chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Overdose; 7 year old patient was administered the adult dose of Engerix-B.; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 7-year-old female patient who received HBV (Engerix B adult) (batch number K9HS5, expiry date 18-MAR-2024) for prophylaxis.   On 12-JAN-2024, the patient received the 2nd dose of Engerix B adult. On 12-JAN-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: 7 year old patient was administered the adult dose of Engerix-B.). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-JAN-2024 The nurse reported that the child patient had received adult dose of Engerix-B which led to, overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via mail.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Blood test abnormal, Cough, Headache, Hodgkin's disease
Clinical narrative: Developed persistent cough and severe headaches within days after 2nd Covid vaccine (worsened over following weeks and months. Other symptoms of illness arose (flu-pneumonia like symptoms, night sweats, unexplained weight loss). Antibiotics (Zpak & amoxicillin) were useless. This information was reported immediately to my primary care physician and shows on record.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Metastases to bone, Night sweats, Red blood cell count abnormal
Clinical narrative: Developed persistent cough and severe headaches within days after 2nd Covid vaccine (worsened over following weeks and months. Other symptoms of illness arose (flu-pneumonia like symptoms, night sweats, unexplained weight loss). Antibiotics (Zpak & amoxicillin) were useless. This information was reported immediately to my primary care physician and shows on record.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count abnormal
Clinical narrative: Developed persistent cough and severe headaches within days after 2nd Covid vaccine (worsened over following weeks and months. Other symptoms of illness arose (flu-pneumonia like symptoms, night sweats, unexplained weight loss). Antibiotics (Zpak & amoxicillin) were useless. This information was reported immediately to my primary care physician and shows on record.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: No adverse event, Product storage error
Clinical narrative: temp excursion of storage unit discovered 1/4/24 temp of storage unit was -2.4 degrees C prior to patient receiving his vaccines on 1/4/24. Temp on data logger device downloaded and temp was -2.4 degrees C for 4hrs 8 min no harm to patient per mfr. but potency and immunity may be compromised
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: No adverse event, Product storage error
Clinical narrative: temp excursion of storage unit discovered 1/4/24. temp of storage unit was -2.4°C prior to patient receiving her vaccines on 1/4/24. Temp on data logger device was downloaded and temp of -2.4°C noted for 4hr 8min. No harm to patient per Mtr. but potency and immunity may be compromised.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Product storage error
Clinical narrative: Vaccine temp excursion 1-4-24 when temp data logger downloaded Temp decreased -2.4 C degrees on 12/28/23. Pt received vaccine prior to temp excursion discovered. No harm to pt per the mfr. but vaccine may have decreased potency and immunity after being exposed to temp below 0 degree C.
Age: 17.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: temp excursion of storage unit discovered. 1/4/24 temp of storage unit was -2.4 degree C prior to patient receiving his vaccines on 1/3/24. Temp on data logger device was downloaded and temp of -2.4 degree C was noted for 4hr 8min. No harm to patient per MFR. but potency & immunity maybe compromised
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine temp excursion noted when temp data logger downloaded on 1-4-24. Temp decreased - 2.4 C degrees on 12-28-23. Pt received vaccines prior to temp excursion discovered. No harm to pt. per mfr. but vaccine may have less potency and immunity
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Vaccine temp excursion discovered after patient received vaccine. Temp decreased -2.4 C degrees per temp logger data download. No harm to patient per mfr. Vaccine may be less potent and provide less immunity. Temp dropped 12/28/23. Excursion discovered 1/4/24
Age: 2.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine temp excursion discovered 1-4-24 when temp data logger downloaded. Temp decreased to -2.4°C on 12/28/23. Patient received vaccine prior to excursion noted. No harm to patient per mfr. Vaccine may have decreased potency and immunity after to exposure to temp below 0°C
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Product storage error
Clinical narrative: Vaccine temp excursion discovered 1-4-24 when temp data logger downloaded. Temp decreased to -2.4°C on 12/28/23. Pt received vaccines prior to temp excursion discovered. No harm to patient per the mfr. vaccines may have decreased potency and immunity after being exposed to temp below 0°C.
