to pharmacy, and she was told that she should not get the senior shot the next time.  They think that maybe the antigen was not a good thing for her to have.  She was to call them back if anything flared up.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Stress
Clinical narrative: She got her vaccine, around 9:30 Friday night she did not feel as if she would make it to bed as she felt so tired.  She went to bed, her heart rate was kind of all over the place all night long.  She wears a smart watch to monitor her heart rate, and she felt lousy when she got up.  She felt faint standing in the kitche at one point and had to sit down.  She got herself into the family room (she was alone at this time), she felt as if her heart was racing, and found out later in the day and checked the smart watch and believes at a time that she felt faint her heart rate got down to 54.  At the time that she was sitting in the family room it jumped up to 105.  She did not feel very well on Saturday.  Looking The next day she was feeling better, was able to move around the house, kept busy.  Monday night she had another terrible night, nightmare, got her feet tangled up in her bed, and has bunions on her feet, and had rested her feet together and woke up with tingling and burning pain in her feet.  She sat with her legs over the bed, she called for her husband.  It went away, she felt nauseaous and took a Lorazepam to help with the stress and nausea.  Every day she has gotten gradually better, but she don't feels particularly sharp.  She feels kind of achy, stretching twice a day and in touch with her massage therapist to get a message, and feels like she has been run over by a truck.    She did call her doctor and she was told to hydrate as much possible, she should report it to pharmacy, and she was told that she should not get the senior shot the next time.  They think that maybe the antigen was not a good thing for her to have.  She was to call them back if anything flared up.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: Patient denied any side effects
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: At vaccine clinic, Hep B vaccine given to pt rather than the Men B.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child received the 2nd second dose of hepatitis A vaccine before the minimum interval.  The 2nd dose of MMR and Varicella were administered before the 4th birthday.
Age: 80.0
Sex: M
Vaccine: FLU4, TDAP, UNK, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Inadvertently gave a 3rd dose of Shingrix. Our charting software apparently did not send the 2nd dose of Shingrix to the state registry where I had referred to his previous vaccine record. Upon charting his bill for today's vaccines, I saw the 2nd dose of Shingrix had been givine in June of 20222 which did not show  on the state registry where I had reviewed his record.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: During college Vaccine clinic pt given Hep B instead of Men B.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Received Moderna Spikevax  (12+ PFS 23-24-INJ MO) at 11:20 AM on 9/26/23.  At approximately 10:30 AM on 9/27/23 experienced nausea with mild abdominal cramps.  Within 15 minutes started diarrhea which resulted in 5 episodes of diarrhea spread out over the next 24 hours.  Diarrhea stopped at approximately noon on 9/28/23.  Prior to this had been feeling well, no illness or other issues.  Previous COVID vaccinations were all Pfizer doses and other than a slightly sore injection site, no adverse issues.
Age: 64.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was inadvertently given 2 Spikevax shots (one in each arm). Multiple patients' paperwork and prepared vaccines were in the same area of the vaccination room, so a second Spikevax was accidentally grabbed and administered into his other arm rather than the intended RSV shot. Patient still opted to receive RSV vaccine after being informed of the error. Patient has not reported any adverse reactions as of now, but will call if he does.
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out in the store after receiving the vaccination. No injuries noted. She stated that all she had eaten all day was a piece of toast. Store called EMS who then evaluated patient and she sat around for awhile and then left the store.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient broke out in hives on different parts of body. Has been using Benadryl to treat the itching and has not had any other complications.  Hives have yet to resolve.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Device malfunction, Injury associated with device, Needle issue
Clinical narrative: Needle wouldn't work and allow me to administer the vaccine.  I put on a new needle and readministered the shot without issue.  It was a double stick.  The vaccine was Spikevax.  It is not a choice on the drop down won't let me pick other vaccine.
Age: 73.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Back pain, C-reactive protein increased, Catheterisation cardiac abnormal, Chest pain, Electrocardiogram change
Clinical narrative: Reported to us by FNP:  pt presented to walk in clinic with complaints of left chest pain, left arm pain, left jaw pain and back pain.  Went unresponsive. Clinic started CPR, AED advised no shock. Admitted to ER.  Had heart cath - pericarditis diagnosed.  EKG had changes consistent with pericarditis.  sed rate 74.  CRP 13.3  Admitted to hospital for 4 days.
