chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Recipient fainted on the way out of the clinic.  Dr. (anesthesiologist) happened to be at clinic.  He had her sit up and checked blood pressure and everything was fine.   Staff called her mother at 10:16 am and left a message that was returned at 10:50 am. She left voice mail stating that patient was just fine.
Age: 9.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Blister rupture, Injection site reaction, Injection site vesicles, Skin wound
Clinical narrative: Patient received a flu shot on 09/07/24. The next day mom called and said that the patient developed what looks like a blister at the injection site. The blister popped and now there is a small wound. Despite putting neosporin for a few days it got worse. The patient ultimately saw a doctor and received oral antibiotic therapy which resolved the issue.
Age: 9.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injection site reaction, Injection site vesicles, Wound
Clinical narrative: Patient received a flu shot on 09/07/24. The next day mom called and said that the patient developed what looks like a blister at the injection site. The blister popped and now there is a small wound. Despite putting neosporin for a few days it got worse. The patient ultimately saw a doctor and received oral antibiotic therapy which resolved the issue.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: patient was concerned about swelling and pain in arm
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness unilateral, Magnetic resonance imaging abnormal, Multiple sclerosis, Optic neuritis
Clinical narrative: Loss of vision in right eye throughout the course of the following week after vaccine. Diagnosed with optic neuritis. Received an MRI and was diagnosed with Multiple Sclerosis. Was given steroids after about 3 months. Currently taking a fumarate to prevent relapsing episode
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed a large red area at injection site. She indicated no itchiness just pain. I contacted several times during the next week. The pain got less and less but lasted more than a week.
Age: 16.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: Patient was given 2 vaccines, covid vaccine and then 2nd shot was flu vaccine. Right after 2nd shot, patient started to say something and then started to slump down in chair and was unresponsive. Mom was with me, He quickly came back and was able to given his name in less than a minute, but I opened door to pharmacy and had tachnician call 911. There was no information on VAR report to indicate this had happened before. Both patient and mom advised patient had never passed out before. Patients sister has history of seizures, so we wanted EMS to know that as well. EMS quickly showed up in about 5 minutes. They took his vitals, he was able to give complete answers and they came to the conclusion patient probably did just have a syncope episode. They did not feel the need to transport him to the hospital. They advised mom to make an appointment with family doctor just to report what happened.
Age: 68.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Atrial flutter, Blood pressure increased, Chills, Feeling cold, Heart rate increased
Clinical narrative: Patient contacted the pharmacy shortly after receiving vaccines complaining of a "sense of cold, and shivering" sensations.  He sought immediate medical attention.  He mentioned increased heart rate and increased blood pressure were present, which could be non related to the vaccines per the providers he had seen.  The same evening patient reported feeling fine and symptoms dissipating.  A few days later patient contacted the pharmacy saying he had been treated for atrial flutter, which he mentioned may or may not have been related to the vaccines received.  He said he is stable and fine but being treated for blood pressure and atrial issues.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: extreme dizziness, vomiting
Age: 14.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Several minutes after his vaccines were administered the patient complained of feeling dizzy, then passed out.  He woke up quickly.  He did not fall from chair.  We gave him water and he remained seated with his father for approximately 20 minutes until he felt well enough to walk away.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Syncope
Clinical narrative: After administering the second vaccine in the left arm, the patient fainted briefly. The pharmacist and immunizing technician attended to the patient until she fully recovered. The patient then left with her sister and grandmother. The patient had no known lasting side effects.