Age: 7.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Product storage error
Clinical narrative: Temp excursion discovered on 1/4/24 that occurred on 12/28/23 prior to patient receiving the vaccines. Temp was -2.4 degrees C per the temp logger data download for 4 hrs 8min. Vaccines were exposed to temp excursion.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: No adverse event, Product storage error
Clinical narrative: Temp excursion discovered 1-4-24 when temp data logger downloaded. Temp decreased - 2.4 C on 12/28 /23. Pt had received vaccines prior to excursion discovered. No harm to patient per mfr. Vaccine may have decreased potency and immunity after being exposed to below 0C temp.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine temp excursion discovered 1-4-24 when temp data logger downloaded. Temp decreased -2.4 degrees C on 12/28/23 pt received vaccines prior to excursion noted. No harm to patient per mfr. Vaccine may have decreased potency and immunity after being exposed to below 0 degree C temp
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Temp excursion of storage unit discovered 1/4/24, temp of storage unit was -2.4 degrees C prior to patient receiving his vaccines on 12/28/23. Temp on temp logger data device was downloaded and temp of -2.4 degrees C noted for 4hr 8 min. No harm to patient per mfr. but potency and immunity may be compromised.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Product storage error
Clinical narrative: Temp excursion of storage unit discovered 1-4-24, temp of unit was -2.4 C degrees prior to pt. receiving vaccines on 12-28-23. Temp on temp logger data device was downloaded and temp at -2.4 C degrees was noted for 4h 8min. No harm to patient per mfr. but potency and immunity may be compromised.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Temp excursion of storage unit discovered 1-4-24, temp of unit was -2.4 C degrees prior to pt. receiving vaccines on 12-28-23. Temp on temp logger data device was downloaded and temp at -2.4 C degrees was noted for 4h 8min. No harm to patient per mfr. but potency and immunity may be compromised.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: Temp excursion discovered on 1/4/24, temp of storage unit dropped to -2.4 degree C prior to patient receiving his vaccine on 12/28/23. Temp of storage unit was -2.4 degrees C per the temp logger data download for 4 degrees 8 min. No harm to patient per mfr. Potency may be affected.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Musculoskeletal stiffness, Tremor
Clinical narrative: Uncontrolled shaking for 15 minutes and extreme muscle stiffness, possibly a febrile seizure.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: Within 12 hours of the shot woke up with SEVERE chills, 7 blankets couldn't even help! By hour 13 I was throwing up at 3am along with diarrhea.  Arm is severely still sore 5 days after injection.  3 inches below injection is a huge red swollen sore spot on my arm.  Headaches have continued and a "blister" on the inside of my mouth showed up yesterday.   I was perfectly healthy before this shot.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Oral mucosal blistering, Pain in extremity, Sleep disorder, Vomiting
Clinical narrative: Within 12 hours of the shot woke up with SEVERE chills, 7 blankets couldn't even help! By hour 13 I was throwing up at 3am along with diarrhea.  Arm is severely still sore 5 days after injection.  3 inches below injection is a huge red swollen sore spot on my arm.  Headaches have continued and a "blister" on the inside of my mouth showed up yesterday.   I was perfectly healthy before this shot.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: After vaccination I felt lightheaded but the feeling seemed to susbdide for a short while. A few hours later I began to feel extreme body aches all over, chills and overheating, excessive sweating, a fever between 102 and 103, tightness in my chest and slightly labored breathing, and extreme pain in my legs, especially in the calves which felt pulsating as if pain increased with my heartbeat, this lasted about 2.5 days and mostly went away. During this time, I was bedridden and absolutely writhing in pain. However, I had frequent recurring chest pain for over a year and when I got actual covid about 4-5 months later most of those symptoms returned, including the leg pain. I still struggle with chest pain to a less frequent extent. I saw the doctor for chest pain over the next year but have not determined it. I did not seek hospitalization immediately after the vaccine but wish I had.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Mobility decreased, Pain, Pain in extremity
