chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: The day of the shot my left arm hurt worse than any other shot in my entire life. By evening, I could not move the arm at all. The morning after the shot at 6am, I woke with nausea and crawled to the kitchen for a nausea pill. I felt like my body had been run over by a truck. I had aches and pains throughout my body, I was scattered, cloudy, and could not think straight. I was confused, I had a severe pain in my neck on the left side that kept me awake the next 4 nights. It was so painful that there was no position in bed that didn't hurt to the point of keeping me up. I doubled a sleeping pill on night 3, and it didn't matter, I was still woken up from the pain. It is now 11 days since the shot, and my pains are not gone. The neck pain is the worse. Other pains show up down my right leg, in my lower back on the left side, and body aches here and there. NONE of this was here before I got that shot.!
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: No adverse event, Unevaluable event
Clinical narrative: Patient was given their first dose of Rotarix at 4 months of age, 16 weeks. Pt should not have received this medication after the age of 15 weeks to start series. No adverse reactions have occurred.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pruritus
Clinical narrative: Patient is 30 weeks pregnant (EDD: 08/18/2024) and presented to the OBGYN to receive her Tdap vaccination. Patient received the vaccination at 1127 and started experiencing itchiness and scratching at the injection site on her right arm around 1140. Patient reported itchiness is a 6/10. Denies signs and symptoms of an anaphylactic reaction. Injection site is red. Patient's VS are stable and within normal limits.  Cold compress applied to reaction site. Patient received IV Benadryl 25mg  around 1215 per MD order.  Patient expresses a 2/10 itchiness after medication administration. Patient was educated on how to take prescribed Benadryl and when her next dose would be. Patient educated to go to the ED if signs and symptoms of an allergic reaction occur. Patient verbalized understanding. Patient left facility stable with a coworker and will be at home with husband. VS at 1322: HR: 102, SpO2: 97%, Temp: 36.8 C, BP 98/67.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report a T/E for PEDVAXHIB (see T/E case 02615297) and reported vaccine was administered to patient after T/E occurred.  No symptoms reported.  Consent to contact HCP provided.  No additional AE/PQC.; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, unk, lot #X008998, expiration date: 14-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion (Product storage error). No additional adverse event was reported.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Sciatica
Clinical narrative: Woke up at 2 am with severe sciatic nerve pain in R buttock,  extending down R leg to ankle. Unable to move without agonizing pain. Nothing precipitated this. Constant pain in buttock & leg even when staying still. Nambumetone 750 mg. 8:30 am, able to ambulate. Constant pain but not excruciating.  ER prescribed Robaxin, Prednisone,  and Lidocaine patch with some relief until meds wear off. Pain continues.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: pt. alomost immediately experienced lightheadedness and lost of consciousness in the chair while I was consulting the patient about following visit and possible side effects from the vaccine. 911 was called and the event last about 1-2 minutes. pt resumed consciousness right before Epipen injection. BP readings were 70+/40+ for 2 times, the third time was 90+/60+. (during BP measurement. the patient seemed to be sweating. ) pt claimed that he felt much better, and i recommended pt to go to ED to get it checked due to low BP.  pt revealed that during previous dental visit, he was told that he had lower BP baseline. However other doctors visits, his BP readings were generally within normal range. I will follow up with pt later today and make sure he is doing okay, and recommened to discuss this A/E with PCP.
Age: 55.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Arthralgia, Burning sensation, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient has had pain and burning in right arm along arm and up around shoulder. Swelling and soreness at injection site, pain that continues for over two weeks now.  Pain remains at all times whether at rest or not.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Periorbital swelling, Rash, Swelling face
Clinical narrative: Patient with hx of egg allergies typically causing him to throw up & was rx'd an EpiPen for egg allergy after he had some facial swelling with last egg exposure. Mom brought patient to clinic specifically to receive flu vaccine. I read statement from CDC regarding flu vaccines for persons with egg allergy and mom chose to move forward with vaccination. Patient was monitored after vaccination in exam room for about 10-12 minutes and then asked to wait in the waiting area and instructed to let us know of any concerns for potential reaction. The morning after vaccination mom called and reports that patient had red puffy cheeks, slightly puffy eyes and a rash in neck area. She gave patient benadryl. I asked her if she would be able to monitor patient closely for any change or worsening in symptoms and she said she would. I told her to call patient's allergist and follow their instructions. I followed up with mom a few days later and she reports that symptoms improved and patient did not have to be taken to urgent care/ER. Allergist instructed that patient not receive that type of flu vaccine again which was also my recommendation. Patient received Fluzone Prefilled Syringe, we did not have any egg free flu vaccine at the time of service which I explained to mom.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Fall, Syncope
Clinical narrative: Pt came to clinic for physical and vaccinations for school. Questionnaire answered, no contraindications answered for vaccines. Consent was obtained, RN prepared vaccinations, adminstered vaccines. As patient was getting off exam table, knees started to buckle and pt slowly moved toward floor, braced arms on table and lowered herself more, RN assisted to floor, pt had sycnopal episode. Pt came to very quickly, RN obtained vitals, all normal, once pt stated she was feeling better, pt slowly assisted to exam table. Discovered pt had no consumed food or drink that day. Repeated vital signs q5 min x5, RN remained at bedside. Pt consumed 1 juice box and some crackers. MD examined, vitals remained stable, pt ok to ambulate independently out of clinic.
Age: 60.0
Sex: M
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Rash
Clinical narrative: patient reported rash and itches at site of injection. Rash spread to patient's wrist.  advised patient to take over the counter benadryl and use hydrocortisone cream.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No clinical symptoms or signs in child after the 3 vaccines were given .Child received Hep A,  MMR  , MMRV (Proquad) which contains additional MMR dose
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: angina like symptoms that lasted about 30 seconds to 1 minute.  Pt went to see a cardiologist about symptoms and there was nothing found
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Received Heplisav-B While Pregnant; Initial Report Received on 29-Apr-2024.  A pharmacist reported that a female patient (age race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.   On 26-Apr-2024, the patient received a dose of HEPLISAV-B (Lot # 943888, expiration date 14-May-2026, and NDC # 43528-003-01) while pregnant. No adverse reactions were reported.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First Dose May 2023, and Second Dose May 2024; Initial report received on 07-May-2024.  A medical assistant reported that a 52-year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 30-May-2023 and received the second dose on 07-May-2024  Relevant medical history is noted as allergies to DEMEROL [meperidine] and MOTRIN [ibuprofen].  No relevant concomitant medications were reported.    On 30-May-2023, the patient received the first dose of HEPLISAV-B (lot # 941590, expiration date 31-Aug-2025, and NDC # 43528-002-01) in the right deltoid.   On 07-May-2024, 344 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (lot # 943888, expiration date 14-May-2026; NDC # and site not reported).  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: It Has Been Two Months Since First Dose, and Has Not Had Second Dose; Initial report received on 07-May-2024  A pharmacist reported that a 19-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient did not return for her second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 26-Apr-2024, the patient received the first dose of HEPLISAV-B (lot #, expiration date, NDC #, site, and route not reported).   The reporter stated it has been two months since the patient received the first dose of HEPLISAV-B and the patient had not yet returned to receive the second dose.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 72.0
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: Received First Dose of Heplisav-B, and Second Dose of Engerix; Initial report received on 10-May-2024  A medical assistant reported that a 72-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was accidentally given ENGERIX-B as the second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 09-Apr-2024, the patient received the first dose of a hepatitis B vaccine, HEPLISAV-B (lot # 943006, expiration date 30-Sep-2025, and NDC # 43528-003-01) intramuscularly in the left deltoid.   On 09-May-2024, 31 days after having received the first dose of HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine, ENGERIX-B (lot # 9LK2G, expiration date 21-Aug-2026, and NDC # 58160-821-43) intramuscularly in the left deltoid. No adverse events were reported for either vaccination.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received The Second Dose of Heplisav-B 15 Days After Receiving The First Dose.; Initial report received on 15-May-2024.  A nurse reported that a patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received the second dose of HEPLISAV-B 15 days later.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 05-Apr-2024, the patient received the first dose of HEPLISAV-B (NDC # 43528-002-01; lot # and expiration date not provided).  On 20-Apr-2024, 15 days after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (NDC #, lot #, and expiration date not reported).  No other information was available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Received First Dose of Heplisav When They Were 17 Years and 10 Months Old; Initial report received on 24-May-2024.  A nurse reported that a 17-year-old (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unknown date, the patient received the first dose of HEPLISAV-B (NDC # 43528-002-01; lot #, expiration date, site, and route not reported). The patient was 17 years and 10 months old at the time of vaccination.  The patient reported no adverse events as a result of this.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial report received on 28-May-2024.  A physician reported to the Pregnancy Registry that, a female patient (race, age and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On an unknown date, the patient received an unknown dose of HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported) while pregnant.  No additional information was provided.  At the time of reporting, the pregnancy registry was closed and no longer accepting subjects.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure / so true, vaccine did not work; so true, vaccine did not work; 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 / so true, vaccine did not work) (serious criteria GSK medically significant) and shingles (Verbatim: so true, vaccine did not work). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-JUN-2024 This case was reported by a patient via interactive digital media. The patient reported that so true, the vaccine did not work. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Joint stiffness
Clinical narrative: Joint stiffness; Fatigue; This non-serious case was reported by a consumer and described the occurrence of stiff joint in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4f452, expiry date 20-AUG-2025) for prophylaxis.   Concomitant products included metoprolol succinate (Toprol).   On 31-MAY-2024, the patient received Arexvy .5 ml. On 31-MAY-2024, less than a day after receiving Arexvy, the patient experienced stiff joint (Verbatim: Joint stiffness) and fatigue (Verbatim: Fatigue). The outcome of the stiff joint and fatigue were not resolved.   It was unknown if the reporter considered the stiff joint and fatigue to be related to Arexvy.     It was unknown if the company considered the stiff joint and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-JUN-2024 This report was submitted via the online direct entry reporting system.  The reporter reported that the symptoms of joint stiffness were treated, and symptoms of fatigue were not treated.
Sex: U
Vaccine: RVX
Symptoms: Dyspnoea, Immediate post-injection reaction
Clinical narrative: I can not breath right after taking RSV shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, immediately after receiving RSV vaccine, the patient experienced difficulty breathing (Verbatim: I can not breath right after taking RSV shot). The outcome of the difficulty breathing was not reported.   It was unknown if the reporter considered the difficulty breathing to be related to RSV vaccine.   It was unknown if the company considered the difficulty breathing to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 03-JUN-2024 This case was reported by a patient via interactive digital media. The reporter was agreed, and stated that he or she could not breath right after taking the RSV vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: She said it appears to be shingles; shingles like rash on my upper back; Itch's like mad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: She said it appears to be shingles), vesicular rash (Verbatim: shingles like rash on my upper back) and pruritus (Verbatim: Itch's like mad). The outcome of the shingles, vesicular rash and pruritus were not reported.   The reporter considered the shingles, vesicular rash and pruritus to be possibly related to Shingles vaccine.   The company considered the shingles, vesicular rash and pruritus to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUN-2024 This case was reported by a patient via interactive digital media. The patient reported that he or she just received the 2nd vaccine.  The reporter stated that 1 day out from that he or she had a shingles like rash on his/her upper back. Patient had itching like mad and there was no painful other than he/she was scratching himself/herself raw. The nurse looked at it and stated that it appeared to be shingles. The patient stated that hopefully it was minor outbreak and seemed to had been triggered from the vaccine. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: It had been out of the refrigerator for 2.5 hours; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted product storage error in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: It had been out of the refrigerator for 2.5 hours). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt date: 05-JUN-2024 A reporter reported that he picked up a prescription last night for his wife, but the staff at the pharmacy did not tell the product needed refrigerated, 2.5 hours later, his wife noticed that it needed to be. The prescription was for Shingrix and it had been out of the refrigerator for 2.5 hours which led to Intercepted product storage error.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, MENB, MNQ
Symptoms: Product storage error
Clinical narrative: Product storage error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and Flu Seasonal QIV (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   On an unknown date, the patient did not receive Kinrix, Pediarix, Infanrix, Bexsero, Menveo and FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving Kinrix, Pediarix, Infanrix, Bexsero, Menveo and FluLaval Quadrivalent 2023-2024 season, the patient experienced intercepted product storage error (Verbatim: Product storage error). The outcome of the intercepted product storage error was unknown.   It was unknown if the reporter considered the intercepted product storage error to be related to Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the intercepted product storage error to be related to Flulaval Tetra Pre-Filled Syringe Device.   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: 29-MAY-2024 A reporter reported that Havrix, Kinrix, Pediarix, Infanrix, Hiberix, Engerix-B, Rotarix (prefilled), Bexsero, Menveo (1-vial), Flulaval, Boostrix were exposed to a maximum temperature of 9.8 C for a total time out of range of 14 min which led to Intercepted product storage error. This case was linked with case US2024067179 with same reporter.; Sender's Comments:  US-GSK-US2024067179:same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pruritus, Skin cancer, Skin disorder
Clinical narrative: skin cancer eruptions on his arms; skin problems; itching; but never received the 2nd dose; This serious case was reported by a consumer via call center representative and described the occurrence of skin cancer in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mepolizumab (Nucala Liquid) solution for injection in pre-filled pen for asthma.   Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and Nucala Liquid. On an unknown date, an unknown time after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Nucala Liquid, the patient experienced skin cancer (Verbatim: skin cancer eruptions on his arms) (serious criteria GSK medically significant), skin disorder (Verbatim: skin problems), pruritus (Verbatim: itching) and incomplete course of vaccination (Verbatim: but never received the 2nd dose). The patient was treated with prednisone acetate (Prednisone). The action taken with Nucala Liquid was unknown. The outcome of the skin cancer, skin disorder, pruritus and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the skin cancer, skin disorder and pruritus to be related to Shingrix, Shingrix, Nucala Liquid and Nucala Autoinjector Device.     The company considered the skin cancer to be unrelated to Shingrix, Shingrix, Nucala Liquid and Nucala Autoinjector Device. It was unknown if the company considered the skin disorder and pruritus to be related to Shingrix, Shingrix, Nucala Liquid and Nucala Autoinjector Device.   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: 31-MAY-2024 The patient self-reported this case. The patient reported that he had taking Nucala for over a year now. He stated after starting Nucala he had twice had skin cancer eruptions on his arms. He stated it was the 2nd most common type of skin cancer but was not able to clearly state the name. Perhaps squamous cell skin cancer.  He also sometimes had skin problems on his legs.  The patient start itching, and his physician prescribes a prednisone cream to put on them.  Prior to starting Nucala the patient had received 1st dose of shingles vaccine, but never received the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.; Sender's Comments: Skin cancer is an unlisted event which is considered unrelated to GSK's Shingrix (dose 1), Shingrix (dose 2),  Nucala Liquid and Nucala Autoinjector Device.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the administration of Kinrix to a 35 month-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 22-MAY-2024, the patient received Kinrix. On 22-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: the administration of Kinrix to a 35 month-old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-JUN-2024 The health care professional (HCP) reported the administration of Kinrix to a 35 month old patient, which led to inappropriate age at vaccine administration. The HCP asked for recommendations on this situation.
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Inappropriate reconstitution technique/the powder component, it was mixed with sterile diluent; Inappropriate reconstitution technique/the powder component, it was mixed with sterile diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA926A, expiry date 31-MAY-2024) for prophylaxis.   On 15-MAY-2024, the patient received Menveo. On 15-MAY-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate reconstitution technique/the powder component, it was mixed with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate reconstitution technique/the powder component, it was mixed with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-JUN-2024 The reporter was medical assistant. The reporter reported that any medical information if a Menveo vaccine was partially administered to a patient. The reporter said that the administration was only of the powder component, it was mixed with the sterile diluent and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered a dose of Engerix-B to a 4 week old patient but the vaccine expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-week-old female patient who received HBV (Engerix B) (batch number YM444, expiry date 22-MAY-2024) for prophylaxis.   On 04-JUN-2024, the patient received Engerix B. On 04-JUN-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered a dose of Engerix-B to a 4 week old patient but the vaccine expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-JUN-2024 The nurse reported that they administered a dose of Engerix-B (birth through 19 years old presentation) to a patient but the vaccine was expired one, which led to expired vaccine used.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: patient received an expired dose of Priorix; 3 weeks old received Priorix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-week-old female patient who received MMR (Priorix) (batch number CB979, expiry date 13-MAY-2024) for prophylaxis.   On 05-JUN-2024, the patient received Priorix. On 05-JUN-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Priorix) and inappropriate age at vaccine administration (Verbatim: 3 weeks old received Priorix). The outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-JUN-2024 The registered nurse reported that patient received an expired dose of Priorix which led to expired vaccine used. 3 weeks old received Priorix which led to inappropriate age at vaccine administration.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: diluent from Merck instead of the diluent provided with Priorix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong diluent used in a 24-year-old male patient who received MMR (Priorix) for prophylaxis.   On 04-JUN-2024, the patient received Priorix. On 04-JUN-2024, an unknown time after receiving Priorix, the patient experienced wrong diluent used (Verbatim: diluent from Merck instead of the diluent provided with Priorix.). The outcome of the wrong diluent used was unknown.   Additional Information: GSK receipt date: 05-JUN-2024 The nurse had a staff member that used diluent from Merck instead of the diluent provided with Priorix, which led wrong diluent used. She does not have any more information. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Menveo instead of Menquadfi on Monday; over 55 years patient inadvertently received Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 65-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number L7373, expiry date 30-NOV-2024) for prophylaxis.   On 03-JUN-2024, the patient received Menveo. On 03-JUN-2024, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: received Menveo instead of Menquadfi on Monday) and inappropriate age at vaccine administration (Verbatim: over 55 years patient inadvertently received Menveo). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt date: 06-JUN-2024 A pharmacist reported that a patient over 55 years of age inadvertently received Menveo instead of Menquadfi on Monday administered by a new floater pharmacist which led to Wrong vaccine administered and Inappropriate age at vaccine administration. This case was linked with case US2024070752 with same reporter.; Sender's Comments:  US-GSK-US2024070752:same reporter
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: I had tachycardia after the second dose; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (I had tachycardia after the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 1 and Batch Number -039K20-21) on 29-Jan-2021. Past adverse reactions to the above products included No adverse event with Moderna. Family history included Brain tumor (Mother has metastatic brain  tumors. Just completed gamma knife procedure but the outlook was grim) and Breast cancer (A mastectomy should be performed).   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2022, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (I had tachycardia after the second dose). At the time of the report, TACHYCARDIA (I had tachycardia after the second dose) outcome was unknown.            No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Sex: U
Vaccine: PNC13
Symptoms: Asthma, Inappropriate schedule of product administration, Malaise
Clinical narrative: was sick all the time; asthma; They have a 6 year old patient who had Prevnar 13, one dose at 3 months, one at 5 months, and one at 17 months; This is a spontaneous report received from a Physician from medical information team.  A 6-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "was sick all the time"; ASTHMA (non-serious), outcome "unknown"; INCOMPLETE COURSE OF VACCINATION (non-serious), outcome "unknown", described as "They have a 6 year old patient who had Prevnar 13, one dose at 3 months, one at 5 months, and one at 17 months". Additional information: The caller was calling about Prevnar 20. They have a 6 year old patient who had Prevnar 13, one dose at 3 months, one at 5 months, and one at 17 months. She stated "if it is after a year you need two, basically it is the 2, 4, 6 thing but we didn't complete that and usually they would have completed it." He was sick all the time and when he came in they gave him the flu shot. She looked in the records and saw that they only ended up giving him the flu shot. He has asthma but it is not bad, it used to be worse. She wanted to know if they can give Prevnar 20 to complete the series? She stated she thinks they can give it.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29May2024 to 02Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Physician.  An 88-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). There were no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid via oral from 25Jan2024 to 30Jan2024.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 17:00 as dose 1 (toppac); single (Lot number: hg4628) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no known allergies. The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (Dose 3 (Booster), Single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 01Oct2022, when the patient was 30-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (Dose 2, Single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 01Mar2022, when the patient was 29-year-old, for COVID-19 Immunization; johnson and johnson COVID-19 vaccine (Dose 1, Single, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 07May2021, when the patient was 28-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 28May2024 to 02Jun2024.
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: She had a vaccine with Pfizer, it affected her eyes; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 15May2024 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: COVID-19 vaccine (1st dose), administration date: 17Feb2021, for covid-19 immunization; Covid-19 vaccine (2nd dose), for covid-19 immunization; Covid-19 vaccine (3rd dose), for covid-19 immunization. The following information was reported: EYE DISORDER (non-serious), outcome "unknown", described as "She had a vaccine with Pfizer, it affected her eyes".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400191091 Same reporter/patient, different shot/event;
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Itching scar, Neoplasm malignant, Scar inflammation, Vaccination site erythema
Clinical narrative: I was told that it could be some form of cancer; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I was told that it could be some form of cancer"; VACCINATION SITE SCAR (non-serious), VACCINATION SITE  ERYTHEMA (non-serious), ITCHING SCAR (non-serious), SCAR INFLAMMATION (non-serious), WOUND (non-serious), outcome "not recovered" and all described as "the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed". The patient underwent the following laboratory tests and procedures: Biopsy: (05Jun2024) awaiting the result, notes: some form of cancer suspected. Therapeutic measures were taken as a result of neoplasm malignant, vaccination site scar, erythema, itching scar, scar inflammation, wound. Course of events: Since the COVID's Pfizer -Booster injection, in Sep2021, the place, where the needle was put into patient's arm, had never healed! It was almost three years, when patient experienced an open, red, itching scar, inflamed. The steroid injection, patient received this year did not help out. Yesterday 05Jun2024, the biopsy was performed, and patient was awaiting the result. Patient was told that it could be some form of cancer. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site scar, Wound
Clinical narrative: I was told that it could be some form of cancer; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I was told that it could be some form of cancer"; VACCINATION SITE SCAR (non-serious), VACCINATION SITE  ERYTHEMA (non-serious), ITCHING SCAR (non-serious), SCAR INFLAMMATION (non-serious), WOUND (non-serious), outcome "not recovered" and all described as "the place, where the needle was put into my arm had never healed/ an open,red, itching scar, inflamed". The patient underwent the following laboratory tests and procedures: Biopsy: (05Jun2024) awaiting the result, notes: some form of cancer suspected. Therapeutic measures were taken as a result of neoplasm malignant, vaccination site scar, erythema, itching scar, scar inflammation, wound. Course of events: Since the COVID's Pfizer -Booster injection, in Sep2021, the place, where the needle was put into patient's arm, had never healed! It was almost three years, when patient experienced an open, red, itching scar, inflamed. The steroid injection, patient received this year did not help out. Yesterday 05Jun2024, the biopsy was performed, and patient was awaiting the result. Patient was told that it could be some form of cancer. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.