chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Sleep disorder, Visual impairment
Clinical narrative: She got her vaccine, had no problem, then on Friday she started having back pain but not moving as much as she does.  Then she went to sleep and did not sleep due to the pain which was all the way up the left side from buttock, including the spine.  She also had on the right side chest pain and upper back pain, upper right area, and the front area on the right as well.  She is not able to move as she had severe pain.  They have to put diapers on her, which she does not normally wear.  She has a bedside commode and was able to use it yesterday and they put a Depends on her as it was difficult for her to get out of the bed to do that.  Her daughter has been giving Ibuprofen and Icy hot on her areas that hurt, which has not started to work.  She does not want to use the Depends for fear or urinating in the bed.  Her legs are hurting, her whole entire body mainly on the left but the upper right back and chest area.    She is normally a very active person without any disabilities.  She is still working full time but from home.  She is also complaining of a headache this morning, and having problems with her vision.    She has not gone to the doctor or gone to the ER as she had been there previously and they did not take good care of her.
Age: 90.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: Within 30 minutes of having the vaccine shot in my right shoulder I had a reaction in my left leg in the ligament all the way down my leg with pain . It has been difficult to walk and is still hurting on Monday September 11.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Electromyogram abnormal, Injection site reaction, Magnetic resonance imaging neck, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: Vaccine was given on 10/24/22 and first known issue in clinic was 12/5/22.  According to employee he had issues "about five days after injection he noticed when in the gym with only my tricep muscle being weak.  I can do all my work its just weak.  I called my primary but they were not worried.  He went to facility and they ordered an MRI of neck and then he came to the clinic to have information documented."
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Radial nerve injury
Clinical narrative: Vaccine was given on 10/24/22 and first known issue in clinic was 12/5/22.  According to employee he had issues "about five days after injection he noticed when in the gym with only my tricep muscle being weak.  I can do all my work its just weak.  I called my primary but they were not worried.  He went to facility and they ordered an MRI of neck and then he came to the clinic to have information documented."
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, Blood fibrinogen increased, Blood lactic acid normal, Blood pressure increased
Clinical narrative: Patient is a 65 y.o. female who presented from clinic on 8/21/2023 with COVID-19 and acute respiratory failure. She had been having worsening SOB, non-productive cough, fatigue, myalgias, malaise, and nausea for the past week. She tested positive for COVID-19 on admission to hospital and required 2L NC supplemental oxygen. She was transferred to a different for further care. On admission to hospital, she was started on IV Remdesivir and Decadron. She was able to be weaned off supplemental oxygen on the morning of 8/22, so Remdesivir and Decadron were both stopped at discharge. She was discharged home with instructions to follow-up with her PCP later this week and follow-up with her Pulmonologist in next week.   COVID-19 Acu COVID-19  Acute hypoxic respiratory failure  - Presented with: SOB, non-productive cough, h/a, fatigue, myalgias, malaise, and nausea  - Symptom onset: 7 days   - Positive COVID-19: 8/21 at clinic  - Vaccination status: Moderna x 2, last dose on 3/27/21  - CXR on admission showed no acute findings   - Oxygen status: On admission required 2L NC for O2 as low as 78% on RA. Currently low to mid 90's on RA.  - Decadron: Yes. End date 8/22.  - Remdesivir: Yes. End date 8/22.  - DVT prophylaxis: Lovenox  - Serial COVID labs ordered: No  - Case Management/Social Services consulted: No  - D-dimer only mildly elevated at 0.53. CRP and lactic acid WNL. Fibrinogen 484.     - Encouraged IS and acapella use.  - Remdesivir and Decadron stopped at discharge. Will follow-up with PCP later this week and Pulmonologist next week.     COPD   - Follows with a pulmonologist. Wears 2L NC at night and when she is short of breath.  - No signs/symptoms of acute exacerbation  - Previously on Spiriva, no longer taking.  - Home regimen consists of Symbicort, PRN albuterol inhalers, and prednisolone.  - Prednisolone held while hospitalized since she was on decadron. Continue prednisolone on discharge since decadron stopped.  - Started Dulera in in the hospital since Symbicort is not on formulary. Continue home medication at discharge.  - Continue PRN albuterol     Essential HTN   - BP slightly elevated overnight, but now normotensive  - Continue amlodipine/valsartan and hydrochlorothiazide
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, COVID-19, Chest X-ray normal, Cough, Dyspnoea
Clinical narrative: Patient is a 65 y.o. female who presented from clinic on 8/21/2023 with COVID-19 and acute respiratory failure. She had been having worsening SOB, non-productive cough, fatigue, myalgias, malaise, and nausea for the past week. She tested positive for COVID-19 on admission to hospital and required 2L NC supplemental oxygen. She was transferred to a different for further care. On admission to hospital, she was started on IV Remdesivir and Decadron. She was able to be weaned off supplemental oxygen on the morning of 8/22, so Remdesivir and Decadron were both stopped at discharge. She was discharged home with instructions to follow-up with her PCP later this week and follow-up with her Pulmonologist in next week.   COVID-19 Acu COVID-19  Acute hypoxic respiratory failure  - Presented with: SOB, non-productive cough, h/a, fatigue, myalgias, malaise, and nausea  - Symptom onset: 7 days   - Positive COVID-19: 8/21 at clinic  - Vaccination status: Moderna x 2, last dose on 3/27/21  - CXR on admission showed no acute findings   - Oxygen status: On admission required 2L NC for O2 as low as 78% on RA. Currently low to mid 90's on RA.  - Decadron: Yes. End date 8/22.  - Remdesivir: Yes. End date 8/22.  - DVT prophylaxis: Lovenox  - Serial COVID labs ordered: No  - Case Management/Social Services consulted: No  - D-dimer only mildly elevated at 0.53. CRP and lactic acid WNL. Fibrinogen 484.     - Encouraged IS and acapella use.  - Remdesivir and Decadron stopped at discharge. Will follow-up with PCP later this week and Pulmonologist next week.     COPD   - Follows with a pulmonologist. Wears 2L NC at night and when she is short of breath.  - No signs/symptoms of acute exacerbation  - Previously on Spiriva, no longer taking.  - Home regimen consists of Symbicort, PRN albuterol inhalers, and prednisolone.  - Prednisolone held while hospitalized since she was on decadron. Continue prednisolone on discharge since decadron stopped.  - Started Dulera in in the hospital since Symbicort is not on formulary. Continue home medication at discharge.  - Continue PRN albuterol     Essential HTN   - BP slightly elevated overnight, but now normotensive  - Continue amlodipine/valsartan and hydrochlorothiazide
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer increased, Headache, Malaise, Myalgia
Clinical narrative: Patient is a 65 y.o. female who presented from clinic on 8/21/2023 with COVID-19 and acute respiratory failure. She had been having worsening SOB, non-productive cough, fatigue, myalgias, malaise, and nausea for the past week. She tested positive for COVID-19 on admission to hospital and required 2L NC supplemental oxygen. She was transferred to a different for further care. On admission to hospital, she was started on IV Remdesivir and Decadron. She was able to be weaned off supplemental oxygen on the morning of 8/22, so Remdesivir and Decadron were both stopped at discharge. She was discharged home with instructions to follow-up with her PCP later this week and follow-up with her Pulmonologist in next week.   COVID-19 Acu COVID-19  Acute hypoxic respiratory failure  - Presented with: SOB, non-productive cough, h/a, fatigue, myalgias, malaise, and nausea  - Symptom onset: 7 days   - Positive COVID-19: 8/21 at clinic  - Vaccination status: Moderna x 2, last dose on 3/27/21  - CXR on admission showed no acute findings   - Oxygen status: On admission required 2L NC for O2 as low as 78% on RA. Currently low to mid 90's on RA.  - Decadron: Yes. End date 8/22.  - Remdesivir: Yes. End date 8/22.  - DVT prophylaxis: Lovenox  - Serial COVID labs ordered: No  - Case Management/Social Services consulted: No  - D-dimer only mildly elevated at 0.53. CRP and lactic acid WNL. Fibrinogen 484.     - Encouraged IS and acapella use.  - Remdesivir and Decadron stopped at discharge. Will follow-up with PCP later this week and Pulmonologist next week.     COPD   - Follows with a pulmonologist. Wears 2L NC at night and when she is short of breath.  - No signs/symptoms of acute exacerbation  - Previously on Spiriva, no longer taking.  - Home regimen consists of Symbicort, PRN albuterol inhalers, and prednisolone.  - Prednisolone held while hospitalized since she was on decadron. Continue prednisolone on discharge since decadron stopped.  - Started Dulera in in the hospital since Symbicort is not on formulary. Continue home medication at discharge.  - Continue PRN albuterol     Essential HTN   - BP slightly elevated overnight, but now normotensive  - Continue amlodipine/valsartan and hydrochlorothiazide
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test positive
