chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administration error
Clinical narrative: 2ND DOSE DOES NOT MEET MINIMUM INTERVAL FROM LAST DOSE (DOSE #1 HAVRIX ON 05/11/2023 LOT 77LYT) ADMINISTERED IN ERROR PATIENT REPORTS NO ADVERSE EFFECTS
Age: 77.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever of 101 degrees fahrenheit for 24 hours. injection site red, swollen and hot to the touch from date of injection up through the date of event reporting.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA ANGINA, UNSPECIFIED
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Musculoskeletal stiffness, Mydriasis, Pain in extremity
Clinical narrative: Vaccines administered at 8:40 am. Immediately following vaccination patient leaned back on bed. Pupils dilated and arms stiffened for 3-5 seconds. Patient rolled onto side. Patient states she dreamed on eating chicken nuggets. Patient alert and oriented. States that her arms were sore. When asked why she was able to state that she got two shots in her left arm and one in her right. Patient rolled onto back and feet elevated. At 8:45 patient sat up in bed. States that she was fine. At 8:50 am patient given gatorade. Patient drank 2-3 ounces. No complaint on nausea, dizziness, or headache. Patient ambulated out of clinic at 9:08 am. Parents state they were taking her to the emergency room for follow-up.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, MMRV, PNC15
Symptoms: Eye swelling, Pyrexia
Clinical narrative: Mother returned on 08/14/2023 for a different reason and mentioned that her child, who was vaccinated 08/11/2023, had experienced swollen eyes and fever the night of 08/11/2023. Mother knew fever was expected but concerned about the swollen eyes. Mother reports this symptom last until 08/13/2023. Mother reported no other symptoms.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: The patient presented with an episode of syncope within 2 minutes after getting the HPV vaccine. The patient remained in the chair provided with an ice pack, HR 75, and BP 85/60. At 12:43 patient was relieved of syncope, and vitals were reassessed BP 90/65, HR 75. Patient and patients mother re-educated about normal side effects of HPV vaccine. 12:45 patient walked to her car.
Age: 13.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt received a Dtap instead of a Tdap. No other adverse reactions
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site discolouration, Injection site discomfort, Injection site erythema, Injection site haemorrhage, Injection site induration
Clinical narrative: Patient complaining of discomfort on the site of arm administration, the day the vaccine was administered (08/17/2023). Patient indicates that he bled a lot when withdrawing the needle. On August 20, 2023, patient noted hardness, swelling, and redness in the site of administration area. On August 23, 2023, it indicates that the site area began to turn purple, more hardened, more inflamed and the area felt hot. Patient has not presented generalized fever only in the area of ??vaccine administration. It was suggested to visit a doctor for review and treatment.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling
Clinical narrative: Patient complaining of discomfort on the site of arm administration, the day the vaccine was administered (08/17/2023). Patient indicates that he bled a lot when withdrawing the needle. On August 20, 2023, patient noted hardness, swelling, and redness in the site of administration area. On August 23, 2023, it indicates that the site area began to turn purple, more hardened, more inflamed and the area felt hot. Patient has not presented generalized fever only in the area of ??vaccine administration. It was suggested to visit a doctor for review and treatment.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: diluent was not mixed with powder conjugate compound, only diluent was given to patient
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: gave a second TDAP one was given 3/27/2023 for a nail in foot and was not noticed so during yearly PE was given again no reactions
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Symptom recurrence
Clinical narrative: PERIPHERAL NEUROPATHY 11/20/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event or side effects...pt was given vaccine that was beyond use date by 3 weeks
Age: 74.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Lacrimation increased, Periorbital swelling, Swelling face
Clinical narrative: Pt received Prevnar and Covid-19 on 8/10, on 8/11 she started to get swelling up the right side of her face/eye causing puffiness/watering of the eye.  This lasted about 3-4 days.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/18/2022 &   3/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Pulmonary embolism, Symptom recurrence
Clinical narrative: STABLE ANGINA ACUTE PULMONARY EMBOLISM 5/11/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hallucination, Pyrexia
Clinical narrative: Customer stated he experienced symptoms of hallucinations, fever over 100 degrees, shaking chills beginning 6 hours after the injection.      He called this morning  (approx 24 hours later) stating his symptoms were beginning to subside, but still has a fever at or above 100 degrees.   I recommended he continue to take tylenol and consult his primary care doctor.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: no adverse event
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Redness to site, swelling site, vomiting 6 hours later and every 4-6 hours for 24 hours. Return to urgent care for treatment of reactions.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain, Pain in extremity, Periarthritis
Clinical narrative: "I had pain in the right upper arm/shoulder specially with rapid movement. This started shortly after the booster shot and lasted for several months. During that time I went to physical therapy, acupuncture, and chiropractor for help. My PT was at the clinic and said he had seen several similar cases. similar to a frozen shoulder."
