chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling to entire extremity
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Malaise, SARS-CoV-2 test negative, Swelling face
Clinical narrative: Client felt like he was having a fever on Monday night (10/07/2024). The following day, he spent most of his day in bed feeling unwell. On Wednesday, he felt some relief, but the left side of his face suffered mild swelling (eyebag), which is the site of the affected area of Bell's palsy. On Thursday, he consulted with his PCP regarding the swelling of his left eye. The PCP prescribed prednisone due to possible adverse reaction to the Flucelvax vaccine. He felt some relief on Thursday afternoon, after taking prednisone.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Upon injecting the vaccine in the left deltoid muscle, the needle malfunctioned, and liquid leaked out and was not injected into the muscle. Administered a new Flucelvax vaccine in the right arm with no issues. Patient is doing fine with no local reaction in the left arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Three weeks past - left arm at injection site muscle aches often radiating down my arm.   Keeps me up at night.  Very achy.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Ear pain, Fatigue, Gastrooesophageal reflux disease, Influenza virus test negative, Myalgia
Clinical narrative: Nasal discharge, post nasal drip, ear pain, acid reflux, muscle aches , fatigue starting  16 days after Covid vaccination and 2 days after contact with many coughing people at. Crowded airport.   Symptoms resolving after 5 days with otc tx.  Note patient?s spouse developed similar sx 3 days later, so  sx are unlikely vaccine related.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Respiratory syncytial virus test negative, Rhinorrhoea, SARS-CoV-2 test negative, Upper-airway cough syndrome
Clinical narrative: Nasal discharge, post nasal drip, ear pain, acid reflux, muscle aches , fatigue starting  16 days after Covid vaccination and 2 days after contact with many coughing people at. Crowded airport.   Symptoms resolving after 5 days with otc tx.  Note patient?s spouse developed similar sx 3 days later, so  sx are unlikely vaccine related.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Patient uncooperative, Underdose
Clinical narrative: During the COVID vaccine, child tensed up right in the middle of the vaccine.  I tried to get her to loosen her arm so that I could complete the vaccine, but she wouldn't.  The dad told me to remove the needle from her arm in the middle of the vaccine and do it over again.  I explained that I can't use the same needle again, and that she need's to have the vaccine administered in an MD's office.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Chills, Dyspnoea, Hypoaesthesia, Oedema peripheral
Clinical narrative: I got the tdap shingles covid  I do not know the brands .. I was supposed to get the flu shot but he gave me covid instead
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash, Swelling, Wrong product administered
Clinical narrative: I got the tdap shingles covid  I do not know the brands .. I was supposed to get the flu shot but he gave me covid instead
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Nasal congestion, Pain
Clinical narrative: Developed severe cough with 101 temperature. nasal congestion and body aches
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Injection site pruritus, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: not sure of the name of the flu vaccine or other information needed, however, within hours of the vaccine the site started itching, then my face and neck felt like it was on fire and was itching, hives started breaking out on my face and neck,  then spreading head to chest and arms, was able to take Benadryl to calm the itching, however after my shift was over about 7 pm 8 pm i started flaring up again. took more benadryl
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD administered to a patient after experiencing a temperature excursion.; This spontaneous report was received from a medical assistance, concerning to a patient of an unknown age and gender.   The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent.  On an unknown date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin)(rHA)) (PROQUAD) suffered a temperature excursion of 37 minutes at 20.7 Fahrenheit degrees. No other temperature excursion reported.   