chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity, Palpitations, Pruritus, Scan myocardial perfusion
Clinical narrative: She got her vaccine, felt soreness in her arm.  Woke up the next morning, felt something on her forehead and felt another and noticed sores on her hairline on both sides of her forehead.  She popped them she thinks, and then they spread.  There was one by her eye.  She started having heart palpitations and dizziness, weakness, and fatigue and confusion.  She did not want to do anything, the idea of getting dressed was miserable.  She went to the cardiologist and was diagnosed with PVC's, and still having anxiety about doing things, like beginning something and following through.  She has sores on her arms, by her private areas, her butt and her legs as well.  It is not like there are multiple of them and usually comes in 2's.  They itch, she scratches them and then they pop and has something that looks like an open wound like she took some of the skin off.  She is tired of having sores, they are itching, and don't look pretty.  She also has one on her chin.  She has them on her upper arms.  She usually has 10-12 going at a time on different parts of her body, and not on her hands or feet.  She did not go to the doctor for her sores as she has been focusing on her heart.  She went to an UC and then was sent to the  ER while traveling, and ended up that her lungs were good, but was having PVC's, which they recommended for her to go to the cardiologist.  She goes for a test for electrodes on her heart, and going to have an MRI.  She is on a heart monitor at this time.  She had a cath in her arm, no blockage.  Had x-ray of her lungs, no fluid or any cancer, and continued having multiple tests performed.  She is having the MRI on 7/31/24 locally.  They are not finding a reason why she is having an irregular heart beat.  She was given a medicine to regulate her heartbeat Flecanide which she takes 50 mg twice a day.  She did not have any heart issues prior to the vaccine.  She did have COVID twice and wondes if she has long-COVID now.   She sees a cardiologist.  She had a sonogram on her carotid artery, on her heart, testing on her heart.  She had a thallium  stress test but the medicine made her so weak she could not continue with it.  She did not have any other health issues prior to receiving the vaccine.   She was at the ER for hours, and recommended to see a cardiologist.  She went home and saw her PCP and got her into the cardiologist who as ordered tests.  She would slowly get up, her legs were heavy, was dizzy and spreading throughout her body and her arms were heavy.   She wants to know whether this is from the vaccine or not so that she can get on with her life.  She wants to be able to move around without being dizzy.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Ultrasound Doppler, Ventricular extrasystoles, Wound
Clinical narrative: She got her vaccine, felt soreness in her arm.  Woke up the next morning, felt something on her forehead and felt another and noticed sores on her hairline on both sides of her forehead.  She popped them she thinks, and then they spread.  There was one by her eye.  She started having heart palpitations and dizziness, weakness, and fatigue and confusion.  She did not want to do anything, the idea of getting dressed was miserable.  She went to the cardiologist and was diagnosed with PVC's, and still having anxiety about doing things, like beginning something and following through.  She has sores on her arms, by her private areas, her butt and her legs as well.  It is not like there are multiple of them and usually comes in 2's.  They itch, she scratches them and then they pop and has something that looks like an open wound like she took some of the skin off.  She is tired of having sores, they are itching, and don't look pretty.  She also has one on her chin.  She has them on her upper arms.  She usually has 10-12 going at a time on different parts of her body, and not on her hands or feet.  She did not go to the doctor for her sores as she has been focusing on her heart.  She went to an UC and then was sent to the  ER while traveling, and ended up that her lungs were good, but was having PVC's, which they recommended for her to go to the cardiologist.  She goes for a test for electrodes on her heart, and going to have an MRI.  She is on a heart monitor at this time.  She had a cath in her arm, no blockage.  Had x-ray of her lungs, no fluid or any cancer, and continued having multiple tests performed.  She is having the MRI on 7/31/24 locally.  They are not finding a reason why she is having an irregular heart beat.  She was given a medicine to regulate her heartbeat Flecanide which she takes 50 mg twice a day.  She did not have any heart issues prior to the vaccine.  She did have COVID twice and wondes if she has long-COVID now.   She sees a cardiologist.  She had a sonogram on her carotid artery, on her heart, testing on her heart.  She had a thallium  stress test but the medicine made her so weak she could not continue with it.  She did not have any other health issues prior to receiving the vaccine.   She was at the ER for hours, and recommended to see a cardiologist.  She went home and saw her PCP and got her into the cardiologist who as ordered tests.  She would slowly get up, her legs were heavy, was dizzy and spreading throughout her body and her arms were heavy.   She wants to know whether this is from the vaccine or not so that she can get on with her life.  She wants to be able to move around without being dizzy.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose given a couple days too early
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: Patient's wife,reported that 7 days after receiving the second dose of Pfizer Covid vaccine he developed congestive heart failure and was hospitalized for a couple of days
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chest discomfort, Chills, Hyperhidrosis, Influenza like illness
Clinical narrative: She got her vaccine, it stung real bad and was burning.  She did not pay too much attention to that as she was too busy worried about another issue she was seeing the clinic for.  That night she went home and laid in her bed and her arm was hurting and burning real bad.  She went to touch it and it was hot to touch and had excruciating pain in touching it.  She thought that maybe it was due to a little reaction from just getting it.  It then swelled up and continued to get worse and swell up.  She developed a flu-like symptoms, tightness in her chest, and coughing up mucus.  She called virtual doctor who suggested she call her PCP, which she did and could not get in to see a doctor until Friday.  Does not know what she should take or what she can do.  Does she need to come in to get an x-ray and did not tell her anything, so she is upset with her doctors office.   She is taking pain medicine that she has around her house and is having chills/sweats and using a heating blanket off and on.   The welt on her arm is as large as her hand and has continued to grow and is finally starting to taper off, but is not as severe.  She is able to touch it, sore and still has fever in it.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling, Productive cough, Skin warm
Clinical narrative: She got her vaccine, it stung real bad and was burning.  She did not pay too much attention to that as she was too busy worried about another issue she was seeing the clinic for.  That night she went home and laid in her bed and her arm was hurting and burning real bad.  She went to touch it and it was hot to touch and had excruciating pain in touching it.  She thought that maybe it was due to a little reaction from just getting it.  It then swelled up and continued to get worse and swell up.  She developed a flu-like symptoms, tightness in her chest, and coughing up mucus.  She called virtual doctor who suggested she call her PCP, which she did and could not get in to see a doctor until Friday.  Does not know what she should take or what she can do.  Does she need to come in to get an x-ray and did not tell her anything, so she is upset with her doctors office.   She is taking pain medicine that she has around her house and is having chills/sweats and using a heating blanket off and on.   The welt on her arm is as large as her hand and has continued to grow and is finally starting to taper off, but is not as severe.  She is able to touch it, sore and still has fever in it.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Urticaria
Clinical narrative: She got her vaccine, it stung real bad and was burning.  She did not pay too much attention to that as she was too busy worried about another issue she was seeing the clinic for.  That night she went home and laid in her bed and her arm was hurting and burning real bad.  She went to touch it and it was hot to touch and had excruciating pain in touching it.  She thought that maybe it was due to a little reaction from just getting it.  It then swelled up and continued to get worse and swell up.  She developed a flu-like symptoms, tightness in her chest, and coughing up mucus.  She called virtual doctor who suggested she call her PCP, which she did and could not get in to see a doctor until Friday.  Does not know what she should take or what she can do.  Does she need to come in to get an x-ray and did not tell her anything, so she is upset with her doctors office.   She is taking pain medicine that she has around her house and is having chills/sweats and using a heating blanket off and on.   The welt on her arm is as large as her hand and has continued to grow and is finally starting to taper off, but is not as severe.  She is able to touch it, sore and still has fever in it.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Axillary pain, Chest discomfort, Dizziness, Feeling abnormal, Headache
Clinical narrative: Within the first 30 minutes of receiving the injection I began getting a pounding headache and feeling dizzy.  I had sharp pain in the left armpit and tingling down my left arm into my left pinky and ring finger. Later that evening, about 6 hours post injection, I had a discomfort running across my upper chest and noticed swelling on my arm all around the injection site.  I was forced to lay down due to feeling very unstable with nausea.  The following morning, 7/19/2024, I still had a headache but not as bad as the day before.  However, I woke up with hives on my neck and took an antihistamine.  Most of these symptoms subsided within 36 hours, however the headache still seems to linger.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Injection site swelling, Nausea, Paraesthesia, Urticaria
Clinical narrative: Within the first 30 minutes of receiving the injection I began getting a pounding headache and feeling dizzy.  I had sharp pain in the left armpit and tingling down my left arm into my left pinky and ring finger. Later that evening, about 6 hours post injection, I had a discomfort running across my upper chest and noticed swelling on my arm all around the injection site.  I was forced to lay down due to feeling very unstable with nausea.  The following morning, 7/19/2024, I still had a headache but not as bad as the day before.  However, I woke up with hives on my neck and took an antihistamine.  Most of these symptoms subsided within 36 hours, however the headache still seems to linger.
Age: 12.0
Sex: M
Vaccine: HPV9, PNC20
Symptoms: Wrong product administered
Clinical narrative: Patent given the incorrect vaccine.  Provider notified, parent and patent consoled by provider.  Patent given the correct vaccine.  Patent was given PCV -20 and was to get HPV.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt received children's dose of COVID rather than the adult dose. No reactions at this time
Age: 19.0
Sex: M
Vaccine: HEP, UNK, YF
Symptoms: Depressed level of consciousness, Dyspnoea, Pruritus, Urticaria
Clinical narrative: Patient about 30 minutes after receipt of YF-VAX and several other vaccines, he experienced generalized urticaria and pruritus, with progressively worsening dyspnea and near lost of consciousness.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient was given 3rd dose of Gardasil that was not needed. Patient received first dose before age of 15 and had already received 2nd dose.
Age: 22.0
Sex: F
Vaccine: CHOL
Symptoms: Nausea, Oral administration complication, Vomiting
Clinical narrative: Patient advised that she had a period of vomiting approximately 35-40 mins after ingesting cholera vaccine. Patient stated that she felt nauseous for the remainder of the day but felt perfectly fine the following day. Patient denied any chest pain, shortness of breath, Loss of consciousness or any other symptoms.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Malaise, Pyrexia, Rash, Rash erythematous
Clinical narrative: Approximately 1 hour after vaccine on 7/19 (day 1), mom noticed red bumps on back. On day 2-3, increased number of vesicles and developed fever up to 102.3 and malaise. Reported to clinic on Day 4 (7/22). At time of call, continued with fever and malaise. Vesicles noted head to toe, including on face and ears. Some vesicles were starting to crust.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab
Clinical narrative: Approximately 1 hour after vaccine on 7/19 (day 1), mom noticed red bumps on back. On day 2-3, increased number of vesicles and developed fever up to 102.3 and malaise. Reported to clinic on Day 4 (7/22). At time of call, continued with fever and malaise. Vesicles noted head to toe, including on face and ears. Some vesicles were starting to crust.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Limb mass
Clinical narrative: Patient has a lump on her arm and felt pain and soreness in her head. She also reported that she felt headache, slight dizziness from time since the vaccine. She came  and told us this on 5 days after the vaccine. She said she is still feeling pain and headache. She will continue to monitor her symptoms and let us know on the 7th day. She is taking tylenol OTC at the moment and will apply some cold/heating compress on her arm.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site mass
Clinical narrative: The parent stated that the patient received vaccines on  L lateral thigh and, today noted a lump at the injection site.   Per mom, the patient has not had a fever,  not crying or fussiness, and no sign of pain/sensitivity.   Concern for lump which mom feels is "large".   Mom confirmed no redness or heat L lateral thigh;  no swelling into leg.   Mom stated she has been gently bending/exercising the legs and patient has not shown sign of discomfort.   Parent denies patient having vomiting, diarrhea, rash or unusual movements/behavior.  No reported or audible distress or inconsolability; patient with parent at time of this Triage call.   Mom confirmed baby did not have much appetite this am but did begin to eat normally by this afternoon,  feedings are breast feeding alternated with bottle feeds/formula.   No fever.  Patient is wetting diapers through day;  stooling normally.   TRIAGE ref P - immunization reactions.   Criteria meets for Home Care.  Reviewed home care info from protocol including normal reactions,  application of heat or cold,  recommended to always wrap ice in towel and use 10min on 10 min off;   Reviewed use of OTC analgesic,  Pedi Tylenol 160mg/5ml,  for baby weight 17 lb,  can give 2.5ml pedi liq Tylenol every 4-6hrs as needed for pain/fever.   Reviewed S&S when to call provider back and encouraged to call over weekend if concerns as on-call provider will return the call.   ER precautions.   No additional questions.    The vaccine manager followed up on 7/22 and the patient's mother stated the patient is better now, inflammation have went down and does seems to be in any pain.
Age: 9.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: Patient came in with mother for a nurse only visit on 7/17/2024, around 11:20AM. Patient was pulled back from waiting room and put in an exam room. I spoke with the mother about what vaccines where to be given today and the mother stated Prevnar 23. I then went to our vaccine fridge and pulled the shot. I drew up the vaccine and placed the vaccine sticker on our Immunization form for the parent to sign. I went into the exam room and had the mother sign our form and administered the vaccine in the left arm, IM. The patient then left the office. A few minutes later I went to my desk to scan the vaccine into the chart, and it gave a flag. I then looked at the paper and realized it was a Trumenba (Men B) vaccine. I then notified my office manager and the provider about the event. When I went back to the fridge to see how this had happened, I noticed that the box was in the wrong spot in our fridge and the Prevnar 23 was behind it. The mother then was notified by Dr. of the error. With further research there was no harm to the patient. She got the vaccine 2 months early.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Tremor, Vision blurred
Clinical narrative: 1230 pm: 10 minutes after injection employee complains of feeling dizzy, blurry vision, and shaky arms. Observed in RN office seated in chair, ice pack applied to injection site. 2:00PM: no resolution of symptoms. Remains seated quietly in office.
Age: 11.0
Sex: M
Vaccine: HPV9, MNP, TD
Symptoms: Headache, Vomiting
Clinical narrative: headache and vomiting approx. 1 hour after vaccine was given.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Nurse unable to determine after checking EMR and system that patient had already had MCV  4.  Menveo administered as above. Spoke with clinic at the time and was still unable to determine status. Local back in clinic 7/18/24 and reviewed record and informed administering nurse at the end of the day that a VAERS report needed to be done. Attempts made on 7/19/24 to complete report. Call to clinic who again looked into EMR and system with me and asked why it didn't show it on the day of service. She looked a couple of times at both records and finally determined that the child had received a MCV 4 and should have received a MenB. Guardian of patient notified of error on 7/19/24. She stated that child had no problems except some soreness at injection site. I informed her that this happens at times and not be alarmed. Informed guardian that if she desired the MenB vaccine to contact us at the clinic to schedule..
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Rash, Urticaria
Clinical narrative: Patient began experiencing burning sensation in arm during vaccine administration, that evening she reports noticing a rash/hives on left arm, trunk, and neck. She does not report any difficulty breathing, vomiting, fainting, or dizziness.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Dermatitis
Clinical narrative: pt woke up next morning with severe dermatitis on face and around eyes,
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: swelling and redness in left arm about 4 in in diameter lasting 6 days, reported today
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Crying, Decreased appetite, Diarrhoea, Dyschezia
Clinical narrative: diarrhea since 7/7 Patient had his 11 year vaccines 7/5 and woke up 7/7 having a fever of 7 01 F, weakness, tingling in his bilateral arms and legs, and the diarrhea started shortly after. Fever went away after a few hours. Patient has had watery diarrhea with little consistency and no blood visualized every morning and will sit on the toilet on and off (will go to toilet 8-9x) for 2 hours. Even after he has evacuated his bowels, he will stay on the toilet because his abdomen hurts. Mom said during the past two days he was crying while trying to stool and that he was in pain. He has not been eating well and mom has to force him to drink fluids. Before tile onset of symptoms, he had no new food introduction, he had well cooked chicken on July 4, no reheated t1ce, no steak, he went swimming In  a lake a few days before symptoms started, no other travel history, no sick contacts. No allergies, no pertinent medical or surgical history. Immunizations up to date
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Escherichia test positive, Muscular weakness, Paraesthesia, Pyrexia
Clinical narrative: diarrhea since 7/7 Patient had his 11 year vaccines 7/5 and woke up 7/7 having a fever of 7 01 F, weakness, tingling in his bilateral arms and legs, and the diarrhea started shortly after. Fever went away after a few hours. Patient has had watery diarrhea with little consistency and no blood visualized every morning and will sit on the toilet on and off (will go to toilet 8-9x) for 2 hours. Even after he has evacuated his bowels, he will stay on the toilet because his abdomen hurts. Mom said during the past two days he was crying while trying to stool and that he was in pain. He has not been eating well and mom has to force him to drink fluids. Before tile onset of symptoms, he had no new food introduction, he had well cooked chicken on July 4, no reheated t1ce, no steak, he went swimming In  a lake a few days before symptoms started, no other travel history, no sick contacts. No allergies, no pertinent medical or surgical history. Immunizations up to date
Age: 59.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient states that she had soreness and swelling from the arm starting on Wednesday 7/17/24 and the swelling had moved to under the arm around the arm pit on Sunday 7/21/24. She has been icing the area and had started on Ibuprofen to reduce swelling.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient had swelling and pain in the arm following Hep B vaccination on 7/17/2024. She has never had a reaction to any previous vaccinations. She developed a swollen and itchy arm following the hepatitis B vaccination. Her arm was significantly swollen and itchy for two to three days after the vaccination. To alleviate the symptoms, she took Benadryl, which helped. She mentions that there is still a bump at the injection site, but the itching has subsided, and the swelling has decreased. She describes the injection site as being sore during the initial days after the vaccination. No spreading redness around the site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Headache, Muscular weakness
Clinical narrative: severe headache, muscle weakness
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong vaccine given, patient was supposed to receive Kinrix instead of Adacel
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX was administered to a patient after experiencing a T/E; This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 15-MAR-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X021930, expiration date: 29-AUG-2025, administered for prophylaxis (strength, and route of administration were not provided), after a temperature excursion (product storage error). No additional adverse events.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: HCP reports adult patient received 2 Pediatric doses of RECOMBIVAX in 2007.  Specific administration dates unspecified. Caller states patient received 3rd RECOMBIVAX but did not know if this dose was adult or pediatric.  Caller provided 3 separate lo; No additional AE. No PQC.; This spontaneous report was received from a nurse and refers to a 47-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On an unknown date in 2007 the patient was vaccinated with 2 pediatric doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (exact dose, dose number, route and site of administration were not provided). On unknown date the patient received hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (unknown if adult or pediatric) for prophylaxis (exact dose, dose number, route and site of administration were not provided). Lot numbers provided for these doses were as follow: # 0610F and expiration date 14-NOV-2008 , #0007U  and expiration date 07-JUN-2009 and #0223F and expiration date 19-SEP-2008 (underdose and no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; product was administered to a patient after a temperature excursion occurred; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 26-JUN-2024, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #y000202, expiration date: 03-JAN-2026, (strength, exact dose, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error). On an unspecified date, the suspect vaccine underwent a temperature excursion of 21.7 Fahrenheit (F) degrees for 1 hours and 7 minutes. There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event; HCP called to report a pediatric patient received a third dose of VAQTA.  No symptoms have been reported.  The patient's first dose was administered 7/19/2023 and second dose administered 2/7/2024.  The third dose was administered on 7/11/2024.  Con; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-JUL-2023, the patient was vaccinated with first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 07-FEB-2024, the patient was vaccinated with second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 11-JUL-2024, the patient was vaccinated with third hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #X025484, expiration date: 13-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided) (Extra dose administered). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event report; Pharmacist calling to inquire about the validity of an administered dose of an expired VARIVAX vaccine.  Caller stated that the VARIVAX  dose had a labeled expiration date of 07/10/2024 and was administered on  07/11/2024. No symptoms reported. No fu; This spontaneous report was received from registered pharmacist and refers to a patient of unknown age nad gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-JUL-2024, the patient was vaccinated with second dose of expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W021740, expiration date: 10-JUL-2024, administered subcutaneously for prophylaxis (strength was not provided) (Expired product administered). No additional adverse event was reported.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: fourth dose administered on 19-AUG-2004; Second dose administered on 24-FEB-2003 (1 month and 17 days between both doses); This spontaneous report has been received from a physician, via a medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (#2406USA004420), concerning an 4-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-JAN-2003 (at 2 months and 14 days of age), the patient was vaccinated with first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection. Subsequently, on 24-FEB-2003 (at 4 months of age), she received a second dose (inappropriate schedule of product administration). Moreover, on 08-JAN-2004 (at 14 months, 15 days of age), she received a third dose of the vaccine. Lastly, on 19-AUG-2004, she received a fourth dose of the vaccine (extra dose administered). All doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; Nurse reported that an 11-year-old patient was accidently administered GARDASIL 9 subcutaneously instead of intramuscularly; This spontaneous report was received from a nurse referring to a 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 12-JUL-2024, the patient was accidently administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 1 dose, subcutaneously instead of intramuscularly, for prophylaxis (strength, dose, anatomical location, Lot # and expiration date were not reported) (Incorrect route of product administration). No additional adverse event (AE) was reported.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: they accidentally administered a pediatric dose of Engerix-B to an adult patient; they accidentally administered a pediatric dose of Engerix-B to an adult patient; Drug dose administration interval too short; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 41-year-old female patient who received HBV (Engerix B 10 mcg) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis.   Previously administered products included Engerix b (Received Engerix b on 21-FEB-2024) and Recombivax (Received Recombivax on 24-JAN-2024).   On 02-JUL-2024, the patient received the 3rd dose of Engerix B 10 mcg .5 ml. On 02-JUL-2024, an unknown time after receiving Engerix B 10 mcg, the patient experienced adult use of a child product (Verbatim: they accidentally administered a pediatric dose of Engerix-B to an adult patient), underdose (Verbatim: they accidentally administered a pediatric dose of Engerix-B to an adult patient) and drug dose administration interval too short (Verbatim: Drug dose administration interval too short). The outcome of the adult use of a child product, underdose and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 02-JUL-2024 The nurse reported that, they accidentally administered a pediatric dose of Engerix-B (10 micrograms, 0.5 milliliters) to an adult patient which led to adult use of a child product and underdose.  The nurse reported, two prior Hepatitis B vaccines were administered Recombivax and on Engerix-B. The patient received 3rd dose of Engerix b shorter than the recommended interval which led to drug dose administration interval too short The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect dose administered
Clinical narrative: We don't think the patient received the full vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number A5AD4, expiry date 31-JAN-2027) for prophylaxis.   On 08-JUL-2024, the patient received the 2nd dose of Bexsero. On 08-JUL-2024, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: We don't think the patient received the full vaccine). The outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUL-2024 The pharmacist reported that they had a patient that received the vaccine was Bexsero and the nurse reported that some of the vaccine scored back out and so, they were curious. The pharmacist tried to look into the errors and deviations and he/she could not find anything for Bexsero. The pharmacist asked should if they should administer Bexsero again or should they wait. The pharmacist did not think the patient received the full vaccine, which led to incomplete dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on her buttocks; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex.   On an unknown date, the patient received the 1st dose of Shingrix. In MAR-2024, more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles on her buttocks). In JUN-2024, the outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR091519   Additional Information: GSK Receipt Date: 08-JUL-2024 The patient self-reported this case for herself. The patient received her 1st dose of Shingrix about 4 years ago (prior to reporting date).  In MAR-2024 and again in MAY-2024, the patient had shingles on her buttock.; Sender's Comments:  US-GSK-US2024AMR091519:Same patient/2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number 4B54B, expiry date 09-JUL-2024) for prophylaxis.   On 11-JUL-2024, the patient received Shingrix. On 11-JUL-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2024 The patient received expired vaccine which led to expired vaccine used. The reporter did not consent to follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass, Pain in extremity
Clinical narrative: lumps on right side of my neck; my axillary lymph nodes activated on R side and they're still reactive; pain shoots down my inner arm toward my pinkie finger; This spontaneous case was reported by a patient and describes the occurrence of NECK MASS (lumps on right side of my neck), LYMPHADENOPATHY (my axillary lymph nodes activated on R side and they're still reactive) and PAIN IN EXTREMITY (pain shoots down my inner arm toward my pinkie finger) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 milliliter. On 11-Jul-2024, the patient experienced NECK MASS (lumps on right side of my neck), LYMPHADENOPATHY (my axillary lymph nodes activated on R side and they're still reactive) and PAIN IN EXTREMITY (pain shoots down my inner arm toward my pinkie finger). At the time of the report, NECK MASS (lumps on right side of my neck), LYMPHADENOPATHY (my axillary lymph nodes activated on R side and they're still reactive) and PAIN IN EXTREMITY (pain shoots down my inner arm toward my pinkie finger) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. It was reported that a few days after vaccine, my axillary lymph nodes activated on R side, and they were still reactive and painful at least once a week. Patient now being followed for lumps on right side of neck. It was unknown if the patient experienced any additional symptoms/events.
Sex: M
Vaccine: MEN, MENB
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: fever; chills; felt sick; got his first Trumenba on 17Mar2022/ At the same time, he got another meningococcal conjugate combination vaccine; got his first Trumenba on 17Mar2022/ At the same time, he got another meningococcal conjugate combination vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 16-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 17Mar2022 as dose 1, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine conj (MENINGOCOCCAL CONJUGATE), on 17Mar2022 as dose 1, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 17Mar2022, outcome "unknown" and all described as "got his first Trumenba on 17Mar2022/ At the same time, he got another meningococcal conjugate combination vaccine"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "felt sick". Additional information: Caller stated that her son got his first meningococcal group b Rlp2086 on 17Mar2022. At the same time, he got another meningococcal conjugate combination vaccine and afterwards he had fever, chills, felt sick and was in bed.  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400216459 Same patient/ vaccine, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots in leg; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 29-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (hospitalization) with onset Aug2023, outcome "unknown", described as "blood clots in leg". The patient had blood clots and stuff like that and had to go to the hospital to get blood clots removed from her leg. Therapeutic measures were taken as a result of thrombosis.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Food allergy
Clinical narrative: Having progressive food and plant allergy; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Not Provided) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOOD ALLERGY (non-serious), outcome "unknown", described as "Having progressive food and plant allergy".
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disturbance in attention, Dizziness, Headache, Nystagmus
Clinical narrative: Nystagmus; Photophobia; Dizziness; Vertigo; Headache; Difficulty concentrating; Balance issues; This is a spontaneous report received from a Nurse.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 at 13:00 as dose 1, single (Lot number: EH9899) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "NIDDM" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Paroxysmal atrial fibrillation" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BALANCE DISORDER (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering", described as "Balance issues"; DISTURBANCE IN ATTENTION (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering", described as "Difficulty concentrating"; DIZZINESS (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering"; HEADACHE (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering"; NYSTAGMUS (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering"; PHOTOPHOBIA (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering"; VERTIGO (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering". Therapeutic measures were taken as a result of balance disorder. Additional information: The patient did not receive any other vaccines on the same date as the vaccine (BNT162b2). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. The patient had no known allergies. The patient underwent/received physical therapy for balance as treatment.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Photophobia, Vertigo
Clinical narrative: Nystagmus; Photophobia; Dizziness; Vertigo; Headache; Difficulty concentrating; Balance issues; This is a spontaneous report received from a Nurse.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 at 13:00 as dose 1, single (Lot number: EH9899) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "NIDDM" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Paroxysmal atrial fibrillation" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BALANCE DISORDER (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering", described as "Balance issues"; DISTURBANCE IN ATTENTION (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering", described as "Difficulty concentrating"; DIZZINESS (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering"; HEADACHE (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering"; NYSTAGMUS (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering"; PHOTOPHOBIA (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering"; VERTIGO (non-serious) with onset 20Dec2020 at 13:00, outcome "recovering". Therapeutic measures were taken as a result of balance disorder. Additional information: The patient did not receive any other vaccines on the same date as the vaccine (BNT162b2). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. The patient had no known allergies. The patient underwent/received physical therapy for balance as treatment.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller mentioned that he had received Pfizer COVID shots 2 or 3 years ago. He was also not sure if he was beyond the initial 5 days of symptoms in order to take Paxlovid. Caller confirmed that he has been taking Mucinex for a couple days. He was not sure when his Covid symptoms started, it may be 5 to 7 days or more. He wanted to know if Paxlovid would still be effective if he starts taking it beyond the first 5 days of symptoms.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: PNC13
Symptoms: Cochlea implant, Inappropriate schedule of product administration
Clinical narrative: get a cochlear implant on Sep2023; This is a spontaneous report received from a Nurse from medical information team, Program ID:.  A 20-month-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), on 15Apr2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine conj 15v (CRM197) (PNEUMOCOCCAL VACCINE CONJ 15V (CRM197)), on 07May2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COCHLEA IMPLANT (medically significant) with onset Sep2023, outcome "unknown", described as "get a cochlear implant on Sep2023". Therapeutic measures were taken as a result of cochlea implant. Additional information: the nurse called about the patient who had a cochlear implant in Sep2023. It was reported that the patient is behind regularly scheduled dosing guidelines and caller is seeking guidance on when to administer subsequent pneumococcal doses.     The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on known disease pathophysiology, the event cochlea implant is assessed as not related to PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), and more likely a procedure performed for an underlying medical condition of the inner ear that can be congenital.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: reduction or elimination of cold sore breakouts after the Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cold sore breakout", start date: 1983 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "reduction or elimination of cold sore breakouts after the Pfizer vaccine". Additional information: The patient would like some type of data done on the reduction or elimination of cold sore breakouts after the Pfizer vaccine. Patient had not had a break out in four years and previously he/she had at least one breakout since 1983.  Batch/lot number is not provided, and it cannot be obtained.