chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Troponin normal, Urine analysis normal, Vitamin B12 normal
Clinical narrative: 8/31/2023 developed right sided lower extremity weakness, numbness to bilateral lower extremities, muscle contractions, and inability to walk dragging right leg and left leg feeling heavy- admitted to hospital for evaluation and treatment . Took Medrol dose pack, Ibuprofen and started Baclofen 10 mg for muscle spasms.  9/7/2023- fasciculation's and tremors began in bilateral lower and upper extremities with intentional movement, difficulty with gait, right leg locking out. .  9/8/2023- follow up with neurology for symptoms, Dr- more extensive lab testing ordered at this time 9/10/2023- numbness and tingling in ascending fashion, extended to right side up body up to the scapular on the back- went back to ER for evaluation and neurological consultation started with tremors. Home on motrin and baclofen and no explanation still.  09/13/2023 1700- lost ability to speak clearly- difficulty getting words out although thoughts were clear, EMS called to my house transported to ED and stroke code activated for speech and gait changes Scans negative but extensive nerve pain and burning in bilateral feet began making it hard to ambulate with shocking and shooting fashion. Only lab abnormality low potassium- supplemented  09/17/2023- speech normalized bilateral lower extremity weakness and activity intolerance persisted.  09/18/2023- EMG completed showed no sign of large skeletal muscle disease but did not exclude a small fiber neuropathy. physical therapy consultation for neurological rehabilitation 09/25/2023- symptoms improving aside from shocks remaining in left foot and occasional twitching of muscles in back arms and legs.
Age: 71.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Rash, Urticaria
Clinical narrative: Broke out in hives/rash covering head to waist including inner elbows. symptoms continued for approx. 10 days before fading. Took Sudafed and Benydrahl for symptoms.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Impaired work ability, Musculoskeletal stiffness, Pain
Clinical narrative: Influenza (FLU) Vaccine Adverse Reaction Template: Employee calling to report a reaction after receiving a Influenza vaccine.   Vaccine Name - Unknown Vaccine Date - ?9.20.2023  Date of Symptom Onset - Saturday (?9.23.2023) Symptoms - ?Pain to Right arm with pulsating sensation, warmth, redness, swelling and bruising (R forearm); Pain when lifting R arm (Can raise however painful); Tenderness to R arm with bent elbows; R-side Neck stiffening. Last day of work and shift - ?9.25.2023; EE is currently at work. This nurse advised to leave work due to report of moderate pain.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Skin warm, Swelling, Tenderness
Clinical narrative: Influenza (FLU) Vaccine Adverse Reaction Template: Employee calling to report a reaction after receiving a Influenza vaccine.   Vaccine Name - Unknown Vaccine Date - ?9.20.2023  Date of Symptom Onset - Saturday (?9.23.2023) Symptoms - ?Pain to Right arm with pulsating sensation, warmth, redness, swelling and bruising (R forearm); Pain when lifting R arm (Can raise however painful); Tenderness to R arm with bent elbows; R-side Neck stiffening. Last day of work and shift - ?9.25.2023; EE is currently at work. This nurse advised to leave work due to report of moderate pain.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 3rd dose in a 2-dose series of Zoster (Shingrix) vaccine because patient's chart was not up to date. No adverse effects were reported by patient.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Chest discomfort, Pericarditis
Clinical narrative: THREE DAYS AFTER RECEIVING VACCINE PATIENT DEVELOPED CHEST TIGHTNESS AND WENT TO THE ER.  THEY DID A WORK UP AND DIAGNOSISED IT AS PERICARDITIS
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Pt came to the clinic and received MMR vaccine on 6/9/23.  She was then seen for a new OB pt on 7/11/23. Pt became pregnant within 1 month of receiving MMR.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Diarrhoea, Gastrointestinal disorder, Muscle spasms
Clinical narrative: severe cramping, diarrhea, weakness, stomach issues
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient is not experiencing any side effects.  She was given the high dose when she is 63 and should have received the regular dose.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 1.67
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was inadvertently given a meningococcal vaccine instead of MMR.  Provider f/u with family the next day no adverse reactions. Pt was doing well.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Angiogram pulmonary abnormal, Deep vein thrombosis, Dyspnoea, Fibrin D dimer increased, Pleuritic pain
Clinical narrative: Patient developed pleuritic chest pain and difficulty breathing a few days after the vaccine and was ultimately diagnosed with DVT and PE
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Pulmonary embolism
Clinical narrative: Patient developed pleuritic chest pain and difficulty breathing a few days after the vaccine and was ultimately diagnosed with DVT and PE
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Arthralgia, Chills, Listless, Musculoskeletal stiffness, Tremor
Clinical narrative: Severe chills and shaking for 1 hour the night of 9/24/23.   Day of 9/25/23  extreme stiffness and joints were achy.  Chills returned in the late morning.  Listlessness.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Chills, Listless, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: Severe chills and shaking for 1 hour the night of 9/24/23.   Day of 9/25/23  extreme stiffness and joints were achy.  Chills returned in the late morning.  Listlessness.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: SARS-CoV-2 test, Tremor, Vomiting
Clinical narrative: Severe chills and shaking for 1 hour the night of 9/24/23.   Day of 9/25/23  extreme stiffness and joints were achy.  Chills returned in the late morning.  Listlessness.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Severe diarrhea, fever, tiredness (still after a week) some nausea  during the weekend, I pooped out skin like chunks and water
Age: 1.58
Sex: F
Vaccine: FLU4, HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was due for booster shot of Hepatitis A vaccine and signed the consent form. Patient was offered influenza vaccine but declined and signed a declination form.  Vaccine was administered and they called afterwards to explain that had given the flu vaccine and not the hepatitis vaccine.
Age: 38.0
Sex: F
Vaccine: PNC20
Symptoms: Axillary pain, Chest discomfort, Chills, Dyspnoea, Dyspnoea exertional
Clinical narrative: Shot received Friday 9/22 pain at injection site, pain in left axilla,  swollen lymph nodes in left axilla area,  chills Friday and Saturday vomiting and shortness of breath Saturday night into Sunday (worse with stairs/exertion).  Reports having some chest tightness.  Treatment - Prednisone 10mg 4 tablets daily x 3 days, 3 tablets daily x 3 days, 2 tablets daily x 3 days, 1 tablet daily x 3 days
Age: 38.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Lymphadenopathy, Vomiting
Clinical narrative: Shot received Friday 9/22 pain at injection site, pain in left axilla,  swollen lymph nodes in left axilla area,  chills Friday and Saturday vomiting and shortness of breath Saturday night into Sunday (worse with stairs/exertion).  Reports having some chest tightness.  Treatment - Prednisone 10mg 4 tablets daily x 3 days, 3 tablets daily x 3 days, 2 tablets daily x 3 days, 1 tablet daily x 3 days
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pruritus
Clinical narrative: Redness and itchness starting 2 days after vaccine, on the 3rd day redness spread down her arm to her wrist and patient went to urgent care.  They said it was cellulitis and gave keflex and triamcinolone cream.  Resolved it in 2 days.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Fatigue, Measles, Pyrexia, Rash morbilliform
Clinical narrative: Onset of fatigue and fever 9.20.23, decreased appetite and  vomiting, development of koplik's spots on buccal mucosa 9.23.23, eruption of measles-like rash on 9.25.23
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Onset of fatigue and fever 9.20.23, decreased appetite and  vomiting, development of koplik's spots on buccal mucosa 9.23.23, eruption of measles-like rash on 9.25.23
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report vaccine was administered after experiencing a temperature excursion. Product was supported. Case filed. Permission to contact HCP was granted. No additional information. No AE/PQC reported.; No addtional AE reported; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.     On 05-SEP-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # X010525, expiration date: 11-APR-2025) (dose, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion (product storage error). Product was supported, no additional adverse event (AE) reported.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired regular dose flu vaccine administered to Employee.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: 12y female who became dizzy after receiving 3 vaccines: HPV, MCV4,Tdap  DR at bedside with pt now laying supine with feet elevated . alert oriented, pale  bp supine 94/60, hr 76.  mom reports she just ate lunch prior to appointment  no prior reaction to injections in the past  HR normal. lungs CTA per auscultation by DR   bp re checked with pt supine 1337 99/64, hr 86, color improved reports no dizziness  so pt moved to sitting upright position with stable vs  transitioned to standing with stable vs and no return of dizziness  pt dc home with mom 1443  instructed to inform staff at next HPV injection of near syncope /dizzy episode and to remain laying down longer
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No known adverse effects at this time.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Fatigue, Measles, Pyrexia, Rash morbilliform
Clinical narrative: Onset of fatigue and fever 9.21.23, decreased appetite and  vomiting, development of koplik's spots on buccal mucosa 9.23.23, eruption of measles-like rash on 9.25.23
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Onset of fatigue and fever 9.21.23, decreased appetite and  vomiting, development of koplik's spots on buccal mucosa 9.23.23, eruption of measles-like rash on 9.25.23
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Employee received expired flu vaccine
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Fatigue, Pain, Rash, Swelling face
Clinical narrative: PATIENT STARTED FEELING TIRED AND ACHY ON THE DAY FOLLOWING THE VACCINATION (9/23). THIS RESOLVED THE NEXT DAY (9/24) BUT HER CHEEKS BECAME RED AND SWOLLEN. THIS HAS NOT RESOLVED AS OF 15:20 ON 9/25 AND ADDITIONALLY, SHE HAS BROKEN OUT IN A RASH.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea, excessive vomitting, diarrhea
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Arthralgia, Hypoaesthesia, Joint swelling, Pain, Peripheral swelling
Clinical narrative: Patient received vaccines on 9/19/23. On 9/24/23, patient noticed their right arm, wrist, and hand was swollen and was experiencing right shoulder pain with movement. Patient also reports numbness and lost feeling in the right hand which occasionally switches to the left hand. Patient has not tried any treatments for pain at time of report. Recommended patient take Tylenol as needed and ice and elevate arm.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Itchy, swollow, erythemous, warm injection site the day after vaccination. Unaware of any treatment. Symptoms subsided approximately 1-2 days after injection.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Accidental exposure to product, Injury associated with device
Clinical narrative: Pharmacy technician was vaccinating patient and when disposing of needle sharp it bounced off the sharps container and she tried to push down the needle into the sharps container and pricked herself.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: N/a
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reported VARIVAX was administered after a temperature excursion to patient. Date of administration is Sep 1, 2023. No further information provided. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): VARIV; No additional AE reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.     On 01-SEP-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # X006981, expiration date: 07-MAR-2025), given once (dose, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion at 6 Fahrenheit (F) during 20 minutes (product storage error). No additional adverse event (AE) reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Laboratory test
Clinical narrative: SPIKEVAX WAS GIVEN, PATIENT HAD TROUBLE WITH BREATHING, COULD NOT CATCH HIS BREATH, WENT TO ER THEY EVALUATED HIM AND HE WAS THEN DISCHARGED ONCE NORMAL BREATHING RESUMED IN SEVERAL HOURS
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: N/a
Age: 64.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Urticaria
Clinical narrative: 3 days after the shot I broke out in hives on my torso only.  I tried to use benedryl and calamine lotion to ease the symptoms to no avail.  The hives lasted almost 4 months.  I did not have insurance at the time and did not go to a medical professional or hospital. I have had hives before as I am allergic to other medicines and know the symptom and how to resolve.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Patient came in 2 weeks after vaccination in upper  left arm complaining itchy red rash on upper arm from shoulder down to upper forearm
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Palpitations
Clinical narrative: Pharmacy has my records for all vaccines.  I experienced hard heartbeats on and off for about a month after taking the dual COVID booster.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Peripheral swelling, Skin swelling
Clinical narrative: patient states her arm that got the flu shot starting puffing up and was super red at the site. she said it was as big as a golf ball. no other symptoms and it wasn't hurting.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphonia, Ear pruritus, Sneezing, Swelling face, Throat irritation
Clinical narrative: Within 10 minutes of receiving vaccine pt started with itchy tongue, itchy throat, ear itching, sneezing in office and was given Benadryl, 1-2 hours later after arriving home pt started with face swelling, throat closing, voice change. Pt was taken to ER- where he was given Epinephrine, Benadryl, Pepcid, steroids and IV fluids.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Throat tightness, Tongue pruritus
Clinical narrative: Within 10 minutes of receiving vaccine pt started with itchy tongue, itchy throat, ear itching, sneezing in office and was given Benadryl, 1-2 hours later after arriving home pt started with face swelling, throat closing, voice change. Pt was taken to ER- where he was given Epinephrine, Benadryl, Pepcid, steroids and IV fluids.
Age: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Dyspnoea, Muscle tightness, Productive cough
Clinical narrative: Two hours after the injection, pt reported SOB, coughing (productive), and tightness around his neck.   Pt's wife called RN around 1615 to report symptoms and RN instructed them to seek emergency care.   Pt's wife called ambulance and patient was treated at local hospital.
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP reported VARIVAX was administered after a temperature excursion to patient. Date of administration is Sep 1, 2023. No further information provided. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): VARIV; No addtional AE; This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.     On 01-SEP-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # X006981, expiration date: 07-MAR-2025), given once (dose, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion at 6 Fahrenheit (F) during 20 minutes (product storage error). No additional adverse event (AE) reported.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Lethargy, Oxygen saturation decreased, Presyncope
Clinical narrative: After about 4 hrs patient became lethargic and nearly passed out as oxygen dropped to under 60%.  Rose after trip to hospital with an overnite stay.  Its been three weeks and it takes him longer to catch his breath and return to 94%+ oxygen saturation.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Feeling hot, Pallor
Clinical narrative: Within 2 or 3 minutes after the injection she became very pale and clammy and said she didn't feel well at all.  Shaky, weak, a little dizzy. She said the back of her neck became suddenly very hot as well. Lasted for 15-20 min after injection.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Within 2 or 3 minutes after the injection she became very pale and clammy and said she didn't feel well at all.  Shaky, weak, a little dizzy. She said the back of her neck became suddenly very hot as well. Lasted for 15-20 min after injection.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Endocrine ophthalmopathy, Graves' disease, Orbital decompression, Thyroid hormones test
Clinical narrative: Graves Disease and TED
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received high-dose vaccine under age 65
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Pentacel was not mixed with manufacture diluent. It was mixed with saline.  NO adverse reaction
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Patient said they developed cellulitis after that shot.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Defaecation urgency, Dizziness, Dysphonia
Clinical narrative: Around 4 hours after vaccination on 9/23/23,  the patient began experiencing extreme fatigue and aching in all joints and developed a severe headache.  She went to bed early but was unable to sleep that night.  The next morning, she felt dizzy and nauseous.  She felt an urgency to go to the bathroom but no diarrhea.  She also had chills and fever Saturday night 9/23/23 through Sunday and Monday.  The chills were not as severe on Monday.  She experienced vomiting periodically Sunday 9/24/23 , beginning  late morning  and continuing through Sunday evening.  She feels like her voice is altered currently but does not have a sore throat.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Sleep disorder
Clinical narrative: Around 4 hours after vaccination on 9/23/23,  the patient began experiencing extreme fatigue and aching in all joints and developed a severe headache.  She went to bed early but was unable to sleep that night.  The next morning, she felt dizzy and nauseous.  She felt an urgency to go to the bathroom but no diarrhea.  She also had chills and fever Saturday night 9/23/23 through Sunday and Monday.  The chills were not as severe on Monday.  She experienced vomiting periodically Sunday 9/24/23 , beginning  late morning  and continuing through Sunday evening.  She feels like her voice is altered currently but does not have a sore throat.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Around 4 hours after vaccination on 9/23/23,  the patient began experiencing extreme fatigue and aching in all joints and developed a severe headache.  She went to bed early but was unable to sleep that night.  The next morning, she felt dizzy and nauseous.  She felt an urgency to go to the bathroom but no diarrhea.  She also had chills and fever Saturday night 9/23/23 through Sunday and Monday.  The chills were not as severe on Monday.  She experienced vomiting periodically Sunday 9/24/23 , beginning  late morning  and continuing through Sunday evening.  She feels like her voice is altered currently but does not have a sore throat.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Head ache, muscle and joint pain, fatigue, stomach upset.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cyst, Laboratory test abnormal, Lesion excision, Nodule, Pathology test
Clinical narrative: Pt developed a cystic lesion of the left thigh that was surgically excised. Specimen was sent to dermatopathology.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Plasma cell disorder, Skin lesion, Tissue infiltration
Clinical narrative: Pt developed a cystic lesion of the left thigh that was surgically excised. Specimen was sent to dermatopathology.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Chest pain, Limb discomfort
Clinical narrative: First day not hardly anything on Friday, then Saturday came and I was pretty good in the morning the come the evening I started having some chest pain so I took some slow deep breaths and laid down holding my chest and did some tossing and turning all night. THen Sunday I started having more pain and heaviness on the left of my chest like tightness. When I moved around id was ok but when I laid sown it felt worse. That's why I am calling today but feels like it is subsiding today I managed to get out and move around, eat, drink and take my pills.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: I received the above RSV vaccine 09/24 and had no immediate issues. I awoke this morning with low grade fever and myalgias. Temp of 1 degree above normal . No specific symptoms other than myalgias. no cough , sore throat bad headache. If I stilll have fever in am I will check a COVID swab. I have had COVID x 2 . I am better as the day has progresses. No Rash , no bleeding , only mild soreness at the injection site. I have not had major reaction to prior vaccine other than Low grade fever after my second COVID booster. I intend to get the Influenza vaccine in October as well as the COVID booster.
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Patient states she has rash on face, neck, and hands. She states that she has welps on her neck also.
Age: 65.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Diarrhoea, Erythema, Malaise, Peripheral swelling
Clinical narrative: Patient's daughter states the patient has a red arm, swollen, and experienced diarrhea and not feeling will starting approximately on Friday
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Adverse reaction, Dyspnoea
Clinical narrative: PATIENT CAME IN FOR FLUCELVAX AND HEPLISAV-B.  AFTER SITTING DOWN AFTER ADMINISTRATION, HE RETURNED TO THE PHARMACY IN A FEW MINUTES AND SAID HE HAD A HARD TIME BREATHING.  WE SAT AND WAITED FOR A FEW MINUTES, AND IT ONLY WORSENED.  WE TOOK HIM BACK INTO OUR IMMUNIZATION ROOM AND THEN WAITED A FEW MORE MINUTES WHERE HE SAID HE CANNOT BREATHE.  AT THAT POINT I ADMINISTERED EPIPEN AND AFTER 5-10 MINUTES HE START TO FEEL RELIEF.  HE THEN WENT TO THE ER WHERE THEY CONTINUED TO ADMINISTER IV MEDS FOR HIS ALLERGIC REACTION AND MONITORING BEFORE HE WAS RELEASED, AND HE SAID HE FELT MUCH BETTER AFTER THE IV MEDS.  HE HAS BEEN FINE SINCE.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: On September 21, 2023, the patient received a dose of bivalent Pfizer vaccine. This vaccine was deauthorized on September 11, 2023, FDA authorized updated mRNA COVID-19 vaccines formulated to protect against COVID -19 due to currently circulating variants
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 88.0
Sex: M
Vaccine: FLU4, RSV, TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient had vaccine on 9/11/23 and woke up to a rash all over body, including face. Patient describes rash as small, flat, red and itchy spots. Patient was seen at a walk-in clinic and treated with hydroxyzine and cetirizine on 9/22/23. Still has not resolved as of  9/25/23. Going to see provider/physician on 9/26/23.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Not Applicable
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; Vaccine administered experienced a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about patient's medical history, concurrent conditions and concomitant medications was provided.   On 20-JUN-2023, the patient was vaccinated with improperly dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #W026137, expiration date 05-FEB-2024, exact dose and route of administration were not provided) for prophylaxis (Product storage error).  On unknown day, the suspect vaccine experienced a temperature excursion of 8.74 degrees Celsius (C) for 35 minutes. There was no previous temperature excursion. No side effects reported (No adverse event). No other medical information known. No product quality complaint (PQC).  This is one of several reports received from the same reporter.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: A customer called to report an AE that was reported to her by a nurse yesterday, 20SEP2023. The nurse reported that a boy received his second shot of GARDASIL 9. The nurse was not aware that he had to be monitored for 15 minutes after his second dose and; This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided.      On an unknown date the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided).         On an unknown date the patient received his second shot of GARDASIL 9. The nurse was not aware that he had to be monitored for 15 minutes after his second dose and the mother was in a hurry, so they let the boy go prior to the 15-minute hold time and the boy passed out (loss of consciousness). The outcome of loss of consciousness was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.   The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event was not provided.  Upon internal review event loss of consciousness was considered medically significant based on ASTL list.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; patient who was administered improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medications was not provided.  On 19-SEP-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #W031813, expiration date 05-OCT-2024, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On unknown days, the suspect vaccine experienced a temperature excursion of -14 degrees Celsius (C) up to -10 C for 4 hours and 15 minutes and -8.33 C/-10 C up to 8 C for 7 hours 45 minutes. No symptoms reported. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: HCP reported pregnant patient received VARIVAX and experienced a rash. Patient received vaccination on 09/19/2023 and noticed rash that appeared the evening of vaccination. No additional details provided. Reported patient also received MENQUADFI vacc; HCP reported pregnant patient received VARIVAX; This spontaneous report was received from Other Health Professional and refers to a 31-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI).   On 19-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X007373, expiration date: 12-MAR-2025 (strength, route of administration, and indication were not provided).  On 19-SEP-2023, HCP reported pregnant patient received VARIVAX and experienced a rash. Patient noticed rash that appeared the evening of vaccination. No additional details provided. Reported patient also received MENQUADFI vaccination on the same day in the same arm. See case 02477021. VZVIP information packet was emailed to HCP. No additional AE/no PQC. At the time of reporting, the patient had not recovered from the event rash. The action taken with VARIVAX regarding rash was reported as Not Applicable.   The causal relationship between rash and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My husband had the shingles shots and He got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: My husband had the shingles shots and He got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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: 18-SEP-2023 This case was reported by a patient's wife via interactive digital media. The reporter reported that her husband received Shingles vaccine and experienced shingles, what a waste. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: The 2nd Shingrix shot gave me Guillan-Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: The 2nd Shingrix shot gave me Guillan-Barre Syndrome) (serious criteria GSK medically significant).The outcome of the guillain barre syndrome was not reported.   The reporter considered the guillain barre syndrome to be related to Shingrix.   The company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt date: 18-SEP-2023 This case was reported by a patient via interactive digital media. The Shingrix shot gave him/her Guillan barre syndrome. No he/she could not take any kind of vaccines, not even the flu nor pneumonia vaccine. The reporter stated that think hard about what was the best for you before you commit.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles / Suspected vaccination failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 17-SEP-2023, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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 and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient had two shingles shots several years ago from reporting and today (on reporting day) the patient finds out he/she had shingles. This case was considered as suspected vaccination failure since the detail regarding the laboratory confirmation of shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Was vaccinated in 22 got shingles in 23 / Suspected vaccination failure; Was vaccinated in 22 got shingles in 23; 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, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Was vaccinated in 22 got shingles in 23 / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Was vaccinated in 22 got shingles in 23).  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: 18-SEP-2023 The case was received from the patient via interactive digital media. The patient was vaccinated in 2022 and got shingles in 2023. The patient stated that learned only after vaccination that there was still risk of getting it. The patient stated that you need to be more informative about the effectiveness of your vaccine. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: rash quickly; I'm 2 weeks in . Got vaccinated 6 months ago but still happened/ suspected vaccination failure; still happened; 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.   In MAR-2023, the patient received Shingles vaccine. In SEP-2023, between 5 and 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I'm 2 weeks in . Got vaccinated 6 months ago but still happened/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still happened). On an unknown date, the patient experienced rash (Verbatim: rash quickly).  The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the rash was resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 The case was received from the patient via interactive digital media. The patient got vaccinated 6 months ago from reporting but still (shingles) happened and the patient was 2 weeks in. The doctor stated it was uncommon. However, it did reduce the severity and duration the patient was told. The patient tend to believed that as his/her more tolerable compare to other and Valtrex stopped rash quickly. This case was considered as suspected vaccination failure since the details regarding the completion of vaccination schedule and laboratory confirmation of shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: I did get the shot afterward. But I have had shingles twice since then/ Suspected vaccination failure; Shingles is awful; nerve pain; 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.   The patient's past medical history included shingles (the patient had shingles 6 years ago, it was awful).   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: I did get the shot afterward. But I have had shingles twice since then/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles is awful) and post herpetic neuralgia (Verbatim: nerve pain).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: Gsk receipt date 18 Sep 2023 This case was reported by a consumer via interactive digital media. The patient stated that shingles was awful, the patient had them and still had nerve pain on the day of reporting. It had been 6 years the patient had shingles and he/she did get shot afterward. The patient had shingles twice since then, but it was not bad as 1st time. The patient advised to get shot if you had chickenpox.   This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles a couple months later; 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, several months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles a couple months later). 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: 18-SEP-2023 The case was received from the consumer interactive digital media. The reporter stated that two people (patient) in the neighborhood got the shingles vaccine and they were also the only two people in the neighborhood who got shingles a couple months later. The reporter stated that people were starting to wake up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR128156, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shingles vaccine series (last year) and I currently have the shingles/suspected vaccination failure; and I currently have the shingles; 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, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shingles vaccine series (last year) and I currently have the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: and I currently have the shingles ).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   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: 18-SEP-2023 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine last year and currently have shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   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: 18-SEP-2023 This case was reported the patient via interactive digital media. The patient had the shot and currently had the 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. Follow-up not possible as no contact details provided.