chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Eye pruritus, Feeling hot, Flushing, Full blood count, Joint stiffness
Clinical narrative: Reaction /Symptoms began around 11/29/24 with rash red splotchy rash on hands, up arm, legs with itching that felt like was beneath my skin and paresthesia. Visited Student Health Services first week of December 2024 because rash and itching did not go away. Prescribed antihistamine and steroid, Symptoms did not resolve and progressed to all over joint pain (hands, fingers, ankles, knees, wrists, elbows so returned to clinic 12/12/24 and saw Dr, Chief Medical Officer and she said it sounded like  serum like sickness  from the vaccine and to not continue series.  Referred to allergist and told to continue Aleve.  12/19/24 visit to Internal Medicine.  Symptoms had somewhat subsided. Dr wrote a waiver to not receive 2nd dose of Hepatitis B vaccine and ordered a complete blood panel and ANA Screen IFA for autoimmune disease. Eosinophils and potassium came back high , ANA panel was normal.  Beginning of January 2025 , symptoms returned and continue to this date. Wake up with swollen hands and fingers that remain that way for hours some days.  Itching, paresthesia, red splotchy rash on hands, wrists, and sometimes knees, comes and goes.  Stiff feeling in hands fingers and ankles.  Itchy eyes and flushed hot feeling and face has also occurred. Established with Dr on 1/15/25. Dr ordered complete blood panel and repeat of ANA Screen and scheduled appointment with rheumatologist on 5/9/24. ANA screen done on 2/14/25 came back abnormal.
Age: 19.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Musculoskeletal stiffness, Paraesthesia, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Reaction /Symptoms began around 11/29/24 with rash red splotchy rash on hands, up arm, legs with itching that felt like was beneath my skin and paresthesia. Visited Student Health Services first week of December 2024 because rash and itching did not go away. Prescribed antihistamine and steroid, Symptoms did not resolve and progressed to all over joint pain (hands, fingers, ankles, knees, wrists, elbows so returned to clinic 12/12/24 and saw Dr, Chief Medical Officer and she said it sounded like  serum like sickness  from the vaccine and to not continue series.  Referred to allergist and told to continue Aleve.  12/19/24 visit to Internal Medicine.  Symptoms had somewhat subsided. Dr wrote a waiver to not receive 2nd dose of Hepatitis B vaccine and ordered a complete blood panel and ANA Screen IFA for autoimmune disease. Eosinophils and potassium came back high , ANA panel was normal.  Beginning of January 2025 , symptoms returned and continue to this date. Wake up with swollen hands and fingers that remain that way for hours some days.  Itching, paresthesia, red splotchy rash on hands, wrists, and sometimes knees, comes and goes.  Stiff feeling in hands fingers and ankles.  Itchy eyes and flushed hot feeling and face has also occurred. Established with Dr on 1/15/25. Dr ordered complete blood panel and repeat of ANA Screen and scheduled appointment with rheumatologist on 5/9/24. ANA screen done on 2/14/25 came back abnormal.
Age: 19.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Rash macular, Rash pruritic, Serum sickness
Clinical narrative: Reaction /Symptoms began around 11/29/24 with rash red splotchy rash on hands, up arm, legs with itching that felt like was beneath my skin and paresthesia. Visited Student Health Services first week of December 2024 because rash and itching did not go away. Prescribed antihistamine and steroid, Symptoms did not resolve and progressed to all over joint pain (hands, fingers, ankles, knees, wrists, elbows so returned to clinic 12/12/24 and saw Dr, Chief Medical Officer and she said it sounded like  serum like sickness  from the vaccine and to not continue series.  Referred to allergist and told to continue Aleve.  12/19/24 visit to Internal Medicine.  Symptoms had somewhat subsided. Dr wrote a waiver to not receive 2nd dose of Hepatitis B vaccine and ordered a complete blood panel and ANA Screen IFA for autoimmune disease. Eosinophils and potassium came back high , ANA panel was normal.  Beginning of January 2025 , symptoms returned and continue to this date. Wake up with swollen hands and fingers that remain that way for hours some days.  Itching, paresthesia, red splotchy rash on hands, wrists, and sometimes knees, comes and goes.  Stiff feeling in hands fingers and ankles.  Itchy eyes and flushed hot feeling and face has also occurred. Established with Dr on 1/15/25. Dr ordered complete blood panel and repeat of ANA Screen and scheduled appointment with rheumatologist on 5/9/24. ANA screen done on 2/14/25 came back abnormal.
