chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dyspnoea, Eyelid ptosis, Fall, Guillain-Barre syndrome, Inappropriate schedule of product administration
Clinical narrative: Guillian Barre Syndrome; paralyzed from the eyes down; problems walking/relearn to walk; had to relearn to talk, swallow and walk; had to relearn to talk, swallow and walk; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in January 2023 via intramuscular route in unknown arm, 0.5 ml and no adverse effects from the first Shingrix vaccine).   On 28-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, right arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillian Barre Syndrome) (serious criteria hospitalization and GSK medically significant), paralysis (Verbatim: paralyzed from the eyes down) (serious criteria hospitalization and GSK medically significant), walking difficulty (Verbatim: problems walking/relearn to walk) (serious criteria hospitalization), speech disorder (Verbatim: had to relearn to talk, swallow and walk) (serious criteria hospitalization) and swallowing difficult (Verbatim: had to relearn to talk, swallow and walk) (serious criteria hospitalization).The outcome of the guillain barre syndrome was not resolved and the outcome of the paralysis, walking difficulty, speech disorder and swallowing difficult were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis, walking difficulty, speech disorder and swallowing difficult to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome, paralysis, walking difficulty, speech disorder and swallowing difficult to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter reported that he received his Shingrix vaccine in the right arm.  The reporter reported that 1 week after receiving the Shingrix vaccine he started to have problems walking. Two weeks after receiving his Shingrix vaccine he was paralyzed from the eyes down.  The reporter reported that he was in the hospital for 10 weeks, in rehab for 31 days and now in rehab at home.  The reporter reported that he had to relearn to talk, swallow and walk. The reporter reported he must use a walker to walk.  The reporter reported that his neurologist diagnosed him with Guillian Barre Syndrome (via spinal tap). The patient also asked for the GlaxoSmithKline Legal Department to sue for assistance with bills. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Intensive care, Lumbar puncture abnormal, Mechanical ventilation, Paraesthesia, Paralysis
Clinical narrative: Guillian Barre Syndrome; paralyzed from the eyes down; problems walking/relearn to walk; had to relearn to talk, swallow and walk; had to relearn to talk, swallow and walk; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in January 2023 via intramuscular route in unknown arm, 0.5 ml and no adverse effects from the first Shingrix vaccine).   On 28-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, right arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillian Barre Syndrome) (serious criteria hospitalization and GSK medically significant), paralysis (Verbatim: paralyzed from the eyes down) (serious criteria hospitalization and GSK medically significant), walking difficulty (Verbatim: problems walking/relearn to walk) (serious criteria hospitalization), speech disorder (Verbatim: had to relearn to talk, swallow and walk) (serious criteria hospitalization) and swallowing difficult (Verbatim: had to relearn to talk, swallow and walk) (serious criteria hospitalization).The outcome of the guillain barre syndrome was not resolved and the outcome of the paralysis, walking difficulty, speech disorder and swallowing difficult were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis, walking difficulty, speech disorder and swallowing difficult to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome, paralysis, walking difficulty, speech disorder and swallowing difficult to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter reported that he received his Shingrix vaccine in the right arm.  The reporter reported that 1 week after receiving the Shingrix vaccine he started to have problems walking. Two weeks after receiving his Shingrix vaccine he was paralyzed from the eyes down.  The reporter reported that he was in the hospital for 10 weeks, in rehab for 31 days and now in rehab at home.  The reporter reported that he had to relearn to talk, swallow and walk. The reporter reported he must use a walker to walk.  The reporter reported that his neurologist diagnosed him with Guillian Barre Syndrome (via spinal tap). The patient also asked for the GlaxoSmithKline Legal Department to sue for assistance with bills. The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Computerised tomogram, Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: The patient received the RSV (Arexvy) vaccine on 8/21/23.  The patient called the pharmacy today, 9/18/23, and reported to me (pharmacist) that he felt dizzy and tired with shortness of breath later in the day after he got the vaccine. He went to the ER and was diagnosed with TIA (transient ischemic attack).  He said that the doctor tested him for other conditions but everything was normal.  He told the doctor that he got the RSV vaccine earlier in the day, and the doctor had suggested that it may be the vaccine that triggerred the TIA. The patient's health is normal now, per patient.
Age: 71.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Dizziness, Dyspnoea, Fatigue, Laboratory test normal, Transient ischaemic attack
Clinical narrative: The patient received the RSV (Arexvy) vaccine on 8/21/23.  The patient called the pharmacy today, 9/18/23, and reported to me (pharmacist) that he felt dizzy and tired with shortness of breath later in the day after he got the vaccine. He went to the ER and was diagnosed with TIA (transient ischemic attack).  He said that the doctor tested him for other conditions but everything was normal.  He told the doctor that he got the RSV vaccine earlier in the day, and the doctor had suggested that it may be the vaccine that triggerred the TIA. The patient's health is normal now, per patient.
Sex: U
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: gave the patient only the diluent portion of the Arexvy vaccine; I got distracted and gave the patient only the diluent portion of the Arexvy vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-SEP-2023, the patient received Arexvy. On 08-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: gave the patient only the diluent portion of the Arexvy vaccine) and inappropriate dose of vaccine administered (Verbatim: I got distracted and gave the patient only the diluent portion of the Arexvy vaccine).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 09-SEP-2023 The reporter left message on after hours VM box, that he got distracted and gave the patient only the diluent portion of the Arexvy vaccine. The reporter contacted provided permission for Safety team follow-up for additional patient details & adverse event details. The reporter consented to follow up. The reporter left message on after hours VM box, that he got distracted and gave the patient only the diluent portion of the Arexvy vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse administered a dose of expired Fluzone High Dose QIV to the patient with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 71 years old female patient whom nurse administered a dose of expired influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received a dose 0.7 ml of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength: not reported lot UJ924AB via unknown route in unknown administration site for Immunization.  On 11-SEP-2023 nurse administered a dose of expired fluzone high dose qiv to the patient with no reported adverse event (expired product administered) on the same day following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  Action taken was not applicable.  Reportedly, Today, a nurse administered a dose of expired Fluzone High Dose QIV to the patient (last year's formula). The injection site information was not available at the time of the call due to the nurse who administered the dose was with another patient. The patient received no other vaccines today.  At time of reporting, the outcome was Unknown for the event nurse administered a dose of expired fluzone high dose qiv to the patient with no reported adverse event.  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: 35.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Headache, Throat pain, Joint pain, Fever, Chills, Fatigue, Dizziness, Vomiting
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Headache, Throat pain, Joint pain, Fever, Chills, Fatigue, Dizziness, Vomiting
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Tight, hot red circle around the injection site more than 24 hours later. Severe pain in my left arm. Low grade fever, diarrhea and body aches beginning approximately 20 minutes after the vaccine was administered.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered an expired pentacel with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 years old female patient who was inadvertently administered an expired pentacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection expiry date: 09-Sep-2023 via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number: unknown), inadvertently administered an expired pentacel with no reported adverse event (expired product administered) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered  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: 75.0
Sex: M
Vaccine: RSV
Symptoms: Tinnitus
Clinical narrative: Developed loud tinnitus in right ear
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Injection site rash, Injection site swelling, Rash macular
Clinical narrative: patient returned to the pharmacy 1 week after receiving rsv vaccine and reports having an approximately 3 inch diameter red raised blotchy area surrounding the injection site. patient reports no itching/pain/sensations in the area other than cosmetic redness and area is slightly raised
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: 3" x 5" red, swollen  and hot arm  (much more than any other vaccine).  After 3 days, still red, a little itchy.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4, PNC20, RSV
Symptoms: Cough, Diarrhoea, Headache, Oropharyngeal pain
Clinical narrative: Patient received 4 vaccines- Prevnar 20, Arexvy, FluzoneHD, and pfizer bivalent on 9/2/23. She reported on 9/17/23 that she had side effects the next day. The patient experienced headache, diarrhea, sore throat, and cough. Pt believes these side effects were due to the Arexvy since she has never had side effects with any of the other vaccines before. Patient stated she had these side effects for about 1 week, she has recovered from them by now.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: On August 28, 2023, a RN was preparing to administer a Menveo-meningococcal vaccine to a patient. She noted that there were 2 component/powder-Vial 1 and one Vial 2 component left in Menveo box. In inventory, it showed that there was 0-Menveo vaccine left after she administered that dose. After reviewing the barcode, 4 doses had been previously administered. Those 4 doses had been administered by 2 others RNs. Each RN was questioned about mixing vials, but neither can remember if they had mixed vial 1 and vial 3. Dr. was notified of incident and his recommendation was to contact parents of each patient and let them know that each patient is covered on Meningococcal C, Y and W -135 but not cove Dr. was notified of incident and his recommendation was to contact parents of each patient and let them know that each patient is covered on Meningococcal C, Y and W -135 but not covered on Group A, which is not needed unless traveling outside of the country No adverse reactions noted.
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Dysmenorrhoea, Menstrual discomfort, Polymenorrhoea
Clinical narrative: Early onset of menstruation, beginning with heavier spotting, approximately 2 wks earlier than anticipated. Accompanied by cramping and discomfort.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: child was in to get ACWY and Tdap to update her vaccines, nurse accidently gave a DTaP instead of a Tdap.
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: child behind on vaccines, came in for vaccine catch up, DTaP was given instead of Tdap.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine - the expiration date on this product was 7/15/2023.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Dizziness, Fatigue, Feeling hot, Headache
Clinical narrative: Shortly after injection my upper arm was very swollen and hot-the injection itself was not painful at all.  Then I developed a headache and didn't think anything of it.  I became tired and weak feeling and laid down, fell asleep which I never do in the day time.  I woke up with severe tachycardia and felt very dizzy.  I slowly stood up and felt very faint, then vomited.  I had not eaten anything in several hours and had not had anything my spouse had not eaten.  He had not taken the RSV vaccine and was fine.  All the next day I was very weak feeling and slept a lot, my blood pressure was very low.  I drank a lot of fluid, the headache persisted-actually became a pounding headache the evening of the 16th and is still there today but I feel I am almost back to normal otherwise today.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Hypersomnia, Hypotension, Peripheral swelling, Somnolence, Tachycardia
Clinical narrative: Shortly after injection my upper arm was very swollen and hot-the injection itself was not painful at all.  Then I developed a headache and didn't think anything of it.  I became tired and weak feeling and laid down, fell asleep which I never do in the day time.  I woke up with severe tachycardia and felt very dizzy.  I slowly stood up and felt very faint, then vomited.  I had not eaten anything in several hours and had not had anything my spouse had not eaten.  He had not taken the RSV vaccine and was fine.  All the next day I was very weak feeling and slept a lot, my blood pressure was very low.  I drank a lot of fluid, the headache persisted-actually became a pounding headache the evening of the 16th and is still there today but I feel I am almost back to normal otherwise today.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: Shortly after injection my upper arm was very swollen and hot-the injection itself was not painful at all.  Then I developed a headache and didn't think anything of it.  I became tired and weak feeling and laid down, fell asleep which I never do in the day time.  I woke up with severe tachycardia and felt very dizzy.  I slowly stood up and felt very faint, then vomited.  I had not eaten anything in several hours and had not had anything my spouse had not eaten.  He had not taken the RSV vaccine and was fine.  All the next day I was very weak feeling and slept a lot, my blood pressure was very low.  I drank a lot of fluid, the headache persisted-actually became a pounding headache the evening of the 16th and is still there today but I feel I am almost back to normal otherwise today.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Imperception, Motor dysfunction, Tremor
Clinical narrative: Decreased Motor Control, Shakes, Decreased Spatial Perception, Craziness
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Dysstasia, Hypoaesthesia, Nervousness, Walking aid user
Clinical narrative: body feels numb and she describes hard to stand up - feels like fainting.  possible shortness of breath but said that might be because she is so nervous about how she is feeling
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Exposure via skin contact, Immunisation, Syringe issue
Clinical narrative: While administering an Influenza vaccine,ordered, vaccine solution leaked around the base near luer lock, where the needle attaches to the prefilled syringe. When noticed, CMA immediately withdrew the needle and safety engaged on needle. No obvious defect in syringe or needle. Patient did not experience any discomfort or immediate ill effects due to this issue. Needle was noted to be secured to the syringe tightly and verified by RN. Unknown amount leaked down the patient's arm and collected in the threads of the syringe. Dr notified immediately. Pt agreed to a second Influenza vaccine, per Dr.'s recommendations. Vaccine was administered at 11:20a.m. lot # 371597.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: ActHib vaccine was involved in a temperature excursion and was advised to be pulled from stock and to not be given. One of the nurses was not aware of the instructions given and administered the vaccine before being notified . Patient did not have any adverse effects/reactions. Sanofei, the vaccine company was contacted and told what happened, the case worker from the vaccine company stated patient would just need to be re-vaccinated. Patient has an appointment to do so.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Grunting
Clinical narrative: PATIENT RECEIVED HIS HEPATITIS A VACCINE YESTERDAY.HE HAD NO OTHER ISSUES GOING ON WITH HIM AT THAT TIMEFRAME.  FOLLOWING THAT APPROXIMATELY 1 HOUR LATER HE STARTED HAVING ISSUES WITH GRUNTING/DIFFICULTY BREATHING.  THIS IS ALSO ACCOMPANIED BY A INCREASED TONE THROUGHOUT HIS BODY.  NO DEFINITE SEIZURE ACTIVITY NOTED.  THIS LASTED SEVERAL MINUTES BUT LESS THAN 10 MINUTES.  HE HAD ANOTHER RECURRENCE OF THIS 1 TO 2 HOURS LATER.  I ADVISED HIM ON THIS IS SOME SORT OF REACTION TO THE HEPATITIS A VACCINE.  WE WILL FILL OUT A VAERS REPORT.  TREAT WITH BENADRYL FOR NOW.
Age: 65.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Body temperature increased, Fatigue, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Severe left axillary lymph node/ tissue swelling, baseball size.  Right axillary lymph node discomfort. Significant exhaustion, body aches.  102. temperature onset within 48 hours
Age: 65.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Abdominal pain upper, Axillary pain, Body temperature increased, Fatigue, Insomnia
Clinical narrative: Severe left axillary lymph node/ tissue swelling, baseball size.  Right axillary lymph node discomfort. Significant exhaustion, body aches.  102. temperature onset within 48 hours
Age: 65.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Lymphadenopathy, Peripheral swelling, Pyrexia, Sleep disorder, Somnolence
Clinical narrative: Severe left axillary lymph node/ tissue swelling, baseball size.  Right axillary lymph node discomfort. Significant exhaustion, body aches.  102. temperature onset within 48 hours
Age: 22.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Adult patient received Kinrix instead of Boostrix.  Patient aware, no adverse effects noted.
Age: 39.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PT denies any symptoms at this time he was  given high dose flu rather than flulaval, side effects/adverse reactions given; pt will contact PCP if any concerns.
Age: 60.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Oropharyngeal pain, Throat tightness
Clinical narrative: Patient said it felt like her throat was sore and tight. She called and spoke with her MD who advised her to take Benadryl. She did this every 4 hours until around 1am when she was starting to feel better
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Proquad was given in conjunction with Varicella vaccine.
Age: 2.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt denies any symptoms at this time, father was educated on side effects/adverse reactions.  High dose FLUAD given IM rather than Flulaval.  Pt father will contact his PCP  if any symptoms occur.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis mesenteric vessel
Clinical narrative: Developed a blood clot in my intestines
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Nodule, Pruritus, Rash macular
Clinical narrative: Red, itchy, splotchy about 2 inches in size with knot; itching has subsided but redness remains.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Diarrhoea, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient came to the health department on 8/18/23 for the first in a series of 2 for his M-Pox vaccination. On 8/19/23 he stated that his left lymph node or gland was swollen to the touch and his abdomen was swollen and sensitive with diarrhea. These symptoms lasted approximately 2-3 weeks. The patient called the health department on 9/18/23 to report these events.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: arm aches in muscle in upper arm, aches travels down arm also into forearm area.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 35.0
Sex: F
Vaccine: FLUR4, HPV9
Symptoms: Hyperhidrosis, Malaise, Nausea, Pallor
Clinical narrative: 35-year-old female came in for Flushot and HPV on 09/16/2023. After reviewing patient profile and form, Flublok (NDC 49281072310, Lot QFAA2313, exp 06/2024) was given IM to patient Left Arm,  and Gardasil 9 (NDC 00006412102, Lot W014209, exp 01/06/2025) was given IM to patient Right Arm. Approximately 5 minutes later, patient stated that she did not feel very well and would like a glass of water. At this time, patient looked pale to pharmacist. She began sweating and became nauseous. Pharmacist checked, and no sign of anaphylaxis, injection sites looked clean and clear. Patient remained consciousness and fully alert. Pharmacist recommended patient to stay at the pharmacy for observation. After ~ 5 minutes of resting, patient began to feel better. No medication was given to patient. Patient had called her mother to pick her up from pharmacy after 15 minutes. Follow up with patient on Sunday 09/17/2023 around 10:15am via phone, patient stated that she felt better, no other symptoms/issue.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia
Clinical narrative: Severe fever, muscle & joint pain, nausea for 3 days
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: The wrong shot was given on a mistake on 9/18/23 at 11;44am and the parent was call in noticed.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: diffuse urticaria. no angioedema. no involvement mucosal surfaces. starting few hours after administration of vaccine. seen by urgent care 2 days later adn started on zyrtec and prednisone. urticaria symptoms persist on day 4 despite treatment
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Pain, Pain in extremity
Clinical narrative: flu like symptoms the first three days. Arm remained very sore for several weeks. My joints are inflamed and very sore. Hard to raise my arms due to pain. Literally every joint in my body hurts. My husband has the same symptoms as well. We had the shots at the same time.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Mobility decreased, Myalgia
Clinical narrative: I began having significant muscle soreness into my neck and distal to site into left arm. Symptoms are unilateral on left. The muscle soreness limited my ability to drink from a glass, requiring resting neck due to fatigue, limiting cervical ROM with extension and left rotation. I have been taking Ibuprofen for pain, heat/ice at night when worst. Symptoms at injection site have diminished.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Chills, muscle aches, joint pain, and fever up to 100.8 degrees F. Symptoms lasted for twelve hours then resolved.
Age: 76.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Blood glucose abnormal, Condition aggravated, Diabetes mellitus
Clinical narrative: Uncontrolled blood sugar 2 days after vaccination.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Magnetic resonance imaging head, Restless legs syndrome, Tremor
Clinical narrative: Severe right side parkinsonian hand tremor and right leg RLS. I ALREADY HAD MILD TREMOR. AFTER VAX BECAME SEVER
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 14.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient has already received a valid meningococcal on 01-20-23, patient has had serology on MMR and VRZ titers which were (+). Patient received immunizations which she did not need.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Flushing, Pharyngeal paraesthesia, Skin warm
Clinical narrative: Patient felt her face flush, and felt tingling in her throat, and her ears were hot. Breathing was ok.
Age: 12.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Meningococcal B in error. Patient is 12 years of age which is under qualified age group for this vaccination.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Device connection issue, Immunisation, No adverse event
Clinical narrative: When injecting the pre-filled fluzone syringe into the patient's arm, approximately 80% of the liquid squirted from the connection of the barrel to the luer-lock connected needle.  Discussed the incident with the patient and agreed the best course of action would be a second injection. A new prefilled syringe and needle were used at a second injection site 1.5 inches from the original without incidence. Patient has not reported feeling any adverse effects at this time.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Heavy menstrual bleeding
Clinical narrative: Patient experienced Amenorrhea the day of vaccinations. Patient experienced heavy menstrual flow on day of vaccine. last menses was 09/02/2023.
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, IPV, MENB, MMR, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: The adverse event was a vaccine administration error-- not the PCP's fault as they did not have the immunization record for the second doses. The Child did not have any reportable symptoms.   Vaccines invalidated due to repeats:  HEPB, HPV9, and TDAP.  Not validated or unvalidated: 3rd dose of Varicella vaccine
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given, but vaccinator did not see expiration date until after it was given. Vaccine was administered expired.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Lymphadenopathy, Mammogram abnormal, Ultrasound scan abnormal
Clinical narrative: Patient received her Arexvy vaccine on 9/5/23 and reported to pharmacy on 9/18/23 that her lymph nodes were swollen on 9/15/23 due to Arexvy vaccine. She saw her pcp and radiologist on 9/15/23.  Patient said she had her mammogram and ultrasound scan done.  Per her radiologist,  the results showed that her lymph nodes were swollen.  She said her radiologist  told her that it's caused by Arexvy vaccine and it will take at least 6 months for her lymph nodes to return to normal.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and Swelling on almost entire upper arm on injection site
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Rash
Clinical narrative: Patient received Influenza, Quad PF in right arm on 9/7/23.  Reaction noted numb tongue and lips and soon after rash all over.  Was seen at ER 9/7/23.  Patient had taken Benadryl at recommendation of her NP.  Patient is now going to see an allergy Dr.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Localized reaction at site of injection:  inflamed (red, hot the the touch, swollen), very itchy.  Area of inflammation measured about 2 inches in diameter. Started around 26 hours after vaccine administered, continued to worsen for an additional 24 hours.  3 days post vaccine itching is starting to improve.  Treated with hydrocortisone cream OTC 1%, and Benadryl.
Age: 0.67
Sex: F
Vaccine: PNC20
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: I took out vaccine, Prevnar 13 & Prevnar 20 are placed side by side.  Gave syringe to another employee, she verified that it was correct.  She was in training, did not realize it was the 20 instead of the 13.  It was administered, no reactions at that time.  It was not found incorrect until it was placed in the computer system and the NDC did not match.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Optic neuritis
Clinical narrative: 2 days after vaccination developed optic neuritis, seen by eye doctor and Hospital, admitted and treated with a 3 day course of 1g MethylPREDNISolone for image negative optic neuritis
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic aneurysm, Cardiac failure congestive, Oedema, Systemic lupus erythematosus
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 6/15/2023 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART J96.00 ACUTE RESPIRATORY FAILURE 6/15/2023 SLE (SYSTEMIC LUPUS ERYTHEMATOSUS) J96.00 ACUTE RESPIRATORY FAILURE 6/15/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 6/15/2023 EDEMA
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Hypoxia
Clinical narrative: R09.02 HYPOXEMIA 5/26/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Pulmonary embolism
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 5/11/2023 ACUTE NON ST ELEVATION MI I26.99 ACUTE PULMONARY EMBOLISM 5/11/2023 ACUTE NON ST ELEVATION MI
Age: 64.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient Received the Fluzone High Dose even though patient was not indicated for high dose and should have received the regular version of the flu vaccine. Per staff, patient has not experience any issues.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Hypersomnia
Clinical narrative: Soreness in the arm. Immediately I was very tired. I laid down and slept a lot. I slept through the night and when I woke up I had a dull headache and continued to sleep through the day. I still have muscle and joint pain. I had severe diarrhea all day 9/17. 9/18 still have fatigue and some muscle and joint pain.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Myalgia, Pain in extremity
Clinical narrative: Soreness in the arm. Immediately I was very tired. I laid down and slept a lot. I slept through the night and when I woke up I had a dull headache and continued to sleep through the day. I still have muscle and joint pain. I had severe diarrhea all day 9/17. 9/18 still have fatigue and some muscle and joint pain.
Age: 39.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluad is administrated at age of 39. Informed the patient and patient did not report any side effect nor any change of status after 1 hour 30 minutes of the vaccine administration.
Age: 26.0
Sex: M
Vaccine: HEPA, SMALLMNK
Symptoms: Urticaria
Clinical narrative: Patient reported that one week after vaccination they experienced hives that started on the arm that was vaccinated and spread to the chest, abdomen, and legs. They report that the hives lasted 3-4 days and were mild. They reported taking Benadryl and that it helped with the hives. The hives resolved after 3-4 days. Denies any itching or swelling in the mouth or throat. Patient reported that they did go camping a few days before the hives showed up. They are unsure if that is related to the hives.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash on Back
Age: 19.0
Sex: M
Vaccine: HEPA, MMR, MMR, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 9/14/2023, my client was inadvertently given an expired dose (Exp. 9/4/2023) of MMR. When the error was discovered, the remaining box of vaccine was removed from inventory and expired. Since the client was leaving the country and unable to return to the clinic at 28 days to repeat the dose, a decision made between both the client and I was to administer another UNexpired dose of MMR immediately. This was done,  tolerated well, and there were no adverse effects following a 15 minute wait time.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration pleural cavity, C-reactive protein, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Admitted with cough, SOB, lightheadedness; + covid in ED; CXR wit patchy infiltrates bilat; Dx Covid PNA Labs: D-dimer 2.39; CRP 3.8; Ferritin 102; Tx: Patient started on IV Zosyn, azithromycin, dexamethasone, Lovenox, solu-medrol.  Also rec' d remdesivir, baricitinib, zinc, Vit C; Patient initially required high-flow nasal cannula, BiPAP noninvasive ventilation, prone ventilation.  Thoracentesis on 2/13 for pleural effusion;  During course of hospital stay, patient gradually improved.  Back to baseline for home O2 by d/c.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Fibrin D dimer, Lung infiltration
Clinical narrative: Admitted with cough, SOB, lightheadedness; + covid in ED; CXR wit patchy infiltrates bilat; Dx Covid PNA Labs: D-dimer 2.39; CRP 3.8; Ferritin 102; Tx: Patient started on IV Zosyn, azithromycin, dexamethasone, Lovenox, solu-medrol.  Also rec' d remdesivir, baricitinib, zinc, Vit C; Patient initially required high-flow nasal cannula, BiPAP noninvasive ventilation, prone ventilation.  Thoracentesis on 2/13 for pleural effusion;  During course of hospital stay, patient gradually improved.  Back to baseline for home O2 by d/c.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion, Positive airway pressure therapy, Prone position, SARS-CoV-2 test positive, Serum ferritin normal
Clinical narrative: Admitted with cough, SOB, lightheadedness; + covid in ED; CXR wit patchy infiltrates bilat; Dx Covid PNA Labs: D-dimer 2.39; CRP 3.8; Ferritin 102; Tx: Patient started on IV Zosyn, azithromycin, dexamethasone, Lovenox, solu-medrol.  Also rec' d remdesivir, baricitinib, zinc, Vit C; Patient initially required high-flow nasal cannula, BiPAP noninvasive ventilation, prone ventilation.  Thoracentesis on 2/13 for pleural effusion;  During course of hospital stay, patient gradually improved.  Back to baseline for home O2 by d/c.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Nausea, Pyrexia, Vomiting
Clinical narrative: emergency room because of nausea and vomiting associated with fever on cough for the last 3 days Patient admitted to the hospital Will start the patient on Decadron 6 mg IV daily Will start the patient on the remdesivir 200 mg IV x1 dose today Continue remdesivir 100 mg IV daily starting tomorrow for 4 doses
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Approx 9 hours later I had a low grade fever. I had sweats on and off for an hour at a time until bed time. I had it again in the morning. I finally called the insurance help nurse desk. The RN said to take 2 tylenol and see what happens and it helped and my fever has been gone for about 40 hours now.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, COVID-19 pneumonia, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: Presented with SOB; flu-like symptoms, cough x2-3 days; CXR: right basiliar opacity suspicious for PNA; dx NSTEMI and Covid + PNA; Tx: Decadron, heparin, remdesivir, Vit C, Zinc; Initially on HFO2, down to 4 LPM O2 @ d/c
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lung opacity, SARS-CoV-2 test positive
Clinical narrative: Presented with SOB; flu-like symptoms, cough x2-3 days; CXR: right basiliar opacity suspicious for PNA; dx NSTEMI and Covid + PNA; Tx: Decadron, heparin, remdesivir, Vit C, Zinc; Initially on HFO2, down to 4 LPM O2 @ d/c
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Dyspnoea, Positive airway pressure therapy
Clinical narrative: Presented with SOB; Acute on chronic respiratory failure --Multi-factorial i.e possible healthcare acquired pneumonia in addition to  COVID Positive and advanced COPD; Rec'd IV steroids, Singulair, vitamin C, Pepcid, zinc sulfate, Remdesiver; tocilizumab, merrem, vanc; Supplemental O2 via CPAP/BIPAP/HFO2; pt failed to improve and decided on hospice
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Presented with SOB; Acute on chronic respiratory failure --Multi-factorial i.e possible healthcare acquired pneumonia in addition to  COVID Positive and advanced COPD; Rec'd IV steroids, Singulair, vitamin C, Pepcid, zinc sulfate, Remdesiver; tocilizumab, merrem, vanc; Supplemental O2 via CPAP/BIPAP/HFO2; pt failed to improve and decided on hospice
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Eczema, Herpes zoster, Pain, Pruritus
Clinical narrative: He got his vaccine, he was fine at first during that hour, later on the next day he started to feel whelps on his back on the side.  He looked further and there was a red mark that was a little swollen and he felt a little pain.  He decided to call his doctor on that Monday, went to see him and said that he had shingles.  He was prescribed pills for a week, 3 times a day which kind of subsided.  His left side is now swollen, larger than the other.  He has slight discomfort and pain, not itching that much.  The middle of his back is kind of itchy every other day, and has some cream that he is applying that goes away and then comes back.  It has erupted some type of eczema in him, and cannot believe he has shingles. His doctor told him to probably not take the 2nd one, and he is not going to take it.  He took Valacyclovir for a week.  He hopes that this clears up and hopes he is not affected for the rest of his life.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: He got his vaccine, he was fine at first during that hour, later on the next day he started to feel whelps on his back on the side.  He looked further and there was a red mark that was a little swollen and he felt a little pain.  He decided to call his doctor on that Monday, went to see him and said that he had shingles.  He was prescribed pills for a week, 3 times a day which kind of subsided.  His left side is now swollen, larger than the other.  He has slight discomfort and pain, not itching that much.  The middle of his back is kind of itchy every other day, and has some cream that he is applying that goes away and then comes back.  It has erupted some type of eczema in him, and cannot believe he has shingles. His doctor told him to probably not take the 2nd one, and he is not going to take it.  He took Valacyclovir for a week.  He hopes that this clears up and hopes he is not affected for the rest of his life.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, C-reactive protein increased, COVID-19 pneumonia, Dyspnoea, Fibrin D dimer
Clinical narrative: Presented with SOB, afib; Dx Covid PNA; Labs: D-dimer 1.94 CRP 12.9, Ferritin 2757.5; Tx:  Decadron, Remdesivir, Vit C, Lovenox, Singulair, Zinc;  Supplemental O2 from 2-5 LPM; Remained on 5 LPM O2 at d/c
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Serum ferritin increased
Clinical narrative: Presented with SOB, afib; Dx Covid PNA; Labs: D-dimer 1.94 CRP 12.9, Ferritin 2757.5; Tx:  Decadron, Remdesivir, Vit C, Lovenox, Singulair, Zinc;  Supplemental O2 from 2-5 LPM; Remained on 5 LPM O2 at d/c
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives from the waist down to feet for 3 days.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature increased, COVID-19, Chest X-ray abnormal, Computerised tomogram abdomen abnormal
Clinical narrative: Presented with prod cough, low grade temp, dyspnea x 1 week; decreased sense of taste and smell; L arm weakness; + covid at home PTA; CT/MRI negative for cerebral event; ; Tx: started on IV steroids, lovenox, Vit C, antibiotics,  and acemra, (no remdesivir as symptom onset >10 days); Initiallly on 2-3 LPM NC; 12/10 worsening dyspnea; O2 increased HFNC; 12/11 Transitioned to AirVo and transferred to to ICU with worsening O2 requirements; resulted on Continuous bipap; 12/14 CXR with bilat pul opacities; placed on AirVo; 12/15 abd pain and dizziness; CT with RLQ retroperitoneal hemorrhage; pt became hypotensive, req levo and PRBC transfusion; protamine, Intubated;  Pt with PEA arrest with ROSC; max pressor support;  family requested comfort care and pt ultimately extubated and died at 02:17