chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, Vaccination failure
Clinical narrative: Posttransplant HBV vaccine completion with HBsAb testing. HBsAb < 10 IU/L. = 5 (71);   This literature marketed report has been received from the authors of the published article and refers to a 43-year-old male adult patient.  The patient's medical history included heart transplantation with no acute rejection. The patient's concurrent conditions were not reported. Concomitant therapies included alemtuzumab (induction).   On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) 40 mcg/mL, 3 dosage regimen (0, 1, 6 months) (RECOMBIVAX HB) (route of administration, vaccination site, vaccination scheme, lot #, and expiration date were not reported) as a prophylaxis.  On an unknown date (Posttransplant HBV vaccine completion), the hepatitis B surface antigen (HBsAb) testing was minor to 10 IU/L (vaccination failure). At the reporting time, the outcome of was unknown.   The reporter considered the event of vaccination failure to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).   This is one case of several received from the same literature article. Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, Vaccination failure
Clinical narrative: Posttransplant HBV vaccine completion with HBsAb testing. HBsAb < 10 IU/L. = 5 (71);   This literature marketed report has been received from the authors of the published article and refers to a 71-year-old female adult patient.  The patient's medical history included lung transplantation with no acute rejection. The patient's concurrent conditions were not reported. Concomitant therapies included anti-thymocyte globulin (ATG) (induction).   On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) 40 mcg/mL, 3 dosage regimen (0, 1, 6 months) (RECOMBIVAX HB) (route of administration, vaccination site, vaccination scheme, lot #, and expiration date were not reported) as a prophylaxis.  On an unknown date (Posttransplant HBV vaccine completion), the hepatitis B surface antigen (HBsAb) testing was minor to 10 IU/L (vaccination failure). At the reporting time, the outcome of was unknown.   The reporter considered the event of vaccination failure to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).   This is one case of several received from the same literature article. Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, Vaccination failure
Clinical narrative: Posttransplant HBV vaccine completion with HBsAb testing. HBsAb < 10 IU/L. = 5 (71);   This literature marketed report has been received from the authors of the published article and refers to a 53-year-old female adult patient.  The patient's medical history included lung transplantation with no acute rejection. The patient's concurrent conditions were not reported. Concomitant therapies included alemtuzumab (induction).   On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) 40 mcg/mL, 3 dosage regimen (0, 1, 6 months) (RECOMBIVAX HB) (route of administration, vaccination site, vaccination scheme, lot #, and expiration date were not reported) as a prophylaxis.  On an unknown date (Posttransplant HBV vaccine completion), the hepatitis B surface antigen (HBsAb) testing was minor to 10 IU/L (vaccination failure). At the reporting time, the outcome of was unknown.   The reporter considered the event of vaccination failure to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).   This is one case of several received from the same literature article. Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   In JAN-2025, the patient received the 2nd dose of Shingrix. In JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date:25-MAR-2025 The reporter was a Pharmacist that was calling in regards to her mother who had taken the first Shingrix vaccine in 2018 and then, received her 2nd vaccine 2 months ago.  Daughter did not give me any further information in regards to her mother. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2025036051:same reporter
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received HBV (Engerix B) (batch number EP274, expiry date 14-MAR-2025) for prophylaxis.   On 19-MAR-2025, the patient received Engerix B. On 19-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix-B administration). The outcome of the expired vaccine used 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: 19-MAR-2025 A registered nurse wanted to know the efficacy on Engerix-B immunization after given an expired dose to patient after the expiration date (less than 30 days), which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2025033657:Same reporter/Different patient
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Dose administered after temperature excursion; 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 a specified number of patients who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Dose administered after temperature excursion). 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: 20-MAR-2025 Healthcare Provider stated they stored Priorix in the freezer instead of the fridge and lowest temperature reached would be probably -17 degrees Fahrenheit and the vaccine was administered to about 4 patients after the temperature excursion, which led to incorrect storage of vaccine. Caller did not have any patient demographics or dates of administration. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: The vaccine was administer on 24-Mar-2025, and the vaccine was expire since 15-Mar-2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received HBV (Engerix B) (batch number E42X5, expiry date 15-MAR-2025) for prophylaxis.   On 24-MAR-2025, the patient received Engerix B. On 24-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: The vaccine was administer on 24-Mar-2025, and the vaccine was expire since 15-Mar-2025). The outcome of the expired vaccine used 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: 24-MAR-2025 The reporter was informed by a nurse that a vaccine (Engerix-B) was expired and was given to a patient, which led to expired vaccine used. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Respiratory disorder
Clinical narrative: Covid-19; Covid-19; almost not breathing; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient in her 50's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "almost not breathing". The event "almost not breathing" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient mentioned that she had a reaction with the Pfizer Covid-19 shot, and that was years ago when she was under 60 years old (she is now over 60 years old). She explained that when she received the Pfizer COVID vaccine years ago, she had to go to the hospital because she was almost not breathing. She said it was scary for her and they recommended not to get the second shot. So her doctor told her not to take the covid shot. She now has COVID and was prescribed Paxlovid. So now that she has Covid-19 and will be taking Paxlovid, she was wondering if she will have a reaction to the medication as well because she had a reaction last time with Pfizer covid-19 shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; ROTATEQ was administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On 17-Mar-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (frequency once, lot # X027423, expiration date: 05-Oct-2025; strength and dose were not reported) administered by oral route for prophylaxis by a health professional, which was administered after a temperature excursion (Product storage error). The excursion temperature was 52.5 Fahrenheit with time frame of 1 hour. There was no previous temperature excursion. No additional adverse event (AE) was reported (No adverse event).   This is one of four reports received from the same reporter.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure 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: 24-MAR-2025 The patient self-reported this case for himself/herself. This case was reported by a patient via interactive digital media. Patient had the shingles vaccine and got it anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; 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 disease) is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction.
Age: 23.0
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction
Age: 38.0
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction.
Age: 30.0
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction. Client complained of heat, itching, swelling, reddness, and pain at injection site. No papules or tohter complaint voiced. Self medicated with tylenol and benadryl. Hydrocortizone cream applied to injection site.
Age: 30.0
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction. Client complained of heat, itching, swelling, reddness, and pain at injection site. No papules or tohter complaint voiced. Self medicated with tylenol and benadryl. Hydrocortizone cream applied to injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose of Shingrix vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis
Clinical narrative: parent reports they went to ER  yesterday 3/27/2025 for eval and was told he has cellulitis. Unable to locate any ER report.  Family cancelled appt with provider in this office yesterday.  We have not seen injection to verify local reaction or cellulitis.
Age: 60.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Fatigue, Injection site discharge, Injection site erythema, Injection site warmth
Clinical narrative: Had pneumococcal and tetanus vaccines both injected IM to left arrm Received Tuesday Warm red area began late Tuesday night Pt now says area has discoimfort in region Is applying ice and taking Tylenol Feels maybe a little tired but no definitive nor acute consistent symptoms. Was prescribed Keflex on 3/21/25. Went to ED on 3/24/25 for worsening spread. Was prescribed doxycycline additionally.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Dizzy. Nauseous. Vomiting. Bile. Diarrhea
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Ultrasound scan
Clinical narrative: Patient returned to PCP office on 03/26/2025, c/o redness, swelling and pain at site of PCV20 injection on left upper arm last week. Denies fever, SOB but felt chilly. Also worried about abdomen , worry about shingles. Referral of abd. US given.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Vertigo, Vomiting
Clinical narrative: patient states that he had a very sore arm, vertigo, nausea / vomiting that required a visit to urgent care a couple of days after receiving vaccine; patient has now recovered
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB, MMR, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMR given incorrectly due to age. MMR vaccine given at same time as other vaccines, no reaction per mother.
Age: 51.0
Sex: F
Vaccine: PNC15
Symptoms: Cold sweat, Erythema, Injection site erythema, Myalgia
Clinical narrative: redness , had myalgias, cold sweats and developed erythema over her left arm at the site of the injection
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, raised rash at injection site. 5.5 cm x 10 cm
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, raised rash at injection site. 5.5 cm x 6 cm
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Red, hot, raised rash at injection site. 5 cm x 6 cm
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: APRN  alerted nursing staff through Teams Chat to give a TDAP vaccine to a patient . I did not see the message when it was sent, and 10 minutes later provider came to the lab where nurses work and asked if we had seen the message and the patient had been waiting. I prepared the vaccine, scanned the vaccine in the patient's chart and went to the patient room I believed I was supposed to go to. I was rushing a bit because I knew the patient had been waiting. In the room I asked the patient his first name starting with the same letter and he confirmed. Unfortunately, I did not ask any other identifiers, as I was concerned he had been waiting for a while.  I explained to the patient that he would be getting a TDAP and proceeded to ask the following standard questions we ask prior to giving any vaccine, He said no to all of these.  He agreed to take the vaccine and asked if it could be administered in the right arm. I then gave the vaccine, and afterwards he asked if he was still going to see the provider. At that moment I realized that this was not the patient the provider wanted me to give the vaccine to, as he always asks for vaccines after he has seen the patient. I asked the patient to repeat his name, and he said initials. I asked why he confirmed his name started with a different letter and he said he was distracted with his phone. I had to explain to the patient what happened. He asked if there was any danger getting the TDAP if he did not need it at this time. I looked in his chart and saw he had a TDAP in 2023. I told him this would not be detrimental to his health, but apologized for the incident and told him I would report this to his provider, my managers and take all the proper channels to report what happened. The patient was very nice about it, and said he understood it was a mistake but he was not going to pursue any actions. I reported the incident to my supervisor and she contacted our regional manager for the next step which was to report the incident to VAERS as well as our own company adverse event reporting system.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Vaccination error
Clinical narrative: Patient was given vaccine that wasn't on his care gap.  No patient history of vaccine being received or administered in patients chart previously, however.   Outcome, provider discussed with patient the vaccination issue.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Pyrexia, Rash, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Pt was visiting family from 3/8 to 3/15.  Shortly after they left, they became aware that young family member they were visiting went on to develop Varicella infection.  Pt was fine and seen on 3/18 at primary care office for 4yo routine visit, in which Varicella vaccine 2nd dose was given.  Pt went on to develop lowgrade fever and rash c/w mild case of Varicella beginning on 3/27.  Seen in primary care office that day and PCR testing from skin swab confirmed Varicella infection.  Unclear if symptoms are due to vaccine or wild-type infection after known exposure.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Muscular weakness, Myalgia, Neuralgia, Paraesthesia
Clinical narrative: muscle paralysis, difficulty lifting or using left arm. difficulty applying pressure or holding anything with left arm. nerve pain and tingling in in left hand. muscle weakness, exessery muscle soreness. had to wear an arm splint for pain relief and support.  No muscular inflammation or pain initially following vaccine. Muscle paralysis began less than 24 hours after vaccine administration in left deltoid/shoulder area.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Pyrexia
Clinical narrative: fever - tylenol and motrin, right arm redness and streaks - Urgent care gave steroids.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Nausea, Sleep disorder, Tremor
Clinical narrative: EVENING OF SHOT PT STATES SHE WAS "FREEZING COLD AND COULD NOT STOP SHAKING AND HAD SOME NAUSEA BUT NO VOMITING. WENT TO BED AND WAS UP ABOUT EVERY HOUR TO FIGURE OUT HOW TO GET TO BATHROOM TO PEE" NEXT MORNING "HAD NAUSEA OFF AND ON DURING THE DAY AND WAS STILL WEAK AND SHAKING" AND IS SHAKING UNTIL TODAY WHEN SHE CAME  INTO REPORT HER REACTION.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No adverse event at this time
Age: 5.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood test, Electroencephalogram, Lumbar puncture, Magnetic resonance imaging, Seizure
Clinical narrative: 3/23/25 had 3 seizures
Age: 53.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports small injection site reaction (few cm wide red marking) on 3/26. By 3/28, reaction had spread to entire lower half of bicep (7inches wide by 7inches tall). Patient reports slight burning sensation, swelling and warm to the touch. Patient reports taking Benadryl with no relief.
Age: 66.0
Sex: M
Vaccine: PNC21
Symptoms: Erythema, Pain
Clinical narrative: Pt received vaccine on 3/21 and came back to the pharmacy on 3/28. Patient still had red marking 8"x5" redness but report pain and swelling has gone away
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a 5-day expired dose of Moderna COVID vaccine.  No adverse effects.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient received the pediatric dose of the Hep B vaccine instead of the adult dose.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear discomfort, Ear pain, Injection site rash, Injection site warmth
Clinical narrative: Muscle and body aches and shivering within 15 hrs of administering  and 2 days later , hot painful rash on arm 1 inch under vaccine and 9 days after vax , Swollen and enlarged and painful right cervical lymph node in neck along with burning and pain in right ear   CURRENTLY BEING TREATED AND WILL GO BACK IN ONE WEEK IF NO CHANGE
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Pain, Rash
Clinical narrative: Muscle and body aches and shivering within 15 hrs of administering  and 2 days later , hot painful rash on arm 1 inch under vaccine and 9 days after vax , Swollen and enlarged and painful right cervical lymph node in neck along with burning and pain in right ear   CURRENTLY BEING TREATED AND WILL GO BACK IN ONE WEEK IF NO CHANGE
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: A dose of RSV vaccine was administered when they had previously received a dose.
Age: 1.33
Sex: F
Vaccine: COVID19, DTAPIPVHIB, FLU3, HEPA, MMR, PNC20, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Pentacel was given on 2/28 intramuscularly in left thigh,  possibly without the hib component.  Spoke with mom on the phone and she does not report any s/s.  Was discovered in vaccine count. Mom is coming to administer single hib vaccination to patient to make up for the potentially missed vaccination on 3/31/2025.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist administered Fluzone HD instead of Fluzone (regular). Patient had no complaints at time of report.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Brief resolved unexplained event
Clinical narrative: BRUE, possible seizure
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two high dose flu shots 1 month apart. Patient received 1 shot  on 02/19/25 and the second on 03/14/25. Patient is feeling fine, reported no sickness.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Aspiration pleural cavity, Blood test, Computerised tomogram thorax, Pleural effusion, Respiratory distress
Clinical narrative: pleural effusion and respiratory distress resulting in multiple hospitalizations.  324/25-3/26/25 and readmit 3/27/25 until current
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan, X-ray
Clinical narrative: pleural effusion and respiratory distress resulting in multiple hospitalizations.  324/25-3/26/25 and readmit 3/27/25 until current
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: SHINGRIX DOSE 2: PT HAD ITCHY RED INFLAMMED RASH WITHOUT BUMPS AT SITE OF INJECTION THAT LASTED AT LEAST 2 WEEKS
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Muscle swelling, Superficial vein prominence
Clinical narrative: LEFT HAND,  PALM MUSCLE RIGHT BELOW THUMB WAS SLIGHTLY SWOLLEN . PATIENT IS NOT SURE IF ITS SWOLLEN, OR IN THEIR HEAD, BUT IT SEEMS BIGGER THAN THEIR OTHER HAND WITH SLIGHTLY MORE PROMINENT VEINS
Age: 21.0
Sex: F
Vaccine: HPV9, TD, TDAP
Symptoms: Dizziness, Syncope, Vomiting
Clinical narrative: Adverse event: dizziness, fainted, and vomiting . Pharmacist gave her water and some candies. After she vomited, she felt better, no epi pen needed or EMS
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Body temperature increased
Clinical narrative: Both vaccines were given at Well Check at 0955.  Pt developed a temperature of 99.0 early afternoon, then approximately at 1630, temp went up to 101.4.  Pt vomited twice, last episode was at 1450.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult patient administered pediatric dose of vaccine.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Erythema, Induration, Injection site infection, Pain in extremity
Clinical narrative: Received vaccines On Friday 3/21/2025 and noticed arm soreness  on  Saturday and the walnut size on Sunday that area got bigger and harder. Called primary on Monday and they saw patient and informed she had infection at site of injections and gave first antibiotic Bactrim. Then 3/27 woke up with red spot and hives.  She picked up medication for clindamycin and prednisone 3/28.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Urticaria
Clinical narrative: Received vaccines On Friday 3/21/2025 and noticed arm soreness  on  Saturday and the walnut size on Sunday that area got bigger and harder. Called primary on Monday and they saw patient and informed she had infection at site of injections and gave first antibiotic Bactrim. Then 3/27 woke up with red spot and hives.  She picked up medication for clindamycin and prednisone 3/28.
Sex: M
Vaccine: MMR, MMR
Symptoms: Inflammation
Clinical narrative: inflammation; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age.   The patient's medical history, concurrent conditions were, and concomitant therapies were not reported.   On 24-Feb-2025, the patient was vaccinated for prophylaxis with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot #Y013131, expiration date: 30-Jul-2026), 0.5 mL/ series) reconstituted with sterile diluent (BAXTER STERILE DILUENT).  On an unspecified date in 2025, the patient probably experienced inflammation as the pharmacist received an order for methylprednisolone (MEDROL DOSE PACK).   At the reporting time, the outcome of inflammation was unknown.   The causal relationship between the event of inflammation and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) sterile diluent (BAXTER STERILE DILUENT) was not reported.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report inadvertent administration of VARIVAX after a temperature excursion. Vaccine was administered on 04MAR2025 to a patient. Limited demographics provided. No additional AE/PQC. No additional information.         ?    Names of vacc; This spontaneous report was received from a Nurse 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.   HCP called to report inadvertent administration of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE) (dose, units, and route of administration were not reported) (lot #Y011019, expiration date: 18-Jun-2026) for prophylaxis after a temperature excursion (Product storage error). Vaccine was administered on 04-MAR-2025 to a patient. Temperature excursion was reported as follows: -12.13C for a time frame of 0 hours 39 minutes 0 seconds. Previous temperature excursion of -14.19C for 9 minutes; and -14.25C for 16 minutes. There was no additional AE/PQC (No adverse event).
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: sitting wait woman whose daughter is 28 and pregnant. Has HPV.; sitting wait woman whose daughter is 28 and pregnant. Has HPV.; This spontaneous prospective pregnancy report was received from a Consumer or other non-health professional and refers to a 28-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. The patient's gravidity was reported as 1 and information regarding her fetal outcome was not provided.   On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) dose number 1 as prophylaxis (lot #, expiration date, dose, units, route of administration and anatomical location were not reported) (exposure during pregnancy).  On an unknown date, the patient experienced human papillomavirus virus (HPV) infection (papilloma viral infection). By the reporting time, the patient had not recovered from the event papilloma viral infection, whereas regarding exposure during pregnancy was not provided.  The causal relationship between the events and the suspect vaccine was not provided.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: HCP calling to report that her partner did not receive his 3rd dose of GARDASIL 9 that was due on 1/31/2025 because his insurance denied it since he is 46 years old. First and second GARDASIL 9 doses were administered appropriately.; No adverse effects reported.; This spontaneous report was received from a nurse and refers to a 46-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown dates, the patient was vaccinated with the first and second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, formulation, route of administration, lot # and expiration date were not reported) as prophylaxis.  Health care professional (HCP) called to report that her partner did not receive his third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) that was due on 31-Jan-2025 because his insurance denied it since he was 46 years old (Incomplete course of vaccination). First and second doses were administered appropriately. No adverse effects reported (No adverse event).
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient did not report any adverse issues or side effects from the administered dose; Expired dose was inadvertently administered to a patient on 03/10/2025.  The dose had never undergone any temperature excursions; This spontaneous report was received from Other health professional and refers to a 11-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 10-Mar-2025, the patient was inadvertently vaccinated with and expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection, 0.5 mL, once (strength, route of administration, site of administration, and vaccination scheme were not provided; lot # X014788 which has been verified as a valid number, and expiration date reported and validated as 07-Mar-2025) as a prophylaxis. The dose had never undergone any temperature excursions. The patient did not report any adverse issues or side effects from the administered dose.
Sex: F
Vaccine: PNC21
Symptoms: Chills, Gaze palsy, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: agent called on behalf of a consumer friend who reported via text that she experienced injection site redness and swelling after receiving CAPVAXIVE. The CAPVAXIVE was administered on 3/15/25 at a pharmacy. The consumer reported ha; headache; vaccination site swelling; fever; body chills; body aches; This spontaneous report was received from the patient's friend and refers to a female patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions included Celiac disease, and Asthma. Concomitant therapies were not reported.   On 15-Mar-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On unspecified date in March 2025 at a pharmacy (also reported as: After receiving CAPVAXIVE), the patient experienced injection site redness and swelling , also experienced fever, body chills, body aches and headaches. It was mentioned that as of 17-MAR-2025, the patient reported feeling better, however the outcome of all adverse events was reported as recovering. The causal relationship between all adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
Age: 0.17
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: calling on behalf of Medical Assistant with a report of an adverse event regarding GARDASIL 9.  FBE reporting that the Medical Assistant stated: "A patient of our practice was inadvertently administered a dose of GARDASIL 9 when they were 2 month; No additional AE; This spontaneous report has been received from a certified medical assistant (C.M.A.) via company representative and refers to a 2-month-old patient of unknown gender.  There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date, at the age of 2 months old, the patient was inadvertently administered a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection, 0.5 ml (lot#, expiration date, route of administration, anatomical location were not reported), for prophylaxis (Product administered to a patient of inappropriate age).   At the reporting time, the patient was 11 years old and the reporter was inquiring if the patient would be eligible for vaccination with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) as they were within the recommended age. The reporter confirmed they did not receive any reports of the patient having any medical concerns or symptoms at the time they were administered the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) inadvertently.  No additional adverse event was reported.  Lot# is being requested and will be submitted if received.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Inbound call from HBP regarding T/E for VARIVAX on 1/29/2025. See T/E case #0277601. HBP reported that vaccines were administered to patients. No symptomatic events reported. MD agrees to be correspondence contact for AE case. No additional AE/No PQC; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 21-MAR-2025, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, lot #Y011712, expiration date: 02-JUL-2026 (route of administration and anatomical location were not provided), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not reported). On 29-JAN-2025, the vaccine underwent a temperature excursion of 14.65 Fahrenheit (F) degrees for 13 hours and 15 minutes. There was no previous temperature excursion. Data logger was not involved. No symptomatic events, no additional adverse events were reported.
Sex: M
Vaccine: PNC15, PNC15, PNC15
Symptoms: Pneumonia, Sepsis
Clinical narrative: pneumonia sepsis; pneumonia sepsis; This spontaneous report was received from an Other health professional (HCP) via field employee and refers to a Child male patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown dates, the patient was vaccinated 3 doses of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) Suspension for injection, (indication, expiration date, and lot # were not reported) for prophylaxis. Reporter said that after the third dose the child developed pneumonia sepsis. This happened last year (in approximately 2024), the HCP did not have an exact date and the nurse who worked with the child was not available. Child was hospitalized.  At the reporting time, the outcome of pneumonia sepsis was unknown.   The causal relationship between the event of pneumonia sepsis and Pneumococcal 15-valent Conjugate Vaccine was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted; This spontaneous report was received from a physician via a company employee and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-MAR-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (exact dose, expiration date, lot #, route of administration, and anatomical location were not reported) for prophylaxis.  On that day, after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), the patient fainted. Once the patient was responsive again, she was assessed and allowed to leave with her father. The patient returned to school after their doctor's visit and proceeded to participate in normal activities during and after school, including sports, with no issue. No further issues were reported about this patient. At the reporting time, the outcome of the event was not reported.  The causal relationship between the event of fainted and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) was not provided.   Upon internal review, the events of fainted was determined to be medically significant.
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; HCP called to report a patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 days instead of the recommended 42 day vaccination schedule. No side effects or symptoms reported. No Additional AE/ No PQC.; This spontaneous report was received from an other health professional and refers to a 1-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 03-Jan-2025, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine Injection (lot #Y005351, expiration date: 08-Jan-2027) 0.5 mL, Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Y009786, expiration date: 20-Nov-2025) 2 mL, administered by Oral route and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (VAXELIS), Injection (lot #u7767aa was an invalid lot#, expiration date was reported as 26-May-2026) 0.5 mL at 41 days instead of the recommended 42 day vaccination schedule (Product administered to patient of inappropriate age). No side effects or symptoms reported. No Additional AE (no adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac disorder, Heart valve replacement, Impaired work ability, Surgery
Clinical narrative: Has a pig valve in his heart to save his life; that virus attacked his heart; has had multiple surgeries; had to retire early from his bank; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: Has a pig valve in his heart to save his life) (serious criteria GSK medically significant and life threatening), heart disorder (Verbatim: that virus attacked his heart) (serious criteria life threatening and clinically significant/intervention required), surgery (Verbatim: has had multiple surgeries) (serious criteria clinically significant/intervention required) and impaired work ability (Verbatim: had to retire early from his bank). The outcome of the near death experience, heart disorder, surgery and impaired work ability were not reported.   The reporter considered the near death experience, heart disorder, surgery and impaired work ability to be related to Shingles vaccine.     The company considered the near death experience, heart disorder, surgery and impaired work ability to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date : 22-MAR-2025 This case was reported by a patient via interactive digital media. The reporter stated that he/she took his chances.  No vaccine for him/her.  The shingles vaccine almost killed his brother in law and he was been fighted for his life eversince.  Had a pig valve in his heart to save his life.  The patient had multiple surgeries since and had to retired early from his bank management job.  All because the vaccine , that virus attacked his heart.; Sender's Comments: Near death experience, Cardiac disorder, Surgery and Impaired work ability are unlisted events which are considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Multiple sclerosis
Clinical narrative: Multiple sclerosis; This serious case was reported by a consumer via interactive digital media and described the occurrence of multiple sclerosis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced multiple sclerosis (Verbatim: Multiple sclerosis) (serious criteria GSK medically significant). The outcome of the multiple sclerosis was not reported.   It was unknown if the reporter considered the multiple sclerosis to be related to Shingles vaccine.     The company considered the multiple sclerosis to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2025 This case was reported by a patient via interactive digital media. The patient got Multiple sclerosis right after they gave a shingle vaccine.; Sender's Comments: Multiple sclerosis  is an unlisted event which is considered unrelated to GSK vaccine  Shingles vaccine
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Tremor, Vertigo
Clinical narrative: vertigo; Dizziness; Headache; shaky legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stent placement (Coronary artery disease history of stents 2 times). Concurrent medical conditions included hypothyroidism, coronary artery disease (Coronary artery disease history of stents 2 times), hyperlipidemia, blepharitis and hypertension. Concomitant products included levothyroxine sodium (Levothyroxine), metoprolol, doxycycline, atorvastatin and hydrocortisone.   On 13-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 14-MAR-2025, 1 days after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness), headache (Verbatim: Headache) and tremor limb (Verbatim: shaky legs). On an unknown date, the patient experienced vertigo (Verbatim: vertigo). The outcome of the dizziness, headache, tremor limb and vertigo were unknown.   It was unknown if the reporter considered the dizziness, headache, tremor limb and vertigo to be related to Shingrix.     It was unknown if the company considered the dizziness, headache, tremor limb and vertigo to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-DEC-2024  The patient reported that she received her Shingrix dose number one on 13th March 2025. Beginning on 14th March 2025 she began experiencing dizziness and headache along with shaky legs. The lot number for the dose was not provided to the patient. She was referred to an urgent care facility and was diagnosed with vertigo there. The name of the treating physician was not available. The patient's own Primary care physician had just recently retired, so she had no HCP to contact at this time.