Age: 0.33
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: No adverse event
Clinical narrative: None noted.- RN
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Adverse reaction
Clinical narrative: OTHER THAN THE NORMAL SYMPTOMS AFTER RECIEVING THE VACCINE PREVIOUSLY, PT CLAIMS THERE IS NO NEW SYMPTOMS
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was administered the pediatric dose instead of the adult dose.  The age range does not appear on the syringe only the box on ENGERIX-B.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Child was seen in another clinic on March 25, 2025 and was given the DTaP-Hep B-IPV vaccination.   The Hep B was missed when checking vaccines needed. There are 4 children in the family.  Two were given Hep B at the appointment and two were not. Child was given a Hep B vaccine 8 days after the first one.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Induration, Peripheral swelling, Vomiting
Clinical narrative: The day after having vaccine, she started vomiting. leg swollen and hard, difficulty swallowing. went to the dr., was give a diuretic. She has been diagnosed with lung cancer before having the vaccine. Still having difficulty swallowing. Taking  Xalkori 250mg
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Erythema, Headache, Nausea
Clinical narrative: Around 9 or 10 o'clock I had pain redness, swelling, stomach pain, headache, nauseous, pain in back, i felt like my cycle was coming back
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Around 9 or 10 o'clock I had pain redness, swelling, stomach pain, headache, nauseous, pain in back, i felt like my cycle was coming back
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: arexvy; Manufacturer: gsk; LotNumber: 9sb34; Route: intramuscular; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Asthenia, Back pain, Dizziness, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient has pain and swelling in the arm and down her back. Described as shooting pain down arm, neck, and back. Going for Xray. Patient went to PCP and has a referral for a neurologist from PCP. Pain is progressing and getting worse.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Neck pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient has pain and swelling in the arm and down her back. Described as shooting pain down arm, neck, and back. Going for Xray. Patient went to PCP and has a referral for a neurologist from PCP. Pain is progressing and getting worse.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Pain, Pain in extremity, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient has pain and swelling in the arm and down her back. Described as shooting pain down arm, neck, and back. Going for Xray. Patient went to PCP and has a referral for a neurologist from PCP. Pain is progressing and getting worse.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient has pain and swelling in the arm and down her back. Described as shooting pain down arm, neck, and back. Going for Xray. Patient went to PCP and has a referral for a neurologist from PCP. Pain is progressing and getting worse.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient mentioned she feels tingling on her injection site.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Severe
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Fatigue, Lethargy, Malaise, Mouth swelling
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Additional Details: Six to eight hours after immunixation patient felt sick. Woke up next day slightly swollen in face. Monday 4/1/25 it kept getting worse and they instructed her to take benadryl. Took benadryl Monday and Tuesday. Swelling went down a little bit on Tuesday 4/2/25. Patient is going to the doctor due to the fact she is still swollen and can't smile fully as of 4/2/25.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Additional Details: Six to eight hours after immunixation patient felt sick. Woke up next day slightly swollen in face. Monday 4/1/25 it kept getting worse and they instructed her to take benadryl. Took benadryl Monday and Tuesday. Swelling went down a little bit on Tuesday 4/2/25. Patient is going to the doctor due to the fact she is still swollen and can't smile fully as of 4/2/25.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: patient reported seeking treatment for ongoing joint pain at injection site after receiving injection on 9/14/2024. , Other Vaccines:  VaccineTypeBrand: fluzone; Manufacturer: ; LotNumber: u8499ca; Route: im; BodySite: la; Dose: ; VaxDate: UNKNOWN
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Fall, Fatigue, Feeling abnormal, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient had a reaction about 5 minutes after injection was given. Patient says he is not feeling good and fainted, patient fell down to the floor. I had the patient lay down with legs elevated for about 5 minutes, then he felt good enough to sit up which he was given water and orange juice. BP taken measured 88/62 mmhg. After about 10-15 minutes, bp measured at 102/64 with colors returning to the lips. Patient then said he felt good enough to leave which I agreed.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient had a reaction about 5 minutes after injection was given. Patient says he is not feeling good and fainted, patient fell down to the floor. I had the patient lay down with legs elevated for about 5 minutes, then he felt good enough to sit up which he was given water and orange juice. BP taken measured 88/62 mmhg. After about 10-15 minutes, bp measured at 102/64 with colors returning to the lips. Patient then said he felt good enough to leave which I agreed.