Age: 73.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Pain in extremity, Pain in jaw, Pericarditis, Red blood cell sedimentation rate increased, Resuscitation
Clinical narrative: Reported to us by FNP:  pt presented to walk in clinic with complaints of left chest pain, left arm pain, left jaw pain and back pain.  Went unresponsive. Clinic started CPR, AED advised no shock. Admitted to ER.  Had heart cath - pericarditis diagnosed.  EKG had changes consistent with pericarditis.  sed rate 74.  CRP 13.3  Admitted to hospital for 4 days.
Age: 73.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Unresponsive to stimuli
Clinical narrative: Reported to us by FNP:  pt presented to walk in clinic with complaints of left chest pain, left arm pain, left jaw pain and back pain.  Went unresponsive. Clinic started CPR, AED advised no shock. Admitted to ER.  Had heart cath - pericarditis diagnosed.  EKG had changes consistent with pericarditis.  sed rate 74.  CRP 13.3  Admitted to hospital for 4 days.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Influenza like illness, Muscle spasms, Pain
Clinical narrative: Shock.  After 8 pm, increasing temperature, shaking chills, sore all over body like influenza pins and needles. Shock - almost called EMS - needed fluids - couldn't drink enough to keep temperature down. Shock - shaking chills.  Runny nose, 100.4 temperature at highest, took acetaminophen (325 mg 1 tablet at 10:30 pm) stabilized extreme up and down temperature.  toes on left foot bending backward, splayed out, physically grabbed toes with hand to force gently downward into normal curvature (too much potassium? like a cramp.   needed fluids)  Felt better by 12 pm, temperature 99.3.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rhinorrhoea, Shock, Tremor
Clinical narrative: Shock.  After 8 pm, increasing temperature, shaking chills, sore all over body like influenza pins and needles. Shock - almost called EMS - needed fluids - couldn't drink enough to keep temperature down. Shock - shaking chills.  Runny nose, 100.4 temperature at highest, took acetaminophen (325 mg 1 tablet at 10:30 pm) stabilized extreme up and down temperature.  toes on left foot bending backward, splayed out, physically grabbed toes with hand to force gently downward into normal curvature (too much potassium? like a cramp.   needed fluids)  Felt better by 12 pm, temperature 99.3.
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: The Clinical Assistant, who prepared and administered the vaccination, did not reconstitute the medication by adding diluent prior to drawing it up into the syringe.  Volume in the syringe was correct, but dose was incorrect due to not being diluted.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Anticoagulant therapy, Atrial fibrillation, Blood thyroid stimulating hormone normal
Clinical narrative: Patient is a 71 y.o. male patient of DPM with history of HFrEF, pulm hypertension, A-fib on Eliquis, type 2 diabetes, hypothyroidism, GERD, peripheral vascular disease, status post amputation to the right fifth and fifth toe presented to Hospital with septic shock.   Septic shock, POA COVID-19 pneumonia Acute hypoxemic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 8/30 Symptoms present on admission: Hypoxia Date of covid positive test: 8/31 Vaccination status: vaccinated Imaging: CXR with severe alveolar and interstitial opacities seen bilaterally concerning for severe pulmonary edema.  Some underlying inflammatory infectious pneumonitis would be difficult to exclude.  Cardiomegaly with evidence of CABG.  Right atria, right ventricle and coronary sinus pacing leads redemonstrated.  External cardiac pads overlying the left subhilar region.  No acute osseous abnormality Oxygen requirements on admission: BiPAP Current oxygen requirements: Ventilated Medical therapy: steroids Consultants following: Critical care, infectious disease Anticipated special isolation end date: TBD Critical care managing ventilator and pronating Off NMB  Weaning sedation per critical care Family refusing remdesivir      Status post amputation to right fourth and fifth toe Hold Augmentin Zosyn, changed to  meropenem and vanc as per ID   Elevated troponin Secondary to sepsis, inflammatory mediated Continue heparin for 48 hrs from peak of troponin Appreciated cardiology input     A-fib Continue mexiletine Currently on heparin ggt, hold metoprolol   HFrEF Ejection fraction 36% in 3/2023 Hold medications at this time due to severe sepsis and hypotension AKI on chronic kidney disease Monitor urine output and renal function     Type 2 diabetes uncontrolled Last A1c 6.8 Hold insulin until tube feeds restarted     Hypothyroidism, primary Continue levothyroxine Last TSH 5.24 in November/2022     Neuropathy Continue gabapentin obesity   Obesity Outpatient management following resolution of acute illness    on 9/13 AM Pt experiencing worsening hypotension. Levo required to be increased throughout the night. Also on vasopressin. Remains proned.    After meeting with family , plans to transition to comfort care with a compassionate extubation per the family's wishes.      Condition at Discharge: Expired
