chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Troponin increased
Clinical narrative: WOKE UP WENT OUT TO PLACE WHERE EXCERCISE HOLDING ONTO CHAIR WHERE I DO LEG DIDN'T EVEN START THEM SAID 'YOU NEED TO COME NOW' SAW ME 'SOFT FALL' DON'T REMEMBER THE FALL BUT "I WAS ON THE FLOOR GASPING FOR AIR" .  CALLED 911 THEY DIRECTED HIM TO GIVE HIM AN ASPIRIN (325 MG) , SX: NON THAT I WAS AWARE OF ON 10/25 TAKEN BY AMBULANCE {TO HOSPITAL] ADMITTED TO ICU MET WITH CARDIAC TEAM. NEVER LOST CONSCIOUSNESS, TROPONIN WAS WAY OFF THE CHARTS, HAD A "WINDOW OF TIME" THAT WAS EXPLAINED. MADE DECISION TO HAVE [BLOOD CLOT REMAOVED] . I HAD ... CATHETERIZATION, THEY WENT UP THROUGH THE GROIN . OUTCOME WAS THAT I WAS 2 DAYS IN THE ICU THEN WENT TO POST OP [AFTER THAT] 2 DAYS POST OP, CAME HOME ON THE 29TH . PER HUSBAND, SAID THEY GOT "95-98% OF [THE CLOT]" . SUBSEQUENTLY HAD "LITTLE PINGS" FROM PARTS OF THE CLOT "HITTING THE NERVES" . MD PLANS FOLLOW UP ON 2/8 FOR VASCULAR. IN DISCUSSION, MD ASKED "WHAT HAD I BEEN DOING" ; PATIENT EXPLAINED "I HAD THE COVID VACCINE ON WEDNESDAY" AT WHICH TIME MD'S "EYES WENT UP". PATIENT WAS ADVISED NOT TO TAKE ANY MORE VACCINES.
Age: 43.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was scheduled to receive the flu vaccine, but the COVID vaccine was administered by mistake. The flu vaccine was administered after. Patient did not have any adverse reaction to the COVID vaccine. They were eligible to receive that vaccine and were given the correct dose, it was simply against their wishes to receive it.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 80 yo patient received Moderna vaccine for pediatric dose, not adult dose. Have scheduled to receive correct dosing for 01/20/2025.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Pt did not have any adverse effects, I by mistake gave patient a smaller dose then was needed (6 months- 4 years) and pt is 6. I informed the mother of pt and my supervisor, I will be filling out an incident report and calling mother of child to schedule them for a correct dose 28 days from today.
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a Flu Vaccine already this season, and received an extra dose.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Paraesthesia, Pruritus, Swelling face
Clinical narrative: Patient called clinic approximately 15-20 minutes after receiving vaccination, reporting significant full body itching, hand erythema, and itching on tongue. At time of call with RN did not have further symptoms. Was advised to take PO benadryl immediately, monitor for worsening symptoms and if so call 911. Later received update that patient reported shortness of breath, facial swelling, and tingling, but airway intact. 50mg IV benadryl given by EMS prior to arrival to local ER. Currently in ER for monitoring.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue pruritus
Clinical narrative: Patient called clinic approximately 15-20 minutes after receiving vaccination, reporting significant full body itching, hand erythema, and itching on tongue. At time of call with RN did not have further symptoms. Was advised to take PO benadryl immediately, monitor for worsening symptoms and if so call 911. Later received update that patient reported shortness of breath, facial swelling, and tingling, but airway intact. 50mg IV benadryl given by EMS prior to arrival to local ER. Currently in ER for monitoring.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12+ dose given instead of 5-11 year dose
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Zoster (Shingles)  Administering Vaccines  The medical assistant inadvertently administered a 0.5 mL dose of the Shingrix diluent only. The dose did not contain any antigen powder.  The pt and provider and Health department were notified and all recommended that the pt be revaccinated 4 weeks after the invalid dose.  pt agreed and future revaccination appt was made.