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Symptom recurrence
Clinical narrative: ALLERGIC REACTION, SUBSEQ 3/25/2022,  8/17/2022,  3/11/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: LEFT BELLS PALSY
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash erythematous, Swelling face
Clinical narrative: This vaccine was administered by outside facility from anther medical office two days ago (8-21-23). Pt began having symptoms of arm pain, followed by red rash on arms, chest, neck and face along with facial swelling. Pt was treated with prednisone, hydroxyzine and pepcid to begin on 8-23-23.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Chills, Dizziness, Fatigue, Headache, Hepatic enzyme increased
Clinical narrative: Client called 8/7/23 to report lightheadedness,  diaphoresis, and a low grade temp of 99 starting late on 8/4 after vaccinations. On sat 8/5 she experienced N/V, chills, HA, fatigue and aching. She did not take her temp. She drank fluids and took OTC tylenol alternating with ibuprophen however stated it did not help symptoms. Chills, HA and fatigue a "little better" 8/6 in the am however returned in the PM. Mon, 8/7 she still experience same symptoms and took her temperature, she reported 106F. She called the office to report the symptoms and felt like she should go to the ER. Advised if she felt like she should go then proceed to ER. Reported in the ER her fever was 105.6  her lab work showed high liverenzymes. Stated she was admitted for a consult with infectious disease and GI specialist due to elevated liver enzymes and fever. Fever "broke" on the 4th day of hospitalization.  Remained in hospital to monitor liver function. Requested lab results and discharge summary from pt. Still waiting on those reports.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Hyperhidrosis, Laboratory test abnormal, Liver function test, Nausea, Pain
Clinical narrative: Client called 8/7/23 to report lightheadedness,  diaphoresis, and a low grade temp of 99 starting late on 8/4 after vaccinations. On sat 8/5 she experienced N/V, chills, HA, fatigue and aching. She did not take her temp. She drank fluids and took OTC tylenol alternating with ibuprophen however stated it did not help symptoms. Chills, HA and fatigue a "little better" 8/6 in the am however returned in the PM. Mon, 8/7 she still experience same symptoms and took her temperature, she reported 106F. She called the office to report the symptoms and felt like she should go to the ER. Advised if she felt like she should go then proceed to ER. Reported in the ER her fever was 105.6  her lab work showed high liverenzymes. Stated she was admitted for a consult with infectious disease and GI specialist due to elevated liver enzymes and fever. Fever "broke" on the 4th day of hospitalization.  Remained in hospital to monitor liver function. Requested lab results and discharge summary from pt. Still waiting on those reports.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Client called 8/7/23 to report lightheadedness,  diaphoresis, and a low grade temp of 99 starting late on 8/4 after vaccinations. On sat 8/5 she experienced N/V, chills, HA, fatigue and aching. She did not take her temp. She drank fluids and took OTC tylenol alternating with ibuprophen however stated it did not help symptoms. Chills, HA and fatigue a "little better" 8/6 in the am however returned in the PM. Mon, 8/7 she still experience same symptoms and took her temperature, she reported 106F. She called the office to report the symptoms and felt like she should go to the ER. Advised if she felt like she should go then proceed to ER. Reported in the ER her fever was 105.6  her lab work showed high liverenzymes. Stated she was admitted for a consult with infectious disease and GI specialist due to elevated liver enzymes and fever. Fever "broke" on the 4th day of hospitalization.  Remained in hospital to monitor liver function. Requested lab results and discharge summary from pt. Still waiting on those reports.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Hyperhidrosis, Lethargy
Clinical narrative: ABOUT 30 MINUTES AFTER RECEIVING FIRST DOSE OF HEP B, EMPLOYEE BACAME SWEATY, WEAK AND LETHARGIC. WAS SENT TO ER FOR EVAL. WAS RECOMMENED NOT TO RECEIVE ANY MORE DOSES OF HEP B VACCINE BY ER DOCTOR.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Dyspnoea, Fatigue, Hypertension
