chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient presented for flu vaccine 1/30/24. Discovered 2/1/24 that patient had already received seasonal dose of flu vaccine on 9/29/23, therefore, vaccine was given at incorrect interval.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Headache, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Myalgia
Clinical narrative: 1/3/24 Office visit notes:  16 yr old with myositis in both legs, fever, sinusitis and Acute pharyngitis - r/o strept throat- Rapid strept PCR negative; Rapid Covid-19, Flu, and RSV PCR test negative  DX 1:  M60.861 Other myositis, right lower leg, DX 2:  M60.862 Other myositis, left lower leg,  DX 3:  R50.9 Fever  2/1/24 ER  report from visit on 1/31/24: Patient was seen in the emergency room because of fever, headache, and muscle aches for the last 3 days. Even though he tested negative for the flu, Covid, and RSV, he most likely has a viral illness causing his symptoms. He also tested negative for strep.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Myositis, Pharyngitis, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: 1/3/24 Office visit notes:  16 yr old with myositis in both legs, fever, sinusitis and Acute pharyngitis - r/o strept throat- Rapid strept PCR negative; Rapid Covid-19, Flu, and RSV PCR test negative  DX 1:  M60.861 Other myositis, right lower leg, DX 2:  M60.862 Other myositis, left lower leg,  DX 3:  R50.9 Fever  2/1/24 ER  report from visit on 1/31/24: Patient was seen in the emergency room because of fever, headache, and muscle aches for the last 3 days. Even though he tested negative for the flu, Covid, and RSV, he most likely has a viral illness causing his symptoms. He also tested negative for strep.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Sinusitis, Streptococcus test negative, Viral infection
Clinical narrative: 1/3/24 Office visit notes:  16 yr old with myositis in both legs, fever, sinusitis and Acute pharyngitis - r/o strept throat- Rapid strept PCR negative; Rapid Covid-19, Flu, and RSV PCR test negative  DX 1:  M60.861 Other myositis, right lower leg, DX 2:  M60.862 Other myositis, left lower leg,  DX 3:  R50.9 Fever  2/1/24 ER  report from visit on 1/31/24: Patient was seen in the emergency room because of fever, headache, and muscle aches for the last 3 days. Even though he tested negative for the flu, Covid, and RSV, he most likely has a viral illness causing his symptoms. He also tested negative for strep.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient received the Prevnar 20 vaccination on 12/12/2023, and called on the morning of 1/31/2024 to report she was still experiencing left arm/shoulder pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lymphadenopathy, Ultrasound scan normal
Clinical narrative: Patient reports enlarged/swollen left side lymph node. Pt reports arm tenderness and pain at injection site. Pt does not report any redness/swelling at injection site.  Pt went to doctor's office. Dr performed a sonogram and did not find any abnormalities. Dr put pt on abx and pt reports swelling has gone down
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain upper, Musculoskeletal stiffness, Nausea
Clinical narrative: Siff Body, tummy pain, nausea
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: As I mentioned earlier, I contracted Covid-19 after getting vaccinated. I just wanted the CDC to be aware of.  I had Covid-19 like symptoms, so I did a home test, and to my surprise it came up Positive.
