chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash erythematous, Rash pustular
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: 67 yo F described developed small area on back of left upper leg that is red with "cluster of small white filled something." MD notes: multiple pustular lesions with erythematous base which is likely BP A strep vs H2 which has clear vesicles in dermatomal pattern. likely related to Shingrix vaccine --will hold off on 2nd dose and add to allergy/intolerance listing. improving rash with topical bactericidal (Bacitracian) agents , no systemic s/e -no fever, pain or itching at this time. Other Relevant HX: Other:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: Diagnosed with A-fib/developed A-fib (after shots); This is a spontaneous report and received from Consumer or other non HCPs.  A 73-year-old male patient received BNT162b2 (COMIRNATY), on 15Jul2022 as dose 4 (booster), single (Lot number: FK9894, Expiration Date: 30Sep2022) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: Pfizer FL3302), administration date: 22Jan2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: Pfizer EL9263, Expiration date: 31May2021), administration date: 12Feb2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3, SINGLE, Lot number: Pfizer FF2590), administration date: 15Nov2021, when the patient was 71-year-old, for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset May2023, outcome "recovered", described as "Diagnosed with A-fib/developed A-fib (after shots)". Therapeutic measures were taken as a result of atrial fibrillation.  Clinical Course: Consumer reported that on May2023 he was diagnosed with A-fib. Developed A-fib (after shots), had heart shocked 15Dec2023 to put it back in rhythm. Still in rhythm at this time. Also reported "We both have had covid 3 times. The 1st time was 02Aug2021 we went to the (withheld) and was given monoclonal antibody treatments. The other time we have had covid we were given Paxlovid. The last time we had covid was 26Feb2024."
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Diagnosed with A-fib/developed A-fib (after shots); This is a spontaneous report and received from Consumer or other non HCPs.  A 73-year-old male patient received BNT162b2 (COMIRNATY), on 15Jul2022 as dose 4 (booster), single (Lot number: FK9894, Expiration Date: 30Sep2022) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: Pfizer FL3302), administration date: 22Jan2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: Pfizer EL9263, Expiration date: 31May2021), administration date: 12Feb2021, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3, SINGLE, Lot number: Pfizer FF2590), administration date: 15Nov2021, when the patient was 71-year-old, for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset May2023, outcome "recovered", described as "Diagnosed with A-fib/developed A-fib (after shots)". Therapeutic measures were taken as a result of atrial fibrillation.  Clinical Course: Consumer reported that on May2023 he was diagnosed with A-fib. Developed A-fib (after shots), had heart shocked 15Dec2023 to put it back in rhythm. Still in rhythm at this time. Also reported "We both have had covid 3 times. The 1st time was 02Aug2021 we went to the (withheld) and was given monoclonal antibody treatments. The other time we have had covid we were given Paxlovid. The last time we had covid was 26Feb2024."
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5, DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Death
Clinical narrative: No adverse event was reported, this was requested by Medical examiner to repot due to patients death the day after.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from medical assistant (MA) (also reported as office coordinator), concerning a 4-year-old male.  The patient's medical history and concomitant medication was not reported. The patient's concurrent conditions included  eczema.  On 15-JAN-2024, the patient was vaccinated by MA with improperly stored of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered in the left thigh subcutaneously for prophylaxis (lot number W025567 has been verified to be valid, expiration date not reported but upon internal validation established as 14-AUG-2024) (albumin status recombinant human albumin). On that same day, the patient also received hepatitis a vaccine inact (HEP A IN VAC), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) and polio vaccine inact (IPV) as prophylaxis (dose, frequency, route, anatomical location, lot number and expiration date were not reported.  No adverse event reported.   This is one of the several cases created from the same source.
Age: 4.0
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: products been administered post excursion with no reported adverse event; Initial information received on 12-Apr-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 4-year-old and unknown gender patient and the reporter stated IPV (VERO) [IPOL], products been administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation.  On 11-Apr-2024, the patient received a dose 1 of 0.5 ml dose of suspect IPV (VERO), Suspension for injection (strength: unknown) (lot: W1A191M, expiry date: 28-Feb-2025) via intramuscular route in the right deltoid for immunization and products been administered post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly, Medical Assistant called to report temperature excursion that lasted 4 hours. Products: PUNCTURED IPOL MDV Reason: REFRIGERATOR MALFUNCTIONED Human Error: NO Max/Low Temperature reached: 32.3F Duration out of labelled range: 4 HOURS     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: 12.0
Sex: M
Vaccine: FLUA4, HPV9, MNQ, TDAP
Symptoms: Nausea
Clinical narrative: Patient started to feel nauseated after receiving all 4 shots. Had the patient lay down on the table with feet elevated. @1104am BP-93/61, oxy-96 and pulse 73. Observation on the patient and asking him questions. He stated that he ate breakfast at 7am.  He refused to drink water. Gave him trident flavored bubble gum and he started feeling better. @ 1110 BP 102/70. Patient stated that he was starting to feel better and if he seat up. @1127am Oxy-98 and pulse 80. Released patient from observation and send to class.
Sex: U
Vaccine: RSV
Symptoms: Bronchitis, Pneumonia
Clinical narrative: pneumonia; brochitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant) and bronchitis (Verbatim: brochitis). The outcome of the pneumonia and bronchitis were not reported.   It was unknown if the reporter considered the pneumonia and bronchitis to be related to Arexvy.     It was unknown if the company considered the pneumonia and bronchitis to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 The patient experienced pnemonia and brochitis.
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: the second dose was given later that 1 month after the first; underdose; was given a pediatric dose for the first dose instead of an adult dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On 15-JAN-2024, the patient received the 1st dose of Engerix B pediatric. On 05-MAR-2024, the patient received the 2nd dose of Engerix B. On 15-JAN-2024, an unknown time after receiving Engerix B pediatric and not applicable after receiving Engerix B, the patient experienced underdose (Verbatim: underdose) and adult use of a child product (Verbatim: was given a pediatric dose for the first dose instead of an adult dose). On 05-MAR-2024, the patient experienced drug dose administration interval too long (Verbatim: the second dose was given later that 1 month after the first). The outcome of the underdose, adult use of a child product and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 04-APR-2024 The pharmacist intern reported that the patient received the two doses of Engerix B vaccine. The first dose received the pediatric dose which led to Adult use of Child product and Underdose. The second dose was given later the 1month after the first dose which led to Drug dose administration interval too long. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (QUADRIVALENT INFLUENZA VACCINE) for Prophylactic vaccination.    Previously administered products included for COVID-19 prophylaxis: Moderna (Dose: 1, Lot number: 037B21A, Dose: 0.5 ml; Vaccination site: Left arm) on 12-Apr-2021, Moderna (Dose: 2, Lot number: 022021A, Dose: 0.5 ml; Vaccination site: Left arm) on 11-May-2021, Moderna (Dose: 3, Lot number: 069H21A and Dose: 0.5 ml; Vaccination site: Left arm) on 20-Dec-2021. Past adverse reactions to the above products included No adverse event with Moderna, Moderna and Moderna. Concurrent medical conditions included GERD and Hyperlipidemia. Concomitant products included OMEPRAZOL [OMEPRAZOLE] for GERD, ROSUVASTATIN for Hyperlipidemia.   On 14-Oct-2022 at 5:15 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient received dose of INFLUENZA VACCINE INACT SPLIT 4V (QUADRIVALENT INFLUENZA VACCINE) (unknown route) 1 dosage form. On 16-Nov-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2023, SARS-CoV-2 test: Positive.         No treatment medications provided by the reporter.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Hypoaesthesia, Malaise, Tremor
Clinical narrative: his legs were shaking, his entire body was shaking; son was numb; he was very sick the entire day; her son was given a dose of Pentacel that has been expired; Initial information received on 11-Apr-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (health care professional).  This case involves a 15 months old male patient who experienced legs were shaking, his entire body was shaking, was numb, was very sick the entire day after receiving Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] that has been expired.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Apr-2024, the patient had received expired (dose and units unknown) suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) (lot number and strength not reported) (expiry date: Mar-2024) via unknown route in unknown administration site for Immunization (expired product administered) (Latency: same day).  On 04-Apr-2024 (latency: same day) the patient's legs were shaking, his entire body was shaking (tremor), was numb (hypoaesthesia) and was very sick the entire day (illness) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events (his legs were shaking, his entire body was shaking, was numb and he was very sick the entire day).  At time of reporting, the outcome was Unknown for all the events.   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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Asthma, Cardiac flutter, Cardiac stress test abnormal, Chest pain
Clinical narrative: Unsure which Pfizer manufacturer; heart racing, fluttering, chest pain, sob, thirst/appetite/digestion changes; asthma exacerbation
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspepsia, Dyspnoea, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: Unsure which Pfizer manufacturer; heart racing, fluttering, chest pain, sob, thirst/appetite/digestion changes; asthma exacerbation
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial ischaemia, Palpitations, Pericardial effusion, Thirst
Clinical narrative: Unsure which Pfizer manufacturer; heart racing, fluttering, chest pain, sob, thirst/appetite/digestion changes; asthma exacerbation
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: Patient was to receive Menveo (Men A,C,W and Y) but received Bexsero (Men B) the Men B administered had expired on 3/31/24 but was administered on 4/3/24
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at the injection site with pain and no itchiness.  Developed 18 hours after injection.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: patient reports continued itching and soreness at injection site 2 weeks post injection
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Mistakenly gave an expired Hib vaccine
Sex: M
Vaccine: HEP
Symptoms: Bradycardia, Oxygen saturation decreased
Clinical narrative: Nirsevimab 50 mg IM was given on 11/29/23 @11:09 along with Hepatitis B vaccine. Patient had a bradycardia and desaturation episode on 11/3023 @ 08:28
Age: 35.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Decreased appetite, Depressed mood, Nausea, Pyrexia
Clinical narrative: On 3/25/2024 at 9:30 AM, I received my 2nd dose of the Gardasil 9 vaccine (1 month after my 1st dose). It was 0.5 ml in my left deltoid. I had a normal breakfast and lunch that day. However, I started feeling sick in the evening. I experienced fever, chills, and nausea. Eventually, around 10 PM or so, I vomited a couple time. The next day, I had no appetite all day. I had a liquid breakfast, but no other meals. Same thing the day after that - a liquid breakfast and no appetite all day. By the 3rd day after the vaccine, I was back to normal and felt fine.
Age: 35.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: On 3/25/2024 at 9:30 AM, I received my 2nd dose of the Gardasil 9 vaccine (1 month after my 1st dose). It was 0.5 ml in my left deltoid. I had a normal breakfast and lunch that day. However, I started feeling sick in the evening. I experienced fever, chills, and nausea. Eventually, around 10 PM or so, I vomited a couple time. The next day, I had no appetite all day. I had a liquid breakfast, but no other meals. Same thing the day after that - a liquid breakfast and no appetite all day. By the 3rd day after the vaccine, I was back to normal and felt fine.
Sex: F
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Hypotonia, Skin warm, Somnolence
Clinical narrative: feeling hot; floppy infa; somnole; Information has been received from regulatory authority [AU-TGA-0000763640] on 08-APR-2024.  This spontaneous report was received from a other health professional and refers to a female patient whose age was reported as less than 1 years old. No information on patient's medical history, current conditions and concomitant medications was provided. The patient had no previous reactions to vaccines.   On 24-APR-2013, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (exact dose, dose number, route of administration, lot number and expration date were not provided). Other suspect therapies included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13).  On 24-APR-2013, the patient was chirpy, happy and smiling, then sleepy and floppy. Colour remained good although the baby was warm to touch. Breathing was well and pulse was palpable. The outcome of feeling hot, somnolence and floppy infant was unknown. Action taken with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) regarding the event was not applicable.  The reporter considered feeling hot, somnolence and floppy infant to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).     Upon internal review event floppy infant was considered medically significant.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Tinnitus
Clinical narrative: Shortly after my first two vaccine injections (they happened close together) I developed tinnitus. I noticed it about a month after the injections. A high pitched ringing that was persistent and very distracting. I went to hospital as a walk in and was examined. I also had a hearing test done through my health network. Both of these visits showed almost no hearing loss, and both doctors said there was no treatment for the tinnitus. I have used masking sound apps and devices daily for the past three years to sleep and function normally. In moments of high anxiety i use Xanax to alleviate the panic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: red rash around injection site. hydrocortizone cream applied and zyrtec given.  Observed patient for an hour until rash was gone
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Depression, Obsessive-compulsive disorder, Post-traumatic stress disorder
Clinical narrative: Anxiety and depression, OCD, PDSD
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Urticaria
Clinical narrative: Patient had developed a cluster of urticaria below elbow of right arm and urticaria at the zygomatic areas of both eyes. Patient denied itching at all 3 sites.  Site of right arm urticaria was where mother had held arm to restrain patient.  Patient was very tearful, screaming and resistant to receiving vaccines. Vital signs, O2 saturation remained stable and were checked every fifteen minutes for one hour. No shortness of breath, lungs clear, heart rate normal rhythm. No treatment was administered, although epinephrine was ready in syringe.  Urticaria resolved, patient remained active.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site reaction
Clinical narrative: Patient received Priorix intradermal, it bubbled under the patient's skin. Patient tolerated injection and had no immediate adverse reaction. Vaccine was administered by trainee.
Age: 0.58
Sex: M
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: Vaccine was mixed incorrectly, diluent from manufacturer not used. Diluent used unknown. Vaccine drawn up and administered by trainee, who could not give reliable account of what was used. Pharmacy was called and stated if Merck diluent used it is compatible and patient was not harmed.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Skin warm
Clinical narrative: client returned for a separate vaccine on 4/16/24 and showed nurse that she had some redness on her arm. Instructed to call PCP if it got worse. She called us this morning to report she thought it was getting better, but that it seems more red this morning and feels warm to touch. Instructed client to call her PCP. She reports she is here for school and her PCP is back home. Then instructed her to see University Health or Urgent Care. She verbalized that she would seek evaluation at one of those options.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dysphonia, Feeling cold, Gait disturbance, Headache
Clinical narrative: Per patient, she experienced several symptoms including difficulty walking, stomach aches, and feeling cold. Also, she stated her voice sound funny and cannot think.  At round 10 pm on 4/18/2024 she had a headache and having difficulty walking.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Mental impairment
Clinical narrative: Per patient, she experienced several symptoms including difficulty walking, stomach aches, and feeling cold. Also, she stated her voice sound funny and cannot think.  At round 10 pm on 4/18/2024 she had a headache and having difficulty walking.
Age: 35.0
Sex: F
Vaccine: JEV1
Symptoms: Axillary pain, Lymphadenitis, Mass, White blood cell count increased
Clinical narrative: Member states that about 5 days following a JEV, she began experiencing pain in bilateral armpit area. She began feeling lumps (5 total).  She saw her primary care provider who confirmed they were inflamed lymph nodes.  Her labs showed slightly elevated WBC.  Her primary told her she may be experiencing an infection which may be connected to the vaccine.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was accidentally given a second dose of RSV.  No side effects mentioned by the patient.  Was documented.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Injection site urticaria, Pain in extremity, Pyrexia, Rash
Clinical narrative: Within 1 hour of vaccine was administered in Left Arm, Left arm had a lump at injection site with many hives around his upper arm. Child complained his arm was hurting. Hives also presented on left buttocks and knee. Pediatrician suggested Benadryl (5ml)  which was given at home by parent. 1 hour post-Benadryl, child developed welts over 4" in diameter at the injection site as well as two on his left waist/buttocks.  Child also spiked a fever of 103F at this time with complaints of left arm hurting. Motrin (5ml) was administered by parent and child was taken to the emergency room. Child's welts improved over the course of 4 hours with no further treatment. Child had no breathing issues or mouth swelling. Fever and rash was mild the following morning.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Within 1 hour of vaccine was administered in Left Arm, Left arm had a lump at injection site with many hives around his upper arm. Child complained his arm was hurting. Hives also presented on left buttocks and knee. Pediatrician suggested Benadryl (5ml)  which was given at home by parent. 1 hour post-Benadryl, child developed welts over 4" in diameter at the injection site as well as two on his left waist/buttocks.  Child also spiked a fever of 103F at this time with complaints of left arm hurting. Motrin (5ml) was administered by parent and child was taken to the emergency room. Child's welts improved over the course of 4 hours with no further treatment. Child had no breathing issues or mouth swelling. Fever and rash was mild the following morning.
Age: 18.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Cardiac disorder, Cyanosis, Dizziness, Loss of consciousness, Pallor
Clinical narrative: After administration of both immunizations at 1520, client stated feeling a tingling sensation traveling down her arm and feeling lightheaded. Client's skin became pale and lip color blue. In the process of reclining client back, client had syncopal episode. Client was unconscious for 7 seconds before becoming alert. Client was alert for 30 seconds - aware having had syncopal episode - before stating "I think I'm going to pass out again" and becoming unconscious for 5 seconds before becoming alert and orientedx4 again. Offered client water and green apple Jolly Rancher. Lip color pink, cheeks became pink but not as much color as baseline. Client stated has POTS and cardiac hyperactivity which increases her risk of syncopal episodes, but stated has not had a syncopal episode "for several years." Client stated there is no specific trigger for syncopal episodes; medical education has been to recognize personal warning signs that syncopal episode is coming and lying down to prevent injury. Client stated had "a good lunch" but was two hours ago. Client called parents to have them drive her home - parents live 30 minutes away. After 5 minutes of being reclined, client requested to try sitting up. Moved client to sitting position. After 4 minutes, lips became blue again and client stated feeling lightheaded again. Returned client to reclined position. Lip color pink after 2 minutes reclined; client remained alert and orientedx4. After about 20 minutes in reclined position, client requested to try sitting again. Client able to tolerate sitting position. Parents arrived at facility at 1607. Client requested to try standing. Client able to tolerate. Escorted by RN from clinic to private vehicle at 1610.
Age: 18.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Paraesthesia, Syncope
Clinical narrative: After administration of both immunizations at 1520, client stated feeling a tingling sensation traveling down her arm and feeling lightheaded. Client's skin became pale and lip color blue. In the process of reclining client back, client had syncopal episode. Client was unconscious for 7 seconds before becoming alert. Client was alert for 30 seconds - aware having had syncopal episode - before stating "I think I'm going to pass out again" and becoming unconscious for 5 seconds before becoming alert and orientedx4 again. Offered client water and green apple Jolly Rancher. Lip color pink, cheeks became pink but not as much color as baseline. Client stated has POTS and cardiac hyperactivity which increases her risk of syncopal episodes, but stated has not had a syncopal episode "for several years." Client stated there is no specific trigger for syncopal episodes; medical education has been to recognize personal warning signs that syncopal episode is coming and lying down to prevent injury. Client stated had "a good lunch" but was two hours ago. Client called parents to have them drive her home - parents live 30 minutes away. After 5 minutes of being reclined, client requested to try sitting up. Moved client to sitting position. After 4 minutes, lips became blue again and client stated feeling lightheaded again. Returned client to reclined position. Lip color pink after 2 minutes reclined; client remained alert and orientedx4. After about 20 minutes in reclined position, client requested to try sitting again. Client able to tolerate sitting position. Parents arrived at facility at 1607. Client requested to try standing. Client able to tolerate. Escorted by RN from clinic to private vehicle at 1610.
Age: 13.0
Sex: F
Vaccine: HEP, IPV, VARCEL
Symptoms: Pallor, Peripheral coldness, Staring
Clinical narrative: Pediatric Engerix-B, Varivax and IPOL vaccines administered at 8:45 am. The patient reported feeling dizzy after receiving third vaccination (IPOL). At time of vaccinations patient was sitting in a chair, however noted patient becoming pale, and stating ?I am feeling dizzy.? Mother was holding onto the patient and reported ?She is becoming heavy.? Wheelchair requested to transport patient to the exam table in the room next door, however patient could not hold herself up independently anymore and was assisted gently to the floor to prevent any falls/injuries. After assisting the patient on the floor, patient lost consciousness. This nurse placed wet cold towels on patients face and a cold back to the back of her neck. Patient regained consciousness approximately after 4 seconds, and began stating "My arms are feeling heavy, and they are cramping." Noted patient clenching both fists, upon further assessment hands cold to touch and bilateral nail beds pale.  Patient was immediately assessed by the nurse, patient is observed to be pale, however conscious and has her eyes open. Hands continue to be clenched, cold and nail beds pale. Vital signs checked at 8:56am - Blood Pressure right arm lying 121/69 mmHg; Pulse 95 bpm; Respirations 28. Patient is alert and oriented to name and place, in no respiratory distress, denies any dizziness. Continues to report cramping of both hands. Physician on site was notified immediately for further assessment. MD further evaluated the client, per MD no visual or palpable injuries observed to any parts of her body at this time. Mother reported that daughters last full meal was yesterday evening, and this morning she just had half of an apple. Repeat Vital signs at 9:00am   Blood Pressure right arm lying 119/84 mmHg; Pulse 106 bpm.  Provider advised to give Ensure (nutrition shake) to the patient. After a few sips of Ensure patient began to report she was feeling better. 9:05 am Repeat Vital Signs: Blood Pressure right arm lying 118/71 mmHg; Pulse 85 bpm; Pulse oximeter 100%.  Continued to observe client, mother reported that this is the first time that her daughter has had this kind of reaction after a vaccination.  Patient reported feeling much better and no longer reporting arms feeling heavy or cramping to her hands. Patient assisted to the chair, sitting upright. At 9:12am Vital signs re-checked Blood pressure right arm sitting 127/68 mmHg; Pulse 87 bpm; Respirations 18; Oxygen via pulse oximeter 100%. After 30 minutes, client is observed to regain her normal color, talking more and is alert and oriented to name, time, and place, denies any headache, nausea, or dizziness. Nurse re-assessed no visual or palpable injuries noted at this time. On-site physician advised mother to continue to observe the child for any dizziness, headache, nausea, altered mental status, or sleepiness. If any of these occur to call EMS or take the child to the nearest Emergency Room as soon as possible. Client is ambulatory with a steady gait, discharged to home at 9:40am, accompanied by mother.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vertigo
Clinical narrative: Patient came into pharmacy on 4/18/24 complaining of intermittent vertigo that started on 4/14/24, 4 days after receiving COVID vaccine . Patient also felt extreme nausea , fatigue, on 4/14/24 only. Patient is still experiencing vertigo 8 days post vaccine. Pharmacist offered meclizine OTC to help with symptoms and instructed patient to contact PCP if symptoms do not go away or if they worsen.
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: DTAP was supposed to be given in as the 4th dose in the series. The Medical Assistant gave a Pediarix (DTAP+IPV+HEPB) in error.  She noticed after the administration and informed the Physician and called the Mother.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Muscle spasms
Clinical narrative: About 5 minutes after vaccination, patient experienced severe pain/cramping in lower back, described as if somebody was "pulling her backwards by the muscles". Laying down and stretching alleviated the pain. She was back up and walking within a few minutes.
Age: 15.0
Sex: M
Vaccine: COVID19, HEPA, HPV9, VARCEL
Symptoms: Syncope
Clinical narrative: Pt had syncope episode aprox 7-10 minutes after vaccination from sitting position in watiting room. Had eaten tacos de chicharon before coming. Marked no to history of fainting on consent form. After vaccination, the father reported history of fainting when he received shots but had no reaction the previous time when I vaccinated this pt in March. Juice and crackers were offered and at first declined by the pt, but accepted by the parent post vaccination. Juice and crackers were then given and pt waited 5 minutes post vaccination after the report of fainting before leaving the room. Pt was asked multiple times before leaving if he felt dizzy or nautious and said no he was not. Pt had Pulse ox- 100, Hr 60, BP 116/66 @ 1056. Ice pack applied to eye. Redness/erythema noted on right cheek under eye. Walked into vaccination room unassisted at 1100, layed on bed for another 20 minutes. Felt good to leave on own unassisted with ice pack. Instructed to call back if any changes occured and to go to ER if any changes in mentation occured.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Mass, Pain in extremity, Sleep disorder
Clinical narrative: pt noted lump redness and pain to right arm. hard to sleep.  Pt seen in office and assessed for vaccine complication. Provider notes erythematous, warm firm indurated area. No etension into axilla or up to neck. no adenopathy. good ROM.   She was prescribed triamcinolone cream as topical treatment twice daily. pt declined prednisone . unable to take Tylenol as she gets a rash and ibuprofen is hard on her stomach. Encouraged to follow up in 5-7 days if not better or sooner if worse.
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Product preparation issue
Clinical narrative: Patient was given the meningococcal conjugate vaccination, but the powder was mixed with dilutant, not the 2nd vial of liquid it was supposed to be mixed with
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: DILUENT GIVEN WITHOUT MIXING VACCINE POWDER.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPAB
Symptoms: Crying, Headache, Lethargy, Pain in extremity, Peripheral swelling
Clinical narrative: Child is complaining of leg pain and his leg hurts to touch. He has swelling in his leg and a 102.4 fever. He is complaining of severe headache, holding his head and crying. Lethargy.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPAB
Symptoms: Pyrexia, Tenderness
Clinical narrative: Child is complaining of leg pain and his leg hurts to touch. He has swelling in his leg and a 102.4 fever. He is complaining of severe headache, holding his head and crying. Lethargy.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given to 7 year old
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Barium double contrast, Infantile vomiting, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Baby developed vomiting on 4/11/24. Taken to ER and diagnosed with intussusception after imaging. Needed surgery.
Age: 33.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Disorientation, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Pain
Clinical narrative: Immediately  10 min after vaccine had left arm pain. Within 3 hr. pain continued and couldn't move left arm ,pain due to.shoulder when lifting arm . She had a  high fever over 101. didn't sleep well at night after the vaccine .She was feeling  disoriented when she she went to the urgent care was feeling hot and arm was swelling .   She is on her way to the doctor office for a steroid.shot now.
Age: 33.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Immediately  10 min after vaccine had left arm pain. Within 3 hr. pain continued and couldn't move left arm ,pain due to.shoulder when lifting arm . She had a  high fever over 101. didn't sleep well at night after the vaccine .She was feeling  disoriented when she she went to the urgent care was feeling hot and arm was swelling .   She is on her way to the doctor office for a steroid.shot now.
Age: 33.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Arthralgia, Injection site warmth
Clinical narrative: Immediately  10 min after vaccine had left arm pain. Within 3 hr. pain continued and couldn't move left arm ,pain due to.shoulder when lifting arm . She had a  high fever over 101. didn't sleep well at night after the vaccine .She was feeling  disoriented when she she went to the urgent care was feeling hot and arm was swelling .   She is on her way to the doctor office for a steroid.shot now.
Age: 33.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Disorientation, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Pain
Clinical narrative: heat/warmth mid-humorous to left shoulder, intense shoulder pain.
Age: 33.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: heat/warmth mid-humorous to left shoulder, intense shoulder pain.
Age: 33.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Arthralgia, Injection site warmth
Clinical narrative: heat/warmth mid-humorous to left shoulder, intense shoulder pain.
Age: 0.83
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: THERE WAS NO ADVERSE REACTION
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: menquadfi given to patient age 10 years and 9 months
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Diarrhoea, Headache, Lymphadenopathy, Nausea
Clinical narrative: Specialty pharmacist discovered DDI between Humira/Hyrimoz when alerted that patient received MMR vaccine on 03/05/2024. Contacted patient to discuss and patient explained she had nausea, vomiting, diarrhea, fever, headache, loss of appetites, and swollen glands for 3 weeks and was seen by PCP regarding symptoms but PCP not aware patient recently received MMR vaccine while on Humira therapy. Advised patient of contraindication and to follow-up with provider for evaluation and how to proceed with biologic regimen. Spoke to the pharmacist at the pharmacy retail store where MMR vaccine was administered and patient answered "no" to all questions on vaccine intake consent form but pharmacist confirmed that a hard stop DUR warning occurred at verification regarding the CI between Humira and MMR vaccine and this was overridden by pharmacist and no notes explaining rationale/if patient was counseled.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Specialty pharmacist discovered DDI between Humira/Hyrimoz when alerted that patient received MMR vaccine on 03/05/2024. Contacted patient to discuss and patient explained she had nausea, vomiting, diarrhea, fever, headache, loss of appetites, and swollen glands for 3 weeks and was seen by PCP regarding symptoms but PCP not aware patient recently received MMR vaccine while on Humira therapy. Advised patient of contraindication and to follow-up with provider for evaluation and how to proceed with biologic regimen. Spoke to the pharmacist at the pharmacy retail store where MMR vaccine was administered and patient answered "no" to all questions on vaccine intake consent form but pharmacist confirmed that a hard stop DUR warning occurred at verification regarding the CI between Humira and MMR vaccine and this was overridden by pharmacist and no notes explaining rationale/if patient was counseled.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site haemorrhage, Injection site nodule, Injection site pain
Clinical narrative: EE had Tdap vaccine 5 days ago. Since then she has developed swelling and redness at the injection site as well as radiating pain down her right arm. EE took tylenol yesterday with good relief of pain. No Fever, chills, or sweats. No previous adverse reaction to vaccines. No neurologic symptoms. 3 in diameter nodule of the R upper arm. Injection site appears to be very low on the deltoid muscle. Nodule is minimally tender. There is overlying mild erythema and faint ecchymosis. EE has FROM of R shoulder and elbow, but intermittent report of R wrist pain with extension of the elbow. There is tenderness at the wrist. No specific point tenderness. Pain of wrist is intermittent and sharp in nature. B upper extremities are neurovascularly intact. unclear whether this is an adverse reaction to the vaccine vs possible vaccine injury. Patient will do gentle ROM exercises. She will take OTC ibuprofen or tylenol as needed. Ice as needed. ER precautions given. She will RTC if no better in 2-3 days.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: EE had Tdap vaccine 5 days ago. Since then she has developed swelling and redness at the injection site as well as radiating pain down her right arm. EE took tylenol yesterday with good relief of pain. No Fever, chills, or sweats. No previous adverse reaction to vaccines. No neurologic symptoms. 3 in diameter nodule of the R upper arm. Injection site appears to be very low on the deltoid muscle. Nodule is minimally tender. There is overlying mild erythema and faint ecchymosis. EE has FROM of R shoulder and elbow, but intermittent report of R wrist pain with extension of the elbow. There is tenderness at the wrist. No specific point tenderness. Pain of wrist is intermittent and sharp in nature. B upper extremities are neurovascularly intact. unclear whether this is an adverse reaction to the vaccine vs possible vaccine injury. Patient will do gentle ROM exercises. She will take OTC ibuprofen or tylenol as needed. Ice as needed. ER precautions given. She will RTC if no better in 2-3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented to clinic reporting pain in right arm status post first vaccination with Shingrix.  Upon evaluation, patient has an area of erythema approximately 6 cm in circumference at injection site.  Site is slightly indurated.  Right arm has minor swelling with pain and localized tenderness.  Patient reports difficulty lifting arm above her head.    Patient reports alternating Tylenol and Ibuprofen for pain.  Patient denies fever, denies illness, denies signs or symptoms of anaphylaxis.    Advised patient that reaction is within the range of possible reactions but if area of redness continued to grow,  or pain increased, or if she develops fever or additional symptoms to make an appointment with her doctor.  Advised hot/cold pack for comfort and continuation  of OTC pain relief as needed.  Patient acknowledged.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient presented to clinic reporting pain in right arm status post first vaccination with Shingrix.  Upon evaluation, patient has an area of erythema approximately 6 cm in circumference at injection site.  Site is slightly indurated.  Right arm has minor swelling with pain and localized tenderness.  Patient reports difficulty lifting arm above her head.    Patient reports alternating Tylenol and Ibuprofen for pain.  Patient denies fever, denies illness, denies signs or symptoms of anaphylaxis.    Advised patient that reaction is within the range of possible reactions but if area of redness continued to grow,  or pain increased, or if she develops fever or additional symptoms to make an appointment with her doctor.  Advised hot/cold pack for comfort and continuation  of OTC pain relief as needed.  Patient acknowledged.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood chloride increased, Blood creatinine, Blood glucose normal, Blood urea increased, Cold sweat
Clinical narrative: resident had a change in condition. He was noted to be more lethargic than his baseline. He was not as alert as he usually is, Skin clammy,  pale grey skin color temp 100.2, pulse 83, BP 92/60. Resident was sent to the hospital. he was admitted with the following diagnoses: leukocytosis, sepsis, uti. There is no indication in the hospital notes that state this is caused by the immunization.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Glomerular filtration rate, Haemoglobin decreased, Lethargy, Leukocytosis
Clinical narrative: resident had a change in condition. He was noted to be more lethargic than his baseline. He was not as alert as he usually is, Skin clammy,  pale grey skin color temp 100.2, pulse 83, BP 92/60. Resident was sent to the hospital. he was admitted with the following diagnoses: leukocytosis, sepsis, uti. There is no indication in the hospital notes that state this is caused by the immunization.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil count, Pallor, Respiratory pathogen panel, Sepsis, Urinary tract infection
Clinical narrative: resident had a change in condition. He was noted to be more lethargic than his baseline. He was not as alert as he usually is, Skin clammy,  pale grey skin color temp 100.2, pulse 83, BP 92/60. Resident was sent to the hospital. he was admitted with the following diagnoses: leukocytosis, sepsis, uti. There is no indication in the hospital notes that state this is caused by the immunization.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis abnormal, White blood cell count increased
Clinical narrative: resident had a change in condition. He was noted to be more lethargic than his baseline. He was not as alert as he usually is, Skin clammy,  pale grey skin color temp 100.2, pulse 83, BP 92/60. Resident was sent to the hospital. he was admitted with the following diagnoses: leukocytosis, sepsis, uti. There is no indication in the hospital notes that state this is caused by the immunization.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Ear infection, Ear pain, Fatigue, Head discomfort
Clinical narrative: 3/5/24 headache, ear pain bilateral- resulting in bilateral ear infections, bad swelling- generalized resulting in leg and foot swelling, head pressure causing eye discomfort.  Sore throat intermittently, low grade fevers daily.  Hidradenitis suppurativa has flared.  Severe fatigue. No treatment currently.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Hidradenitis, Ocular discomfort, Oropharyngeal pain, Peripheral swelling
Clinical narrative: 3/5/24 headache, ear pain bilateral- resulting in bilateral ear infections, bad swelling- generalized resulting in leg and foot swelling, head pressure causing eye discomfort.  Sore throat intermittently, low grade fevers daily.  Hidradenitis suppurativa has flared.  Severe fatigue. No treatment currently.