Clinical narrative: After vaccination I felt lightheaded but the feeling seemed to susbdide for a short while. A few hours later I began to feel extreme body aches all over, chills and overheating, excessive sweating, a fever between 102 and 103, tightness in my chest and slightly labored breathing, and extreme pain in my legs, especially in the calves which felt pulsating as if pain increased with my heartbeat, this lasted about 2.5 days and mostly went away. During this time, I was bedridden and absolutely writhing in pain. However, I had frequent recurring chest pain for over a year and when I got actual covid about 4-5 months later most of those symptoms returned, including the leg pain. I still struggle with chest pain to a less frequent extent. I saw the doctor for chest pain over the next year but have not determined it. I did not seek hospitalization immediately after the vaccine but wish I had.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: After vaccination I felt lightheaded but the feeling seemed to susbdide for a short while. A few hours later I began to feel extreme body aches all over, chills and overheating, excessive sweating, a fever between 102 and 103, tightness in my chest and slightly labored breathing, and extreme pain in my legs, especially in the calves which felt pulsating as if pain increased with my heartbeat, this lasted about 2.5 days and mostly went away. During this time, I was bedridden and absolutely writhing in pain. However, I had frequent recurring chest pain for over a year and when I got actual covid about 4-5 months later most of those symptoms returned, including the leg pain. I still struggle with chest pain to a less frequent extent. I saw the doctor for chest pain over the next year but have not determined it. I did not seek hospitalization immediately after the vaccine but wish I had.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Haemoglobin decreased, Haemorrhage, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: My father was a hemophilia, hemophiliac A. I had a bleed. my hemoglobin went down to 7.9. I was hospitalized, I went septic and I almost died. I had to learn to walk again and they said if I hadn't come in I would've died within 24 hours. I have had to relearn how to do a lot of things.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: My father was a hemophilia, hemophiliac A. I had a bleed. my hemoglobin went down to 7.9. I was hospitalized, I went septic and I almost died. I had to learn to walk again and they said if I hadn't come in I would've died within 24 hours. I have had to relearn how to do a lot of things.
Age: 71.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Fall
Clinical narrative: 30 minutes post vaccines, patient reported falling down in aisle while grocery shopping
Age: 37.0
Sex: F
Vaccine: DTAP, HPV9
Symptoms: Lymphadenopathy
Clinical narrative: Massive and swollen lymph glands under the chin
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Aphasia, Dysgraphia, Dyskinesia, Eating disorder
Clinical narrative: In July 5th I ended up in the hospital and I was there 23 days. They didn't know what was wrong. I was moved to a nursing home. I still cannot say simple words, for example if I want to say clock I have to describe it as "the thing that tells time". I don't remember the transport to the nursing home. They asked my name and I didn't know it. I spent 3 months to learn to walk and eat right. I had to learn to do everything! The doctor said I was like a baby that needed to learn to do everything all over again. I also don't have control of my fingers. I have illegible writing. My fingers are jerking and I cant hardly control it.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Laboratory test, Loss of personal independence in daily activities, Musculoskeletal disorder
Clinical narrative: In July 5th I ended up in the hospital and I was there 23 days. They didn't know what was wrong. I was moved to a nursing home. I still cannot say simple words, for example if I want to say clock I have to describe it as "the thing that tells time". I don't remember the transport to the nursing home. They asked my name and I didn't know it. I spent 3 months to learn to walk and eat right. I had to learn to do everything! The doctor said I was like a baby that needed to learn to do everything all over again. I also don't have control of my fingers. I have illegible writing. My fingers are jerking and I cant hardly control it.
Age: 77.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Extra dose administered
Clinical narrative: Resident received an extra dose of Covid Vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiomegaly, Chest X-ray abnormal, Inflammatory marker increased
Clinical narrative: Cannot remember all the Vacs, and dates - Pfizer - prob at least four prob 5 shots - took one in July 2022 and new booster in Nov 2022 plus Dec 1 2023 and two prior to that when vac was first released to public                                                   PLEASE NOTE:   first two vacs where at drive thru in facility - other vacs should be captured via pharmacy network  - ALL PFIZER  - no adverse effects until Dec 1 2023
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient was given a dose too low for actual vaccination. Dose should be .3mL and dose given was .1mL. Patient was under vaccinated and will need to start the series over again.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Cardiac function test, Cardiac stress test, Computerised tomogram
Clinical narrative: Since the covid vaccine (w/ 2nd dose) I've been to the ER twice for anaphylaxis conditions twice. Once in JAN 2023 and again in JUL 2023. I've never had anaphylaxis conditions prior to the vaccine.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: Since the covid vaccine (w/ 2nd dose) I've been to the ER twice for anaphylaxis conditions twice. Once in JAN 2023 and again in JUL 2023. I've never had anaphylaxis conditions prior to the vaccine.
Age: 5.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient received an HPV9 vaccine instead of the polio vaccine.  No symptoms were reported after vaccination.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Condition aggravated, Gastrooesophageal reflux disease, Urticaria, Vulvovaginal rash
Clinical narrative: Vulvar rash and hives present within two hours. Marked increase in reflux since administration.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Genital ulceration, Pain
Clinical narrative: Vulvar apthous ulcer; size close to that of a quarter. Patient reported that she thought an ulcer was forming on January 11. The pain increased over the weekend. She was seen Monday January 15th by her PCP, Dr. She prescribed pain medication, topical steroid, and a medrol dose pack. She referred Patient to GYN for further evaluation.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema
Clinical narrative: Donor developed a large 4x4 inch area of redness to upper arm several days after receiving injection.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Administration error as patient received DTaP+IPV (Kinrix) which is only licensed for use in ages 4 years - 6 years.  As per local health department, this does is counted as valid since it was given as 3rd dose for both DTaP and IPV. No adverse reaction reported by patient.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Flushing, Skin warm
Clinical narrative: Extreme "blushing" of the cheeks both sides of face.  Large red  spots approx. 3" in diameter on both cheeks which felt hot to the touch and lasted for hours.  This happened multiple time over the past month.
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Diarrhoea, Eye swelling, Fatigue
Clinical narrative: 48 hours later- I had fatigue, weakness, diarrhea. My right eye swelled up which is a similar reaction Ihave to cats. It lasted a couple days and went away.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 20 days beyond use date on product.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine21 days beyond use date on product. And enter how many days beyond use.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient at clinic for appointment, was asked by provider to administer flu shot, went to document vaccine and noted patient had previously had flu shot on 10/4/2023
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Apnoea, Crying, Diarrhoea, Infant irritability, Infantile spitting up
Clinical narrative: PATIENT EXPERIENCED APNEIC EPISODES, SPITTING UP, VOMITING, LARGE LOOSE STOOLS, FLUID COLLECTION ON SCALP, FUSSINESS, CRYING/SCREAMING, NO LONGER SMILING. WENT TO ER AND ULTRASOUND DONE, DIAGNOSED WITH SUBGALEAL HEMATOMA.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Localised oedema, Screaming, Subgaleal haematoma, Ultrasound scan abnormal, Vomiting
Clinical narrative: PATIENT EXPERIENCED APNEIC EPISODES, SPITTING UP, VOMITING, LARGE LOOSE STOOLS, FLUID COLLECTION ON SCALP, FUSSINESS, CRYING/SCREAMING, NO LONGER SMILING. WENT TO ER AND ULTRASOUND DONE, DIAGNOSED WITH SUBGALEAL HEMATOMA.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Skin warm, Tenderness
Clinical narrative: PATIENT RECEIVED VACCINATION IN THEIR LEFT DELTOID ON 1/09/24-BOOSTRIX. PATIENT CALLED ON 1/16/24 STATING THAT ABOUT 3 DAYS AGO THEIR ELBOW WAS HURTING AND THAT THERE WAS REDNESS THAT SPREAD DOWN TO THEIR LEFT FOREARM, CONFIRMED WITH PATIENT NO REDNESS NEAR THE SHOULDER OR DELTOID AREA. NO SYMPTOMS PRIOR TO THAT POST-VACCINATION. PATIENT REPORTED TENDERNESS, WARMNESS, AND PAIN NEAR THEIR LEFT ELBOW. NO FEVER REPORTED. PATIENTS LEFT DELTOID WAS SWABBED WITH AN ALCOHOL SWAB PRIOR TO INJECTION, PT DID RECOLLECT THAT INFORMATION-AT THIS TIME THE ORIGIN OF THE PAIN IS UNKNOWN, AN INFECTION HAS NOT BEEN CONFIRMED. PT WAS TOLD TO FOLLOW-UP WITH THEIR PRIMARY CARE PROVIDER TO EXAMINE THE ARM AND ELBOW AS SOON AS POSSIBLE TO RULE OUT ANY POTENTIAL INFECTION. INFORMED PATIENT THAT THE EVENT WILL ALSO BE REPORTED TO VAERS. INFORMATION COULD NOT BE CONFIRMED SINCE IT WAS PROVIDED OVER THE PHONE.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: CHILD WAS GIVEN A DOSE OF PENTACEL INSTEAD OF DAPTACEL . PARENT WAS CONTACTED AND NOTIFIED.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Pfizer but wanted Moderna. No adverse event occurred.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Amnesia, Aphasia, Confusional state
Clinical narrative: woke up unable to retrieve words, couldn't remember layout of apartment, general confusion
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Infant here for well child visit. Fluzone 0.5 ml IM to Left thigh given instead of his scheduled prevnar vaccine. No adverse reaction at time of discharge, but mother of child will notify  clinic of any concens
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine beyond use date on product.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Anxiety, Arthralgia, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Joint pain, fatigue, headache, muscle pain, erythema near injection site, diarrhea, anxiety, reduced appetite
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Injection site erythema, Myalgia
Clinical narrative: Joint pain, fatigue, headache, muscle pain, erythema near injection site, diarrhea, anxiety, reduced appetite
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 21 days beyond use date on product.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: It was discovered that this product expired 12/11/23. Manager called Pfizer for further direction and was advised that the beyond use date is at maximum 74 days past refrigeration date. There was a sticker on box of 12/11/23. Pfizer advised that there is no current evidence to support or advise against redosing patients in this scenario. Provider to contact patient via phone with three attempts to advise of error and to discuss options of redosing at no charge or declining to do so.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: It was discovered that this product expired 12/11/23. Manager called Pfizer for further direction and was advised that the beyond use date is at maximum 74 days past refrigeration date. There was a sticker on box of 12/11/23. Pfizer advised that there is no current evidence to support or advise against redosing patients in this scenario. Provider to contact patient via phone with three attempts to advise of error and to discuss options of redosing at no charge or declining to do so.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: It was discovered that this product expired 12/11/23. Manager called Pfizer for further direction and was advised that the beyond use date is at maximum 74 days past refrigeration date. There was a sticker on box of 12/11/23. Pfizer advised that there is no current evidence to support or advise against redosing patients in this scenario. Provider to contact patient via phone with three attempts to advise of error and to discuss options of redosing at no charge or declining to do so.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid Vaccine 8 days beyond use date on product
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 16 days beyond use date on product.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU4, HPV9, MNQ
Symptoms: C-reactive protein, Chest discomfort, Chest pain, Haemoglobin normal, Intensive care
Clinical narrative: 6 days after receiving vaccine patient went to emergency department for chest pressure and pain.  After lab work up patient was admitted to the ICU for Acute Myocarditis.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU4, HPV9, MNQ
Symptoms: Myocarditis, Red blood cell count normal, Red blood cell sedimentation rate increased, Troponin
Clinical narrative: 6 days after receiving vaccine patient went to emergency department for chest pressure and pain.  After lab work up patient was admitted to the ICU for Acute Myocarditis.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: It was discovered that this product expired 12/11/23. Manager called Pfizer for further direction and was advised that the beyond use date is at maximum 74 days past refrigeration date. There was a sticker on box of 12/11/23. Pfizer advised that there is no current evidence to support or advise against redosing patients in this scenario. Provider to contact patient via phone with three attempts to advise of error and to discuss options of redosing at no charge or declining to do so.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal wall pain, Asthenia, COVID-19, Cough, Decreased appetite
Clinical narrative: 1/11/24: shaky, harsh cough. vomiting, loss of appetite, progressive lightheadedness, abdominal wall pain, and generalized weakness. 1/14/24: COVID-19 positive
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, SARS-CoV-2 test positive, Tremor, Vomiting
Clinical narrative: 1/11/24: shaky, harsh cough. vomiting, loss of appetite, progressive lightheadedness, abdominal wall pain, and generalized weakness. 1/14/24: COVID-19 positive
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid Vaccine 8 days beyond use date on product
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Device leakage, Immunisation, Underdose
Clinical narrative: During administration of flu vaccine, over 1/2 of the vaccine leaked out of area between the needle and the syringe while remaining intacted. Medical director and director were notified and advised re-revaccination per clinic protocol. Pt and pt's mother were agreeable to re-vaccination and another dose was administered without incident at that time.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: It was discovered that this product expired 12/11/23. Manager called Pfizer for further direction and was advised that the beyond use date is at maximum 74 days past refrigeration date. There was a sticker on box of 12/11/23. Pfizer advised that there is no current evidence to support or advise against redosing patients in this scenario. Provider to contact patient via phone with three attempts to advise of error and to discuss options of redosing at no charge or declining to do so.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered the Covid Vaccine 8 days beyond use date on product
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Nasopharyngitis, Pain
Clinical narrative: I had no side effects after the first dose. After the second dose, I ache all over, the injection site hurts and feel like I have a head cold. This started the morning after the vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Vaccine administered was: COVID-19 mRNA, PF, XBB 1.5. Pt reported lip swelling and slight tongue swelling.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Full blood count, Generalised tonic-clonic seizure, Metabolic function test, Urine analysis
Clinical narrative: Generalized tonic clonic seizure 11 days after vaccinations.  Child normal after resolution
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 22 day beyond use date on product.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 8 days beyond use date on product.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 8 days beyond use date on product.
Age: 57.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Pain in extremity
Clinical narrative: Pt reporting extreme soreness in arm after injection of 2 vaccines. She sought care by her primary care provider who started a course of meloxicam 15 mg daily with no relief. She was also prescribed cetirizine 10 mg daily as it was thought to possible be an allergic reaction. She will be having an MRI done to assess further
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 8 days beyond use date on product.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Condition aggravated, Erythema, Feeling hot, Gout
Clinical narrative: increasing heat, spreading redness, lump. Went to urgent care and saw PA-C who diagnosed cellulitis and verbally noted that it was red, swollen and warm.  I also had a very bad gout flare up at the same time, within a few hours of the Arexvy injection.  I am taking cephalexin 500 mg x 4/day, 20 mg prednisone, and colchicine.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Skin mass, Swelling
Clinical narrative: increasing heat, spreading redness, lump. Went to urgent care and saw PA-C who diagnosed cellulitis and verbally noted that it was red, swollen and warm.  I also had a very bad gout flare up at the same time, within a few hours of the Arexvy injection.  I am taking cephalexin 500 mg x 4/day, 20 mg prednisone, and colchicine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 7 days beyond use date on product.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Covid symptoms, confirmed by at-home antigen test, were present on Friday, January 5, 2024.  Had sore throat, headache, fever, fatigue, sneezing, cough.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Covid symptoms, confirmed by at-home antigen test, were present on Friday, January 5, 2024.  Had sore throat, headache, fever, fatigue, sneezing, cough.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Full blood count normal, Haematoma, Headache, Lymphadenopathy, Pain
Clinical narrative: I presented for the first time (I have already received all of the Moderna Covid 19 vaccines prior to this one) symptoms of headache, body pain, and swollen nodules in the left armpit area. I understand the symptoms reported in other patients. But, three days later (January 12, 2024) a hematoma formed in the area between the swollen nodule and the left breast. I consulted with my doctor, and he informs me that there are no reports of that type of reaction. To this day the hematoma still persists.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Injection site pain
Clinical narrative: Dizziness, fever of 101, diarrhea, headache, nausea, pain and swelling at injection site, chills.  Most of these symptoms subsided in 24 hours.  Dizziness, headache, and pain and swelling at injection site has persisted at 48 hours.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Dizziness, fever of 101, diarrhea, headache, nausea, pain and swelling at injection site, chills.  Most of these symptoms subsided in 24 hours.  Dizziness, headache, and pain and swelling at injection site has persisted at 48 hours.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Myocarditis
Clinical narrative: Myocarditis
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Bivalent vaccine given in error. No adverse symptom nor sign reported by the patient.