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cardiomegaly, Chest X-ray abnormal, Chronic kidney disease
Clinical narrative: Patient is a 71 y.o. male patient of DPM with history of HFrEF, pulm hypertension, A-fib on Eliquis, type 2 diabetes, hypothyroidism, GERD, peripheral vascular disease, status post amputation to the right fifth and fifth toe presented to Hospital with septic shock.   Septic shock, POA COVID-19 pneumonia Acute hypoxemic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 8/30 Symptoms present on admission: Hypoxia Date of covid positive test: 8/31 Vaccination status: vaccinated Imaging: CXR with severe alveolar and interstitial opacities seen bilaterally concerning for severe pulmonary edema.  Some underlying inflammatory infectious pneumonitis would be difficult to exclude.  Cardiomegaly with evidence of CABG.  Right atria, right ventricle and coronary sinus pacing leads redemonstrated.  External cardiac pads overlying the left subhilar region.  No acute osseous abnormality Oxygen requirements on admission: BiPAP Current oxygen requirements: Ventilated Medical therapy: steroids Consultants following: Critical care, infectious disease Anticipated special isolation end date: TBD Critical care managing ventilator and pronating Off NMB  Weaning sedation per critical care Family refusing remdesivir      Status post amputation to right fourth and fifth toe Hold Augmentin Zosyn, changed to  meropenem and vanc as per ID   Elevated troponin Secondary to sepsis, inflammatory mediated Continue heparin for 48 hrs from peak of troponin Appreciated cardiology input     A-fib Continue mexiletine Currently on heparin ggt, hold metoprolol   HFrEF Ejection fraction 36% in 3/2023 Hold medications at this time due to severe sepsis and hypotension AKI on chronic kidney disease Monitor urine output and renal function     Type 2 diabetes uncontrolled Last A1c 6.8 Hold insulin until tube feeds restarted     Hypothyroidism, primary Continue levothyroxine Last TSH 5.24 in November/2022     Neuropathy Continue gabapentin obesity   Obesity Outpatient management following resolution of acute illness    on 9/13 AM Pt experiencing worsening hypotension. Levo required to be increased throughout the night. Also on vasopressin. Remains proned.    After meeting with family , plans to transition to comfort care with a compassionate extubation per the family's wishes.      Condition at Discharge: Expired
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Ejection fraction decreased, Feeding tube user, Glycosylated haemoglobin normal
Clinical narrative: Patient is a 71 y.o. male patient of DPM with history of HFrEF, pulm hypertension, A-fib on Eliquis, type 2 diabetes, hypothyroidism, GERD, peripheral vascular disease, status post amputation to the right fifth and fifth toe presented to Hospital with septic shock.   Septic shock, POA COVID-19 pneumonia Acute hypoxemic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 8/30 Symptoms present on admission: Hypoxia Date of covid positive test: 8/31 Vaccination status: vaccinated Imaging: CXR with severe alveolar and interstitial opacities seen bilaterally concerning for severe pulmonary edema.  Some underlying inflammatory infectious pneumonitis would be difficult to exclude.  Cardiomegaly with evidence of CABG.  Right atria, right ventricle and coronary sinus pacing leads redemonstrated.  External cardiac pads overlying the left subhilar region.  No acute osseous abnormality Oxygen requirements on admission: BiPAP Current oxygen requirements: Ventilated Medical therapy: steroids Consultants following: Critical care, infectious disease Anticipated special isolation end date: TBD Critical care managing ventilator and pronating Off NMB  Weaning sedation per critical care Family refusing remdesivir      Status post amputation to right fourth and fifth toe Hold Augmentin Zosyn, changed to  meropenem and vanc as per ID   Elevated troponin Secondary to sepsis, inflammatory mediated Continue heparin for 48 hrs from peak of troponin Appreciated cardiology input     A-fib Continue mexiletine Currently on heparin ggt, hold metoprolol   HFrEF Ejection fraction 36% in 3/2023 Hold medications at this time due to severe sepsis and hypotension AKI on chronic kidney disease Monitor urine output and renal function     Type 2 diabetes uncontrolled Last A1c 6.8 Hold insulin until tube feeds restarted     Hypothyroidism, primary Continue levothyroxine Last TSH 5.24 in November/2022     Neuropathy Continue gabapentin obesity   Obesity Outpatient management following resolution of acute illness    on 9/13 AM Pt experiencing worsening hypotension. Levo required to be increased throughout the night. Also on vasopressin. Remains proned.    After meeting with family , plans to transition to comfort care with a compassionate extubation per the family's wishes.      Condition at Discharge: Expired
