chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site swelling, Peripheral swelling, Pruritus, Skin irritation
Clinical narrative: about 2 inch down from injection site, it started with small round spot that was hard. As the days progressed the spot got larger and became irriated and itchy. It spread to the middle part of my forearm. It itchy, red and swollen. Emergency room: keefle 500 mg capsle and atarvx 25mg.
Age: 0.08
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administration error
Clinical narrative: No adverse events reported; this was an administration error only
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Patient experienced body aches, fever, headache, nausea, arm pain and redness
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient experienced body aches, fever, headache, nausea, arm pain and redness
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Pt developed a large area of redness around injection site.
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Dizziness, Erythema, Injected limb mobility decreased, Injection site erythema
Clinical narrative: She got her vaccine, all was well immediately.  she got dressed, went home, walked the dog and she started to feel some pain in the arm and felt it was from the shot and felt it would go away.  Then she was making supper and she could hardyl raise her arm.  She went in to take her shower and noticed that her arm was blown up and red from her shoulder to her elbow, beet red in color.  When she went to bed it went into her neck, like the bone in her neck and going down to her breast area.  Today, it has now gone out of her breast area but still in her neck.  She went to her doctor and they told her that they she had cellulitis and was prescribed Doxycycline isonate 100 mg.  She is now afraid to take a shower that she may pass out due to the pain.   She had pain in her arm of a 10 out of 1/10.  She has a FU appointment on Monday.  She feels that if she had not gotten this shot she would have been alright.  She goes to facility and they use weights and exercise and has never had any problems with her arms or shoulders.  She also does yoga twice a week, line dancing once a week and facility twice a week.   She was there to have her yearly well visit and everything else was OK, and the NP gave her the shot, and it did not hurt as much as she thought as she does not like shots.   She wants to be an advocate for people getting this vaccine and having the reaction like she did.
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling, Pain in extremity, Swelling
Clinical narrative: She got her vaccine, all was well immediately.  she got dressed, went home, walked the dog and she started to feel some pain in the arm and felt it was from the shot and felt it would go away.  Then she was making supper and she could hardyl raise her arm.  She went in to take her shower and noticed that her arm was blown up and red from her shoulder to her elbow, beet red in color.  When she went to bed it went into her neck, like the bone in her neck and going down to her breast area.  Today, it has now gone out of her breast area but still in her neck.  She went to her doctor and they told her that they she had cellulitis and was prescribed Doxycycline isonate 100 mg.  She is now afraid to take a shower that she may pass out due to the pain.   She had pain in her arm of a 10 out of 1/10.  She has a FU appointment on Monday.  She feels that if she had not gotten this shot she would have been alright.  She goes to facility and they use weights and exercise and has never had any problems with her arms or shoulders.  She also does yoga twice a week, line dancing once a week and facility twice a week.   She was there to have her yearly well visit and everything else was OK, and the NP gave her the shot, and it did not hurt as much as she thought as she does not like shots.   She wants to be an advocate for people getting this vaccine and having the reaction like she did.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Respiratory tract congestion
Clinical narrative: patient stated 3 days after receiving vaccine had congestion that has been fairly consistent, especially at night. Has not had in past and no signs of infection per provider
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt received expired vaccine, no poor outcomes are known at this time
Age: 9.0
Sex: M
Vaccine: COVID19-2, HPV9
Symptoms: Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Full blood count normal, Glycosylated haemoglobin normal, Incorrect product formulation administered
Clinical narrative: Wrong formulation of the COVID-19 vaccine was administered: it was given Pfizer Bivalent 12+ instead of Pfizer 5-11y (orange cap). Error was not noticed at the time. Patient remained in exam room for adverse effects for 15-20 minutes. No adverse events noted. Pt and mother where walked to the lab for routine blood work ordered by PCP.