Age: 36.0
Sex: M
Vaccine: HPV9
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: cellulitus-Medium, Additional Details: 3 days post vaccination went to dr and diagnosed with cellulitis - took antibiotics that cleared it up within 3-4 days
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered one day past "exp", no reaction or harm to patient observed. MD & clinic manager notified, safety event reported on orgs Safety Event reporting system.
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Back pain, Headache, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Patient described having a headache for a couple of days starting the day after vaccination, sore arm  starting during the day of vaccination, and starting 2 days after vaccination, having a sharp pain in back and ribs. He tried taking OTC Tylenol and/or aspirin with some relief, but pain continues. He requested and his doctor prescribed him a muscle relaxant.
Age: 57.0
Sex: M
Vaccine: HEPAB
Symptoms: Condition aggravated, Deafness unilateral, Ear pain
Clinical narrative: Patient had ear ached the morning of vaccination, saw prescriber that gave him prescription medications. Ear ache got worse 4/3/2025 and eventually lose hearing in ear.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Blood glucose, Cardiac death, Cardiomegaly, Death
Clinical narrative: Patient began experiencing sweating and stated he felt "weird". Checked blood sugar and contacted clinic. Stated that it was just the body making antibodies. On 9/29/22, patient was found deceased. Autopsy showed enlarged heart which was not previously detected prior to vaccine on 9/2/22 (patient was due to have elective surgery on 10/6 and had been cleared with all pre-op testing).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis
Clinical narrative: Patient began experiencing sweating and stated he felt "weird". Checked blood sugar and contacted clinic. Stated that it was just the body making antibodies. On 9/29/22, patient was found deceased. Autopsy showed enlarged heart which was not previously detected prior to vaccine on 9/2/22 (patient was due to have elective surgery on 10/6 and had been cleared with all pre-op testing).
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Limb discomfort, Musculoskeletal discomfort, Product administered at inappropriate site
Clinical narrative: This Vaccine was administered higher than the recommended zone for vaccination. It was closer to the shoulder than it should have been. The patient is now having shoulder/arm discomfort.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Rash, Urticaria
Clinical narrative: Extreme exhaustion started 2 hours after dose, laid down and slept for 2 hours.  Awoke and realized a rash had started.  The following day it progressed to hives all over neck, chest and trunk.  Hives continue through today.  Patient has not taken anything to help decrease the reaction.  I counselled that she could take allergy medication or see a provider for a course of steroids.  She said she was going to continue to ride this out without medications.
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue
Age: 1.58
Sex: M
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: There are no current adverse events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation
Clinical narrative: I have inflamed blood vessels in my eyes.  My doctor said people he has seen with this all had received COVID shots.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, HPV9, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received HPV9 instead of PCV20 as was intended.  Dr. made aware by Medical Assistant.  Dr. discussed with the mother immediately.  No none adverse events were reported to our office.
Sex: M
Vaccine: PNC15
Symptoms: Fatigue, Hypersomnia, Hypopnoea, Hypotonia, Mobility decreased
Clinical narrative: After third pneumococcal vaccine Vaxneuvance given 9/17/24 at 11 months old at office (first time seen by our group): slept a very long time and difficult to awaken. It was like he was unconscious and wouldn't wake up for an hour though pinching him, yelling his name and shaking him.  Wouldn't even move and limp when picked up.  Breathing very shallow.  Had to hold head as falling backwards. Considered taking to ED, but then after an hour woke up with yelling at him, but still was groggy and fell back asleep. Went back to sleep but breathing back to normal. Acted fatigued for another day.
Sex: M
Vaccine: PNC15
Symptoms: Posture abnormal, Somnolence
Clinical narrative: After third pneumococcal vaccine Vaxneuvance given 9/17/24 at 11 months old at office (first time seen by our group): slept a very long time and difficult to awaken. It was like he was unconscious and wouldn't wake up for an hour though pinching him, yelling his name and shaking him.  Wouldn't even move and limp when picked up.  Breathing very shallow.  Had to hold head as falling backwards. Considered taking to ED, but then after an hour woke up with yelling at him, but still was groggy and fell back asleep. Went back to sleep but breathing back to normal. Acted fatigued for another day.
Age: 89.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: the patient has experienced no adverse effects, however this was a duplicate dose. Patient also received a Prevnar 20 shot in January. After speaking with the patient, he said he is not experiencing any adverse effects other than the normal sore arm
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Loss of personal independence in daily activities, Migraine, Musculoskeletal disorder, Shoulder injury related to vaccine administration
Clinical narrative: Patient has called multiple times in regards to having a bad reaction to a vaccine. There are multiple rx notes on file for the patient from multiple pharmacists that have talked to the patient in the past. I called personally and spoke to the patient the evening of 4/3/2025. She reiterated everything that we have on file. She only wanted a regular flu shot, but stated she was pressured or told that she couldn't and in her words, forced to get a high dose flu shot by the pharmacist on file for this complaint. She then stated immediately after the vaccine that she began to have migraines and that her left arm began to lose function and that her daily life wasn't the same anymore. She could no longer do activities that she enjoyed or basic daily activities such as getting ready. She now stated that she went to a orthopedic surgeon and they diagnosed her with SIRVA.
Age: 43.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Expired product administered
Clinical narrative: 1st dose Help B given to patient at 11:15 - Pt left and as soon as I went to plug all info in computer, I realized it was expired. Exp 2/10/25- Med room notified, Doctor notified, manufacturer was called. Advised to give again ASAP. Pt came back at 1300 for another one. Charted in safety net and (redacted) notified. As soon as I realized it was expired, I went to the med room and I notified (redacted) who then notified (redacted). She advised to speak with Doctor. Doctor was notified ASAP, (redacted) then notified and Manufacturer called as well. They recommended giving it again ASAP. Pt was called and I explained what happened. She came back here and got it again at 1300. VAERS form filled out, (redacted) notified and charted incident in safety net (redacted) also emailed pt information so that patient isn't billed for today's incident involving the 1st one given. Pt tolerated both injections well.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Paraesthesia, Visual impairment
Clinical narrative: On 4/2/25 @ 4:39 pm patient received both vaccines approx. 5-10 later, patient indicated to mom & Dr. that she was feeling some tingling in her face and little visual distortion & felt like she was going to faint. Patient was then moved onto a stretcher and placed in Trendelenburg position VS were normal except for transient increments of the blood pressure (180/95) patient improved after 20 mins.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Laboratory test
Clinical narrative: Gillian Barre Syndrome
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a Consumer or other non health professional (reported as vaccine coordinator) and refers to a 22-month-old female patient.   The patient's medical history and concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP).  On 24-OCT-2024, the patient was vaccinated with an improper stored dose of hepatitis A Vaccine, Inactivated (lot #X026658, expiration date: 29-MAY-2025) administered by Intramuscular route as prophylaxis (exact dose and anatomical location were not provided). The temperature excursion was reported as 25 degrees Fahrenheit, for 1 hour, 0 minutes, and 0 seconds (improper storage of product in use). No previous temperature excursion.  No symptoms were reported (No adverse event).  This is one of several reports received from the same reporter.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Product origin unknown; Improper storage of product in use; This spontaneous report was received from vaccine provider and refers to a 12-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Oct-2024, the patient was vaccinated with improperly storage doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) or Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (reported as HPV) (Product origin unknown), invalid lot #X009193, expiration date: 06-Jun-2026, administered by Intramuscular route; Meningococcal vaccine B (MenB) lot#A2743, expiration date: 30-Sep-2027), administered by Intramuscular route, and Influenza vaccine (Fluzone) lot# UT8485LA, expiration date: 30-Jun-2026, administered by Intramuscular route (lot # was not reported). All the vaccines were administered for prophylaxis. No additional adverse events were reported.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic events reported; T/E for VARIVAX on 1/29/2025. reported that vaccines were administered to patients.; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5mL (vaccination site, route of administration, and vaccination scheme were not provided; lot #Y011712 which has been verified to be valid, expiration date reported on 29-Jan-2025, but upon internal review it was established as 02-Jul-2026) as a prophylaxis, along with a sterile diluent for dilution. However, the vaccine experienced a temperature excursion. The vaccine administered was stored at temperature of 14.65 degrees Fahrenheit (F) for a time frame of 3 hours and 15 minutes. There was no previous temperature excursion, and no data logger was used. No symptomatic events reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: prescribed Paxlovid/they have Covid/got the Pfizer Covid Vaccine; prescribed Paxlovid/they have Covid/got the Pfizer Covid Vaccine; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID:.  A 64-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: Blood pressure high; "Covid" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral; METFORMIN oral; GABAPENTIN oral; LORATADINE; TELMISARTAN/HCTZ oral; ALLERCLEAR; VITAMIN B-12; VITAMIN D NOS. The patient also took other concomitant therapy. The patient was taking a lot of different medications for high blood pressure. The patient also took a multivitamin and probiotics. Vaccination history included: BNT162b2 (LOT: EN6207, DOSE 1, SINGLE), administration date: 19Mar2021, when the patient was 60-year-old, for covid-19 immunization; Pfizer covid-19 vaccine (received one every six months), for covid-19 immunization. All the patient's previous vaccinations was Pfizer's vaccine. The patient normally get the vaccines on left arm. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "prescribed Paxlovid/they have Covid/got the Pfizer Covid Vaccine". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had Covid again. The physician had prescribed Paxlovid yesterday (26Mar2025). The patient was going to the pharmacy to pick up Paxlovid and a steroid (Intent: Treatment). The patient got the Pfizer Covid Vaccine this past Sep (Sep2024). Other than last year, the patient had received one every six months. No investigation. Patient will start taking Paxlovid as soon as he gets to the pharmacy.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.  Follow-up (03Apr2025): This is a spontaneous follow-up report received from a Consumer or other non HCP from product quality group, Program ID:. Updated information included: treatment received.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A 69-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jan2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took the Pfizer injection in Jan2025, got Covid "right" away (as reported).The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Laboratory test normal, Magnetic resonance imaging
Clinical narrative: I started to have heart palpitations soon after these then resolved. Ever since this booster, I have had 8 respiratory infections. I am tired all the time. I get light headed standing up. I have new onset anxiety. I have exercise intolerance. My heart races when I get out of bed in the morning. I had a seizure 3 days after this shot.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations, Respiratory tract infection
Clinical narrative: I started to have heart palpitations soon after these then resolved. Ever since this booster, I have had 8 respiratory infections. I am tired all the time. I get light headed standing up. I have new onset anxiety. I have exercise intolerance. My heart races when I get out of bed in the morning. I had a seizure 3 days after this shot.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: Arexvy less than 30 days expired dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4L5My, expiry date 29-MAR-2025) for prophylaxis.   On 02-APR-2025, the patient received Arexvy. On 02-APR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Arexvy less than 30 days expired dose administration). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 03-APR-2025 Pharmacist wanted to know how to proceed after administering an expired dose of Arexvy which led to expired vaccine used. The health care provider requested to remain anonymous.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: a third dose of Shingrix was inadvertently administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 7349L, expiry date 25-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (First dose of Shingrix was given on 21st June 2023) and Shingrix (Second dose of Shingrix was given on 30th August 2023).   On 03-APR-2025, the patient received the 3rd dose of Shingrix. On 03-APR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: a third dose of Shingrix was inadvertently administered to a patient). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date : 03-APR-2025 Pharmacist called to report a third dose of Shingrix was inadvertently administered to a patient which led to extra dose administered. The vaccine administration facility was the same as primary reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Viral test
Clinical narrative: Dx'd with herpes / PCR: Positive, HSV 1 and HSV 2; This spontaneous case was reported by a patient and describes the occurrence of HERPES SIMPLEX (Dx'd with herpes / PCR: Positive, HSV 1 and HSV 2) in a 61-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Not sexually active (Had not been sexually active in over 20 years / patient remained sexually inactive). Concurrent medical conditions included Blood pressure high, Allergic asthma, Hashimoto's disease and Thyroid disorder.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (Dx'd with herpes / PCR: Positive, HSV 1 and HSV 2). The patient was treated with Valaciclovir hydrochloride (Valacyclovir) for Herpes infection, at a dose of 500 milligram twice a day. At the time of the report, HERPES SIMPLEX (Dx'd with herpes / PCR: Positive, HSV 1 and HSV 2) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral test: (Positive) HSV 1 and HSV 2.         No concomitant medication was reported. The patient diagnosed with herpes. She was not sexually active in over 20 years. In 2019, learned late husband a different lifestyle in early years. She had doctor test for ALL STDs. She added herpes because it was automatically done. All returned negative. She had remained sexually inactive. She had the Moderna vaccine and booster. Two years later, went for routine woman's visit. She mentioned a sore on buttocks that wouldn't go away. Doctor tested it and was positive for herpes. Devastated, tested several more times. It was positive. She started researching. The patient did not experience any additional symptoms or events.  The patient did not have any additional medical history, concomitant disease or risk factor.  There were no additional lab data or results available.   This case was linked to US-MODERNATX, INC.-MOD-2025-784464 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-784464:Invalid case for multiple patients
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Malaise, Nausea
Clinical narrative: Patient was unwell after receiving the covid vaccine; legs are not good and a need to lie down; bad headache; nausea; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Patient was unwell after receiving the covid vaccine), LIMB DISCOMFORT (legs are not good and a need to lie down), HEADACHE (bad headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Pneumonia (Pneumonia before Christmas 2024). Previously administered products included for Product used for unknown indication: Covid-19 vaccine (bad headache), RSV Vaccine, Covid-19 vaccine and Covid-19 vaccine. Past adverse reactions to the above products included Headache with Covid-19 vaccine; Leg discomfort with Covid-19 vaccine; Nausea with Covid-19 vaccine; and No adverse effect with RSV Vaccine. Concurrent medical conditions included Urticaria and Allergic reaction to food (allergic reaction to Juniper Berries in Gin).    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient was unwell after receiving the covid vaccine), LIMB DISCOMFORT (legs are not good and a need to lie down), HEADACHE (bad headache) and NAUSEA (nausea). At the time of the report, MALAISE (Patient was unwell after receiving the covid vaccine), LIMB DISCOMFORT (legs are not good and a need to lie down), HEADACHE (bad headache) and NAUSEA (nausea) outcome was unknown.            No concomitant medication was reported. Patient was unwell after receiving the covid vaccine. She had bad headache, nausea, legs were not good and needed to lie down. It was the same with every covid vaccine. They report as if there was completely poisoned. Patient reported never having faced any issues with vaccine even when taking RSV vaccine. Moreover, over years never over the year had reaction to vaccines. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported.   This case was linked to MOD-2025-784473 (Patient Link).
Vaccine: VARZOS
Symptoms: Cranial nerve paralysis, Diplopia, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; eye 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 ophthalmic herpes zoster (Verbatim: eye shingles) (serious criteria GSK medically significant). The patient was treated with prednisone. The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2025 This case was reported by the patient via interactive digital media. The patient reported no one told you that it (eye shingles) could cause double vision, and it paralyzed your cranial nerves behind the eye. Because the patient had his/her shots 2 years ago in 2023 (from the date of reporting) and he/she was able to take prednisone and get his/her vision back to normal. However, without the Shingrix shots you would not get better. This was a terrible fate without the shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming ophthalmic herpes zoster were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Ophthalmic herpes zoster  is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles ear; still got shingles left side of scalp neck; 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), herpes zoster otitis externa (Verbatim: still got shingles ear) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles left side of scalp neck). The outcome of the vaccination failure, herpes zoster otitis externa and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had the Shingles vaccine and still got shingles left side of scalp, neck and ear. But it was not as bad as patient had expected it to be. So, patient guessed it helped to have the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles) is considered unrelated to GSK Shingles vaccine. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: DTAP, DTAPIPV, FLU3, HEP, HEPA, HIBV, MENB, MMR, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: Improper storage error/stored at 47.5F for 36 mins 11secs prior above temperature excursions; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAV (Havrix) (batch number A3X2K, expiry date 07-SEP-2026) for prophylaxis.   Co-suspect products included Rota (Rotarix liquid formulation) (batch number 7E9Y2, expiry date 30-MAY-2026) for prophylaxis, Men B NVS (Bexsero) (batch number ZK9D4, expiry date 30-APR-2027) and (batch number B4J4B, expiry date 31-OCT-2027) for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 5YB5G, expiry date 09-OCT-2026) for prophylaxis, DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis, DTPa (Infanrix) (batch number Y97N7, expiry date 31-AUG-2026) for prophylaxis, MMR (Priorix) (batch number KH2BB, expiry date 01-JAN-2026) for prophylaxis, Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number DJ22N, expiry date 13-JUN-2025) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis, Hib (Hiberix) (batch number 3A2KF, expiry date 14-JUL-2026) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Havrix, Rotarix liquid formulation and Bexsero. On an unknown date, the patient received Boostrix, Kinrix, Infanrix, Priorix, FluLaval 2024-2025 season, Menveo, Hiberix and Engerix B. On an unknown date, an unknown time after receiving Havrix, Rotarix liquid formulation, Bexsero, Boostrix, Kinrix, Infanrix, Priorix, FluLaval 2024-2025 season, Menveo, Hiberix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Improper storage error/stored at 47.5F for 36 mins 11secs prior above temperature excursions). The outcome of the incorrect storage of drug was not applicable.   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: 27-MAR-2025 The reporter reported the stability data for an excursion than occurred on 13th March 2025 for Bexsero, Menveo (1-vial), Flulaval, Havrix, Kinrix, Boostrix, Infanrix, Engerix-B, Hiberix, Rotarix (liq), Priorix stored at 47.5F for 36 mins 11secs which led to, incorrect storage of drug. The reporter stated the vaccines prior above temperature excursions, called into GlaxoSmithKline, details not provided. The reporter mentioned the several vaccines were used in patients prior to called to GlaxoSmithKline.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event to report. Wanted to inform of the extra dose. Put that the child received 5 doses of IVP due to the extra vaccine given. An additional dose of IPV was administered by a newly on boarded medical assistant who was still becoming familiar with the immunization schedule. The issue has been addressed through immediate correction education and reinforcement of protocol.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Brain fog, Death, Dizziness, Gastrointestinal disorder
Clinical narrative: Dizziness, Brain fog, Intestial problems joint pain, Blood clots  My grand mother died on April 12, 2022 due to Hypoxic Respiratory Failure, Pneumonia and pulmonary Embolism. She was in good health until she took the second Moderna and continue to get worse when she got the Booster.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, Pulmonary embolism, Respiratory failure, Thrombosis
Clinical narrative: Dizziness, Brain fog, Intestial problems joint pain, Blood clots  My grand mother died on April 12, 2022 due to Hypoxic Respiratory Failure, Pneumonia and pulmonary Embolism. She was in good health until she took the second Moderna and continue to get worse when she got the Booster.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Activated partial thromboplastin time, Blood urine present, C-reactive protein increased, Differential white blood cell count, Full blood count
Clinical narrative: Rash and joint swelling noted 48 hours after receiving Men B & HPV. Rash to lower extremities is consistent with purpura.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Joint swelling, Metabolic function test, Protein urine absent, Prothrombin time prolonged, Purpura
Clinical narrative: Rash and joint swelling noted 48 hours after receiving Men B & HPV. Rash to lower extremities is consistent with purpura.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Rash
Clinical narrative: Rash and joint swelling noted 48 hours after receiving Men B & HPV. Rash to lower extremities is consistent with purpura.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Product preparation issue
Clinical narrative: Menveo 2vial immunization given but only the powder reconstituted with sterile dilutant was given. Contacted GSK medical information and they recommended giving another Menveo vaccine with all components to make sure patient is fully immunized.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother states later in the evening after receiving the vaccine on her upper right leg, she started noticing some redness, mild swelling, and warmth at the site.  It seemed to worsen in the next day, and There might have been some mild associated pain.  Denies any other symptoms such as headaches, shortness of breath, fevers, N/V, changes in bowel or urinary habits, swelling of the throat, or any other systemic symptoms during this time.  Mother does feel that the site has improved as compared to how it initially looked within the 1st 24 hours of receiving the injection but still notes that there is redness at the site.
Age: 63.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Back pain
Clinical narrative: Lower back pain