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Hypoxia, Illness, Inflammation, Intensive care
Clinical narrative: Patient is a 71 y.o. male patient of DPM with history of HFrEF, pulm hypertension, A-fib on Eliquis, type 2 diabetes, hypothyroidism, GERD, peripheral vascular disease, status post amputation to the right fifth and fifth toe presented to Hospital with septic shock.   Septic shock, POA COVID-19 pneumonia Acute hypoxemic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 8/30 Symptoms present on admission: Hypoxia Date of covid positive test: 8/31 Vaccination status: vaccinated Imaging: CXR with severe alveolar and interstitial opacities seen bilaterally concerning for severe pulmonary edema.  Some underlying inflammatory infectious pneumonitis would be difficult to exclude.  Cardiomegaly with evidence of CABG.  Right atria, right ventricle and coronary sinus pacing leads redemonstrated.  External cardiac pads overlying the left subhilar region.  No acute osseous abnormality Oxygen requirements on admission: BiPAP Current oxygen requirements: Ventilated Medical therapy: steroids Consultants following: Critical care, infectious disease Anticipated special isolation end date: TBD Critical care managing ventilator and pronating Off NMB  Weaning sedation per critical care Family refusing remdesivir      Status post amputation to right fourth and fifth toe Hold Augmentin Zosyn, changed to  meropenem and vanc as per ID   Elevated troponin Secondary to sepsis, inflammatory mediated Continue heparin for 48 hrs from peak of troponin Appreciated cardiology input     A-fib Continue mexiletine Currently on heparin ggt, hold metoprolol   HFrEF Ejection fraction 36% in 3/2023 Hold medications at this time due to severe sepsis and hypotension AKI on chronic kidney disease Monitor urine output and renal function     Type 2 diabetes uncontrolled Last A1c 6.8 Hold insulin until tube feeds restarted     Hypothyroidism, primary Continue levothyroxine Last TSH 5.24 in November/2022     Neuropathy Continue gabapentin obesity   Obesity Outpatient management following resolution of acute illness    on 9/13 AM Pt experiencing worsening hypotension. Levo required to be increased throughout the night. Also on vasopressin. Remains proned.    After meeting with family , plans to transition to comfort care with a compassionate extubation per the family's wishes.      Condition at Discharge: Expired
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Lung opacity, Mechanical ventilation, Neuropathy peripheral, Obesity, Positive airway pressure therapy
Clinical narrative: Patient is a 71 y.o. male patient of DPM with history of HFrEF, pulm hypertension, A-fib on Eliquis, type 2 diabetes, hypothyroidism, GERD, peripheral vascular disease, status post amputation to the right fifth and fifth toe presented to Hospital with septic shock.   Septic shock, POA COVID-19 pneumonia Acute hypoxemic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 8/30 Symptoms present on admission: Hypoxia Date of covid positive test: 8/31 Vaccination status: vaccinated Imaging: CXR with severe alveolar and interstitial opacities seen bilaterally concerning for severe pulmonary edema.  Some underlying inflammatory infectious pneumonitis would be difficult to exclude.  Cardiomegaly with evidence of CABG.  Right atria, right ventricle and coronary sinus pacing leads redemonstrated.  External cardiac pads overlying the left subhilar region.  No acute osseous abnormality Oxygen requirements on admission: BiPAP Current oxygen requirements: Ventilated Medical therapy: steroids Consultants following: Critical care, infectious disease Anticipated special isolation end date: TBD Critical care managing ventilator and pronating Off NMB  Weaning sedation per critical care Family refusing remdesivir      Status post amputation to right fourth and fifth toe Hold Augmentin Zosyn, changed to  meropenem and vanc as per ID   Elevated troponin Secondary to sepsis, inflammatory mediated Continue heparin for 48 hrs from peak of troponin Appreciated cardiology input     A-fib Continue mexiletine Currently on heparin ggt, hold metoprolol   HFrEF Ejection fraction 36% in 3/2023 Hold medications at this time due to severe sepsis and hypotension AKI on chronic kidney disease Monitor urine output and renal function     Type 2 diabetes uncontrolled Last A1c 6.8 Hold insulin until tube feeds restarted     Hypothyroidism, primary Continue levothyroxine Last TSH 5.24 in November/2022     Neuropathy Continue gabapentin obesity   Obesity Outpatient management following resolution of acute illness    on 9/13 AM Pt experiencing worsening hypotension. Levo required to be increased throughout the night. Also on vasopressin. Remains proned.    After meeting with family , plans to transition to comfort care with a compassionate extubation per the family's wishes.      Condition at Discharge: Expired
