chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: Given VAXELIS, and IPOL on the same day/prescribed; Patient received 2 doses of Polio on the same day (from the VAXELIS and IPOL),/ Dr. prescribed the vaccines; This non-serious spontaneous safety report, with the reference numbers: 2024SA242971 and 02180708 (inquiry number) was received by a partner on 14-AUG-2024 and forwarded on 16-AUG-2024 from a healthcare professional.  Due to the nature of the events, the causal relationship between Vaxelis and "Given VAXELIS, and IPOL on the same day/prescribed", and "Patient received 2 doses of Polio on the same day (from the VAXELIS and IPOL),/ Dr. prescribed the vaccines"  was not applicable.  Further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Syringe issue
Clinical narrative: Syringe came apart; Everything started to disintegrate; Vaccine came out; This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Syringe came apart; Everything started to disintegrate; Vaccine came out".  Additional information: Pharmacist reported a situation where he went to go draw the vaccine Abrysvo with the syringe and the syringe just came apart and he said everything started to disintegrate. Reporter (Pharmacist) stated, "Yes, when I twisted the syringe onto that little adapter thing where you pull up into the diluent, it actually came apart and vaccine came out. We can't give it to the patient. The sample of the product is not available to be returned as it was in the sharps container because a needle was on it.  Causality for "syringe came apart; everything started to disintegrate; vaccine came out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: inhaler
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: She stated that she had hives/rash on her neck, face, and arms Friday 9/27/24 when she woke up in the morning to the afternoon around 3 pm. Pt denied a compromised airway that day. The hives/rash resolved the same day and are not present today on assessment.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Blood lead, Crying, Full blood count, Hyporesponsive to stimuli, Pallor
Clinical narrative: vasovagal spell occurred about 15 minutes after the injection.  Child had these two shots and also had blood drawn for CBC and lead level.  Cried her typical amount during the procedures, but seemed ok.  Packed up to go a few minutes later, but while checking out, the child started to look very pale and was not responding appropriately.  We brought her back to the room and lay her down.  She had a normal BP, cap refill and blood sugar, but was very pale for almost 15 minutes, after which point she returned to normal.  She was able to leave the office about 20 minutes later, and when we check on her by phone later that day parents reported she was back to normal.   This has never happened to this child before, but there is a family history of vasovagal response, particularly with painful procedures.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Presyncope
Clinical narrative: vasovagal spell occurred about 15 minutes after the injection.  Child had these two shots and also had blood drawn for CBC and lead level.  Cried her typical amount during the procedures, but seemed ok.  Packed up to go a few minutes later, but while checking out, the child started to look very pale and was not responding appropriately.  We brought her back to the room and lay her down.  She had a normal BP, cap refill and blood sugar, but was very pale for almost 15 minutes, after which point she returned to normal.  She was able to leave the office about 20 minutes later, and when we check on her by phone later that day parents reported she was back to normal.   This has never happened to this child before, but there is a family history of vasovagal response, particularly with painful procedures.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-1 Breakthrough Infection
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Emotional distress, Muscle twitching, Tic
Clinical narrative: Within 1 hour after his flu vaccine, Pt developed motor tics with twitching of his neck. He also started wringing his hands. The involuntary movements are happening several times an hour, but never happened prior to the vaccine. They are clearly involuntary and upsetting for him.