Age: 0.92
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product administration error
Clinical narrative: Vaxelis vaccine administered in error. Patient was not due for vaxelis at the time of service. Manufacturer notified and parent notified.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dysstasia, Fear
Clinical narrative: She got her vaccine, did not have any reaction initially and then 9 hours later like the other vaccines she got she started having chills, shaking, teeth chattering, hot face, feeling weak, hallucinations which she has never had hallucinations before.  Things were moving, the rug was moving to her (wall to wall carpeting).  She took a Benadryl which she thought would work and to calm her down.  She went to go to bed and she slid down and thinks her BP dropped and her legs went out from underneath her.  She was then there for 24 hours on the floor without any assistance.  Her sister kept calling her to tell her that she could not get a hold of her.  The family then called 9-1-1 and they then able to stand her up and she was just wiped out, and is still wiped out but is getting stronger.  After she was up she had not eaten, drank or used the bathroom or taken her dog out to the bathroom in 24 hours.  They wanted to take her to the hospital but she declined it.  She then slept really good and has been weak since then.  She has been using a walker and using a cane which she does use on occasion but not the walker and due to her weakness and fear of falling she is using it.  She did have loss of appetite but it is coming back.  She does feel like she is improving, and does not want to take any Moderna vaccines in the future.  She has had similar reactions to the other vaccines from Moderna, but not as bad as this one.  She thinks the reactions have gotten a little worse each time she gets a vaccine.   She did have her flu and pneumonia vaccines prior to this by a few months and had no reactions at all with those.  She is going to get her RSV in the next month.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Fluid intake reduced, Hallucination, Hallucination, visual, Hypophagia
Clinical narrative: She got her vaccine, did not have any reaction initially and then 9 hours later like the other vaccines she got she started having chills, shaking, teeth chattering, hot face, feeling weak, hallucinations which she has never had hallucinations before.  Things were moving, the rug was moving to her (wall to wall carpeting).  She took a Benadryl which she thought would work and to calm her down.  She went to go to bed and she slid down and thinks her BP dropped and her legs went out from underneath her.  She was then there for 24 hours on the floor without any assistance.  Her sister kept calling her to tell her that she could not get a hold of her.  The family then called 9-1-1 and they then able to stand her up and she was just wiped out, and is still wiped out but is getting stronger.  After she was up she had not eaten, drank or used the bathroom or taken her dog out to the bathroom in 24 hours.  They wanted to take her to the hospital but she declined it.  She then slept really good and has been weak since then.  She has been using a walker and using a cane which she does use on occasion but not the walker and due to her weakness and fear of falling she is using it.  She did have loss of appetite but it is coming back.  She does feel like she is improving, and does not want to take any Moderna vaccines in the future.  She has had similar reactions to the other vaccines from Moderna, but not as bad as this one.  She thinks the reactions have gotten a little worse each time she gets a vaccine.   She did have her flu and pneumonia vaccines prior to this by a few months and had no reactions at all with those.  She is going to get her RSV in the next month.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Tremor, Walking aid user
Clinical narrative: She got her vaccine, did not have any reaction initially and then 9 hours later like the other vaccines she got she started having chills, shaking, teeth chattering, hot face, feeling weak, hallucinations which she has never had hallucinations before.  Things were moving, the rug was moving to her (wall to wall carpeting).  She took a Benadryl which she thought would work and to calm her down.  She went to go to bed and she slid down and thinks her BP dropped and her legs went out from underneath her.  She was then there for 24 hours on the floor without any assistance.  Her sister kept calling her to tell her that she could not get a hold of her.  The family then called 9-1-1 and they then able to stand her up and she was just wiped out, and is still wiped out but is getting stronger.  After she was up she had not eaten, drank or used the bathroom or taken her dog out to the bathroom in 24 hours.  They wanted to take her to the hospital but she declined it.  She then slept really good and has been weak since then.  She has been using a walker and using a cane which she does use on occasion but not the walker and due to her weakness and fear of falling she is using it.  She did have loss of appetite but it is coming back.  She does feel like she is improving, and does not want to take any Moderna vaccines in the future.  She has had similar reactions to the other vaccines from Moderna, but not as bad as this one.  She thinks the reactions have gotten a little worse each time she gets a vaccine.   She did have her flu and pneumonia vaccines prior to this by a few months and had no reactions at all with those.  She is going to get her RSV in the next month.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Urinary tract infection
Clinical narrative: UTI
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abdominal pain upper, Attention deficit hyperactivity disorder, Autism spectrum disorder, Fatigue, Irritability
Clinical narrative: Had bad fever the night of the vaccine and large bump at site of vaccine. ?overnight, he developed a verbal tic, repeating the same phrase over and over again.  ?the tic has progressively gotten worse ?he has also been throwing up, having stomach pain ?extremely tired. irritability. ? ?developed OCD behaviors suddenly (getting into chair and out of chair a few times before settling down into the chair) .  Since then, has now been diagnosed with ASD I and ADHD.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Obsessive-compulsive disorder, Pyrexia, Tic, Vaccination site swelling, Vomiting
Clinical narrative: Had bad fever the night of the vaccine and large bump at site of vaccine. ?overnight, he developed a verbal tic, repeating the same phrase over and over again.  ?the tic has progressively gotten worse ?he has also been throwing up, having stomach pain ?extremely tired. irritability. ? ?developed OCD behaviors suddenly (getting into chair and out of chair a few times before settling down into the chair) .  Since then, has now been diagnosed with ASD I and ADHD.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 17 days beyond use date on product.