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Septic shock, Troponin increased
Clinical narrative: Patient is a 71 y.o. male patient of DPM with history of HFrEF, pulm hypertension, A-fib on Eliquis, type 2 diabetes, hypothyroidism, GERD, peripheral vascular disease, status post amputation to the right fifth and fifth toe presented to Hospital with septic shock.   Septic shock, POA COVID-19 pneumonia Acute hypoxemic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 8/30 Symptoms present on admission: Hypoxia Date of covid positive test: 8/31 Vaccination status: vaccinated Imaging: CXR with severe alveolar and interstitial opacities seen bilaterally concerning for severe pulmonary edema.  Some underlying inflammatory infectious pneumonitis would be difficult to exclude.  Cardiomegaly with evidence of CABG.  Right atria, right ventricle and coronary sinus pacing leads redemonstrated.  External cardiac pads overlying the left subhilar region.  No acute osseous abnormality Oxygen requirements on admission: BiPAP Current oxygen requirements: Ventilated Medical therapy: steroids Consultants following: Critical care, infectious disease Anticipated special isolation end date: TBD Critical care managing ventilator and pronating Off NMB  Weaning sedation per critical care Family refusing remdesivir      Status post amputation to right fourth and fifth toe Hold Augmentin Zosyn, changed to  meropenem and vanc as per ID   Elevated troponin Secondary to sepsis, inflammatory mediated Continue heparin for 48 hrs from peak of troponin Appreciated cardiology input     A-fib Continue mexiletine Currently on heparin ggt, hold metoprolol   HFrEF Ejection fraction 36% in 3/2023 Hold medications at this time due to severe sepsis and hypotension AKI on chronic kidney disease Monitor urine output and renal function     Type 2 diabetes uncontrolled Last A1c 6.8 Hold insulin until tube feeds restarted     Hypothyroidism, primary Continue levothyroxine Last TSH 5.24 in November/2022     Neuropathy Continue gabapentin obesity   Obesity Outpatient management following resolution of acute illness    on 9/13 AM Pt experiencing worsening hypotension. Levo required to be increased throughout the night. Also on vasopressin. Remains proned.    After meeting with family , plans to transition to comfort care with a compassionate extubation per the family's wishes.      Condition at Discharge: Expired
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Ringing in ears, constant, started on 11/30/2021 and has not let up since then.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Headache
Clinical narrative: horrific headache head pain and ear pain; horrific headache head pain and ear pain; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP), based on a report from Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in Mar2021 as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), EAR PAIN (non-serious), outcome "unknown" and all described as "horrific headache head pain and ear pain." Therapeutic measures were taken as a result of headache, ear pain.  Additional information: Patient reported "Your vaccine COVID in Mar2021 w/ horrific headache head pain and ear pain I've tried every medication under the sun with my doctors The only thing that worked was "Nurtex," it's dollar 1,900 a month. I think the least you could do is send me this because I cannot afford it. I would like a script of this a month please can you help me since your vaccine did this to me, I feel that's the least you can do.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have COVID now for the 2nd time despite being vaccinated and not doing great; I have COVID now for the 2nd time despite being vaccinated and not doing great; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID now for the 2nd time despite being vaccinated and not doing great".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Hepatitis A Havrix pediatric/adolescent dose inadvertently given to an adult client instead of the adult dose. The client received a 2nd Hepatitis A pediatric/adolescent dose per guidelines to count as an adult dose.
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received this vaccine despite her age being outside of guidelines for administration.  No adverse reactions noted.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse events, treatments, or outcomes to report at time of vaccination
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Limb discomfort, Paraesthesia, Peripheral coldness
Clinical narrative: When the provider first tried to inject, I felt a sudden and intense pain. I'm not sure what the provider felt or saw, but they removed the needle and injected the content of the same syringe lower in the same arm. The actual injection was fine. The provider denied any wrongdoing. During the 30 minutes I waited after the injection, I felt quite light headed and my arm was feeling weird down to my hand. Almost 5 hours later, my hand feels extremely cold and is still not feeling like the other one. I'm not sure about the rest of the arm, but the left hand is definitely not feeling normal, with a light tingling.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: When the provider first tried to inject, I felt a sudden and intense pain. I'm not sure what the provider felt or saw, but they removed the needle and injected the content of the same syringe lower in the same arm. The actual injection was fine. The provider denied any wrongdoing. During the 30 minutes I waited after the injection, I felt quite light headed and my arm was feeling weird down to my hand. Almost 5 hours later, my hand feels extremely cold and is still not feeling like the other one. I'm not sure about the rest of the arm, but the left hand is definitely not feeling normal, with a light tingling.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: > 65 years old vaccine given to patient under 65 years old
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain radiates from injection site site to right elbow. Can no longer raise arm up.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No observed adverse effects, treatment, or outcomes observed or to report.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Fatigue, Wrong product administered
Clinical narrative: The patient was supposed to receive the RSV vaccine Abrysvo, but received Fluzone HD in error. The patient had already received Fluzone HD on 9/1/2023, so this was the patient's 2nd flu shot within a month. The patient was informed of the mistake on 9/28/23. The patient said she only felt tired starting 9/28/23, no other side effects.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Severe pain to shoulder, arm, and clavicle region with and without movement. Not improving with ibuprofen.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Department of Health Services informed pcp office after hours on 9/12/2023. Pt received vaccine in the am prior to office staff being informed of discontinuation of COVID vaccine. No adverse reaction at time of administration. Pt was monitored post vaccine administration as per CDC guidelines.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was within BUD; however, the EUA was revoked on 9/11/23 and vaccine was given 9/12/23.
Age: 0.75
Sex: M
Vaccine: MENB
Symptoms: Irritability, Pyrexia
Clinical narrative: Patient is a 9 month old male that was given Meningococcal B (Trumemba) instead of Hepatitis B vaccine. That same night of vaccination had fever and irritability.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Decreased appetite, Dizziness, Feeling abnormal, Injection site pain
Clinical narrative: Started out with swelling & soreness at injection site.  About three days later the pain started in my left arm & it was a constant throbbing & was pretty bad.  Then came the upset stomach & could barely eat for days except for toast & some days I could tolerate peanut butter & maybe some crackers.  Really upset stomach.  Sneezing, blowing nose.  Dizzy.  Just plain feeling rotten most every day plus the brutal pain in my arm.  It's now the 28th of Sept & I am just starting to feel pretty normal again.  The pain in my arm lasted up until a few days ago when I noticed the swelling in my upper arm & started to ice it twice a day.  All in all, a horrible experience.  I got a double dose due to my age & that was the first mistake.....never again.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Pain, Pain in extremity, Sneezing
Clinical narrative: Started out with swelling & soreness at injection site.  About three days later the pain started in my left arm & it was a constant throbbing & was pretty bad.  Then came the upset stomach & could barely eat for days except for toast & some days I could tolerate peanut butter & maybe some crackers.  Really upset stomach.  Sneezing, blowing nose.  Dizzy.  Just plain feeling rotten most every day plus the brutal pain in my arm.  It's now the 28th of Sept & I am just starting to feel pretty normal again.  The pain in my arm lasted up until a few days ago when I noticed the swelling in my upper arm & started to ice it twice a day.  All in all, a horrible experience.  I got a double dose due to my age & that was the first mistake.....never again.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 24.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: Severe swelling on entire upper arm from shoulder to elbow, hot to touch, painful to move arm at all.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, and swelling and some pain around injection site area
