chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Feeling cold, Injection site erythema, Injection site pruritus
Clinical narrative: Immunization Administration Patient is a 11 y.o. 3 m.o. patient here to receive the immunization(s) as ordered today. The VIS(s) and/or appropriate Immunization Fact Sheets were made available to the caregiver for review of indications and any contraindications prior to immunization administration. No contraindications or concerns were voiced by the parent/guardian and all questions answered.   Temp: 98.2 °F (36.8 °C) today. Immunization(s) administered and the patient instructed to wait for 15-20 minutes after the injection to watch for any side effects or syncopal symptoms.   At 1045, pt complained of being lightheaded, itchy at sites where vaccines were administered and on legs. Noted redness at sites and splotchiness down arms. Had pt lay down on table. Removed bandaids due to possible tape sensitivity. Took blood pressure, oxygen saturation and heart rate and continued to monitor with pulse ox- vital signs were within normal range. Mom states she has not eaten anything this morning because planning on doing fasting labs after the appointment.    At 1050, patient started to complain of more itchiness and throat tightness. Dr. came to assess pt and administered 10 mg zyrtec. Gave patient water and applesauce.    At 1107- took blood pressure, oxygen saturation and heart rate which were within normal range. Dr. re-assessed pt. Instructed pt to keep lying down and told mom to let us know if she is having any new or worsening symptoms. We would come back in the next 15-20 minutes to reassess.   At 1130- Dr. re assessed pt. Pt complaining of lightheaded, cold, clammy. Dr. ordered 0.3 mg epi-pen administration.   At 1139- Administered epi-pen. Dr. reassessed pt. Took set of vital signs and were within normal range. Per Dr., patient pulses were strong and overall looked better.    At 1200- pt used the restroom. Pt complains of feeling shaky and being lightheaded. Dr. reassessed pt and reassured patient shakiness was due to epi-pen administration.    At 1204- took another set of vitals- within normal range. Dr. advised mom to take pt to ER and mom verbalized understanding and had no further questions. Patient and mom left clinic to drive to ER.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Nervousness, Pruritus, Rash macular, Throat tightness
Clinical narrative: Immunization Administration Patient is a 11 y.o. 3 m.o. patient here to receive the immunization(s) as ordered today. The VIS(s) and/or appropriate Immunization Fact Sheets were made available to the caregiver for review of indications and any contraindications prior to immunization administration. No contraindications or concerns were voiced by the parent/guardian and all questions answered.   Temp: 98.2 °F (36.8 °C) today. Immunization(s) administered and the patient instructed to wait for 15-20 minutes after the injection to watch for any side effects or syncopal symptoms.   At 1045, pt complained of being lightheaded, itchy at sites where vaccines were administered and on legs. Noted redness at sites and splotchiness down arms. Had pt lay down on table. Removed bandaids due to possible tape sensitivity. Took blood pressure, oxygen saturation and heart rate and continued to monitor with pulse ox- vital signs were within normal range. Mom states she has not eaten anything this morning because planning on doing fasting labs after the appointment.    At 1050, patient started to complain of more itchiness and throat tightness. Dr. came to assess pt and administered 10 mg zyrtec. Gave patient water and applesauce.    At 1107- took blood pressure, oxygen saturation and heart rate which were within normal range. Dr. re-assessed pt. Instructed pt to keep lying down and told mom to let us know if she is having any new or worsening symptoms. We would come back in the next 15-20 minutes to reassess.   At 1130- Dr. re assessed pt. Pt complaining of lightheaded, cold, clammy. Dr. ordered 0.3 mg epi-pen administration.   At 1139- Administered epi-pen. Dr. reassessed pt. Took set of vital signs and were within normal range. Per Dr., patient pulses were strong and overall looked better.    At 1200- pt used the restroom. Pt complains of feeling shaky and being lightheaded. Dr. reassessed pt and reassured patient shakiness was due to epi-pen administration.    At 1204- took another set of vitals- within normal range. Dr. advised mom to take pt to ER and mom verbalized understanding and had no further questions. Patient and mom left clinic to drive to ER.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling and  large red area at the site of injection
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling, numbness on the fingers. Come and go but definitely after getting the COVID shot per pt
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope, first aid rendered. pt recovered within 5-10 min