On 01-OCT-2024, the patient was vaccinated with a dose of the vaccine of the improper storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, at a dose of 0.5 milliliter (mL), administered for prophylaxis (strength and route of administration were not provided; Lot No. X012417 has been verified to be a valid lot number for this vaccine, expiration date was reported and validated as 28-OCT-2024 ). (Improper storage of product in use). No additional adverse event (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; patient received a dose of VARIVAX after a temperature excursion; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-SEP-2024, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (1 dose, lot #Y004555 was valid, expiration date: 20-FEB-2026, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Temperature excursion (TE) of 10.2 F for 1 hour and 30 minutes was reported. No previous TE. No adverse event (AE) or product quality complaint (PQC) (No adverse event).  This is one of few reports from the same reporter.; Sender's Comments:  US-009507513-2410USA001590:MSD US-009507513-2410USA001583:MSD US-009507513-2410USA001624:MSD US-009507513-2410USA001630:MSD US-009507513-2410USA001312:MSD US-009507513-2410USA001417:MSD US-009507513-2410USA001318:MSD US-009507513-2410USA001454:MSD US-009507513-2410USA001596:MSD
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; HCP called to report TE where products were administered after stored improperly.; This spontaneous report has been received from a licensed practical nurse referring to a 16-year-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 02-OCT-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, dose of 0.5 mL, lot number: Y010374, expiration date: 05-JUN-2026 (dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). On unknown dates (reported as prior), the vaccine experienced the following temperature excursions: -11.25 degrees Celsius (C) for 30 minutes, -11.63 C for 30 minutes, -8.69 C for 44 minutes and -9.63 C for 36 minutes. It was reported that the current excursion was for 44 minutes at -8.25 C. It was unknown if digital data logger was involved. No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA003090:MSD US-009507513-2410USA003126:MSD US-009507513-2410USA003167:MSD US-009507513-2410USA003178:MSD US-009507513-2410USA003185:MSD US-009507513-2410USA003188:MSD US-009507513-2410USA003473:MSD US-009507513-2410USA003474:MSD US-009507513-2410USA003497:MSD US-009507513-2410USA003533:MSD
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE/ No PQC.; HCP called to report TE where products were administered after stored improperly. No Additional information provided. No Additional AE/ No PQC.    0 hours 30 minutes 0 seconds @ -11.25c (prior) o hours 30 minutes 0 seconds @-11.63c (prior) 0 hours 44; This spontaneous report as received from a nurse and refers to a 12-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 03-OCT-2024 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # Y010374 and expiration date 05-JUN-2026, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). Current excursion lasted 44 minutes in -8.25 Celsius degrees (C). Prior excursions included 30 minutes in -11.25 C, 30 minutes in -11.63 C, 44 minutes in -8.69 C and 36 minutes in -9.63 C (product storage error). No additional adverse events were reported (no adverse event).; Sender's Comments:  US-009507513-2410USA003525:MSD
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Customer reported patient administered GARDASIL 9 after product experienced a temperature excursion; This spontaneous report was received from other health care professional referring to a patient age and gender was not reported.    Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis 0.5 milliliter (ml) (route of administration, vaccination scheme frequency, anatomical location were not reported, lot number Y000205 with an expiration date on 23-SEP-2026)    It was reported that the vaccine was exposed to a temperature excursion of 31.7 degrees Fahrenheit for 18 minutes (Product storage error). Moreover, it was not reported if the information was recorded by a data logger or not. There was not previous temperature excursion. There was no adverse effect reported.
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms were reported.; Inbound call from HBP calling to request temperature excursion evaluation for ROTATEQ and VAXELIS and stated that the vaccines were administered after the excursion.; This spontaneous report was received from a health business professional (HBP) and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 27-SEP-2024  the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 unk, lot #y003996; which have been verified to be valid, expiration date: 27-APR-2025 (dose number, units, strength, vaccination scheme and route of administration were not provided); and  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, 0.5 milliliter, lot #u7899aa, expiration date: 31-AUG-2026 (dose number, strength vaccination scheme and route of administration were not provided). The vaccines have been administered for prophylaxis.   In addition, the vaccines were administered after a temperature excursion of 32.7 Fahrenheit during a time frame of 5 hours and no previous temperature excursion were reported. No further information provided. No additional adverse event (AE) was reported (no adverse event).