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Myalgia, Pain
Clinical narrative: A few days after receiving the vaccine the patient reported that she experienced an intense muscle pain in her left arm that hasn't gone away instead, intensified whenever she moves her arm.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Zoster (Shingles)  Administering Vaccines  The medical assistant inadvertently administered a 0.5 mL dose of the Shingrix diluent only. The dose did not contain any antigen powder.  The pt and provider and Health department were notified and all recommended that the pt be revaccinated 4 weeks after the invalid dose.  pt agreed and future revaccination appt was made.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: no reaction noted
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; inadvertently administering a dose of PROQUAD to an adult patient; This spontaneous report was received from an Other Health Professional and refers to an adult patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-DEC-2024, the adult patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (lot #Y011214, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 18-DEC-2025; strength, dose and route of administration were not provided) (Product administered to patient of inappropriate age). It stated the patient had not experienced any symptoms. There was no additional adverse event (AE) or product quality complaint (PQC) was reported, and no additional information was provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported.  No additional AE/PQC.; an expired product was administered. The product is PNEUMOVAX 23.; This spontaneous report was received from an other health professional and refers to a patient of unknown gender and age.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 16-DEC-2024, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection administered for prophylaxis (strength, dose, vaccination scheme, lot#, expiration date, anatomical location and route of administration were not provided) (Expired product administered). No symptoms reported. No additional adverse event was reported.  Lot # is being requested and will be submitted if received.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: painful lump at injection site that developed 5 weeks after injection; painful lump at injection site that developed 5 weeks after injection; This spontaneous report was received from a nurse and refers to a 14-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-NOV-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date in December 2024 (also reported as 5 weeks after injection- discrepancy), the patient experienced painful lump at injection site. At the time of reporting, the outcome of the events was not known. The action taken with suspect vaccine was not applicable.  The causal relationship between events and suspect vaccine was not provided.  Lot # is being requested and will be submitted if received.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported / No additional AE details provided / The patient is fine and is not having any problems; a 2 year old male patient was inadvertently given a Vaqta vaccine on 24Dec2024 thad had expired on 13Dec2024; This spontaneous report has been received from a healthcare worker, referring to a 2-year-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 24-DEC-2024, the patient was inadvertently vaccinated with expired hepatitis A vaccine, inactivated (VAQTA), lot# X017317, expiry date 13-DEC-2024, for prophylaxis (dose, route of administration and anatomical location were not provided) (expired product administered). The patient was fine and did not have any problems. No additional adverse events were reported (no adverse event).
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Hepatitis B vaccine that expired on 14-DEC-2024 and the patient got it on 23-DEC-2024; This spontaneous report was received from a registered nurse referring to a 17-year-old patient of unknown gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 23-DEC-2024, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, that expired on 14-DEC-2024, administered for prophylaxis (strength, lot #, and route of administration were not provided). There was no adverse event.
Age: 0.17
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via breast milk, Foetal exposure during pregnancy
Clinical narrative: The patient is breastfeeding the infant; This non-serious case was reported by a consumer via call center representative and described the occurrence of vaccine exposure via breast milk in a male infant exposed to Herpes zoster (Shingrix) in utero. The mother received the product for prophylaxis.   On 03-DEC-2024, the mother received Shingrix. The infant was diagnosed with vaccine exposure via breast milk (Verbatim: The patient is breastfeeding the infant). The outcome of the vaccine exposure via breast milk was unknown.   Pregnancy exposure: Pregnancy Exposure (Shingrix): To mother while nursing   See case US2024AMR152842 for details regarding the mother case.   Additional Information: GSK Receipt Date: 03-DEC-2024 and 04-DEC-2024 The reporter reported that she was erroneously given Shingrix by her pharmacy, instead of flu vaccine.  The was currently breastfeeding. The reporter reported that it was not clarified if the infant was breast fed after receiving Shingrix.; Sender's Comments:  US-GSK-US2024AMR152842:Mother case
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: she felt the medication being injected into her arm because of how she felt the pain of the medicine going in/injection site soreness; Injection site inflammation; Injection site hot; she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow; she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow; Uncomfortable; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old female 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 injection site pain (Verbatim: she felt the medication being injected into her arm because of how she felt the pain of the medicine going in/injection site soreness), injection site inflammation (Verbatim: Injection site inflammation), injection site warmth (Verbatim: Injection site hot), joint inflammation (Verbatim: she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow), pain in elbow (Verbatim: she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow) and discomfort (Verbatim: Uncomfortable). The outcome of the injection site pain, injection site inflammation, injection site warmth, joint inflammation, pain in elbow and discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site inflammation, injection site warmth, joint inflammation, pain in elbow and discomfort to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site inflammation, injection site warmth, joint inflammation, pain in elbow and discomfort to be related to Shingrix.   