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine that expired the previous day 10/31/2024 (given on 11/1/2024), Patient was contacted, and she did not report any adverse reactions. She was told that she should come back and receive a dose of non-expired Novavax, but she declined. She said she did not feel that one day from the expiration date was going to make much difference. I explained that since it was past expiration it may not be as effective, but she said she was ok with the dose she got.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No adverse event; Customer reported patient administered GARDASIL 9 after product experienced a temperature excursion. TE filed: 02687250.  No symptoms reported. See related AE cases: 0267305, 02687306 and 02687307. Consent to correspond granted.  No additional AE/No; This spontaneous report was received from a nurse practicioner and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-OCT-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 mL, lot #Y000205, which was considered a valid lot#, expiration date: 23-SEP-2026, administered for prophylaxis (strength, and route of administration were not provided). It was reported that the vaccine was administered to the patient after the product experienced a temperature excursion with the temperature of 31.7 F, for a time frame of 18 minutes (Product storage error). There was no previous temperature excursion and no additional adverse event (AE). ; Sender's Comments:  US-009507513-2410USA003805:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant calling to report that an expired dose of VAQTA was administered. The product DID undergo a temperature excursion. No additional AE, no PQC. No additional information.   Temperature Excursion Request - Administered Doses Case Number; The product DID undergo a temperature excursion; This spontaneous report was received from certified medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 01-NOV-2024, the patient was vaccinated with expired dose of inappropriately stored Hepatitis A Vaccine, Inactivated (VAQTA) 1 milliliter (mL), lot # X006702, expiration date 01-OCT-2024 (expired vaccine used) (route of administration and anatomical location were not reported) for prophylaxis. The reporter stated that stored Hepatitis A Vaccine, Inactivated (VAQTA) did undergo temperature excursion (product storage error). There was no additional adverse event reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Caller reported ROTATEQ administered after temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided.  On 03-NOV-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid for prophylaxis, lot number 2003176 which had beed verified to be valid, expiration date reported and validated as 04-OCT-2025 (strength, dose, route of administration and anatomical location not reported).   The administered dose was stored at 51.7 Fahrenheit degree for 1 hour and 20 minutes. There was no previous temperature excursions. There were no symptoms reported.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: They provided a second dose to the patient; This non-serious case was reported by a pharmacist via patient support programs and described the occurrence of extra dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received on an unknown date).   On 07-OCT-2024, the patient received the 2nd dose of Arexvy. On 07-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: They provided a second dose to the patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-OCT-2024 The pharmacist called to inquired if there was anything they needed to warn the patient regarding the Arexvy vaccine. They provided a second dose to the patient which led to extra dose administered.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Left pectoral soreness; Left pectoral discomfort; This non-serious case was reported by a other health professional and described the occurrence of chest pain in a 60-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number DG3TN, expiry date 30-JUN-2025) for prophylaxis.   On 02-OCT-2024, the patient received Fluarix 2024-2025 season .5 ml. On 02-OCT-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced chest pain (Verbatim: Left pectoral soreness) and chest discomfort (Verbatim: Left pectoral discomfort). On 03-OCT-2024, the outcome of the chest pain and chest discomfort were resolved (duration 1 day).   It was unknown if the reporter considered the chest pain and chest discomfort to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the chest pain and chest discomfort to be related to Fluarix 2024-2025 season and Fluarix 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: 08-OCT-2024 The health care professional reported that a patient received Fluarix vaccine and experienced left pectoral soreness (left pectoral discomfort) which was lasted 24 hours. The symptoms were not treated. The patient did not receive other products.
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity, Tenderness
Clinical narrative: arm still tender; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 15-OCT-2024, the patient received RSV vaccine. In OCT-2024, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: arm still tender). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 20-OCT-2024 This case was reported by a patient via interactive digital media The patient received RSV vaccine five days ago and experienced his/her arm still tender. The patient mentioned imagine what the real thing would feel like.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Syringe issue, Underdose
Clinical narrative: syringe had a hole and vaccine leaked out; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-NOV-2023, the patient received Arexvy. On 20-NOV-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: syringe had a hole and vaccine leaked out). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 07-OCT-2024 Pharmacist called and reported that on 20th November 2023, Arexvy was given to a patient and during administration the syringe had a hole and vaccine leaked out which led to accidental underdose. Pharmacist did not know how much was injected. Expiration date asked and declined, the information was not available. Incomplete dose of Arexvy (less volume) was given to a patient, pharmacist was considering giving another dose to same patient. No pqc involved in this case because Arexvy was packaged without syringes or needles.
Sex: U
Vaccine: DTAP, DTAPIPV, TDAP
Symptoms: Product storage error
Clinical narrative: Product Storage Error and Administration; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number 25A2F, expiry date 19-JAN-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 47Y5M, expiry date 26-JUN-2026) for prophylaxis and DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On an unknown date, the patient received Boostrix, Infanrix and Kinrix. On an unknown date, an unknown time after receiving Boostrix, Infanrix and Kinrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error and Administration). The outcome of the incorrect storage of drug 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: 07-OCT-2024 The reporter reported that t Boostrix, Kinrix and Infanrix had multiple excursions (highest temp 12.5 C and lowest was negative 1.3 C). He states that before they found out, they might had administered some. The reporter did not think many vaccines left as they had an influx of kids getting vaccines in July, but he did not had an exact number of those who may had received the vaccines.
Sex: U
Vaccine: DTAP, DTAPIPV, HEP, HEPA, HIBV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Administration of vaccines after temperature excursion to patients; 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 unspecified number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Hib (Hiberix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Havrix, Kinrix, Infanrix, Boostrix, Hiberix, Menveo and Engerix B. On an unknown date, an unknown time after receiving Havrix, Kinrix, Infanrix, Boostrix, Hiberix, Menveo and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Administration of vaccines after temperature excursion to patients). The outcome of the incorrect storage of drug 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: 07-OCT-2024 The healthcare professional contacted GlaxoSmithKline to make corrections on the case 02071397, which was filed, and it included Havrix, Kinrix, Infanrix, Boostrix, Hiberix, Menveo (the one vial presentation) and Engerix-B.  The healthcare professional did mention that the previous healthcare professional that initiated the medical information inquiry was no longer at the site and that they would be taking over a period verifying the stability of the vaccines adding that the vaccines had been exposed to 60.4-degree Fahrenheit, but they did so for a cumulative 6 hours and 35 minutes. Some of these doses had already been administered and they wanted to know how to proceed.  They requested a thermal stability information and even though, the adverse events were mentioned, the healthcare professional did state that they did not have the information on hand and accepted to receive follow up from GSK's safety team.  Furter it was confirmed that the case did not report an adverse event since the vaccines included in the temperature excursion were not administered to a patient. The reporter mentioned that within the list of vaccines (Havrix, Kinrix, Infanrix, Boostrix, Hiberix, Menveo (the one vial presentation) and Engerix-B), a couple of them were administered to patients but no exact information on which one was administered, which led to an incorrect storage of drug. No more information was provided Consented to follow up. The vaccine administration facility was the same as primary reporter. This was 1 of 2 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024123268:Same reporter/Different patient
Sex: U
Vaccine: DTAP, DTAPIPV, HEP, HEPA, HIBV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines had been exposed to 60.4°F but they did so for a cumulative 6 hours and 35 minutes.; 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 patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Hib (Hiberix) for prophylaxis, HBV (Engerix B) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Kinrix, Havrix, Infanrix, Boostrix, Hiberix, Engerix B and Menveo. On an unknown date, an unknown time after receiving Kinrix, Havrix, Infanrix, Boostrix, Hiberix, Engerix B and Menveo, the patient experienced incorrect storage of drug (Verbatim: vaccines had been exposed to 60.4°F but they did so for a cumulative 6 hours and 35 minutes.). The outcome of the incorrect storage of drug 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: 07-OCT-2024 The healthcare professional contacted GlaxoSmithKline to make corrections on the case 02071397, which was filed, and it included Havrix, Kinrix, Infanrix, Boostrix, Hiberix, Menveo (the one vial presentation) and Engerix-B.  The healthcare professional did mention that the previous healthcare professional that initiated the medical information inquiry was no longer at the site and that they would be taking over a period verifying the stability of the vaccines adding that the vaccines had been exposed to 60.4-degree Fahrenheit, but they did so for a cumulative 6 hours and 35 minutes. Some of these doses had already been administered and they wanted to know how to proceed.  They requested a thermal stability information and even though, the adverse events were mentioned, the healthcare professional did state that they did not have the information on hand and accepted to receive follow up from GSK's safety team.  The reporter mentioned that within the list of vaccines (Havrix, Kinrix, Infanrix, Boostrix, Hiberix, Menveo (the one vial presentation) and Engerix-B), a couple of them were administered to patients but no exact information on which one was administered, which led to an incorrect storage of drug. No more information was provided Consented to follow up. The vaccine administration facility was the same as primary reporter. This was 1 of 2 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024123266:Same reporter/Different patient