Age: 9.0
Sex: M
Vaccine: COVID19-2, HPV9
Symptoms: Laboratory test normal, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong formulation of the COVID-19 vaccine was administered: it was given Pfizer Bivalent 12+ instead of Pfizer 5-11y (orange cap). Error was not noticed at the time. Patient remained in exam room for adverse effects for 15-20 minutes. No adverse events noted. Pt and mother where walked to the lab for routine blood work ordered by PCP.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: none
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Rash started the next day and continued to get worse. Went to Urgent Care for treatment. Rash/hives to entire body
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Herpes zoster
Clinical narrative: Shingles
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Neuropathy peripheral, Seizure, Vision blurred
Clinical narrative: non-epileptic seizures; muscle twitching; neuropathy of feet; blurred vision-all occurred within 3-4 months post vaccination. Non-epileptic seizures worsened over several month with peak of increased frequency in July 2022.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Left shoulder pain, numbness and decreased mobility
Age: 20.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Circumstance or information capable of leading to medication error, Wrong patient
Clinical narrative: The wrong vaccine sheet was printed on a different patient with the same name but different DOB. The vaccine sheet was not double checked before giving vaccines.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Syncope
Clinical narrative: pt experienced syncope and shortness of breath
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Full blood count normal, Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong formulation of the COVID-19 vaccine was administered: Pfizer BioNTech (tozinameran 5y-11y) was given, instead of Pfizer BioNTech (tozinameran 6m-11y). Patient as stable at the time, after 15-20 min wait in exam room before being discharged.  Staff in clinic did not notice the error until it was brought up in May 2024. Mother was contacted on the phone, she denied recalling any adverse events after vaccination during that time.  Patient has had several visits with the PCP after the event, with no remarkable outcome from the vaccine administration.
Age: 79.0
Sex: M
Vaccine: PNC20
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: fever,  body aches, cough
Age: 0.17
Sex: F
Vaccine: HEP, PNC13
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into immprint for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. Parent was contacted and notified of recommendation to repeat vaccines that underwent temp excursion. Child revaccinated with Engerix B and Vaxneuvance on 05/16/2024.
Age: 63.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: The patient daughter called and reported that her mother could not get out bed and had a mild fever with a very sore arm.
Age: 76.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: The patient called our pharmacy on the advice of her prescriber to report an adverse event from a vaccination clinic that had been done at her living facility and was attached to our store. It is unknown if the vaccinations caused the event or not. The patient stated she began feeling unwell awhile after receiving two vaccines, Arexvy and Shingrix. She still did not feel well the next morning and was taken to the hospital where she was admitted. Her prescriber assumed a case of shingles and treated her for such, although he did recommend she call us to report the event.
Age: 0.25
Sex: F
Vaccine: RV5, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the correct vaccine that she was due for today (5/16) - pneumococcal conjugate (Prevnar 20) and an additional two that she was not yet due for. (Vaxelis, which is a combination of DTAP-IPV-HIB-HEPB and Rotavirus.) She was due for the additional two vaccines in 1 month. Immediate action taken: patient's father was made aware who accompanied her to today's visit (5/16). It was not harmful for patient to receive these 2 vaccine doses, but we will carefully monitor her vaccine needs during future visits.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Person given an expired Tetanus
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose normal, Dizziness, Head injury, Nausea, Syncope
Clinical narrative: Patient walked out into the lobby of our facility and fainted about 20 minutes later. She hit her head  and woke up about 5 minutes later. the medical staff checked her pulse and blood pressure immediately. Medically staff were concerned about concussion as nausea and dizziness were present. about 15 minutes after she was up and moved to an exam room. She was then transported by ems to the nearest hospital for further testing (advent health emergency room) .