Linked case(s) involving the same patient:US2024152156   Additional Information: GSK Receipt Date: 03-DEC-2024 Pharmacist reported that a patient Shingrix who received the vaccine reported that she had some inflammation and soreness at the injection site.  After 4 days, it kind of spread down to her elbow.  It's hot, it's not impeding her daily living but it's just uncomfortable.  On her 1st dose, she knew that she got it, she felt the medication being injected into her arm because of how she felt (felt the pain of the medicine going in).  The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2024152156.; Sender's Comments:  US-GSK-US2024152156:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: We have a patient who got a shingrix vaccination years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got a Shingrix vaccination years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: We have a patient who got a shingrix vaccination years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-DEC-2024 The reporter reported that they had a patient who got a Shingrix vaccination years ago. It was just the first shot of the two shot series. They were wondering if they should just got the second shot to complete the series or if they should start the series over by doing both shots again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles 2 to 3 times a year; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles 2 to 3 times a year). The patient was treated with lysine. The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that there was homeopathy for this. Reporter's ex who took the shot now gets shingles 2 to 3 times year. Nothing doctors gave to stop the pain.  She used homeopathic remedies and Lysine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: received 2 doses and by error 3rd dose of Menveo; received 2 doses and by error 3rd dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB0308, expiry date 30-APR-2025) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 02-DEC-2024, the patient received the 3rd dose of Menveo. On 23-OCT-2023, the patient received the 2nd dose of Menveo. On 23-OCT-2023, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: received 2 doses and by error 3rd dose of Menveo). On 02-DEC-2024, the patient experienced extra dose administered (Verbatim: received 2 doses and by error 3rd dose of Menveo). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 03-DEC-2024 The Healthcare professional reported that an 18 year old patient received 2 doses of Menveo last year, for the first dose they did not know date of administration and second dose was given on 23rd October 2023. Additionally, they received another Menveo vaccine this year by error on 2nd December 2024, which led to extra dose administered. Lot number and expiration dates of the 2 prior doses were unknown by caller since they were administered at another facility.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: tiredness/ fatigue; malaise; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old female 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 tiredness (Verbatim: tiredness/ fatigue) and malaise (Verbatim: malaise). The outcome of the tiredness and malaise were unknown.   It was unknown if the reporter considered the tiredness and malaise to be related to Shingrix.     It was unknown if the company considered the tiredness and malaise to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR165825   Additional Information: GSK Receipt Date: 03-DEC-2024 The reporter was a friend of the patient.  The reporter did not wish to provide date of birth, or the initials of the patient.  The reporter stated that the patient received both doses of Shingrix. After the first dose of shingrix, the patient experienced tiredness, malaise and fatigue.  The reporter did not provide consent to follow-up. For tolerance to 2nd dose, refer case US2024AMR165825.; Sender's Comments:  US-GSK-US2024AMR165825:2nd dose case
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: elbow inflamation; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-NOV-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong technique in drug usage process (Verbatim: elbow inflamation) and underdose (Verbatim: Underdose). The outcome of the wrong technique in drug usage process and underdose were unknown.   Linked case(s) involving the same patient:  US2024152154, US2024AMR154060   Additional Information: GSK Receipt Date: 03-DEC-2024 The pharmacist stated a patient who received the Shingrix vaccine reported that on her 2nd dose, she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow. It was hot, it was not impeding her daily living, but it was just uncomfortable. The pharmacist went on to state that the patient feels in comparison to her first dose that she did not get the full vaccine, she only got a partial dose. On her 1st dose, she knew she got it, she felt the medication being injected into her arm because of how she felt the pain of the medicine going in. The patient did not felt that way the 2nd time around, she felt that she barely received it because she felt like the pharmacist who gave her the immunization did not even give her the full dose, she did not felt the pain at all. As soon as the needle went in, she felt like 2 seconds later, it came back out which led to wrong technique in drug usage process. The patient did not felt leakage or anything like that, the pharmacist just pulled the needle out like very fast. The patient also did not had the date of the first dose, but the 2nd was administered, which was within the 2 to 6 month time frame.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HIBV, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Improper Storage Error; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and Hib (Hiberix) for prophylaxis.   On an unknown date, the unspecified number of patients received Bexsero, Menveo, Kinrix, Pediarix, Boostrix, Infanrix and Hiberix. On an unknown date, an unknown time after receiving Bexsero, Menveo, Kinrix, Pediarix, Boostrix, Infanrix and Hiberix, the patient experienced incorrect storage of drug (Verbatim: Improper Storage Error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-DEC-2024 Nurse reported that requests to stability data for Bexsero, Menveo (1-vial), Kinrix, Pediarix, Boostrix, Infanrix, Hiberix stored at 1 Celsius for 3 hours 33 minutes ,which led to incorrect storage of drug. No prior excursions. No signs of freezing/slushing.  Excursion happened on 19th November 2024, potential patient use of vaccines. No signs of freezing/slushing.  Excursion happened on 19NOV2024, potential patient use of vaccines. The reporter was consented to follow up.
Age: 1.17
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: patient received by accident a fourth dose of Engerix-B instead of a Hepatitis A vaccine; patient received by accident a fourth dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 14-month-old female patient who received HBV (Engerix B) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   On 03-DEC-2024, the patient received the 4th dose of Engerix B. On an unknown date, the patient received Hepatitis A vaccine. On 03-DEC-2024, an unknown time after receiving Engerix B and not applicable after receiving Hepatitis A vaccine, the patient experienced wrong vaccine administered (Verbatim: patient received by accident a fourth dose of Engerix-B instead of a Hepatitis A vaccine) and extra dose administered (Verbatim: patient received by accident a fourth dose of Engerix-B). The outcome of the wrong vaccine administered and extra dose 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: 03-DEC-2024 Healthcare Provider explained that a 14 month old patient received by accident a fourth dose of Engerix-B instead of a Hepatitis A vaccine that they needed, which led to Wrong vaccine administered and Extra dose administered. Reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Headache, Herpes zoster, Injection site pain, Pyrexia
Clinical narrative: dry spot; shingles; 5 tiny white spots; sore at the injection site; mild fever; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-NOV-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm) .5 meq/kg. On 25-NOV-2024, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: sore at the injection site), fever (Verbatim: mild fever) and headache (Verbatim: headache). On 03-DEC-2024, the patient experienced skin discoloration (Verbatim: 5 tiny white spots). On an unknown date, the patient experienced dry skin (Verbatim: dry spot) and shingles (Verbatim: shingles). On 27-NOV-2024, the outcome of the injection site pain, fever and headache were resolved. The outcome of the skin discoloration was not resolved and the outcome of the dry skin and shingles were not reported.   It was unknown if the reporter considered the injection site pain, fever, headache, skin discoloration, dry skin and shingles to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, headache, skin discoloration, dry skin and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-DEC-2024 The patient's arm was sore at the injection site, she had a mild fever, and headache. The reporter reported her physical therapist noticed about 5 white spots around a scar from a back surgery she had 6 months ago that goes vertically along her spine. The therapist said there was also a dry spot on the scar on her back. The therapist said it could be shingles since she just had the vaccine last week. Referenced Shingrix was a non-live vaccine. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: dry spot; shingles; 5 tiny white spots; sore at the injection site; mild fever; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-NOV-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm) .5 meq/kg. On 25-NOV-2024, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: sore at the injection site), fever (Verbatim: mild fever) and headache (Verbatim: headache). On 03-DEC-2024, the patient experienced skin discoloration (Verbatim: 5 tiny white spots). On an unknown date, the patient experienced dry skin (Verbatim: dry spot) and shingles (Verbatim: shingles). On 27-NOV-2024, the outcome of the injection site pain, fever and headache were resolved. The outcome of the skin discoloration was not resolved and the outcome of the dry skin and shingles were not reported.   It was unknown if the reporter considered the injection site pain, fever, headache, skin discoloration, dry skin and shingles to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, headache, skin discoloration, dry skin and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-DEC-2024 The patient's arm was sore at the injection site, she had a mild fever, and headache. The reporter reported her physical therapist noticed about 5 white spots around a scar from a back surgery she had 6 months ago that goes vertically along her spine. The therapist said there was also a dry spot on the scar on her back. The therapist said it could be shingles since she just had the vaccine last week. Referenced Shingrix was a non-live vaccine. The reporter did not consent to follow-up.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: vaccine expired on 12/1/2024 and was given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received MMR (Priorix) (batch number T3H32, expiry date 01-DEC-2024) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: vaccine expired on 12/1/2024 and was given to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-DEC-2024 The reporter reported vaccine expired was given to a patient, which led to expired vaccine used. The reporter asked what if any adverse reaction could that have. The reporter just need to know if the shelf life was longer on this vaccine then the expiration date. The date of vaccine administration was not provided, reporter disconnected chat prior to completing safety information.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Priorix - Administration after expiration date; 40 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received MMR (Priorix) (batch number T3H32, expiry date 01-DEC-2024) for prophylaxis.   On 04-DEC-2024, the patient received Priorix. On 04-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Priorix - Administration after expiration date) and inappropriate age at vaccine administration (Verbatim: 40 year old patient). The outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-DEC-2024 Medical assistant mentioned that a 40-year-old patient received a Priorix dose on the day of reporting that expired, which led to which led to inappropriate age at vaccine administration and expired vaccine used. The medical assistant asked if the shelf life was longer than the expiration date.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: box of Shingrix and one of their staff put it in the freezer for 12 hours where it was exposed to 5F; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: box of Shingrix and one of their staff put it in the freezer for 12 hours where it was exposed to 5F). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2024 The pharmacist stated they received a box of Shingrix and one of their staff put it in the freezer for 12 hours where it was exposed to 5 F and they were wondering if there was any chance of saving it. When asked, pharmacist stated there was no reason given as to why it was placed in the freezer which led to incorrect storage of drug.
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: didn't come in for the second until 23-Sep-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received HAB (Twinrix) (batch number 2553X, expiry date 25-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 09-SEP-2020).   On 23-SEP-2024, the patient received the 2nd dose of Twinrix. On 23-SEP-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: didn't come in for the second until 23-Sep-2024). The outcome of the drug dose administration interval too long 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: 06-DEC-2024 The pharmacist reported that a patient started the Twinrix series on 09th September 2020 and did not came in for the second until 23th September 2024. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 26.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: 26 years old patient; it actually was given Intramuscularly; 26 years old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old male patient who received MMR (Priorix) for prophylaxis.   Co-suspect products included MMR (Priorix) (batch number 9594A) for prophylaxis.   On 06-DEC-2024, the patient received the 2nd dose of Priorix (subcutaneous). On 23-OCT-2024, the patient received the 1st dose of Priorix (intramuscular). On 23-OCT-2024, not applicable after receiving Priorix and an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: it actually was given Intramuscularly) and inappropriate age at vaccine administration (Verbatim: 26 years old patient). On 06-DEC-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: 26 years old patient). The outcome of the inappropriate age at vaccine administration, subcutaneous injection formulation administered by other route 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: 06-DEC-2024 and 07-DEC-2024 The other health professional reported that they had a 26 years old patient for their very first dose of Priorix which led to inappropriate age at vaccine administration.  The Priorix was given intramuscularly which led to subcutaneous injection formulation administered by other route, so the other health professional think from what he/she know, GlaxoSmithKline know, Priorix was usually given subcutaneous and then, so on the day of reporting, the patient got their Second dose which was given subcutaneous, the right way which led to inappropriate age at vaccine administration. The other health professional asked that first dose given in October, would that be valid.
Age: 73.0
Sex: F
Vaccine: PPV, RVX
Symptoms: Pneumonia
Clinical narrative: pneumonia; This serious case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 73-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   Concurrent medical conditions included emphysema and chronic obstructive pulmonary disease.   In NOV-2023, the patient received RSV vaccine. On an unknown date, the patient received PNEUMOCOCCAL VACCINE. On 01-NOV-2023, an unknown time after receiving RSV vaccine, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria hospitalization and GSK medically significant). The outcome of the pneumonia was unknown.   It was unknown if the reporter considered the pneumonia to be related to RSV vaccine.     The company considered the pneumonia to be unrelated to RSV vaccine.   Linked case(s) involving the same patient:  US2024AMR160812   Additional Information: GSK Receipt Date: 18-DEC-2024 The patient received her RSV vaccination in November 2023, but she did not know which manufacturer's product it was. She reported that she was hospitalized last month with pneumonia despite having had her pneumonia vaccination several years ago. Did not consent to follow-up. Emergency room visit was required. The patient initially provided consent to contact her HCP but later revoked that consent, stating that they were too busy for that. This case was linked with case US2024AMR160812 for the same patient.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine. US-GSK-US2024AMR160812:Same patient
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Drug ineffective, Vaccination site erythema, Vaccination site pain
Clinical narrative: Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic); Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic); Localized redness and pain at injection site; Localized redness and pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Localized redness and pain at injection site), VACCINATION SITE PAIN (Localized redness and pain at injection site), DERMATITIS ATOPIC (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) and DRUG INEFFECTIVE (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product Dupilumab (Dupixent) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   In June 2020, the patient started Dupilumab (Dupixent) (Subcutaneous use) 300 milligram. On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Localized redness and pain at injection site) and VACCINATION SITE PAIN (Localized redness and pain at injection site). On an unknown date, the patient experienced DERMATITIS ATOPIC (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) and DRUG INEFFECTIVE (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)). At the time of the report, VACCINATION SITE ERYTHEMA (Localized redness and pain at injection site), VACCINATION SITE PAIN (Localized redness and pain at injection site), DERMATITIS ATOPIC (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) and DRUG INEFFECTIVE (Patient reported medication stopped working as well and was experiencing flares (Dermatitis atopic)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported.  On 31-Mar-2021, patient had injection site pain and erythema while still being on Dupilumab therapy. Patient also reported that the medication stopped working and experienced dermatitis flare. No action was taken for the events of injection site erythema and injection site pain.  Treatment medication was not reported.; Reporter's Comments: Company comment: The events of dermatitis atopic and drug ineffective are assessed as not related as reported for dupilimab therapy which was used for atopic dermatitis. The benefit-risk relationship of product is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic function abnormal
Clinical narrative: liver dysfunction; This spontaneous case was reported by a physician and describes the occurrence of HEPATIC FUNCTION ABNORMAL (liver dysfunction) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Dec-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 26-Dec-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced HEPATIC FUNCTION ABNORMAL (liver dysfunction). At the time of the report, HEPATIC FUNCTION ABNORMAL (liver dysfunction) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient was administered the vaccine 23rd December 2024 and 3 days later had liver dysfunction. Reporter causality was not reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: pain legs; dark urine; fever; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain legs), CHROMATURIA (dark urine), PYREXIA (fever) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     CLL, breast cancer,colon cancer.  Previously administered products included for Product used for unknown indication: Rsv on 27-Nov-2024 and Flu on 11-Dec-2024. Past adverse reactions to the above products included No adverse effect with Flu and Rsv. Concurrent medical conditions included CLL, Breast cancer and Colon cancer.    On 27-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 27-Dec-2024, the patient experienced PAIN IN EXTREMITY (pain legs), CHROMATURIA (dark urine), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with Paracetamol (Acetaminophen) at an unspecified dose and frequency. On 31-Dec-2024, PAIN IN EXTREMITY (pain legs), CHROMATURIA (dark urine), PYREXIA (fever) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was unknown if the patient experienced any additional symptoms or events.  There were no lab data or results were available.  Reporter causality was not reported.
Age: 51.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Anger, Anxiety, Depression
Clinical narrative: Depression; anxiety; anger; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Oct2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 23Oct2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEPRESSION (non-serious) with onset 06Nov2024, outcome "recovered" (17Dec2024); ANGER (non-serious) with onset 06Nov2024, outcome "recovered" (17Dec2024); ANXIETY (non-serious) with onset 06Nov2024, outcome "recovered" (17Dec2024). Therapeutic measures were not taken as a result of depression, anxiety, anger.  Additional Information: Patient didn't receive any other vaccines within 4 weeks PRIOR to the suspect vaccine. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs were reported; Medical assistant reported that a 4 year old patient only supposed to receive PROQUAD but the patient also inadvertently received VARIVAX on the same day.  No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from medical assistant referring to a 4-year-old patient. The patient's medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 16-DEC-2024, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHa) lot number reported as y009588 have been verified to be valid, expiration date: 17-NOV-2024; but also inadvertently received (accidental overdose) one dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number y007955 have been verified to be valid, expiration date: 17-APR-2026; both vaccines for prophylaxis (strengths, routes of administration and anatomical locations were not provided). No additional AEs were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Muscle spasms, Muscle twitching
Clinical narrative: whole body muscle spasms/tummy muscle spasms; muscle twitching; Digestive issues; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Oct2024 at 18:30 as dose 1, single (Lot number: LM7786) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: FLULAVAL taken for immunisation, on 18Oct2024 as dose number unknown, single. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset 22Nov2024 at 08:00, outcome "not recovered", described as "Digestive issues"; MUSCLE TWITCHING (non-serious) with onset 22Nov2024 at 08:00, outcome "not recovered"; MUSCLE SPASMS (non-serious) with onset 22Nov2024 at 08:00, outcome "not recovered", described as "whole body muscle spasms/tummy muscle spasms". Therapeutic measures were taken as a result of muscle spasms, muscle twitching, gastrointestinal disorder.  Additional information: past drug allergy was no. Facility vaccine was administered pharmacy or Drug Store. Patient was not taking any other medications within 2 weeks of the event starting. On 22Nov2024, 08:00, the patient had whole body muscle spasms and muscle twitching starting, digestive issues, tummy muscle spasms. Treatment received for the adverse events Endoscopy, colonoscopy, number of visits to facility.