chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient came in with her father and brother.  There were no records in the state immunization database.  I asked if they had any copies of her records.  He said he had them on his phone and I asked if he would send them to my work email.  When I got them I looked the form over and told him that she needed her second Varicella and the second Meningitis vaccines.  They were trying to decide if she remembered getting any shots in the states or if she got them all while out of the country.  We compared her records from the base to her brothers' records. On both records the Varicella was showing on the bottom of the record on both siblings' records.  The brother's record showed the statement " Last item" after his second Varicella.  Her record showed the "Last item" statement after her first Varicella so we all agreed that she had only one dose before moving.  I administered both patient's vaccines and they left.  By the time I was done, it was the end of the day so I put the papers in the area where I work on them the next work day.  That day was super busy so I did not get to input the records into the medical record until the 21st of August.  It was then that I realized that halfway down the record it listed MMRV vaccination under the MMR vaccine.  So evidently for the second varicella vaccination she received the combination MMR and Varicella vaccine and that is why it looked like she did not receive a second Varicella.
Age: 51.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient at the offsite clinic was 51 yrs old only. Indication for RSV vaccine at that time was for 60 and over. No adverse reaction was reported. just filling out to report and document incident of patient below recommended age received the vaccine.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Bronchitis, Cough, Malaise
Clinical narrative: 2 Days after vaccination patient developed a cough that progressed to full bronchitis. She is only feeling  better now after 3 weeks of being sick
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Feeling abnormal, Injection site swelling, Pyrexia, Rash
Clinical narrative: The mother stated that the patient had a rash on both thighs starting last night. The patient felt like they had a fever. but the mother did not take the temperature. The mother has been giving the patient Tylenol as instructed by the provider. The mother stated the child is feeling bad today and wants to be carried. The mother stated the provider also instructed her to put an ice pack on injection sites to help with swelling.
Age: 17.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Chills, Decreased appetite, Electrocardiogram J wave abnormal, Electrocardiogram abnormal, Feeling cold
Clinical narrative: HPV vaccine 8/21/2024 at 1:30 pm, around 6 pm, , The first thing that happened was that she felt very cold, shivering with chills.  Pt had sudden onset fever, heart racing, feeling unwell, headache. Mom took her to the ED around 7 pm.  They gave her an ibuprofen to help with the sx and she had some relief. ED did screening for COVID, flu, RSV which were all negative.  Her HR was in the 150s when she arrived, took an EKG, and when HR improved was discharged home to f/u with PCP. Fever this morning on 8/22 was 100.5, lowest has been 98.7 HR is down to 99, lowest it has been, but averaging around 114 bpm.  Continuing sx include rapid heart rate, fever, headache. decreased appetite,  Patient states that overall she is feeling a little better this afternoon but still unwell.
Age: 17.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Headache, Heart rate increased, Influenza virus test negative, Malaise, Palpitations
Clinical narrative: HPV vaccine 8/21/2024 at 1:30 pm, around 6 pm, , The first thing that happened was that she felt very cold, shivering with chills.  Pt had sudden onset fever, heart racing, feeling unwell, headache. Mom took her to the ED around 7 pm.  They gave her an ibuprofen to help with the sx and she had some relief. ED did screening for COVID, flu, RSV which were all negative.  Her HR was in the 150s when she arrived, took an EKG, and when HR improved was discharged home to f/u with PCP. Fever this morning on 8/22 was 100.5, lowest has been 98.7 HR is down to 99, lowest it has been, but averaging around 114 bpm.  Continuing sx include rapid heart rate, fever, headache. decreased appetite,  Patient states that overall she is feeling a little better this afternoon but still unwell.
Age: 17.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Sinus tachycardia
Clinical narrative: HPV vaccine 8/21/2024 at 1:30 pm, around 6 pm, , The first thing that happened was that she felt very cold, shivering with chills.  Pt had sudden onset fever, heart racing, feeling unwell, headache. Mom took her to the ED around 7 pm.  They gave her an ibuprofen to help with the sx and she had some relief. ED did screening for COVID, flu, RSV which were all negative.  Her HR was in the 150s when she arrived, took an EKG, and when HR improved was discharged home to f/u with PCP. Fever this morning on 8/22 was 100.5, lowest has been 98.7 HR is down to 99, lowest it has been, but averaging around 114 bpm.  Continuing sx include rapid heart rate, fever, headache. decreased appetite,  Patient states that overall she is feeling a little better this afternoon but still unwell.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9, MENB
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Pt suffered a temporary loss of consciousness with quick recovery post vaccinations.  Pt had a total of three vaccines administered, and reported she was nervous about receiving vaccines.  Mother reported patient gets this reaction with any type of pain.  This was not mentioned when I asked if she has had any adverse reactions to past vaccines.  Doctor was consulted and reported pt had a vasovagal episode.  Pt recovered quickly and was discharged.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pain redness and swelling  in arm. Pain to where I?m unable to move my  upper arm
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Multiple use of single-use product
Clinical narrative: Needle Stick after the vaccination was administered to another patient
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Pt is under age for TDaP and was not due for it
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Product administered at inappropriate site
Clinical narrative: Child seemed alright until I went to give him the vaccine.  He was doing everything he could think of to avoid receiving the vaccine.  He would not take off his hoodie and he was moving so his father could not get his arm out of the hoodie either.  He got up and tried getting out of the door. His father tried physically to hold him so I could give the vaccine but the child was as big as the father so he could not hold him.   The father used verbal threats and bribes to try to get the child to be still for the vaccine.  This went on for several minutes but I did not feel it was safe for any of us to get the vaccine administered.  Finally the dad said "Ok that is it, you are grounded and we are done here."  He then turned to me and said sorry he guessed they were not doing it that day.  I left the room very briefly to grab his shot record so that he could show the school what vaccines he had received from us prior to that day's visit.   When I opened the door I saw the older brother who had received his vaccines moments earlier waiting beside one of the nurses.  As I was heading back into the room and was handing the father the shot record she stepped forward and asked if any help was needed.  I was beginning to say "No thank you" when the father said sure.  The boy was at that time sitting in the chair closest to my desk and the  nurse then picked up the vaccine that was on my desk and proceeded to physically lay on the child along with the father helping to hold him down.  She then jabbed the vaccine into the child's Left arm below the known deltoid area and into the area about an inch or two above the elbow.   The placement of the band aid showed that it was not a properly administered vaccine.  I was in shock and did not say anything to the father about the method used or the location of the shot given.  He stated to the nurse "You are awesome!! Thank You!!"  This statement put me into further shock and I just felt unable to speak at that point.  Shortly after this time it was time to  leave for the day.  I had been contemplating what to do about the situation then it was vacation time.  I spoke with my supervisor.
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Note     Today during a shift change there was some confusin with the shots order and the shots written on the micr, I was rushing and failed to pay attention and gave patient vaxelis and hib (2 doses of hib)   I called mom and informed her of my mistake and that she is advised to keep an eye on him. Per staff he might have some side effects similar to regular vaccine administrations.  I told her she may call us, come in, or go to er with any concerns.     8/22/24 7:24pm
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The Patient came in for a dose of flu and rsv. I administered both vaccines. Afterward I found out he had already had a dose of abrysvo  02/17/24. Only 1 dose is indicated so this is an additional dose. The patient stayed in the pharmacy for 45 minutes and had no side effects.
Age: 12.0
Sex: M
Vaccine: FLU4, TDAP, UNK
Symptoms: Cold sweat, Pallor, Syncope
Clinical narrative: Patient came in for 3 vaccines, when he received the first shot, he was  without symptoms. He was fine after the second vaccine. When I administed the 3 vaccine,  patient had a fainted. I assigned a pharmacy technician to call EMS while I attended to the patient. Patient was conscious and awake but  pale with clamppy hands. Patient was about to follow insdtruction of squeezing my hand. After about few minutes, patient's mother requested for orand juice for the patient. Patient was able sit up and drink the orange juice while we wait of the first responders. When the first responders arrived, patient able to say his name, date of birth, his school, and what he had for lunch. Patient's vitals were stable.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Lethargy, Pain in extremity
Clinical narrative: Day 1 - sore arm, Day 2 - headache, lethargy, Day 3 - severe dizziness.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Dyspnoea, Headache, Rash, Syncope
Clinical narrative: Patient reported shortness of breath almost immediately after injection was administered, after fainted rash on chest/neck area that faded away with minutes also reported a headache. Patient was instructed to lay down and ambulate both feet. Patient was monitored for about 30 minutes .
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: baseball sized redness and swelling. itching the first two days but better by the time patient presented to pharmacy
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: Patient describes an itchy feeling after receiving the vaccine in her arm.  Later when she got home she says she broke out in a rash all over and was very itchy.  She took Benadryl and was better this morning and no longer itching.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TD, VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: 17-year-old female patient was here for vaccination. Patient received Hepatitis A intramuscular, Hepatitis B intramuscular, Inactivated Polio Virus intramuscular, Td intramuscular, MMR subcutaneous and Varicella subcutaneous at 1:20 pm. During observation, patient felt nauseous and dizzy. At 1:45 PM BP 82/59 HR 60 O2 99% TEMP 97.5. At 2:00 PM BP 91/71 HR 67 O2 99%. At 2:05 PM BP 94/72 HR 73 O2 98%. At 2:10 PM BP 99/73 HR 73 O2 99%. Provider was contacted at 2:12 pm. The patient was not complaining of any other symptoms. Patient's mom refused ambulance transport for her child. Patient was advised to stay with us for 15 more minutes for observation. After 15 minutes, the patient stated that she felt fine and had no other symptoms. Patient was stable. Patient's mom stated after the event that her daughter had a very small meal at about 8 am in the morning and did not have anything else to eat since then.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Cardiac monitoring abnormal, Cardioversion, Catheterisation cardiac normal, Chest discomfort
Clinical narrative: Two days after vaccine, patient developed light-headedness and "thumping in chest" followed by another episode 4 days after vaccine.  Patient sought medical evaluation and had multiday heart monitor.  The report some days later indicated runs of supraventicular tachycardia.  On Nov. 20, patient had irregular heart rate and evaluated in emergency department.  Atrial fibrillation detected and patient transferred to major health care facility.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Echocardiogram normal, Full blood count normal, Heart rate irregular, Laboratory test normal
Clinical narrative: Two days after vaccine, patient developed light-headedness and "thumping in chest" followed by another episode 4 days after vaccine.  Patient sought medical evaluation and had multiday heart monitor.  The report some days later indicated runs of supraventicular tachycardia.  On Nov. 20, patient had irregular heart rate and evaluated in emergency department.  Atrial fibrillation detected and patient transferred to major health care facility.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Sinus rhythm, Supraventricular tachycardia
Clinical narrative: Two days after vaccine, patient developed light-headedness and "thumping in chest" followed by another episode 4 days after vaccine.  Patient sought medical evaluation and had multiday heart monitor.  The report some days later indicated runs of supraventicular tachycardia.  On Nov. 20, patient had irregular heart rate and evaluated in emergency department.  Atrial fibrillation detected and patient transferred to major health care facility.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Blood test normal, COVID-19, Cardiovascular evaluation, Chest X-ray normal
Clinical narrative: 03/01/2021: mild Lt arm soreness, resolution 7 days. 03/22/2021: fever to 101F resolution 5 days. LT arm pain 03/23/2021: Lt arm pain Lt axilla pain swelling. Rt axilla pain, Bilateral chest wall pain from axillas to xiphoid to manubrium. 06/2021: complete cardiopulmonary w/u- WNL. 50% better by 10/04/2021 (Pfizer booster). Reoccurence of chest wall pain. Better by 05/22. Contracted COVID 08/2022.reoccurance of chest wall pain. Intermittent reoccurences. Severe relapse. 05/2024. Non associated illnesses. Repeat cardioplumonary E/U including Rheumatology. All WNL except for elevated total complement. Now 50% improved.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Complement analysis, Computerised tomogram thorax, Echocardiogram normal, Electrocardiogram normal, Illness
Clinical narrative: 03/01/2021: mild Lt arm soreness, resolution 7 days. 03/22/2021: fever to 101F resolution 5 days. LT arm pain 03/23/2021: Lt arm pain Lt axilla pain swelling. Rt axilla pain, Bilateral chest wall pain from axillas to xiphoid to manubrium. 06/2021: complete cardiopulmonary w/u- WNL. 50% better by 10/04/2021 (Pfizer booster). Reoccurence of chest wall pain. Better by 05/22. Contracted COVID 08/2022.reoccurance of chest wall pain. Intermittent reoccurences. Severe relapse. 05/2024. Non associated illnesses. Repeat cardioplumonary E/U including Rheumatology. All WNL except for elevated total complement. Now 50% improved.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Musculoskeletal chest pain, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: 03/01/2021: mild Lt arm soreness, resolution 7 days. 03/22/2021: fever to 101F resolution 5 days. LT arm pain 03/23/2021: Lt arm pain Lt axilla pain swelling. Rt axilla pain, Bilateral chest wall pain from axillas to xiphoid to manubrium. 06/2021: complete cardiopulmonary w/u- WNL. 50% better by 10/04/2021 (Pfizer booster). Reoccurence of chest wall pain. Better by 05/22. Contracted COVID 08/2022.reoccurance of chest wall pain. Intermittent reoccurences. Severe relapse. 05/2024. Non associated illnesses. Repeat cardioplumonary E/U including Rheumatology. All WNL except for elevated total complement. Now 50% improved.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Laboratory test, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat, stuffy head, runny nose, headache
Age: 45.0
Sex: M
Vaccine: COVID19, HEP, MMR, UNK, MMR
Symptoms: Blood glucose normal, Dizziness, Injection site pruritus, Loss of consciousness, Nausea
Clinical narrative: A few minutes after administration, the patient had a syncopal episode lasting a few minutes.; HCP called to report that a full dose of MMRII was accidentally administered intradermally instead of IM/SQ to a 45 year old male patient on 08/13/2024. Caller reported a few minutes after administration, the patient had a syncopal episode lasting a; This spontaneous report was received from a nurse and refers to a 45-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 13-AUG-2024, the patient was accidentally vaccinated with a full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, 1 dose, valid lot #X022411, expiration date reported and confirmed as 05-JUN-2025, administered intradermally instead of intramuscular/subcutaneously (IM/SQ) (Incorrect route of product administration) for prophylaxis (strength, exact dose, and anatomical location were not provided).  On the same day, a few minutes after vaccination, the patient had a syncopal episode lasting a few minutes (syncope). Initially it was thought the patient as having a seizure and called the emergency number but once the physician went into the room, they cancelled the call because the patient "came to" and his vital signs were starting to normalize. The patient was treated in the office by laying him down, elevating his legs, monitoring his vitals, and giving him crackers and juice. In addition, it was informed that he continued being monitored in the office for an unspecified amount of time and was never hospitalized. No additional details were reported. At the time of reporting, the patient was recovering from the event of syncope.  The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) was not provided.   Upon internal review, the event of syncope was determined to be medically significant.
Age: 45.0
Sex: M
Vaccine: COVID19, HEP, MMR, UNK, MMR
Symptoms: Peripheral coldness, Syncope, Unresponsive to stimuli
Clinical narrative: A few minutes after administration, the patient had a syncopal episode lasting a few minutes.; HCP called to report that a full dose of MMRII was accidentally administered intradermally instead of IM/SQ to a 45 year old male patient on 08/13/2024. Caller reported a few minutes after administration, the patient had a syncopal episode lasting a; This spontaneous report was received from a nurse and refers to a 45-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 13-AUG-2024, the patient was accidentally vaccinated with a full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, 1 dose, valid lot #X022411, expiration date reported and confirmed as 05-JUN-2025, administered intradermally instead of intramuscular/subcutaneously (IM/SQ) (Incorrect route of product administration) for prophylaxis (strength, exact dose, and anatomical location were not provided).  On the same day, a few minutes after vaccination, the patient had a syncopal episode lasting a few minutes (syncope). Initially it was thought the patient as having a seizure and called the emergency number but once the physician went into the room, they cancelled the call because the patient "came to" and his vital signs were starting to normalize. The patient was treated in the office by laying him down, elevating his legs, monitoring his vitals, and giving him crackers and juice. In addition, it was informed that he continued being monitored in the office for an unspecified amount of time and was never hospitalized. No additional details were reported. At the time of reporting, the patient was recovering from the event of syncope.  The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) was not provided.   Upon internal review, the event of syncope was determined to be medically significant.
Age: 45.0
Sex: M
Vaccine: COVID19, HEP, MMR, UNK, MMR
Symptoms: Incorrect route of product administration, Syncope
Clinical narrative: A few minutes after administration, the patient had a syncopal episode lasting a few minutes.; HCP called to report that a full dose of MMRII was accidentally administered intradermally instead of IM/SQ to a 45 year old male patient on 08/13/2024. Caller reported a few minutes after administration, the patient had a syncopal episode lasting a; This spontaneous report was received from a nurse and refers to a 45-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 13-AUG-2024, the patient was accidentally vaccinated with a full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, 1 dose, valid lot #X022411, expiration date reported and confirmed as 05-JUN-2025, administered intradermally instead of intramuscular/subcutaneously (IM/SQ) (Incorrect route of product administration) for prophylaxis (strength, exact dose, and anatomical location were not provided).  On the same day, a few minutes after vaccination, the patient had a syncopal episode lasting a few minutes (syncope). Initially it was thought the patient as having a seizure and called the emergency number but once the physician went into the room, they cancelled the call because the patient "came to" and his vital signs were starting to normalize. The patient was treated in the office by laying him down, elevating his legs, monitoring his vitals, and giving him crackers and juice. In addition, it was informed that he continued being monitored in the office for an unspecified amount of time and was never hospitalized. No additional details were reported. At the time of reporting, the patient was recovering from the event of syncope.  The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) was not provided.   Upon internal review, the event of syncope was determined to be medically significant.
Age: 65.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Atrial fibrillation, Heart rate increased
Clinical narrative: patient experience high heart rate  during the regular visit with her PCP the day after vaccination. Her PCP sent her to ER immediately and found she experienced A-fiB. She discharged home with medication for blood thinning and  new med for heart and blood pressure.
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, CHIK
Symptoms: Arthralgia, Menstruation irregular, Pyrexia
Clinical narrative: Joint pain; Got her period two weeks early; The following information was received from an healthcare professional on 12 Aug 2024.  A female vaccinee of unknown age received one dose of IXCHIQ (Chikungunya virus vaccination(CHIKV), batch number not provided) on 08 Aug 2024.  On an unknown date she experienced joint pain. She also stated that she got her period two weeks earlier than usual.  An outcome was not provided.; Sender's Comments: Causality assessed as possibly related for Arthralgia, as time to onset is plausible (maximum 4 days past vaccination, exact date unknown). Moreover, arthralgia is well known for IXCHIQ, indicative of a systemic vaccination reaction. Causality assessed as excluded for menstruation irregular, as there is no scientific evidence so far linking vaccination with IXCHIQ to this adverse event, although time to onset might be possible.  As detailed information on these events are scarce, a more detailed assessment is not possible based on data provided.  Follow-up was initiated.
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, CHIK
Symptoms: Arthralgia, Menstruation irregular
Clinical narrative: Joint pain; Got her period two weeks early; The following information was received from an healthcare professional on 12 Aug 2024.  A female vaccinee of unknown age received one dose of IXCHIQ (Chikungunya virus vaccination(CHIKV), batch number not provided) on 08 Aug 2024.  On an unknown date she experienced joint pain. She also stated that she got her period two weeks earlier than usual.  An outcome was not provided.; Sender's Comments: Causality assessed as possibly related for Arthralgia, as time to onset is plausible (maximum 4 days past vaccination, exact date unknown). Moreover, arthralgia is well known for IXCHIQ, indicative of a systemic vaccination reaction. Causality assessed as excluded for menstruation irregular, as there is no scientific evidence so far linking vaccination with IXCHIQ to this adverse event, although time to onset might be possible.  As detailed information on these events are scarce, a more detailed assessment is not possible based on data provided.  Follow-up was initiated.
Age: 0.17
Sex: U
Vaccine: PNC20, RV1, VARCEL, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No additional AE; HCP calling to report a patient inadvertently received VARIVAX instead of VAXELIS at age 2 months. No side effects reported. No additional information/clarification provided. No additional AE/no PQC.; patient inadvertently received VARIVAX instead of VAXELIS at age 2 months; This spontaneous report was received from a nurse and refers to a 2-month-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 20-AUG-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml, lot #Y003892, expiration date: 06-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided) instead of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) (reported as Vaxelis) (Wrong product administered) (Product administered to patient of inappropriate age).
Age: 0.17
Sex: U
Vaccine: PNC20, RV1, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; HCP calling to report a patient inadvertently received VARIVAX instead of VAXELIS at age 2 months. No side effects reported. No additional information/clarification provided. No additional AE/no PQC.; patient inadvertently received VARIVAX instead of VAXELIS at age 2 months; This spontaneous report was received from a nurse and refers to a 2-month-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 20-AUG-2024, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml, lot #Y003892, expiration date: 06-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided) instead of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) (reported as Vaxelis) (Wrong product administered) (Product administered to patient of inappropriate age).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Diarrhoea, Housebound, Impaired work ability, Spinal implantation
Clinical narrative: --Hair loss that has lasted for years. Loss of hairline like male pattern baldness. --Diarrhea 24/7 for 2 1/2 years. Could not go into work and was mostly homebound. Had to have surgery to implant a device in my spine. Axonics.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood lactic acid, Chills, Dehydration, Dizziness
Clinical narrative: abdominal pain, fever, dehydration, vomiting,  dizziness, and chills/Treatments: Intravenous (IV) fluids, acetaminophen, cefTRIAXone, famotidine, iohexol, ketorolac, metroNIDAZOLE, MORPHINE, & ondansetron
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil count, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: abdominal pain, fever, dehydration, vomiting,  dizziness, and chills/Treatments: Intravenous (IV) fluids, acetaminophen, cefTRIAXone, famotidine, iohexol, ketorolac, metroNIDAZOLE, MORPHINE, & ondansetron
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Back pain, Myalgia, Sleep disorder
Clinical narrative: Night of 8/19- a lot of soreness in left shoulder, as well as muscle aches throughout the body but especially in lower back, which made it difficult to sleep; 8/20 all day- some lingering soreness in left shoulder and ache in lower back; 8/21 and 8/22- soreness in left shoulder, lessening each day (tolerable)
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No side effects reprted. No additional AE/PQC.; Patient received less than a recommended dose of RECOMBIVAX HB on 02AUG2024. The patient was a 22 year old female who received 0.5mL of the dose.; This spontaneous report was received from a nurse and referred to a 22-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-AUG-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB), 0.5 milliliter, lot #x021478, (expiration date: 18-MAY-2026), administered for prophylaxis (strength, and route of administration were not provided), therefore, the patient received less than a recommended dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (Underdose). No side effects reported, no other medical information known. No additional adverse event (AE)/product quality complaint (PQC) (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported. No PQC reported; Medical assistant reported VARIVAX was administered after a temperature excursion to one patient; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown gender and age.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.   On unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) lot #X028613, expiration date: 13-DEC-2025, underwent a temperature excursion (TE) at a temperature of 7.9 Fahrenheit (F) for time frame of 7 hours 25 minutes.  On 19-AUG-2024, the patient was vaccinated with improperly stored vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, lot #X028613, expiration date was reported and confirmed as 13-DEC-2025, administered for prophylaxis (strength, exact dose and route of administration were not provided). There was not a previous TE reported. Operator of device was reported as health professional. No further information provided. No additional adverse event or product quality complaint were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2408USA006726:
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Extreme shoulder pain and soreness at time of injection and ever since
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; to a 16 year old; This spontaneous report was received from Other Health Professional and refers to a 16-year-old female patient.  The patient's previous adverse drug reaction history and family adverse drug reactions were not reported. The patient's concomitant therapies, medical histories and drug allergies were not reported.  On 30-JUL-2024, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, once, administered for prophylaxis (lot #X005171, expiration date: 13-NOV-2025) (strength, and route of administration were not provided) (Product administered to patient of inappropriate age).   It was reported that no side effects, no symptoms or side effects are present, no additional AE information (No adverse event).
Age: 8.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix was administered to an 8 year old on 9-AUG-2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 09-AUG-2024, the patient received the 1st dose of Pediarix. On 09-AUG-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix was administered to an 8 year old on 9-AUG-2024). The outcome of the inappropriate age at vaccine administration was not reported.   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: 13-AUG-2024 The Pediarix was administered to an 8 year old patient, which led to inappropriate age at vaccine administration. No further information was known such as intended vaccine. The Pediarix shot administered on last Friday, was the first Dtap IPV and hep B vaccine on patient vaccination history.  The patient received as well, hep A and MMR. Consented to follow up.
Age: 12.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient had already received full series of HPV, 1st dose of Meningococcal and was not due yet for the second, and 1st dose of Tdap and was not due for a booster.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose increased, Loss of consciousness
Clinical narrative: Patient had vaccine at approx at 1440  -- no reactions at the time of vaccine , Patients mother reported it approx 12 the next afternoon. They had called from the school and her blood glucose was high which had caused her to  pass out.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic valve sclerosis, Blood culture negative, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Admit date: 8/12/2024  Discharge date: 08/14/2024  Admitting Physician: MD  Attending Physician at the Time of Discharge: MD  Primary Care Physician: None Physician, DO, None  Reason for Admission: syncope   Brief Summary of Hospital Stay:   Patient 74yo male with no PMHx who presented to the ED after a presyncopal episode. Patient has not had any medical care since 1970 and takes no medications at home. On admission patient was found to be tachycardic, tachypneic, febrile and positive for COVID-19.  Patient was given 1 L of fluids and Tylenol for his fevers.  Troponins were also taken on admission in initially they were 17 and up trended to 25 with a negative EKG.  Repeat troponin decreased to 14.  TSH, K, Na, glucose all were WNL.  Patient had a chest x-ray that was negative in orthostatics done the were also negative.  Patient had an echo completed that showed a normal ejection fraction and mild aortic valve sclerosis.  Given patient's improvement in clinical symptoms and remaining afebrile, patient was stable to be discharged.  There was a possibility that his symptoms were due to a TIA because patient mention that about 7 years ago he had an episode like this were 1 side of his body felt numb.  Patient was started on aspirin therapy and should follow up with the PCP to establish formal medical care.  Hospital Course: Imaging reviewed Echo 8/12 - LVEF 65%, mild aortic valve sclerosis.  Impression/Plan: Sepsis in the setting of COVID-19 - Acetaminophen prn  - Pulm Toilet: IS - Blood cx no new growth   - Respiratory precautions  - Continued Vit D, C and Zinc  Presyncope Cardiac vs Infectious  TSH, Na, K, glucose were WNL Lipid panel significant for LDL 121  Negative orthostatics - Echo as above  - ASA 81mg started   Elevated Troponins, likely demand ischemia Elevated troponins, 17->25 on 8/12, ECG significant only for tachycardia, asx - Repeat troponins 14,  Issues Requiring Follow Up:   Follow-up with PCP for further evaluation of chronic medical conditions. Discharged to Home.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, COVID-19, Chest X-ray normal, Echocardiogram abnormal, Ejection fraction
Clinical narrative: Admit date: 8/12/2024  Discharge date: 08/14/2024  Admitting Physician: MD  Attending Physician at the Time of Discharge: MD  Primary Care Physician: None Physician, DO, None  Reason for Admission: syncope   Brief Summary of Hospital Stay:   Patient 74yo male with no PMHx who presented to the ED after a presyncopal episode. Patient has not had any medical care since 1970 and takes no medications at home. On admission patient was found to be tachycardic, tachypneic, febrile and positive for COVID-19.  Patient was given 1 L of fluids and Tylenol for his fevers.  Troponins were also taken on admission in initially they were 17 and up trended to 25 with a negative EKG.  Repeat troponin decreased to 14.  TSH, K, Na, glucose all were WNL.  Patient had a chest x-ray that was negative in orthostatics done the were also negative.  Patient had an echo completed that showed a normal ejection fraction and mild aortic valve sclerosis.  Given patient's improvement in clinical symptoms and remaining afebrile, patient was stable to be discharged.  There was a possibility that his symptoms were due to a TIA because patient mention that about 7 years ago he had an episode like this were 1 side of his body felt numb.  Patient was started on aspirin therapy and should follow up with the PCP to establish formal medical care.  Hospital Course: Imaging reviewed Echo 8/12 - LVEF 65%, mild aortic valve sclerosis.  Impression/Plan: Sepsis in the setting of COVID-19 - Acetaminophen prn  - Pulm Toilet: IS - Blood cx no new growth   - Respiratory precautions  - Continued Vit D, C and Zinc  Presyncope Cardiac vs Infectious  TSH, Na, K, glucose were WNL Lipid panel significant for LDL 121  Negative orthostatics - Echo as above  - ASA 81mg started   Elevated Troponins, likely demand ischemia Elevated troponins, 17->25 on 8/12, ECG significant only for tachycardia, asx - Repeat troponins 14,  Issues Requiring Follow Up:   Follow-up with PCP for further evaluation of chronic medical conditions. Discharged to Home.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction normal, Electrocardiogram normal, Low density lipoprotein normal, Myocardial ischaemia, Presyncope
Clinical narrative: Admit date: 8/12/2024  Discharge date: 08/14/2024  Admitting Physician: MD  Attending Physician at the Time of Discharge: MD  Primary Care Physician: None Physician, DO, None  Reason for Admission: syncope   Brief Summary of Hospital Stay:   Patient 74yo male with no PMHx who presented to the ED after a presyncopal episode. Patient has not had any medical care since 1970 and takes no medications at home. On admission patient was found to be tachycardic, tachypneic, febrile and positive for COVID-19.  Patient was given 1 L of fluids and Tylenol for his fevers.  Troponins were also taken on admission in initially they were 17 and up trended to 25 with a negative EKG.  Repeat troponin decreased to 14.  TSH, K, Na, glucose all were WNL.  Patient had a chest x-ray that was negative in orthostatics done the were also negative.  Patient had an echo completed that showed a normal ejection fraction and mild aortic valve sclerosis.  Given patient's improvement in clinical symptoms and remaining afebrile, patient was stable to be discharged.  There was a possibility that his symptoms were due to a TIA because patient mention that about 7 years ago he had an episode like this were 1 side of his body felt numb.  Patient was started on aspirin therapy and should follow up with the PCP to establish formal medical care.  Hospital Course: Imaging reviewed Echo 8/12 - LVEF 65%, mild aortic valve sclerosis.  Impression/Plan: Sepsis in the setting of COVID-19 - Acetaminophen prn  - Pulm Toilet: IS - Blood cx no new growth   - Respiratory precautions  - Continued Vit D, C and Zinc  Presyncope Cardiac vs Infectious  TSH, Na, K, glucose were WNL Lipid panel significant for LDL 121  Negative orthostatics - Echo as above  - ASA 81mg started   Elevated Troponins, likely demand ischemia Elevated troponins, 17->25 on 8/12, ECG significant only for tachycardia, asx - Repeat troponins 14,  Issues Requiring Follow Up:   Follow-up with PCP for further evaluation of chronic medical conditions. Discharged to Home.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Sepsis, Syncope, Tachycardia
Clinical narrative: Admit date: 8/12/2024  Discharge date: 08/14/2024  Admitting Physician: MD  Attending Physician at the Time of Discharge: MD  Primary Care Physician: None Physician, DO, None  Reason for Admission: syncope   Brief Summary of Hospital Stay:   Patient 74yo male with no PMHx who presented to the ED after a presyncopal episode. Patient has not had any medical care since 1970 and takes no medications at home. On admission patient was found to be tachycardic, tachypneic, febrile and positive for COVID-19.  Patient was given 1 L of fluids and Tylenol for his fevers.  Troponins were also taken on admission in initially they were 17 and up trended to 25 with a negative EKG.  Repeat troponin decreased to 14.  TSH, K, Na, glucose all were WNL.  Patient had a chest x-ray that was negative in orthostatics done the were also negative.  Patient had an echo completed that showed a normal ejection fraction and mild aortic valve sclerosis.  Given patient's improvement in clinical symptoms and remaining afebrile, patient was stable to be discharged.  There was a possibility that his symptoms were due to a TIA because patient mention that about 7 years ago he had an episode like this were 1 side of his body felt numb.  Patient was started on aspirin therapy and should follow up with the PCP to establish formal medical care.  Hospital Course: Imaging reviewed Echo 8/12 - LVEF 65%, mild aortic valve sclerosis.  Impression/Plan: Sepsis in the setting of COVID-19 - Acetaminophen prn  - Pulm Toilet: IS - Blood cx no new growth   - Respiratory precautions  - Continued Vit D, C and Zinc  Presyncope Cardiac vs Infectious  TSH, Na, K, glucose were WNL Lipid panel significant for LDL 121  Negative orthostatics - Echo as above  - ASA 81mg started   Elevated Troponins, likely demand ischemia Elevated troponins, 17->25 on 8/12, ECG significant only for tachycardia, asx - Repeat troponins 14,  Issues Requiring Follow Up:   Follow-up with PCP for further evaluation of chronic medical conditions. Discharged to Home.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tachypnoea, Troponin increased
Clinical narrative: Admit date: 8/12/2024  Discharge date: 08/14/2024  Admitting Physician: MD  Attending Physician at the Time of Discharge: MD  Primary Care Physician: None Physician, DO, None  Reason for Admission: syncope   Brief Summary of Hospital Stay:   Patient 74yo male with no PMHx who presented to the ED after a presyncopal episode. Patient has not had any medical care since 1970 and takes no medications at home. On admission patient was found to be tachycardic, tachypneic, febrile and positive for COVID-19.  Patient was given 1 L of fluids and Tylenol for his fevers.  Troponins were also taken on admission in initially they were 17 and up trended to 25 with a negative EKG.  Repeat troponin decreased to 14.  TSH, K, Na, glucose all were WNL.  Patient had a chest x-ray that was negative in orthostatics done the were also negative.  Patient had an echo completed that showed a normal ejection fraction and mild aortic valve sclerosis.  Given patient's improvement in clinical symptoms and remaining afebrile, patient was stable to be discharged.  There was a possibility that his symptoms were due to a TIA because patient mention that about 7 years ago he had an episode like this were 1 side of his body felt numb.  Patient was started on aspirin therapy and should follow up with the PCP to establish formal medical care.  Hospital Course: Imaging reviewed Echo 8/12 - LVEF 65%, mild aortic valve sclerosis.  Impression/Plan: Sepsis in the setting of COVID-19 - Acetaminophen prn  - Pulm Toilet: IS - Blood cx no new growth   - Respiratory precautions  - Continued Vit D, C and Zinc  Presyncope Cardiac vs Infectious  TSH, Na, K, glucose were WNL Lipid panel significant for LDL 121  Negative orthostatics - Echo as above  - ASA 81mg started   Elevated Troponins, likely demand ischemia Elevated troponins, 17->25 on 8/12, ECG significant only for tachycardia, asx - Repeat troponins 14,  Issues Requiring Follow Up:   Follow-up with PCP for further evaluation of chronic medical conditions. Discharged to Home.