Age: 35.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Electrocardiogram normal, Heart rate increased, Metabolic function test normal, Urine analysis normal
Clinical narrative: Prolonged elevated heart rate for several hours; noticed around 5am, heart rate was around 120, was 130 by the time I got to the ER around 6am, stayed around 100 for several hours; discharged from the ER around 1pm; only a saline drip was administered during my ER visit. After getting home, heart rate spiked again after eating, continued monitoring it, resting, and trying to stay hydrated
Age: 35.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Heart rate increased
Clinical narrative: Prolonged elevated heart rate for several hours; noticed around 5am, heart rate was around 120, was 130 by the time I got to the ER around 6am, stayed around 100 for several hours; discharged from the ER around 1pm; only a saline drip was administered during my ER visit. After getting home, heart rate spiked again after eating, continued monitoring it, resting, and trying to stay hydrated
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site warmth, Nasopharyngitis
Clinical narrative: Red warm spot around injection spot. Headache, head cold. Patient feels like she has the flu.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: reported 9/5/24 her arm hurt and itched, swelled bad, red spot on arm post vaccination for approx 1 week
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Eye disorder
Clinical narrative: Laying in bed looking at the dresser, suddenly realized she was dizzy and closed eyes. States left eye looked like broken shards of glass in colors.  Happened 4-5 times over the course of the afternoon. Had something like this happen many, many years ago (approx 30 years ago) and hasn't happened since; TIA ruled out at that time and did not happen in color. Last time was unable to see from bottom of eye, that did not happen this time. Patient reported to pharmacy at 5pm, will contact PCP tomorrow.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site discolouration, Injection site haemorrhage, Injection site pain
Clinical narrative: Patient has developed bruises right after administration of the vaccines stated above which caused pain, swelling, and skin discoloration at the sites of the injection. Patient stated the sites of the injection were bleeding. Patient was advised to take tylenol or ibuprofen to help with the pain. The areas at the sites of the injection are still painful and swelling after 5 days.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient has developed bruises right after administration of the vaccines stated above which caused pain, swelling, and skin discoloration at the sites of the injection. Patient stated the sites of the injection were bleeding. Patient was advised to take tylenol or ibuprofen to help with the pain. The areas at the sites of the injection are still painful and swelling after 5 days.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT CALLED AND STATED SHE BROKE OUT IN HIVES AND ITCHING THAT WAS LOCALIZED THE NIGHT AFTER GETTING HER SPIKEVAX AND FLUSHOT. THEY WERE ADMINISTERED IN DIFFERENT ARMS, SHE TREATED HERSELF WITH OTC BENADRYL AND ALLEGRA. ALSO APPLIED CORTISONE CREAM. SHE IS FEELING BETTER TODAY AND STATED THE AREA IS NOT AS ITCHY. AREA IS SMALL AND WAS NOT A FULL BODY OR LARGE AREA BREAKOUT. PATIENT ADVISED TO CONTINUE THOSE OTC TREATMENTS AND ICE, TYLENOL AND IBUPROFEN IF NEEDED. ALSO ADVISED TO SEE A PROVIDER IF HIVES SPREAD, GET WORSE OR DON'T SUBSIDE.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Itchy rash surrounding the injection site about as big around as a golf ball
Age: 6.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Red, itchy rash / hives on torso, arms, and head. Improves with Benadryl but has returned multiple times Ive the last 24 hours since appearing.
Age: 47.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client was given 3rd dose in the HPV series on 6-26-24.  She was 47 years old at this time.   I was informed that this was an error on my part and that she shouldn't have been given it. I w informed that doses couldn't be given to anyone over 45 years old, regardless of the fact that she was incomplete in this series.   Client didn't have any adverse affects from receiving this 3rd dose of the HPV.  It was my error in giving it to her as she was over 45 years old.  - RN
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in jaw, Vomiting
Clinical narrative: Severe chills (shaking) followed by vomiting, headache, then severe pain in upper jaw.
Age: 27.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received the Shingrix vaccine. Developed shingles from the vaccine. Still having symptoms after 17 days.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mobility decreased, Pain, Pruritus, Swelling
Clinical narrative: Swelling, redness, reduced mobility of arm/shoulder, pain, itching
Age: 77.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Injection site swelling
Clinical narrative: Vaccinated patient in middle of deltoid using the C technique, used a 1 inch length needle to get deep enough IM, needle was completely in deltoid. after needle was removed, pt had an anithistamine based reaction (bump about 1 inch across swell up on arm. Monitored patient very closely for 20 minutes. Swelling went down significantly (down to less than 1/4 inch) all by itself. Pt asked if they could leave, they acknowledged to me that they felt completely fine (no s/sx of breathing issues or fainting at all).  Will follow up myself with patient on Monday 9/30/24. Advised pt if condition worsens to seek emergency care.  Pt verbally acknowledged.
Age: 77.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Injection site mass
Clinical narrative: Vaccinated patient in middle of deltoid using the C technique, used a 1 inch length needle to get deep enough IM, needle was completely in deltoid. after needle was removed, pt had an anithistamine based reaction (bump about 1 inch across swell up on arm. Monitored patient very closely for 20 minutes. Swelling went down significantly (down to less than 1/4 inch) all by itself. Pt asked if they could leave, they acknowledged to me that they felt completely fine (no s/sx of breathing issues or fainting at all).  Will follow up myself with patient on Monday 9/30/24. Advised pt if condition worsens to seek emergency care.  Pt verbally acknowledged.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: The patient came in to the pharmacy for an adult covid vaccine. A member of the staff pulled a pediatric dose of the vaccine. The pharmacist did not notice the mistake. The vaccine was given to a registered nurse that did not notice the mistake and was given the incorrect pediatric vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Abdominal distension, Fatigue, Headache, Injection site mass, Nausea
Clinical narrative: Pain - 8 days; Itchiness - 11 days; Red rash - 6 days of increasing size (reaching 45 sq inches); swelling - 5 days; hard lump at injection site - 11 days; nauseau - 3 days; gastro bloating - 3 days; fatigue - 3 days; headache - 5 days.  Treatment: Tylenol, Calomine lotion
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Pain, Pruritus, Rash erythematous, Swelling
Clinical narrative: Pain - 8 days; Itchiness - 11 days; Red rash - 6 days of increasing size (reaching 45 sq inches); swelling - 5 days; hard lump at injection site - 11 days; nauseau - 3 days; gastro bloating - 3 days; fatigue - 3 days; headache - 5 days.  Treatment: Tylenol, Calomine lotion
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: She was administered the vaccine and big bump developed at the vaccine site. I told her to sit for 20 to 30 minutes and I observed her. After that I let her go. The bump had reduced in size
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Parosmia, Pharyngeal hypoaesthesia
Clinical narrative: patient presented about 20 mins following shingles vaccine. she also received a flu vaccine as well, although she states she has never had a reaction to the flu vaccine. she stated she felt a numb feeling in her throat along with a weird taste/smell. took her vitals at 4:30pm. hr 66-68, o2 96-98, bp 122/71, temp 98.4, rr 20. administered 25mg (10ml) of diphenhydramine at 4:35pm. Continued to monitor patient with no changes until 5:05pm and then she voluntarily left to go to urgent care.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Dyspnoea, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Patient was leaving after getting her vaccines (flublok and spikevax) , as she was leaving, she felt dizzy, so she sat down on the chair in wellness room, she then hissed for air, and passed out, looked pale. A few seconds later, she woke up, felt hot and sweating, still felt dizzy, headache. Patient was monitored for about 30 minutes. Patient felt better and left with spouse. Patient has history of of fainting and anxiety getting shots before.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient was leaving after getting her vaccines (flublok and spikevax) , as she was leaving, she felt dizzy, so she sat down on the chair in wellness room, she then hissed for air, and passed out, looked pale. A few seconds later, she woke up, felt hot and sweating, still felt dizzy, headache. Patient was monitored for about 30 minutes. Patient felt better and left with spouse. Patient has history of of fainting and anxiety getting shots before.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Vaginal haemorrhage
Clinical narrative: Spotting/irregular bleeding
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Got vaccine at 10am. Around 3pm suddenly got lightheaded and left nauseated. Vomited 4 times and had diarrhea. Also headache  and sore arm. Lasted  about 12 hours.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Got vaccine at 10am. Around 3pm suddenly got lightheaded and left nauseated. Vomited 4 times and had diarrhea. Also headache  and sore arm. Lasted  about 12 hours.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Urticaria
Clinical narrative: About 30 minutes after receiving the flu shot, I experienced intense heat in my head, followed by severe redness and urticaria on my arms, abdomen, and legs. I took two 20 mg tablets of hydrocortisone, which helped calm the reaction. This same reaction occurred two more times, roughly a week apart . I took 2 tab ( 20 mg) of my prescription as emergency and I took Claritin once.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: At 15 min after the vaccine patient started to itch. We gave liquid benadryl. Itching was better but still occurring after 15 more minutes. Went over what to do for a severe allergic reaction. Patient had family member with her who could keep an eye on her that day.
Age: 25.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour
Clinical narrative: Premature delivery; Premature labor; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2760029-1 (VAERS ID).  A 25-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Dec2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years intramuscular, in left arm for immunization in the pharmacy. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient is expected to deliver one baby(s) on 18Jan2024. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT intramuscular taken for immunisation, on 05Dec2023 as dose 1, single; DAPTACEL intramuscular taken for immunisation as dose 1, single; LEVOTHYROXINE; LAMOTRIGINE; BUPROPION; WESTAB MINI. The patient did not experience an adverse event in the previous vaccinations. The patient also took other concomitant therapy. The following information was reported: PREMATURE LABOUR (hospitalization, congenital anomaly) with onset 10Dec2023, outcome "recovered", described as "Premature labor"; PREMATURE DELIVERY (hospitalization, congenital anomaly) with onset 10Dec2023 at 05:30, outcome "recovered". The patient was hospitalized for premature delivery, premature labour (hospitalization duration: 112 day(s)). The baby was delivered premature, delivery date 10Dec2023. The baby weighed 1814 grams. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from the same Consumer via FDA (2760029-1). This consumer(patient) reported that: Updated information: patient details (age at vaccination, race, ethnic group), historical vaccination, suspect vaccine details (vaccination time, vaccination facility) and additional concomitant medications.  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400107702 baby case;
Age: 23.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Cough, Dyspnoea, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Patient had an anaphylactic reaction that initially presented as a rash 4 inches below the injections site that was 2.5cm round very hot, reports it was itchy at times while also felt like someone poured alcohol on it. Seen at 1106 by 1115 patient had developed a persistent dry cough and then had significant issues breathing. Epi was immediately administered 0.3ml IM right deltoid due to reported weight of patient. Narrative with vital signs: Received HPV vaccine this morning, half dollar size raised area of redness has formed about 5cm inferior of injection site. Reports it goes from burning to feeling like alcohol has been poured on it. Site marked. Denies any difficulty breathing. Reports dry cough but states she has gotten a cat and thinks it is due to that - reports cough was not before the injection. Site marked at 1107. Subjective: Pt developed cough with sensation of SOB while in clinic. She recieved epi 0.3 mg IM, Benadryl 25 mg po, and prednisone 60 mg PO. Symptoms resolved. She was observed approx 4 hours in the clinic and symptoms have resolved.  Medications Reviewed by RN on 9/26/2024 11:11 AM No Active Meds Allergies Reviewed by RN on 9/26/2024 11:11 AM NO KNOWN DRUG ALLERGY NO KNOWN MATERIAL ALLERGY Problem List/History Displayed items reviewed by on 9/26/2024 2:58:36 PM OBJECTIVE Patient went into acute respiratory distress. 0.3 epi given IM right deltoid at 1115, placed on NC at 4LPM 1120 VS 105/74 HRMax 148 O2 88% - transitioned to non-rebreather at 8LPM, max LPM allowed. Oxygen did run out and had to transition to new tank. 1125 BP 96/58 HR108 O2 100%. Given 60mg Prednisone, 25mg Benadryl PO at 1127. 1143 VS 92/52 HR 92 O2 100% NRB 5LPM - transitioned to NC 4LPM at 1150 HR 104 O2 100%. 1205 BP 101/58 HR102 O2 100% NC 2LPM. 1220 BP 98/64 HR93 O2 100% NC 1.5LPM 1235 BP 99/54 HR 84 O2 100% NC 1LPM 1250 BP 90/63 HR84 O2 100%RA 1125 BP 93/53 HR 78 O2 100%RA - Dr. at bedside. Will remain in clinic for one hour for observation. 1430 BP89/56 HR 82 O2 100%RA                                                     Plan: Denies any s/s of respiratory distress. Pt observed approx 4 hrs and remains asymptomatic. Lungs CTA and  resp unlabored, oropharynx without edema, skin without rash. Rx epi -pen and instructed to use. ER precautions discussed. RTC tomorrow for recheck or sooner if worsens/any concerns. Dc'd accompanied by a friend.
Age: 23.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Injection site erythema, Injection site pain
Clinical narrative: Patient had an anaphylactic reaction that initially presented as a rash 4 inches below the injections site that was 2.5cm round very hot, reports it was itchy at times while also felt like someone poured alcohol on it. Seen at 1106 by 1115 patient had developed a persistent dry cough and then had significant issues breathing. Epi was immediately administered 0.3ml IM right deltoid due to reported weight of patient. Narrative with vital signs: Received HPV vaccine this morning, half dollar size raised area of redness has formed about 5cm inferior of injection site. Reports it goes from burning to feeling like alcohol has been poured on it. Site marked. Denies any difficulty breathing. Reports dry cough but states she has gotten a cat and thinks it is due to that - reports cough was not before the injection. Site marked at 1107. Subjective: Pt developed cough with sensation of SOB while in clinic. She recieved epi 0.3 mg IM, Benadryl 25 mg po, and prednisone 60 mg PO. Symptoms resolved. She was observed approx 4 hours in the clinic and symptoms have resolved.  Medications Reviewed by RN on 9/26/2024 11:11 AM No Active Meds Allergies Reviewed by RN on 9/26/2024 11:11 AM NO KNOWN DRUG ALLERGY NO KNOWN MATERIAL ALLERGY Problem List/History Displayed items reviewed by on 9/26/2024 2:58:36 PM OBJECTIVE Patient went into acute respiratory distress. 0.3 epi given IM right deltoid at 1115, placed on NC at 4LPM 1120 VS 105/74 HRMax 148 O2 88% - transitioned to non-rebreather at 8LPM, max LPM allowed. Oxygen did run out and had to transition to new tank. 1125 BP 96/58 HR108 O2 100%. Given 60mg Prednisone, 25mg Benadryl PO at 1127. 1143 VS 92/52 HR 92 O2 100% NRB 5LPM - transitioned to NC 4LPM at 1150 HR 104 O2 100%. 1205 BP 101/58 HR102 O2 100% NC 2LPM. 1220 BP 98/64 HR93 O2 100% NC 1.5LPM 1235 BP 99/54 HR 84 O2 100% NC 1LPM 1250 BP 90/63 HR84 O2 100%RA 1125 BP 93/53 HR 78 O2 100%RA - Dr. at bedside. Will remain in clinic for one hour for observation. 1430 BP89/56 HR 82 O2 100%RA                                                     Plan: Denies any s/s of respiratory distress. Pt observed approx 4 hrs and remains asymptomatic. Lungs CTA and  resp unlabored, oropharynx without edema, skin without rash. Rx epi -pen and instructed to use. ER precautions discussed. RTC tomorrow for recheck or sooner if worsens/any concerns. Dc'd accompanied by a friend.
Age: 23.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Respiratory distress
Clinical narrative: Patient had an anaphylactic reaction that initially presented as a rash 4 inches below the injections site that was 2.5cm round very hot, reports it was itchy at times while also felt like someone poured alcohol on it. Seen at 1106 by 1115 patient had developed a persistent dry cough and then had significant issues breathing. Epi was immediately administered 0.3ml IM right deltoid due to reported weight of patient. Narrative with vital signs: Received HPV vaccine this morning, half dollar size raised area of redness has formed about 5cm inferior of injection site. Reports it goes from burning to feeling like alcohol has been poured on it. Site marked. Denies any difficulty breathing. Reports dry cough but states she has gotten a cat and thinks it is due to that - reports cough was not before the injection. Site marked at 1107. Subjective: Pt developed cough with sensation of SOB while in clinic. She recieved epi 0.3 mg IM, Benadryl 25 mg po, and prednisone 60 mg PO. Symptoms resolved. She was observed approx 4 hours in the clinic and symptoms have resolved.  Medications Reviewed by RN on 9/26/2024 11:11 AM No Active Meds Allergies Reviewed by RN on 9/26/2024 11:11 AM NO KNOWN DRUG ALLERGY NO KNOWN MATERIAL ALLERGY Problem List/History Displayed items reviewed by on 9/26/2024 2:58:36 PM OBJECTIVE Patient went into acute respiratory distress. 0.3 epi given IM right deltoid at 1115, placed on NC at 4LPM 1120 VS 105/74 HRMax 148 O2 88% - transitioned to non-rebreather at 8LPM, max LPM allowed. Oxygen did run out and had to transition to new tank. 1125 BP 96/58 HR108 O2 100%. Given 60mg Prednisone, 25mg Benadryl PO at 1127. 1143 VS 92/52 HR 92 O2 100% NRB 5LPM - transitioned to NC 4LPM at 1150 HR 104 O2 100%. 1205 BP 101/58 HR102 O2 100% NC 2LPM. 1220 BP 98/64 HR93 O2 100% NC 1.5LPM 1235 BP 99/54 HR 84 O2 100% NC 1LPM 1250 BP 90/63 HR84 O2 100%RA 1125 BP 93/53 HR 78 O2 100%RA - Dr. at bedside. Will remain in clinic for one hour for observation. 1430 BP89/56 HR 82 O2 100%RA                                                     Plan: Denies any s/s of respiratory distress. Pt observed approx 4 hrs and remains asymptomatic. Lungs CTA and  resp unlabored, oropharynx without edema, skin without rash. Rx epi -pen and instructed to use. ER precautions discussed. RTC tomorrow for recheck or sooner if worsens/any concerns. Dc'd accompanied by a friend.
Age: 70.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 70.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pain in extremity, Rash, Rash pruritic
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; she received a GARDASIL9 vaccination approximately 20 years ago at another practice that was involved in a temperature excursion; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       In approximately 2004 (reported as "approximately 20 years ago"), the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, Lot # and expiration date were not reported), at another practice. At the time the patient had to sign a waiver stating that she was aware of it. No details of the temperature excursion are available. No additional information available. No additional adverse event (AE) was reported.   Lot # is being requested and will submit if receive.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 4-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX).  On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated  in her right arm with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error).  The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 4-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX).  On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in his right arm with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 13-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for varicella virus vaccine live (oka/merck)(VARIVAX). On 23-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in his right arm with the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 4-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD). and on the same date, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in his left arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received PROQUAD after a temperature excursion.; Confirmed no other AE occurred; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 13-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD). and on the same date, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in his left arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 11-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD). and on the same date, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her right arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 8.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 8-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD). and on 16-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in her right arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500:
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; patient received PROQUAD after a temperature excursion.; This spontaneous report was received from a registered nurse referring to 29 patients of unknown age and gender. The patients' historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y008788, expiration date 30-OCT-2025 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number Y005919, expiration date 13-MAR-2026 (dose and routes of administration not provided) both for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccines was 6 degree Fahrenheit (°F) up to 14°F for 40 minutes, and 14°F up to 46°F (27.5F) for 3 hours 20 minutes. No previous excursions were detected.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the registered nurse regarding a 7-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 12-AUG-2024, a temperature excursion was involved for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) and on 16-AUG-2024, with public funds and at public health clinic/hospital, the patient was inadvertently vaccinated in his left arm with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously (strength, dose and dose number were not provided) for prophylaxis (product storage error). The nurse further specified that the data logger had an excursion, but it did not alarm. A power outage caused the temperature excursion. It was later discovered, on the monthly temperature uploading, that 28 affected doses were administered.  There were no known adverse events and no product quality complaint involved.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.; Sender's Comments:  US-009507513-2409USA000500: