chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no additional AE; HCP reported PROQUAD was inadvertently administered to a 16 year old patient instead of MMR II. No additional AE or PQC reported. No additional information provided.; HCP reported PROQUAD was inadvertently administered to a 16 year old patient instead of MMR II. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from the Medical Assistant, and refers to a 16-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 19-JAN-2023, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (recombinant Human albumin), lot # W019627, expiration date: 19-DEC-2023, for prophylaxis (anatomical location, strength, and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (wrong product administered, product administered to patient of inappropriate age). No additional information was provided.
Age: 1.67
Sex: F
Vaccine: HEPA, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB were administered after a temperature excursion; This spontaneous report was received from a Certified Medical Assistant (C.M.A.) concerning to a 20-month-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. Her birth weight was 4.16 kg.  On 01-DEC-2022, improperly stored vaccine doses underwent a temperature excursion of 47.9 degrees Fahrenheit (F) for 47 minutes at storage in clinical practice. The temperature excursion occurred as a result of a reading from a Digital Data Logger.  On 20-DEC-2022, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), second dose, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly on the left thigh; and hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, third dose, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly on the right thigh. Both vaccines were administered as prophylaxis (product storage error).  It was also reported that vaccines were administered by a healthcare professional trained, and the vaccines/device were used according to the instruction leaflet.  No adverse event was reported. There was not a product quality complaint.  This was one of several reports received from the same reporter.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA administered after a temperature excursion; This spontaneous report was received from a Certified Medical Assistant (C.M.A.) concerning to a 2-year-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. Her birth weight was 3.010 kg.  On 01-DEC-2022, improperly stored vaccine doses underwent a temperature excursion of 47.9 degrees Fahrenheit (F) for 47 minutes at storage in clinical practice. The temperature excursion occurred as a result of a reading from a Digital Data Logger.  On 29-DEC-2022, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, first dose, lot # W017343, expiration date: 13-DEC-2023, administered intramuscularly on the left thigh as prophylaxis (product storage error).  It was also reported that vaccine was administered by a healthcare professional trained, and the vaccine/device was used according to the instruction leaflet.  No adverse event was reported. There was not a product quality complaint.  This was one of several reports received from the same reporter.
Age: 0.42
Sex: M
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a Healthcare Professional (HCP) and refers to a 5-month-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose was not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly in left thigh for prophylaxis (strength and dose was not provided) (product storage error).  On 01-DEC-2022, administered doses of vaccines experienced the temperature excursion of 47.9 degrees Fahrenheit for 47 minutes.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs were reported; an expired VARIVAX dose was given to a patient; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 03-FEB-2023, the patient was vaccinated with one dose of expired varicella virus vaccine live (oka/merck) (VARIVAX) lot # U002398, expiry date 22-JAN-2023 (route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events (AEs) were reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of VAQTA expired on 16JAN2023 and was administered on 02FEB2023; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 02-FEB-2023 the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) lot # W007375, expiry date 16-JAN-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; VARIVAX that experienced temperature excursion was administered to one patient; 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 medications were not reported.  On 26-JAN-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W006412, expiration date: 23-FEB-2024, administered for prophylaxis (strength, dose, dose number and route of administration were not provided); and sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose, lot #, expiry date, route of administration, and indication were not provided) (Product storage error).  On 16-JAN-2023, administered dose of the vaccine experienced the temperature excursion of -14 up to -10 (-14.4) degrees Celsius for 30 minutes. There was no previous temperature excursion.  No additional adverse event or product quality issue reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Dyspnoea, Dyspnoea exertional
Clinical narrative: Congestive Heart Failure; More and more out of breath on any exertion; This case was reported by a consumer and described the occurrence of congestive heart failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included leukemia lymphoblastic acute (found out that she had acute lymphoblastic leukemia in September).   In January 2023, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and acyclovir, the patient experienced congestive heart failure (serious criteria GSK medically significant) and shortness of breath. The patient was treated with acyclovir and dasatinib (Sprycel). On an unknown date, the outcome of the congestive heart failure and shortness of breath were unknown.   It was unknown if the reporter considered the congestive heart failure and shortness of breath to be related to Shingrix.     Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: In September, they found out the patient had acute lymphoblastic leukemia. She was treated with a drug called Sprycel which targets the chromosome, and also Acyclovir, an anti-Shingles drug, because people with compromised immune systems could get shingles.  The patient recently she was told that if she got the Shingrix vaccine, and if it worked, she might not have to take Acyclovir. So she took the first vaccine of the pair (Shingrix was given in 2 doses, 2 months apart). The patient also kept on taking Acyclovir. But since the shot, the patient got more and more out of breath on any exertion and now it turns out that she had congestive heart failure.  This could be for any number of reasons, even the Sprycel could contribute to it. In fact the physician thought the reason was probably the Sprycel. However, did notice an interesting thing about congestive heart failure. There are various drugs that made worse and one website says that, 'a number of medications used to treat cancer was associated with potential heart issues. However, the class of drugs of most concern are anthracyclines, which are derived from antibiotics that inhibit DNA and RNA synthesis and prevent cancer cells from growing.' The reporter did not know if Shingrix works on RNA-Acyclovir does and also looking more closely at the website that says this, the mechanism of action did not seem to be relevant. Acyclovir and Sprycel was coded as treatment as per narrative information and off label use was not coded as event as it was confirm from the physician or health care professional whether it was intentionally given or not.
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Stress, Urticaria
Clinical narrative: hives; blister from corner of mouth; high stressful days; This case was reported by a consumer and described the occurrence of hives in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date January 2023) for prophylaxis.   On 19th January 2023, the patient received Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced stress. On 26th January 2023, the patient experienced hives and blistering of mouth. On an unknown date, the outcome of the hives and blistering of mouth were not recovered/not resolved and the outcome of the stress was unknown.   It was unknown if the reporter considered the hives, blistering of mouth and stress to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-Jan-2023 Reporter's Comments: This case was self-reported by the patient. The patient experienced hives that were blister like going from corner of mouth on my left side starting to sweep out and up towards my eye and still ongoing. The Shingrix manufacturer provided unspecified expiry date of Shingrix. The patient experienced high stressful days after vaccine. The symptoms were not treated.  The reporter had gave the permission to contact you.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Soreness at injection site, worse as time progressed; limited mobility of injection arm.; Full body aches; Shivers; This case was reported by a consumer and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2023, the patient received the 2nd dose of Shingrix. On 1st February 2023, immediately after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, general body pain and shivers. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, general body pain and shivers were unknown.   The reporter considered the injection site pain, injected limb mobility decreased, general body pain and shivers to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The patient received Shingrix injection and experienced soreness at the injection site at time of administration. The patient stated that, progressively worsted as time progressed, limited mobility of injection arm. The patient also experienced full body aches and shivers. The reporter stated that the symptoms were definitely related to GlaxoSmithKline product. The reporter agreed to follow up from GlaxoSmithKline.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Injection site erythema, Injection site reaction, Injection site scab, Injection site swelling
Clinical narrative: scabbed wound of ¼ inch, spot near the needle was injected; scabbed wound of ¼ inch, spot near the needle was injected; really sick; This case was reported by a consumer via call center representative and described the occurrence of wound in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced wound, scab and sickness. On an unknown date, the outcome of the wound and scab were recovering/resolving and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the wound, scab and sickness to be related to Shingrix.  Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comment: The reporter was a customer that received the Shingrix Vaccine in his left arm. The reporter reported that he was really sick over it for 2 to 3 days . It was like a popping sore, like a wound of ¼ inch or more in size (adverse event: wound).  The vaccine was provided at the customer's doctor's office.  The patient described it as a spot near the area where the needle was injected. The patient described that at some point it was swollen and red (adverse event: Swollen), (adverse event: Redness). The patient described it as a scabbed wound, and it has gotten better. Not all information was available.  The patient did not consent to follow up with healthcare professional.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Wound
Clinical narrative: scabbed wound of ¼ inch, spot near the needle was injected; scabbed wound of ¼ inch, spot near the needle was injected; really sick; This case was reported by a consumer via call center representative and described the occurrence of wound in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced wound, scab and sickness. On an unknown date, the outcome of the wound and scab were recovering/resolving and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the wound, scab and sickness to be related to Shingrix.  Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comment: The reporter was a customer that received the Shingrix Vaccine in his left arm. The reporter reported that he was really sick over it for 2 to 3 days . It was like a popping sore, like a wound of ¼ inch or more in size (adverse event: wound).  The vaccine was provided at the customer's doctor's office.  The patient described it as a spot near the area where the needle was injected. The patient described that at some point it was swollen and red (adverse event: Swollen), (adverse event: Redness). The patient described it as a scabbed wound, and it has gotten better. Not all information was available.  The patient did not consent to follow up with healthcare professional.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia, Vaccine positive rechallenge
Clinical narrative: malaise; muscle aches; fever; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose was received on unknown date and also he had experienced muscle aches and a fever, refer this case US2023AMR016444).   On 31st January 2023, the patient received the 2nd dose of Shingrix (intramuscular). On 31st January 2023, less than a day after receiving Shingrix, the patient experienced malaise, muscle pain and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the malaise, muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the malaise, muscle pain and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR016444   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's comments: The reporter was the patient. He received his Shingrix dose in an unknown deltoid and had developed malaise, muscle aches and a fever.  He mentioned that, he had the same effects after his first Shingrix dose several months ago.  Nothing else was reported. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023AMR016444:Same reporter
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 26YO received pediatric dose; 26YO received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 26-year-old male patient who received HAV (Havrix pediatric) (batch number 3397T, expiry date 30th November 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: 2-Feb-2023 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number MY5G5, expiry date 31st January 2023) for prophylaxis.   On 1st February 2023, the patient received Boostrix. On 1st February 2023, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 2-Feb-2023 Reporter's comment: A pharmacist called in to know how they should proceed after accidentally administering an expired dose of Boostrix.  Medical information was given and the details about the vaccine and patient were collected. The reporter seemed to want very specific information, even though it was explicitly stated that it was not available.  It was extremely difficult to understand the reporter in various instances which hampered the quality of the call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Boostrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pigmentation disorder, Scar
Clinical narrative: Black spots on back and upper butt; It felt "like metal in my skin."; Scarring on her back; black spots on her back and upper butt which was severely painful for 6 months; This case was reported by a consumer via call center representative and described the occurrence of spot pigmented in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included immunoglobulin human normal (Hyqvia).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced spot pigmented, pain localized, disturbance of skin sensation and scar. On an unknown date, the outcome of the spot pigmented, disturbance of skin sensation and scar were unknown and the outcome of the pain localized was recovered/resolved.   It was unknown if the reporter considered the spot pigmented, pain localized, disturbance of skin sensation and scar to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: The patient self-reported this case. The patient started HyQvia prior to receiving Shingrix vaccine. The patient reported that she received second dose of Shingrix vaccine in 2021. The patient stated that after received Shingrix vaccine she experienced broke out in black spots on her back and upper butt which was severely painful for 6 months. The patient reported that it was felt like metal in her skin and she had scarring on her back as a result. The patient stated that she was immunocompromised at that time and she was received infusions of HyQvia. The patient stopped the infusions after experienced the reaction with Shingrix vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number H4h53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 2nd February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 2-Feb-2023 Reporter's comment: The reporter declined follow-up and providing additional information. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: an expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 2nd February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 2-Feb-2023 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 45-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 1st February 2023, the patient received the 1st dose of Havrix. On 1st February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 2-Feb-2023 Reporter's comment: Information for adverse event and vaccine was collected. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient accidentally received an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered without the proper diluent; Administered without the proper diluent; This 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 patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comments: The reporter reported that a dose of Menveo had been administered without the proper diluent.  The Health care professional told that it was unsure when the patient had received that vaccine and even who the patient was. Health care professional realized that this adverse event might had happened because a vial of liquid was left in the fridge but there was no powder vial left to reconstitute. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo without the proper diluent, which led to  wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old received Kinrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, 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: 03-FEB-2023 Reporter's Comment: The reporter did not have any patient demographic details to provide at time of call. The reporter reported that administration of Kinrix to a 4-month old patient. The reporter consented to follow up. Additional Supportive Information: The 4-month old patient was administered with Kinrix, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 07-FEB-2023 Reporter's Comment: The pharmacist reported that a nurse inadvertently administered an expired dose of Engerix-B. The additional patient information was not known. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Engerix B, which led to expired vaccine used.
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination complication
Clinical narrative: I've had a total of 4 injections. 2 shots and 2 boosters. Last booster was on 11/23/2022. I'm having surgery on the 9th of this month; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (I've had a total of 4 injections. 2 shots and 2 boosters. Last booster was on 11/23/2022. I'm having surgery on the 9th of this month) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I've had a total of 4 injections. 2 shots and 2 boosters. Last booster was on 11/23/2022. I'm having surgery on the 9th of this month). At the time of the report, VACCINATION COMPLICATION (I've had a total of 4 injections. 2 shots and 2 boosters. Last booster was on 11/23/2022. I'm having surgery on the 9th of this month) outcome was unknown.            No concomitant medications were reported.  It was reported that patient having surgery on the 9th of this month and also stated that patient was due for another booster. Patient thought that, there were only 4 shots all together.  No treatment medications were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Autoimmune disorder
Clinical narrative: symptoms of an autoimmune disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AUTOIMMUNE DISORDER (symptoms of an autoimmune disease) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (symptoms of an autoimmune disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (symptoms of an autoimmune disease) outcome was unknown.            No concomitant medications were reported. Patient had been vaccinated multiple times and had been in and out of the hospital. Patient was showing symptoms of an autoimmune disease. Now that there was overwhelming evidence that vaccine was killing people and harming people. The reporter did not see why it would be a problem to get money through the court system. Treatment information was not provided.  Company comment:  This spontaneous case report concerns a female patient of unknown age, with no medical history provided, who experienced the unexpected serious (medically significant) event of autoimmune disorder. Reportedly, the patient had symptoms of an autoimmune disease. The event occurred on an unknown date after a dose of mRNA-1273.222 (bivalent vaccine, dose of the vaccine in vaccination schedule was not specified). As per information provided, the patient had been vaccinated multiple times and had been in and out of the hospital, however, no additional details were provided. No further information regarding final diagnosis, specific signs and symptoms, clinical course, laboratory investigations, diagnostic procedures and treatment medications was provided. Limited information precludes a meaningful medical assessment at this point. Case will be re-assessed upon receipt of additional information. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-707862, US-MODERNATX, INC.-MOD-2023-707867 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707862:case for grandfather US-MODERNATX, INC.-MOD-2023-707867:case for mother
Sex: F
Vaccine: COVID19-2
Symptoms: Pancreatitis acute
Clinical narrative: acute pancreatitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PANCREATITIS ACUTE (acute pancreatitis) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient was thin, athletic and young.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS ACUTE (acute pancreatitis) (seriousness criteria hospitalization and medically significant). At the time of the report, PANCREATITIS ACUTE (acute pancreatitis) outcome was unknown.            No concomitant medications were reported.   The patient was hospitalized twice, the first time for 6 weeks, second time for a little bit less with acute pancreatitis.  No treatment details were reported.  Company comment:  This spontaneous case report concerns a female patient of an unknown age with no medical history or underlying conditions, who experienced serious (medically significant and hospitalization) unexpected event of special interest - Pancreatitis acute. The event occurred after the patient had received the mRNA-1273.222 vaccine (bivalent dose, the exact dose in vaccination schedule was not reported). The onset latency between vaccination and the reported event remained unknown since no dates were provided. As per information provided, the patient was hospitalized twice, the first time for 6 weeks and the second time for a little bit less with acute pancreatitis. At the time of this report, no further information regarding clinical course, laboratory investigations and diagnostic procedures was disclosed. At the time of this report, the outcome of the event remained unknown and treatment medications were not provided. Limited information precludes a meaningful medical assessment at this stage. Case will be re-assessed upon receipt of additional information. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypereosinophilic syndrome
Clinical narrative: Idiopathic hypereosinophilic syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of HYPEREOSINOPHILIC SYNDROME (Idiopathic hypereosinophilic syndrome) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.       Concurrent medical conditions included Asthma.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPEREOSINOPHILIC SYNDROME (Idiopathic hypereosinophilic syndrome) (seriousness criterion medically significant). At the time of the report, HYPEREOSINOPHILIC SYNDROME (Idiopathic hypereosinophilic syndrome) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.   Authors stated that hypereosinophilia may occur rarely following COVID-19 vaccination and would be considered in patients presenting with symptoms consistent with eosinophilic disease. This may be due to Th2-skewing, a phenomenon observed in vaccine associated enhanced disease which had occurred with other vaccines.  Company comment: This is a literature non-study case concerning a 23-year-old, female patient with a concurrent medical condition of Asthma, who experienced the serious (due to medically significant) unexpected, event of Hypereosinophilic syndrome reported as Idiopathic hypereosinophilic syndrome. The event occurred approximately 1 week after the second dose of mRNA-1273 vaccine. The outcome of the event was reported as unknown. The mentioned medical condition of Asthma remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-708167, US-MODERNATX, INC.-MOD-2023-708168 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708168:Adult Patient 2 US-MODERNATX, INC.-MOD-2023-708167:Adult Patient 1
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a dose of Moderna COVID-19 Vaccine Bivalent on 16Jan2023 instead of the 1st dose of the primary series; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a dose of Moderna COVID-19 Vaccine Bivalent on 16Jan2023 instead of the 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 16-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Jan-2023,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a dose of Moderna COVID-19 Vaccine Bivalent on 16Jan2023 instead of the 1st dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a dose of Moderna COVID-19 Vaccine Bivalent on 16Jan2023 instead of the 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a dose of Moderna COVID-19 Vaccine Bivalent on 16Jan2023 instead of the 1st dose of the primary series).    Concomitant product use was not provided by the reporter.  Unknown if patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP stated they have a report of another facility where a patient received a dose of Moderna COVID-19 Vaccine Bivalent instead of the first dose of the primary series.  Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 056M21A and 047B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 23JUN2021, and dose 2 was administered on 12AUG2022, which is greater than 35 days).    No concomitant medications were reported.  Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-707984 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707984:Bivalent dose case
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 patients were vaccinated with vaccines after manufacturing expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients were vaccinated with vaccines after manufacturing expiry date) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients were vaccinated with vaccines after manufacturing expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients were vaccinated with vaccines after manufacturing expiry date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 patients were vaccinated with vaccines after manufacturing expiry date).    No concomitant medications were reported.   HCP stated patient was  vaccinated with vaccines after manufacturing expiry date. Patient number 2 received the vaccine on 19-Dec-2022. No AEs were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.   This case was linked to MODERNATX, INC.-MOD-2023-708312 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-708312:same reporter
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Hasn't been well since the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Hasn't been well since the second dose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced MALAISE (Hasn't been well since the second dose). At the time of the report, MALAISE (Hasn't been well since the second dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2023-707334 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: Tinnitus; While patient was reporting their own AE; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus) and VACCINATION COMPLICATION (While patient was reporting their own AE) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus) and VACCINATION COMPLICATION (While patient was reporting their own AE). At the time of the report, TINNITUS (Tinnitus) and VACCINATION COMPLICATION (While patient was reporting their own AE) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. While patient was reporting own AE , the doctor mentioned that there were other patients that come in with tinnitus as well with the Moderna that want to rip the ear off. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-708656 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708656:For other patients