chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor positive, Vitamin D decreased, Vitamin supplementation
Clinical narrative: I had Moderna for my first vaccines. The fifth dose, booster was my first pfizer on 8/10/2022. A week later I could barely walk due to acute inflammation and pain. I struggled for months with overall joint, muscle, nerve pain throughout my body, particularly in my ankle, knees and legs. The inflammation and pain has seriously impacted my quality of life. I saw my primary physician for examination and bloodwork and she referred me to a rheumatologist due to the highly elevated inflammation markers in my blood and a positive RA factor which I have never had before. I could barely function at work as a teacher. My life consisted of managing pain with NSAIDS, joint braces, ice packs etc. It took over my life. Finally I got an appointment with the Rheumatology Clinic in November, 2022. I was then treated with 400 mg Plaquenil and naproxen as well as high doses of Vitamin D. Follow up 4 months later in March showed some improvement in symptoms. I then began  Physical Therapy for 12 weeks. Almost a year after my pfizer booster, i am still suffering with pain and inflammation, and the recent visit to Rheumatology clinic recommended that i remain on Plaquenil indefinitely. I may have to deal with Auto immunity Disease, RA, for the rest of my life. I walk with a noticable limp, as my righ leg is still the most impacted. Prior to this Vaccine Injury on 8/10/2022, I was perfectly healthy. I did not take any medications regularly, had no chronic health conditions, and enjoyed an active healthy lifestyle. This Covid 19 , pfizer vaccine Injury has not only stolen this past year of my life, but the future outcome and impact is still uncertain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: Pt has redness, swelling, and induration greater than 100mm (approx. 6-8 inches in diameter).  Pt also had redness and pain develop at a previous surgery site 3 days after the vaccine
Age: 18.0
Sex: M
Vaccine: HEP, MNQ, VARCEL
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient was vaccinated at 1:05 with Hep B, at 1:06 with MCV4, at 1:07 pm with varicella. At 1:08, Patient stated, "I feel dizzy". Patient became sweaty. Applied cold pack to the back of patients neck. BP 100/61, O2 sat. 99% RA, P 68, Resp. 20, At 1:15 patient was alert and oriented x3, stopped sweating and stated, "I feel better". BP 110/78, P 64, O2sat 99%, Resp. 20, At 1:35, patient had no symptoms of distress or dizziness. Patient smiling and stated,  "I feel fine". BP 114/78, P 72, Resp. 20, Temp. 97.7, O2 sat 99%. Alert and oriented x 3. Discharged with father and instructed to call EMS or ER if symptoms return. Patient verbalized understanding.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine
Clinical narrative: About two days after my vaccine, I started getting sinus migraines that would start in the middle of the afternoon and get progressively worse through the rest of the day.  I tried using my migraine medicine to relieve but was only moderately successful.  By morning I would be back to normal, but then middle of the day the migraine would return.  This lasted for about ten days, and occurs after every follow up vaccine, but the duration of the migraines is much shorter.  The other adverse event is that ever since the vaccine, every month when I get my period, the migraine returns on the second day of my period and lasts the duration.  Same as after the vaccine, the migraine starts mid-afternoon and my migraine medicine is the only thing that will relieve it.  Sinus medications do not work.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dysgeusia, Product administered to patient of inappropriate age, Product availability issue
Clinical narrative: I administered an Adacel immunization. (we did not have Boostrix in stock). About 10 -15 minutes later the patient said she was a little dizzy and had a bitter taste in her mouth. We gave her some water to drink. Shortly thereafter she shopped for a few items and checked out at the pharmacy. We tried twice to phone her later to see how she was doing, but it went to voicemail. The bitter taste is an unusual side effect from the Adacel immunization, so I will fill out a VAERS
Age: 40.0
Sex: M
Vaccine: COVID19-2, MMR
Symptoms: Feeling hot, Musculoskeletal stiffness, Nausea
Clinical narrative: Vaccinated the pt. with pfizer bivalent at 3:07 in left deltoid he commented how I had good hands he didn't feel it. Then vaccinated with MMR in Left subq at 3:08 he started to get hot. His wife asked for alcohol wipes to put under his nose and on his forehead. I put an alcohol wipe on the back of his neck to help cool him off. The patient started to close his eyes and his arms and legs tightened up. So I asked for help, and he came right in and got an ice pack, a bag for nausea and started taking vitals at 3:10. The 1st set of vitals were B/P 99/60 P80 O2 100% at 3:13 the patient stated he was feeling better. Next set of vitals were B/P 108/69 P78 O2 100% at 3:17. Pt. wife stated he was fine to continue to finish the vaccines. He said it was my decision so I finished vaccinating the pt. and he was observed for 15 minutes and went home.
