chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, RVX, VARZOS
Symptoms: Neuralgia, Pain in extremity, Rash
Clinical narrative: rash; nerve pain; right arm hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis and Influenza vaccine for prophylaxis.   On an unknown date, the patient received Shingles vaccine, RSV vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and RSV vaccine, the patient experienced rash (Verbatim: rash), nerve pain (Verbatim: nerve pain) and pain in arm (Verbatim: right arm hurt). The outcome of the rash and pain in arm were not reported and the outcome of the nerve pain was unknown.   It was unknown if the reporter considered the rash, nerve pain and pain in arm to be related to Shingles vaccine and RSV vaccine.     It was unknown if the company considered the rash, nerve pain and pain in arm to be related to Shingles vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2024 This case was reported by a patient via interactive digital media. The patient went to doctor in time and started medicines right away.  The patients rash was not bad, but after 3 weeks the nerve pain started and it was awful, because it can last up to 2 to 3 years. The patient got a Flu shot and RSV shot and the day he/she planned on getting the Shingles shot ended up at doctor'soffice because his/her right arm hurt so bad and patient noticed a rash. It was unknown if the reporter considered the rash, nerve pain and pain in arm to be related to Influenza vaccine.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: liquid component of PENTACEL was given to a patient and the HIB component was not given with no reported adverse event; Initial information received on 15-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who experienced liquid component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was given to a patient and the hib component was not given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) for Prophylactic vaccination.  On 06-Mar-2024, the patient received a dose 4  of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine  (Suspension for injection) lot UJ981AA,Expiry date : 11-Feb-2025, strength was unknown via intramuscular route in the left thigh for Prophylactic vaccination (Immunization) and liquid component of pentacel was given to a patient and the hib component was not given with no reported adverse event (single component of a two-component product administered) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Allergy to vaccine, Hypersensitivity, Injection site irritation, Injection site swelling, Reaction to preservatives
Clinical narrative: Pt came into office on 3/13/24 for routine follow up appointment, received prevnar vaccine in left deltoid - pt reported that she began having swelling and irritation at injection site on Sunday 3/17/24 and went to urgent care on 3/17/24 where she was evaluated and recommended to take benadryl and apply cortisone cream and ice to injection site. Patient called internal med on 3/19/24 stating she did not see any improvement and would like an appointment to be evaluated. Patient came in for office visit on 3/20/24 and was prescribed doxycycline and cetirizine. Per PCPs office visit note it was determined pt was having an allergic reaction to preservative in Prevnar Vaccine and the prevnar vaccine was updated/added to pts allergy list on 3/20/24.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Asthenia, Diarrhoea, Eye swelling, Fatigue
Clinical narrative: Anaphylaxis but NOT anaphylactic shock.  Swollen lip, face, eyes and hives from lower legs to scalp, tight throat, and diarrhea  begins on day 3 after shot (03/18/2024).  General overall tiredness and lack of energy. This continues on day 4 after shot (03/19/2024). Most symptoms subside, but eyes are still swollen on day 5 (03/21/2024). I visited my doctor on 03/19/2024 with these concerns and pictures. Blood pressure and pulse was normal and he could detect no fluid around my lungs. Prescribed a stronger antihistamine (hydroxyizine), which I have been taking since then with much relief.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling, Swelling face, Throat tightness, Urticaria
Clinical narrative: Anaphylaxis but NOT anaphylactic shock.  Swollen lip, face, eyes and hives from lower legs to scalp, tight throat, and diarrhea  begins on day 3 after shot (03/18/2024).  General overall tiredness and lack of energy. This continues on day 4 after shot (03/19/2024). Most symptoms subside, but eyes are still swollen on day 5 (03/21/2024). I visited my doctor on 03/19/2024 with these concerns and pictures. Blood pressure and pulse was normal and he could detect no fluid around my lungs. Prescribed a stronger antihistamine (hydroxyizine), which I have been taking since then with much relief.
Sex: M
Vaccine: TDAP
Symptoms: Blindness unilateral, General symptom, Immune system disorder
Clinical narrative: pt reports he recently had a flareup of his symptoms in which he lost sight in his left eye around 2 weeks ago. he said he went to the hospital on 3/6/23, where they gave him solumedrol injections, and he left the hospital on 3/13/23. pt states that he's been taking gilenya/fingolimid for years with no issues and believes the medication works well for him. he said that he actually got the tdap vaccine, and the day after is when he started to have symptoms, which he thinks affected his immune system to cause the flareup. he said his md is aware of the flareup event. he provided no other information.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Dysgeusia, Pruritus
Clinical narrative: Itching and metalic test in mouth
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Incomplete course of vaccination, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient did not complete DTAP series. He is 8 years old. When he came in, Infanrix (DTaP) was administered. Patient did not experience any symptoms that we are aware of.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Bell's palsy, Computerised tomogram head normal, Facial pain, Facial paralysis
Clinical narrative: right sided Bell's Palsy.  Patient has had mild improvement in facial paralysis, but now ha permanent dense right sided facial paralysis, pain, twicthing.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: right sided Bell's Palsy.  Patient has had mild improvement in facial paralysis, but now ha permanent dense right sided facial paralysis, pain, twicthing.
Age: 14.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: CHILD WAS GIVEN HEP A VACCINE A MONTH BEFORE DUE TIME.  GIVEN 5 MONTHS INSTEAD OF 6 MONTHS.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired driving ability, Muscular weakness, Pain in extremity
Clinical narrative: Patient was seen in office for 3 month follow up today (3/21/24) and just now reporting this. Per MD note, "patient states within a week of shingles vaccine he developed leg pain from toes to his back.  Unable to drive clutch truck and now slowly improving.  He had weakness and pain in legs R>L".  Called and spoke with patient to determine a date for onset and he said it was 12/21/23 or 12/23/23. Again, patient reports that this is slowly improving at this time. Patient did not call in prior to 3 month follow-up today but did report at appointment to MD.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Vaccination error
Clinical narrative: Was given by mistake no adverse reaction noted by patients parents
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Lip swelling, Rash
Clinical narrative: SWOLLEN LIPS AND RASH ALL OVER THE BODY. BOTH SYMPTOMS LASTED 24 HOURS. PATIENT TOOK BENADYL 25MG AND ZYRTEC.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given too early, prior to 16 years of age. No known symptoms post injection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Antibody test abnormal, Arthropod-borne disease, Echocardiogram, Electrocardiogram
Clinical narrative: MALAISE, EFFORT INTOLERANCE, POST EXERTIONAL FATIGUE, ANEMIA, REACTIVATION OF POST TICK BORNE ILLNESS WITH ELEVATED ANTIBODY TITERS.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Laboratory test, Malaise, Pulmonary hypertension
Clinical narrative: MALAISE, EFFORT INTOLERANCE, POST EXERTIONAL FATIGUE, ANEMIA, REACTIVATION OF POST TICK BORNE ILLNESS WITH ELEVATED ANTIBODY TITERS.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Shot given too soon no adverse reactions per Pt mom
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Venipuncture
Clinical narrative: Blisters, redness and swelling at the injection site.  Patient did not mention she was going for blood work immediately after vaccination and states that the nurse wrapped a rubber elastic tightly compressed at the exact injection site in order to assist in drawing blood and may have enhanced the reaction.  Patient was seen by MD afterwards, but symptoms mostly healed on their own.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash papular
Clinical narrative: left outer thigh at injection site with pink oval 3 cm by 2 cm slightly raised rash. itchy. no cellulitis. given triamcinolone 0.1% ointment .  still with rash on day 2. less itching per mom
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Presyncope
Clinical narrative: Near syncope
Age: 30.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Fluid retention, Pain, Pain in extremity
Clinical narrative: Patient came in for further vaccinations and reported that about 2 days after last visit he experienced shooting, stabbing pains down his left arm; said it is resolving and he is not worried about it. RN said it could be brachial neuritis. He also reported fluid collection under his arm that has since resolved.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was mistakenly administered a third Shingrix vaccine, when he should have received a Covid booster.  Patient is not experiencing any side effects and requests a Covid booster at this time.  This has been reported to Pharmacy Risk Management
Age: 66.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Computerised tomogram, Injection site reaction, Joint swelling, Myalgia
Clinical narrative: Shoulder pain swelling  with radiation to neck and a mark left on lateral shoulder at injection site. severe pain and myalgiia ongoing for 4 months since shot. First reported to me 3/21/2024 after she had discussed with pharmacy and patient states pharmacy did a physical exam on her and told her to come to my office. Xrays, ct of shoulder, prednisone, muscle relaxer and tylenol started. Inflammatory labs ordered.
Age: 66.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Neck pain, Pain, X-ray limb
Clinical narrative: Shoulder pain swelling  with radiation to neck and a mark left on lateral shoulder at injection site. severe pain and myalgiia ongoing for 4 months since shot. First reported to me 3/21/2024 after she had discussed with pharmacy and patient states pharmacy did a physical exam on her and told her to come to my office. Xrays, ct of shoulder, prednisone, muscle relaxer and tylenol started. Inflammatory labs ordered.
Age: 66.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Myalgia, Pain, Pain in extremity, X-ray
Clinical narrative: Shoulder pain swelling  with radiation to neck and a mark left on lateral shoulder at injection site. severe pain and myalgiia ongoing for 4 months since shot. First reported to me 3/21/2024 after she had discussed with pharmacy and patient states pharmacy did a physical exam on her and told her to come to my office. Xrays, ct of shoulder, prednisone, muscle relaxer and tylenol started. Inflammatory labs ordered.
Age: 66.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Computerised tomogram, Injection site reaction, Joint swelling, Myalgia
Clinical narrative: PAIN (MUSCLE SORENESS) RADIATING FROM SHOULDER TO ELBOW THAT STARTED A DAY AFTER THE IMMUNIZATION
Age: 66.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Neck pain, Pain, X-ray limb
Clinical narrative: PAIN (MUSCLE SORENESS) RADIATING FROM SHOULDER TO ELBOW THAT STARTED A DAY AFTER THE IMMUNIZATION
Age: 66.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Myalgia, Pain, Pain in extremity, X-ray
Clinical narrative: PAIN (MUSCLE SORENESS) RADIATING FROM SHOULDER TO ELBOW THAT STARTED A DAY AFTER THE IMMUNIZATION
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Extra dose administered
Clinical narrative: Administered third dose to client who had already completed the 2 dose hepatitis A series.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Both legs with redness and raised x 1 day at vaccine sites. Right side worse with large redness, warmth and swelling around injection site.  Vaccines given 3/18/24 with Dtap/IPV in R vas lat, MMRV at L thigh.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: PT REPORTS 1 DAY AFTER GETTING RSV VACCINE, HIS HEART FELT LIKE IT WAS BEATING FASTER AND IRREGULAR. THESE SYMPTOMS HAVE CONTINUED SINCE 03/08/2024.
Age: 39.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: Varivax received on 03/19/2024.  Patient presented to clinic with reports of right arm soreness as well as fatigue, and diaphoresis. She reports that her symptoms began 3/19/2024. She denies headache, sore throat or cough. She received both Varicella and TDAP on 3/19/24.  She reports taking Ibuprofen 400mg every 4 hours, while also alternating with Tylenol.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Hypotension, Presyncope
Clinical narrative: VASOVAGAL SYNCOPE, LOW BP. RECOVERED IN APPROXIMATELY 30 MINS
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test positive, Blood thyroid stimulating hormone decreased, Graves' disease, Thyroxine increased, Tri-iodothyronine increased
Clinical narrative: Diagnosed with Graves? disease 12/2021
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling of lymph node, left side, underarm. Roughly the size of an orange. Painful. Lasted one full week from injection.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient less than 13 years old, given Varicella #2 6 weeks after Varicella dose #1.  Will need another dose of varicella.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Computerised tomogram, Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: I developed severe myositis starting 2 months post my 4th COVID vaccine. The condition progressed within the next 1.5 years. I tried variety of treatments: acupuncture, massage, Chiropractic adjustments, as well as Ibuprofen, Tylenol, Vit D, Calcium, herbal supplements. I lost my job and was without health insurance and went to Ortho doctors and paid for MIRs and XRays all normal. I paid for epidural injections and various consultations with neurologists and finally paid for extensive autoimmune labs all normal. Finally, a CPK muscle test was elevated and I was diagnosed with inflammatory myositis. I believe this is due to the COVID vaccine as prior to this condition I was a very healthy person and walked 2 miles a day and was working several jobs. I am now in constant pain when I walk and my movements are very restricted. This has affected my life profoundly in a very negative way. Sometimes I feel death is better than living with this condition.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myositis, Pain, Suicidal ideation, X-ray
Clinical narrative: I developed severe myositis starting 2 months post my 4th COVID vaccine. The condition progressed within the next 1.5 years. I tried variety of treatments: acupuncture, massage, Chiropractic adjustments, as well as Ibuprofen, Tylenol, Vit D, Calcium, herbal supplements. I lost my job and was without health insurance and went to Ortho doctors and paid for MIRs and XRays all normal. I paid for epidural injections and various consultations with neurologists and finally paid for extensive autoimmune labs all normal. Finally, a CPK muscle test was elevated and I was diagnosed with inflammatory myositis. I believe this is due to the COVID vaccine as prior to this condition I was a very healthy person and walked 2 miles a day and was working several jobs. I am now in constant pain when I walk and my movements are very restricted. This has affected my life profoundly in a very negative way. Sometimes I feel death is better than living with this condition.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Concussion, Echocardiogram, Ejection fraction normal, Electrocardiogram normal
Clinical narrative: JANSSEN 3/25/2021.  FEB 2024 HAD SEVERAL SYNCOPAL EPISODES AT NIGHT AFTER GETTING OUT OF BED GOING TO THE BATHROOM.  HIT HEAD AND HAS CONCUSSION.   FOUND TO BE ORTHOSTATIC.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Laboratory test, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: JANSSEN 3/25/2021.  FEB 2024 HAD SEVERAL SYNCOPAL EPISODES AT NIGHT AFTER GETTING OUT OF BED GOING TO THE BATHROOM.  HIT HEAD AND HAS CONCUSSION.   FOUND TO BE ORTHOSTATIC.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Dizziness, Ear discomfort, Ophthalmic migraine
Clinical narrative: Ocular migraine improved with rest; pulsatile tinnitus of variable intensity continues;  lightheadedness, rest, dizziness, treated with 2.5 mg Lorazepam if severe; vertigo treated with 10 mg Lorazepam; ear fullness continues, sometimes aided by Allegra 7.5 mg, hearing loss. Currently taking Prednisone 10mg 3 tablets daily.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Ocular migraine improved with rest; pulsatile tinnitus of variable intensity continues;  lightheadedness, rest, dizziness, treated with 2.5 mg Lorazepam if severe; vertigo treated with 10 mg Lorazepam; ear fullness continues, sometimes aided by Allegra 7.5 mg, hearing loss. Currently taking Prednisone 10mg 3 tablets daily.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no symptoms. need Tdap for age instead.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Altered state of consciousness, Chills, Diarrhoea, Fatigue, Feeling of despair
Clinical narrative: Aprox 2 hours after vaccine he began having worsening sx including fever, chills , body aches and muscle weakness. He reports later in the early evening he took a shower and sometime later his wife found him in the shower in a state of despair thinking his family had died.  He states he was not  asleep but not in a state of awareness.  Seeing his wife brought him to the present place and time and he has not had a lapse since.  He reports still feeling fatigued and having loose stools but replenishing fluids with water and gatorade mixed.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Pyrexia
Clinical narrative: Aprox 2 hours after vaccine he began having worsening sx including fever, chills , body aches and muscle weakness. He reports later in the early evening he took a shower and sometime later his wife found him in the shower in a state of despair thinking his family had died.  He states he was not  asleep but not in a state of awareness.  Seeing his wife brought him to the present place and time and he has not had a lapse since.  He reports still feeling fatigued and having loose stools but replenishing fluids with water and gatorade mixed.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Vaccination site discomfort, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Mother of patient called and reported swelling, itchiness, and some discomfort of the MMR vaccination site.  Upon inspection the area was notably swollen, hot, and hard to the touch. MOP also noted some redness under her eyes. Cold compress applied, told to give her Tylenol and a prescription of Benadryl was written. Denies hives or shortness of breath, no swelling of the face or throat noted.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: rash and hive around face and body, started after 3 days of vaccines . pt said she took antihistamine and was okay then
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Computerised tomogram thorax abnormal, Cough, Echocardiogram, Electrocardiogram
Clinical narrative: PFIZER #1 8/24/2021 PFIZER #2 9/14/2021, VACCINES FAIL SHE DEVELOPS COVID-19 SUMMER OF 2023 AND THEN POST COVID-19 BOOP WITH PERSISENT COUGH, WHEEZING, AND ABNORMAL CT DEMONSTRATING PULMONARY FIBROSIS.  TREATED WITH INHALERS EMPIRIC ANTIBIOTICS WITH NO IMPROVEMENT.  MARCH 2024, STARTED ON PROTOCOL BASE SPIKE DETOXIFICATION WITH EMPIRIC PROLONGED IVM PLUS CROMOLYN.  WILL SEEK HYPERBARIC OXGEN TREATMENT IN HER HOME TOWN.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Post-acute COVID-19 syndrome, Pulmonary fibrosis, Wheezing
Clinical narrative: PFIZER #1 8/24/2021 PFIZER #2 9/14/2021, VACCINES FAIL SHE DEVELOPS COVID-19 SUMMER OF 2023 AND THEN POST COVID-19 BOOP WITH PERSISENT COUGH, WHEEZING, AND ABNORMAL CT DEMONSTRATING PULMONARY FIBROSIS.  TREATED WITH INHALERS EMPIRIC ANTIBIOTICS WITH NO IMPROVEMENT.  MARCH 2024, STARTED ON PROTOCOL BASE SPIKE DETOXIFICATION WITH EMPIRIC PROLONGED IVM PLUS CROMOLYN.  WILL SEEK HYPERBARIC OXGEN TREATMENT IN HER HOME TOWN.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nausea, Vomiting
Clinical narrative: Pt reports redness and swelling at injection site, nausea and vomiting w/in 24 hrs of administration.
Age: 1.42
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: No adverse event, Product administration error
Clinical narrative: Administration error.     No adverse effects
Sex: U
Vaccine: HEPA, MMR, PNC15, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 3-5  minutes after vaccine administration, the patient developed a hive next to the injection site of MMR and Hep A vaccines. After 30-40 minutes of observation the provider gave 4 mL of Benadryl to the patient. No more adverse reactions.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Polycystic ovarian syndrome, Weight increased
Clinical narrative: PCOS and insane weight gain.
Age: 39.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired vaccine. The vaccine expired on 3/1/2024. Per manufacturer there is data that show that the vaccine is still potent at the time of administration. Patient was notified of the error. No adverse event has been reported.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Rash erythematous
Clinical narrative: Red rash on skin presented several days after vaccine was administered. Patient was observed for the required 15 minutes post administration of the vaccine. No AE present at that time
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia
Clinical narrative: arm is sore and red - has fever, chills and high fever- covering pharmacist who answered the call told patient to alternate tylenol and motrin to help with symptoms. temp fluctuating , 99-100 degrees
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19-2, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses of cominarty on accident
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Rash, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Swelling, redness and rash around vaccine site. Rash also spread around thigh, right hand and right foot.
Age: 80.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Herpes virus infection
Clinical narrative: Herpes outbreak
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen around injection site.  Patient very whiney, laying around more, walking like leg hurt.  Parent tried treating with benadryl with no relief. Physician observed extensive erythema and some induration.  Advised to continue benadryl and prescribed cephalexin 450 mg (9ml) PO Q12 hour for 7 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed first shingles outbreak to left shoulder after vaccination.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt was give vax past BUD. It was place in the refrigerator 2/12 and was given on 3/21
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt was given shot past BUD date. Box was placed in refrigerator 2/12 and shot given 3/21
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Electroencephalogram, Herpes zoster, Laboratory test, Lumbar puncture
Clinical narrative: The day after vaccination the vaccine reactivated the shingles virus and patient got shingles. Five days later, shingles turned in to meningitis. Patient admitted to hospital for three days and peripheral neuropathy developed in legs/feet.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging, Meningitis, Neuropathy peripheral, Varicella meningitis
Clinical narrative: The day after vaccination the vaccine reactivated the shingles virus and patient got shingles. Five days later, shingles turned in to meningitis. Patient admitted to hospital for three days and peripheral neuropathy developed in legs/feet.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Arteriosclerosis coronary artery, Blood calcium, Blood test, Cardiac stress test, Echocardiogram
Clinical narrative: MYASTHENIA GRAVIS-LIKE SYMPTOMS OF FATIGUE WITH TALKING AND CHEWING OVER THE COURSE OF A DAY OR A LONG CONVERSATION.  PROGRESSIVE ATHEROSCLEROTIC CORONARY ARTERY DISEASE WITH CORONARY ARTERY CALCIUM SCORE 2024 FOUND TO BE 1398.  NO CARDIOVASCULAR SYMPTOMS.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Electrocardiogram, Fatigue
Clinical narrative: MYASTHENIA GRAVIS-LIKE SYMPTOMS OF FATIGUE WITH TALKING AND CHEWING OVER THE COURSE OF A DAY OR A LONG CONVERSATION.  PROGRESSIVE ATHEROSCLEROTIC CORONARY ARTERY DISEASE WITH CORONARY ARTERY CALCIUM SCORE 2024 FOUND TO BE 1398.  NO CARDIOVASCULAR SYMPTOMS.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Event report 4 plus months after vaccine, redness and sore at the injection site, sore still visible after 4 months, although not right in the area of the deltoid muscle
Age: 63.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Nodule, Pain
Clinical narrative: Patient suffered from knot in muscle for about 3 months. Now they are having pin-point ache with weight barring movements.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave high dose flu vaccine instead of regular dose flu vaccine.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Death, Haemorrhage intracranial, Platelet count decreased, Thrombocytopenia
Clinical narrative: he had Shingrix vaccine-12/17/23 and 3/12/24-had h/o nose bleeds,dizziness,went to ER-noted low platelet count,had severe thrombocytopenia,admitted to hospital and treated,expired due to intracranial bleed
Age: 66.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Headache, Muscle spasms, Myalgia, Nausea, Spinal pain
Clinical narrative: SEVERE pain in vertebra and in muscles attached to spinal column.   Charlie horses in quadriceps.  Nausea.  Headache.  This happened about midnight following an early afternoon injection on the previous day.  It is now after 5 pm on 03/21/2024 and pain has not subsided.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: Blood clot, pulmonary embolism
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; HCP calling to report MMRII was administered after experiencing a temperature excursion. Original TE case# 02554191 filed. Assessment was not supported, new TE case# 02554822 filed for Escalation. Permission to contact HCP was granted. No additional; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. N information on patient's medical history, current conditions and concomitant medications was provided.  On 19-FEB-2024 the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # X013192 and expiration date 08-MAY-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The temperature during excursion was 54.5 Fahrenheit degrees (F) with length of 10 Hours 0 Minutes 0 Seconds (product storage error and no adverse event).
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE/PQC; This second dose was inadvertently administered; 1 month and 18 days earlier than recommended; This spontaneous report was received from a nurse and refers to an 11-year-old male patient of unknown ethnicity.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-MAR-2024, the patient was vaccinated with the second dose of the second dose regimen of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered also as prophylaxis, lot number 1957407 verified as valid and expiration date reported and upon internal review established as 23-JAN-2026 (strength, and route of administration were not provided). This second dose was inadvertently administered; 1 month and 18 days earlier than recommended (Inappropriate schedule of vaccine administered).
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Somnolence
Clinical narrative: HCP reported a female patient experienced a fever and felt very sleepy the day of the vaccination.  No other symptoms reported and no additional details provided.  No other A; HCP reported a female patient experienced a fever and felt very sleepy the day of the vaccination.  No other symptoms reported and no additional details provided.  No other A; This spontaneous report was received from a health care professional referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On the same day after the vaccination, the patient experienced a fever and felt very sleepy. It was unknown if any treatments given for the events. The outcome of the events was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable. The causal relationship between the events and vaccination was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC was reported; inadvertent administration of VARIVAX after expiration; This spontaneous report was received from nurse and refers to patient of unspecified age and gender.  The patient's medical history, concurrent conditions, previous drug allergies and reactions and concomitant therapies were not reported.  On 07-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot #U024220, expiration date: 04-AUG-2023, valid lot number per internal review), administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse events were provided.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: HCP reported patient received VARIVAX and then found out she was pregnant one month later; No additional AE/no PQC.; This spontaneous prospective pregnancy report was received from a nurse prescriber referring to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, dose number, route, anatomical location, lot# and expiration date were not provided) for prophylaxis and then found out she was pregnant one month later (unspecified date and details) (exposure during pregnancy). No adverse events reported.   The last menstrual period (LMP) and estimated date of delivery (EDD) was unknown. The pregnancy outcome was pending.  Lot # is being requested and will be submitted is received.
Age: 16.0
Sex: U
Vaccine: HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 16-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 13-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided); and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1957405, expiration date: 11-NOV-2025, administered intramuscularly for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA016206:
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Induration, Skin injury
Clinical narrative: Had cellulitis; skin is injured; arm turned into a rock; This serious case was reported by a consumer via other manufacturer and described the occurrence of cellulitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac device implantation and chemotherapy. Concurrent medical conditions included stenosis, cancer (cancer survivor) and ventricular tachycardia.   On an unknown date, the patient received Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced cellulitis (Verbatim: Had cellulitis) (serious criteria hospitalization), skin injury (Verbatim: skin is injured) and induration (Verbatim: arm turned into a rock). The outcome of the cellulitis, skin injury and induration were not resolved.   It was unknown if the reporter considered the cellulitis, skin injury and induration to be related to Shingrix.     It was unknown if the company considered the cellulitis, skin injury and induration to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2024 The reporter stated that 4-6 years ago, received a Shingrix vaccine in left arm at a pharmacy and arm turned into a rock. The patient had cellulitis and needed hospitalization for IV antibiotics.  The reporter stated that despite telling the Pharmacy that was unable to receive the vaccine in left arm due to having stenosis and an implanted cardiac device.  The reporter stated that at the time reported the hospitalization to the vaccine company and the FDA and was informed by the company that should not had the shingles vaccine after already having had shingles. The reporter denied having recovered from the event since now experienced cellulitis every time skin was injured (i.e. no blood drawn, no IVs).  The reporter was a cancer survivor and had chest radiation, chemotherapy and a number of surgeries.  The reporter reported having ventricular tachycardia, therefore could not take a number of medications also reported having no lymph nodes on one side and complete stenosis on the other and ended up septic therefore could not receive vaccines in either arm.  The reporter provided consent for our safety department to contact and healthcare professional.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: shingles/ suspected vaccination failure; shingles; 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.   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: shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) 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 resolved (duration 15 months).   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 received date: 14-Mar-2024 This case was reported by a patient via interactive digital media. Patient had all shots. Patient got shingles and had the nerve pain for almost 15 months. It was acting up under stress. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Paralysis
Clinical narrative: Paralyzed; Unknown cause of death; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death 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, less than 9 months after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant) and paralysis (Verbatim: Paralyzed) (serious criteria hospitalization and GSK medically significant). The outcome of the paralysis was not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death and paralysis to be related to Shingles vaccine.     It was unknown if the company considered the unknown cause of death and paralysis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2024 This case was reported by a reporter via interactive digital media. The reporter stated that the patient took the Shingle shot and two days later he was in the hospital paralyzed. After 8 months in the hospital, he got to go home and after 2 days, he died in his sleep. The reporter had GBS in 1975, so he/she knew a little bit about it. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Age: 3.0
Sex: F
Vaccine: DTAPIPV, DTPPVHBHPB
Symptoms: Extra dose administered, Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: received Kinrix and stating they are interchanging with a non-GSK vaccine of Vaxelis; 3 year old patient received a Kinrix dose on 2/20/2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 3-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included Vaxelis (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 20-FEB-2024, the patient received Kinrix and Vaxelis. On 20-FEB-2024, an unknown time after receiving Kinrix, the patient experienced overdose (Verbatim: received Kinrix and stating they are interchanging with a non-GSK vaccine of Vaxelis) and inappropriate age at vaccine administration (Verbatim: 3 year old patient received a Kinrix dose on 2/20/2024). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAR-2024 The 3-year-old patient received a Kinrix dose, which led to an inappropriate age at vaccine administration. The registered nurse (RN) wanted to know would this still be considered a valid dose or how to proceed. The reporter mentioned the patient was behind on shots and was getting caught up.  The expert noted, HCP (health care professional) stated they were interchanging with a non-GSK vaccine of Vaxelis.  The patient received Kinrix and Vaxlelis on the same day, which led to an overdose. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: Priorix via intramuscular route versus the approved subcutaneous route; 50 year old patient was administered Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 50-year-old male patient who received MMR (Priorix) (batch number 22J27, expiry date 01-NOV-2024) for prophylaxis.   On 07-MAR-2024, the patient received the 1st dose of Priorix (intramuscular). On 07-MAR-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix via intramuscular route versus the approved subcutaneous route) and inappropriate age at vaccine administration (Verbatim: 50 year old patient was administered Priorix). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-MAR-2024 The pharmacist requested information about the administration of Priorix via intramuscular route versus the approved subcutaneous route, which led to subcutaneous injection formulation administered by other route. Medical information was given, data about the patient, vaccine and event was collected. The 50 years old patient received Priorix, which led to an inappropriate age vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received late; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 27th July 2023). Concurrent medical conditions included immunocompromised.   On 23-OCT-2023, the patient received the 2nd dose of Engerix B. On 23-OCT-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 11-MAR-2024 Nurse reported that patient initiated Engerix B series on 24 July 2023, and did not get second dose until 23 October 2023.  The nurse mentioned that the patient was immunocompromised.  At the time of reporting, the nurse did not have the product lot numbers.  At the time of reporting, the patient has not yet received a third dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 1.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient should receive MMR-II but Nurse Practitioner Manager declared they gave Menveo instead; 12 month patient received Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 2R7L7) for prophylaxis.   On 11-MAR-2024, the patient received the 1st dose of Menveo. On 11-MAR-2024, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: The patient should receive MMR-II but Nurse Practitioner Manager declared they gave Menveo instead) and inappropriate age at vaccine administration (Verbatim: 12 month patient received Menveo). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 11-Mar-2024 The reporter reported that the patient should receive MMR-II vaccine but nurse practitioner manager  declared that they gave Menveo vaccine instead, which led to wrong vaccine administered. The reporter stated that the Menveo 1 vial presentation was administered to a patient under the prescribing Information indicated age. The reporter reported that MMR-II was the right medication, was administered already. The reporter wanted to know the reactions the child might had and the monitoring time for the child. The vaccine administration facility was the same as primary reporter. The patient received Menveo vaccine who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.