Clinical narrative: Patient is a 65 y.o. female who presented from clinic on 8/21/2023 with COVID-19 and acute respiratory failure. She had been having worsening SOB, non-productive cough, fatigue, myalgias, malaise, and nausea for the past week. She tested positive for COVID-19 on admission to hospital and required 2L NC supplemental oxygen. She was transferred to a different for further care. On admission to hospital, she was started on IV Remdesivir and Decadron. She was able to be weaned off supplemental oxygen on the morning of 8/22, so Remdesivir and Decadron were both stopped at discharge. She was discharged home with instructions to follow-up with her PCP later this week and follow-up with her Pulmonologist in next week.   COVID-19 Acu COVID-19  Acute hypoxic respiratory failure  - Presented with: SOB, non-productive cough, h/a, fatigue, myalgias, malaise, and nausea  - Symptom onset: 7 days   - Positive COVID-19: 8/21 at clinic  - Vaccination status: Moderna x 2, last dose on 3/27/21  - CXR on admission showed no acute findings   - Oxygen status: On admission required 2L NC for O2 as low as 78% on RA. Currently low to mid 90's on RA.  - Decadron: Yes. End date 8/22.  - Remdesivir: Yes. End date 8/22.  - DVT prophylaxis: Lovenox  - Serial COVID labs ordered: No  - Case Management/Social Services consulted: No  - D-dimer only mildly elevated at 0.53. CRP and lactic acid WNL. Fibrinogen 484.     - Encouraged IS and acapella use.  - Remdesivir and Decadron stopped at discharge. Will follow-up with PCP later this week and Pulmonologist next week.     COPD   - Follows with a pulmonologist. Wears 2L NC at night and when she is short of breath.  - No signs/symptoms of acute exacerbation  - Previously on Spiriva, no longer taking.  - Home regimen consists of Symbicort, PRN albuterol inhalers, and prednisolone.  - Prednisolone held while hospitalized since she was on decadron. Continue prednisolone on discharge since decadron stopped.  - Started Dulera in in the hospital since Symbicort is not on formulary. Continue home medication at discharge.  - Continue PRN albuterol     Essential HTN   - BP slightly elevated overnight, but now normotensive  - Continue amlodipine/valsartan and hydrochlorothiazide
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Hypophagia, Oral disorder, Rash
Clinical narrative: Patient's mother noticed rash on the child's body starting on 9/9/23. Patient's mother reported that child had lesions in her mouth which seemed to cause a decrease in oral intake. Child was still having wet diapers. No fevers were reported.   Patient's mother took child to the ER on 9/11/23 at 2:00 AM  where the child was diagnosed with you vaccine-induced varicella.   Patient then followed up with her PCP (APRN) at 9:40 AM on 9/11/23. Patient was prescribed triamcinolone acetonide cream (0.1%), ibuprofen 100mg/5mL, and Benadryl Allergy 12.5mg/5mL.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: None found
Age: 0.5
Sex: F
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: Syringe issue
Clinical narrative: When vaccine was being administered to the 6 month old patient a part of the vaccine syringe finger phalange broke off from the syringe. Vaccine was fully administered and there were no complications or injuries that occurred to the patient. The small plastic piece that broke off from the syringe did not enter the vaccine part of the syringe, no contamination to vaccine occurred. The part that broke off did cause a small scratch on the administering nurse's right index finger that did not require any treatment other than use of a band-aid and injury healed 2 days after incident.
Age: 0.5
Sex: F
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: No adverse event, Poor quality product administered, Syringe issue
Clinical narrative: When vaccine was being administered to the 6 month old patient a part of the vaccine syringe finger phalange broke off from the syringe. Vaccine was fully administered and there were no complications or injuries that occurred to the patient. The small plastic piece that broke off from the syringe did not enter the vaccine part of the syringe, no contamination to vaccine occurred. The part that broke off did cause a small scratch on the administering nurse's right index finger that did not require any treatment other than use of a band-aid and injury healed 2 days after incident.
Age: 0.5
Sex: F
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: Injury, Scratch, Syringe issue
Clinical narrative: When vaccine was being administered to the 6 month old patient a part of the vaccine syringe finger phalange broke off from the syringe. Vaccine was fully administered and there were no complications or injuries that occurred to the patient. The small plastic piece that broke off from the syringe did not enter the vaccine part of the syringe, no contamination to vaccine occurred. The part that broke off did cause a small scratch on the administering nurse's right index finger that did not require any treatment other than use of a band-aid and injury healed 2 days after incident.
