chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; tender lymph node; trouble sleeping; pain swallowing,; minimal coughing; sore throat; This non-serious case was reported by a physician via call center representative and described the occurrence of sore throat in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-JUN-2024, the patient received the 2nd dose of Shingrix. In JUN-2024, 24 hrs after receiving Shingrix, the patient experienced sore throat (Verbatim: sore throat), fever (Verbatim: fever), lymph node tenderness (Verbatim: tender lymph node), difficulty sleeping (Verbatim: trouble sleeping), swallowing painful (Verbatim: pain swallowing,) and cough (Verbatim: minimal coughing). The patient was treated with ibuprofen. In JUN-2024, the outcome of the fever was resolved. The outcome of the sore throat, difficulty sleeping, swallowing painful and cough were not resolved and the outcome of the lymph node tenderness was unknown.   It was unknown if the reporter considered the sore throat, fever, lymph node tenderness, difficulty sleeping, swallowing painful and cough to be related to Shingrix.     It was unknown if the company considered the sore throat, fever, lymph node tenderness, difficulty sleeping, swallowing painful and cough to be related to Shingrix.   Additional Information: GSK receipt date: 18-JUN-2024 Physician reported a patient the patient received vaccine and at 48 hours had severe sore throat and now at 72 hours the throat, she was having trouble sleeping, really a lot of pain swallowing, minimal coughing and no fever, had fever in the first 24 hours.  There was little to suggest any infectious etiology so the clear symptoms were related to inflammation.  So really one tender lymph node but the throat looks otherwise fine.  At 24 hours she developed a severe throat and it was just been progressing, fevers were gone by 48 hours, had no more fevers and otherwise felt ok, but the sore throat was just severe.  Tried ibuprofen, tried lozenges but nothing seems to help. Consented to follow up.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: when I got COVID; when I got COVID; This is a spontaneous report received from an Other HCP.  A 35-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Jan2024 as dose 1, 0.3 ml single (Lot number: HM7010) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer 12yr+COVID -19 bivalent (Vaccine name: PFIZER 12YR+ COVID-19 BIVALENT, Manufacturer: PFIZER MANUFACT, Lot # GJ3274, Route: Injection, intramuscular, Site: Left arm, Volume (ml): 0.3 ml), administration date: 21Dec2022, for covid-19 immunization; Covid-19 vaccine (Primary Immunization Series complete: Unknown manufacturer), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "when I got COVID".  No follow-up attempts are possible.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY (2023-2024 FORMULA) can not be fully excluded.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: inappropriate use due to the patient receiving the vaccine several days post-exposure with no adverse event; Initial information received on 19-Jun-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 33 years old female patient who experienced inappropriate use due to receiving the Rabies (HDC) Vaccine [Imovax Rabies] several days post-exposure with no adverse event.  The patient's past medical history included Animal bite on 17-JUN-2024. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pyrexia. List concomitant- No other vaccines   On 19-Jun-2024, the patient received a standard dose 1 with 1 ml TOTAL dosage of suspect Rabies (HDC) Vaccine Powder and solvent for suspension for injection (lot W1C431M, Expiry: 31-Oct-2025) via unknown route in the right deltoid as post exposure immunization after 12 days of dog bite which was considered as inappropriate use due to the patient receiving the vaccine several days post-exposure with no adverse event (inappropriate schedule of product administration) (latency: same day).   It was reported "Pharmacist does not know if the patient was previously immunized or not at all."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Dizziness, Headache, Insomnia, Muscle spasms
Clinical narrative: Insomnia - meclizine, leg muscle spasms - treated with another dose of guanfacine, shaky chest, right arm tremor, headache, lightheaded - still having some of these symptoms
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Insomnia - meclizine, leg muscle spasms - treated with another dose of guanfacine, shaky chest, right arm tremor, headache, lightheaded - still having some of these symptoms
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Activated partial thromboplastin time, Amnesia, Arthralgia, Asthenia
Clinical narrative: swollen legs, joint pains, muscle pain, blurred vision, hyper tension. was admitted to hospital for abdominal pain surgeons removed mystery fluid. weakness , loss of memory, dizziness. itchy skin, rash. insomnia ,
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Blood ethanol, Blood grouping, Blood iron, Blood lactic acid
Clinical narrative: swollen legs, joint pains, muscle pain, blurred vision, hyper tension. was admitted to hospital for abdominal pain surgeons removed mystery fluid. weakness , loss of memory, dizziness. itchy skin, rash. insomnia ,
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium, Blood phosphorus, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram spine
Clinical narrative: swollen legs, joint pains, muscle pain, blurred vision, hyper tension. was admitted to hospital for abdominal pain surgeons removed mystery fluid. weakness , loss of memory, dizziness. itchy skin, rash. insomnia ,
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Differential white blood cell count, Dizziness, Drug screen, Flow cytometry
Clinical narrative: swollen legs, joint pains, muscle pain, blurred vision, hyper tension. was admitted to hospital for abdominal pain surgeons removed mystery fluid. weakness , loss of memory, dizziness. itchy skin, rash. insomnia ,
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Gram stain, Hypertension, Insomnia, International normalised ratio
Clinical narrative: swollen legs, joint pains, muscle pain, blurred vision, hyper tension. was admitted to hospital for abdominal pain surgeons removed mystery fluid. weakness , loss of memory, dizziness. itchy skin, rash. insomnia ,
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Investigation, Iron binding capacity total, Laboratory test, Lipase, Liver function test
Clinical narrative: swollen legs, joint pains, muscle pain, blurred vision, hyper tension. was admitted to hospital for abdominal pain surgeons removed mystery fluid. weakness , loss of memory, dizziness. itchy skin, rash. insomnia ,
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Myalgia, Peripheral swelling, Platelet count, Prothrombin time
Clinical narrative: swollen legs, joint pains, muscle pain, blurred vision, hyper tension. was admitted to hospital for abdominal pain surgeons removed mystery fluid. weakness , loss of memory, dizziness. itchy skin, rash. insomnia ,
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Red blood cell morphology, Scan with contrast, Serum ferritin
Clinical narrative: swollen legs, joint pains, muscle pain, blurred vision, hyper tension. was admitted to hospital for abdominal pain surgeons removed mystery fluid. weakness , loss of memory, dizziness. itchy skin, rash. insomnia ,
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Therapeutic aspiration, Ultrasound scan, Urine analysis, Vision blurred, X-ray limb
Clinical narrative: swollen legs, joint pains, muscle pain, blurred vision, hyper tension. was admitted to hospital for abdominal pain surgeons removed mystery fluid. weakness , loss of memory, dizziness. itchy skin, rash. insomnia ,
Age: 13.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; This spontaneous report has been received from a physician, via an immunization record from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (#1811USA004645), concerning a 13-year-old female patient. The patient's medical history, concurrent conditions please refer to link case. Concomitant therapies were not reported.  On 03-MAY-2017, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacture unknown) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 03-NOV-2017, the patient was vaccinated with hepatitis a vaccine inact (HAVRIX) (strength, dose, formulation, lot #, expiry date, route of administration, and indication were not provided) (Interchange of vaccine products).  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-1811USA008839: US-009507513-1811USA004645: US-009507513-2406USA004685:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Tenderness
Clinical narrative: I had the most horrible headache and pain of my life! I felt like someone was hammering my head while a knife was also being stabbed in my skull. It also hurt to just touch the surface of my head.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Blood test, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: Chest pain and SOB occured 5/16. Went to Urgent care. EKG and chest X-Ray completed. 5/21 seen primary regarding symptoms. Steroids given.5/31 chest discomfort, palpatations and SOB. Went to ER. Bloodwork done, Troponint, two sets. Sat for over 4 hours with chest discomfort but never seen, called Cardiology on 5/31/224. Seen by employee. Ekg complwtwd. Put on ToprolXL25mg to control PVC,s. Echo rodered and completed. Never had SOB or arrhythmia issues before vaccine.  Can send copies of ALL Testing upon request
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Palpitations
Clinical narrative: Chest pain and SOB occured 5/16. Went to Urgent care. EKG and chest X-Ray completed. 5/21 seen primary regarding symptoms. Steroids given.5/31 chest discomfort, palpatations and SOB. Went to ER. Bloodwork done, Troponint, two sets. Sat for over 4 hours with chest discomfort but never seen, called Cardiology on 5/31/224. Seen by employee. Ekg complwtwd. Put on ToprolXL25mg to control PVC,s. Echo rodered and completed. Never had SOB or arrhythmia issues before vaccine.  Can send copies of ALL Testing upon request
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin, Ventricular extrasystoles
Clinical narrative: Chest pain and SOB occured 5/16. Went to Urgent care. EKG and chest X-Ray completed. 5/21 seen primary regarding symptoms. Steroids given.5/31 chest discomfort, palpatations and SOB. Went to ER. Bloodwork done, Troponint, two sets. Sat for over 4 hours with chest discomfort but never seen, called Cardiology on 5/31/224. Seen by employee. Ekg complwtwd. Put on ToprolXL25mg to control PVC,s. Echo rodered and completed. Never had SOB or arrhythmia issues before vaccine.  Can send copies of ALL Testing upon request
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Blood test normal, Electrocardiogram normal, General physical condition abnormal, Infant irritability, Infantile vomiting
Clinical narrative: Aproximately 3 hours after vaccination, child was fussy and had brief unresponsive episode with color change. looked "lifeless" to parents and then vomited. Was fussy after. Parents went to ER due to concern for vaccine injury and are concerned about H.H.E. event. Decision made to report to VAERS. child had many studies done at hospital and was observed overnight.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Laboratory test normal, Skin discolouration, Ultrasound abdomen normal, Unresponsive to stimuli, X-ray normal
Clinical narrative: Aproximately 3 hours after vaccination, child was fussy and had brief unresponsive episode with color change. looked "lifeless" to parents and then vomited. Was fussy after. Parents went to ER due to concern for vaccine injury and are concerned about H.H.E. event. Decision made to report to VAERS. child had many studies done at hospital and was observed overnight.
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP did not report any side effects from the administration of the expired dose; a patient was inadverntly administered an expired dose of the PROQUAD vaccine; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-MAY-2024, the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (rHA) (PROQUAD), (lot# W035472, has been verified to be a valid lot number, expiration date: 06-MAY-2024 [PT: Expired product administered]) (strength, route of administration, and anatomical location were not provided) for prophylaxis. Health care professional (HCP) did not report any side effects from the administration of the expired dose (PT: No adverse event). HCP stated that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) vaccine did not have any prior temperature excursions (T.Es).   Follow-up information has been received from the registered nurse on 14-JUN-2024, regarding a 7-year-old female patient. The patient was vaccinated at public health clinic/hospital. No temperature excursions noted. The vaccine had full potency. It was reported that the patient was recovered from the event expired product administered (on unknown date in 2024). It was previously reported to doctor and manufacturer. It was recommended to revaccinate in 28 days. No adverse reaction /side effects. The patient tolerated immunization well.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from a physician, via an immunization record from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (#1811USA004645), concerning a 6-month-old female patient. The patient's medical history, concurrent conditions please refer to link case. Concomitant therapies were not reported.  On 16-JUN-2004, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacture unknown) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). Patient also received the vaccine on 17-AUG-2004, 26-OCT-2004 (Inappropriate schedule of product administration) and 20-JUL-2005 (Extra dose administered).  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-1811USA008839: US-009507513-1811USA004645: US-009507513-2406USA004686:
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FBE called on behalf of Pharmacist who reported a prescription of GARDASIL 9 was prescribed and then dispensed to a 49 year old male patient about 6 months ago.  No additional information was provided.  Consent unspecified.  Per WI-006676097, HCP Vac; FBE called on behalf of Pharmacist who reported a prescription of GARDASIL 9 was prescribed and then dispensed to a 49 year old male patient about 6 months ago.  No additional information was provided.  Consent unspecified.  Per WI-006676097, HCP Vac; No additional AE/PQC.; This spontaneous report was received from a pharmacist and refers to a 49-year-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On an unknown date (reporter as "about six months ago") the patient was prescribed with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided). Pharmacist reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was prescribed and then dispensed to a 49 year old male patient (product prescribing issue, no adverse event and product dispensing issue).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Absolutely the worst; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Absolutely the worst). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JUN-2024 This case was reported by a consumer via interactive digital media. The reporter reported that absolutely the worst, even after being vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is an listed event, which is considered related to GSK vaccine Shingles vaccine. Herpes zoster is unlisted event, which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: HIBV
Symptoms: Device leakage, Incorrect dose administered, Underdose, Wrong device used
Clinical narrative: patients are getting less than a full dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in an unspecified number of patients who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: patients are getting less than a full dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 17-JUN-2024 The nurse reported that after reconstitution of Hiberix their office changes the needle and uses a needle the office supplies (not a GSK supplied needle) to withdraw and administer the vaccine. The nurse stated that more than one staff member had reported leaking at the hub of the syringe and needle and patients were getting less than a full dose which led to incomplete dose administered.
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Pyrexia, Rash macular, Rash papular
Clinical narrative: slight fever for a couple of days; developed red blotches/ red blotches getting a little bit of a raise to it but is not blistering, it is possible it is more of a rash; patient is also experiencing sharp muscle pain which goes down the left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   In JUN-2024, the patient received the 1st dose of Bexsero (left arm). In JUN-2024, less than a week after receiving Bexsero, the patient experienced fever (Verbatim: slight fever for a couple of days) and muscle pain (Verbatim: patient is also experiencing sharp muscle pain which goes down the left arm). On 17-JUN-2024, the patient experienced red blotches (Verbatim: developed red blotches/ red blotches getting a little bit of a raise to it but is not blistering, it is possible it is more of a rash). In JUN-2024, the outcome of the fever was resolved. The outcome of the muscle pain and red blotches were not resolved.   It was unknown if the reporter considered the fever, muscle pain and red blotches to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, muscle pain and red blotches to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 17-JUN-2024 The reporter was the father of the patient. The patient received the first dose of Bexsero 6 days ago (from the date of reporting).  The patient experienced a slight fever for a couple of days. The reporter stated that the patient was also experiencing sharp muscle pain which goes down the left arm.  Today (on the day of reporting), less than a week after, the patient developed red blotches on the same arm the vaccine was given. The red blotches were getting a little bit of a raise to it but was not blistering; the reporter stated it was possible it was more of a rash. The patient's initials and date of birth was not provided by the reporter. The reporter did not wish to provide any further demographics for himself or his daughter (patient).
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received pediatric dose of engerix b; adult patient received pediatric dose of engerix b; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient received pediatric dose of engerix b) and adult use of a child product (Verbatim: adult patient received pediatric dose of engerix b). The outcome of the underdose and adult use of a child product were 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: 18-JUN-2024 A reporter reported that they had a patient who, an adult patient, who was needing the hepatitis b series and they administered the Engerix B pediatric dose to the adult, they just give one vaccine, one injection instead of two which led to Adult use of a child product and underdose. The reporter wondering if that one counts.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Pyrexia
Clinical narrative: neuropathic pain is still present; she experienced an outbreak of shingles; awoke with a low-grade fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-MAR-2024, the patient received the 1st dose of Shingrix. On 29-MAR-2024, 1 days after receiving Shingrix, the patient experienced shingles (Verbatim: she experienced an outbreak of shingles) and fever (Verbatim: awoke with a low-grade fever). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: neuropathic pain is still present). The outcome of the shingles was resolved and the outcome of the post herpetic neuralgia was not resolved and the outcome of the fever was resolved (duration 1 day).   It was unknown if the reporter considered the shingles, post herpetic neuralgia and fever to be related to Shingrix.     It was unknown if the company considered the shingles, post herpetic neuralgia and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUN-2024 The patient self-reported this case for herself. The patient received her first Shingrix dose and awoke with a low-grade fever that resolved the next day.  The reporter reported that, she experienced an outbreak of shingles.  The lesions were now gone but the neuropathic pain was still present at the time of reporting.  The reporter consented to follow up.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was due for HIB and DTap. patient was given Hep A in place of HIB. Patient had no reactions or side effects. Provider was notified and stated patient would be okay that it just didn't count. Parents were notified and will come back in for the correct HIB vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Disability, Migraine, Scan brain
Clinical narrative: After the second dose of the primary series (1/21/21), my migraines have become almost daily .  I am incapacitated on most days.
Age: 78.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Chills, Cough, Fatigue, Rhinorrhoea, Wheezing
Clinical narrative: She got her vaccines, was fine and then about 4-5 hours later she started having extreme fatigue and chills.  She did not take anything for her symptoms.  Her husband also had similar symptoms, and believe that it may have been the RSV as they have never had problems with the COVID vaccines.  These symptoms lasted for a couple of days.  They never left the house for 2 days, which is unusual for them.  She did tell her doctor about it and he had no suggestions for them.  She also was wheezing, and it seems like every day for about 20 minutes she had a runny nose and cough, but other than that she did not have much symptoms at all after the first 2 days.  The symptoms come on all of a sudden a couple of times a day, the runny nose and cough.  Would take a cough drop to keep the coughing down.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Chills, Fatigue
Clinical narrative: He got her vaccines, was fine and then about 4-5 hours later she started having extreme fatigue and chills.  He did not take anything for her symptoms.  They believe that it may have been the RSV as they have never had problems with the COVID vaccines.  These symptoms lasted for a couple of days.  They never left the house for 2 days, which is unusual for them.  She did tell her doctor about it and he had no suggestions for them.
Age: 13.0
Sex: M
Vaccine: MNQ, PNC13, TDAP
Symptoms: Aphasia, Dizziness, Headache, Incoherent, Lacrimation increased
Clinical narrative: pt became pale c/o nausea, dizziness, lightheadedness. Pt was moved with assistance to exam table he was placed supine with knees bent. His color improved and he was resting on the exam table, he was observed with normal HR. He was slightly shaky but aware.  mostly shaking his head to answer questions. He was observed for another 5 min, and he became teary and shakier. He was asked to speak but was unable to produce coherent sounds.  He was able to understand commands and follow them. he was able to open his mouth, had normal tongue movements. he was able to squeeze my hands bilaterally but with reduced strength. he was able to move both feet and toes bilaterally.  he did c/o some headache but no pain on palpation of neck or shoulders. BP at this time was 170/82 with HR92 and PO 99. he continued to have difficulty with speaking- made noises with some lip movements and was able to utter "hi" but not able to say "dad".  he was able to follow commands to move body parts, point to father. Pt was transported by ambulance to Hospital
Age: 13.0
Sex: M
Vaccine: MNQ, PNC13, TDAP
Symptoms: Nausea, Pallor, Tremor
Clinical narrative: pt became pale c/o nausea, dizziness, lightheadedness. Pt was moved with assistance to exam table he was placed supine with knees bent. His color improved and he was resting on the exam table, he was observed with normal HR. He was slightly shaky but aware.  mostly shaking his head to answer questions. He was observed for another 5 min, and he became teary and shakier. He was asked to speak but was unable to produce coherent sounds.  He was able to understand commands and follow them. he was able to open his mouth, had normal tongue movements. he was able to squeeze my hands bilaterally but with reduced strength. he was able to move both feet and toes bilaterally.  he did c/o some headache but no pain on palpation of neck or shoulders. BP at this time was 170/82 with HR92 and PO 99. he continued to have difficulty with speaking- made noises with some lip movements and was able to utter "hi" but not able to say "dad".  he was able to follow commands to move body parts, point to father. Pt was transported by ambulance to Hospital
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: MA mistakenly gave a Tdap vaccine instead of a DTaP vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient now has shingles; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-JUN-2024, the patient received Shingrix. On 18-JUN-2024, 5 days after receiving Shingrix, the patient experienced shingles (Verbatim: The patient now has shingles). The outcome of the shingles was not 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.   Additional Information: GSK Receipt Date: 18-JUN-2024 The patient received Shingrix on Thursday and today (on the day of reporting) he/she had shingles.  The reporter was not sure if this was a common side effect or if this was an adverse reaction.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Burning sensation
Clinical narrative: Intermittent burning sensation in hands and feet
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HPV9, MMRV
Symptoms: Arthralgia
Clinical narrative: The patient was in the office with his sibling for yearly well check. After the provider was done and ordered the vaccines for both of the children, the MA returned to the room to administer the vaccines. The 5 year old went first and the MA stated after a struggle she administered 2 vaccines. She thought she had grabbed the Kinrix and Proquad vaccines, but in fact she grabbed the HPV 9 and Kinrix vaccines. The MA noticed immediately her mistake after the injection and went and told the HCM. The HCM then informed the NP and both of them went into the room and explained wat had happened to the parent. The parent was advised of possible side effects and was told this dose would be invalid to complete the futures series. The patient was monitored in the room for 15 minutes after speaking with the mom. Patient had no reactions at that time. Mom's questions were all addressed. The office contacted the parent on 3/19/2024 to follow up with the parent about the patients conditions and if there were any concerns at that time. Mom stated that the patient was fine and she had no concerns.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid 19 Breakthrough Infection
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 6/21/24-Had a red, painful lump, 6/26/24-redness spread throughout upper left arm, swelling, itching
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Patient was administered the MenQuadfi vaccine when he should have been administered Gardasil due to a communication error between the Physician and MA.  Patient and Mother have been notified.  Patient has had no adverse reactions to the vaccine.  His last MenQuadfi vaccination was 06/30/2022.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient received Tdap and Meningococcal twice on date of service 10/9/2021 and 8/19/2022. Patient was seen recently for a physical on 6/17/2024 and doctor notice patient had duplicate vaccines.
Age: 0.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash macular
Clinical narrative: Splotchy red rash that spread over both legs between knees and ankles
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site induration
Clinical narrative: Within 12 hours after vaccine administration, sudden onset of drowsiness, injection site redness/hardness/pruritus, chills, nausea, appetite loss, muscle aches, mild headache, and subjective fever. Advised to initiate OTC analgesics as needed, rest. Will monitor for symptom progression and report any red flags including chest pain, dyspnea, widespread rash, etc.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site pruritus, Myalgia, Nausea, Pyrexia, Somnolence
Clinical narrative: Within 12 hours after vaccine administration, sudden onset of drowsiness, injection site redness/hardness/pruritus, chills, nausea, appetite loss, muscle aches, mild headache, and subjective fever. Advised to initiate OTC analgesics as needed, rest. Will monitor for symptom progression and report any red flags including chest pain, dyspnea, widespread rash, etc.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Vaccine given while patient is COVID positive
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Vaxelis was given as the 4th dose in series
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Aspiration, Chest X-ray, Concussion, Dizziness, Echocardiogram
Clinical narrative: Dizziness and nausua followed by projectile vomiting and fainting.  Aspirated some vomit into lungs.  While fainting I fell, causing a concussion.  Hospitalization for one day.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram, Fall, Lipids, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: Dizziness and nausua followed by projectile vomiting and fainting.  Aspirated some vomit into lungs.  While fainting I fell, causing a concussion.  Hospitalization for one day.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Metabolic function test, Nausea, Syncope, Vomiting projectile
Clinical narrative: Dizziness and nausua followed by projectile vomiting and fainting.  Aspirated some vomit into lungs.  While fainting I fell, causing a concussion.  Hospitalization for one day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Dyspnoea, Rash
Clinical narrative: Pt grandmother called at 5:19 pm on 6/25/24 after pt left clinic stating pt was experiencing SOB, cough, and rash. Pt grandmother was instructed to take child to the nearest ER. Provider contacted pt and spoke with dad and pt confirmed that they were at the ER and pt was receiving a steroid injection at 5:40 pm on 6/25/24.
Age: 4.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Unevaluable event
Clinical narrative: No adverse reaction.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Unevaluable event
Clinical narrative: Unknown
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site bruising, Injection site mass, Injection site necrosis, Injection site nodule
Clinical narrative: fever, large local reaction in first 12 hours.  eventually treated for cellulitis (unknown if this helped), now (7 weeks out) has persistent nodular mass at site of injection. usn obtained shows fat necrosis
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction, Pyrexia
Clinical narrative: fever, large local reaction in first 12 hours.  eventually treated for cellulitis (unknown if this helped), now (7 weeks out) has persistent nodular mass at site of injection. usn obtained shows fat necrosis
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus
Clinical narrative: ITCHING ON RIGHT ARM RIGHT AFTER ADMINISTERED VACCINE-IT WENT AWAY AFTER 1 DOSE OF 10ML BENADRYL LIQUID (25MG)
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Lethargy, Urticaria
Clinical narrative: Minutes after vaccine administration, child covered with hives and parents concerned with lethargic condition. 2.5 mL oral benadryl given and repeated 2 minutes later while doctor was doing exam, 0.1 epi drawn up and immediately given sub Q left thigh.Hives cleared immediately, ambulance called to transport to ED for 4 hour observation.
Age: 37.0
Sex: F
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Arthralgia, C-reactive protein normal, Chest pain, Chikungunya test, Epistaxis
Clinical narrative: Patient developed fever, fatigue, arthralgia, bleeding gums, nose bleeds, flank pain, rash on arms and legs, and chest pain. Tylenol PRN, Zyrtec PRN, fluids.
Age: 37.0
Sex: F
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Fatigue, Flank pain, Full blood count normal, Gingival bleeding, Liver function test normal
Clinical narrative: Patient developed fever, fatigue, arthralgia, bleeding gums, nose bleeds, flank pain, rash on arms and legs, and chest pain. Tylenol PRN, Zyrtec PRN, fluids.
Age: 37.0
Sex: F
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Metabolic function test normal, Pyrexia, Rash, Red blood cell sedimentation rate normal
Clinical narrative: Patient developed fever, fatigue, arthralgia, bleeding gums, nose bleeds, flank pain, rash on arms and legs, and chest pain. Tylenol PRN, Zyrtec PRN, fluids.
Age: 37.0
Sex: F
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Arthralgia, Epistaxis, Fatigue, Gaze palsy, Gingival bleeding
Clinical narrative: Patient developed fever, fatigue, arthralgia, bleeding gums, nose bleeds, flank pain, rash on arms and legs, and chest pain. Tylenol PRN, Zyrtec PRN, fluids.
Age: 37.0
Sex: F
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Patient developed fever, fatigue, arthralgia, bleeding gums, nose bleeds, flank pain, rash on arms and legs, and chest pain. Tylenol PRN, Zyrtec PRN, fluids.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Mother reports patient started feeling pain, discomfort later on in the day after vaccination but thought was normal. Patient woke up next day 06/20/2024 after vaccination with left deltoid swollen with pain and limited ROM. Mom brought patient into office and provider prescribed medication prednisoLONE and Ibuprofen .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Inflammation
Clinical narrative: Cellulitis , inflammation and redness
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Hot flush, Myalgia, Nausea, Vomiting
Clinical narrative: hot flashes, nausea, vomiting, sore muscles, headache
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Nausea, Pyrexia, Vomiting
Clinical narrative: acute facial discoloration - extreme redness and heat covering both sides of face and part of frontal top of head -- lasting more than 2 days. Nausea, vomiting, fever with first 24 hours.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No patient impact.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: The patient had an appointment on June 24th 2024 for her 4 Year visits after giving her the vaccine mom notice  redness in her right thigh and then she saw her Itching her thigh, mom give us a called she sent us a picture she came to the office saw  the doctor  and prescribe  medication.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient describes breaking out in a rash the day after receiving the vaccination. He does not want to try the 2nd dose as a precautionary measure
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fall, Malaise, Tremor
Clinical narrative: Patient fell and still not feeling well but getting a little better. Spouse stated he felt really weak and shaking beforehand.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site hypoaesthesia, Injection site vesicles, Pain in extremity
Clinical narrative: I took an allergy pill 20 minutes prior to shot. I don't recall any significant response except a sore arm the first day. I woke up with a very sore arm the second day. I woke up with a huge bruise with two clear blisters near injection site on the third day. I also had numb sensation near injection site on the third day. I went to see my doctor's office on the fourth day due to still having these issues. The doctor told me I had an adverse reaction to the Shingles vaccine that I received and told me to take acetaminophen for pain, allergy pill for reactions, and to apply lidocaine cream and hydrocortisone creams to the area.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: pt reported having burning sensation in the bicep. started a few days after admin and continue until now.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The wrong COVID vaccine was given for the patient's age. She was given the 12 years and up dose instead of the 5-11yr dose. No physical symptoms noted or reported.
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of MMRV: First read her younger sister's profile which said they were from another country and have no records therefore treat as completely vaccine naive. And I mistakenly applied this understanding to pt, the older child and didn't go under documents or her profile.  Therefore I just looked onto system and made my assessment that pt. needed her second MMMRV to finish her series, but she was actually finished in Feb 2024 since she got first one in 6/2015.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: REDNES , TENDERNESS  AND ITCHINESS ON INJECTION SITE
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Biopsy, Blood test, Fungal skin infection, Gastrointestinal tube insertion
Clinical narrative: Rash started on 2/16 and progressively got worse.  It was all over me.  Open itchy lesions.  Dermatologist took biopsy.  Fungus growing on my souls.  Lesions on my face lowering my quality of life.  Very painful joints and 2 hospitalizations.  Emergency laparotomy due to medication used to combat vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired quality of life, Laboratory test, Laparotomy, Pruritus, Rash
Clinical narrative: Rash started on 2/16 and progressively got worse.  It was all over me.  Open itchy lesions.  Dermatologist took biopsy.  Fungus growing on my souls.  Lesions on my face lowering my quality of life.  Very painful joints and 2 hospitalizations.  Emergency laparotomy due to medication used to combat vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder, Skin lesion, Wound
Clinical narrative: Rash started on 2/16 and progressively got worse.  It was all over me.  Open itchy lesions.  Dermatologist took biopsy.  Fungus growing on my souls.  Lesions on my face lowering my quality of life.  Very painful joints and 2 hospitalizations.  Emergency laparotomy due to medication used to combat vaccine.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Vomiting
Clinical narrative: severe lower hip /back pain ( that wraps sometimes to the front of the body) and vomiting ( one time and a just a little bit)- Tylenol at 3000mg is not touching her pain- did verify pt. that she is not having weakness/numbness in her feet that is crawling up ( was making sure she does not have symptoms of Guillen-Barr ) also made sure to ask patient if she had a rash - making sure pt.  does not have shingles. I also I made sure to ask the pt. if she was having any symptoms of UTI to make sure she does not have a UTI/kidney infection
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Additional Hepatitis A vaccine administered in clinic.
Age: 76.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Monoplegia, Pruritus, Urticaria
Clinical narrative: Patient describes that they had a "paralyzed" arm for 3 days. Reports they were able to move it after 3 days. More concerning was patient describing welts underneath bra line and down by the hip. The welts also itched like crazy per patient.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: patient broke out in red itchy patches on neck and arms legs and a little on face day after vaccine.
Age: 93.0
Sex: M
Vaccine: UNK
Symptoms: Blood test, Chest X-ray, Pneumonia
Clinical narrative: pneumonia
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Headache, Hyperhidrosis, Myalgia, Neck pain
Clinical narrative: Patient received RSV and Tdap on  6/18/24.  On 6/19/24 Patient reported mild temp all day and night, it got worse and at 530pm on 6/19/24 temp was at 101.2F.  Minor  cough started on 6/21/24 Patient reports temp over 101 again in the evening of 6/20/24 and neck soreness started.    Two nights in a row of soaked shirt.  Fever up by 1 degree 6/21/24 and sore neck muscles.  Soreness in arm is almost gone.  If temps continue MD advised to go to Urgent care on 6/22/24.  Next response from pt was on 6/25/24 - when he noted temp of 100.6 on 6/19/24(3.5 days after the vaccine), temp on 6/22/24 was 100.3 evening.  Temps during the day is normal .  6/23/24 was first day without temp but minor cough still lingering. He did not go to urgent care. Next response from Patient  was on 6/26/24 -- temp is now at 97.0F where it has been 98.6F prior to these 2 vaccines continues with slight morning headache.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient received RSV and Tdap on  6/18/24.  On 6/19/24 Patient reported mild temp all day and night, it got worse and at 530pm on 6/19/24 temp was at 101.2F.  Minor  cough started on 6/21/24 Patient reports temp over 101 again in the evening of 6/20/24 and neck soreness started.    Two nights in a row of soaked shirt.  Fever up by 1 degree 6/21/24 and sore neck muscles.  Soreness in arm is almost gone.  If temps continue MD advised to go to Urgent care on 6/22/24.  Next response from pt was on 6/25/24 - when he noted temp of 100.6 on 6/19/24(3.5 days after the vaccine), temp on 6/22/24 was 100.3 evening.  Temps during the day is normal .  6/23/24 was first day without temp but minor cough still lingering. He did not go to urgent care. Next response from Patient  was on 6/26/24 -- temp is now at 97.0F where it has been 98.6F prior to these 2 vaccines continues with slight morning headache.