Clinical narrative: After the first dose which should be recorded, I experienced shortness of breath and my heart was racing badly. After the second dose on January 12, 2021, I experienced the same issues along with feeling extremely tired. Approximately 3 weeks later, I had a rash that started on my inner arms which then spread over my torso, chest, breasts, and lower legs. The rash remained for 7 weeks. I then continued to have rashes for 6 to 7 weeks and a break in between that varied between 3 to 4 weeks. I mentioned this to my previous doctor's nurse practitioner who said the rashes were not from an allergy but looked to be from the vaccine. In addition, my a-fib which was very controlled with 10mg of metoprolol once daily, had to be changed to 20mg twice daily. It's been 3 and a half years since getting the vaccine and I must take my heart medication twice daily, and I still experience these rashes. Currently, the rash is on my inner arms, lower legs, face, neck, ears, chest, and torso. I wouldn't wish this raw, red, itchy rash on my worst enemy. It's horrible! And to have my heart race all over the place is equally upsetting.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Laboratory test abnormal, Palpitations, Rash, Rash erythematous
Clinical narrative: After the first dose which should be recorded, I experienced shortness of breath and my heart was racing badly. After the second dose on January 12, 2021, I experienced the same issues along with feeling extremely tired. Approximately 3 weeks later, I had a rash that started on my inner arms which then spread over my torso, chest, breasts, and lower legs. The rash remained for 7 weeks. I then continued to have rashes for 6 to 7 weeks and a break in between that varied between 3 to 4 weeks. I mentioned this to my previous doctor's nurse practitioner who said the rashes were not from an allergy but looked to be from the vaccine. In addition, my a-fib which was very controlled with 10mg of metoprolol once daily, had to be changed to 20mg twice daily. It's been 3 and a half years since getting the vaccine and I must take my heart medication twice daily, and I still experience these rashes. Currently, the rash is on my inner arms, lower legs, face, neck, ears, chest, and torso. I wouldn't wish this raw, red, itchy rash on my worst enemy. It's horrible! And to have my heart race all over the place is equally upsetting.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: After the first dose which should be recorded, I experienced shortness of breath and my heart was racing badly. After the second dose on January 12, 2021, I experienced the same issues along with feeling extremely tired. Approximately 3 weeks later, I had a rash that started on my inner arms which then spread over my torso, chest, breasts, and lower legs. The rash remained for 7 weeks. I then continued to have rashes for 6 to 7 weeks and a break in between that varied between 3 to 4 weeks. I mentioned this to my previous doctor's nurse practitioner who said the rashes were not from an allergy but looked to be from the vaccine. In addition, my a-fib which was very controlled with 10mg of metoprolol once daily, had to be changed to 20mg twice daily. It's been 3 and a half years since getting the vaccine and I must take my heart medication twice daily, and I still experience these rashes. Currently, the rash is on my inner arms, lower legs, face, neck, ears, chest, and torso. I wouldn't wish this raw, red, itchy rash on my worst enemy. It's horrible! And to have my heart race all over the place is equally upsetting.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Neuropathy peripheral
Clinical narrative: CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ NEUROPATHY HYPOXIA
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Staff member administered vaccine from other supply instead of our private supply. No signs, symptoms or adverse reactions.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Hives
Age: 51.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Fever, chills, headache, sinus pressure, tired, nausea, pain at injection sites. Start shortly after injection. Persist still at 24 hrs
Age: 51.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Paranasal sinus discomfort, Pyrexia
Clinical narrative: Fever, chills, headache, sinus pressure, tired, nausea, pain at injection sites. Start shortly after injection. Persist still at 24 hrs
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Endotracheal intubation, Hypopnoea, Pulse absent, Respiratory arrest, Resuscitation
Clinical narrative: Wife had patient in the bathroom and started screaming help. Patient's breathing very shallow. This nurse called 911. Put to bed immediately. No pulse. No respirations. At 10:25am CPR started. At 10:26am O2 applied. EMS here at 10:35am. Intubated at 10:37am. IV placed at 10:40am. EPI x 1 given at 10:41am. Another EPI x 1 given at 10:44am. Sodium bicarb given at 10:45am. Patient leaving with EMS. Blood pressure 171/130.Patient was at baseline this morning and vitals signs were in normal range. Patient was alert and oriented x 3.Patient took medications whole without complications. No complications noted.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 7.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: No adverse event