Age: 12.0
Sex: M
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: No additional adverse effects; HCP called to report that a patient was given PEDVAXHIB by mistake instead of Meningococcal Vaccine.  Patient (12 year old male) also received TDAP (GSK) and HEPATITIS A (GSK) and GARDASIL 9 on the same day as the PEDVAXHIB (10/4/2024). No adverse ef; This spontaneous report was received from medical assistance concerning a 12-year-old male.  The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 04-OCT-2024, the patient was vaccinated mistakenly with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) instead of meningococcal vaccine (wrong vaccine administered) (dose, indication, strength, lot #, expiry date, and route of administration were not provided). Patient also received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, strength, route, lot number and expiration date not provided), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (other manufacturer) and hepatitis a vaccine (other manufacturer) (dose, indication, strength, lot #, expiry date, and route of administration were not provided). .   Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Facial pain, Facial paralysis
Clinical narrative: facial paralysis; right sided pain in my face; This serious case was reported by a consumer via interactive digital media and described the occurrence of facial paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial paralysis (Verbatim: facial paralysis) (serious criteria GSK medically significant) and facial pain (Verbatim: right sided pain in my face). The outcome of the facial paralysis and facial pain were not resolved.   It was unknown if the reporter considered the facial paralysis and facial pain to be related to Shingles vaccine.     The company considered the facial paralysis to be unrelated to Shingles vaccine. It was unknown if the company considered the facial pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-OCT-2024 This case was reported by a patient via interactive digital media. The reporter reported that, me too, they (unspecified) were just getting over it. The reporter mentioned that they told him/her case was not as severe because he/she had the shots, but he/she still had right sided pain in his/her face and facial paralysis. The reporter mentioned that he/she did not regret getting the shot, but it was not a fail-safe.; Sender's Comments: Facial paralysis is an unlisted event which is considered unrelated to GSK  vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Myocardial infarction
Clinical narrative: heart attack; This serious case was reported by a consumer via interactive digital media and described the occurrence of heart attack in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID-19 vaccine (received a booster on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced heart attack (Verbatim: heart attack) (serious criteria death and GSK medically significant). The reported cause of death was heart attack.   It was unknown if the reporter considered the heart attack to be related to Shingles vaccine.     The company considered the heart attack to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-OCT-2024 The case was received from the consumer via interactive digital media. The reporter reported that did not take a Shingles vaccine because his/her buddy took one after getting boosted for covid and had dead heart attack, same day another friend early and covid took the vaccine and dead heart attack and the third friend died sitting at the hospital because the vaccine never believed these people they were psychotic murders and told if you would study history, you would learn that 150 million people in the last 100 years were killed by their own government.; Sender's Comments: Myocardial infarction  is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.; Reported Cause(s) of Death: Heart attack
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female 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 pain (Verbatim: painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK receipt date: 31-DEC-2023 This case was reported by a patient via interactive digital media. The patient stated that she had most painful shot ever had. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Skin exfoliation
Clinical narrative: patients hands peeled; This non-serious case was reported by a physician via sales rep and described the occurrence of skin peeling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received Shingrix and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin peeling (Verbatim: patients hands peeled). The outcome of the skin peeling was not reported.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.     It was unknown if the company considered the skin peeling to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2024 The HCP (healthcare professional) shared that a patient had got Shingrix and Covid-19 vaccines at the same time and experienced an adverse event and said that the patient's hand's peeled. It was unknown if the reporter considered the skin peeling to be related to Covid-19 vaccine.
Age: 13.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: patient was supposed to get menquadfiI, but the doctor administered Bexsero vaccine; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of wrong vaccine administered in a 13-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero and Menquadfi. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient was supposed to get menquadfiI, but the doctor administered Bexsero vaccine). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-OCT-2024 The reporter reported that the patient was supposed to get Menquadfi, but on an unknown date doctor administered Bexsero vaccine to the patient which led to, wrong vaccine administered. The reporter mentioned that the dose number, batch number and expiry date were unknown.  No further information were available.
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate irregular, Supraventricular tachycardia
Clinical narrative: diagnosed with supraventricular tachycardia; heart rate has continued to be elevated since that time; This non-serious case was reported by a consumer via call center representative and described the occurrence of supraventricular tachycardia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2021, the patient received Shingrix. In AUG-2021, less than a month after receiving Shingrix, the patient experienced heart rate increased (Verbatim: heart rate has continued to be elevated since that time). On an unknown date, the patient experienced supraventricular tachycardia (Verbatim: diagnosed with supraventricular tachycardia). The outcome of the supraventricular tachycardia was not reported and the outcome of the heart rate increased was not resolved.   It was unknown if the reporter considered the supraventricular tachycardia and heart rate increased to be related to Shingrix.     It was unknown if the company considered the supraventricular tachycardia and heart rate increased to be related to Shingrix.   Additional Information: GSK receipt date: 01-OCT-2024  The patient was diagnosed with supraventricular tachycardia in 2022 after receiving the Shingrix vaccine beginning in August 2021. The patient's heart rate had continued to be elevated since that time. After tracking his/her heart rate twice daily for two years, it fluctuated dramatically (high to low) on any given day. The patient was trying to learn more about SVT so that he/she could appropriately advocate for him/her with providers.
Sex: F
Vaccine: MEN
Symptoms: Somnolence
Clinical narrative: slept the whole next; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleepiness in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   In SEP-2024, the patient received Meningococcal B vaccine. In SEP-2024, 1 day after receiving Meningococcal B vaccine, the patient experienced sleepiness (Verbatim: slept the whole next). In SEP-2024, the outcome of the sleepiness was resolved (duration 1 day).   It was unknown if the reporter considered the sleepiness to be related to Meningococcal B vaccine.     It was unknown if the company considered the sleepiness to be related to Meningococcal B vaccine.   Additional Information: GSK Receipt Date: 01-OCT-2024 The case was received from the patient's mother via interactive digital media. The patient's mother stated that this was so scary and to hear some of the other stories. The reporter's son was due for his physical. The reporter knew for 10th grade it was mandated to get the meningitis vaccine.  The patient (reporter's daughter) had hers a month ago and slept the whole next day. The reporter asked that how meningitis was spread.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Unapproved schedule.; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a patient who received HAV (Havrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Unapproved schedule.). The outcome of the inappropriate schedule of vaccine administered was unknown.   Additional Information: GSK receipt date: 17-SEP-2024 The Medical Information Specialist from called to inform that a physician stated when they did hepatitis A accelerated, we do 2 shots, as least one week apart, which led to inappropriate schedule of vaccine administered Reporter stated that the physician didn't confirm that it was the Havrix, and that a brand was not specified, but they were concerned that it was a GSK vaccine.  Also, reporter mentioned that the physician mentioned this because there was a patient that would soon go to the and the physician was planning to do an accelerated schedule of for the patient (just as with HepA). Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: Nausea; sick as a dog for 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-SEP-2024, the patient received the 2nd dose of Shingrix (left arm). In SEP-2024, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea) and sickness (Verbatim: sick as a dog for 2 days). In SEP-2024, the outcome of the sickness was resolved (duration 2 days). The outcome of the nausea was not reported.   It was unknown if the reporter considered the nausea and sickness to be related to Shingrix.     It was unknown if the company considered the nausea and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-SEP-2024 The patient self-reported this case. The patient received her second dose of Shingrix vaccine and was sick as a dog for 2 days and had been experienced nausea for 8 days. The patient stated the nausea seems to get better after she eats but was present again by next morning.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Inappropriate schedule of product administration, Nasal congestion, Sleep disorder
Clinical narrative: stuffy nose; shivering; back pain; Drug dose administration interval too short; This non-serious case was reported by a consumer via call center representative and described the occurrence of nasal stuffiness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 30-SEP-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 30-SEP-2024, less than a day after receiving Shingrix, the patient experienced nasal stuffiness (Verbatim: stuffy nose), shivering (Verbatim: shivering), back pain (Verbatim: back pain) and drug dose administration interval too short (Verbatim: Drug dose administration interval too short). The outcome of the nasal stuffiness, shivering, back pain and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the nasal stuffiness, shivering and back pain to be related to Shingrix.     It was unknown if the company considered the nasal stuffiness, shivering and back pain to be related to Shingrix.   Additional Information: GSK receipt date: 01-OCT-2024 The patient reported that she received her first dose of SHINGRIX two weeks ago, and her 2nd dose yesterday on 30th September 2024. The patient was awakened from sleep last night with shivering,stuffy nose and back pain. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received an Arexvy dose last year, in December 2023, and today the patient was administered a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in December 2023).   On 01-OCT-2024, the patient received the 2nd dose of Arexvy. On 01-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received an Arexvy dose last year, in December 2023, and today the patient was administered a second dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-OCT-2024 The pharmacist reported that a patient received an Arexvy dose last year, in December 2023, and on the day of reporting the patient was administered a second dose which led to extra dose administered.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Pain
Clinical narrative: reported a painful reaction; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in a 61-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number K72S4, expiry date 30-JUN-2025) for prophylaxis.   The patient's past medical history included shingles (patient had shingles previously).   On 01-OCT-2024, the patient received Fluarix 2024-2025 season. On 01-OCT-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced pain (Verbatim: reported a painful reaction). The outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the pain to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-OCT-2024 The nurse reported that an adult patient received Fluarix TIV and after that reported a painful reaction in the area where patient has had shingles previously. The healthcare professional did not know if patient was or was not immunocompromised or if patient had the Shingrix vaccine prior to this shot with Fluarix TIV.
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: severe pain during the injection; it hurts so bad that it burns; it hurts so bad that it burns; product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2008-2009 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Fluarix 2008-2009 season. On an unknown date, immediately after receiving Fluarix 2008-2009 season, the patient experienced injection site pain (Verbatim: severe pain during the injection), pain (Verbatim: it hurts so bad that it burns), burning sensation (Verbatim: it hurts so bad that it burns) and pharmaceutical product complaint (Verbatim: product complaint). The outcome of the injection site pain, pain, burning sensation and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site pain, pain and burning sensation to be related to Fluarix 2008-2009 season.     It was unknown if the company considered the injection site pain, pain and burning sensation to be related to Fluarix 2008-2009 season.   Additional Information: GSK Receipt Date: 01-OCT-2024 The pharmacist had been administering the Fluarix vaccine and many people were reporting that it hurts so bad during the injection, that it burns. Nursing staff and two providers did the vaccination and they all had severe pain when getting the injection. Then they quarantined the vaccines after the medical staff had the shots, so they did not had any specific patient (non healthcare workers) who had got the Fluarix vaccine. The age range of the vaccinated persons were 38 to under 52 years old. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024121112:same reporter, different patient US-GSK-US2024AMR121777:same reporter, different patient US-GSK-US2024AMR121803:same reporter, different patient US-GSK-US2024AMR121802:same reporter, different patient
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: hurts so bad during the injection/it burns; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2008-2009 season) (batch number 72RF2) for prophylaxis.   On an unknown date, the patient received Fluarix 2008-2009 season. On an unknown date, an unknown time after receiving Fluarix 2008-2009 season, the patient experienced injection site pain (Verbatim: hurts so bad during the injection/it burns). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Fluarix 2008-2009 season.     It was unknown if the company considered the injection site pain to be related to Fluarix 2008-2009 season.   Additional Information: GSK receipt Date: 01-OCT-2024 Healthcare Professional reported that they had been administering the Fluarix vaccine and many people were reporting that it hurts so bad during the injection, that it burns.  Nursing staff and two providers did the vaccination and they all had severe pain when getting the injection.  Then they quarantined the vaccines after the medical staff had the shots, so they did not have any specific patient for non-healthcare workers who had got the Fluarix vaccine.  The age range of the vaccinated people were 38 to under 52 years old. This case had been linked with US2024121111 due to same reporter foe different patients.; Sender's Comments:  US-GSK-US2024121111:SAME REPORTER/ DIFFERENT PATIENT
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: severe pain when getting the injection; it hurts so bad that it burns; it hurts so bad that it burns; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2008-2009 season) (batch number 72RF2) for prophylaxis.   On an unknown date, the patient received Fluarix 2008-2009 season. On an unknown date, immediately after receiving Fluarix 2008-2009 season, the patient experienced injection site pain (Verbatim: severe pain when getting the injection), pain (Verbatim: it hurts so bad that it burns) and burning sensation (Verbatim: it hurts so bad that it burns). The outcome of the injection site pain, pain and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain, pain and burning sensation to be related to Fluarix 2008-2009 season.     It was unknown if the company considered the injection site pain, pain and burning sensation to be related to Fluarix 2008-2009 season.   Additional Information: GSK Receipt Date: 01-OCT-2024 The pharmacist had been administering the Fluarix vaccine and many people were reporting that it hurts so bad during the injection, that it burns. Nursing staff and two providers did the vaccination and they all had severe pain when getting the injection. Then they quarantined the vaccines after the medical staff had the shots, so they did not had any specific patient (non healthcare workers) who had got the Fluarix vaccine. The age range of the vaccinated persons were 38 to under 52 years old. This case had been linked with US2024121095, reported by the same reporter.; Sender's Comments:  US-GSK-US2024121095:SAME REPORTER/ DIFFERENT PATIENT
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Therapeutic response decreased
Clinical narrative: she got the titer done, and it was too low; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   The patient's past medical history included adenoma liver (Hepatic Adenomas) and tumor excision (had been removed/they removed something, like a sack).   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapeutic response decreased (Verbatim: she got the titer done, and it was too low). The outcome of the therapeutic response decreased was unknown.   Additional Information: GSK Receipt Date: 01-OCT-2024 The pharmacist reported that the patient was trying to get a job even if she had the series, she got the titer done and it was too low from what they wanted, she then told the pharmacist that she wanted to check to see if it was okay. The pharmacist reported that the patient could not get the job unless she had the shot. The patient had a history of hepatic adenomas, the pharmacist was going with this cause he/she had never heard of this, they thought it was possibly due to her birth control, they had been removed and they were benign, no subtype of the tamer. The patient had a scan done this past september and it showed no new tumors, only like a pocket of flux where they removed something, like a sack where they had removed and nothing had grown. The pharmacist reported that the patient needs to get the series of three.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Ulcer
Clinical narrative: Ulceration of the smallpox scar; This spontaneous case was reported by a patient and describes the occurrence of ULCER (Ulceration of the smallpox scar) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Sleep apnea in 1989. Concurrent medical conditions included Drug allergy (Allergic to losartan), Drug allergy (Allergy to sulpha drugs), Grass allergy, Pollen allergy (Allergy to tree pollen), Type II diabetes mellitus since 2010 and Arthritis since 2015. Concomitant products included HYDROXYCHLOROQUINE, TIRZEPATIDE (MOUNJARO), ROSUVASTATIN, TOPIRAMATE and FAMOTIDINE for an unknown indication.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ULCER (Ulceration of the smallpox scar). At the time of the report, ULCER (Ulceration of the smallpox scar) had not resolved.            No treatment medications were reported.   This case was linked to MOD-2024-773975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2024: Live follow-up received that contains no new information
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Ulcer
Clinical narrative: Ulceration of the smallpox scar; This spontaneous case was reported by a patient and describes the occurrence of ULCER (Ulceration of the smallpox scar) in a 72-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Sleep apnea in 1989. Concurrent medical conditions included Drug allergy (Allergy to losartan), Drug allergy (Allergy to sulfa drugs), Pollen allergy (Allergy to tree pollen), Type II diabetes mellitus since 2010 and Arthritis since 2015. Concomitant products included HYDROXYCHLOROQUINE, TIRZEPATIDE (MOUNJARO), ROSUVASTATIN, TOPIRAMATE and FAMOTIDINE for an unknown indication.   In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ULCER (Ulceration of the smallpox scar). At the time of the report, ULCER (Ulceration of the smallpox scar) had not resolved.            It was reported that patient had same effect (ulceration of smallpox scar) with each previous Moderna Covid vaccinations in 2022 and 2023. No treatment medications were reported.   This case was linked to MOD-2024-773975, MOD-2024-774870 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2024: Live follow-up received that contains no new information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (seizure) in an 84-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043160) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse effect with Flu vaccine. Concurrent medical conditions included Diabetic.    On 04-Oct-2024, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 04-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  Company comment:  This is a spontaneous case concerning an 84-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) AESI of seizure which occurred on the same day of the administration of SPIKEVAX 2024-2025 KP.2 PFS vaccine, used as a second dose. An HCP reported that a patient developed seizure after vaccination. Outcome reported as unknown. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of SPIKEVAX 2024-2025 KP.2 PFS Vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm/bit of a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm/bit of a sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included PANTOPRAZOLE and CELECOXIB (CELEXAL) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm/bit of a sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of when needed. At the time of the report, PAIN IN EXTREMITY (sore arm/bit of a sore arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated that the first four or five that she had, she just whizzed through that with no problem at all, just a little bit of a sore arm. which didn't bother her. The patient insisted that for these vaccines, she didn't have any problems except the sore arm.   This case was linked to US-MODERNATX, INC.-MOD-2024-774931, US-MODERNATX, INC.-MOD-2024-774910 (E2B Linked Report). This case was linked to MOD-2024-774913, MOD-2024-774918, MOD-2024-774924, MOD-2024-774928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2024: Non-significant follow up added. On 05-Oct-2024: Non-significant follow up added. references added. On 05-Oct-2024: Live non-significant follow up added. On 07-Oct-2024: Live significant information accepted. Reporter details, Patient DOB and References added, concomitant medication, treatment drug was added. On 08-Oct-2024: Live non-significant follow up added. On 08-Oct-2024: Live Follow up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774931:Invalid other people case US-MODERNATX, INC.-MOD-2024-774910:Invalid for another friend
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Wrong technique in product usage process
Clinical narrative: frozen as she was administering the shot; a sore lymph node on her left side,; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (a sore lymph node on her left side,) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (frozen as she was administering the shot) in a 99-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043822) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 04-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced LYMPH NODE PAIN (a sore lymph node on her left side,). On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (frozen as she was administering the shot). At the time of the report, LYMPH NODE PAIN (a sore lymph node on her left side,) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (frozen as she was administering the shot) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: bitter nasty taste in their mouth; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (bitter nasty taste in their mouth) in a 65-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043029) for COVID-19 prophylaxis.     The patient's past medical history included Sinus disorder.    On 08-Oct-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 08-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced DYSGEUSIA (bitter nasty taste in their mouth). At the time of the report, DYSGEUSIA (bitter nasty taste in their mouth) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had not known allergy. The concomitant medication was not reported by reporter. It was reported that patient received their vaccine on 8-Oct-2024 and then 15 min later they started experiencing a bitter nasty taste in their mouth. Patient confirmed that it was not a loss of taste. The treatment medication was not reported by reporter.