Age: 1.25
Sex: M
Vaccine: DTAPIPV, FLUN4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse symptoms noted.  Mother of patient counseled to monitor for adverse outcomes.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered high-dose flu vaccine, patient is 60 years old and was supposed to get the regular flu vaccine
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inadvertently received a double dose of IPV during this visit.  He received Kinrix which has IPV in that combo vaccine and also received a plain IPV vaccine.  No adverse events to my knowledge.  This was discovered by our coding team that patient received two of the same vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache. Extreme fatigue.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: LEFT ARM BECAME SWOLLEN, RED AND WARM TO THE TOUCH.  PT WAS GIVEN IBUPROFEN. MOM STATES PT HAS A REACTION ANY TIME A BANDAID IS LEFT ON BODY,  BUT PT HAD VENIPUNCTURE AT THE SAME TIME AND THERE WAS NO REACTION TO VENIPUNCTURE SITE.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE; medication came out of the back of the syringe rather than from the needle while medication was being injected; medication came out of the back of the syringe rather than from the needle while medication was being injected; This spontaneous report was received from a medical assistant and referred to a 52-year-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were reported as unknown.  On 03-JAN-2024, the patient was vaccinated with hepatitis vaccine, inactivated (VAQTA) intramuscular injection (lot # x006702 was confirmed to be valid, expiry date was reported as 01-OCT-2024, dose and anatomical location were not provided) intramuscularly for prophylaxis. The reporter reported that hepatitis vaccine, inactivated (VAQTA) came out of the back of the syringe rather than from the needle while medication was being injected (syringe issue and poor quality device used). The syringe needle was attached to the syringe tip before the leaking occurred, and the needle able to be attached securely to the syringe. The situation that the plunger rod was being pushed forward was this defect noticed. The hepatitis vaccine, inactivated (VAQTA) had no notable defects upon inspection. No one was injured during administration and no reported signs/symptoms of adverse effects. The reporter would retain product for return. The sought medication attention by reporter was unknown. The treatment given for event was reported as unknown. The events were not the cancer. No additional adverse event (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Pharmacist reported that a patient received an expired MMR II vaccine.; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JAN-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) injection, lot #W017556, expiration date: 07-JAN-2024, administered for prophylaxis (dose, and route of administration were not provided) (Expired product administered). No additional AEs were reported. No further information provided.
Age: 8.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient did not report any adverse issues or side effects; a dose of VAQTA was administered to a patient on 15-JAN-2024 after experiencing three current temperature excursions; This spontaneous report was received from a nurse referring to an 8-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medications were not reported.  On 15-JAN-2024, the patient was vaccinated with a dose of improperly stored hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (lot # X017083 has been verified to be a valid lot number for hepatitis A vaccine, inactivated, expiration date: 13-DEC-2024), 0.5 ml, administered by a health professional for prophylaxis (strength and route of administration were not reported) (product storage error). The vaccine had experienced three temperature excursions: 9.4 degrees Celsius (C) for 2 minutes on 03-JAN-2024, 8.2 C for 1 minute on 04-JAN-2024, and 10.3 C for 10 minutes on 12-JAN-2024. There was no prior excursion. The patient did not report any adverse issues or side effects after the vaccination. ; Sender's Comments:  US-009507513-2401USA014344:
Sex: U
Vaccine: HEPA
Symptoms: Patient uncooperative, Underdose
Clinical narrative: Caller stated no patient symptoms have been reported; an 18 month old patient did not receive the full dose of VAQTA; some of the product to squirt onto their leg instead of being injected; some of the product to squirt onto their leg instead of being injected; This spontaneous report was received from an office manager and refers to an 18-month-old patient of unknown gender. The patient was "squirmy" when getting the vaccine. The patient's medical history and concomitant therapies were not provided.      On 22-JAN-2024, the patient was vaccinated with an incomplete dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # X023973, expiration date 26-DEC-2024 (route of administration was not provided) for prophylaxis. The patient was squirmy" when getting the vaccine and moved during the injection causing some of the suspect vaccine to squirt onto their leg instead of being injected. The reporter stated they were unsure how much of hepatitis a vaccine, inactivated (VAQTA) the patient actually received. No adverse events were reported.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration. No other AE information was able to be provided; A HCP called to report a TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 01/08/2024.; This spontaneous report was received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-JAN-2024, the patient was vaccinated with improper stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml / once, lot #X019196, expiration date: 25-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursions: 04-DEC-2023: 54.3F for 9 hours 32 minutes 0 seconds, on 05-DEC-2023: 57.7F for 15 hours 30 minutes 0 seconds, on 06-DEC-2023: 50.2F for 5 hours 43 minutes 0 seconds, on 07-DEC-2023: 30.6F for 1 hour 55 minutes 0 seconds, on 07-DEC-2023: 52.7F for 11 hours 3 minutes 0 seconds, on 11-DEC-2023: 48.4F for 1 hour 47 minutes 0 seconds. The patient did not report any adverse issues or side effects from the administration.   This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2401USA015432: US-009507513-2401USA015463: US-009507513-2401USA015454:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: did not report any adverse issues or side effects from the administration.; A HCP called to report a TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 01/05/2024.  The patient did not report any adverse issues or side effects from the administration.  No other AE information was able to be pr; This spontaneous report was received from a medical assistant and refers to a 12 years old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided.  On 05-JAN-2024, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in dose 0.5 ml administered once (lot # X019196 was verified to be valid, with expiration date 25-APR-2025) for prophylaxis (dose number, route of administration and anatomical location were not reported).  There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: 54.3F for 9 hours 32 minutes 0 seconds on 04-DEC-2023, 57.7F for 15 hours 30 minutes 0 seconds 05-DEC-2023, 50.2F for 5 hours 43 minutes 0 seconds on 06-DEC-2023, 30.6F for 1 hour 55 minutes 0 seconds on 07-DEC-2023, 52.7F for 11 hours 3 minutes 0 seconds on 07-DEC-2023, 48.4F for 1 hour 47 minutes 0 seconds on 11-DEC-2023. No other reported current or previous temperature excursions.  This is one of multiple reports received from the same reporter. ; Sender Comments: Keywords :  US-009507513-2401USA015432: US-009507513-2401USA015463: US-009507513-2401USA015454:
Age: 0.67
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; RECOMBIVAX HB was inadvertently administered today 1/26/2024 after its labelled expiry date of 11/19/2023; This spontaneous report has been received from an other, regarding a 8-month-old patient with unknown gender. The patient's concurrent condition, pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 26-JAN-2024, the patient was inadvertently vaccinated with hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) intramuscular injection (0.5 milliliter, lot number W016842 has been verified to be a valid lot number and expiration date was 19-NOV-2023, frequency, route of administration and anatomical location were not reported) for prophylaxis after its labelled expiration date of 19-NOV-2023 (expired product administered). No side effects were reported. It had not had any previous temperature excursions. No additional adverse event (AE).
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A HCP called to inquire about GARDASIL 9 dosing schedule.  The caller stated a patient came in today to get his second GARDASIL 9 vaccine but misread the information on when to return, so he came in at 6 months to receive the second vaccine instead o; No additional AE information was provided during the call; This spontaneous report was received from pharmacist and refers to a 30-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-JAN-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W029724, expiration date: 08-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). On 26-JAN-2024, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W029724, expiration date: 08-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). The patient came in for second dose at 6 months instead of 2 months (Inappropriate schedule of product administration). No additonal adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 25JAN2024 and was administered to a patient on 26JAN2024. No additional AE/PQC.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 26-JAN-2024 the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # W002787 and expiration date for prophylaxis (exact dose, dose number, route and site of administration were not provided) (expired product administered and no adverse event).
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Now has a hardened mass in the area of the injection site; Now has a hardened mass in the area of the injection site; They returned to the office on 1/12/2024 for pain and swelling at the injection site; They returned to the office on 1/12/2024 for pain and swelling at the injection site; This spontaneous report has been received from a nurse, regarding a 9-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 05-JAN-2024, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters intramuscularly as prophylaxis (lot number: 1957404, which was determined to be valid as syringe formulation, with an expiration date reported as 02-OCT-2025, but confirmed to be on 05-OCT-2025) (strength and anatomical location of administration were not reported).  On 12-JAN-2024, the patient returned to the office where she was vaccinated because she was experiencing pain and swelling at the injection site (vaccination site pain, vaccination site swelling). The patient was instructed to ice it and take anti-inflammatories for pain, and to return if the pain/swelling persists.  Then on 29-JAN-2024, the patient returned with an overall improvement of symptoms, but with a hardened mass in the area of the injection site (vaccination site mass, vaccination site induration)  The outcome of vaccination site swelling, and vaccination site pain was recovering, while vaccination site mass was not recovered by the time of the report.   The causal relationship between the aforementioned events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.   No additional information/clarification was provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report adverse event regarding an improperly stored and administered RECOMBIVAX HB.; No additional AE/PQC reported.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.The patient's medical history,  concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated  with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, (valid lot number X023303, expiration date: 17-MAY-2026), administered for prophylaxis (frequency, vaccination scheme and route of administration were not provided), the patient was inadvertently administered an improperly stored dose (product storage error), the patient did not report any medical concerns or symptoms related to the administration (no adverse event), the healthcare provider (HCP) did not provide specific dates in which the vaccine was exposed to temperature outside the recommended range or when the dose was administered.
Sex: F
Vaccine: RSV
Symptoms: Localised infection, Nerve injury
Clinical narrative: hole in arm and is infected; nerve damage; This non-serious case was reported by a consumer via call center representative and described the occurrence of arm infection in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In DEC-2023, the patient received Arexvy (left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced arm infection (Verbatim: hole in arm and is infected) and nerve damage (Verbatim: nerve damage). The outcome of the arm infection and nerve damage were not resolved.   It was unknown if the reporter considered the arm infection and nerve damage to be related to Arexvy.     It was unknown if the company considered the arm infection and nerve damage to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-JAN-2024 The patient reported that she got the vaccine during the 1st week of December 2023. The patient received the vaccine in her left arm at a local pharmacy. The patient reported that she had a hole in her arm which got infected and she nerve damage in her arm. The patient stated she was under medical care. The patient requested medical advice for her nerve damage and was referred to her healthcare professional. The patient disconnected abruptly and stated before she disconnected that she will get an attorney. The patient stated that she did not understand how this medicine can cause this type of side effects.  The patient stated that she did not want to get a lawyer and sue, but she needed to know with who she need to talk too. Lot and expiration date are unknown.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Joint pain in my hands; This non-serious case was reported by a consumer and described the occurrence of pain in joint involving hand in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JAN-2024, the patient received Shingrix. On 20-JAN-2024, 1 days after receiving Shingrix, the patient experienced pain in joint involving hand (Verbatim: Joint pain in my hands). The outcome of the pain in joint involving hand was not resolved.   It was unknown if the reporter considered the pain in joint involving hand to be related to Shingrix.     It was unknown if the company considered the pain in joint involving hand to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JAN-2024 This report was submitted via the online direct entry reporting system. The patient self-reported this case. The patient received Shingrix vaccine and experienced joint pain in his hand which was ongoing. The patient had going to call his doctor tomorrow (day after reporting) due to very bad pain in his hands. No other products received by the patient. The symptoms were not treated. The consent to follow up requested.
Sex: U
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: high fever, in excess of 102 degrees F; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: high fever, in excess of 102 degrees F). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-JAN-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient received Arexvy vaccine and experienced high fever, in excess of 102 degrees F. The follow up considered, no not as per process.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Tenderness
Clinical narrative: burning sensation; tender feeling; itching sensation; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced burning sensation (Verbatim: burning sensation), tenderness (Verbatim: tender feeling) and pruritus (Verbatim: itching sensation). The outcome of the burning sensation, tenderness and pruritus were not reported.   It was unknown if the reporter considered the burning sensation, tenderness and pruritus to be related to Shingrix.     It was unknown if the company considered the burning sensation, tenderness and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JAN-2024 and 25-JAN-2024 The reporter stated that can a 2nd vaccine shot be taken if one gets a mild case of shingles. The patient suffered from burning & itching sensation, no blisters or bumps. The patient questioned regarding how long did the burning & inching usually last. The patient received the first dose of Shingrix in September/October 2023. The patient had not yet received the second dose of the vaccine. The patient stated that he did not have a rash or bumps but had itchiness and a tender feeling. He was told by his doctor that he did not have Shingles. The patient had limited contact information for the pharmacy. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: genital herpes outbreak; This non-serious case was reported by a consumer via call center representative and described the occurrence of genital herpes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced genital herpes (Verbatim: genital herpes outbreak). The outcome of the genital herpes was not reported.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.     It was unknown if the company considered the genital herpes to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JAN-2024 The patient had a chat with GlaxoSmithKline agent and had question that how long he/she needs to wait to get the second shingrix shot after a genital herpes outbreak. The follow-up could not be possible as no contact details were available.
Age: 75.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received his second Havrix dose earlier than the recommended time frame; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old male patient who received HAV (Havrix adult) for prophylaxis.   Previously administered products included Havrix adult (1st dose received on 26-JULY-2023).   On 17-DEC-2023, the patient received the 2nd dose of Havrix adult. On 17-DEC-2023, an unknown time after receiving Havrix adult, the patient experienced drug dose administration interval too short (Verbatim: received his second Havrix dose earlier than the recommended time frame). The outcome of the drug dose administration interval too short 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: 22-JAN-2024 The patient self-reported this case. The patient inadvertently went and received his second Havrix dose earlier than the recommended time frame. He got the 2nd dose of Havrix adult vaccine 4 and 1/2 months after the 1st dose instead of after 6 months. The patient received second dose of Havrix vaccine at a local pharmacy earlier than the recommended time by the prescription information, which led to shortening of vaccination schedule. Lot and expiration date were unknown.  It was unknown in which arm the vaccine was administered. No additional information was provided. The reporter consented to the follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Malaise, Respiratory tract congestion
Clinical narrative: I felt like somebody has hit my chest; I got really congested; Got really sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of chest discomfort in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included tuberculosis test positive (tested positive for tuberculosis).   On 09-DEC-2023, the patient received the 1st dose of Shingrix. On 12-DEC-2023, 3 days after receiving Shingrix, the patient experienced chest discomfort (Verbatim: I felt like somebody has hit my chest), respiratory tract congestion (Verbatim: I got really congested) and sickness (Verbatim: Got really sick). The outcome of the chest discomfort, respiratory tract congestion and sickness were not resolved.   It was unknown if the reporter considered the chest discomfort, respiratory tract congestion and sickness to be related to Shingrix.     It was unknown if the company considered the chest discomfort, respiratory tract congestion and sickness to be related to Shingrix.   Additional Information: GSK receipt date: 22-JAN-2024 The patient self-reported this case. The patient received 1st dose of Shingrix and stated by December 12th, she felt like somebody had hit her chest, she got really congested, got really sick and she had been since ever since. The patient denied demographics. The reporter did not consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Blister, Condition aggravated, Herpes virus infection
Clinical narrative: she had blisters on her face; current outbreak of herpes/look like shingles or herpes; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included herpes virus infection (she had a history of herpes). Previously administered products included Shingrix (Received 1st dose of shingrix on an unknown date).   In JAN-2024, the patient received Arexvy. In JAN-2024, immediately after receiving Arexvy, the patient experienced blister (Verbatim: she had blisters on her face) and herpes virus infection (Verbatim: current outbreak of herpes). The patient was treated with acyclovir. The outcome of the blister was unknown and the outcome of the herpes virus infection was not reported.   It was unknown if the reporter considered the blister and herpes virus infection to be related to Arexvy.     It was unknown if the company considered the blister and herpes virus infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-JAN-2024 The patient self reported this case for herself. The patient received arexvy about 3 weeks ago. The patient reported that, shortly thereafter she had blisters on her face that look like shingles or herpes. The patient had a history of herpes. The patient went to hcp and they did not give her a diagnosis but started her on Acyclovir. The patient asked  if it is safe to get 2nd dose of shingrix because it is due soon. The patient  did not wanted to provided any additional information. The reporter did not consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: he experienced pain at the injection site; had muscle pain in his left arm which radiated down to wrist; muscle pain in his left arm which radiated down to wrist; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In JAN-2024, the patient received Arexvy (intramuscular, left arm). In JAN-2024, less than a month after receiving Arexvy, the patient experienced injection site pain (Verbatim: he experienced pain at the injection site), muscle pain (Verbatim: had muscle pain in his left arm which radiated down to wrist) and radiating pain (Verbatim: muscle pain in his left arm which radiated down to wrist). The outcome of the injection site pain was resolved and the outcome of the muscle pain was unknown and the outcome of the radiating pain was not reported.   It was unknown if the reporter considered the injection site pain, muscle pain and radiating pain to be related to Arexvy.     It was unknown if the company considered the injection site pain, muscle pain and radiating pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-JAN-2024 The patient is the Reporter he received a dose of Arevxy 10-12 day ago in his left arm. The patient stated after receiving the dose, he had experienced pain at the injection site which lasted about2-3 days. The patient had muscle pain in his left arm which radiated down to his wrist.  The reporter consented to follow up.
Age: 39.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 39 year old patient received Infanrix; Infanrix today instead of Boostrix; 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 39-year-old male patient who received DTPa (Infanrix) for prophylaxis.   On 22-JAN-2024, the patient received Infanrix. On 22-JAN-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 year old patient received Infanrix) and wrong vaccine administered (Verbatim: Infanrix today instead of Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 22-JAN-2024 The reporter was a manager from a medical practice who stated that a patient was given Infanrix instead of Boostrix, which led to wrong vaccine administered. According to the reporter the patient was doing perfectly fine. The reporter consented to follow-up. The reporter reported that the above mentioned age patient, received Infanrix, which led to inappropriate age at vaccine administration.
Age: 58.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Decreased immune responsiveness, Fatigue, Incomplete course of vaccination, Nasopharyngitis
Clinical narrative: I am not sure if due to this vaccine or the other I will list, but episodic joint pain, achiness, decreased immunity from colds, fatigue. I was intentionally exposed to chicken pox x2 as a child and incidentally as an adult. I did not develop chicken pox, however, since my titer was negative, even though this job in healthcare was a remote position, I was required to get the vaccine. I was not contacted for further shot on this although I believe it was a 2 shot series. I would have most likely declined due to my training schedule conflicting with this dept schedule and my concerns with getting this vaccine and possibility of shingles.
Age: 58.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pain
Clinical narrative: I am not sure if due to this vaccine or the other I will list, but episodic joint pain, achiness, decreased immunity from colds, fatigue. I was intentionally exposed to chicken pox x2 as a child and incidentally as an adult. I did not develop chicken pox, however, since my titer was negative, even though this job in healthcare was a remote position, I was required to get the vaccine. I was not contacted for further shot on this although I believe it was a 2 shot series. I would have most likely declined due to my training schedule conflicting with this dept schedule and my concerns with getting this vaccine and possibility of shingles.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 1/31/2024 and was administered to the patient. Patient was called 15 minutes after vaccination was administered. Patient to return to clinic in 4 weeks to have another dose administered.  Patient understood and acknowledged what was explained to him.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: a staff member accidentally place shingrix in the freezer for maybe 5 hours today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On 22-JAN-2024, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: a staff member accidentally place shingrix in the freezer for maybe 5 hours today). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 22-JAN-2024 The reporter sent a webform inquiry to ask if it was still okay to use the Shingrix vaccine that was accidentally placed by their staff member in the freezer, for maybe 5 hours today (on the day of reporting) and when they removed the Shingrix vaccine from freezer, it thawed within a few minutes, which led to an intercepted product storage error. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive the 2nd dose in SHINGRIX series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 20th April 2018, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive the 2nd dose in SHINGRIX series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2024 The reporter was a patient. The patient reported that she received first dose of Shingrix and did not receive the 2nd dose in Shingrix series. The reporter consented to follow-up. Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to 3 y/o patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Concomitant products included Vaxelis.   On 23-JAN-2024, the patient received Kinrix. On 23-JAN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to 3 y/o patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JAN-2024 The licensed practitioner nurse reported that the administration of Kinrix to 3 years old patient after patient received 1st dose of Vaxelis. The reporter consented to follow-up. The reporter reported that the patient below recommended age patient received Kinrix, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix under age administration; Kinrix administered instead of Pediarix administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix under age administration) and wrong vaccine administered (Verbatim: Kinrix administered instead of Pediarix administration). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 24-Jan-2024 The reporter reported that from March 2023 to December 2023, 8 patients under age 4 years received Kinrix vaccine instead of Pediarix, which led to wrong vaccine administered.  The reporter stated that no adverse reactions had been reported. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2024011355:Diferent Patient US-GSK-US2024011353:Diferent Patient US-GSK-US2024011352:Diferent Patient US-GSK-US2024011347:Diferent Patient US-GSK-US2024011346:Diferent Patient US-GSK-US2024011343:Diferent Patient US-GSK-US2024011329:Diferent Patient
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix instead of Pediarix administration; Kinrix under age administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix instead of Pediarix administration) and inappropriate age at vaccine administration (Verbatim: Kinrix under age administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-Jan-2024 The reporter reported that from March 2023 to December 2023, 8 patients under age 4 years received Kinrix vaccine instead of Pediarix, which led to wrong vaccine administered.  The reporter stated that no adverse reactions had been reported. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2024011355:Diferent Patient US-GSK-US2024011343:Diferent Patient US-GSK-US2024011346:Diferent Patient US-GSK-US2024011349:Diferent Patient US-GSK-US2024011329:Diferent Patient US-GSK-US2024011353:Diferent Patient US-GSK-US2024011347:Diferent Patient
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix instead of Pediarix administration; Kinrix under age administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 13-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix instead of Pediarix administration) and inappropriate age at vaccine administration (Verbatim: Kinrix under age administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-Jan-2024 The reporter reported that from March 2023 to December 2023, 8 patients under age 4 years received Kinrix vaccine instead of Pediarix, which led to wrong vaccine administered.  The reporter stated that no adverse reactions had been reported. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2024011352: US-GSK-US2024011355:Diferent Patient US-GSK-US2024011343:Diferent Patient US-GSK-US2024011347: US-GSK-US2024011346: US-GSK-US2024011349:Diferent Patient US-GSK-US2024011329:Diferent Patient
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix under age administration; Kinrix instead of Pediarix administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a child male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix under age administration) and wrong vaccine administered (Verbatim: Kinrix instead of Pediarix administration). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 24-Jan-2024 A nurse reported that from March 2023 to December 2023, 8 patients under age 4 years received Kinrix vaccine instead of Pediarix, which led to wrong vaccine administered.  The reporter stated that no adverse reactions had been reported. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2024011349:Diferent Patient US-GSK-US2024011343:Diferent Patient US-GSK-US2024011346:Diferent Patient US-GSK-US2024011353:Diferent Patient US-GSK-US2024011352:Diferent Patient US-GSK-US2024011329:Diferent Patient US-GSK-US2024011347:Diferent Patient
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: received only the diluent portion of Arexvy; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number B945F, expiry date 01-FEB-2025) for prophylaxis.   On 04-JAN-2024, the patient received Arexvy. On 04-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: received only the diluent portion of Arexvy) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date:24-JAN-2024 The pharmacist stated that a patient might have received only the diluent portion of Arexvy, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was not certain that the patient received only the diluent portion but there was a possibility. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.