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient history of Tdap/Td series Patient received Tdap /#1 on 1/18/2023 Patient received Td on/  08/24/2023 RN gave Td on 09/28/2023 - given too soon than the recommended schedule which is 6 months after 2nd dose. No adverse reaction noted from the time the vaccine was given. Patient left without complaints of untoward reaction.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: SPIKEVAX MODERNA  LOT: 3031279 MANUFACTURER: MODERNA EXPIRATION: 04/14/2024 Patient experiencing numb arms and feet and loss of movement. Patient seeking emergency treatment.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Analgesic drug level therapeutic, Blood alcohol normal, Blood electrolytes normal, Chest X-ray normal, Computerised tomogram head normal
Clinical narrative: Developed Seizure starting at 10:13 PM, had 6 witnessed convulsions lasting up to 30 seconds, resolved by 10:26 PM.  Seizures were resolved after 13 minutes when Grandmother came and found him unresponsive and foaming at mouth. She performed CPR, causing him to vomit and breathe. Brought to the ED. Returned to baseline and had no seizures in the 16 hours since. Patient also on atomoxetine 18mg and clonidine 0.1 mg for ADHD; atomoxetine may be aswsociated with seizures.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Foaming at mouth, Resuscitation, Seizure, Toxicologic test normal
Clinical narrative: Developed Seizure starting at 10:13 PM, had 6 witnessed convulsions lasting up to 30 seconds, resolved by 10:26 PM.  Seizures were resolved after 13 minutes when Grandmother came and found him unresponsive and foaming at mouth. She performed CPR, causing him to vomit and breathe. Brought to the ED. Returned to baseline and had no seizures in the 16 hours since. Patient also on atomoxetine 18mg and clonidine 0.1 mg for ADHD; atomoxetine may be aswsociated with seizures.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Troponin normal, Unresponsive to stimuli, Vomiting
Clinical narrative: Developed Seizure starting at 10:13 PM, had 6 witnessed convulsions lasting up to 30 seconds, resolved by 10:26 PM.  Seizures were resolved after 13 minutes when Grandmother came and found him unresponsive and foaming at mouth. She performed CPR, causing him to vomit and breathe. Brought to the ED. Returned to baseline and had no seizures in the 16 hours since. Patient also on atomoxetine 18mg and clonidine 0.1 mg for ADHD; atomoxetine may be aswsociated with seizures.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 78.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Loss of consciousness, Road traffic accident, Syncope
Clinical narrative: Pt reported fainting "blackout" 1.5hrs after vaccination.  Pt  was driving at the time, resulted in minor car accident.  No injuries reported.
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Vaccines administered experienced a temperature excursion; This spontaneous report was received from a other health professional and refers to a patient (age and gender was unknown)  The patient's medical history, concurrent condition, and concomitant therapies were not reported.  On 19-JUN-2023, the patient was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, (lot #U7374BA, expiration date: 06-MAY-2025), administered for prophylaxis (strength, and route of administration were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #W026137, expiration date: 05-FEB-2024), administered orally for prophylaxis (strength was not provided), after vaccines experienced a temperature excursion (8.74 C, time frame: 35 Minutes, had no previous temperature excursion) (Product storage error).  There was no side effect reported (No adverse event), and no product quality complaint (PQC).
Age: 0.75
Sex: M
Vaccine: MMR, PNC15, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; Information has been received from Centers for Disease Control (CDC) On 21-SEP-2023 referring to a 9-month-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 14-JUL-2023, the patient (at 9 month instead of at 12 months by mistake) (product administered to patient of inappropriate age) was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X004289, expiration date was validated as 10-DEC-2024, administered intramuscularly (strength was not provided) at Left Lower Forearm; and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered intramuscularly (lot #X005838; strength, dose, and expiry date were not provided) at right Lower Forearm; varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W039688, expiration date was validated as 13-DEC-2024, administered intramuscularly at Left Lower Forearm(strength was not provided). All vaccines were vaccinated for prophylaxis. Patient was held for 20 min after the vaccinations were given. there was no adverse reactions to the vaccinations (no adverse event). The only issue was that they were given early for what was considered the time frame to receive these vaccinations.  Lot No. X005838 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date not reported, but upon internal validation established as 03-JUN-2024.