Age: 0.5
Sex: F
Vaccine: PNC15, PNC15, PNC15, PNC15
Symptoms: Injury, Injury associated with device, Poor quality device used, Scratch, Skin laceration
Clinical narrative: When vaccine was being administered to the 6 month old patient a part of the vaccine syringe finger phalange broke off from the syringe. Vaccine was fully administered and there were no complications or injuries that occurred to the patient. The small plastic piece that broke off from the syringe did not enter the vaccine part of the syringe, no contamination to vaccine occurred. The part that broke off did cause a small scratch on the administering nurse's right index finger that did not require any treatment other than use of a band-aid and injury healed 2 days after incident.
Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth, Rash pruritic
Clinical narrative: Area surrounding injection was warm to touch starting day of injection.  5 days following injection pt noticed raised, red, warm, itchy rash about the size of a golf ball around the site of injection.
Age: 13.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MNQ, TDAP
Symptoms: Blood glucose, Syncope
Clinical narrative: Patient had syncope for about 3-5 seconds. Doctor was informed about the incident. Orthostatic vitals was measured and glucose was checked. Doctor assessed the patient before the patient left the office.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC15
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever, seizure
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe pain in arm. Patient said the pain has lasted for about 6 months. Said she was in bed most of the time. Says arm is still not the same to this day
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood glucose, C-reactive protein, Electrocardiogram, Electroencephalogram, Full blood count
Clinical narrative: vomiting, 3 seizures that were otherwise unprovoked
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Metabolic function test, Seizure, Vomiting
Clinical narrative: vomiting, 3 seizures that were otherwise unprovoked
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Menopause, Musculoskeletal disorder, Pain in extremity
Clinical narrative: No soreness or issue at first dose, no symptoms at all including no soreness at injection site, no swelling or bruising. 2nd dose resulted in extreme pain in arm for approximately 7 days with pain throughout arm to fingers. Unable to use left hand with confidence for this period. Patient was not yet in menopause confirming regular periods every 28 days for 3 to 4 days in length. No heat flashes, no symptoms of pre menopause. Following second dose patient did not menstruate again. Patient has not experience any  pre or premeno symptoms and is now in menopause.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization in Swing Bed status
Age: 4.0
Sex: M
Vaccine: HEP, MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The medical assistance gave MMR vaccine instead of the Varicella. No symptoms, Patient waited in the office for 15Minutes. Patient Mother was informed.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Blood test, Heart rate irregular, Immunoglobulin therapy, Lumbar puncture, Paralysis
Clinical narrative: Events were: Paralyzation of lower of half of body and upper body, blurred vision, inconsistent heart rate. Treatments: 5 rounds of IVIG treatment. Outcomes: paralyzation of lower body and sometimes blurred vision.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Vision blurred
Clinical narrative: Events were: Paralyzation of lower of half of body and upper body, blurred vision, inconsistent heart rate. Treatments: 5 rounds of IVIG treatment. Outcomes: paralyzation of lower body and sometimes blurred vision.
Age: 72.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Eyelid pain, Eyelids pruritus, Pain
Clinical narrative: She got her vaccine around 12:30 on Saturday 9/9/23, and she reports inside corner of eyelid, when she blinks it hurts and itchy.  It does not affect her vision and used a lubricating eye drop and it helped relieve the symptoms.  She was informed that if it became more uncomfortable to go to UC and she said that she felt that it was OK.  She asked if she had heard of that reaction and the pharmacy told her that they had not.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Pain in extremity, Respiratory tract congestion
Clinical narrative: 1 hour afterwards started having right leg pain, 1 day later became left leg pain. 2 days afterwards still walking with stiff left leg, though seems to be improving. Described legs as feeling numb, though normal sensation. Developed congestion after the vaccine as well. No swelling, redness, fevers.
Age: 0.67
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose as administered.  Patient was to receive 0.25 mL/25 ug but patient received 0.2 mL/10 ug.  Patient's caregiver has been instructed to restart the series.
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Expired product administered
Clinical narrative: Expired PCV20 administered. Situation explained to client via in-person interpreter. Vaccine repeated same clinic day as recommended. Client in agreement with plan.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling almost to the elbow started on 9/11/23.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: She got her vaccine, it hurt as soon as she put the medicine ill, as she even jumped a little.  It was like tons of pressure when she put the medicine in her arm.  She was fine, and did some shopping and went home.  Last night she knew she was itching, but didn't think any of it.  When she woke up this morning she was scratching her arm like a mosquito bite.  Later on the area went down, and then it started on her hip areas, in between her legs but in the hip area.  It looks like a lot of mosquitos bit her with the redness and swelling, and the itching.  The arm one went down, but the others kind of just started.  She is not taking anything for that reaction.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Back pain, Pain in extremity
Clinical narrative: Patient called on 9/8 to report that her arm was sore, had pain, and she had pain down her back. Followed-up with patient on 9/11/23 to see if the pain had subsided, but she said she is a little better but still wanted us to report it because the initial pain was severe.
Age: 82.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Oesophageal pain, Vomiting
Clinical narrative: PATIENT STATED THAT SHE HAD A BURNING SENSATION IN HER ESOPHAGUS AND PERSISTENT VOMITING.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Respiratory disorder, Skin warm
Clinical narrative: PT HAD KNOT ON ARM THAT WAS HOT TO THE TOUCH AS WELL AS REPIRATORY ILLNESS THAT LASTED APPROXIMATELY A WEEK
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fall
Clinical narrative: Patient was given Boostrix in our shot room appeared fine afterwards.  She stayed in the store not far from the shot room  looking at tylenol products with her sister when she became dizzy, her sister was there and happened to catch her when she started to fall, she did fall into the shelves a little bit but did not hurt herself.  She was given water and sat in the waiting area.  She admitted she hadn't had much to eat or drink that morning and it was a very hot humid day (90's).  After waiting for about 20 minutes she felt well enough to leave with her father who came to pick her up.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: The day after the injection swelling, pain and a rash developed at the site of the injection.  The area affected is about 2 inches wide by 4 inches long.  I learned later that pharmacy had a RSV vaccine from Pfizer but it was not offered to me at the appointment for the shot. This was reported via email to my doctor.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Temp excursion of 1.5 degrees for 34 minutes  Vial was opened with 30 days of excursion
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Headache, Lymphadenopathy, Nausea
Clinical narrative: On the 2nd day after injection (Sept 7th) the lymph nodes located in the area of the left armpit were swollen and remained so for 5 days.  Currently, the swelling is gone.  In addition, on September 7th and continuing as of today the 11th, I have had mild but persistent headaches, nausea, and intermittent diarrhea.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Injection site pain
Clinical narrative: Pain (Soreness) at injection site, fatigue (weakness), headache, muscle pain, joint pain (flu like) for approx. 24 hours.  Unusual for me as I have already had all (6) COVID) vaccines/boosters plus a course of Paxlovid with little to no such symptoms. I.e., I was surprised by the intensity of these symptoms. Still feeling some fatigue after 36 hours although other symptoms appear to have ended. I was especially surprised by sore calf muscles which were very sensitive as well as elbow joint pain which was rare if not unknown to me. Since the symptoms abated the following day I did not feel the need to visit a doctor. I did take some extra strength Acetaminaphen which helped.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: Pain (Soreness) at injection site, fatigue (weakness), headache, muscle pain, joint pain (flu like) for approx. 24 hours.  Unusual for me as I have already had all (6) COVID) vaccines/boosters plus a course of Paxlovid with little to no such symptoms. I.e., I was surprised by the intensity of these symptoms. Still feeling some fatigue after 36 hours although other symptoms appear to have ended. I was especially surprised by sore calf muscles which were very sensitive as well as elbow joint pain which was rare if not unknown to me. Since the symptoms abated the following day I did not feel the need to visit a doctor. I did take some extra strength Acetaminaphen which helped.
Age: 23.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Wrong product administered
Clinical narrative: Patient accidentally given HEP B dose.
Age: 8.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Wrong product administered
Clinical narrative: Patient presented with documentation for school advising patient of need for 5th dose of DTAP; DTAP vaccination administered, despite child being 8 years old, should have received Tdap
Age: 65.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Asthenia, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: He got his vaccine, had not reaction then at 6:00 AM he had muscle pain, fever, nausea, diarrhea, headache, weakness.  Those symptoms are still prevalent today but are better.  He has taken Motrin and Tylenol for his symptoms.
Age: 65.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Pyrexia
Clinical narrative: He got his vaccine, had not reaction then at 6:00 AM he had muscle pain, fever, nausea, diarrhea, headache, weakness.  Those symptoms are still prevalent today but are better.  He has taken Motrin and Tylenol for his symptoms.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Face injury, Fall, Hypotonia, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Patient received Menveo #1, tolerated well and moved from exam table to chair, roughly 5 minutes later patient became limp, started to slide down in chair, immediately stiffened up, lost consciousness, and rolled over arm of chair striking forehead on floor.  Patients Mother picked patients head up off floor, patients doctor was emergently called back onto patient room to assess patient.  Patient was lifted from the floor to exam table where he laid for approx. 20 minutes.  He was given 2 ice packs, one for forehead and one for back of neck and lights were turned off .  Over the next 20 minutes patient was observed by provider and myself, given some juice and was released by provider to leave office with mom.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cellulitis, End stage renal disease, Endotracheal intubation
Clinical narrative: TESTED + FOR COVID ON    8-22-23  - ADMITTED 8-13 TO MEDICAL CENTER  FOR SEPSIS, CELLULITIS, END STAGE RENAL DISEASE AND LATER DEVELOPED COVID AND WAS INTUBATED ON 8-22. HAS METASTATIC RCC , VIRAL PNEUMONITIS FROM COVID ,
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Metastatic renal cell carcinoma, SARS-CoV-2 test positive, Sepsis
Clinical narrative: TESTED + FOR COVID ON    8-22-23  - ADMITTED 8-13 TO MEDICAL CENTER  FOR SEPSIS, CELLULITIS, END STAGE RENAL DISEASE AND LATER DEVELOPED COVID AND WAS INTUBATED ON 8-22. HAS METASTATIC RCC , VIRAL PNEUMONITIS FROM COVID ,
Age: 48.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Acupuncture, Arthralgia, Arthropathy, Laboratory test, Spinal operation
Clinical narrative: significant joint pain in hips, shoulders, knee, spine ever since I got the first injection on 1/7/21.
Age: 48.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Spinal pain, Surgery
Clinical narrative: significant joint pain in hips, shoulders, knee, spine ever since I got the first injection on 1/7/21.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Dizziness, Eye disorder, Headache
Clinical narrative: Vertigo type symptoms - spinning, off balance, dizziness, eye disturbances, headache  Went away after about 12-14 days however has now come back in May 2023 and September 2023 so far
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vertigo
Clinical narrative: Vertigo type symptoms - spinning, off balance, dizziness, eye disturbances, headache  Went away after about 12-14 days however has now come back in May 2023 and September 2023 so far
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Patient came in today (9/11/23)  stating that the day after vaccination (8/30/2023) she felt a slight burning sensation in her legs. As time progressed, patient states that it has now spread to most of her body (arms, legs, stomach). As of today (9/11/23) she is still experiencing these symptoms. Patient called her primary care physician and they did not provide any treatment.
Age: 86.0
Sex: M
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was administered before the date reccomended by CDC. Pt has completed the series with ppsv23 on 12/18/2020 (previous doses of PCV13 on 12/17/2019). the next dose was supposed to be administered on 2025.
Age: 59.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient age 59 received influenza vaccine for patients 65+.
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Balance disorder, Constipation, Decreased appetite, Dizziness, Headache
Clinical narrative: Night 1: dizziness, poor balance, broken sleep Day after Night 1: dizziness, poor balance, mild headache Night 2: very heavy night sweat Days1 through 7: constipation, poor appetite, low food intake
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Hypophagia, Night sweats, Sleep disorder
Clinical narrative: Night 1: dizziness, poor balance, broken sleep Day after Night 1: dizziness, poor balance, mild headache Night 2: very heavy night sweat Days1 through 7: constipation, poor appetite, low food intake
Age: 62.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient age 62 received influenza vaccine for patients 65+.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: Shortly after taking the vaccine as patient was standing at the checkout window with mom and started to feel dizzy. Got patient into a room adjacent to the check out window and propped her feet up. Placed cool cloths and a fan on her. Checked BP @ 2:02 pm BP- 99/56 P-85 and @2:05pm - BP -105/65 P-83. Gave patient a soda to drink and peanut butter crackers. Patient began to feel better after 10 mins. Advised mom to wait an additional 15 mins in the lobby before leaving.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt received a second bivalent booster and the pt is not 65 or older and does not appear to be immunocompromised. no adverse effects happened due to this.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Administered after deauthorization of vaccine (day of)
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: SWELLED UP TO TENNIS BALL SIZE, VERY ITCHY FOR TWO DAYS, HOT NIGHT OF DONATION.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash
Clinical narrative: Mom reports Pt was taken to the pediatrician on the same day of health dept visit for a rash after vaccination. Mom reported this to the clinic on her return for further vaccination on 9.7.23. Mom reports pediatrician advised for the child not to receive the Quadracel combination in future.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: There is a possibility that the child only received one component of the vaccine being that the box contained 2 vials and only one vial was present days after the child's immunization visit. The child was not hurt or harmed in any way. Dr. was notified of the incident.
Age: 0.5
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; HCP called to report AE for VARIVAX. Caller reported the HCP inadvertently gave the vaccine to a 6-month-old. Date of administration was 08/17/2023. Caller reported the patient is asymptomatic. No additional details provided. Patient demographic info; This spontaneous report was received from a nurse referred to a 6-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 17-AUG-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, as prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). The patient was asymptomatic. No additional adverse event (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: not reported any adverse reaction; HBP calling to report adverse event for expired administration of PROQUAD.; This spontaneous report was received from health business partner (HBP) (Office Manager) and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and historical therapies were not reported.  On 17-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml / two dose series, lot #W002785, expiration date: 24-JUL-2023, administered for prophylaxis (strength, anatomical site of administration, and route of administration were not provided) (expired vaccine used). The HBP stated the patient involved had not reported any adverse reaction (no adverse event) related to the administration of the expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine or otherwise.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AEs or PQC reported; Caller reports expired dose of PNEUMOVAX 23 was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 23-AUG-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, intramuscularly (IM), lot number U035117 with expiration date 18-AUG-2023 (anatomical location was not reported) for prophylaxis (expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No further AE.; Medical assistant calls to report PNEUMOVAX 23 lot#u035117  8/18/2023 administered after expiration date.  See AE case.  No further AE.  No PQC.  MIR request case; 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 07-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot #u035117, expiration date: 18-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 07-SEP-2023, medical assistant called to report PNEUMOVAX 23  was administered after expiration date. See AE case.  No further AE. No PQC. MIR request case.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AE; HCP calling to report AE for patient that received expired dose of PROQUAD.; This spontaneous report was received from a medical assistant, referring to 4-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 07-SEP-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection rHA (single dose, lot #W007747, expiration date 04-SEP-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse event (AE). No product product quality complaint (PQC). (Expired dose administered, No adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC; HCP calling to report a patient was given an expired vaccine on 5/2/2019.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-MAY-2019, the patient was vaccinated with first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot # L049316, expiration date 03-DEC-2017 (dose, route of administration and anatomical location were not reported) for prophylaxis (expired vaccine used). It was unknown if the vaccine had any prior temperature excursions. No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP called to report inadvertent administration of RECOMBIVAX HB to a patient on 08/30/2023 after experiencing a temperature excursion. Additional vaccines during the temperature excursion were administered to multiple patients (See AE case #02467645; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-AUG-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #X006977, expiration date: 01-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion foe 6 hours 5 minutes in -0.4 degree Celsius (Product storage error). Previous exursions occured on unknown dae for 32 minutes in 0.5 degree Celsius and 2 hours 1 minute in 1 degree Celsius. No additional adverse event was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Vaccine positive rechallenge
Clinical narrative: Bone pain; This non-serious case was reported by a physician and described the occurrence of bone pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of bone pain (received 1st dose on an unknown date and experienced bone pain , for tolerance of 1st dose, refer case US2023AMR120469).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bone pain (Verbatim: Bone pain).Rechallenge with Shingrix was positive. The outcome of the bone pain was not reported.   It was unknown if the reporter considered the bone pain to be related to Shingrix.   It was unknown if the company considered the bone pain to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR120469   Additional Information: GSK Receipt Date: 31-AUG-2023 The case was reported by patient's wife. The patient did take the second Shingrix shot after the wait period.  He again experienced bone pain but reported he did not want to get shingles, so put up with the side effect.; Sender's Comments:  US-GSK-US2023AMR120469:First Dose, same reporter
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: mentioned that both Havrix and an IPV vaccine was also administered at the same time on the same day (8/31/23) as the Pediarix dose; Pediarix dose was inadvertently administered to a 7 year old patient on 8/31/23 instead of the intended Boostrix; Pediarix dose was inadvertently administered to a 7 year old patient on 8/31/23 instead of the intended Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 7-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included POLIOMYELITIS VACCINE INACTIVATED (IPV) (batch number 25L32, expiry date 28-MAR-2025) for prophylaxis.   On 31-AUG-2023, the patient received Pediarix (right arm) and IPV (right arm). On 31-AUG-2023, an unknown time after receiving Pediarix, the patient experienced accidental overdose (Verbatim: mentioned that both Havrix and an IPV vaccine was also administered at the same time on the same day (8/31/23) as the Pediarix dose), wrong vaccine administered (Verbatim: Pediarix dose was inadvertently administered to a 7 year old patient on 8/31/23 instead of the intended Boostrix) and inappropriate age at vaccine administration (Verbatim: Pediarix dose was inadvertently administered to a 7 year old patient on 8/31/23 instead of the intended Boostrix).  The outcome of the accidental overdose, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 01-SEP-2023 Medical Assistant called to inquire about what to look for in the patient. How to proceed.  The health care professional reported that a Pediarix dose was inadvertently administered to a 7 year old patient received instead of the intended Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The Boostrix dose was not administered but health care professional mentioned that both Havrix and an IPV vaccine was also administered at the same time on the same day as the Pediarix dose which led to accidental overdose for IPV antigen.  The health care professional declined follow-up from Safety.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Influenza virus test negative, Lethargy, Nausea
Clinical narrative: Diarrhea; Nausea; Fever; Shivers/ Chills; Shakes; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of lethargy (on 9th or 3rd March the patient received 1st dose and experienced lethargy, reference case US2023AMR120465) and Tylenol (did take 4 Tylenol over the course of the lethargy). Concomitant products included TETANUS VACCINE TOXOID (TETANUS SHOT).   On 28-AUG-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. In AUG-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Fever), shivers (Verbatim: Shivers/ Chills) and tremor (Verbatim: Shakes). On 31-AUG-2023, the patient experienced diarrhea (Verbatim: Diarrhea) and nausea (Verbatim: Nausea).  The outcome of the fever, shivers, tremor, diarrhea and nausea were not resolved.   It was unknown if the reporter considered the fever, shivers, tremor, diarrhea and nausea to be related to Shingrix.     It was unknown if the company considered the fever, shivers, tremor, diarrhea and nausea to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR120465   Additional Information: GSK receipt date: 01-SEP-2023 Reporter was the wife calling on behalf of her husband. The patient received the 1st dose of Shingrix most likely in his left arm (reporter was not sure), on either March 3, 2023 or March 9, 2023 (reporter was not sure), and reports the patient was lethargic. The patient received his 2nd dose of Shingrix, and had fever of 102 degree Fahrenheit, chills, shakes, and shivers that night, and is still experiencing these adverse events today (on the day of reporting. The fever went up to 102.7F the next day, 29 August 2023.  The patient also started having diarrhea and nausea yesterday (the day before reporting), and still had those adverse events.  The Patient did go to his health care professional (HCP) office today (on the day of reporting) and had a Covid and Flu test that were negative, and blood work drawn that was not back yet. Reporter also reported the patient had a Tetanus shot (no further information provided), 3 weeks before the 2nd dose of Shingrix, at his HCP office. The wife consented to follow up with HCP, and said she had power of action  (POA) for her husband. For the tolerance of 1st dose reference case US2023AMR120465, by same reporter.; Sender's Comments:  US-GSK-US2023AMR120465:Second dose
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative, Tremor
Clinical narrative: Diarrhea; Nausea; Fever; Shivers/ Chills; Shakes; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of lethargy (on 9th or 3rd March the patient received 1st dose and experienced lethargy, reference case US2023AMR120465) and Tylenol (did take 4 Tylenol over the course of the lethargy). Concomitant products included TETANUS VACCINE TOXOID (TETANUS SHOT).   On 28-AUG-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. In AUG-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Fever), shivers (Verbatim: Shivers/ Chills) and tremor (Verbatim: Shakes). On 31-AUG-2023, the patient experienced diarrhea (Verbatim: Diarrhea) and nausea (Verbatim: Nausea).  The outcome of the fever, shivers, tremor, diarrhea and nausea were not resolved.   It was unknown if the reporter considered the fever, shivers, tremor, diarrhea and nausea to be related to Shingrix.     It was unknown if the company considered the fever, shivers, tremor, diarrhea and nausea to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR120465   Additional Information: GSK receipt date: 01-SEP-2023 Reporter was the wife calling on behalf of her husband. The patient received the 1st dose of Shingrix most likely in his left arm (reporter was not sure), on either March 3, 2023 or March 9, 2023 (reporter was not sure), and reports the patient was lethargic. The patient received his 2nd dose of Shingrix, and had fever of 102 degree Fahrenheit, chills, shakes, and shivers that night, and is still experiencing these adverse events today (on the day of reporting. The fever went up to 102.7F the next day, 29 August 2023.  The patient also started having diarrhea and nausea yesterday (the day before reporting), and still had those adverse events.  The Patient did go to his health care professional (HCP) office today (on the day of reporting) and had a Covid and Flu test that were negative, and blood work drawn that was not back yet. Reporter also reported the patient had a Tetanus shot (no further information provided), 3 weeks before the 2nd dose of Shingrix, at his HCP office. The wife consented to follow up with HCP, and said she had power of action  (POA) for her husband. For the tolerance of 1st dose reference case US2023AMR120465, by same reporter.; Sender's Comments:  US-GSK-US2023AMR120465:Second dose