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Balance disorder, Dizziness, Dyskinesia, Fall, Hyperhidrosis
Clinical narrative: Shortly after 4th vaccine pt was unsteady while sitting on exam table, fell to his side and had 2 short jerking movements, then tried to get up on his own and walk, was unstable, I caught him, he then had another short jerking motion while in my arms, then tried to get up again and walk, I was able to guide him to chair. He was slow to reply but answering questions, he said he was dizzy. He was diaphoretic.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ, VARCEL
Symptoms: Hyporesponsive to stimuli
Clinical narrative: Shortly after 4th vaccine pt was unsteady while sitting on exam table, fell to his side and had 2 short jerking movements, then tried to get up on his own and walk, was unstable, I caught him, he then had another short jerking motion while in my arms, then tried to get up again and walk, I was able to guide him to chair. He was slow to reply but answering questions, he said he was dizzy. He was diaphoretic.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood thyroid stimulating hormone, Full blood count, Metabolic function test, Mononucleosis heterophile test negative, Nausea
Clinical narrative: Onset of symptoms day of vaccination. Fever, nausea, body aches, and congestion. On-going since patient vaccinated. Symptoms last 4-5 days and then go away for about 1 week and come back the same as before. Lab work being completed and other causes ruled out via testing in clinic.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pyrexia, Respiratory tract congestion, Serum ferritin, Streptococcus test negative
Clinical narrative: Onset of symptoms day of vaccination. Fever, nausea, body aches, and congestion. On-going since patient vaccinated. Symptoms last 4-5 days and then go away for about 1 week and come back the same as before. Lab work being completed and other causes ruled out via testing in clinic.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Thyroxine free
Clinical narrative: Onset of symptoms day of vaccination. Fever, nausea, body aches, and congestion. On-going since patient vaccinated. Symptoms last 4-5 days and then go away for about 1 week and come back the same as before. Lab work being completed and other causes ruled out via testing in clinic.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse event after administration of this vaccine
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient came to office 5/15/24, arm was red at injection site, no swelling or spreading of redness. Instructed patient to monitor and update us with any changes. Patient came back to office 5/16/24 to report redness had spread, still localized to injection site but area of redness is now a circle about 4cm in diameter. Patient reports site is very tender to touch, appears slightly swollen. Notified provider, who examined site.  Patient has outlined the redness and will monitor for any spreading of redness or changes in symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness at site of injection, warm and tender to touch, has gotten better
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV
Symptoms: Unevaluable event
Clinical narrative: none known
Age: 18.0
Sex: M
Vaccine: IPV, MMRV, MNQ, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse RN inadvertently administered MMRV & Varicella vaccine during patient's visit today 5/16/2024
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Haematemesis, Haemorrhage, Hypoaesthesia, Nasopharyngitis
Clinical narrative: Reports having swelling under armpit and numbness, bleeding symptoms i.e. bruising and throwing up blood, upper respiratory  "cold symptoms" on 5/16/24 9:55am
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oedema peripheral, Respiratory symptom
Clinical narrative: Reports having swelling under armpit and numbness, bleeding symptoms i.e. bruising and throwing up blood, upper respiratory  "cold symptoms" on 5/16/24 9:55am
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient was given an RSV immunization on 5/13/24, but had gotten one in 2023
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test normal, Brain fog, Computerised tomogram normal, Dizziness, Electrocardiogram normal
Clinical narrative: Numbness on left side of body - face, arm, hand, leg and foot. Dizziness, Light headed / Foginess started on Monday 4-15-2024 in afternoon. Had a rough night.    Tuesday, 4-16-2024 early am was felling worse and ambulance was called a around 6:00am or so. Ambulance checked me out and vitals were a little high, EKG was normal, oxygen was good, no fever and Blood test was okay.  Went to Primary Care Doctor on Tuesday, 4-16 at 10:00am and she ordered a CT scan for same day.  CT scan came back good. Called Primary Doctor on Wednesday morning, 4-17-2024 letting her know systems had not improved. Primary Doctor scheduled me an appointment with a Neurologist for Wednesday, 4-17 at 1:00pm. Neurologist checked me and scheduled me for a MRI for Thursday, 04-18-2024. MRI cam back good. Called Primary Care Doctor back on Friday, 4-19-2024 as I still had symptons. Was still feeling numb in the face, arm and leg. On Friday morning the right lower leg was feeling numb. The numbness was moving around to the right side.  Was scheduled with a Cardiologist for Friday, 4-19-2024 at 1:00pm. Symptoms were starting to improve but still had some numbiness and was still feeling foggy in my head. I could not drive. Family members have been bring me to my doctor appts.  I just started to drive to work two days a week starting on 05-08-2024.  As of today, 05-15-2024 my systems are better but at times they do come back mostly in the morning.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia, Impaired work ability, Magnetic resonance imaging normal, Symptom recurrence
Clinical narrative: Numbness on left side of body - face, arm, hand, leg and foot. Dizziness, Light headed / Foginess started on Monday 4-15-2024 in afternoon. Had a rough night.    Tuesday, 4-16-2024 early am was felling worse and ambulance was called a around 6:00am or so. Ambulance checked me out and vitals were a little high, EKG was normal, oxygen was good, no fever and Blood test was okay.  Went to Primary Care Doctor on Tuesday, 4-16 at 10:00am and she ordered a CT scan for same day.  CT scan came back good. Called Primary Doctor on Wednesday morning, 4-17-2024 letting her know systems had not improved. Primary Doctor scheduled me an appointment with a Neurologist for Wednesday, 4-17 at 1:00pm. Neurologist checked me and scheduled me for a MRI for Thursday, 04-18-2024. MRI cam back good. Called Primary Care Doctor back on Friday, 4-19-2024 as I still had symptons. Was still feeling numb in the face, arm and leg. On Friday morning the right lower leg was feeling numb. The numbness was moving around to the right side.  Was scheduled with a Cardiologist for Friday, 4-19-2024 at 1:00pm. Symptoms were starting to improve but still had some numbiness and was still feeling foggy in my head. I could not drive. Family members have been bring me to my doctor appts.  I just started to drive to work two days a week starting on 05-08-2024.  As of today, 05-15-2024 my systems are better but at times they do come back mostly in the morning.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Brain fog, Hypoaesthesia
Clinical narrative: Numbness on left side of body - face, arm, hand, leg and foot. Dizziness, Light headed / Foginess started on Monday 4-15-2024 in afternoon. Had a rough night.    Tuesday, 4-16-2024 early am was felling worse and ambulance was called a around 6:00am or so. Ambulance checked me out and vitals were a little high, EKG was normal, oxygen was good, no fever and Blood test was okay.  Went to Primary Care Doctor on Tuesday, 4-16 at 10:00am and she ordered a CT scan for same day.  CT scan came back good. Called Primary Doctor on Wednesday morning, 4-17-2024 letting her know systems had not improved. Primary Doctor scheduled me an appointment with a Neurologist for Wednesday, 4-17 at 1:00pm. Neurologist checked me and scheduled me for a MRI for Thursday, 04-18-2024. MRI cam back good. Called Primary Care Doctor back on Friday, 4-19-2024 as I still had symptons. Was still feeling numb in the face, arm and leg. On Friday morning the right lower leg was feeling numb. The numbness was moving around to the right side.  Was scheduled with a Cardiologist for Friday, 4-19-2024 at 1:00pm. Symptoms were starting to improve but still had some numbiness and was still feeling foggy in my head. I could not drive. Family members have been bring me to my doctor appts.  I just started to drive to work two days a week starting on 05-08-2024.  As of today, 05-15-2024 my systems are better but at times they do come back mostly in the morning.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: complete series (2 doses) given as extra doses.  Patient series completed in 1991 and 2 additional doses were given on 3/18/24 and 5/1/24.  No adverse reactions noted
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Dysstasia, Fall, Haemorrhage, Loss of consciousness, Nasal injury
Clinical narrative: On 5.10.24 @ 3:00PM, the patient enetered the pharmacy her partner requesting vaccinations as prescribed by Dr. Pt was sitting at the time of vaccination, and waited for his partner vaccination to be completed. After couple of minutes, the patient attempted to stand up, she collapsed, lost her conssiouness. She felts on the pharmacy floor face down, damaging her nose. The pharmacy manager (me) was all the time next to her, we called 911, and the patient refused medical attention. 911 called back the pharmacy, and again the patient refused any ambulance. The client was offered Free Chocolate Candy (to balance her sugar lever), free water, napkins and all the materials necessary to clean the blood due to her fall. After 30 minutes or so, the patient gained completed consciousness and left the pharmacy walking towards their car with her partner. The client was contacted by phone the next day as a followup, and the client partner stated that she is ?doing fine?, and the patient is still talking to her doctor regarding if the patient experiencing any injuries after the face down fall to the ground.
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Refusal of treatment by patient, Syncope
Clinical narrative: On 5.10.24 @ 3:00PM, the patient enetered the pharmacy her partner requesting vaccinations as prescribed by Dr. Pt was sitting at the time of vaccination, and waited for his partner vaccination to be completed. After couple of minutes, the patient attempted to stand up, she collapsed, lost her conssiouness. She felts on the pharmacy floor face down, damaging her nose. The pharmacy manager (me) was all the time next to her, we called 911, and the patient refused medical attention. 911 called back the pharmacy, and again the patient refused any ambulance. The client was offered Free Chocolate Candy (to balance her sugar lever), free water, napkins and all the materials necessary to clean the blood due to her fall. After 30 minutes or so, the patient gained completed consciousness and left the pharmacy walking towards their car with her partner. The client was contacted by phone the next day as a followup, and the client partner stated that she is ?doing fine?, and the patient is still talking to her doctor regarding if the patient experiencing any injuries after the face down fall to the ground.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metastases to peritoneum, Myocardial infarction
Clinical narrative: 3 Covid shots  end stage abdominal carcinomatosis and heart attack
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Educational problem, Fatigue, Hemiparesis, Hyperhidrosis, Hypersomnia
Clinical narrative: Left arm pain , 3 days after vaccine (5/13) started developing mild nasal congestion, that evening tenderness in arm, 5/14 developed diffuse sweating, fatigue and increasing pain in arm with limited mobility, missed school and slept 17 hours. Pain had not improve with Tylenol and heat. Feels weak on Left side, cannot raise arms more that 45 degrees laterally , no numbness, tingling or pain down arm or hands or finger. Pain is muscular not bony, No fever, no redness or swelling of arm.  Has previous sports injury to that shoulder. Prescribed Ibuprofen and ice initially, then  oral steroid taper.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Myalgia, Nasal congestion, Pain in extremity, Tenderness
Clinical narrative: Left arm pain , 3 days after vaccine (5/13) started developing mild nasal congestion, that evening tenderness in arm, 5/14 developed diffuse sweating, fatigue and increasing pain in arm with limited mobility, missed school and slept 17 hours. Pain had not improve with Tylenol and heat. Feels weak on Left side, cannot raise arms more that 45 degrees laterally , no numbness, tingling or pain down arm or hands or finger. Pain is muscular not bony, No fever, no redness or swelling of arm.  Has previous sports injury to that shoulder. Prescribed Ibuprofen and ice initially, then  oral steroid taper.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Ultrasound Doppler normal
Clinical narrative: Left arm pain , 3 days after vaccine (5/13) started developing mild nasal congestion, that evening tenderness in arm, 5/14 developed diffuse sweating, fatigue and increasing pain in arm with limited mobility, missed school and slept 17 hours. Pain had not improve with Tylenol and heat. Feels weak on Left side, cannot raise arms more that 45 degrees laterally , no numbness, tingling or pain down arm or hands or finger. Pain is muscular not bony, No fever, no redness or swelling of arm.  Has previous sports injury to that shoulder. Prescribed Ibuprofen and ice initially, then  oral steroid taper.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Localized reaction at the injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Sore arm. Nauseous and a headache next day. Extreme fatigue. Sleepiness, sore throat. Slightly dizzy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Sore arm. Nauseous and a headache next day. Extreme fatigue. Sleepiness, sore throat. Slightly dizzy.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Pt. complains of left arm pain after receiving Fluzone 65+ vaccine on 11/17. Pt. states that the pain radiates to her fingers. No lump is present. All higher acuity Sx. are negative.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Unevaluable event
Clinical narrative: Pt did not get any further treatment, pt is doing well
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Patient received PedvaxHib instead of Meningicoccal. Patient's mother has been notified of the information and explained how it happened. Discussed that the MA involved would go through more training and would have a second set of eyes view all vaccines that are provided for accuracy.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient was given expired vaccination. Calls were made to patient's parent to notify of the concern. Mother was advised that staff that staff that performed the vaccine will be receiving training and supervision before adminstering vaccines.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event occurred; the vaccine expiration date was 4/30/24 at midnight, but the vaccine was not pulled from the refrigerator that day because we were out of clinic for the afternoon at an all staff meeting. The nurse went to give the vaccine and noted that it was expired, and didn't give it, but the health tech replaced the expired vaccine with more expired vaccine, because she thought the date on that day was April 30th,; it didn't occur to her that the date was actually May 1st. We called Moderna, and received information from Moderna Quality Assurance that the vaccine was still viable because it was frozen until use. We have those documents on record. The client was notified and had no adverse reaction.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Duplicate Prevnar20 administered outside of recommended vaccination schedule (received 12/03/2023)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood cholesterol increased, Blood test, COVID-19, Chills
Clinical narrative: Flu like symptoms following the vaccine, within 12 hours including nausea, headache, muscle aches, sweating, chills and swollen and sore arm.  Then, symptoms of chronic fatigue, insomnia, poor quality sleep, nasal stuffiness and drainage, migraines, dizziness, ear ringing, anxiety, panic attacks, and stomach problems stayed for 3+ years (so far).  Subsequent Covid infections made me very sick and I then had sudden onset of very loud ear ringing, migraines, clogged ears, and deafness in March of 2024.  My cholesterol began reading high (wasn't before) and my vitamin D levels plummeted after the vaccine.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Dizziness, Ear discomfort, Echocardiogram, Electrocardiogram
Clinical narrative: Flu like symptoms following the vaccine, within 12 hours including nausea, headache, muscle aches, sweating, chills and swollen and sore arm.  Then, symptoms of chronic fatigue, insomnia, poor quality sleep, nasal stuffiness and drainage, migraines, dizziness, ear ringing, anxiety, panic attacks, and stomach problems stayed for 3+ years (so far).  Subsequent Covid infections made me very sick and I then had sudden onset of very loud ear ringing, migraines, clogged ears, and deafness in March of 2024.  My cholesterol began reading high (wasn't before) and my vitamin D levels plummeted after the vaccine.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endoscopy, Fatigue, Gastrointestinal disorder, Headache, Hyperhidrosis
Clinical narrative: Flu like symptoms following the vaccine, within 12 hours including nausea, headache, muscle aches, sweating, chills and swollen and sore arm.  Then, symptoms of chronic fatigue, insomnia, poor quality sleep, nasal stuffiness and drainage, migraines, dizziness, ear ringing, anxiety, panic attacks, and stomach problems stayed for 3+ years (so far).  Subsequent Covid infections made me very sick and I then had sudden onset of very loud ear ringing, migraines, clogged ears, and deafness in March of 2024.  My cholesterol began reading high (wasn't before) and my vitamin D levels plummeted after the vaccine.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Insomnia, Laboratory test, Malaise, Migraine
Clinical narrative: Flu like symptoms following the vaccine, within 12 hours including nausea, headache, muscle aches, sweating, chills and swollen and sore arm.  Then, symptoms of chronic fatigue, insomnia, poor quality sleep, nasal stuffiness and drainage, migraines, dizziness, ear ringing, anxiety, panic attacks, and stomach problems stayed for 3+ years (so far).  Subsequent Covid infections made me very sick and I then had sudden onset of very loud ear ringing, migraines, clogged ears, and deafness in March of 2024.  My cholesterol began reading high (wasn't before) and my vitamin D levels plummeted after the vaccine.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Nausea, Pain in extremity, Panic attack
Clinical narrative: Flu like symptoms following the vaccine, within 12 hours including nausea, headache, muscle aches, sweating, chills and swollen and sore arm.  Then, symptoms of chronic fatigue, insomnia, poor quality sleep, nasal stuffiness and drainage, migraines, dizziness, ear ringing, anxiety, panic attacks, and stomach problems stayed for 3+ years (so far).  Subsequent Covid infections made me very sick and I then had sudden onset of very loud ear ringing, migraines, clogged ears, and deafness in March of 2024.  My cholesterol began reading high (wasn't before) and my vitamin D levels plummeted after the vaccine.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Poor quality sleep, Rhinorrhoea, Tinnitus, Vitamin D decreased
Clinical narrative: Flu like symptoms following the vaccine, within 12 hours including nausea, headache, muscle aches, sweating, chills and swollen and sore arm.  Then, symptoms of chronic fatigue, insomnia, poor quality sleep, nasal stuffiness and drainage, migraines, dizziness, ear ringing, anxiety, panic attacks, and stomach problems stayed for 3+ years (so far).  Subsequent Covid infections made me very sick and I then had sudden onset of very loud ear ringing, migraines, clogged ears, and deafness in March of 2024.  My cholesterol began reading high (wasn't before) and my vitamin D levels plummeted after the vaccine.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Back pain, Fatigue, Headache
Clinical narrative: Pain in injection started day of injection, following day had intense muscle (back and neck pain, aches in thighs and calf muscles) and joint pain (shoulders, hips, knees, feet, hands), redness at injection site, swelling at injection site, swelling and pain in left armpit (left arm is injection site), sore throat, headache, fatigue. Lasted through two days after vaccination administration. Treated with ice packs at injection site, Tylenol, resting, and heating pad on muscles.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Neck pain
Clinical narrative: Pain in injection started day of injection, following day had intense muscle (back and neck pain, aches in thighs and calf muscles) and joint pain (shoulders, hips, knees, feet, hands), redness at injection site, swelling at injection site, swelling and pain in left armpit (left arm is injection site), sore throat, headache, fatigue. Lasted through two days after vaccination administration. Treated with ice packs at injection site, Tylenol, resting, and heating pad on muscles.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Oropharyngeal pain, Pain in extremity
Clinical narrative: Pain in injection started day of injection, following day had intense muscle (back and neck pain, aches in thighs and calf muscles) and joint pain (shoulders, hips, knees, feet, hands), redness at injection site, swelling at injection site, swelling and pain in left armpit (left arm is injection site), sore throat, headache, fatigue. Lasted through two days after vaccination administration. Treated with ice packs at injection site, Tylenol, resting, and heating pad on muscles.
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Product distribution issue, Product storage error
Clinical narrative: No additional AE; IMPROPERLY STORED DUE TO LATE SHIPMENT; ADMINISTERED; HBP called to report receiving a late shipment of PROQUAD and VARIVAX from their wholesaler.; repeat dose; This non-valid spontaneous report was received from HBP and refers to an unspecified number of patients with no identifiers. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) from their wholesaler. Products were received on 08-MAR-2024 with a "must be received by" date of 02-MAR-2024. HBP did not realize that the products arrived late and stated that the products were administered to multiple patients between the dates of 08-MAR-2024 to 09-APR-2024. It was reported that the suspect vaccines were improperly stored due to late shipment (product storage error, product distribution issue). Temperature ranges and excursion data were unknown by reporter so the products could not be evaluated. No additional adverse event (AE) was reported.  The case was considered as non-valid as it refers to an unspecified number of patients with no identifiers.  Follow-up has been received from the Vaccine Provider on 07-MAY-2024. The primary reporter was desribed as a Healthcare Worker. The patient was updated to a 4-year-old male. Concomitant medication included hepatitis a vaccine (+) inactivated (VAQTA). On 22-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (recombinant Human albumin), lot #X023876, expiration date: 27-MAR-2025, administered subcutaneously for prophylaxis at "RTL" (strength was not provided). The product was ordered on 28-FEB-2024. Shipment was to be received in clinic on or before 02-MAR-2024. Shipment was delayed during transport for an additional 6 days. Received in clinic on 08-MAR-2024. Unable to confirm temperature of vaccine for those additional days. The product was mistakenly put into clinic stock and administered. During inventory it was discovered that 10 doses were given. The patients were notified and scheduled for a repeat dose as per "COG" recommendations after contacting the manufacturer (extra dose administered). No adverse reactions were reported with initial dose of repeat dose. The vaccine involved was confirmed to be varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection. Staff was educated on the cold chain, storage and handling of vaccines to avoid future mishaps.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred 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 26-APR-2024, the patient received the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid lot #1968386, expiration date: 23-MAY-2024, administered orally for prophylaxis (strength was not provided) after a temperature excursion of 32.9 degree F for 3 hours 18 minutes (Product storage error). There was no previous temperature excursion. No additional adverse event was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA000970: US-009507513-2405USA001251:2405USA001152 US-009507513-2405USA001261:2405USA001152 US-009507513-2405USA001088: US-009507513-2405USA000954:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred 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 01-MAY-2024, the patient received the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid lot #1968386, expiration date: 23-MAY-2024, 1 dose (specified dose number not reported) administered orally for prophylaxis (strength was not provided) after a temperature excursion of 32.9 degree F for 3 hours 18 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA000970: US-009507513-2405USA001088: US-009507513-2405USA001261:2405USA001167 US-009507513-2405USA001251:2405USA001167 US-009507513-2405USA000954:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction; improper storage of product in use; shipping issue; Additional dose administered; This spontaneous report was received from a Healthcare Worker refers to a 4-year-old male patient. The patient's medical history, concurrent conditions were not provided. The patient's concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL).  On 21-MAR-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection lot # X023876, expiration date: 27-MAR-2025, subcutaneous in the right thigh (exact dose was not provided) for prophylaxis.    The product was ordered on 28-FEB-2024. Shipment was to be received in clinic on or before 02-MAR-2024. Shipment was delayed during transit for an additional 6 days. Received in clinic on 08-MAR-2024 (product distribution issue). Unable to confirm temperature of vaccine for those additional days (product storage error). The product was mistakenly put into clinic stock and administered. During inventory it was discovered that 10 doses were given. The patients were notified and scheduled for a repeat dose as per recommendations after contacting the manufacturer (extra dose administered). No adverse reactions were reported with initial dose of repeat dose (no adverse event). The vaccine involved was confirmed to be varicella (oka-merck) virus vaccine live (PROQUAD). Staff was educated on the cold chain, storage and handling of vaccines to avoid future mishaps.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received improperly stored VARIVAX; excursion temperature 9.5 F; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 06-MAY-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #X025845, expiration date: 31-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided). The vaccine underwent a temperature excursion of 9.5 Fahrenheit for 3 hours 5 minutes. There was no previous temperature excursion.  No adverse events were reported.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported at time of call.; GARDASIL 9 inadvertently administered to a 12-month-old patient.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, lot number 1957407, expiration date: 23-JAN-2026, that has been verified to be valid, administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age) No symptoms reported at time of call. No additional AE/PQC.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; a 12-month-old was supposed to receive a dose of MMR-II and VARIVAX. The consumer was inadvertently administered VARIVAX with PROQUAD.; a 12-month-old was supposed to receive a dose of MMR-II and VARIVAX. The consumer was inadvertently administered VARIVAX with PROQUAD.; This spontaneous report has been received from other health professional (medical assistant) referring a 12-month-old patient of an unknown gender.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  The patient was supposed to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and varicella virus vaccine live (oka/merck) (VARIVAX) injection; but on 13-MAY-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # reported as X025846, which is a valid lot # for this vaccine,  expiration date validated to be on 31-OCT-2025) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, rHA (lot # reported as X020572, which is a valid lot # for this vaccine, expiration date validated to be on 03-FEB-2025) (wrong product administered, accidental overdose); the suspect vaccines were administered as prophylaxis (strength, dose, route and anatomical location of administration were not provided regarding any of the suspect vaccines). No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic adverse events were reported / No additional AE/ No PQC.; patient received an expired dose of MMR II. The dose expired on 05/03/2024 and was administered on 05/10/2024.; This spontaneous report was received from a consumer regarding to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 10-MAY-2024, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, at a dose of 0.5 milliliter (ml)/series, lot number X005836 (lot number X005836 had been verified to be valid lot number for measles, mumps, and rubella [wistar RA 27-3] virus vaccine, live [rHA] [M-M-R II]), expiration date 03-MAY-2024 (expired product administered) (strength, route of administration and anatomical injection site were not provided) for prophylaxis. It was informed that the diluent used to reconstitute the vaccine was not expired.  No symptomatic adverse events were reported. The product was supported by the post expiry memo. No additional adverse evento (AE)/no producto quality complaint (PQC) (no adverse event).