chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Vomiting
Clinical narrative: The patient experienced fainting within 5 minutes of receiving the vaccine. He was seated at the time, and immediately started to fall over losing consciousness. After about 1 minute, he became fully alert and asked what happened. He said he "blacked out." He was sweating. After another 5 minutes, he became nauseous and started vomiting. EMS arrived shortly after and checked his vitals. His pulse was around 50, and blood pressure was around 80/60. They waited a few minutes and rechecked vitals which stayed about the same. They wanted to take him to the hospital, but the patient was unwilling. They stayed a bit longer to recheck the vitals - his vitals improved to around 98/70, the patient was able to stand at this point and said he was feeling much better. We gave him some water. I checked in with the patient later that night and he did get home okay and said he was doing fine.
Age: 63.0
Sex: F
Vaccine: PNC20, RSV, TDAP, VARZOS
Symptoms: Device issue, Needle issue, Underdose
Clinical narrative: WHILE ADMINISTERING THE PREVNAR-20, THE PLUNGER DID NOT FULLY DEPRESS, AND VACCINE SHOT OUT OF NEEDLE UPON REMOVAL FROM THE ARM. NEEDLE WAS ALSO BENT UPON REMOVAL FROM ARM. RE-ADMINISTERED WITH NEW PFS FOR FULL DOSE.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Patient states she started to experience numbness and tingling sensation in her left hand and fingers about 4 days after receiving her second Shingrix vaccine. The symptoms have continued since then and have spread to her forearm. She has also experienced weakness in her hand and the inability to grasp certain items with her left hand.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Borrelia test negative, Cardiac monitoring normal, Cardiac stress test normal, Chest X-ray, Computerised tomogram normal
Clinical narrative: These symptoms have been present since I got the vaccine.  Exercise intolerance:  my heart rate rises quickly when exercising, and I have decreased endurance. Sleeplessness: I have had markedly greater problems sleeping and especially if I am physically active within several hours of going to bed.  Fatigue: I feel tired and especially so when I have exercised or when I have slept poorly. Note: I received an "influenza virus vaccine, inactivated" at the same time, but I do not have more specific info, so I could not choose it from the drop down menu.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Echocardiogram, Electrocardiogram normal, Epstein-Barr virus antibody positive, Exercise tolerance decreased, Fatigue
Clinical narrative: These symptoms have been present since I got the vaccine.  Exercise intolerance:  my heart rate rises quickly when exercising, and I have decreased endurance. Sleeplessness: I have had markedly greater problems sleeping and especially if I am physically active within several hours of going to bed.  Fatigue: I feel tired and especially so when I have exercised or when I have slept poorly. Note: I received an "influenza virus vaccine, inactivated" at the same time, but I do not have more specific info, so I could not choose it from the drop down menu.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Heart rate increased, Inflammatory marker test, Insomnia, Pulmonary function test normal, Scan with contrast normal
Clinical narrative: These symptoms have been present since I got the vaccine.  Exercise intolerance:  my heart rate rises quickly when exercising, and I have decreased endurance. Sleeplessness: I have had markedly greater problems sleeping and especially if I am physically active within several hours of going to bed.  Fatigue: I feel tired and especially so when I have exercised or when I have slept poorly. Note: I received an "influenza virus vaccine, inactivated" at the same time, but I do not have more specific info, so I could not choose it from the drop down menu.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient had previously received influenza vaccine on 11/9/23 and was given an additional dose of influenza vaccine on 3/12/24.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Patient had previously received MMR doses on 2/10/20 and 10/19/22.  Additional dose administered on 3-7-24, as clinic nurse thought dose needed after age 4 years.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reports of any symptomatic adverse events; HCP called to state that the patient was inadvertently administered a dose of ROTATEQ that expired on 05/05/2024.; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 07-MAY-2024 (also reported as today), the patient was inadvertently vaccinated with a expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter as prophylaxis (scheme, route of administration, and lot number were not provided). The vaccine expired on 05-MAY-2024 (expired product administered). There were no reports of any symptomatic adverse events (no adverse event). Additionally, it was reported that the vaccine did not have any prior temperature excursions and was supported by the post expiry memo. The adverse event (AE) follow-up was declined.
Age: 5.0
Sex: M
Vaccine: FLU4, HEPA, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered Daptacel, patient received Meningococcal B (Bexsero) by error of myself Medical Assistant. Patient had no adversed reaction to the vaccine.
Age: 64.0
Sex: F
Vaccine: PNC20, PNC20, PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5cm area of redness and swelling around injection site
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; HCP called to inform a patient was administered ROTATEQ on 5/9/2024 inadvertently after its labeled expiry date (5/04/2024).; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-MAY-2024, the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 DS X 10 TUBES 00006404741) oral liquid, administered orally, lot #1947622, which had been confirmed to be a valid lot number, expiration date reported and confirmed as 04-MAY-2024 (expired product administered), administered for prophylaxis (strength and dose were not provided). No side effects were reported (no adverse event). It was confirmed that no temperature excursion occurred. An agent provided ''supported'' outcome from '' post expiry memo'' and the health care professional (HCP) insisted on getting the supported disclaimer that the agent read from the article in an email, however, agent informed the disclaimer was verbal only and could not be sent in writing. HCP stated the needed of the supported disclaimer in writing to present to quality/risk department team so they could decide about revaccination. Therefore, agent requested to be escalated to manager for her request. In addition, HCP did not request any ''MIR''. No other information was provided.
Age: 6.0
Sex: U
Vaccine: COVID19, DTAPIPV, HEPA, PNC15, VARCEL
Symptoms: Accidental overdose, Vaccination site pain
Clinical narrative: the vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/ was given 0.5 ml when it should have been 0.25 ml; the patient developed after vaccine no noticeable side effects besides achy shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (the patient developed after vaccine no noticeable side effects besides achy shot site) and ACCIDENTAL OVERDOSE (the vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/ was given 0.5 ml when it should have been 0.25 ml) in a 6-year-old patient of an unknown gender who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis.    Co-suspect products included non-company products HEPATITIS A VACCINE INACT (VAQTA) for Prophylactic vaccination, VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination and QUADRACEL for Prophylactic vaccination.    No Medical History information was reported.   On 26-Oct-2023, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter, first dose of HEPATITIS A VACCINE INACT (VAQTA) (Intramuscular use) 1 dosage form, second dose of VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) (Subcutaneous use) 1 dosage form, first dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form and fifth dose of QUADRACEL (Intramuscular use) 1 dosage form. In 2023, the patient experienced VACCINATION SITE PAIN (the patient developed after vaccine no noticeable side effects besides achy shot site). On 26-Oct-2023, the patient experienced ACCIDENTAL OVERDOSE (the vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/ was given 0.5 ml when it should have been 0.25 ml). At the time of the report, VACCINATION SITE PAIN (the patient developed after vaccine no noticeable side effects besides achy shot site) and ACCIDENTAL OVERDOSE (the vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/ was given 0.5 ml when it should have been 0.25 ml) outcome was unknown.            No concomitant medication was reported.  It was not reported if the patient received a correct treatment for the event.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The dose that was given was 5/18/24.  The Beyond Use Date was 5/3/24.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient received a dose with Beyond Use Date of 5/3/24
Age: 53.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Redness and itch at injection site followed by hives and itchiness all over body. Symptom onset was 6 days after injection. Patient was advised to take benadryl and pepcid to alleviate the hives and topical benadryl for the injection site.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Abdominal X-ray, Barium double contrast, Decreased appetite, Flatulence, Gastrooesophageal reflux disease
Clinical narrative: n/v lack appetite, fussy day 9 after Rotarix = diagnosed intussusception   Symptoms: NAUSEA W VOMITING,UNSPECIFIED(R112), DIARRHEA, UNSPECIFIED(R197).   Summary HPI: 2/9/2024 2 month old WCC visit -normal. 2/18/24 to ER  since 2300 parents report repetitive vomiting, "stomach acid", not eating, 1 wet diaper this AM, stools yesterday normal. Diet: bottle/breast fed (3oz formula and breast milk)  During patient's ED visit he had multiple post feeding emesis with bilious content in addition to a bloody bowel movement x 2. Exam: vss, afebrile, US abd large structure in upper abdomen  dx intussusception - transferred  and treated with air enema w/resolution.  4/10/24: WCC 4m of age  exam normal.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Haematochezia, Infant irritability, Infantile diarrhoea, Infantile vomiting, Intussusception
Clinical narrative: n/v lack appetite, fussy day 9 after Rotarix = diagnosed intussusception   Symptoms: NAUSEA W VOMITING,UNSPECIFIED(R112), DIARRHEA, UNSPECIFIED(R197).   Summary HPI: 2/9/2024 2 month old WCC visit -normal. 2/18/24 to ER  since 2300 parents report repetitive vomiting, "stomach acid", not eating, 1 wet diaper this AM, stools yesterday normal. Diet: bottle/breast fed (3oz formula and breast milk)  During patient's ED visit he had multiple post feeding emesis with bilious content in addition to a bloody bowel movement x 2. Exam: vss, afebrile, US abd large structure in upper abdomen  dx intussusception - transferred  and treated with air enema w/resolution.  4/10/24: WCC 4m of age  exam normal.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Nausea, Ultrasound abdomen abnormal, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: n/v lack appetite, fussy day 9 after Rotarix = diagnosed intussusception   Symptoms: NAUSEA W VOMITING,UNSPECIFIED(R112), DIARRHEA, UNSPECIFIED(R197).   Summary HPI: 2/9/2024 2 month old WCC visit -normal. 2/18/24 to ER  since 2300 parents report repetitive vomiting, "stomach acid", not eating, 1 wet diaper this AM, stools yesterday normal. Diet: bottle/breast fed (3oz formula and breast milk)  During patient's ED visit he had multiple post feeding emesis with bilious content in addition to a bloody bowel movement x 2. Exam: vss, afebrile, US abd large structure in upper abdomen  dx intussusception - transferred  and treated with air enema w/resolution.  4/10/24: WCC 4m of age  exam normal.
Age: 70.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: ERYTHEMA 2.5 IN X 2 IN, WARMCH, ITCHING, PAIN
Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Ageusia, Anosmia, Fatigue, Pain in extremity
Clinical narrative: Patient experienced arm soreness, loss of taste and smell, extreme fatigue. Some of these symptoms were so severe that it required several different week-long stays at different hospitals and rehab facilities.
Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Ageusia, Amnesia, Anosmia, Dysphonia, Dysstasia
Clinical narrative: Patient experienced arm soreness, loss of taste and smell, extreme fatigue. Some of these symptoms were so severe that it required several different week-long stays at different hospitals and rehab facilities.
Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Fatigue, Gait disturbance, Loss of personal independence in daily activities, Peripheral swelling, Walking aid user
Clinical narrative: Patient experienced arm soreness, loss of taste and smell, extreme fatigue. Some of these symptoms were so severe that it required several different week-long stays at different hospitals and rehab facilities.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: On 7/31/23, a TDAP consent form was signed by the patient despite the provider's notation in the chart indicating that the patient received HBV during the visit. Subsequently, it was revealed that the patient received a PCV20 administered by the medical assistant.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came to our clinic on 5/23/2024 for a New Patient general check up and vaccine appointment  When MOC gave us the immunization record, I reconciled them, check both records to see which vaccines were due for.  After checking both sites, the vaccines needed were Dtap, Hep A, Hep B, Hib, IPV, Pneumoccocal and Varicella. Mother of the child declined varicella at the time of appointment. Due to the age and vaccine regulations. Patient was elegible to get Pediarix (Dtap-IPV and Hep B). I  gave the following vaccines: Pediarix (Dtap-IPV-hep B), Hib, Hep A and PCV 13. In the beginning, all the administrations were marked as VALID until the mother of the patient sent a Message stating there might have been a confusion with the vaccines.  She stated that there was more records that could have been added at the time of the appointment. She then proceeded to send the other records, which I don't recall seeing them at the time of the appointment. However,  MOC said she did bring them but thought the confusion might've been because of the amount of papers brought they might have gotten shuffled around. Furthermore, when I entered them on the patient's record, the Dtap and IPV vaccine came back as not valid due to the patient age. I talked to the provider on site about the situation and provider reach out to mom to clarify the situation. The mother of the patient was told about it and she understood. The patient will still need a 4th dose of polio when she turns 4 due to the age requirement for the vaccine.  Patient did not presented any side effects of the vaccines after the 15 minutes wait. Pt. is doing good per mom as of today 5/24/2024.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Eye swelling, Injection site rash, Ocular hyperaemia, Pruritus, Rash
Clinical narrative: Patient is a 15 month old child.  He was seen for his 15-month well child visit.  He received 3 immunizations (Dtap, Hib & Varicella) at approximately 12:30 pm without any incident.  Mom left the clinic and returned home.  Mom called the clinic at 3:00 pm to report that Patient had a rash on his stomach, legs and neck.  She also reported that he was itching.  Other than the itching, he did not appear in any distress.  There was no redness, swelling or signs of increased work of breathing.    Mom was advised by nurse to give Patient 3/4 teaspoon (3.75 ml) benadryl suspension and observe him for 15-30 minutes.  If his symptoms did not improve or worsened, mom advised to take him to the ER.    After 30-45 minutes mom reported that the rash was improving, and Patient was no longer itching.  However, his eyes were red and swollen.  There was no other swelling and no signs of increased work of breathing.  Nurse advised mom to take Patient to the emergency room for evaluation and treatment.  He was evaluated in the ER.  The rash was still present on his scalp and neck.  He was no longer itching and he had minimal swelling of his left upper eyelid.  He was given Benadryl 10 mg and Motrin 102 mg.  He was discharged from the ER.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Swelling of eyelid
Clinical narrative: Patient is a 15 month old child.  He was seen for his 15-month well child visit.  He received 3 immunizations (Dtap, Hib & Varicella) at approximately 12:30 pm without any incident.  Mom left the clinic and returned home.  Mom called the clinic at 3:00 pm to report that Patient had a rash on his stomach, legs and neck.  She also reported that he was itching.  Other than the itching, he did not appear in any distress.  There was no redness, swelling or signs of increased work of breathing.    Mom was advised by nurse to give Patient 3/4 teaspoon (3.75 ml) benadryl suspension and observe him for 15-30 minutes.  If his symptoms did not improve or worsened, mom advised to take him to the ER.    After 30-45 minutes mom reported that the rash was improving, and Patient was no longer itching.  However, his eyes were red and swollen.  There was no other swelling and no signs of increased work of breathing.  Nurse advised mom to take Patient to the emergency room for evaluation and treatment.  He was evaluated in the ER.  The rash was still present on his scalp and neck.  He was no longer itching and he had minimal swelling of his left upper eyelid.  He was given Benadryl 10 mg and Motrin 102 mg.  He was discharged from the ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis right arm, treated with clindamycin; has f/u on 5/24/24
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: She got her vaccine, her left arm was sore.  Her whole arm was sore, her elbow joint and wrist joint were sore.  She also has a large red bump at the injection site.  She did not notice any other symptoms last night.  This morning around 7:30 when she got up she could tell that she was running a low grade fever, which is about 100.  She took 2 extra strength Tylenol.  She has muscles aches, back ache and a headache.  The arm is still red with the bump, which is hot to touch and not any larger than it was.   She got her first Shingrix vaccine on 3/22/2024 and also had a reaction.  She was throwing up, had a fever of 102, and had severe chills.  Then about 3 weeks later she noticed large red patches on her skin, one below her right breast, and 2 on her right shoulderblade.   She did see a doctor and by that time it had started to fade and they could not tell what it was.  It then finally went away on it's own within a week or two.  They were large red patches that were flaking.   She also had gotten a COVID vaccine at the same time with the first Shingrix.  She had had several COVID vaccines and had not had any reaction from any previous COVID vaccines.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: She got her vaccine, her left arm was sore.  Her whole arm was sore, her elbow joint and wrist joint were sore.  She also has a large red bump at the injection site.  She did not notice any other symptoms last night.  This morning around 7:30 when she got up she could tell that she was running a low grade fever, which is about 100.  She took 2 extra strength Tylenol.  She has muscles aches, back ache and a headache.  The arm is still red with the bump, which is hot to touch and not any larger than it was.   She got her first Shingrix vaccine on 3/22/2024 and also had a reaction.  She was throwing up, had a fever of 102, and had severe chills.  Then about 3 weeks later she noticed large red patches on her skin, one below her right breast, and 2 on her right shoulderblade.   She did see a doctor and by that time it had started to fade and they could not tell what it was.  It then finally went away on it's own within a week or two.  They were large red patches that were flaking.   She also had gotten a COVID vaccine at the same time with the first Shingrix.  She had had several COVID vaccines and had not had any reaction from any previous COVID vaccines.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pt was given the powder portion of the vaccine, reconstituted with sterile water instead of the included vial of Hib. Vaccine was given on Friday, identified on Wednesday. No signs or symptoms noted.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Anaphylaxis treatment, Erythema, Erythema of eyelid, Rash, Respiratory tract congestion
Clinical narrative: RotaTeq reaction after it was administered. Baby received RotaTeq @ 10:35 AM. Patient developed redness in the LT eyelid but was not swollen. The tongue and mouth were not swollen either, no rash observed at the time. After a few minutes the  baby started to develop a rash all over the body and mild questionable hives. EMS was called @10:49 AM. Baby started to get congested and developed redness on his nose.  Baby with given certadose epinephrine. Certa dose (7.2kg) was drawn up and was administered @ 10:55AM on the RT Thigh. EMS arrived and did an assessment on the baby. Per EMS all VS were stable after epi was administered. EMS offered to take them to the ER, parents declined. Mother stated she was going to stay home with the baby to monitor him.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: PATIENT HAD A SEIZURE.  AMBULANCE WAS CALLED.  PATIENT WAS TRANSPORTED TO HOSPITAL
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: Mom states that the baby has a fever for 1 day. T max 102. Mom is giving Tylenol and alternating with Motrin. He broke out with rash today that started on face, then spread to his scalp and all over his body. He is irritable at times, and eating less than usual. No additional concerns. He received his 1 yr vaccines, including Varicella 10 days ago
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Rash, Rash erythematous
Clinical narrative: Mom states that last night her Rt thigh was red and swollen at site of varicella vaccine. This morning the redness came down, but she noticed a blister on top. No fever and no limitation of movement. Later this morning mom noticed red bumps spreading over her extremities, face and trunk. She received varicella vaccine 10 days ago.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Anaphylaxis treatment, Dyspnoea, Swelling face
Clinical narrative: Approximately 15 minutes after vaccine administration, patient was already at home when father noted facial swelling and some trouble breathing. He gave her a dose of Benadryl and brought her right back to the clinic where Epi-pen Jr was administered in left thigh. The patient was observed for over twenty minutes and had returned to her usual state of health with normal O2 saturation and heart rate. Father felt comfortable bringing her back home. Epi-pen Jr was prescribed and a referral to the Allergist was made.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Confusional state, Headache, Lethargy, Monoplegia
Clinical narrative: Violent chills, spinal pain, headache, fever,  left arm paralysis, lethargy, confusion
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Spinal pain
Clinical narrative: Violent chills, spinal pain, headache, fever,  left arm paralysis, lethargy, confusion
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Anaphylaxis treatment, Infant irritability, Lip swelling, Oxygen saturation decreased, Respiratory distress
Clinical narrative: Patient with mild lip swelling of the lower lip about 20 minutes after vaccination. Then progressed to irritability, fussiness, and b/l wheezing. Placed on O2 monitor - desaturation event to 80%. Given Epinephrine and Albuterol with improvement in respiratory status. Transferred to hospital for anaphylaxis.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Wheezing
Clinical narrative: Patient with mild lip swelling of the lower lip about 20 minutes after vaccination. Then progressed to irritability, fussiness, and b/l wheezing. Placed on O2 monitor - desaturation event to 80%. Given Epinephrine and Albuterol with improvement in respiratory status. Transferred to hospital for anaphylaxis.
Age: 89.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Hosted a vaccination clinic at patient's home at the Senior Living Facility on 5/22/2024. Patient was vaccinated with Prevnar 20 by MA at the clinic. Patient was monitored for 15 minutes after his vaccine and did not experience any adverse side effects. After the clinic, MA identified that patient had already received a dose of Prevnar 20 on 8/22/2023 and was not due for another dose. Medical Director, Dr, was notified and advised informing the patient and that there should be no adverse reactions besides expected side effects. A message has been left for patient to return call.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hidradenitis
Clinical narrative: new onset of hidradenitis suppurativa
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness, Myalgia
Clinical narrative: Patient states she got sick after receiving the vaccine like she had COVID and she has had problems ever since getting the vaccines, having muscle aches and weakness. She has been to several doctors and they cannot find anything wrong with her except normal things for elder people.
Age: 72.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Chills, Photosensitivity reaction, Pneumonia, Pyrexia
Clinical narrative: Fever, Chills, photosensitivity that evening after recieving vaccinations. Six days later still running 101-104 temps and admitted to hospital with pneumonia.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Product preparation error
Clinical narrative: Patient was injected with ACT HIB powder, however nurse used Sterile Diluent instead of using the Saline Diluent Component (04.% sodium chloride that comes with the ACT HIB.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient given expired varicella vaccine.  Pt notified to come back to clinic in 4 weeks for vaccine. Counseled per protocol.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Electrocardiogram, Exposure during pregnancy, Hyperhidrosis, Malaise
Clinical narrative: Approx 2-3 mins after vaccine administered, pt noted to be pale, diaphoretic and stated "I don't feel good". Pt remained seated and guided back towards the wall. Given a bottle of water. Vitals BP 66/44, 97%, HR 69. Pt guided to the exam table to lay down, given more water. 2nd BP 99/61. Most recent BP 105/61.Pt was assesed by the walk in provider Dr.  EKG performed and scanned into the pt's Chart RN. Pt transferred to Facility via Fire Medic 3. Pt is 21 weeks Pregnant at time of administration.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: Approx 2-3 mins after vaccine administered, pt noted to be pale, diaphoretic and stated "I don't feel good". Pt remained seated and guided back towards the wall. Given a bottle of water. Vitals BP 66/44, 97%, HR 69. Pt guided to the exam table to lay down, given more water. 2nd BP 99/61. Most recent BP 105/61.Pt was assesed by the walk in provider Dr.  EKG performed and scanned into the pt's Chart RN. Pt transferred to Facility via Fire Medic 3. Pt is 21 weeks Pregnant at time of administration.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Blood pressure increased, Chills, Dyspnoea, Erythema
Clinical narrative: face became red, felt hot and tingly, ears were red, nauseau, non stop vomiting, rapid heart beat, weakness, short of breath,shivering, fever, elevated blood pressure.  She couldn't walk from her car into school.  Tranported via wheelchair to school nurses office.  I got her back into my car and she collapsed outside of the Dr office, people offered to call an ambulance but I borrowed another wheelchair to get her into the building.  She was extremely weak and sick.  Gave her tylenol for fever and aches and sat at Dr. ofc for an hour then tranported her home.  She was ill for two days.  Lymph nodes still swollen and gets winded easy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fall, Feeling hot, Gait inability, Heart rate increased, Lymphadenopathy
Clinical narrative: face became red, felt hot and tingly, ears were red, nauseau, non stop vomiting, rapid heart beat, weakness, short of breath,shivering, fever, elevated blood pressure.  She couldn't walk from her car into school.  Tranported via wheelchair to school nurses office.  I got her back into my car and she collapsed outside of the Dr office, people offered to call an ambulance but I borrowed another wheelchair to get her into the building.  She was extremely weak and sick.  Gave her tylenol for fever and aches and sat at Dr. ofc for an hour then tranported her home.  She was ill for two days.  Lymph nodes still swollen and gets winded easy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: face became red, felt hot and tingly, ears were red, nauseau, non stop vomiting, rapid heart beat, weakness, short of breath,shivering, fever, elevated blood pressure.  She couldn't walk from her car into school.  Tranported via wheelchair to school nurses office.  I got her back into my car and she collapsed outside of the Dr office, people offered to call an ambulance but I borrowed another wheelchair to get her into the building.  She was extremely weak and sick.  Gave her tylenol for fever and aches and sat at Dr. ofc for an hour then tranported her home.  She was ill for two days.  Lymph nodes still swollen and gets winded easy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting, Wheelchair user
Clinical narrative: face became red, felt hot and tingly, ears were red, nauseau, non stop vomiting, rapid heart beat, weakness, short of breath,shivering, fever, elevated blood pressure.  She couldn't walk from her car into school.  Tranported via wheelchair to school nurses office.  I got her back into my car and she collapsed outside of the Dr office, people offered to call an ambulance but I borrowed another wheelchair to get her into the building.  She was extremely weak and sick.  Gave her tylenol for fever and aches and sat at Dr. ofc for an hour then tranported her home.  She was ill for two days.  Lymph nodes still swollen and gets winded easy.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Cough, Decreased appetite, Oropharyngeal pain, Pain, Painful respiration
Clinical narrative: Difficulty inhaling deeply (painful), wheezing, dry cough, body ache, sore throat, no appetite
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Wheezing
Clinical narrative: Difficulty inhaling deeply (painful), wheezing, dry cough, body ache, sore throat, no appetite
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to County Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to County Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to County Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into immprint for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. Patient was contacted by phone and recommended vaccine be repeated. Patient declined at this time.
Age: 13.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pt was given MMRV this is not recommended for patients over 12 years old . Pt is 13 years old. Pt was also given 2 doses of varicella on 05/22/2024.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Body temperature increased, Restlessness
Clinical narrative: The mother reports that the patient received vaccinations yesterday and was advised by the provider to administer over-the-counter Tylenol if needed. The mother gave Children's Tylenol to the patient and received medication education. When asked, the mother reported that the patient was restless and had a temperature of 103°F at around 10:30 AM this morning. She applied a cool compress and checked the temperature again at 2:50 PM, finding it to be 104°F. The mother was urged to take the patient to the nearest emergency room immediately for further evaluation and treatment, and to follow up with the provider upon discharge. The mother agreed to take the patient to the ER at this time. Provider spoke with hospital staff child was seen in ER on arrival had 101.2 baby was given tylenol no tests ordered and baby discharged home.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial flutter, Electrocardiogram
Clinical narrative: Atrial flutter diagnosed 5/22/2024 but don?t know if related to vaccine.
Age: 0.67
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered too early/incorrect interval.
Age: 41.0
Sex: M
Vaccine: PNC20
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: Myalgias, weakness, fevers
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Weakness both arms, Left shoulder started evening of 23rd, continued into 05/24/24.  Patient has no tremors.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Arthralgia, Asthenia, Fatigue, Joint range of motion decreased
Clinical narrative: Weakness both arms, Left shoulder started evening of 23rd, continued into 05/24/24.  Patient has no tremors.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Leukaemia, Limb injury, Muscular weakness, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: Weakness both arms, Left shoulder started evening of 23rd, continued into 05/24/24.  Patient has no tremors.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Rhinitis allergic, Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: Weakness both arms, Left shoulder started evening of 23rd, continued into 05/24/24.  Patient has no tremors.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Patient administered expired Pentacel vaccine on 5/22/24. Expired on 4/13/2024. Voicemail message left with parent for plan to repeat vaccine in 4 weeks.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Irritability, Measles post vaccine, Rash, Rash erythematous
Clinical narrative: Approximately 24 hours after her shot, a few red spots started to become visible on her body. By the next afternoon she was completely covered from head to toe in the rash. Spots were red, not very raised, and were not pus-filled. She also was very tired, irritable, and cranky for several days after. No signs of fever were noticed and she did not seem to scratch much at the bumps. The spots are starting to dry up and disappear.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Mother noticed places the morning after vaccines were given. Patient with redness on both legs at injection site with a few hive spots on both lower legs.  Patient to start cetirizine 2.5m l orally, once day as needed for 30 days and Hydrocortisone Ointment 1% application to rash twice daily for 14 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: Day 1 (Monday - day of vaccine)  - Fever and malaise started several hours after injection, came on rapidly and worsened over night.  I spent most of Tuesday in bed, asleep.  High fever, chills, nausea. diarrhea continued all day Tuesday.  Wednesday, I had a severe headache (I very rarely ever have even a mild headache) and hives started on both arms and legs.  Hives worsened on Thursday.  Thursday night itching was severe while sleeping and awakened me often.  Today is Friday and the hives and diarrhea are the only remaining symptoms.  I had NO systems after the first vaccine in 2020.  I delayed the second dose due to getting the COVID vaccines.  I deeply regret getting the second shingles vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Sleep disorder, Urticaria
Clinical narrative: Day 1 (Monday - day of vaccine)  - Fever and malaise started several hours after injection, came on rapidly and worsened over night.  I spent most of Tuesday in bed, asleep.  High fever, chills, nausea. diarrhea continued all day Tuesday.  Wednesday, I had a severe headache (I very rarely ever have even a mild headache) and hives started on both arms and legs.  Hives worsened on Thursday.  Thursday night itching was severe while sleeping and awakened me often.  Today is Friday and the hives and diarrhea are the only remaining symptoms.  I had NO systems after the first vaccine in 2020.  I delayed the second dose due to getting the COVID vaccines.  I deeply regret getting the second shingles vaccine.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Fatigue, Gastrointestinal pathogen panel
Clinical narrative: Patient developed a local reaction at injection site. Started with a red ring around injection site and progressed to a 4x4 splotchy rash on L deltoid.  Two days after immunization patient 's mother reported fatigue, lethargy, decreased appetite, vomiting, diarrhea, and abdominal pain lasting 5 days so far.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Lethargy, Local reaction, Rash macular
Clinical narrative: Patient developed a local reaction at injection site. Started with a red ring around injection site and progressed to a 4x4 splotchy rash on L deltoid.  Two days after immunization patient 's mother reported fatigue, lethargy, decreased appetite, vomiting, diarrhea, and abdominal pain lasting 5 days so far.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Stool analysis, Vomiting
Clinical narrative: Patient developed a local reaction at injection site. Started with a red ring around injection site and progressed to a 4x4 splotchy rash on L deltoid.  Two days after immunization patient 's mother reported fatigue, lethargy, decreased appetite, vomiting, diarrhea, and abdominal pain lasting 5 days so far.
Age: 77.0
Sex: M
Vaccine: RSV, TDAP, VARZOS
Symptoms: Asthenia, Gait disturbance, Pyrexia
Clinical narrative: Patient's son stated he was feeling weak, had an unstable gait and had a fever
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash
Age: 7.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse reaction at time of immunization
Age: 57.0
Sex: F
Vaccine: HEP, TDAP, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Inadequate immunity
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Varicella had a shortened expiration date due to temperature excursion.  The box was marked with a large red expiring sticker with the new expiration date. Patient was given this vaccine.  No symptoms have occurred.
Age: 68.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Patient was given a 2 vaccine injections in the left deltoid muscle, each vaccine being at least an inch apart from each other. After the injection, a hard, stiff lump developed at the injection site. Other then the lump, the patient did not feel any adverse reactions. The lump subsided after 15 minutes of waiting. The patient was given an icepack and told to monitor; also, they were told if anything out of the ordinary happens at the injection site or in their overall health to call our facility and speak to a pharmacist.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received Abrysvo in the month of February which is outside of the seasonal guidelines (September through January) per the ACIP. No Adverse effects.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient received Abrysvo in the month of February which is outside of the seasonal guidelines (September through January) per the ACIP.
Age: 17.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt reports having full pruritic body rash that looked like small pimples. Rash was located on the extremities as well. Adverse event lasted 5 days and self resolved.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb immobilisation, Pain in extremity
Clinical narrative: SEVERE PAIN, IMMOBILITY IN THE ARM
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Gait disturbance, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: On 5/22/24, woke up and parents noted swelling of R thigh. Patient complained of R thigh pain and was limping when walking. No fever, redness, hives, nausea, vomiting, diarrhea, or trouble breathing. On 5/23/24 presented to pediatric office for evaluation. Edema was noted from the R hip to the R knee. No redness, warmth, tenderness. Patient reported the pain had resolved. Was ambulating normally in clinic.  On 5/24/24, mom reported via phone that the swelling was still present but there was no pain or difficulty walking.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Arm swollen, itchy,
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called for TE evaluation of VAQTA. Caller stated that product was administered after a not supported excursion. No reported signs/symptoms of adverse effects. Limited information provided. Permission to contact HCP was given. No additional AE/no; HCP called for TE evaluation of VAQTA. Caller stated that product was administered after a not supported excursion. No reported signs/symptoms of adverse effects. Limited information provided. Permission to contact HCP was given. No additional AE/no; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-APR-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X025342, expiration date: 12-MAY-2025, administered for prophylaxis (strength, dose and route of administration were not provided) which had temperature excursion (TE). It was administered after a not supported excursion (Product storage error). No reported signs/symptoms of adverse effects (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; Caller stated that product was administered after a not supported excursion.; This spontaneous report was received from a medical assistant and referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-APR-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X025342, expiration date: 12-MAY-2025, administered for prophylaxis (strength, dose, and route of administration were not provided) which was stated that product was administered after a not supported temperature excursion (TE) (Product storage error). No reported signs/symptoms of adverse effects (No adverse event).