Sex: U
Vaccine: PNC15, UNK
Symptoms: Product storage error
Clinical narrative: no adverse event; HCP calling to report AE for patient who received VAXELIS PFS and VAXNEUVANCE. Improperly stored vaccines were administered to patient on 08SEP2023. No side effects reported. Operator of Device was a Health Professional. No other medical information; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions  and concomitant therapies were not reported.  On 08-SEP-2023, the patient started therapy with diphtheria toxoid (+) hepatitis B virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection,  (strength, and route of administration were not provided); lot #U7392AA, expiration date: 31-MAY-2025, administered for prophylaxis and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (strength, and route of administration were not provided), lot #X011332, expiration date: 01-JAN-2025, administered for prophylaxis. The vaccines were improperly stored (Temperature 12.1 Celsius degrees for 13 minutes and 13.1 Celsius degrees for 13 minutes). There was also previous temperature excursion reported. No side effects reported. ; Sender's Comments:  US-009507513-2309USA008760:
Age: 12.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE; a 12-year-old patient received PROQUAD and VARIVAX concomitantly and was supposed to only receive MMR II and VARIVAX; This spontaneous report has been received from a licensed practical nurse (LPN) referring to a 12-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 22-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (albumin status unknown) and varicella virus vaccine live (oka/merck) (VARIVAX) injection concomitantly for prophylaxis (strength, exact dose, lot #, expiry date and route of administration were not provided) (overdose). The patient was supposed to only receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Hcp called to report expired PROQUAD inadvertently administered to a patient.; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 23-SEP-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (0.5 ml x1, lot#: W007743, expiration date: 04-SEP-2023; route of administration was not provided) for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
Sex: M
Vaccine: RVX
Symptoms: Coeliac disease, Flatulence, Mucous stools
Clinical narrative: Celiac deisease; gas with stool; Mucus with stool; This serious case was reported by a consumer and described the occurrence of celiac disease in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included cardiac disorder. Concomitant products included bisoprolol.   On 13-SEP-2023, the patient received RSV vaccine. On 14-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced celiac disease (Verbatim: Celiac deisease) (serious criteria GSK medically significant), flatulence (Verbatim: gas with stool) and mucus stools (Verbatim: Mucus with stool).  On 20-SEP-2023, the outcome of the celiac disease was resolved and the outcome of the flatulence and mucus stools were resolved (duration 6 days).   It was unknown if the reporter considered the celiac disease, flatulence and mucus stools to be related to RSV vaccine.     It was unknown if the company considered the celiac disease, flatulence and mucus stools to be related to RSV vaccine.   Additional Information: GSK receipt date: 21-Sept-2023 No symptoms were treated. The reporter consented to follow-up.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Eye swelling, Periorbital swelling, Wheezing
Clinical narrative: huge pockets of fluid under his eyes, I inch long by 1/2 inch deep; mild swelling below his eyes; "feel whoozy"; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wheezing in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-SEP-2023, the patient received the 1st dose of Arexvy (right arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced wheezing (Verbatim: "feel whoozy"). On 16-SEP-2023, the patient experienced eye swelling (Verbatim: mild swelling below his eyes). On 18-SEP-2023, the patient experienced bags under eyes (Verbatim: huge pockets of fluid under his eyes, I inch long by 1/2 inch deep).  The outcome of the wheezing, eye swelling and bags under eyes were not resolved.   It was unknown if the reporter considered the wheezing, eye swelling and bags under eyes to be related to Arexvy.     It was unknown if the company considered the wheezing, eye swelling and bags under eyes to be related to Arexvy.   Additional Information: GSK Receipt date: 18-SEP-2023 A pharmacist reported that a patient received Arexvy vaccine on 15 September 2023.  He woke up on Saturday and Sunday (16Sep2023 and 17Sep2023) with some mild swelling below his eyes, but today 18Sep2023, the patient has huge pockets of fluid under his eyes, 1 inch long by 1/2 inch deep.  The patient came back today and showed RPH that he had large swelling pockets under both eyes and states he feels whoozy. The reporter did not consent to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient had waited 5 months before the application of the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 15th May 2023).   On 18-SEP-2023, the patient received the 2nd dose of Twinrix. On 18-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a patient had waited 5 months before the application of the second dose).  The outcome of the drug dose administration interval too long 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: 18-SEP-2023 The pharmacist called in to report that a patient had waited 5 months before the application of the 2nd dose and wanted to know if there was information about the need to restart the series.  Partial information about vaccine, event and patient provided. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose after 5 months, which led to lengthening of the vaccination schedule. The reporter consented to follow up.