chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Feeling hot, Malaise, Nasal congestion, Pyrexia
Clinical narrative: Cough, fever, malaise, nasal congestion, "hot all over"
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Cough, fever, malaise, nasal congestion, "hot all over"
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Pt received Pfizer vaccine 7/5/22 and 7/27/2022, Moderna was administered instead of Pfizer.  No noted reactions.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child has red swollen area around injection site.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pruritus
Clinical narrative: redness and severe itching for couple of days
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: Fever was 101.3 this morning. It comes and goes. I dont know what it is. I havent had a fever continuously, but it'll come and go. It'll go and go down and come back. If the fever continues, I need to go to the er. I am running a fever today. The doctor told me today that if the fever persist, I need to go to the er.
Age: 28.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Arthritis, Blood test, Chills, Diarrhoea, Headache
Clinical narrative: Fever, chills, intense headache,  diarrhea, vomit, multiple joints inflammation, stiffness and pain.
Age: 28.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, intense headache,  diarrhea, vomit, multiple joints inflammation, stiffness and pain.
Age: 53.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Patient reported redness, swelling,  and itching at site of vaccine administration at unknown date or time. Returned to Public Health (PH) on 2/2/2024 at 10:45am. RN noted redness, swelling, and blisters on upper left arm. Patient reported itching symptoms without pain. Patient reports taking OTC benadryl and using Hydrocortisol on area. Patient referred to physician, including urgent care, primary care, or doctor based on patient preference.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash
Clinical narrative: Shingles symptoms began Tuesday, January 23rd: muscle pain, then on 1/24 itchiness under the skin, then on 1/26 rash. Symptoms are continuing through treatment to today, 2/2/2024/
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient (employee) was given a Cominarty vaccine that had expired 2 days ago. The medical director was notified . No significant risk was ascertained. The patient was contacted and informed and given instructions on when another Cominarty dose was safe to receive.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Electrocardiogram normal, Influenza virus test negative, Pain, Pain in extremity
Clinical narrative: One day after I experienced body aches which was normal for me. Three days after I began experiencing severe joint pain in my right shoulder. By the end of the day both shoulders, wrists, fingers, and knees were painful. I went to the urgent care Sunday morning because the pain was persisting where they tested for covid/flu (both negative) and checked my heart with EKG. They recommended I take ibuprofen. It has now been nine days and I am still experiencing pain my my shoulders, wrists, and fingers.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: One day after I experienced body aches which was normal for me. Three days after I began experiencing severe joint pain in my right shoulder. By the end of the day both shoulders, wrists, fingers, and knees were painful. I went to the urgent care Sunday morning because the pain was persisting where they tested for covid/flu (both negative) and checked my heart with EKG. They recommended I take ibuprofen. It has now been nine days and I am still experiencing pain my my shoulders, wrists, and fingers.
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Aphasia, Cerebrovascular accident, Hemiparesis
Clinical narrative: CVA including aphasia, hemiparesis
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: urticaria and fever on 01/30/2024, seen in clinic for urticaria/fever/vomiting on 01/31/2024, diphenhydramine administered in clinic. Nurse follow-up on 02/01/2024 reported that the patient continued to have a low fever ~100 F. Parent was treating with ibuprofen, and the patient was otherwise reported to be doing well.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Fall
Clinical narrative: 15-20 minutes after receiving vaccines patient was standing by door and fell back. pt was elevated, 911 was called, care was given over to fire fighters and patient was held in c-spine transferred to a stretcher and advised to transport to Hospital via ambulance with fathers permission, mom went on the transport with patient.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: She received Menveo and HPV #2 vaccines today. She was lightheaded after the immunizations were administered. MA called me to see her at about 1:50 PM. Her pulse oximetry  was 98 but her pulse came down to 48 and had to give her oxygen by nasal cannula 10L/m that was gradually weaned off by 2:20 PM. Her pulse came back up to 78/m after I started her on supplemental oxygen. BP was 100/60 mmhg. We gave her a Pedialyte popsicle. She was improved and was back to her baseline and left walking at 2:30 PM.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine past its beyond use date (prepared the day prior) was administered to patient.
Age: 62.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no symptoms
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was inadvertently given adult dose instead of pediatric dose.  when patient's parent was contacted, no adverse effects were noted by parent.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy small intestine abnormal, Capsule endoscopy, Colonoscopy, Crohn's disease, Diarrhoea
Clinical narrative: I began having the symptoms of Irritable Bowel Disease beginning either before 11/27 or on it. I remember my holiday was affected by the diarrhea and gas. I had an endoscopy on 12/20 where the doctor found inflammation in the small bowel. Lab analysis of the tissue showed confirmed acute Crohn's Disease (CD) inflammation in the small bowel, meaning that it was less than three months old. This was a new diagnosis for me. On the 5th of January 2024 I received this information from the doctor and immediately began a ketogenic elimination diet to reduce systemic inflammation and ensure that I was not aggravating the CD flare with intolerable foods. I completed a capsule endoscopy on 1/16/24, the results received 1/31/24 were negative for bowel inflammation. My diet changes seem to have quelled the CD flare, I will return for another Colonoscopy/Endoscopy in four months to confirm remission. .
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Endoscopy abnormal, Flatulence, Gastrointestinal inflammation, Inflammation, Irritable bowel syndrome
Clinical narrative: I began having the symptoms of Irritable Bowel Disease beginning either before 11/27 or on it. I remember my holiday was affected by the diarrhea and gas. I had an endoscopy on 12/20 where the doctor found inflammation in the small bowel. Lab analysis of the tissue showed confirmed acute Crohn's Disease (CD) inflammation in the small bowel, meaning that it was less than three months old. This was a new diagnosis for me. On the 5th of January 2024 I received this information from the doctor and immediately began a ketogenic elimination diet to reduce systemic inflammation and ensure that I was not aggravating the CD flare with intolerable foods. I completed a capsule endoscopy on 1/16/24, the results received 1/31/24 were negative for bowel inflammation. My diet changes seem to have quelled the CD flare, I will return for another Colonoscopy/Endoscopy in four months to confirm remission. .
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ketogenic diet
Clinical narrative: I began having the symptoms of Irritable Bowel Disease beginning either before 11/27 or on it. I remember my holiday was affected by the diarrhea and gas. I had an endoscopy on 12/20 where the doctor found inflammation in the small bowel. Lab analysis of the tissue showed confirmed acute Crohn's Disease (CD) inflammation in the small bowel, meaning that it was less than three months old. This was a new diagnosis for me. On the 5th of January 2024 I received this information from the doctor and immediately began a ketogenic elimination diet to reduce systemic inflammation and ensure that I was not aggravating the CD flare with intolerable foods. I completed a capsule endoscopy on 1/16/24, the results received 1/31/24 were negative for bowel inflammation. My diet changes seem to have quelled the CD flare, I will return for another Colonoscopy/Endoscopy in four months to confirm remission. .
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient received DTAP (infanrix) instead of TDAP; per 2024 CDC guidelines, no further or replacement doses needed; dtap dose can be used in place of TDAP dose
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Arm sore and red, chills, body went rigid, convulsions, naseous
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Arm sore and red, chills, body went rigid, convulsions, naseous
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: Patient had received the hepatitis A vaccine two weeks too early. The minimum amount of time to get the second dose of hepatitis A vaccine is 6 months. Patient later received booster dose on 10/27/2023 of the same vaccine due to error.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blindness, Hyperhidrosis, Miosis, Pallor
Clinical narrative: Pt stated that he could not see anything at all. Skin pale and diaphoretic, pupils constricted, awake, alert and oriented. At 2:06p: BP 106/58, HR: 64. Assisted pt to lay down and elevated legs. Cheeks pinked up and vision slowly began to return. At 2:10: BP 99/60, HR: 54. 911 called at 2:05p and arrived at 2:16p. At 2:17p : BP 102/65, pulse ox: 98%. Patient now sitting up, skin pink, patient stated that his vision was normal, PERRL. Paramedics examined patient and mother took patient home.
Age: 20.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Pt is 32 weeks gestation and wanted the RSV vaccine.  We only had Arexvy in stock and the pharmacist working did not realize this is not indicated for maternal use.  Pt should have received Abrysvo only and since we didn't have that available she should have been referred to another location.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Nausea, Rash, Sleep disorder
Clinical narrative: Patient stated that he woke up because of nausea and blister rash on chest.
Age: 1.75
Sex: F
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Eye movement disorder, Pyrexia, Seizure, Shock
Clinical narrative: As reported by parent, patient  was fine all day playing acting normal, at around 9:30pm she got a fever and before we could give her medication her body went into shock she started catching a seizure and her eyes rolled back. this lasted approximately 3 minutes. Returned to baseline shortly afterwards.  She was taken to the Emergency room.
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: While patient sited in the vaccination chair, at 0945 am during Yellow Fever vaccination administration, patient became diaphoretic, sweating, eyes rolling backwards, muscle stiffness, shaky, losing consciousness as if were going to pass out. Patients legs were elevated, ice compress applied to chest area. Patient pulse monitored. symptoms resolved in less than 1 minute initially and started conversing with staff in less than 3 minutes. Vital signs taken B/P 120/70, P 60 Temp 97.2, R 16. Patient skin color return to normal, alert and oriented X 4. Patient states has not eaten since morning. Patient was given drink with crackers. Patient also mentioned this was his first time receiving Influenza and Yellow Fever vaccination. Patient also states he has history of passing out during blood draws. Patient declined to go to the ER for further evaluation. Patient stated he feels well and safe to drive prior to leaving the clinic.
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: Tremor
Clinical narrative: While patient sited in the vaccination chair, at 0945 am during Yellow Fever vaccination administration, patient became diaphoretic, sweating, eyes rolling backwards, muscle stiffness, shaky, losing consciousness as if were going to pass out. Patients legs were elevated, ice compress applied to chest area. Patient pulse monitored. symptoms resolved in less than 1 minute initially and started conversing with staff in less than 3 minutes. Vital signs taken B/P 120/70, P 60 Temp 97.2, R 16. Patient skin color return to normal, alert and oriented X 4. Patient states has not eaten since morning. Patient was given drink with crackers. Patient also mentioned this was his first time receiving Influenza and Yellow Fever vaccination. Patient also states he has history of passing out during blood draws. Patient declined to go to the ER for further evaluation. Patient stated he feels well and safe to drive prior to leaving the clinic.
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Dose administered 0.3ml of undiluted vaccine
Age: 62.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Areflexia, Back pain, Balance disorder, Blood pressure systolic increased, CSF culture negative
Clinical narrative: Tingling and numbness in Both fingers and toes and pain in Thoracic back, difficulty walking starting on 11-28-23 (18 days after Fluzone and Prevar-20 vaccines). Pt went to ER for evaluation on 12-3-23, had high Systolic BP 201, CT brain negative for acute stroke, pt given IV fluids for tachycardia. Pt seen in my office on 12-5-23 and had worsening of B hand and feet numbness and worsening with balance and walking, pt was arreflexic in B arms and lges and pt had grip weakness in B hands. Pt sent to Hospital ER in for urgent Neurology eval for suspected Guilain-Barre Syndrome, admitted from 12-6-23 to 12-10-23, Pt underwent testing and lumbar puncture shows elevated protein in csf and dx with Guaillan -Barre Syndrome and pt given IVIG x5 days. Pt had no improvement initially, Pt seen on 2-2-24 for f/u and there is some improvent, still weak in B ankles
Age: 62.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: CSF protein increased, Computerised tomogram head normal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Tingling and numbness in Both fingers and toes and pain in Thoracic back, difficulty walking starting on 11-28-23 (18 days after Fluzone and Prevar-20 vaccines). Pt went to ER for evaluation on 12-3-23, had high Systolic BP 201, CT brain negative for acute stroke, pt given IV fluids for tachycardia. Pt seen in my office on 12-5-23 and had worsening of B hand and feet numbness and worsening with balance and walking, pt was arreflexic in B arms and lges and pt had grip weakness in B hands. Pt sent to Hospital ER in for urgent Neurology eval for suspected Guilain-Barre Syndrome, admitted from 12-6-23 to 12-10-23, Pt underwent testing and lumbar puncture shows elevated protein in csf and dx with Guaillan -Barre Syndrome and pt given IVIG x5 days. Pt had no improvement initially, Pt seen on 2-2-24 for f/u and there is some improvent, still weak in B ankles
Age: 62.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Immunoglobulin therapy, Muscular weakness, Paraesthesia, Tachycardia, Viral test positive
Clinical narrative: Tingling and numbness in Both fingers and toes and pain in Thoracic back, difficulty walking starting on 11-28-23 (18 days after Fluzone and Prevar-20 vaccines). Pt went to ER for evaluation on 12-3-23, had high Systolic BP 201, CT brain negative for acute stroke, pt given IV fluids for tachycardia. Pt seen in my office on 12-5-23 and had worsening of B hand and feet numbness and worsening with balance and walking, pt was arreflexic in B arms and lges and pt had grip weakness in B hands. Pt sent to Hospital ER in for urgent Neurology eval for suspected Guilain-Barre Syndrome, admitted from 12-6-23 to 12-10-23, Pt underwent testing and lumbar puncture shows elevated protein in csf and dx with Guaillan -Barre Syndrome and pt given IVIG x5 days. Pt had no improvement initially, Pt seen on 2-2-24 for f/u and there is some improvent, still weak in B ankles
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Pain, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Swelling fron the side of neck to the elbow.  Painful and warm to touch .  Arm feels heavy
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Arthropathy, Disorientation, Gait disturbance, Memory impairment
Clinical narrative: PATIENT BEGAN HAVING MEMORY PROBLEMS THE EVENING OF VACCINATION. SHE WAS HOME WITH HER HUSBAND, BUT THOUGHT THAT SHE WAS AT A SKI RESORT AND ASKED HIM TO TAKE HER HOME. SHE HAD DIFFICULTY "CATCHING WORDS", TROUBLE WALKING ,SAID HER KNEES WERE BOUNCY. SHE DID NOT SEEK MEDICAL ATTENTION. SHE HAS CONTINUED TO FEEL BETTER, AND DROVE TO THE PHARMACY TO TELL US ABOUT HER SYMPTOMS ON 2/1/24.  I ADVISED HER TO CALL HER DOCTOR. I ALSO LEFT A MESSAGE FOR HER DOCTOR
Age: 86.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: She got her vaccines, had no problems.  Then about 10 days later in the evening after dinner she started to feel dizzy and it was like a merry go round without any flooring.  She stayed put on the sofa but eventually she had to go to the bathroom.  Then continued.  She canceled her eye APT on the 30th, as she was not steady and did not want to fall.  Yesterday evening she had dizziness, but most of the time it comes in the morning.  She hasn't had any dizziness in the morning today.  Yesterday morning she still had some.  She had contacted the doctor because she did not know if it was related to her BP, and he did not respond or call her back.  She then got worried and a friend told her to write down what she had done day by day and then realized that possibly due to the vaccine.  Then read the AE and believes it's related to this.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Patient  has a welt on the arm for a few days and states it was far back in the arm. I spoke to the pharmacist he states it was done in the muscle.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Colitis, Colon cancer, Laboratory test abnormal
Clinical narrative: Started having abdominal pain.  Thought to be colon inflammation.  Work up eventually showed colon cancer
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: pt had no adverse complaints, but was administered out of the 30 day fridge range by about 7 days
Age: 38.0
Sex: M
Vaccine: YF
Symptoms: Guillain-Barre syndrome, Neurological symptom
Clinical narrative: He said his symptoms started about 48 hours after administration and he was hospitalized for quite some time resulting in a 110K bill. He said he is still being treated and they believe he ended up with Guillain-Barré syndrome  syndrome
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Inflammation
Clinical narrative: DONOR CAME TO CENTER THE DAY AFTER RABIES IMMUNIZATION TO REPORT REDNESS AND INFLAMMATION TO RIGHT ARM 2 HOURS AFTER 3RD SERIES OF RABIES VACCINE. DENIES ANY PAIN/ITCHINESS OR FEVER
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Expired product administered, Pain in extremity
Clinical narrative: ARM GOT RED AND SORE, FINE NOW. Immunization had been in fridge a few days beyond the 30 day mark.
Age: 43.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Arthralgia, Injection site bruising, Injection site pain
Clinical narrative: Patient presented to clinic appx 7 weeks after receiving her vaccine on 2/2/24, complaining of pain in her left upper arm/ shoulder. Pt unsure exactly when the pain started, may have started shortly after receiving her Tdap vaccination. Pt reported some bruising at the site of the injection, but no redness or swelling afterwards.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse reaction, but accidentally gave vaccine out of 30 day range in refrigerator by a couple of days
Age: 1.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Kinrix outside of appropriate age range. No reaction was noted.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects other than receiving the influenza vaccine at 2 months of age.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose 2 of MCV4 given too early, pt not due until 16 yo for booster
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Patient received Tdap vaccine by County Health Department on 1/29/2023, since then, it has become inflamed to the size of a golf ball. It is hot to the touch, red, and very itchy.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccination was reconstituted and stored in fridge for longer than the recommended 4 hour window.  After reconstitution, the vaccine is not supposed to be stored in the fridge.  It was stored in the fridge, and for longer than a 4 hour window.  I spoke with my clinical help desk team and they recommend revaccination.  I spoke with the patient and they will receive a 2nd vaccination over the weekend.  No adverse reaction occurred. Patient did not experience any side effects.
Age: 68.0
Sex: F
Vaccine: MNQ, UNK
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm, Swelling
Clinical narrative: 4?  red  and swollen circle on left arm with pain to touch, and very warm.  This lasted about 1 week.
Age: 68.0
Sex: F
Vaccine: MNQ, UNK
Symptoms: Tenderness
Clinical narrative: 4?  red  and swollen circle on left arm with pain to touch, and very warm.  This lasted about 1 week.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Vaccine shipped out of temperature range. Temperature excursion discovered after vaccine administration.
Age: 0.33
Sex: M
Vaccine: EBZR, PNC15
Symptoms: Blood glucose normal, Cyanosis, Electrocardiogram, Full blood count, Influenza virus test negative
Clinical narrative: Patient had an episode of unresponsiveness at home a few hours after vaccination.   He looked pale and blue in the face per mother's report.  She gave some breaths and rubbed his feet and he started to respond.  He had normal VS when EMS arrived.   They recommended that she take him to the ED where he had negative viral testing (covid, flu and RSV) and a normal blood glucose.   He was admitted to the unit for observation for possible hypotonic hyporesponsive event.
Age: 0.33
Sex: M
Vaccine: EBZR, PNC15
Symptoms: Metabolic function test, Pallor, Respiratory syncytial virus test negative, Resuscitation, SARS-CoV-2 test negative
Clinical narrative: Patient had an episode of unresponsiveness at home a few hours after vaccination.   He looked pale and blue in the face per mother's report.  She gave some breaths and rubbed his feet and he started to respond.  He had normal VS when EMS arrived.   They recommended that she take him to the ED where he had negative viral testing (covid, flu and RSV) and a normal blood glucose.   He was admitted to the unit for observation for possible hypotonic hyporesponsive event.
Age: 0.33
Sex: M
Vaccine: EBZR, PNC15
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient had an episode of unresponsiveness at home a few hours after vaccination.   He looked pale and blue in the face per mother's report.  She gave some breaths and rubbed his feet and he started to respond.  He had normal VS when EMS arrived.   They recommended that she take him to the ED where he had negative viral testing (covid, flu and RSV) and a normal blood glucose.   He was admitted to the unit for observation for possible hypotonic hyporesponsive event.
Age: 12.0
Sex: F
Vaccine: FLUC4, HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: Varicella vaccine was shipped out of temperature range. Temperature excursion discovered after vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Product storage error
Clinical narrative: Varicella vaccine shipped out of temperature range. Temperature excursion identified after vaccine administration.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient was administered a vaccine dose that was expired.
Age: 1.92
Sex: M
Vaccine: DTPPVHBHPB, FLU4, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Fever began 6 days after immunization and Rash began 8 days after immunization. Tmax 101 F.  Fever for two days. Rash is pruritic, fine red bumps. All other ROS negative. No known sick contacts, no one sick at home.  No recent travel. Possible that this is viral, but could also be related to immunization.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to multiple patients.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in December 2023, the patients were vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot number X018572 is an invalid lot number for mumps, rubella and varicella [oka-merck] virus vaccine live [PROQUAD]). The vaccine was administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.  This case was considered non-valid due to multiple patients and lack of patients' identifiers.  Follow-up information was received on 29-JAN-2024   This report referred to a 4-year-old patient of unknown age.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable and the vaccines were not kept frozen enough.  On 05-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025).   This case was considered valid as patient's information was provided.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Cardiac arrest, Catheterisation cardiac normal, Intensive care, Laboratory test abnormal, Myocarditis
Clinical narrative: Cardiac Arrest
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Pericarditis, Resuscitation
Clinical narrative: Cardiac Arrest
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Eye pruritus, Paraesthesia oral, Pruritus
Clinical narrative: Patient received vaccine in the afternoon at approximately 2:45 pm and by 7-8 pm  she was experiencing itchiness of the eye, scalp, skin of her body and slight tingling of the lips.   She called her doctor who reconmended Benadryl to take per package instructions, and to follow up if Benadryl did not resolve the itchiness.  Patient took doses throughout 2-1-24, with the last dose the night of 2-1-24 before bed and by the morning of 2-2-24 symptoms were resolved.
Age: 4.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC20
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Mother reports that patient started with generalized, itchy rash around 1/30/2024, and fever on 1/31/2024. Rash and fever occur in the evening. Per mom's report, doctor said that it could possibly be reaction to the vaccines patient had on 1/9/2024. Told mom I would complete VAERS report, and referred to health care provider for further follow up and assessment.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given a second RSV vaccine by mistake. Had already received abrysvo on 10/30/23 (lot HF5019). Patient reports no adverse effects and does not need us to contact PCP at this time.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event. But  the vaccine is designated for ages 12 years and older. The patient is 9 years  old.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration.; A HCP called to report a TE for ROTATEQ in which the vaccines had also been administered to a patient on 01/18/2024.  The patient did not report any adverse issues or side effects from the administration.  No other AE information was able to be provi; This spontaneous report was received from a medical assistant and referred to a 4-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 18-JAN-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 vial, administered orally for prophylaxis (lot number 1965644 has been verified to be a valid lot number, expiration date reported and validated as 02-OCT-2024) (strength and vaccination scheme were not provided). The vaccine had previous temperature excursions of 54.3 Fahrenheit degree (F) for a timeframe of 9 hours and 32 minutes (on 04-DEC-2023), 57.7 F for a timeframe of 15 hours and 30 minutes (on 05-DEC-2023), 50.2 F for a timeframe of 5 hours and 43 minutes (on 06-DEC-2023), 30.6 F for a timeframe of 1 hour and 55 minutes (on 07-DEC-2023), 52.7 F for a timeframe of 11 hours and 3 minutes (on 07-DEC-2023) and 48.4 F for a timeframe of 1 hour and 47 minutes (on 11-DEC-2023) (product storage error). The patient did not report any adverse issues or side effects from the administration.; Sender's Comments:  US-009507513-2401USA015432: US-009507513-2401USA015463: US-009507513-2401USA015454:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration; A HCP called to report a TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 01/16/2024.  The patient did not report any adverse issues or side effects from the administration.  No other AE information was able to be pr; This spontaneous report as received from a medical assistant refers to a 15-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JAN-2024, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection, lot # X019196, expiration date: 25-APR-2025, 0.5 milliliter (once) (route of administration and anatomical location were not reported) for prophylaxis.   Administered doses of vaccines were exposed the temperature excursion of: 54.3 degrees Fahrenheit (F) for 9 hours and 32 minutes ( on 04-DEC-2023); 57.7 F for 15 hours and 30 minutes (on 05-DEC-2023); 50.2 F for 5 hours and 43 minutes (on 06-DEC-2023); 30.6 F for 1 hour and 53 minutes (on 07-DEC-2023); 52.7 F for 11 hours and 3 minutes (on 07-DEC-2023); 48.4 F for 1 hour and 47 minutes (on 11-DEC-2023) (product storage error). There were no additional adverse events reported (no adverse event). ; Sender Comments: Keywords : MUL US-009507513-2401USA015454: US-009507513-2401USA015432: US-009507513-2401USA015463:
Age: 0.25
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration; A HCP called to report a TE for PEDVAX HIB and ROTATEQ in which the vaccines had also been administered to a patient on 01/02/2024.  The patient did not report any adverse issues or side effects from the administration.  No other AE information was a; This spontaneous report as received from a medical assistant refers to a 3-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-JAN-2024, the patient was vaccinated with an improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X003664, expiration date: 10-NOV-2025, 0.5 milliliter (once) (route of administration and anatomical location were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ); oral liquid, lot # 1965644, expiration date: 02-OCT-2024, 1 dose (exact dose, route of administration and anatomical location were not provided) for prophylaxis.  Administered doses of vaccines were exposed the temperature excursion of: 54.3 degrees Fahrenheit (F) for 9 hours and 32 minutes ( on 04-DEC-2023); 57.7 F for 15 hours and 30 minutes (on 05-DEC-2023); 50.2 F for 5 hours and 43 minutes (on 06-DEC-2023); 30.6 F for 1 hour and 53 minutes (on 07-DEC-2023); 52.7 F for 11 hours and 3 minutes (on 07-DEC-2023); 48.4 F for 1 hour and 47 minutes (on 11-DEC-2023) (product storage error). There were no additional adverse events reported (no adverse event).; Sender Comments: Keywords : MUL US-009507513-2401USA015432: US-009507513-2401USA015463: US-009507513-2401USA015454:
Age: 1.25
Sex: M
Vaccine: PNC15
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: No other adverse effects; needle popped off the syringe; only about 5% of VAXNEUVANCE was administered to patient; This spontaneous report was received from employee and refers to a 15-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-JAN-2024, the patient was vaccinating with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (lot #X019624 was valid for formulation pre-filled syringe, expiration date: 07-NOV-2025, administered intramuscularly, 1 dosage form, anatomical location was not provided) for prophylaxis when needle popped off the syrine and only about 5% of the vaccine was administered to the patient (Underdose, Needle issue). HCP confirmed prefilled syringe was intact and no visible defects in or on the syringe. No other information available. HCP confirmed prefilled syringe was intact and no visible defects in or on the syringe. No other adverse effects (No adverse event). No other product quality complaint (PQC).
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: a 25 year old patient received a 1st dose of GARDASIL 9 on 12/19/2022, a 2nd dose on 4/7/2023, but never received a 3rd dose; patient has not had any symptoms; This spontaneous report was received from a pharmacist and refers to a 25-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-DEC-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis. On 07-APR-2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, and route of administration were not provided). Until the time of this report, the patient never received a 3rd dose (inappropriate schedule of product administration). The patient did not have any symptoms. No additional adverse event reported.
Sex: F
Vaccine: RV5, UNK
Symptoms: Product storage error
Clinical narrative: No additional AE reported; HCP called to report T/E case that occurred on 12/7/2023. HCP stated VAXELIS (PFS) and ROTATEQ were administered on 1/17/2024 to a twin patient during a Temperature Excursion. T/E case was supported based on in house stability data. No other informat; This spontaneous report was received from medical assistant and refers to a 2-month-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2024, the patient was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, unk, lot #U7536AA, expiration date: 30-SEP-2025, administered for prophylaxis (strength, and route of administration were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968392, expiration date: 24-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided). Those vaccines underwent temperature excursion on 17-JAN-2024 IN 0 degree Celsius for 1 hour 29 minutes (Product storage error). No additional adverse event was reported.
Sex: M
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported. No PQC reported.; HCP called to report T/E case that occurred on 12/7/2023. HCP stated VAXELIS (PFS) AND ROTATEQ were administered on 1/17/2024 to a twin patient during a temperature excursion.  T/E case was supported based on in house stability data. No other informa; This spontaneous report was received from a Medical Assistant and refers to a 9-week-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 17-JAN-2024 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968392 and expiration date 24-MAY-2024 for prophylaxis (exact dose, dose number and route of administration were not provided). On 17-JAN-2024 the patient was vaccinated with improperly stored dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(V419) lot # U7536AA and expiration date 30-SEP-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product storage error and no adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, reference case US2023AMR160135).   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 injection site pain (Verbatim: soreness at the injection site). The outcome of the injection site pain was resolved (duration 3 days).   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Linked case(s) involving the same patient: US2023AMR160135   Additional Information: GSK Receipt Date: 24-JAN-2024 The patient shared his own personal experience after receiving Shingrix .  The patient had a soreness at the injection site for approximately 3 days. The reporter did not consent to follow up. This case had been link with US2023AMR160135, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR160135:same reporter
Sex: U
Vaccine: FLUX, RSV
Symptoms: Cellulitis, Culture wound negative, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: open wound of left upper arm/holes in arm; redness in left upper arm; Cellulitis; arm turned black and blue; arm swelling; pain in left upper arm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of skin discoloration in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   Co-suspect products included Influenza vaccine (batch number 44JN3) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Additional patient notes included no prior vaccination within 4 weeks and no adverse events.   On 14-NOV-2023 09:50, the patient received Arexvy (intramuscular, left deltoid) .5 ml and Influenza vaccine (intramuscular, left deltoid). On 27-NOV-2023, 13 days after receiving Arexvy, the patient experienced skin discoloration (Verbatim: arm turned black and blue), swelling arm (Verbatim: arm swelling) and pain in arm (Verbatim: pain in left upper arm). On 04-DEC-2023, the patient experienced erythema of extremities (Verbatim: redness in left upper arm) and cellulitis (Verbatim: Cellulitis). On 21-DEC-2023, the patient experienced upper limb wound (Verbatim: open wound of left upper arm/holes in arm). The patient was treated with sulfamethoxazole, trimethoprim (Bactrim), cefalexin (Cephalexin) and honey (Medihoney). The outcome of the skin discoloration, swelling arm, pain in arm, erythema of extremities and cellulitis were resolved with sequelae and the outcome of the upper limb wound was not resolved.   It was unknown if the reporter considered the skin discoloration, swelling arm, pain in arm, erythema of extremities, cellulitis and upper limb wound to be related to Arexvy.     It was unknown if the company considered the skin discoloration, swelling arm, pain in arm, erythema of extremities, cellulitis and upper limb wound to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-JAN-2024 The patient received Arexvy and Influenza vaccine and had primary infection to the left upper arm. The patient's arm turned black and blue, there was holes in arm. The patient had redness, swelling and pain in left upper arm. The patient experienced cellulitis and had open wound of left upper arm. The patient visited to the emergency room and had frequent office visits. The patient had treatment of saline wet to dry dressing changes. The patient was not admitted to the hospital. On 21-DEC-2023, the patient did wound culture test, with results of no growth. It was unknown if the reporter considered the skin discoloration, swelling arm, pain in arm, erythema of extremities, cellulitis and upper limb wound to be related to Influenza vaccine.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLUX, RSV
Symptoms: Peripheral swelling, Skin discolouration, Wound, Wound treatment
Clinical narrative: open wound of left upper arm/holes in arm; redness in left upper arm; Cellulitis; arm turned black and blue; arm swelling; pain in left upper arm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of skin discoloration in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   Co-suspect products included Influenza vaccine (batch number 44JN3) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Additional patient notes included no prior vaccination within 4 weeks and no adverse events.   On 14-NOV-2023 09:50, the patient received Arexvy (intramuscular, left deltoid) .5 ml and Influenza vaccine (intramuscular, left deltoid). On 27-NOV-2023, 13 days after receiving Arexvy, the patient experienced skin discoloration (Verbatim: arm turned black and blue), swelling arm (Verbatim: arm swelling) and pain in arm (Verbatim: pain in left upper arm). On 04-DEC-2023, the patient experienced erythema of extremities (Verbatim: redness in left upper arm) and cellulitis (Verbatim: Cellulitis). On 21-DEC-2023, the patient experienced upper limb wound (Verbatim: open wound of left upper arm/holes in arm). The patient was treated with sulfamethoxazole, trimethoprim (Bactrim), cefalexin (Cephalexin) and honey (Medihoney). The outcome of the skin discoloration, swelling arm, pain in arm, erythema of extremities and cellulitis were resolved with sequelae and the outcome of the upper limb wound was not resolved.   It was unknown if the reporter considered the skin discoloration, swelling arm, pain in arm, erythema of extremities, cellulitis and upper limb wound to be related to Arexvy.     It was unknown if the company considered the skin discoloration, swelling arm, pain in arm, erythema of extremities, cellulitis and upper limb wound to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-JAN-2024 The patient received Arexvy and Influenza vaccine and had primary infection to the left upper arm. The patient's arm turned black and blue, there was holes in arm. The patient had redness, swelling and pain in left upper arm. The patient experienced cellulitis and had open wound of left upper arm. The patient visited to the emergency room and had frequent office visits. The patient had treatment of saline wet to dry dressing changes. The patient was not admitted to the hospital. On 21-DEC-2023, the patient did wound culture test, with results of no growth. It was unknown if the reporter considered the skin discoloration, swelling arm, pain in arm, erythema of extremities, cellulitis and upper limb wound to be related to Influenza vaccine.  The follow-up could not be possible as no contact details were available.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received 1st Twinrix in June 2023 and 2nd dose October 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix adult in June 2023).   In OCT-2023, the patient received the 2nd dose of Twinrix adult. In OCT-2023, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: patient received 1st Twinrix in June 2023 and 2nd dose October 2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 23-JAN-2024 The pharmacist reported that a patient received 2nd dose of Twinrix adult delayed than the recommended time interval, which led to lengthening of the vaccination schedule. The patient had returned today (on the day of reporting) for her 3rd dose. Twinrix had not administered at close of the call.  The reporter consented to follow up.