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: less than recommended volume/administered Boostrix vaccine today and Boostrix squirted out and she; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 69-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number x449y, expiry date 20-OCT-2026) for prophylaxis.   On 07-OCT-2024, the patient received Boostrix. On 07-OCT-2024, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: less than recommended volume/administered Boostrix vaccine today and Boostrix squirted out and she). The outcome of the incomplete dose administered 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: 07-OCT-2024 The pharmacy technician reported that a technician administered Boostrix vaccine today (On the day of reporting) and Boostrix squirted out and she was not sure how much went into patient. There was no mention of patient being exposed to Boostrix (e.g. on skin, etc.) but question was never asked to confirm.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: administration of Engerix B at Interval greater than 6 months/pateint did not receive second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 08-DEC-2022).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: administration of Engerix B at Interval greater than 6 months/pateint did not receive second dose yet). The outcome of the incomplete course of vaccination 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: 07-OCT-2024 The reporter asked about a patient´s schedule, the patient received first dose of Engerix B vaccine back in 8th of December 2022. The reported asked questioned did they had to begin a new schedule, which was the specific advice could give or they would change to a Heplisav vaccine two dose schedule. No further information was obtained or provided from the pharmacist´s end during this call. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Age: 0.58
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age; 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 7-month-old female patient who received HAV (Havrix pediatric) (batch number 5JA57, expiry date 24-APR-2026) for prophylaxis.   On 12-SEP-2024, the patient received Havrix pediatric (intramuscular). On 12-SEP-2024, an unknown time after receiving Havrix pediatric, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age). 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: 7-OCT-2024 and 9-OCT-2024 7 month child was given Havrix by mistake, which was asymptomatic, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: child gets an adult dose; child gets an adult dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a child patient who received HAV (Havrix adult) for prophylaxis.   On 06-OCT-2024, the patient received Havrix adult. On 06-OCT-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: child gets an adult dose) and adult product administered to child (Verbatim: child gets an adult dose). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 07-OCT-2024 Pharmacist called to ask what happens if the child gets an adult dose of Havrix. According to the reporter they did not have any details of the patient or the vaccine lot number and expiry date. A child received Havrix adult, which led to overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: FLU3
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: product rolled out over the hand of the nurse; product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of occupational exposure via skin contact with product in a 30-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 24PL5, expiry date 09-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced occupational exposure via skin contact with product (Verbatim: product rolled out over the hand of the nurse) and pharmaceutical product complaint (Verbatim: product complaint). The outcome of the occupational exposure via skin contact with product and pharmaceutical product complaint 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: 08-OCT-2024 and 09-OCT-2024 The medical assistant reported that a nurse was preparing a syringe with Flulaval when the plunger came out (one of the nurses got out the Flulaval vaccine, out of the box and when she wanted to take off the end, then the plunger on the back side came out and the medicine came out as well) and the product rolled out over the hand of the nurse which led to, occupational exposure via skin contact with product and pharmaceutical product complaint. The vaccine was not administered to a patient at the time, and it was prepared in a different room. The reporter mentioned that the suspect syringe was available but only the syringe body/barrel and the plunger which fell out has been discarded. There was no needle attached and the plunger fell out during the removal of the tip cap, prior to the attaching of a needle. It was unknown a luer lock needle used and did not get to that step. The reporter mentioned that the rod fell out plunger was loose. The plunger rod or plunger stopper fell out of the body/barrel was the defect related to the plunger rod. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: swelling at the injection site; redness at the injection site; pain; muscle pain; tiredness; headache; fever; shivering; upset stomach; feeling pretty crummy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 18-JUL-2024, for tolerance of 1st dose of Shingrix, refer case US2024123941).   On 07-OCT-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In OCT-2024, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site), injection site erythema (Verbatim: redness at the injection site), pain (Verbatim: pain), muscle pain (Verbatim: muscle pain), tiredness (Verbatim: tiredness), headache (Verbatim: headache), fever (Verbatim: fever), shivering (Verbatim: shivering), upset stomach (Verbatim: upset stomach) and feeling abnormal (Verbatim: feeling pretty crummy). The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. The outcome of the injection site swelling, injection site erythema, pain, muscle pain, tiredness, headache, fever, shivering and upset stomach were not resolved and the outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the injection site swelling, injection site erythema, pain, muscle pain, tiredness, headache, fever, shivering, upset stomach and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site erythema, pain, muscle pain, tiredness, headache, fever, shivering, upset stomach and feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2024123941   Additional Information: GSK Receipt Date: 08-OCT-2024 The patient reported that she received the Shingrix at a local pharmacy.  Patient reports she had the vaccines administered in her left arm on both occasions.  The Lot and expiry were not provided for either vaccine. The patient reported that had all the side effects of Shingrix and she was feeling pretty crummy. The patient reported that pain, redness at the injection site, swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.; Sender's Comments:  US-GSK-US2024123941:same patient case
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: swelling at the injection site; redness at the injection site; pain; muscle pain; tiredness; headache; fever; shivering; upset stomach; feeling pretty crummy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 18-JUL-2024, for tolerance of 1st dose of Shingrix, refer case US2024123941).   On 07-OCT-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In OCT-2024, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site), injection site erythema (Verbatim: redness at the injection site), pain (Verbatim: pain), muscle pain (Verbatim: muscle pain), tiredness (Verbatim: tiredness), headache (Verbatim: headache), fever (Verbatim: fever), shivering (Verbatim: shivering), upset stomach (Verbatim: upset stomach) and feeling abnormal (Verbatim: feeling pretty crummy). The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. The outcome of the injection site swelling, injection site erythema, pain, muscle pain, tiredness, headache, fever, shivering and upset stomach were not resolved and the outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the injection site swelling, injection site erythema, pain, muscle pain, tiredness, headache, fever, shivering, upset stomach and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site erythema, pain, muscle pain, tiredness, headache, fever, shivering, upset stomach and feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2024123941   Additional Information: GSK Receipt Date: 08-OCT-2024 The patient reported that she received the Shingrix at a local pharmacy.  Patient reports she had the vaccines administered in her left arm on both occasions.  The Lot and expiry were not provided for either vaccine. The patient reported that had all the side effects of Shingrix and she was feeling pretty crummy. The patient reported that pain, redness at the injection site, swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.; Sender's Comments:  US-GSK-US2024123941:same patient case
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: swelling at the injection site; redness at the injection site; pain; muscle pain; tiredness; headache; fever; shivering; upset stomach; feeling pretty crummy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 18-JUL-2024, for tolerance of 1st dose of Shingrix, refer case US2024123941).   On 07-OCT-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In OCT-2024, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site), injection site erythema (Verbatim: redness at the injection site), pain (Verbatim: pain), muscle pain (Verbatim: muscle pain), tiredness (Verbatim: tiredness), headache (Verbatim: headache), fever (Verbatim: fever), shivering (Verbatim: shivering), upset stomach (Verbatim: upset stomach) and feeling abnormal (Verbatim: feeling pretty crummy). The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. The outcome of the injection site swelling, injection site erythema, pain, muscle pain, tiredness, headache, fever, shivering and upset stomach were not resolved and the outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the injection site swelling, injection site erythema, pain, muscle pain, tiredness, headache, fever, shivering, upset stomach and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site erythema, pain, muscle pain, tiredness, headache, fever, shivering, upset stomach and feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2024123941   Additional Information: GSK Receipt Date: 08-OCT-2024 The patient reported that she received the Shingrix at a local pharmacy.  Patient reports she had the vaccines administered in her left arm on both occasions.  The Lot and expiry were not provided for either vaccine. The patient reported that had all the side effects of Shingrix and she was feeling pretty crummy. The patient reported that pain, redness at the injection site, swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.; Sender's Comments:  US-GSK-US2024123941:same patient case
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Product Storage Error and Administration; 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 16-year-old female patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error and Administration). The outcome of the incorrect storage of drug 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: 08-OCT-2024 The health care professional reported that the Bexsero was exposed to 48.8 degree Fahrenheit for 78 hours and 35 minute, it was administered to a patient, which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter.; Sender's Comments:  US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123934:Same reporter/Different patient US-GSK-US2024123926:Same reporter/Different patient US-GSK-US2024123922:Same reporter/Different patient US-GSK-US2024123919:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123909:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123905:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123899:
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Product Storage Error and Administration; 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 17-year-old male patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error and Administration). The outcome of the incorrect storage of drug 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: 08-OCT-2024 The health care professional reported that the Bexsero was exposed to 48.8 degree Fahrenheit for 78 hours and 35 minute, it was administered to a patient, which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter.; Sender's Comments:  US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123899: US-GSK-US2024123897:Same reporter/Different patient
Sex: U
Vaccine: HEPA, MMR, MNQ, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Shingrix, Havrix, Menveo and Priorix. On an unknown date, an unknown time after receiving Shingrix, Havrix, Menveo and Priorix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug 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: 09-OCT-2024 The registered nurse called to report a temperature excursion below the normal range and inquired how do we proceed if the vaccines were administered. The temperature excursion was below the normal range, vaccines reached 27.9 degree Fahrenheit. The reporter did not have the information about the patients that got administered but she said that she can provide any further information by email which led to incorrect storage of drug.
Sex: U
Vaccine: COVID19
Symptoms: New daily persistent headache
Clinical narrative: NEW DAILY PERSISTENT HEADACHE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced new daily persistent headache.  The patient who reported developing a new daily persistent headache (dose series 1) after receiving the Janssen COVID vaccine in 2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of new daily persistent headache was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Vaccination site pain
Clinical narrative: achiness; Soreness at the injection site; joint pain; fatigue; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achiness), VACCINATION SITE PAIN (Soreness at the injection site), ARTHRALGIA (joint pain), FATIGUE (fatigue) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043924) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 30-Oct-2024, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site), ARTHRALGIA (joint pain), FATIGUE (fatigue) and CHILLS (chills). On an unknown date, the patient experienced PAIN (achiness). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, PAIN (achiness) outcome was unknown and VACCINATION SITE PAIN (Soreness at the injection site), ARTHRALGIA (joint pain), FATIGUE (fatigue) and CHILLS (chills) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient did not experience any additional symptoms or events.  The patient had heat pack on arm. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: product broke because it was glass and she put it in the sharps container and is requesting replacement; malfunctioning luer lock; This is a spontaneous report received from a Pharmacist, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "product broke because it was glass and she put it in the sharps container and is requesting replacement"; DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "malfunctioning luer lock".  Additional information: A pharmacist was calling in about a malfunctioning luer lock of Abrysvo and mentioned the product broke because it was glass and she put it in the sharps container and is requesting replacement.  Causality for "product broke because it was glass and she put it in the sharps container and is requesting replacement" and "malfunctioning luer lock" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc injury, Nerve injury
Clinical narrative: had a problem with her disc on spinal cord that's causing damage and had surgery done; I have nerve issues due to discs pressing on my spinal cord; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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: NERVE INJURY (medically significant) with onset Jan2024, outcome "recovering", described as "I have nerve issues due to discs pressing on my spinal cord"; INTERVERTEBRAL DISC INJURY (medically significant) with onset Jan2024, outcome "recovering", described as "had a problem with her disc on spinal cord that's causing damage and had surgery done". Therapeutic measures were taken as a result of intervertebral disc injury, nerve injury. Clinical course: Patient was diagnosed Spinal Disc damage at the end of Mar2024, after administration of Comirnaty in Sep2023. In 2024, patient had serious issues and had to have spine surgery because her disks were pressing on her spinal cord and she had numbness going up her hands and arms. Patient had nerve issues due to discs pressing on spinal cord. In Jan2024, caller developed symptoms of numbness, legs were weaker, she had a problem with her disc on spinal cord that's causing damage and had surgery done in Apr2024, but it will take a year or more for nerves to regenerate and still have weakness in arms and legs including numbness, tingling, and stiffness. She had surgery and was recovering. Wondering if taking this covid vaccine might trigger- something. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.