Age: 71.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient called on 8/4/23 stated that her  injection site were swallen , red , painful and Nausea occurred.
Age: 6.42
Sex: F
Vaccine: FLU4, PNC20, TDAP
Symptoms: Hypersensitivity, Swelling face
Clinical narrative: Allergic Reaction Swelling of face
Age: 63.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Pleural effusion
Clinical narrative: None at time of shot. Pleural effusion now
Age: 63.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Aspiration pleural cavity, Malaise, Pleural effusion, Pneumonia
Clinical narrative: None at time of shot. Pleural effusion now
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy
Clinical narrative: I got the shingles shot and now my lymph node under the injected arm is swollen.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy, Pain
Clinical narrative: flu like symptoms, aching pain , feeling very lethargic
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Hypoaesthesia, Paraesthesia
Clinical narrative: Diarrhea- fluids and bland diet.  Tingling and numbness in Left hand.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, C-reactive protein, Chest pain, Headache
Clinical narrative: pain, head, neck, ears, shoulders, chest, back, hips, knees, feet
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Neck pain, Pain in extremity, Rheumatoid factor
Clinical narrative: pain, head, neck, ears, shoulders, chest, back, hips, knees, feet
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Joint stiffness, Musculoskeletal stiffness, Neck pain
Clinical narrative: pain, head, neck, ears, shoulders, chest, back, hips, knees, feet
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: pain, head, neck, ears, shoulders, chest, back, hips, knees, feet
Age: 37.0
Sex: F
Vaccine: TYP
Symptoms: Menstruation delayed
Clinical narrative: Period was expected in middle of four pill dose. It was delayed 4-5 days.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash pruritic
Clinical narrative: Spotted rash across torso, front and back that lasted 4 days. The patient complained of itchiness.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test normal, Brain fog, Fatigue
Clinical narrative: Chronic Pain - Knees, feet, lumbar region, cervical region, trapezius region, occipital region Brain fog Chronic Inflammation  Fatique P.E.M.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Magnetic resonance imaging joint, Malnutrition, Neck pain
Clinical narrative: Chronic Pain - Knees, feet, lumbar region, cervical region, trapezius region, occipital region Brain fog Chronic Inflammation  Fatique P.E.M.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Spinal X-ray normal
Clinical narrative: Chronic Pain - Knees, feet, lumbar region, cervical region, trapezius region, occipital region Brain fog Chronic Inflammation  Fatique P.E.M.
Age: 25.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Erythema, Induration, Pain, Rash, Skin warm
Clinical narrative: 1st of vaccine(July 5th, 2022) results in normal sized swelling but 2nd dose (august 3rd,2022) that was administered on Thursday resulted in considerable swelling, pain, redness, firmness to touch, induration, and very warm/hot to the touch. I have pictures of the progression and marked it as it started to swell just text, call or email me
Age: 25.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Swelling
Clinical narrative: 1st of vaccine(July 5th, 2022) results in normal sized swelling but 2nd dose (august 3rd,2022) that was administered on Thursday resulted in considerable swelling, pain, redness, firmness to touch, induration, and very warm/hot to the touch. I have pictures of the progression and marked it as it started to swell just text, call or email me
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: large local reaction to vaccine
Sex: U
Vaccine: PNC20, VARZOS
Symptoms: Communication disorder, Disorientation, Hyperhidrosis, Loss of consciousness, Nervousness
Clinical narrative: Patient stated she was afraid needles but has had  vaccines in the past. Questionnaire circled no however on past fainting with vaccines. Pharmacist had patient remain in chair and asked to sit before leaving for 15 minutes and when feeling ok. Patient became unconscious in booth  and hit booth made of thin plastic but remained up write and was in sitting position. Pharmacist immediately responded because heard noise, also just from intuition from patient nervousness. Patient was very warm to the touch, eventually awoke after pharmacist had technician call for EMS immediately, however was very disoriented, began to sweat profusely, not able to communicate (disturbances) and then proceeded to vomit. Pharmacist tried to get patient to lay on back patient was adamant on sitting forward near a trash can. Pharmacist applied cold compresses to neck for patient and forehead.  EMS arrived. Patient agreed to go to emergency room for further evaluation.
Sex: U
Vaccine: PNC20, VARZOS
Symptoms: Vomiting
Clinical narrative: Patient stated she was afraid needles but has had  vaccines in the past. Questionnaire circled no however on past fainting with vaccines. Pharmacist had patient remain in chair and asked to sit before leaving for 15 minutes and when feeling ok. Patient became unconscious in booth  and hit booth made of thin plastic but remained up write and was in sitting position. Pharmacist immediately responded because heard noise, also just from intuition from patient nervousness. Patient was very warm to the touch, eventually awoke after pharmacist had technician call for EMS immediately, however was very disoriented, began to sweat profusely, not able to communicate (disturbances) and then proceeded to vomit. Pharmacist tried to get patient to lay on back patient was adamant on sitting forward near a trash can. Pharmacist applied cold compresses to neck for patient and forehead.  EMS arrived. Patient agreed to go to emergency room for further evaluation.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Magnetic resonance imaging, Meniere's disease, Nystagmus, Vertigo
Clinical narrative: severe vertigo attack 8/2021.  i?ve been suffering with and being treated for episodes of vertigo ever since that are increasing in frequency. now have dx of vestibular weakness on right side.  have dx of Ménière's disease. nystagmus.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vestibular disorder
Clinical narrative: severe vertigo attack 8/2021.  i?ve been suffering with and being treated for episodes of vertigo ever since that are increasing in frequency. now have dx of vestibular weakness on right side.  have dx of Ménière's disease. nystagmus.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring abnormal, Echocardiogram, Palpitations, Supraventricular extrasystoles, Supraventricular tachycardia
Clinical narrative: Ongoing Heart palpitations confirmed by Zio patch (PACs, PVCs, nonsustained ventricular tachycardia, SVT)
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles, Ventricular tachycardia
Clinical narrative: Ongoing Heart palpitations confirmed by Zio patch (PACs, PVCs, nonsustained ventricular tachycardia, SVT)
Age: 28.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Angina pectoris, Dyspnoea, Electrocardiogram abnormal, Feeling hot, Lymphocyte count decreased
Clinical narrative: Myocarditis/Pericarditis: 1. Chest Pain: a very painful feeling of my heart pushing against the chest. 2. Heart Inflamation: feeling of noticeable warmth in my heart area and pain when I touched the chest area above my heart. 3. Needing more breath by resorting to opening windows and turning on the air conditioner. 4. Feeling pain in my heart area if I breathed deeply.
Age: 28.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Lymphocyte percentage decreased, Myocarditis, Pericarditis, Tenderness
Clinical narrative: Myocarditis/Pericarditis: 1. Chest Pain: a very painful feeling of my heart pushing against the chest. 2. Heart Inflamation: feeling of noticeable warmth in my heart area and pain when I touched the chest area above my heart. 3. Needing more breath by resorting to opening windows and turning on the air conditioner. 4. Feeling pain in my heart area if I breathed deeply.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test abnormal, Coagulation time shortened, Headache, Paraesthesia
Clinical narrative: Minutes after being vaccinated I felt tingling in my mouth and legs, headaches that lasted for another four months, back pain at the height of my lungs. A week later I had blood tests and I had several changes, my blood was clotting very fast and it was very difficult to be extracted. I had vasculitis, and to this day I'm treating myself.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Vasculitis
Clinical narrative: Minutes after being vaccinated I felt tingling in my mouth and legs, headaches that lasted for another four months, back pain at the height of my lungs. A week later I had blood tests and I had several changes, my blood was clotting very fast and it was very difficult to be extracted. I had vasculitis, and to this day I'm treating myself.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 4/12/21 lot# EW0162;  Pfizer 5/3/21 lot# EW0172
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Breakthrough case admission after 2 vaccines  Moderna 3/9/21 lot# 010A21A;  Moderna 4/6/21 lot# 025B21A;
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 2/5/21 lot# 007M20A;  Moderna 3/5/21 lot# 023M20A
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Arthroscopic surgery, Injected limb mobility decreased, Injection site inflammation, Joint debridement, Magnetic resonance imaging
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe, somewhat alleviated with PT regimen. Ultimately required intervention of extensive arthroscopic surgery and debridement with manipulation; recovery took 9 weeks, but ultimately improved pain & mobility issues.**of note: A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, but they were minor.  SIRVA is strongly suspected, we are told - and there are others who may have experienced these symptoms, though this case seems extreme - but so far an intelligent explanation has not been made clear. It seems that these vaccine diluents - or something else - is responsible for triggering  inflammatory responses, much like an allergic reaction. This patient does not ever want to go through that experience again, and is only seeking vaccination alternatives.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Mobility decreased, Pain, Pain in extremity, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe, somewhat alleviated with PT regimen. Ultimately required intervention of extensive arthroscopic surgery and debridement with manipulation; recovery took 9 weeks, but ultimately improved pain & mobility issues.**of note: A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, but they were minor.  SIRVA is strongly suspected, we are told - and there are others who may have experienced these symptoms, though this case seems extreme - but so far an intelligent explanation has not been made clear. It seems that these vaccine diluents - or something else - is responsible for triggering  inflammatory responses, much like an allergic reaction. This patient does not ever want to go through that experience again, and is only seeking vaccination alternatives.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Arthroscopic surgery, Asthenia, Debridement, Frustration tolerance decreased, Injected limb mobility decreased
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe, somewhat alleviated with PT regimen. Ultimately required intervention of extensive arthroscopic surgery and debridement with manipulation; recovery took 9 weeks, but ultimately improved pain & mobility issues.**of note: A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, but they were minor.  SIRVA is strongly suspected, we are told - and there are others who may have experienced these symptoms, though this case seems extreme - but so far an intelligent explanation has not been made clear. It seems that these vaccine diluents - or something else - is responsible for triggering  inflammatory responses, much like an allergic reaction. This patient does not ever want to go through that experience again, and is only seeking vaccination alternatives.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Injection site inflammation, Injection site pain, Magnetic resonance imaging, Manipulation, Pain in extremity
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe, somewhat alleviated with PT regimen. Ultimately required intervention of extensive arthroscopic surgery and debridement with manipulation; recovery took 9 weeks, but ultimately improved pain & mobility issues.**of note: A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, but they were minor.  SIRVA is strongly suspected, we are told - and there are others who may have experienced these symptoms, though this case seems extreme - but so far an intelligent explanation has not been made clear. It seems that these vaccine diluents - or something else - is responsible for triggering  inflammatory responses, much like an allergic reaction. This patient does not ever want to go through that experience again, and is only seeking vaccination alternatives.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK, COVID19, COVID19, COVID19, UNK
Symptoms: Shoulder injury related to vaccine administration, X-ray
Clinical narrative: A 17-month ordeal of chronic, constant, excruciating pain in left arm (day & night) due to inflammation at - and radiating from - vaccine injection sites. Also degrees of immobility in arm, especially shoulder, usually severe, somewhat alleviated with PT regimen. Ultimately required intervention of extensive arthroscopic surgery and debridement with manipulation; recovery took 9 weeks, but ultimately improved pain & mobility issues.**of note: A flu vaccine in late October 2021, given intramuscularly in the RIGHT arm, also caused pain & mobility problems, but they were minor.  SIRVA is strongly suspected, we are told - and there are others who may have experienced these symptoms, though this case seems extreme - but so far an intelligent explanation has not been made clear. It seems that these vaccine diluents - or something else - is responsible for triggering  inflammatory responses, much like an allergic reaction. This patient does not ever want to go through that experience again, and is only seeking vaccination alternatives.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Very swollen, red, hot, itchy and extremely painful.   This is more than 48 hours after initial injection.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Dyspnoea, Erythema, Pain
Clinical narrative: Fever, Vomiting, redness on arm (to include swelling, tightness and heat), pain spread from arm into armpit and right torso and back,  SOB.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm, Vomiting
Clinical narrative: Fever, Vomiting, redness on arm (to include swelling, tightness and heat), pain spread from arm into armpit and right torso and back,  SOB.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No side effects reported.; HCP calling to report GARDASIL 9 was administered after it experienced a temperature excursion. No side effects reported. Excursion was supported. No additional information provided.         ?    Names of vaccines involved (including lot/exp): GARD; This spontaneous report was received from Other Health Professional and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #W028573, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).  On 27-JUL-2023, HCP called to report GARDASIL 9 was administered after it experienced a temperature excursion. No side effects reported. Excursion was supported. No additional information provided. Expiration occured for 1 hour 40 minutes in 50 F. Additional AEs filed, refer to cases 02437481, 02437482, 02437484, 02437485, 02437486, 02437488, and 02437489. No PQC.
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: A HBP called to report a TE for GARDASIL 9 that had also been administered post excursion.  The GARDASIL 9 TE and administration occurred today, 07/27/2023, and no adverse issues or side effects are reported.  The HCP declined to provide full demogra; No additional AE information was provided.; This spontaneous report was received from Other Health Professional and refers to a 15-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml via injection in the left deltoid, lot #W015894, expiration date: 20-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).  On 27-JUL-2023, a HBP called to report a TE for GARDASIL 9 that had also been administered post excursion. On the same day, the GARDASIL 9 TE and administration occurred, and no adverse issues or side effects are reported. The HCP declined to provide full demographic information for the patient that received the improperly stored vaccine. The GARDASIL 9 was administered by a new MA and the product is not available for retrieval as it had already been discarded. The TE for the GARDASIL 9 was supported - please reference TE case 02437748 for more details. No additional AE information was provided. No PQC.  Lot Number W015894 is valid for V503 formulation prefilled syringe.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details provided/ The patient did not experience medical adverse events because of temperature excursion; HCP called to report that a dose of PROQUAD was administered to a patient after a TE.; This spontaneous report has been received from a nurse, regarding a 5-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 22-MAY-2023, the vaccine freezer was open to allow for scraping ice from sides. The door was left open too long, a temperature excursion of 12.8 degrees Fahrenheit for 25 minutes occurred and was inaccurately reported to manufacturer. The temperature excursion did not occur as a result of a reading from a Data Logger.   On 20-JUN-2023, the patient was vaccinated with an improperly storage second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliters once administered subcutaneously in the left arm (lot number W024552 was determined to be valid, with an expiration date on 31-JAN-2024) (strength was not reported), in combination with a sterile diluent; with the fourth dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (BOOSTRIX POLIO), administered intramuscularly in the right leg, lot number 5AY2J (dose, strength, formulation, and expiration date were not provided), both vaccines administered as prophylaxis (product storage error). The vaccines were administered by a healthcare professional and according to the instruction leaflet and it was not available for return/evaluation.   On 11-JUL-2023, the vaccine was properly reported to manufacturer and seemed safe for use. The patient did not experience medical adverse events because of temperature excursion. The vaccine was no longer in stock. There was a no previous temperature excursion reported.  This is one of four reports from the same reporter.; Sender's Comments:  US-009507513-2307USA002368: US-009507513-2307USA002433: US-009507513-2307USA002154:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 3 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:master case
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menopause
Clinical narrative: After Covid vaccine(Moderna/ Pfizer) my periods stopped am I am in menopause in late 30's
Sex: U
Vaccine: VARZOS
Symptoms: Liquid product physical issue
Clinical narrative: The Community Based Outpatient Clinic Nurse: Shingrix vaccine, lot#: 2739M, exp. 10/06/24. While reconstituting vaccine I noticed a pin-sized black particle. This is the 2nd time this week (1st occurrence 07/17/2023, same lot#.) I did not administer, and saved the vial. I did call the Mfr. Glasgow Smith-Kline and reported the event to the Vaccine Service Center. Also sent an inquiry to the Pharmacy Director regarding protocol for such an event. Fellow clinical staff were asked to look at the vial, with the reconstituted vaccine, to verify presence of the particle in question. The vial has been saved at the request of the Mfr. This vaccine was NOT administered to a patient, thus no patient information was input.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received covid shot after beyond use date.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date.
Age: 8.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received covid shot after beyond use date
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient states 2 weeks after shot pain in back of arm  to elbow. Patient states not rotator cuff. Patient also states immunizing pharmacist gave immunization correctly and received seveal immunization from that pharmacist. Patient had MRI 7-25-23. Doctor recommended physical therapy and voltaren gel. Patient states she thinks Fluad was too strong for her even though she received Fluad since 2019 and age appropriate.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 1st dose was given on September 2022 / She wants to know if the second dose would be valid and how long after the 1st dose the second dose can be given; there is no adverse event; This spontaneous report was received from a pharmacist regarding an adult patient of unspecified gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On an unspecified day in September 2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (no more vaccination details provided).   It was reported that patient was coming in soon on 06-JUL-2023 to get the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). The reported wanted to know if the second dose would be valid and how long after the first dose the second dose could be given as the first one was given in September 2022 (inappropriate schedule of product administration). The reported stated that there was no adverse event. No additional information given or reported.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No event; temperature excursion - vaccine not viable according to manufacturer; This spontaneous report was received from a physician and refers to a 7-week-old male patient.  The patient's medical history and concurrent conditions were not reported. On 08-JUN-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (basic series); pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (booster series).  On the same day, the patient received the first (also reported as booster series; conflicting information), improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # reported and upon internal validation confirmed as: 1968385, expiration date was reported and confirmed as: 22-MAY-2024, administered orally (exact dose was not provided) for prophylaxis, at private doctor's office/hospital, by the physician. No prescription drug treatment was required. Alarm believed to be due to sensory issues, monitoring temperatures with back up logger. Temperature in range, new data logger currently in use. No adverse effects reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: No additional AE/PQC reported.; two patients received expired MMR II vaccine; two patients received expired MMR II vaccine when they were supposed to receive a dose of PROQUAD; This spontaneous report has been received from an other healthcare professional (nurse) referring to patient with unknown gender and age. The patient's concomitant therapies, medical histories and drug allergies were not reported.   On 20-JUL-2023, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (albumin status recombinant human albumin (rHA)) (M-M-R II) subcutaneous injection, 1 dose, lot # U022316, expiration date: 15-JUL -2023, as prophylaxis (strength and route of administration was not specified), when the patient was supposed to receive a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(fomulation, strength, dose, frequency, lot #, expiry date, indication and route of administration were not provided, the product was not administered) (Expired product administered) (Wrong product administered). No further information available during interaction. No additional adverse events (AEs) were reported (no adverse event), and no product quality complaints (PQCs) were reported.    This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA011317:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; HCP called to report a patient today on (7/25/2023) received expired MMR II Vaccine. HCP provided lot#U022174 and exp 7/14/2023 date. HCP did confirm there was no T/E for this product.  Permission was granted to contact HCP. No additional AE reported; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.   On 25-JUL-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection (lot #U022174, expiration date: 14-JUL-2023; strength was not provided) administered subcutaneously as prophylaxis (expired product administered). It was confirmed there was no temperature excursions (T/E) for the vaccine. There was no additional adverse event (AE) reported.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: repeat titer in July and was still not immune to rubeola; received  MMR II on 3/31/2023 and 5/1/2023. Caller stated repeat titer in July and was still not immune to rubeola; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient was not immune to rubeola based on a titer. The patient's concurrent conditions and concomitant medications were not provided.   Since the patient did not had documentation of the original vaccination series, she received 2 doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus vaccine, Live (M-M-R II) on 31-MAR-2023 (Product administered to patient of inappropriate age) and 01-MAY-2023 (doses, frequency, routes and anatomical locations of administration, lot numbers and expiration dates were not provided) administered as prophylaxis.  The patient then had a repeat titer in July of 2023 and was still not immune to rubeola (Vaccination failure, Measles antibody negative). The patient sought medical attention while working with school wellness center. The outcome of vaccination failure and Measles antibody negative was not provided.  The causal relationship of the vaccine was assessed as related to vaccination failure. Causal relationship between the vaccine and Measles antibody negative was not provided.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported.; VAQTA was administered after it experienced a temperature excursion.; This spontaneous report was received from a other health professional and referred to an 1-year-old male patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 27-JUL-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #1971534, expiration date: 06-OCT-2024, administered for prophylaxis (strength, anatomical location and route of administration were not provided) after it experienced a temperature excursion (temperature: 50 fahrenheit (F); time frame: 1 hour, 40 minutes, 0 seconds) (Product storage error). No side effects reported (No adverse event). There was no previous temperature excursion. Excursion was supported. No additional information provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported.; Inbound call from nurse calling to report temperature excursion.; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 31-JUL-2023, the patient was vaccinated with with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-RVAXPRO) subcutaneous injection, 0.5 milliliter (ml) (valid lot number W022640 [expiration date 15-APR-2024]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion of 49.26 degrees Fahrenheit with a time frame of3 hours 45 minutes 0 seconds (product storage error). No previous temperature excursion and it was call because of a data logger.  No symptomatic adverse events were reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Cervix carcinoma, Non-consummation
Clinical narrative: FBE called to report an AE on behalf of an HCP regarding either GARDASIL or GARDASIL 9 (was not sure which one was specifically involved in the report) AE was reported to FBE today, August 1, 2023.  HCP reported to FBE that she had a 20-21 year old f; This spontaneous report was received from a physician via a field based employee (FBE) and refers to a currently 20-21 years old female patient.  The patient's pertinent medical history, drug reactions or allergies and concomitant medication were unknown.  On an unknown date (reported as several years ago), the patient was vaccinated with either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (It was not sure which one was specifically involved in the report).  On 01-AUG-2023, the health care practitioner (HCP) reported the patient developed cervical cancer (Cervix carcinoma) after receiving either with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) several years ago (It was reported exact timing of administration of the vaccine was unknown as well as when the diagnosis of cervical cancer was discovered). The HCP reported that patient maintained she was not sexually active. There was no additional adverse event (AE) or product quality complaint (PQC). It was unknown the patient whether was provided with treatment for the event. At the time of reporting, the outcome of the event was unknown.   The causal relationship between cervical cancer (Cervix carcinoma) and the suspect vaccine was unknown.   Upon internal review, the event cervical cancer (Cervix carcinoma) was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE; HCP calling to reported administering adult dosage of VAQTA to a 16-year-old patient. Permission to contact HCP was granted. No additional information. No AE/PQC reported.; This spontaneous report was received from a nurse and refers to a 16-years-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-AUG-2023, the patient was vaccinated with adult dosage of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #W028824, expiration date: 07-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the vaccine shot years ago and ended up with the shingles/ Suspected vaccination failure; Shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the vaccine shot years ago and ended up with the shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 31-JUL-2023 This case was reported by patient via interactive digital media. The reporter reported that he or she got the vaccine shot years ago from reporting and ended up with the shingles and it was so painful. The reporter reported that it was so painful that he or she would never get another vaccine shot ever again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details confirming shingles were unknown at a time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots an still got shingles /suspected vaccination failure; got the shots an still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shots an still got shingles /suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shots an still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date:01-AUG-2023 This case was reported by a patient via interactive digital media. The reporter reported that his/her daughter got the shots and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow-up could not be possible as no contact details were available.