Age: 12.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect vaccine given; not indicated. No adverse symptoms reported, well tolerated.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Impaired work ability, Injection site pain, Muscular weakness, Neck pain
Clinical narrative: Patient is a 49 y.o. year old male who is being seen today for right arm pain. Patient received TDaP booster injection in right deltoid yesterday late morning in this office when he was seen for wellness exam. He had no problems immediately after injection, but during the night last night he woke w/severe right shoulder pain that radiates to right posterior/lateral neck and distally to level of right elbow (mainly on medial side of upper right arm). He denies redness, warmth, swelling or TTP of injection site. The pain of the affected area is not reproducible with movement of RUE or of palpation of area, but it is constant, severe pain that has times of increased severity. He wasn't able to go to work today d/t severity of pain.  He has tried Tylenol, ibuprofen, tizanidine (rx he already had at home), massage. Only able to get very slight pain relief after total of 2 mg dose of tizanidine.  Denies numbness, tingling, weakness of RUE. Denies tongue/throat swelling, SOA, respiratory difficulty. Patient is having severe arm pain following vaccine in the clinic.  He was seen by chiropractor today who believes he has Parsonage-Turner syndrome which is a brachial plexopathy.  He is having a significant amount of pain down the arm.  Wife is requesting gabapentin to try for pain control. Given a prescription for gabapentin 100 mg, can taper up to 300 mg 3 times daily.  Wife to notify the clinic of the dose that is effective for pain control.    As of this date Patient still has constant pain with muscle weakness.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient is a 49 y.o. year old male who is being seen today for right arm pain. Patient received TDaP booster injection in right deltoid yesterday late morning in this office when he was seen for wellness exam. He had no problems immediately after injection, but during the night last night he woke w/severe right shoulder pain that radiates to right posterior/lateral neck and distally to level of right elbow (mainly on medial side of upper right arm). He denies redness, warmth, swelling or TTP of injection site. The pain of the affected area is not reproducible with movement of RUE or of palpation of area, but it is constant, severe pain that has times of increased severity. He wasn't able to go to work today d/t severity of pain.  He has tried Tylenol, ibuprofen, tizanidine (rx he already had at home), massage. Only able to get very slight pain relief after total of 2 mg dose of tizanidine.  Denies numbness, tingling, weakness of RUE. Denies tongue/throat swelling, SOA, respiratory difficulty. Patient is having severe arm pain following vaccine in the clinic.  He was seen by chiropractor today who believes he has Parsonage-Turner syndrome which is a brachial plexopathy.  He is having a significant amount of pain down the arm.  Wife is requesting gabapentin to try for pain control. Given a prescription for gabapentin 100 mg, can taper up to 300 mg 3 times daily.  Wife to notify the clinic of the dose that is effective for pain control.    As of this date Patient still has constant pain with muscle weakness.
Age: 1.33
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: localized reaction to injection site
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was new to facility and vaccine records were entered.  Pt was identified by system as needing a second Hep A vaccine.  However, unknown to facility we did not have pts full records.  Pt received Hep A vaccine and parent returned later in the afternoon with secondary immunization record containing a 2nd Hep A vaccine we did not previously have.  Therefore, pt received a 3rd Hep A vaccine.  Pt had no adverse reactions and provider discussed with parent.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash on left arm. Cold pack and anti-itch cream on site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Injection site pain, Pyrexia
Clinical narrative: Patient received 4 year old vaccines on 9/30/2024 after already receiving vaccines on 8/2/2024. Kinrix and Proquad (Proquad lot: Y011215 Exp: 11/6/2025). When family was informed, they reported that pt did experience a fever that night (temp not reported) and some leg soreness the following morning. No further reported effects at this time.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, 1.5in radius around flu injection site, warm to touch and sore
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: patient passed out 5 minutes after giving Spikevax.  Finding out that the patient did not eat prior to vaccination, glucose syrup was given and patient felt fine after that.  Ambulance was called to make sure everything is fine with the patient
Age: 0.58
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I was made aware of an incident that happened on 9/12/2024 in regard to a 7-month old baby receiving the wrong immunizations. The day of said incident I was in training with instructor. The baby mom was having some sort of panic attack during this time she was very frantic we had to call on nurses from different areas to calm her down. The mom had put the babies DOB wrong so the patient in question was first put in as 19 months. I had prepared immunizations based on the information given to me. When the baby came to the office in the back I questioned the baby did not look over a year old the information was then corrected in the system. I administered the immunizations and had discussed with instructor that those were the proper vaccines to be given even with the age change.
Age: 1.5
Sex: M
Vaccine: HEPA, PNC20
Symptoms: Wrong product administered
Clinical narrative: I was in the office and the their was a internet outage that morning. We went on doing paper by hand. When pt was seen by NUrse Practioner she stated it was time for 18 month vaccines. I mistaken seeing Prevnar 20 and it was actually Pentacel that I was suppose to give.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red, bumpy, itchy, rash. L arm, chest, lower back, legs, spreading to R side.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: flu injection given high on shoulder now having shoulder pain
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received a second RSV vaccine. No signs or symptoms were observed.
Age: 8.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaxelis Vaccine was given to patient in error instead of Varicella. Doctor and parent of patient notified. Provider called poison control. Poison control  stated that the child should not have a reaction from the combination of vaccines.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Rash, Skin warm, Swelling
Clinical narrative: Patient gets localized reaction with vaccines. Describes reaction as raised, hot rash for several days. Treated with ice on and and went away with time.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Neck pain, Pain, Pain in extremity
Clinical narrative: When attempting to move arm (raising up or reaching up), shooting pain down the arm and up into neck - 7/10.  When arm is at rest, pain/discomfort is at 3/10
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Bone pain, Nausea, Pyrexia
Clinical narrative: Fever 100 .8, nausea, total body bone aches
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test positive, Culture urine, Eye swelling, Lip swelling, Mechanical urticaria
Clinical narrative: Full-body rash, hives; started November 1, 2023-present; six week course of steroids (started with Prednisone 10mg taper over 6 days), Keflex for 10 days, Allegra 180 mg OTC daily, Diphenhydramine PO PRN, Solumedrol & Diphenhydramine injection on 11/1/23 in Emergency Department (due to swelling of lips and eyes), Clobetasol, Famotidine, Benadryl topically; diagnosed Dermatographic urticaria dx on 11/6/23 at Dermatology clinic
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urine analysis, Urticaria
Clinical narrative: Full-body rash, hives; started November 1, 2023-present; six week course of steroids (started with Prednisone 10mg taper over 6 days), Keflex for 10 days, Allegra 180 mg OTC daily, Diphenhydramine PO PRN, Solumedrol & Diphenhydramine injection on 11/1/23 in Emergency Department (due to swelling of lips and eyes), Clobetasol, Famotidine, Benadryl topically; diagnosed Dermatographic urticaria dx on 11/6/23 at Dermatology clinic
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Pyrexia, Retching
Clinical narrative: Vomiting, diarrhea, fever, sweating, and  headache. Starting within 15 hours of vaccines. Vomiting bile then dry heaving. Could not keep water down. Started to level off after 48 hours. After 3 days symptoms were gone.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Vomiting
Clinical narrative: Vomiting, diarrhea, fever, sweating, and  headache. Starting within 15 hours of vaccines. Vomiting bile then dry heaving. Could not keep water down. Started to level off after 48 hours. After 3 days symptoms were gone.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Chills, Erythema, Fatigue
Clinical narrative: Initial first two Pfizer injections in mid 2021.  This was my third injection and first dose of Moderna.  Went to bathroom early Saturday morning and passed out when I went to wash my hands.  Saturday night I noticed 6-7 red spots on non injection arm.  Sunday morning the spots were a solid red patch.  Also, on this morning, pain in armpit of injection arm.  Very, very weak and sleepy and tired on Saturday and Sunday with headache and chills.  As of this morning, still itchy spots on both arms, size of apple on injection arm and golf ball on non injection arm.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Pruritus, Somnolence
Clinical narrative: Initial first two Pfizer injections in mid 2021.  This was my third injection and first dose of Moderna.  Went to bathroom early Saturday morning and passed out when I went to wash my hands.  Saturday night I noticed 6-7 red spots on non injection arm.  Sunday morning the spots were a solid red patch.  Also, on this morning, pain in armpit of injection arm.  Very, very weak and sleepy and tired on Saturday and Sunday with headache and chills.  As of this morning, still itchy spots on both arms, size of apple on injection arm and golf ball on non injection arm.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Patient received the Flucelvax 2024-2025 vaccine on the left deltoid.  Upon injection the patient states she noticed the infusion was "more painful" than previous flu vaccinations.  Within 24 hours the patient reported having a diffuse red rash to the left arm with pain.  The vaccine was administered by an RN with extensive experience administering vaccines.  The LVN lead and myself conducted observation of each nurse providing vaccinations at the immune fair.  The nurses were observed administering vaccines both the intramuscular and subcutaneous routes.  Feedback and corrections were provided as needed.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient requested Pneumonia vaccine on vaccine intake form , but received Fluad instead. No reaction was observed. Pt planned on getting flu vaccine at a later date anyway.
Age: 0.33
Sex: M
Vaccine: PNC20
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Mom reports fever starting 12 hrs after vaccine. Temp 101. Gave Genexax2. Mom reports elevated temperature every evening for 7 days & was seen in our office on 9/30/24
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mast cell activation syndrome, Peripheral swelling, Pyrexia, Rash
Clinical narrative: I broke in in a rash and my harm swelled and I ran a high fever.  After the shots I would randomly get sick and then developed Mast Cell Activation Syndrome in 2023
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Burning sensation, Cough, Sneezing
Clinical narrative: Deep dry cough, burning cough, sneezing
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Patient says that he received Spikevax on Saturday, had arm pain on Sunday, and had arm pain and could barely lift arm on Monday. States that he has shoulder pain as well.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, Neck pain, Pyrexia
Clinical narrative: 24 days after vaccination developed, dry, cough, headache, nasal congestion, neck pain fever. At home Covid test 24 hours after symptoms started was negative at 48 hours Covid testing at healthcare facility was positive.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 24 days after vaccination developed, dry, cough, headache, nasal congestion, neck pain fever. At home Covid test 24 hours after symptoms started was negative at 48 hours Covid testing at healthcare facility was positive.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Tinnitus and loss of hearing
Age: 62.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dysgeusia
Clinical narrative: Patient received flu and covid shot on friday 9/28 at pharmacy. He states that he noticed starting sunday 9/30/2024 anything he eats "tastes like salt" coffee, water, chicken, oatmeal and everything tastes salty
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Paraesthesia, Rash
Clinical narrative: slight swelling to the injection site, skin rash (circular 1.5" by 1") to Lt. AC, and tingling to Lt. thumb. She denied SOB, CP, throat tightness, or difficulty swallowing.  Denied medical treatment at the time,  will self-care at home with OTC medications and follow with HCP in 2 days.
Age: 83.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Asthenia, Computerised tomogram normal, Fall, Gait disturbance, Laboratory test
Clinical narrative: pt states she was weak and had difficulty walking. She fell and had to have ambulance took to her to Hospital. on 9/20/24. Pt had test ran and was admitted overnight for observation. Was discharged to go home and had to return to the ER on 9/24/24. They gave her saline IV, magnesium IV, CT and Xray of right arm. All test were negative. Discharged to come home. She has home health care. She has been inmobile and unable to feed herself but is now feeding herself and walking with assistance. She has care givers, had a telemed visit with PCP and her Neurolgist was notified. She is slowly improving. Seems to be getting some better every day but is still not able to dress herself and has to be taken to the bathroom.
Age: 83.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Urine analysis, Walking aid user, X-ray limb normal
Clinical narrative: pt states she was weak and had difficulty walking. She fell and had to have ambulance took to her to Hospital. on 9/20/24. Pt had test ran and was admitted overnight for observation. Was discharged to go home and had to return to the ER on 9/24/24. They gave her saline IV, magnesium IV, CT and Xray of right arm. All test were negative. Discharged to come home. She has home health care. She has been inmobile and unable to feed herself but is now feeding herself and walking with assistance. She has care givers, had a telemed visit with PCP and her Neurolgist was notified. She is slowly improving. Seems to be getting some better every day but is still not able to dress herself and has to be taken to the bathroom.
Age: 83.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Fall, Gait inability, Loss of personal independence in daily activities
Clinical narrative: pt states she was weak and had difficulty walking. She fell and had to have ambulance took to her to Hospital. on 9/20/24. Pt had test ran and was admitted overnight for observation. Was discharged to go home and had to return to the ER on 9/24/24. They gave her saline IV, magnesium IV, CT and Xray of right arm. All test were negative. Discharged to come home. She has home health care. She has been inmobile and unable to feed herself but is now feeding herself and walking with assistance. She has care givers, had a telemed visit with PCP and her Neurolgist was notified. She is slowly improving. Seems to be getting some better every day but is still not able to dress herself and has to be taken to the bathroom.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Patient came in to store today to report bruising of left arm around injection site. Patient did not report it hurting her or use of her arm, she just happened to notice a large bruise near the injection site the morning after her shot which is still healing but is yellow in color and still visible today. Patient reports bruising is getting better each day.
Age: 53.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Induration, Joint range of motion decreased, Mass, Pain
Clinical narrative: Patient reported pain on the first day which has subsided. He now has swelling in the form of a hard mass in his shoulder. His range of motion is severely limited. He was not able to lift his hand over hit head. He got the vaccine last Saturday and experienced this the same day. He took Tylenol and his wife's gabapentin hoping it would subsided.
Age: 53.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Arthralgia, Electromyogram, Injected limb mobility decreased, Injection site pain, Muscle disorder
Clinical narrative: Patient reported pain on the first day which has subsided. He now has swelling in the form of a hard mass in his shoulder. His range of motion is severely limited. He was not able to lift his hand over hit head. He got the vaccine last Saturday and experienced this the same day. He took Tylenol and his wife's gabapentin hoping it would subsided.
Age: 53.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Pain in extremity, Sleep disorder, X-ray, X-ray limb
Clinical narrative: Patient reported pain on the first day which has subsided. He now has swelling in the form of a hard mass in his shoulder. His range of motion is severely limited. He was not able to lift his hand over hit head. He got the vaccine last Saturday and experienced this the same day. He took Tylenol and his wife's gabapentin hoping it would subsided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Musculoskeletal chest pain, Painful respiration
Clinical narrative: 12 hours after the injection, severe 10/10 pain in left anterior ribcage, worsened by coughing and deep breathing. Pain lasted from Friday night 9/27 until Tuesday night 10/1. No fevers, chills, fatigue, etc. This is my 6th COVID vaccine and I have never had this response. It felt like a sledgehammer was hitting me in the left anterior ribcage for 4 straight days.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: I stopped by the pharmacy the previous day to confirm they carried Novavax, and was told they did. When I came in for my appointment, I confirmed with the pharmacy tech that the shot she was administering was Novavax and was assured it was. Once I received my paperwork after the shot, I found out she had given me Comirnaty. When I brought this to the pharmacists' attention, they told me it was the same thing as Novavax.
Age: 85.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site infection
Clinical narrative: The patient developed an infection at the injection site.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave wrong vaccine gave adult HepA instead of Peds.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Shivering followed by high fever up to 104F. Fever lasted for about 11:PM same day as vaccine give.  Extremely tired, muscles aches.  Next day just tired. Had this high dose vaccine before and never has a reaction other than sore arm
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: No adverse events- this was an administration error. A vial of Menquadfi was reconstituted with 0.7ml diluent resulting in a 1.2ml volume. 0.5ml was drawn out and administered to patient, which is a lower dose than what's considered valid for immunization.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The adverse event that occurred was accidental use of high dose flu on 60 year old patient. No adverse reactions reported.
Age: 35.0
Sex: M
Vaccine: PNC21
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a dose of capvaxive at our pharmacy on 09/27/2024, but did not disclose that he received at dose of prevnar-20 on 06/25/2024 from another provider. our dose was not needed, no side effects, symptoms, or problems reported to our pharmacy as a result.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Body temperature increased, Erythema, Immunisation reaction, Urticaria
Clinical narrative: Morning after vaccines two red patches on arms within 30 minutes it flared up and spread to his face and both arms, and rectal temperature reading at 5:09 p.m was 101.3. Then he intermittently had hives throughout the day. They started to get bigger and were lasting longer which prompted an urgent care visit to urgent care 6/22/24.  Diagnosed with post vaccine fever and acute immunologic urticaria and prescribed Zyrtec 2.5 mg daily, 7.8 mg prednisolone daily for worsening symptoms, and ibuprofen. Parents did not get the prescriptions until today and did not administer Zyrtec until today at 1630 hrs. When they administered, parents report that patient spit most of the zyrtec out and they estimate he only got 1-1.5mL. They did not pick up the prednisolone as they did not want to start this and wanted a second opinion. Seen additionally at urgent care 6/23/24. Dx with hives post vaccinations and given additional Zyrtec. Steroids if hives worsened. Instructed to follow up with primary care.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site swelling, Local reaction
Clinical narrative: The patient had a local injection sight reaction when the shot was administered. A bump about an inch in diameter had formed and had a slightly raised appearance to it. Unsure of pregnancy history, estimated date of delivery, and birth weight. Patient stated they had not had a reaction to the flu vaccine previously to her knowledge. No other pain, itchiness, etc, were reported by the patient, when asked.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Bell's palsy, Computerised tomogram normal, Ear pain, Neck pain
Clinical narrative: Note: I?m not sure about which flu vaccine was taken.  I took Moderna vaccine and flu vaccine on the same date in the right arm. One day later I developed neck and ear pain on the right side. Two days after that I developed Bell?s Palsy on the right side of my face.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away 10/2/24
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH
Age: 1.17
Sex: F
Vaccine: DTAP, HIBV, MENB, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Decreased eye contact, Dyskinesia, Dysphagia, Feeling abnormal, Tension
Clinical narrative: Mom reported concern for possible seizure with a 1-2 minute episode of whole body tenseness, making thick bubbles, abnormal mouth movement, not swallow secretions, not making eye contact, seemed "out of it". Fell immediately to sleep afterwards. Temp was normal. Approx 30-60 min later, mom was able to wake up to feed and was acting back to baseline.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Patient had hives on his face when he was checking out. Hives were noticed by mother. Patient was assessed for SOB and dizziness, but patient did not report having those symptoms. Patient was brought back into the clinic room and was assessed by provider. Provider prescribed Benadryl 50mg capsules to be given orally. Pt was given them and tolerated well. Patient then waited in the room an additional 5 minutes to ensure of no further adverse reactions. Patient was fine and then left the clinic.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Fatigue, Injection site erythema, Injection site oedema, Lethargy
Clinical narrative: The patient was seen in the Emergency Department on 15 September, erythema/edema to L upper arm, also reports generalized fatigue and nausea. PT reported general malaise, lethargy, and chills beginning 12 Sep 2024. She first noted swelling and pain to the extremity on 13 Sep 2024.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Malaise, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: The patient was seen in the Emergency Department on 15 September, erythema/edema to L upper arm, also reports generalized fatigue and nausea. PT reported general malaise, lethargy, and chills beginning 12 Sep 2024. She first noted swelling and pain to the extremity on 13 Sep 2024.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Blood test, Computerised tomogram abdomen, Culture urine
Clinical narrative: On Sept 26 severe cramping in lower abdomen started.  On Sept 27 cramping still occurring on and off.  Felt constipated.  Was very achy and slept 14 hours!  Two NEGATIVE tests for COVID (home test kits).  On Sept 28 morning still cramping and very fatigued.  Went to urgent care.  They sent me to Hospital ER for further evaluation.  After blood work and urinalysis and CT scan the diagnosis of acute diverticulitis was made.  I have never had this before.  Last colonoscopy in November 2023 was clear and was told them I would not need one for 3 years.    On Sept 28 treatment was 125mg twice a day amoxicillin/clavulanate potassium for 10 days.  Also to be on a clear liquid diet for next 48 hours followed by gradual advancement to normal diet with a list of preferred foods.  Also instructed to follow-up with primary physician.  I have done that and have appointment for Oct 9.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Diverticulitis, Fatigue, Full blood count, Hypersomnia
Clinical narrative: On Sept 26 severe cramping in lower abdomen started.  On Sept 27 cramping still occurring on and off.  Felt constipated.  Was very achy and slept 14 hours!  Two NEGATIVE tests for COVID (home test kits).  On Sept 28 morning still cramping and very fatigued.  Went to urgent care.  They sent me to Hospital ER for further evaluation.  After blood work and urinalysis and CT scan the diagnosis of acute diverticulitis was made.  I have never had this before.  Last colonoscopy in November 2023 was clear and was told them I would not need one for 3 years.    On Sept 28 treatment was 125mg twice a day amoxicillin/clavulanate potassium for 10 days.  Also to be on a clear liquid diet for next 48 hours followed by gradual advancement to normal diet with a list of preferred foods.  Also instructed to follow-up with primary physician.  I have done that and have appointment for Oct 9.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lipase, Metabolic function test, Microscopy, Pain, SARS-CoV-2 test negative
Clinical narrative: On Sept 26 severe cramping in lower abdomen started.  On Sept 27 cramping still occurring on and off.  Felt constipated.  Was very achy and slept 14 hours!  Two NEGATIVE tests for COVID (home test kits).  On Sept 28 morning still cramping and very fatigued.  Went to urgent care.  They sent me to Hospital ER for further evaluation.  After blood work and urinalysis and CT scan the diagnosis of acute diverticulitis was made.  I have never had this before.  Last colonoscopy in November 2023 was clear and was told them I would not need one for 3 years.    On Sept 28 treatment was 125mg twice a day amoxicillin/clavulanate potassium for 10 days.  Also to be on a clear liquid diet for next 48 hours followed by gradual advancement to normal diet with a list of preferred foods.  Also instructed to follow-up with primary physician.  I have done that and have appointment for Oct 9.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast, Urine analysis
Clinical narrative: On Sept 26 severe cramping in lower abdomen started.  On Sept 27 cramping still occurring on and off.  Felt constipated.  Was very achy and slept 14 hours!  Two NEGATIVE tests for COVID (home test kits).  On Sept 28 morning still cramping and very fatigued.  Went to urgent care.  They sent me to Hospital ER for further evaluation.  After blood work and urinalysis and CT scan the diagnosis of acute diverticulitis was made.  I have never had this before.  Last colonoscopy in November 2023 was clear and was told them I would not need one for 3 years.    On Sept 28 treatment was 125mg twice a day amoxicillin/clavulanate potassium for 10 days.  Also to be on a clear liquid diet for next 48 hours followed by gradual advancement to normal diet with a list of preferred foods.  Also instructed to follow-up with primary physician.  I have done that and have appointment for Oct 9.
Age: 85.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: Redness swelling and pain in arm.  Body shaking durring night.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Lymph node palpable, Myalgia, Neck pain, Pain
Clinical narrative: Left shoulder pain: 2 days after receiving vaccine for Tdap, experience left shoulder pain in deltoid that radiates to left sternocleidomastoid muscle and up to left lateral neck.  Palpable lymphadenopathy left cervical chain and left suprascapular area.  Has full range motion the shoulder, but is tender to touch and painful when she moves it.  Previous history of for other tetanus shots, that she never had a reaction to.  She reports no other previous vaccine reactions with other vaccines.  No fever
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Left shoulder pain: 2 days after receiving vaccine for Tdap, experience left shoulder pain in deltoid that radiates to left sternocleidomastoid muscle and up to left lateral neck.  Palpable lymphadenopathy left cervical chain and left suprascapular area.  Has full range motion the shoulder, but is tender to touch and painful when she moves it.  Previous history of for other tetanus shots, that she never had a reaction to.  She reports no other previous vaccine reactions with other vaccines.  No fever
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: felt soreness and pain right after receiving the vaccine, saw improvements in pain after 1 week. It still is a little sore and red and firm at around the site of injection. It is significantly below the area that was vaccinated, so unsure if this is truly a vaccine related reaction, but considering timing of reaction from the vaccine is possible extravasation occurred, however not clear and suspect this is unlikely. Patient has not taken any medication but has attempted warm and cold compresses.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Tinnitus
Clinical narrative: Patient developed tinnitus shortly after receiving RSV (Abrysvo) and influenza (Fluzone  High-dose) vaccines. He has had influenza vaccines before without AEs. Patient attributes the tinnitus to the RSV vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Tendonitis
Clinical narrative: Achilles tendinitis  and swelling anterior tibialis - treating with gentle exercise, ice, self massage. Doctor gave referral to PT but 6 weeks before first available appointment.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Clinic received phone call on 10/02/2024, from Mom stating right upper leg was swollen at injection site of pediarix and redness also noted starting Friday morning 09/27/24. She says she then gave child 1 dose of children's tylenol. She noticed Saturday, 09/28/2024 it had developed blisters. She said child scratched them until they busted, and he didn't seem to be bothered by it. Mom states is starting to look better now.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain; This is a spontaneous report received from a Physician.  An 8-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), on 29Sep2024 at 10:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 8 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Drug hypersensitivity" (unspecified if ongoing), notes: past drug history: allergy. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN (non-serious), outcome "recovering". Therapeutic measures were taken as a result of abdominal pain.  Additional information: The patient did not receive any other vaccines on the same date and within 4 weeks as the vaccine for which the physician was reporting. The patient was not taking any other medications within 2 weeks of the event starting. Treatment included Tylenol.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site warmth
Clinical narrative: local purple discoloration at injection site along with warm to touch
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient presented to the pharmacy today 10/2/24 to report red rash on upper right arm around the area where she received the vaccine.  She reported no pain, no discomfort, and no itching.  She first noticed the rash approximately two days prior to arriving to pharmacy on 10/2/24.  The red rash was approximately 6 inches long and 4 inches wide.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: 2023-2024 COVID (6mth-11yr) vaccine was given to the patient after CDC advised to return all 2023-2024 doses and no longer administer. No harm done to patient. No side effects or symptoms. All stock has since been removed and sent back to the state.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Rash covering entire body appeared on morning of 10/01/24, 8 days after vaccines were administered. A low-grade fever accompanied the rash overnight on 10/01/24 and was also present at office visit on 10/02/24. Rash does not seem to bother patient and parents have not given any medications for the rash prior to office visit.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chest pain, Condition aggravated, Dyspnoea
Clinical narrative: Elevated temperature, muscle and joint pain, increased malaise, shortness of breath and chest pain, injection site is red and swollen and spreading down the arm towards the forearm. OTC treatment.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Injection site erythema, Injection site swelling, Malaise, Myalgia
Clinical narrative: Elevated temperature, muscle and joint pain, increased malaise, shortness of breath and chest pain, injection site is red and swollen and spreading down the arm towards the forearm. OTC treatment.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dysphagia, Erythema, Feeling hot, Flushing, Immediate post-injection reaction
Clinical narrative: Immediately after injection, patient started feeling flush. Patient's face turned bright red and patient felt hot. Patient then stated her lips were feeling funny. Dr. evaluated patient and she told him that it was getting hard for her to swallow. Called 911 and EMS took her to Hospital Emergency Room.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Oral discomfort
Clinical narrative: Immediately after injection, patient started feeling flush. Patient's face turned bright red and patient felt hot. Patient then stated her lips were feeling funny. Dr. evaluated patient and she told him that it was getting hard for her to swallow. Called 911 and EMS took her to Hospital Emergency Room.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough, sore throat, fever
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching occurred approximately a few hours post flu vaccination, then hives starting over in the left arm where the flu vaccine was  injected. Progressively through the course of the day, hives appear on his arms and his back, generally all over the body as described by the recipient of the flu vaccine. No other history of reactions in the past. Per recipient, hives remained until Saturday night, and has applied Black Seed Oil which recipient felt alleviated the itching and hives.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: 2023-2024 COVID (6mth-11yr) vaccine was given to patient after CDC advised to return all 2023-2024 doses and no longer administer. No harm done to patient. No side effects or symptoms. All stock has since been removed and returned back to the state.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Muscle spasms, Syncope
Clinical narrative: After about 10 minutes from getting the vaccine, she was walking out in the store and fainted and was spasming
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Bell's palsy, Borrelia test negative, Eye disorder, Facial paralysis, Magnetic resonance imaging head normal
Clinical narrative: PATIENT NOTICED SYMPTOMS IN THE LEFT EYE ON MONDAY 9/23, DIDN'T GO TO THE EYE DOCTOR UTIL FRIDAY 9/27 WHEN LEFT SIDED FACIAL PARALYSIS WAS APPARENT, EYE DOCTOR SENT HER TO THE EMERGENCY DEPARTMENT WHO CONDUCTED AN MRI, WHICH WAS NEGATIVE FOR STROKE. TESTED NEGATIVE FOR LYME. DIAGNOSED AS BELL'S PALSY. GIVEN PREDNISONE TAPER FROM ER. SYMPTOMS ARE STILL RESOLVING
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Presyncope
Clinical narrative: Was called to the scene, after pt receive a vaccine from Staff, patient was found in dad arm, diaphoretic, responsive to name. and normal extremities movement noted. Dad reported that patient had a near syncope episode immediately after injection. offered apple juice, which patient drank. patient was able to walk independently out of the clinic.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error, Underdose
Clinical narrative: Pt was given the diluent, not the vaccine.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Neck pain, Peripheral swelling, Shoulder injury related to vaccine administration
Clinical narrative: Patient reports experiencing pain at site of injection even on day 2 post vaccination but contributed to typical side effects. On day 4 post vaccination, she reports that her arm swelled up to the wrist and felt pain in her neck. She reports she typically is in pain up until 4-5pm daily and is not able to left her arm and when she does, she is only able to left it a little bit. She reports using both ice and heat on the area but it did not help. She went to her doctor today 10/2/2024 and was diagnosed with shoulder injury related to vaccine administration.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Syncope, Urinary tract infection
Clinical narrative: She stated roughly 12 hours after the vaccine she fainted at home and was taken by ambulance to the emergency room. She remained in the hospital for 6 days after being treated with antibiotics. She states the antibiotics were being used to treat a urinary tract infection they found while she was in the hospital. She is home and well now but still does not feel "okay". She denied any swelling, redness, or rash at injection site and any difficulty breathing after the vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardioversion, Myocardial infarction, Pulseless electrical activity, Resuscitation
Clinical narrative: Presumable myocardial infarction on night of 10/01 leading to death on 10/02. Husband found patient down on 10/02 AM for unknown duration, performed CPR. EMS administered 2 shocks for ventricular rhythms, received Amodarone bolus and drip, converted to PEA. EMS given 6 EPI in field. PT received additional 12 doses of epinephrine, sodium bicarb bolus, 2 doses of narcan, and 0.4 mg of magnesium sulfate x2. Pt attached to lukas for time being
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Pruritus, Rhinorrhoea, Skin tightness, Speech disorder
Clinical narrative: Within 15 minutes of receiving the vaccine the employee felt widespread itching and nasal discharge, lower eyelid swelling and   right sided headache.  Within the hour reported tongue thickening with difficulty speaking and right facial tightness.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling of eyelid, Tongue disorder
Clinical narrative: Within 15 minutes of receiving the vaccine the employee felt widespread itching and nasal discharge, lower eyelid swelling and   right sided headache.  Within the hour reported tongue thickening with difficulty speaking and right facial tightness.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus
Clinical narrative: Within 15 minutes of receiving the vaccine the employee felt widespread itching and nasal discharge, lower eyelid swelling and   right sided headache.  Within the hour reported tongue thickening with difficulty speaking and right facial tightness.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Employee described "giant itchy rash" all over body
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Swollen redness, knot at the site of injection. Patient endorsed pain as well. Symptoms started the following day after injection.