chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Bone pain, Cardiovascular disorder, Computerised tomogram normal
Clinical narrative: shot 1 of 3 started off with constant headaches, workup was done and no findings, multiple migraine medications attempted with no relief, ct and mri done with no findings. Shot 2 of 3 and 3 of 3 noted to have hand swelling, intermittent, then noted to have circulation issues along with joint and bone pains,  was dx with raynaud's phenomenon then after further workup was diagnosed with undifferentiated connective tissue disease until recent when skin changes evolved on hands and arms and now diagnosed with sceleroderma. no family hx of auto immune diseases. still having headaches,  intermittent hand/feet swelling, bone/joint pains, decrease in range of motion on extremities.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Connective tissue disorder, Headache, Magnetic resonance imaging normal, Mobility decreased, Peripheral swelling
Clinical narrative: shot 1 of 3 started off with constant headaches, workup was done and no findings, multiple migraine medications attempted with no relief, ct and mri done with no findings. Shot 2 of 3 and 3 of 3 noted to have hand swelling, intermittent, then noted to have circulation issues along with joint and bone pains,  was dx with raynaud's phenomenon then after further workup was diagnosed with undifferentiated connective tissue disease until recent when skin changes evolved on hands and arms and now diagnosed with sceleroderma. no family hx of auto immune diseases. still having headaches,  intermittent hand/feet swelling, bone/joint pains, decrease in range of motion on extremities.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Raynaud's phenomenon, Red blood cell sedimentation rate increased, Scleroderma, Skin disorder
Clinical narrative: shot 1 of 3 started off with constant headaches, workup was done and no findings, multiple migraine medications attempted with no relief, ct and mri done with no findings. Shot 2 of 3 and 3 of 3 noted to have hand swelling, intermittent, then noted to have circulation issues along with joint and bone pains,  was dx with raynaud's phenomenon then after further workup was diagnosed with undifferentiated connective tissue disease until recent when skin changes evolved on hands and arms and now diagnosed with sceleroderma. no family hx of auto immune diseases. still having headaches,  intermittent hand/feet swelling, bone/joint pains, decrease in range of motion on extremities.
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The vaccine was Given at 9:15 am. The wrong dose was given. The patient was given the full dose. Instead of .3 of the vial.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Bone pain, Dizziness, Mobility decreased, Pain, Pain in extremity
Clinical narrative: The morning after the vaccine at 4 am, pt started having fever, pain all over body "in bones", and feeling dizzy. Had swelling and pain in arm, could not move the arm. Did not ever experience difficulty breathing. She was in bed all day Friday 4/19. The fever was on Friday and then improved and stopped. She did take ibuprofen and advil which helped. Today on Tuesday 4/23 her arm still has a little bit of pain and swelling, but has improved.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: The morning after the vaccine at 4 am, pt started having fever, pain all over body "in bones", and feeling dizzy. Had swelling and pain in arm, could not move the arm. Did not ever experience difficulty breathing. She was in bed all day Friday 4/19. The fever was on Friday and then improved and stopped. She did take ibuprofen and advil which helped. Today on Tuesday 4/23 her arm still has a little bit of pain and swelling, but has improved.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Tdap vaccine when they should have received Dtap based on their age.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Tdap when they should have received DTap based on their age.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Body temperature decreased, Cough, Lacrimation increased, Measles post vaccine, Morbillivirus test positive
Clinical narrative: Patient is a A 12-month-old baby girl, accompanied by her mother, presenting for an ER follow up for temperature dysregulation. The baby had a fever around 101 for about 4 days (sx onset 4/12/2024) but had actually begun to feel cold and look "out of it," "not responding to her name as usual," and mother reports temp had dropped to 95 at home (96 in the ER), which is why the mother took the girl to the hospital. She was examined, told she had a viral illness, and sent home. That was yesterday, 4/15/2024.        .        Today, mother notes that in addition to fever the child has had a mild cough, runny nose, and watery eyes.        The mom noted a rash on the child's abdomen when the MA was prepping the patient.        .        Patient received her first dose of MMRV on 4/4/2024, 12 days ago (per RN, MOP requested MMRV rather than MMR + Varicella as separate immunizations to reduce needle sticks for the baby). The child has no known underlying immunocompromised state.        .        MOP states she received an MMR vaccine postpartum, and also states that the other members of their household are fully vaccinated. The child had several visitors for a 1-year-old birthday party, though no known measles contacts. The child typically attends daycare, though again has had no known measles contacts.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Peripheral coldness, Pyrexia, Rash, Rhinorrhoea, Unresponsive to stimuli
Clinical narrative: Patient is a A 12-month-old baby girl, accompanied by her mother, presenting for an ER follow up for temperature dysregulation. The baby had a fever around 101 for about 4 days (sx onset 4/12/2024) but had actually begun to feel cold and look "out of it," "not responding to her name as usual," and mother reports temp had dropped to 95 at home (96 in the ER), which is why the mother took the girl to the hospital. She was examined, told she had a viral illness, and sent home. That was yesterday, 4/15/2024.        .        Today, mother notes that in addition to fever the child has had a mild cough, runny nose, and watery eyes.        The mom noted a rash on the child's abdomen when the MA was prepping the patient.        .        Patient received her first dose of MMRV on 4/4/2024, 12 days ago (per RN, MOP requested MMRV rather than MMR + Varicella as separate immunizations to reduce needle sticks for the baby). The child has no known underlying immunocompromised state.        .        MOP states she received an MMR vaccine postpartum, and also states that the other members of their household are fully vaccinated. The child had several visitors for a 1-year-old birthday party, though no known measles contacts. The child typically attends daycare, though again has had no known measles contacts.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Viral infection
Clinical narrative: Patient is a A 12-month-old baby girl, accompanied by her mother, presenting for an ER follow up for temperature dysregulation. The baby had a fever around 101 for about 4 days (sx onset 4/12/2024) but had actually begun to feel cold and look "out of it," "not responding to her name as usual," and mother reports temp had dropped to 95 at home (96 in the ER), which is why the mother took the girl to the hospital. She was examined, told she had a viral illness, and sent home. That was yesterday, 4/15/2024.        .        Today, mother notes that in addition to fever the child has had a mild cough, runny nose, and watery eyes.        The mom noted a rash on the child's abdomen when the MA was prepping the patient.        .        Patient received her first dose of MMRV on 4/4/2024, 12 days ago (per RN, MOP requested MMRV rather than MMR + Varicella as separate immunizations to reduce needle sticks for the baby). The child has no known underlying immunocompromised state.        .        MOP states she received an MMR vaccine postpartum, and also states that the other members of their household are fully vaccinated. The child had several visitors for a 1-year-old birthday party, though no known measles contacts. The child typically attends daycare, though again has had no known measles contacts.
Age: 17.0
Sex: F
Vaccine: COVID19, MENB
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: swelling, redness, hot to touch, pain, hard bump under skin
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Staff member administered the liquid (adjuvant) to patient without mixing the powder(antigen).  Powder was discarded and another dose was retrieved and the proper liquid(adjuvant) was mixed with powder (antigen) and given to patient in the opposite arm.   Multiple attempts were made to patient to see if any adverse reactions. Pt was finally reached on 4/23/24 and stated he had no adverse reaction.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: The refrigerator had a temperature excursion , the temp on the refrigerator had fallen below the normal range of 36 degrees Fahrenheit.  The vaccine was given , and it wasn't realized that the temperature had fallen. Contacted the manufacturer (Sanofi) and the Department of Health to report . Instructions were given to revaccinate the child, as to ensure potency.  The child  is scheduled to come in 4/23/2025 to receive the vaccine.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong vaccine was administered. It should have been the pediatric dose and not the adult dose.
Age: 6.0
Sex: U
Vaccine: DTAPIPV, DTAPIPV, MMRV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: MOTHER REPORTED TO NURSE ON 4/23/24 AND SHOWED PICTURE OF AREA APPROX 5 IN X 6 IN ON LEFT UPPER ARM OF SWELLING, REDNESS, ITCHING; MOTHER REPORTS NOW RESOLVED.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The refrigerator temperature fell below the safe range of 36 degrees Fahrenheit.  The vaccine was given during the time frame of the temperature excursion.  We reported this to the manufacturer (Sanofi) and the Department of Health for instructions. We are revaccinating the child and he has an appointment in our clinic on 4/23/24 . No other adverse reactions to the patient. No harm was inflicted , we are just revaccinating the child to make sure he is given the proper vaccine potency.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chest pain, Dizziness, Dyspnoea, Fall, Pallor
Clinical narrative: Pt left the office with her mother, reported she felt a dizzy walking to the car, she then fainted and fell in the parking lot. Mom reports she did not hit her head, didn't lose consciousness, vomited times 1 but was noted to be pale. Mom obtained a wheelchair from the entrance of the hospital building and brought her back into the office. Nurse evaluated Pt sitting in wheelchair, noted to be pale in color, denies shortness of breath, chest pain, reports dizziness improved but feels tired. BP 116/70 HR 52, O2 97% room air. Notified MD of incident, evaluated, provided water and crackers. Monitored Pt for another 15 minutes with repeat vital signs 112/68 HR 70 O2 98% room air.a reports no longer feeling dizzy Nurse had Pt stand and evaluated steadiness as well as walking prior to leaving which was stable and steady. Educated on rest, hydration, and home monitoring, call if any issues arise. Mom and Pt agree with plan. Pt also did not eat anything today prior to appointment and vaccines.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope, Vomiting
Clinical narrative: Pt left the office with her mother, reported she felt a dizzy walking to the car, she then fainted and fell in the parking lot. Mom reports she did not hit her head, didn't lose consciousness, vomited times 1 but was noted to be pale. Mom obtained a wheelchair from the entrance of the hospital building and brought her back into the office. Nurse evaluated Pt sitting in wheelchair, noted to be pale in color, denies shortness of breath, chest pain, reports dizziness improved but feels tired. BP 116/70 HR 52, O2 97% room air. Notified MD of incident, evaluated, provided water and crackers. Monitored Pt for another 15 minutes with repeat vital signs 112/68 HR 70 O2 98% room air.a reports no longer feeling dizzy Nurse had Pt stand and evaluated steadiness as well as walking prior to leaving which was stable and steady. Educated on rest, hydration, and home monitoring, call if any issues arise. Mom and Pt agree with plan. Pt also did not eat anything today prior to appointment and vaccines.
Age: 84.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Shoulder pain, with limited ROM, initiated physical therapy
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Breath holding, Crying, Cyanosis
Clinical narrative: 8 mo former 38/4 wk gestation male here for well child visit. He first received Pediarix. Second one was PCV 20. After PCV 20 injection needle went in, about 5-10 seconds later the patient had what appeared to be a breath holding spell and turned blue around lips, nurse grabbed the baby and he immediately took a breath and recovered and cried.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Patient's mother states that her daughter's shoulder has been hurting ever since she received the covid vaccines (2 years plus). PCP doctor just told them "it happens sometimes."
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: The refrigerator temperature fell below the safe range of 36 degrees Fahrenheit.  The polio vaccine was given during the time frame of the temperature excursion.  We reported this to the manufacturer (Sanofi) and the Department of Health  for instructions. We are revaccinating the child and he has an appointment in our clinic on 4/23/24 . No other adverse reactions to the patient. No harm was inflicted , we are just revaccinating the child to make sure he is given the proper vaccine potency.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache
Clinical narrative: The next morning after receiving the vaccine he said that he felt dizzy (lightheaded) and had a headache.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives within 12-24 hours post vaccination
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Face injury, Fall, Loss of consciousness, Orbital swelling, Tenderness
Clinical narrative: Patient was at the providers office for a well child exam and after examination was prepared to receive three vaccines. The patient was seated on the exam table and the patient's guardian was seated in a chair directly beside him. The LPN began to administer the three vaccines at 9:30AM. When the administration was complete and the patient was still seated on the exam table, the LNP took the medication tray and turned around to place the used syringes/needles on the counter behind them. At that same time, the LPN hear a noise and turned around to find the patient on the floor. He had passed out but quickly regained consciousness. He was moved to the exam table and assessed by the provider. The patient hit is face and was experiencing orbital swelling and tenderness in his neck from the fall. He was transported to the ED via squad. All vital signs were stable after the syncopal episode and patient was alert and oriented afterward.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: The refrigerator temperature fell below the safe range of 36 degrees Fahrenheit.  The vaccine was given during the time frame of the temperature excursion.  We reported this to the manufacturer (Sanofi) and the Department of Health  for instructions. We are revaccinating the child and he has an appointment in our clinic on 4/25/24 . No other adverse reactions to the patient. No harm was inflicted , we are just revaccinating the child to make sure he is given the proper vaccine potency.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Tenderness
Clinical narrative: "Covid Arm" rash - slightly itchy, "painful if you touch" red raised rash that occurred a couple of days after vaccination and is slowly abating.  Note that I know this is a harmless reaction, and it will clear up in the next few days, but all the on-line information says it is uncommon and I should report it so you can track it.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient DOB: 01/XX/2023 Patient had vaccines: HPV, T-dap, Meningococcal vaccines at 11:25am She came out of the room and took a look at the books and then when over to the sticker area and fainted.  She hit her head hard on the floor.    Called Dr.- (Ped's MD) over and he talked to mom who was crying.  Both PA and MD assessed patient.  From the time of shots given to the fall was about 10 min.   Patient's VS: BP 110/72, Pulse 99, 02 98%. Patient sat up and drank some juice.  She stayed in the clinic after the fall for about 20 min.  She was able to leave the office feeling much better.  - RN
Age: 0.33
Sex: F
Vaccine: VARCEL
Symptoms: Crying, No adverse event, Wrong product administered
Clinical narrative: Patient was given varivax in place of vaxelis inadvertently on 04/22/2024 well child visit. parent signed consent form was givemn VIS sheets, vaccine was verified by colleague and administer, patient reacted well to injection besides crying after injection. patient viewed for 10 minutes during clinic discharge, the patient sad but alert. After discovering incorrect vaccine was given: discovered 04/23/2024  by employee. patient's mother was notified by way of interpreter via  phone conversation, MOther stated no signs of reaction and that pt is active, happy with no changes in temperature or any other signs.  Explained that if any noticeable adverse reaction begin to immediately call EMS or gp top ED.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Erythema, Eye swelling, Sneezing
Clinical narrative: Approximately 10 minutes after vaccines were given his face was becoming red.  In addition his eyes began to swell, he was coughing and sneezing.  Dad had left office and was headed home.  He also began to have trouble breathing, he vomited, and developed hives.  Because we are next door to hospital pediatric ER dad immediately brought him there.  There he was given 8 mL of pediatric Benadryl and observed for three hours.  He was discharged.  No labs were done.  He was much better and stable at discharge.  Family gave one addition dose of Benadryl at home later in the day.  I spoke to mom again this AM (next day).  She reports that he is fine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: Approximately 10 minutes after vaccines were given his face was becoming red.  In addition his eyes began to swell, he was coughing and sneezing.  Dad had left office and was headed home.  He also began to have trouble breathing, he vomited, and developed hives.  Because we are next door to hospital pediatric ER dad immediately brought him there.  There he was given 8 mL of pediatric Benadryl and observed for three hours.  He was discharged.  No labs were done.  He was much better and stable at discharge.  Family gave one addition dose of Benadryl at home later in the day.  I spoke to mom again this AM (next day).  She reports that he is fine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Drug hypersensitivity, Hyperhidrosis, Withdrawal syndrome
Clinical narrative: Patient states that she started having withdrawal/detox symptoms after receiving the pfizer vaccine. She states that after the receiving the vaccine anytime she would take her clonazepam she would get diarrhea and sweating and that it happened after each clonazepam tablet she would take.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site reaction
Clinical narrative: 4/22/24 @ 2300 felt tingling to back of arm. 4/23/24 in AM felt a burning sensation. area bruised and red. area above injection site with red raised rash. denies itching, pain. Denies SOB, difficulty swallowing. Sent to Occupational Health for evaluation. Diagnosis is adverse effect of MMR vaccine. Bacitracin applied to injections site, and employee instructed to take Tylenol. will have a follow up appointment with Occupational Health on 4/26/24
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash papular
Clinical narrative: 4/22/24 @ 2300 felt tingling to back of arm. 4/23/24 in AM felt a burning sensation. area bruised and red. area above injection site with red raised rash. denies itching, pain. Denies SOB, difficulty swallowing. Sent to Occupational Health for evaluation. Diagnosis is adverse effect of MMR vaccine. Bacitracin applied to injections site, and employee instructed to take Tylenol. will have a follow up appointment with Occupational Health on 4/26/24
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose administered was expired, no adverse effects noted.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Patient started having rash , hives etc on the same day evening  after showering.  she came to the pharmacy on Saturday and Pharmacist( pharmacist on duty )  gave her OTC cream to apply . But she ended up going to ER the same day and received a steroid shot. Started getting better. to day Patient came to the pharmacy to report the progress in her condition. She is doing better better. not completely gone. we requested her to keep us informed about her condition.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Redness, swelling and pain to the L upper arm after immunizations on Friday. Had Tdap and menactra in that arm. No fevers. No prior reactions to vaccines. No seizures or neurologic symptoms. Exam and hx consistent with Tdap red arm local reaction. Reviewed that this is common large local reaction seen after the 5th dose of tetanus combo vaccines. Recommended tylenol or ibuprofen, can ice as well. Should see marked improvement in the next 48-72hrs. Discussed signs of cellulitis and when to return to care. Also reviewed that this is not a contraindication to future vaccination for tetanus.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling about 1-inch spanning around the site of administration. Patient received vaccine on 04/22/2024 and returned to the pharmacy on 04/23/2024 with the injection site reaction.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: reddened area at site of injection with several tiny blisters appeared 9 days after injection. I advised mother to call the clinic to report an the nurse called her back to advise it is "normal and that she has seen reactions similar, but as big as a pop can".
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired, no adverse effects noted
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: Approximately 60 hours post vaccination I developed a cold sore, then approximately 24 hours after the first cold sore developed, a second one started forming.  I have a history of cold sores but had not had one in over three years, and never two at the same time. I did not have any unusual or intense sun exposure for at least several weeks prior to this one developing.  I have not been sick recently other than seasonal allergies, and have not been unusually stressed.  As it was the weekend and the clinic that had given me the vaccine was closed, I utilized pharmacy telehealth to obtain a prescription for Valacyclovir.  Six days post Valacyclovir, both cold sores had healed.   While under item 17 I checked that it was the first dose in the series, I had been fully immunized as a child.  Last year when titers were drawn, I was resistant to measles and rubella but not mumps, so my employer required me to get re-immunized (I am in healthcare). This was the first of two doses of the MMR vaccine  that was to be given.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was given a Pediarix vaccine  by one of our staff members that was expired on 04/15/2024. We have contacted mom to see if patient had any reactions from the vaccine after leaving the office, mom stated that patient is fine and no reactions noticed.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired, no adverse effects noted.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired, no adverse effects noted
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired, no adverse effects noted
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Feeling hot, Pallor
Clinical narrative: Shortly after receiving vaccines while still in the nurses office, patient became pale and stated that he "felt hot inside." Bp check at 3pm- 105/67 P-52. Patient given some coke and peanut butter crackers. BP checked again at 3:05pm- 110/75 P-52. Patient stated that he "felt better." Color returned to face and lips. Advised mom via interpreter that we recommend that child waits an additional 15 mins in the lobby and to make sure that she gets him something to eat when they leave. Mom voices understanding via interpreter. Explained to mom that child is okay and that it is no uncommon for this to occur. Mom voices understanding via interpreter.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired, no adverse effects noted
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Aphasia, Body temperature decreased, Computerised tomogram, Cough, Cytogenetic analysis
Clinical narrative: 8/17 3:45pm - administration, 5:00pm - lethargic, lack of appetite, coughing. 8/18 6:00am - lethargic, lack of appetite, low fever. 8/18 8:00pm - lethargic, lack of appetite, irritability. 8/19 10:00pm - lethargic, lack of appetite, dehydration, fever, irritability. 8/20 4:00am - difficulty waking, low body temperature, lack of appetite, pale. 8/20 9:00am - difficulty waking, lack of appetite, irritability, difficulty breathing, low body temperature, pale, vomiting, diarrhea. 8/20 10am - with EMTs/on ambulance - all previous symptoms plus low blood pressure, low pulse ox, low heart rate, seizures. After 13 days in the ICU he was discharged with the following diagnosis: hypoxic ischemic encephalopathy, seizures, global developmental delay, dysphasia.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Decreased appetite, Dehydration, Developmental delay, Dyspnoea, Heart rate decreased
Clinical narrative: 8/17 3:45pm - administration, 5:00pm - lethargic, lack of appetite, coughing. 8/18 6:00am - lethargic, lack of appetite, low fever. 8/18 8:00pm - lethargic, lack of appetite, irritability. 8/19 10:00pm - lethargic, lack of appetite, dehydration, fever, irritability. 8/20 4:00am - difficulty waking, low body temperature, lack of appetite, pale. 8/20 9:00am - difficulty waking, lack of appetite, irritability, difficulty breathing, low body temperature, pale, vomiting, diarrhea. 8/20 10am - with EMTs/on ambulance - all previous symptoms plus low blood pressure, low pulse ox, low heart rate, seizures. After 13 days in the ICU he was discharged with the following diagnosis: hypoxic ischemic encephalopathy, seizures, global developmental delay, dysphasia.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Hypotension, Hypoxic-ischaemic encephalopathy, Infant irritability, Infantile diarrhoea, Infantile vomiting
Clinical narrative: 8/17 3:45pm - administration, 5:00pm - lethargic, lack of appetite, coughing. 8/18 6:00am - lethargic, lack of appetite, low fever. 8/18 8:00pm - lethargic, lack of appetite, irritability. 8/19 10:00pm - lethargic, lack of appetite, dehydration, fever, irritability. 8/20 4:00am - difficulty waking, low body temperature, lack of appetite, pale. 8/20 9:00am - difficulty waking, lack of appetite, irritability, difficulty breathing, low body temperature, pale, vomiting, diarrhea. 8/20 10am - with EMTs/on ambulance - all previous symptoms plus low blood pressure, low pulse ox, low heart rate, seizures. After 13 days in the ICU he was discharged with the following diagnosis: hypoxic ischemic encephalopathy, seizures, global developmental delay, dysphasia.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Intensive care, Laboratory test, Lethargy, Magnetic resonance imaging, Metabolic function test
Clinical narrative: 8/17 3:45pm - administration, 5:00pm - lethargic, lack of appetite, coughing. 8/18 6:00am - lethargic, lack of appetite, low fever. 8/18 8:00pm - lethargic, lack of appetite, irritability. 8/19 10:00pm - lethargic, lack of appetite, dehydration, fever, irritability. 8/20 4:00am - difficulty waking, low body temperature, lack of appetite, pale. 8/20 9:00am - difficulty waking, lack of appetite, irritability, difficulty breathing, low body temperature, pale, vomiting, diarrhea. 8/20 10am - with EMTs/on ambulance - all previous symptoms plus low blood pressure, low pulse ox, low heart rate, seizures. After 13 days in the ICU he was discharged with the following diagnosis: hypoxic ischemic encephalopathy, seizures, global developmental delay, dysphasia.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Oxygen saturation decreased, Pallor, Pyrexia, Seizure, Somnolence
Clinical narrative: 8/17 3:45pm - administration, 5:00pm - lethargic, lack of appetite, coughing. 8/18 6:00am - lethargic, lack of appetite, low fever. 8/18 8:00pm - lethargic, lack of appetite, irritability. 8/19 10:00pm - lethargic, lack of appetite, dehydration, fever, irritability. 8/20 4:00am - difficulty waking, low body temperature, lack of appetite, pale. 8/20 9:00am - difficulty waking, lack of appetite, irritability, difficulty breathing, low body temperature, pale, vomiting, diarrhea. 8/20 10am - with EMTs/on ambulance - all previous symptoms plus low blood pressure, low pulse ox, low heart rate, seizures. After 13 days in the ICU he was discharged with the following diagnosis: hypoxic ischemic encephalopathy, seizures, global developmental delay, dysphasia.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: X-ray
Clinical narrative: 8/17 3:45pm - administration, 5:00pm - lethargic, lack of appetite, coughing. 8/18 6:00am - lethargic, lack of appetite, low fever. 8/18 8:00pm - lethargic, lack of appetite, irritability. 8/19 10:00pm - lethargic, lack of appetite, dehydration, fever, irritability. 8/20 4:00am - difficulty waking, low body temperature, lack of appetite, pale. 8/20 9:00am - difficulty waking, lack of appetite, irritability, difficulty breathing, low body temperature, pale, vomiting, diarrhea. 8/20 10am - with EMTs/on ambulance - all previous symptoms plus low blood pressure, low pulse ox, low heart rate, seizures. After 13 days in the ICU he was discharged with the following diagnosis: hypoxic ischemic encephalopathy, seizures, global developmental delay, dysphasia.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tenderness, Urticaria, Urticaria pressure
Clinical narrative: I started getting this rash,  I thought was a rash and it turned out to be hives all over my body. I was so itchy but if I scratch them they hurt. It was from anything that touched me that applied  pressure. I never experienced this  until after the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Accidentally gave expired vaccine
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine that was administered was expired. No adverse effects noted.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired. No adverse effects noted.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pentacel given kinrix was ordered
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired, no adverse effects noted
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This 2nd shingrix vaccine was given 49 days after the 1st shingrix vaccine. It should've been given 60 days after the 1st vaccine.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Injection site pain, extreme pain in left armpit lymph node, diarrhea, nausea, headache, mild fever, shivers, fatigue. Have been alternating ibuprofen and acetaminophen but neither has helped
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymph node pain, Nausea, Pyrexia
Clinical narrative: Injection site pain, extreme pain in left armpit lymph node, diarrhea, nausea, headache, mild fever, shivers, fatigue. Have been alternating ibuprofen and acetaminophen but neither has helped
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired, no adverse effects noted
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction as of this time. Erroneous DTAP vaccine administered.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Incorrect route of product administration
Clinical narrative: The oral Rotavirus vaccine was given as an injection.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no adverse effects noted
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: accidentally gave expired vaccine
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient was administered Priorix intramuscularly instead of subcutaneously on 4/22/24.  Patient denies any symptoms when called 4/23/24.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, COVID-19, Eczema, Electrocardiogram, Impetigo
Clinical narrative: PFIZER #1 4/15/2021 PFIZER #2 05/07/2021     PATIENT DEVELOPED BIOPSY PROVEN SPONGIOTIC DERMATITIS WITH SUPERIMPOSED IMPETIGINIZATION INVOLVING CHEST BACK ARMS BUTTOCKS AND LEGS.  EVALUATED BY FOUR DERMATOLOGISTS NOT RESPONSIVE TO ORAL ORAL OR TOPICAL STEROIDS.  REQUIRED SEVERAL COURSES OF ANTIBIOTICS FOR SUPERINFECTION.  FINALLY HAD COVID-19 INFECTION AND MRNA VACCINATION DETERMINED TO BE THE ETIOLOGY AND BEGAN TO RESPOND TO IVERMECTIN AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test
Clinical narrative: PFIZER #1 4/15/2021 PFIZER #2 05/07/2021     PATIENT DEVELOPED BIOPSY PROVEN SPONGIOTIC DERMATITIS WITH SUPERIMPOSED IMPETIGINIZATION INVOLVING CHEST BACK ARMS BUTTOCKS AND LEGS.  EVALUATED BY FOUR DERMATOLOGISTS NOT RESPONSIVE TO ORAL ORAL OR TOPICAL STEROIDS.  REQUIRED SEVERAL COURSES OF ANTIBIOTICS FOR SUPERINFECTION.  FINALLY HAD COVID-19 INFECTION AND MRNA VACCINATION DETERMINED TO BE THE ETIOLOGY AND BEGAN TO RESPOND TO IVERMECTIN AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiomyopathy, Cardioversion, Ejection fraction decreased, Electrocardiogram
Clinical narrative: ASTRAZENECA #1 11/25/20 ASTRAZENECA #2 12/23/20 MODERNA #3 11/22/21 MODERNA BIVALENT #4  4/29/22 PATIENT DEVELOPED ATRIAL FIBRILLATION REQUIRING CARDIOVERSION AND ANTICOAGULATION.  DEVELOPED CARDIOMYOPATHY WITH REDUCED LVEF 45% DUE TO SUBCLINICAL VACCINE MYOCARDITIS.  TREATED WITH METOPROLOL, ELIQUIS, COLCHICINE, PROTOCOL BASE SPIKE DETOXIFICATION
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Laboratory test, Myocarditis, Ultrasound scan
Clinical narrative: ASTRAZENECA #1 11/25/20 ASTRAZENECA #2 12/23/20 MODERNA #3 11/22/21 MODERNA BIVALENT #4  4/29/22 PATIENT DEVELOPED ATRIAL FIBRILLATION REQUIRING CARDIOVERSION AND ANTICOAGULATION.  DEVELOPED CARDIOMYOPATHY WITH REDUCED LVEF 45% DUE TO SUBCLINICAL VACCINE MYOCARDITIS.  TREATED WITH METOPROLOL, ELIQUIS, COLCHICINE, PROTOCOL BASE SPIKE DETOXIFICATION
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 3rd dose of MMRV, 2nd dose given at 06-14-2023, 1st dose given at 03-02-2020. No reported adverse effects reported, vaccine error reported to Parent. on 04-23-24.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no adverse effects noted
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 22.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong patient received product
Clinical narrative: No additional AE; patient who accidentally received PROQUAD, which was intended for another patient (not product confusion). Patient had been previously vaccinated with 2 doses of MMR-II and 1 dose of VARIVAX; patient who accidentally received PROQUAD, which was intended for another patient (not product confusion). Patient had been previously vaccinated with 2 doses of MMR-II and 1 dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a 22-year-old patient of unknown gender.  The patient had been previously vaccinated with two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). The patient's concurrent conditions and concomitant therapies were not reported.  On 28-MAR-2024, the patient accidentally received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5ml/dose, lot #X000996, expiration date reported as and confirmed to be 08-JUL-2024 (route of administration were not provided) administered for prophylaxis (product administered to patient of inappropriate age). This vaccine was intended for another patient (not product confusion) (wrong patient received product). No symptoms were reported. No additional adverse event (AE) or product quality complaint (PQC) were noted (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Pancreatitis
Clinical narrative: The caller stated that after her first dose of the vaccine, she developed pancreatitis.; This spontaneous report was received from a consumer (Patient's father) and referred to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2020 (reported as 4 years ago), 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, administered for prophylaxis (strength, dose, lot #, expiry date, route of administration and anatomical location were not provided).  On an unknown date in 2020 (after her first dose of the vaccine), the patient developed pancreatitis (further details regarding this event were not provided). At the time, they had spoken with patient's doctor who told them that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine and her developing pancreatitis were likely unrelated; however, it was never reported. Furthermore, it was reported that the patient finished the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine series without issue (no further details regarding doses dates of administration provided). The father's patient did not feel comfortable providing demographics for his daughter. No further information was provided. At the reporting time, the outcome of the event was unknown.  The causal relationship between the event of pancreatitis and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided by the reporter.   Upon internal review, the event pancreatitis was determined to be medically significant.
Sex: M
Vaccine: PPV, RSV
Symptoms: Hemiplegia
Clinical narrative: patient was in hospital for Hospitalized for paralyses of the left side of his body; This serious case was reported by a pharmacist via sales rep and described the occurrence of left sided paralysis in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 27NB4) for prophylaxis.   Co-suspect products included Pneumococcal vaccine for prophylaxis.   On 29-JAN-2024, the patient received the 1st dose of Arexvy and Pneumococcal vaccine. On an unknown date, an unknown time after receiving Arexvy, the patient experienced left sided paralysis (Verbatim: patient was in hospital for Hospitalized for paralyses of the left side of his body) (serious criteria hospitalization and GSK medically significant). The outcome of the left sided paralysis was unknown.   The reporter considered the left sided paralysis to be related to Arexvy.     The company considered the left sided paralysis to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-APR-2024 This report was submitted via the online direct entry reporting system. The patient was hospitalized for paralyses of the left side of his body. The patient had Arexvy co-administered with the Pneumonia vaccine. It was unknown if reporter considered left sided paralysis to be related to be related to Pneumonia vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Cured of herpes; This non-serious case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes (had genital herpes since 20s that would flare up at least 2-3 times a year). Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 15-JUL-2019, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: Cured of herpes). The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt Date:10-APR-2024 This report was submitted via the online direct entry reporting system. The reporter stated that after getting Shingrix vaccine back in 2019, herpes had never come back and unless that's a total coincidence, he saw vaccine as a cured for herpes, which led to unexpected therapeutic effect.
Sex: U
Vaccine: COVID19, RSV
Symptoms: Chest discomfort, Cough, Oropharyngeal pain
Clinical narrative: Cough; Sore throat; heavy chest; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received Arexvy and COVID-19 vaccine. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: Cough), sore throat (Verbatim: Sore throat) and chest heaviness (Verbatim: heavy chest). The outcome of the cough, sore throat and chest heaviness were not resolved.   It was unknown if the reporter considered the cough, sore throat and chest heaviness to be related to Arexvy.     It was unknown if the company considered the cough, sore throat and chest heaviness to be related to Arexvy.   Additional Information: GSK Receipt date: 09-APR-2024 This case was reported by consumer via (Open field AE monitoring) interactive digital media. The patient received RSV and Covid vaccine at same and now patient experienced sore throat, cough and heavy chest.  The reporter wanted to know could this came from either of the vaccines. The patient was on zembify for 1.5 to build up his or her immunity system. It was unknown if the reporter considered the cough, sore throat and chest heaviness to be related to Covid vaccine.
Sex: U
Vaccine: RSV
Symptoms: Gastrooesophageal reflux disease, Somnolence
Clinical narrative: feeling drowsy; Reflux symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drowsiness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-APR-2024, the patient received Arexvy. In APR-2024, less than a week after receiving Arexvy, the patient experienced drowsiness (Verbatim: feeling drowsy) and gastroesophageal reflux (Verbatim: Reflux symptoms). The outcome of the drowsiness and gastroesophageal reflux were not reported.   It was unknown if the reporter considered the drowsiness and gastroesophageal reflux to be related to Arexvy.     It was unknown if the company considered the drowsiness and gastroesophageal reflux to be related to Arexvy.   Additional Information: GSK Receipt date: 09-APR-2024 This case was reported by consumer via interactive digital media. The patient received the vaccine yesterday afternoon, feeling drowsy and reflux symptoms not unusual to him/her. Follow-up would not possible as no contact details were available.