Clinical narrative: No adverse effects to patient
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Hives within 24 hours of vaccine. Resolved within 2 days. Was given 1 dose of cetirizine from doctor for rash. On 08/18/2023 patient reported rash gone to doctor.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, INIT
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, SUBSEQ
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was give immunization from other supply instead of private/commercial supply.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: 4 hours after vaccine, patient experienced numbness and tingling in left arm which radiated to left side of face. Face felt heavy for 24 hours. No drooping noted. Did not seek medical attention, symptoms resolved after 24 hours.
Age: 71.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Abdominal pain upper, Asthenia, Discomfort, Fatigue, Headache
Clinical narrative: She got her vaccines, one in one arm and the one in the other.  The arm became very swollen and very very sore.  That evening, all night she was in bed, very uncomfortable.  In the morning yesterday when she stood up she almost fainted twice.  She was very very fatigued, very weak and her stomach hurt.  She had a bad headache as well.  The headache has continued through this morning and her stomach is still hurting.  She has not contact the pharmacist for this as she stated that she had only given 2 other RSV vaccine.  She contacted her doctor who told her if she did not feel better in a couple of days she should see her.  She was not told to take anything for her symptoms.  She took some Maalox and generic Prilosec
Age: 71.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Pain in extremity, Peripheral swelling, Presyncope
Clinical narrative: She got her vaccines, one in one arm and the one in the other.  The arm became very swollen and very very sore.  That evening, all night she was in bed, very uncomfortable.  In the morning yesterday when she stood up she almost fainted twice.  She was very very fatigued, very weak and her stomach hurt.  She had a bad headache as well.  The headache has continued through this morning and her stomach is still hurting.  She has not contact the pharmacist for this as she stated that she had only given 2 other RSV vaccine.  She contacted her doctor who told her if she did not feel better in a couple of days she should see her.  She was not told to take anything for her symptoms.  She took some Maalox and generic Prilosec
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 2 mL were given to patient instead of .8mL.Patient's mom denies patient is having any adverse effects.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was incorrectly administered vaccine from other supply, instead of private/commercial supply.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary infarction, Symptom recurrence
Clinical narrative: TYPE 2 MI PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED 2/11/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: About an hour after I had my Pneumococcal Vaccine I experienced shortness of Breath that lasted several hours -not severe enough to seek medical treatment --ALso - and this is really odd - yesterday which was the 8th day since I was vaccinated  I had pain and redness in my arm where I was given the shot - the area was  hot to the touch. I took a picture of it since I thought that that was so unusual.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, X-ray
Clinical narrative: 8/21/2023 6:10 AM       Notified by nursing regarding: worsening cough   Patient is here with covid and is on IVF. Will get a CXR to ensure no pul edema and will order robitussin. Morning HBS to follow up on the CXR     Electronically signed by  DO   8/21/2023   6:10 AM.         Note Details  Author  (D.O.) File Time 8/21/2023  6:11 AM Author Type PHYSICIAN (D.O.) Status Signed Last Editor (D.O.) Specialty Hospital Medicine Hospital Acct #  Admit Date 8/17/2023  ED to Hosp-Admission (Current) on 8/17/2023  ED to Hosp-Admission (Current) on 8/17/2023   Detailed Report  Note shared with patient Care Timeline  08/18   Admitted from ED (Observation) 0038 08/20   Admitted 1053
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Mom sends picture to APRN.  Pt has red, raised, warm to  touch area at vaccination site.  Pt.'s mom instructed to continue to use Tylenol and cold pack to injection site.  Go to nearest ED if any further concerns like redness spreading or SOB.  Mom verbalizes understanding.
Age: 74.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Incorrect dose administered
Clinical narrative: The patient accidentally took all 4 oral capsules in one dose on 8/22/23 rather than taking one capsule by mouth every other day as instructed. He reported only mild upset stomach.
Age: 40.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient should have received MMR Vaccine, but was given Proquad Vaccine instead. Patient was notified, and no reactions were observed.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Rash, Rash erythematous
Clinical narrative: RED RASH, NO ITCHING, ROUGH TO TOUCH. LOCATION: INNER ARMS, LOWER ABDOMEN, LEGS PATIENT WENT TO DERMATOLOGIST-PREDNISONE AND TRIAMCINOLONE CREAM
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered an expired dose of COVID-19 vaccine after the unfrozen date.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: COvid-19 Breakthrough Infection
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received a dose of undiluted Pfizer bivalent vaccine for age 5-11 (total volume of 0.2mL was injected). This error was realized 5 days after the vaccine was administered. Patient was contacted to see if he had any adverse reactions, but the father stated that the patient had no side effects after the vaccination.  Patient's father and primary care provider was notified of the error. Patient's father was counseled to seek medical attention if the patient experiences any adverse reactions.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Large intestine polyp
Clinical narrative: T78.40XA ALLERGIC REACTION, INIT 1/19/2023 COLON POLYP
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Computerised tomogram pancreas, Lipase increased, Pancreatic cyst
Clinical narrative: Assessment and Plan: Patient is a 66 year old female with a history of DM, HTN, HLD, CAD s/p stent, GERD who presented with abdominal pain with lipase 300 and CT with mild pancreatic inflammation.  Admitted for pancreatitis.   CV:  BP and HR acceptable. Losartan 25mg daily for HTN.  ASA for CAD.  Atorvastatin 40mg daily daily for HLD.  Monitor vitals.     Pul:  Good O2 sat on room air.  No hypoxia..   GI:  IVF, PRN pain meds, and NPO for pancreatitis.  Pancreatic cystic structure to be followed up outpatient.  Pain resolved so will start full liquid diet with plans to advance to low fat diet for lunch.  Likely stop IVF at lunch.     Renal:  NS 75cc/hr currently.     Endo:  Regular SSI QACHS.  Monitor BG.     Heme:  Lovenox proph.     ID:  COVID positive but no symptoms.  Isolation in place but no current treatment.     Dispo:  Likely home later today.           Note Details  Author (M.D.) File Time 8/17/2023  7:35 AM Author Type Physician Status Signed Last Editor  (M.D.) Specialty Hospital Medicine Hospital Acct # Admit Date 8/16/2023  ED to Hosp-Admission (Discharged) on 8/16/2023  ED to Hosp-Admission (Discharged) on 8/16/2023   Detailed Report  Note viewed by patient Care Timeline  08/16   Admitted from ED (Observation) 1835 08/17   Discharged 2118
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pancreatitis, SARS-CoV-2 test positive
Clinical narrative: Assessment and Plan: Patient is a 66 year old female with a history of DM, HTN, HLD, CAD s/p stent, GERD who presented with abdominal pain with lipase 300 and CT with mild pancreatic inflammation.  Admitted for pancreatitis.   CV:  BP and HR acceptable. Losartan 25mg daily for HTN.  ASA for CAD.  Atorvastatin 40mg daily daily for HLD.  Monitor vitals.     Pul:  Good O2 sat on room air.  No hypoxia..   GI:  IVF, PRN pain meds, and NPO for pancreatitis.  Pancreatic cystic structure to be followed up outpatient.  Pain resolved so will start full liquid diet with plans to advance to low fat diet for lunch.  Likely stop IVF at lunch.     Renal:  NS 75cc/hr currently.     Endo:  Regular SSI QACHS.  Monitor BG.     Heme:  Lovenox proph.     ID:  COVID positive but no symptoms.  Isolation in place but no current treatment.     Dispo:  Likely home later today.           Note Details  Author (M.D.) File Time 8/17/2023  7:35 AM Author Type Physician Status Signed Last Editor  (M.D.) Specialty Hospital Medicine Hospital Acct # Admit Date 8/16/2023  ED to Hosp-Admission (Discharged) on 8/16/2023  ED to Hosp-Admission (Discharged) on 8/16/2023   Detailed Report  Note viewed by patient Care Timeline  08/16   Admitted from ED (Observation) 1835 08/17   Discharged 2118
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose shingles vaccine was given 26 days after first shingles dose was given
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given 2nd dose shingles shot 26 days after first shot was given
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Syncope
Clinical narrative: Headaches and fainting x2
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angina unstable, Arteriosclerosis, Arteriosclerosis coronary artery
Clinical narrative: I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 3/16/2023 ASHD NATIVE COR ART W/UNSTABLE ANGINA PECTORIS I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 3/16/2023 NON-ST ELEVATION MYOCARDIAL INFARCTION
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR
Symptoms: Extra dose administered
Clinical narrative: Extra doses of the vaccines were given CDC was called and stated no serious risk of health issues or effects
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Alopecia
Clinical narrative: Major hair loss. Lost palmfuls of hair at a time.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: PATIENT NOTED TO HAVE SYNCOPAL EPISODE AFTER WALKING OUT OF EXAM ROOM AFTER  VACCINES, PALE IN COLOR, UNRESPONSIVE FOR APPROXIMATELY 5-10 SECONDS,NURSE THEN ELEVATED LEGS  , THEN REACTED TO HIS NAME AND TALKING COHERNTLY.B/P 99/63 HR 96 RETOOK  BP APPROX 5 MINS LATER WIT HBP 101/64 HR 102. PATIENT ABLE TO ANSWER QUESTION  CORRECTLY, ABLE TO DRINK WATER ,DENIES PAIN,  STATES FEELING BETTER, AFTER  APPROXIMATELY 20 MINS PATIENT ABLE TO WALK OUT OF CLINIC WITHOUT ANY DIFFICULTY.  MOTHER AT SIDE, INSTRUCTED MOM IF PT HAS ANYMORE PROBLEMS CHILD SHOULD BE SEEN  IN ER. DR CALLED AND MADE AWARE OF SITUATION WITH NO FURTHER ORDERS.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 62.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: At around the 24 hr of receipt pt describes bilateral abdominal/trunkal "splotchy, red, itchy, elongated hives" that lasted 7 days. Symptoms would ebb and flow and improve with Benadryl. No other s/sx reported. No meds, no reported allergies or health conditions, no new products or environmental exposures reported.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse symptoms reported.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pharmacist calling to report adverse event for administration of extra dose of VARIVAX.  Pharmacist stated that in a conversation with a nurse, they mentioned a patient of 12 years of age in their care received a third dose of VARIVAX.  Pharmacist st; No additional AE/PQC reported.; This spontaneous report was received from a pharmacist from the conversation with the nurse, and refers to a 12-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with the 1st dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0.5 milliliter (lot #, expiration date and anatomical location not provided) for prophylaxis.  On an unknown date, the patient was vaccinated with the 2nd dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0.5 milliliter (lot #, expiration date and anatomical location not provided) for prophylaxis.  On an unknown date, the patient was vaccinated with the 3rd dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0.5 milliliter (lot #, expiration date and anatomical location not provided) for prophylaxis (extra dose administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP reports that the patient has not experienced any symptoms.; HCP called to report that an expired dose of PROQUAD was given to a patient today 8/9/2023. Expiration date of PROQUAD 4/6/2023. HCP reports no previous TEs reported on product.  HCP reports that the patient has not experienced any symptoms. HCP gave; This spontaneous report was received from a nurse and  refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant medication included sterile diluent.  On 09-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #U031563 was valid, expiration date established as 06-APR-2023, therapy type rHA for prophylaxis (expired product administered). The reporter stated that the patient had not experienced any symptoms (no adverse event).
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Underdose
Clinical narrative: Confirmed no other AE occurred.; Caller reported an AE for PROQUAD. The caller said they have a patient who moved their arm during administration and less than the full dose was administered. Confirmed no other AE occurred. AE letter sent to prescriber. No other AE. No PQC.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-AUG-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #w038812, expiration date: 04-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 11-AUG-2023, the patient moved their arm during administration and less than the full dose was administered. Confirmed no other AE occurred. AE letter sent to prescriber. No other AE. No PQC.  Patient was sitting on moms lap in bear hug position. Mom had her arm around patients arme. Nurse cleaned patients right arm and explaied each step that she would now be administering the vaccine. During the placement child flinched her arm enough that the needle had been removed. At this point not all the vaccine had been administered. She asked her manager, if this should be readministered. She adviced her to call Merck company for advice. Nurse spoke to Merck team and was told that vaccine would need to be done again. Administered second dose to right vastus lateralis with support of another clinical staff member who held leg in place. Seond vaccine was administered with no issues. Patient was not injured. She and mom were notified of all steps.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; a dose of PROQUAD was given to a patient after a TE; This spontaneous report was received from a Nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 09-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W029554, expiry date 14-MAR-2024, 0.5 milligram once as prophylaxis (route of administration was not provided) and sterile diluent lot# W030845, expiry date 17-JUL-2025.  It was reported that the vaccine was administered after a temperature excursion of -14.3C for 15 minutes (product storage error). There was no previous temperature excursion. No Further AE details reported.
Sex: F
Vaccine: HPV9
Symptoms: Injury, Skin laceration, Syringe issue
Clinical narrative: Registered Nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syri; RN reports that the MA was injured and received a cut from one of the shattered pieces of glass on her right middle; This spontaneous report was received from Other Health Professional and refers to a female of unknown age (medical assistant).  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/once, lot #W026151, expiration date: 20-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 16-AUG-2023, Registered Nurse called to report a PQC for GARDASIL 9. HCP reports that a Medical Assistant, who is a repeat device user was given a patient a GARDASIL 9 injection and was pushing the last bit of the dose into the patient when the barrel of the syringe shattered into multiple pieces. RN reports that the MA was injured and received a cut from one of the shattered pieces of glass on her right middle finger. RN reports that the MA was able to be treated with topical antibiotics and a band aide and did not require stitches. RN reports that the patient receiving the injection was not injured, and the full dose was given. PQC filed: 02453005. No further AE details. At the time of reporting, the outcome of the event laceration of finger was not known. The action taken with GARDASIL 9 regarding laceration of finger was reported as Not Applicable.  The causal relationship between laceration of finger and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reported VAQTA was administered after improper storage; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      On 03-AUG-2023, the patient was vaccinated with one dose of improper storage vaccine hepatitis a vaccine, inactivated (VAQTA) vial (lot # X003791, expiration date: 01-JUN-2024) (strength and route were not reported) for prophylaxis (product storage error). It was unknown of hepatitis a vaccine, inactivated (VAQTA) was prefilled syringe or vial, however it was known that it was a pediatric dose administered. The operator of the device was a healthcare professional.   The vaccine underwent temperature excursion of 51 degrees Fahrenheit for 1 hour. There were no previous temperature excursions. No adverse effects were reported.; Sender's Comments:  US-009507513-2308USA006792: US-009507513-2308USA006780: US-009507513-2308USA006923: US-009507513-2308USA006991: US-009507513-2308USA006972:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: \No other AE and no PQC.; HBP calling to report the office administered an expired dose of GARDASIL 9 to a patient.  No symptoms reported.  No other AE and no PQC.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 18-AUG-2023, the patient was vaccinated an expired vaccine of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (valid lot number U008900 [expiration date 12-AUG-2023]) (dose, dose number, frequency, route of administration, anatomical location, and vaccination scheme were not provided) for prophylaxis (expired product administered). No symptoms reported.  No other adverse event (AE).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE  TE Case02454494; Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE  TE Case02454494; This spontaneous report has been received from a medical tech and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 17-AUG-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant human albumin (rha) (PROQUAD) injection, one time (valid lot number W038815 [expiration date 04-JUN-2024]) (dose, dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion (product storage error).   No further adverse events (AEs) details.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA007402:
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: developed a fever and rash; developed a fever and rash; This spontaneous report has been received from a medical tech and refers to a 7-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 23-MAR-2017, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (dose, dose number, frequency, route of administration vaccination scheme, anatomical location, lot number and expiration date were not provided), administered for routine vaccination and on 03-AUG-2023, he received the second dose.  On 13-AUG-2023, the patient developed a post-vaccination rash with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). The patient received their first dose  with no issues, but with the second dose, he developed a fever and rash "an even rash around the hands, elbows, knees, and torso". The healthcare provider (HCP) was interested in varicella-zoster virus (VZV) analysis by polymerase chain reaction (PCR) and wanted to send viral isolates. The patient sought medical attention, it was unknown by the reporter if he received any treatment or if any laboratory diagnostics or studies were performed. The outcome of the events pyrexia and rash was not recovered.  The causality assessment between the events pyrexia and rash with the suspect vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was not reported.
Age: 0.83
Sex: U
Vaccine: PNC15
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE; a 10 month old patient was administered their 4th dose of VAXNEUVANCE too early; This spontaneous report was received from a nurse referring to a 10-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 16-AUG-2023, the patient was vaccinated with the fourth dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (lot #: W036242, expiration date: 01-OCT-2024; strength, dose, and route of administration were not reported) for prophylaxis, which was too early (inappropriate schedule of product administered). No symptoms reported.  No other adverse events (AE) (no adverse event).
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: vaccinated a patient with PNEUMOVAX 23 on 18-AUG-2023/she realized that the vaccine had expired on 11-JAN-2023; This spontaneous report was received from a pharmacist and refers to an 87-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, lot # reported and confirmed as: U018632, expiration date reported and confirmed as: 11-JAN-2023 (exact dose, site and route of administration were not provided) for prophylaxis, by a pharmacist. After the vaccination, the pharmacist realized that the administered vaccine was expired (Expired product administered ). At the reporting time, the patient was doing fine.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No Additional AE/PQC.; HCP called to state that the patient missed his second dose of MMR II ( first dose 07/07/2023).  HCP states that the facility was out of DILUENT and could not reconstitute the vaccine. No Additional AE/PQC.; This spontaneous report was received from Consumer and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 21-AUG-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5ml/ series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 21-AUG-2023, HCP called to state that the patient missed his second dose of MMR II (first dose 07/07/2023).  HCP states that the facility was out of DILUENT and could not reconstitute the vaccine. No Additional AE/PQC.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: Receipt date: 16-AUG-2023 The patient was over 60. The reporter asked if the vaccine itself could cause a case of Shingles. Reporter stated that she had three patients still get shingles even after the vaccine and discussed that might be a possibility at some point, but she indicated that she believed it might had been a result of the vaccine itself. The reporter discussed that the adverse events that include flu-like symptoms including myalgia, fatigue, headache, shivering and fever and when asked if these might had been the symptoms that the patient experienced, she stated no, and stated what they experienced, was indeed a case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up. This case was linked with US2023AMR112313, US2023AMR112288, by same reporter.; Sender's Comments:  US-GSK-US2023AMR112313: US-GSK-US2023AMR112288: