chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: DTAP, RSV, VARZOS
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea/Vomiting, light headedness, started the evening after the vaccinations, but no treatment taken
Age: 14.0
Sex: M
Vaccine: DT
Symptoms: Injection site hypoaesthesia, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: On the day after injection, he had a sore arm at site of injection plus a blotchy rash at site of injection (about the size of a quarter). On Day 6, the patchy swollen rash had extended to 3 x 2.5 inches. It was hot to the touch and felt quite firm (Arthus hypersensitivity reaction). Pt said his upper arm felt like it was constantly asleep (brachial neuritis symptom), but he can feel when we touch his arm.
Age: 14.0
Sex: M
Vaccine: DT
Symptoms: Rash macular, Rash papular
Clinical narrative: On the day after injection, he had a sore arm at site of injection plus a blotchy rash at site of injection (about the size of a quarter). On Day 6, the patchy swollen rash had extended to 3 x 2.5 inches. It was hot to the touch and felt quite firm (Arthus hypersensitivity reaction). Pt said his upper arm felt like it was constantly asleep (brachial neuritis symptom), but he can feel when we touch his arm.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient woke up with tingling and numbness on her right hand. The feelings came and went. Advised patient to massage hand and arm and to watch out if symptoms increased or became more frequent to contact her physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Pain of skin, Rash, Tenderness
Clinical narrative: Rash in left arm 2 days after, lasting for 4-5 days. Then experience pain on scalp behind left ear, sore lymph node on left side of neck, and and tenderness above left eye.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reported pain at the injection site, and limited range of motion. Patient reported conditions as improving at the time she reported it to the provider.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Mobility decreased
Clinical narrative: Severe - fatigue, headaches unresponsive to OTC meds, muscle aches, pain at injection site lasting several days that spread to entire area around shoulder, fever up to 102. Symptoms were the worst the day after the vaccine.  I spent two days in bed. I do not usually respond to vaccines in this way.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Severe - fatigue, headaches unresponsive to OTC meds, muscle aches, pain at injection site lasting several days that spread to entire area around shoulder, fever up to 102. Symptoms were the worst the day after the vaccine.  I spent two days in bed. I do not usually respond to vaccines in this way.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: Swollen, red arm. Pain at injection site, headache, nausea, chills, all over severe muscle pain, fatigue
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Peripheral swelling
Clinical narrative: Swollen, red arm. Pain at injection site, headache, nausea, chills, all over severe muscle pain, fatigue
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Loss of personal independence in daily activities, Sleep disorder
Clinical narrative: Since I received the Tdap vaccine at the clinic, I have been experiencing sharp shoulder pain that impacts my daily functioning and sleep.  It has been 10 days so far and the pain has been ongoing. I received the vaccine on 5/15/2024.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Diet refusal, Irritability, Vomiting
Clinical narrative: Vomiting, fussiness, unwilling to eat day after vaccines
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional
Clinical narrative: Had trouble breathing while walking
Age: 19.0
Sex: F
Vaccine: FLUX, HEPAB, TDAP
Symptoms: Pyrexia
Clinical narrative: Approximately 20 hours later, High fever, 102.9, unrelieved by fever reducing agents, 1000mg taken as a single dose shortly after symptom onset, 650 mg additional taken approximately 5 hours later. Fever still 102.4-102.8.  Ice bath done at home after Tylenol appeared not to be working, ice bath did manage fever. Continued to do ice bath on and off throughout that night to manage, fever was 101 the next day. Fever resolved approximately 72 hours after vaccines were received, 48 hours after symptom onset
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Approximately 24 hours after vaccine administration, high fever 102-103, 650 mg Tylenol taken right after symptom onset, fever checked approximately 1 hour later no changes, fever approximately 102.8, ice bath helped lower fever, approximately 100.9 when out of the bath, additional Tylenol taken 650mg about 4 hours after initial dose. Ice packs used while sleeping, next morning fever was about 101.4. 650mg Tylenol did not lower the fever in that morning about 40-48 hours after the dose. Fever resolved approximately 60 hours after receiving vaccine
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Lymph node swelling and pain in armpit of arm where injection was given.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Carditis, Chest pain
Clinical narrative: Constant Chest Pain (Heart Inflamation)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Gastrointestinal disorder, Myalgia, Palpitations
Clinical narrative: SOB Heart Palpitations Dizziness Muscle pain GI issues  ETC ......
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Starting the night of the injection I was very drowsy and went to sleep. I woke up not too long after with a 102 fever, full body ache, very out of it, dizzy, couldn't focus my eyes and swelling/redness at the injection site. The next day my temperature stayed about 101 and all the other symptoms were still happening but slightly better with taking Benadryl and acetaminophen every 4-6 hours. My arm was extremely worse though, the injection site swelled horribly, was very painful and the redness started going down into my lower arm.  The side effects lasted for about 3 days before I felt the improvement and my temperature stayed normal.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence, Vision blurred
Clinical narrative: Starting the night of the injection I was very drowsy and went to sleep. I woke up not too long after with a 102 fever, full body ache, very out of it, dizzy, couldn't focus my eyes and swelling/redness at the injection site. The next day my temperature stayed about 101 and all the other symptoms were still happening but slightly better with taking Benadryl and acetaminophen every 4-6 hours. My arm was extremely worse though, the injection site swelled horribly, was very painful and the redness started going down into my lower arm.  The side effects lasted for about 3 days before I felt the improvement and my temperature stayed normal.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling hot, Headache, Injection site pain
Clinical narrative: Received vaccine Friday evening.  By Friday night developed headache, nausea and vomiting.  Saturday developed severe pain at injection site, heat, pain, swelling.  By Saturday evening headache worse, nausea intensified. Woke up today exhausted,  nausea, headache, myalgias, joint pain and a low grade fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Received vaccine Friday evening.  By Friday night developed headache, nausea and vomiting.  Saturday developed severe pain at injection site, heat, pain, swelling.  By Saturday evening headache worse, nausea intensified. Woke up today exhausted,  nausea, headache, myalgias, joint pain and a low grade fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Received vaccine Friday evening.  By Friday night developed headache, nausea and vomiting.  Saturday developed severe pain at injection site, heat, pain, swelling.  By Saturday evening headache worse, nausea intensified. Woke up today exhausted,  nausea, headache, myalgias, joint pain and a low grade fever.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Malaise, Nausea, Pyrexia
Clinical narrative: fever, nausea, chills, feeling sick - red patch on left arm size of palm of hand - going to try ice/cold compresses and topical benadryl - will follow up with provider if not getting better or getting worse
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, Musculoskeletal disorder
Clinical narrative: Three days prior to this report of the event (05/23/24), patient reported immobilization of legs along with a lack of taste or smell. Symptoms have been consistent throughout the days since first onset.
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Chest discomfort, Joint swelling, Pain in extremity, Respiratory rate decreased
Clinical narrative: Patient called the pharmacy said, "it felt like she had something sitting on her chest, like she had fluid in her chest, slower breathing" Patient also reported she had ankle swelling and a sore arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Hypoaesthesia, Mobility decreased, Muscular weakness, Pain
Clinical narrative: Received Vaccination on 5/23/2024 at 4:30 pm or so.  I started having severe back pain  on 5/24/2024 in the morning along with body aches and fever.  Body aches and fever went away on 5/25/2024.  However the severe lower back pain got worse at times, and I started having leg weakness. Once I laid down on bed, I could not get up due to the severe lower pain and leg weakness with tingling and numbness. The symptoms got worse as time went on.  Today 5/26/2024, I laid down to relax my back, and I could not get up as if my lower body was paralyzed. The pain was unbearable. after trying for a longtime, with my spouse's help, I got up and started slowly walking around.  After moving around for a while, I was able to walk better, but the pain is still there with tingling and numbness on both legs.  I have not contacted my doctor and will email her tomorrow (Monday, but holiday) for care instructions.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Paralysis, Pyrexia
Clinical narrative: Received Vaccination on 5/23/2024 at 4:30 pm or so.  I started having severe back pain  on 5/24/2024 in the morning along with body aches and fever.  Body aches and fever went away on 5/25/2024.  However the severe lower back pain got worse at times, and I started having leg weakness. Once I laid down on bed, I could not get up due to the severe lower pain and leg weakness with tingling and numbness. The symptoms got worse as time went on.  Today 5/26/2024, I laid down to relax my back, and I could not get up as if my lower body was paralyzed. The pain was unbearable. after trying for a longtime, with my spouse's help, I got up and started slowly walking around.  After moving around for a while, I was able to walk better, but the pain is still there with tingling and numbness on both legs.  I have not contacted my doctor and will email her tomorrow (Monday, but holiday) for care instructions.
Sex: U
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature delivery
Clinical narrative: Premature delivery; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2751386-1 (VAERS ID).  A neonate patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), transplacental, administration details for the mother: not provided as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE BABY (non-serious), outcome "unknown", described as "Premature delivery". The baby was delivered premature.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter details updated, narrative updated to reflect the correct reporter and that the report was received from the regulatory authority, and reference number 2751386-1 (VAERS ID) added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400064003 Mother case;
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: Cellulitis on the left arm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of cellulitis of arm in a female patient who received Herpes zoster (Shingrix) (batch number 5RX5T, expiry date 27-APR-2026) for prophylaxis.   On 16-MAR-2024, the patient received Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced cellulitis of arm (Verbatim: Cellulitis on the left arm). The outcome of the cellulitis of arm was not reported.   It was unknown if the reporter considered the cellulitis of arm to be related to Shingrix.     It was unknown if the company considered the cellulitis of arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2024 The patient received the Shingrix vaccine and days later returned to the pharmacy to report that she developed cellulitis on the left arm after the vaccine was applied.   The patient required medical attention and treatment. The reporter consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis on the left arm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of cellulitis of arm in a female patient who received Herpes zoster (Shingrix) (batch number 5RX5T, expiry date 27-APR-2026) for prophylaxis.   On 16-MAR-2024, the patient received Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced cellulitis of arm (Verbatim: Cellulitis on the left arm). The outcome of the cellulitis of arm was not reported.   It was unknown if the reporter considered the cellulitis of arm to be related to Shingrix.     It was unknown if the company considered the cellulitis of arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2024 The patient received the Shingrix vaccine and days later returned to the pharmacy to report that she developed cellulitis on the left arm after the vaccine was applied.   The patient required medical attention and treatment. The reporter consent to follow-up.
Age: 51.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a dose of PROQUAD was inadvertently administered to a 51 year old male patient; No additional AE / patient has not had any symptoms; This spontaneous report was received from a medical assistant and refers to a 51-year-old male. The patient's medical and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (recombinant Human albumin (rHA), lot number X022921 with no expiration date, that has been verified to be valid with expiration date established as 12-MAR-2025, administered for prophylaxis (strength, anatomical location and route of administration were not provided) (Product administered to patient of inappropriate age). Patient has not had any symptoms.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia
Clinical narrative: COVID-19; SOUR TASTE IN MOUTH; This spontaneous report received from a health care professional via another company (Pfizer) and concerned patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) (dose series 1) dose, start therapy date were not reported for covid-19 prophylaxis. Batch number was not reported and the company is unable to request for batch number. No concomitant medications were reported.  Non-company suspect drugs included: nirmatrelvir/ritonavir (tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for covid-19. Patient was recently diagnosed with Covid-19 (dose series 1) and because the patient was immunocompromised (dose series 2). Patient decided to take nirmatrelvir/ritonavir which prescribed by doctor. Patient had only taken 2 doses (nirmatrelvir/ritonavir) so far. The consumer enquired that would it be a bad thing to not take remaining 4 days of treatment with nirmatrelvir/ritonavir. The consumer did some research which suggested Paxlovid isn't supposed to be used in wide usage and doesn't seem to be in a category of needing it. The patient woke up with a 'sour taste' in mouth this morning. It was not metallic but a sour taste. Patient was wondering whether should continue taking nirmatrelvir/ritonavir. The action taken with covid-19 vaccine ad26.cov2.s, and nirmatrelvir/ritonavir was not applicable. The outcome of the covid-19 and sour taste in mouth was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Postural orthostatic tachycardia syndrome
Clinical narrative: Muscle aches, joint pain, fatigue, chills, postural orthostatic tachycardia
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix was administered to a patient older than the recommended age; Infanrix was administered to a patient instead of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 14-MAY-2024, the patient received Infanrix. On 14-MAY-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix was administered to a patient older than the recommended age) and wrong vaccine administered (Verbatim: Infanrix was administered to a patient instead of Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAY-2024 The nurse reported a medication error was made and Infanrix was administered to a patient older than the recommended age, which led to inappropriate age at vaccine administration.  The nurse reported that, Infanrix was administered to a patient instead of Boostrix, which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Incomplete course of vaccination, Pain in extremity, Rash vesicular
Clinical narrative: Patient's arm was very red; It was very very sore; patient almost broke out blistered almost with little bumps; almost with little bumps; patient who received only one dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 29GB3, expiry date 16-SEP-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14-SEP-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Patient's arm was very red), pain in arm (Verbatim: It was very very sore), blister (Verbatim: patient almost broke out blistered almost with little bumps), papular rash (Verbatim: almost with little bumps) and incomplete course of vaccination (Verbatim: patient who received only one dose of Shingrix). The outcome of the erythema of extremities, pain in arm, blister, papular rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the erythema of extremities, pain in arm, blister and papular rash to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, pain in arm, blister and papular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2024 The pharmacist had a female adult patient who received only one dose on Shingrix.  The patient's arm was very red, she almost broke out blistered almost with little bumps.  The pharmacist reported, it was very very sore.  The patient was afraid of the 2nd dose.  The patient's doctor was not been very, he was not really getting one way or the other.  Till the time of reporting the patient did not received the 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not consented to follow up.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: gave a 5 days expired Priorix; 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 1-year-old male patient who received MMR (Priorix) (batch number 5YL7Y, expiry date 11-MAY-2024) for prophylaxis.   On 16-MAY-2024, the patient received Priorix. On 16-MAY-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: gave a 5 days expired Priorix). 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: 16-MAY-2024 The Medical Assistant reported that he/she gave the 5 days expired Priorix vaccine to the patient on 16th May 2024 which led to Expired vaccine used. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: was administered Kinrix by accident yesterday; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 15-MAY-2024, the patient received Kinrix. On 15-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: was administered Kinrix by accident yesterday). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-MAY-2024 The father of patient reported that a patient administered Kinrix by accident who was just one year old and wants to know if there was information available. He did not have any more information. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get a second dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in year 2020 from batch number 3K9YH with expiry date 23-SEP-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not get a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 The health care provider reported that the patient did not get a second dose of Shingrix till the time of reporting, which led to an incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: At the moment of the call the patient had not received the 2nd dose of Shingrix yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix in 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: At the moment of the call the patient had not received the 2nd dose of Shingrix yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2024 The patient self-reported this case for herself. The patient reported that, a couple of years ago she began getting her shingles vaccines, when she went for her 2nd dose the computer said that, the patient had already gotten the 2nd dose but she didn't. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. Follow-up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Shingrix 2 years ago and today received the second dose; 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 male patient who received Herpes zoster (Shingrix) (batch number YL7LR, expiry date 15-MAY-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine 2 years ago).   On 17-MAY-2024, the patient received the 2nd dose of Shingrix. On 17-MAY-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received the first dose of Shingrix 2 years ago and today received the second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 17-MAY-2024 The patient received 2nd dose of Shingrix (on the day of reporting), later than the recommended interval, which led to lengthening of vaccination schedule. The HCP (Health care professional) asked if they should administered a third dose.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inadvertently received the second dose of Shingrix just 37 days after the first one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 3ZT24, expiry date 21-APR-2026) for prophylaxis.   Additional patient notes included patient was not immunocompromised. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 17-MAY-2024, the patient received the 2nd dose of Shingrix. On 17-MAY-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: inadvertently received the second dose of Shingrix just 37 days after the first one). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2024. A pharmacist inquired about the recommendations on how to follow up on a patient that had inadvertently received the second dose of Shingrix just 37 days after the first one, earlier than recommended interval, which led to shortening of vaccination schedule.  The vaccine administration facility was the same as primary reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Pain in extremity
Clinical narrative: Diarrhea; sore arm; red arm; This non-serious case was reported by a consumer and described the occurrence of diarrhea in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism, blood pressure high, chronic kidney disease stage 3, anxiety, blood cholesterol increased and hyperacidity. Concomitant products included lisinopril, dapagliflozin propanediol monohydrate (Farxiga), levothyroxine, sertraline, atorvastatin, famotidine and pantoprazole (Pantoprazol).   On 07-MAY-2024, the patient received Shingrix. On 08-MAY-2024, 1 days after receiving Shingrix, the patient experienced diarrhea (Verbatim: Diarrhea), pain in arm (Verbatim: sore arm) and erythema of extremities (Verbatim: red arm). The outcome of the diarrhea, pain in arm and erythema of extremities were not resolved.   It was unknown if the reporter considered the diarrhea, pain in arm and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the diarrhea, pain in arm and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2024 The patient self reported this case. The patient had diarrhea and red, sore arm till now (till the time of reporting). The symptoms were not treated.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: swelling; red mark; This non-serious case was reported by a physician via sales rep and described the occurrence of swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling (Verbatim: swelling) and erythema (Verbatim: red mark). The outcome of the swelling and erythema were resolved.   The reporter considered the swelling and erythema to be related to Shingrix.     The company considered the swelling and erythema to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR062575   Additional Information: GSK Receipt Date: 16-MAY-2024 The patient self reported this case. The patient had a shot of Shingles and had swelling and a red mark. For tolerance of 2nd dose refer case US2024AMR062575.; Sender's Comments:  US-GSK-US2024AMR062575:Same patient/ SECOUND DOSE
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Chronic Hives; This non-serious case was reported by a consumer and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUL-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Chronic Hives). The patient was treated with omalizumab (Xolair). The outcome of the hives was not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2024 The patient had been dealing with chronic hives since injection of Shingrix.  The reporter stated that neither steroid injections or H1 antihistamines had been able to clear the hives.  The patient's dermatologist has recommended using Xolair as the next step in clearing the chronic hives.  The patient asked if any data that could be shared regarding individuals who have had the same experience and what treatments were successful in treating the symptoms.  The patient stated that if any assistance will be greatly appreciated.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: I administered the Shingrix vaccine with sterile water; This non-serious case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution 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 wrong solution used in drug reconstitution (Verbatim: I administered the Shingrix vaccine with sterile water). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 15-MAY-2024 The nurse administered the Shingrix vaccine with sterile water which led to, wrong solution used in drug reconstitution. The reporter asked was it still okay or do he or she need to re-administer the vaccine and if so, how soon. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: RA Receipt Date: 19-MAY-2024 This case was reported by a patient via (privacy) interactive digital media. The patient got the vaccine and 2 days after got shingles. The patient mentioned, they said it happens but rare.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on arms; This non-serious case was reported by a physician via other manufacturer and described the occurrence of rash in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to vaccine.   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 rash (Verbatim: Rash on arms). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR063481   Additional Information: GSK receipt date: 20-MAY-2024 The patient had rash on her arms after 1st dose of Shingrix. The case is linked with US2024AMR063481, same reporter, same patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: was a power outage for 3hrs overnight and vaccines was exposed to 59F. No prior excursions.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 77h34, expiry date 06-DEC-2025) for prophylaxis.   On 16-MAY-2024 09:52, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: was a power outage for 3hrs overnight and vaccines was exposed to 59F. No prior excursions.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 The healthcare professional reported there was a power outage for 3 hours overnight and vaccines was exposed to 59 Fahrenheit and there was no prior excursions, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient got their first shingles shot in September and is now looking for their second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in SEP-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient got their first shingles shot in September and is now looking for their second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2024 The nurse reported that she was wondering if an adult aged over 65 waited over 6 months for their second Shingles shot. The reporter asked if they needed to repeat the series (confirmed Shingrix). The patient got their first Shingles shot in September and now (at the time of reporting) was looking for their second dose, it had been over 6 months. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only one dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st August 2023, batch 97LJ7 and expiry 6th August 2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: only one dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-MAY-2024 Pharmacist reported a patient got only one dose of Shingrix in August 1st 2023, which led to incomplete course of vaccination. Asked if the patient need 2nd dose. The reporter cnsented to follow up.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Medical Assistant administered a dose of the liquid CYW-135 conjugate portion of Menveo without reconstituting with the lyophilized meningococcal A portion.; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA975, expiry date 31-OCT-2025) for prophylaxis.   On 20-MAY-2024, the patient received Menveo. On 20-MAY-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Medical Assistant administered a dose of the liquid CYW-135 conjugate portion of Menveo without reconstituting with the lyophilized meningococcal A portion.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 21-MAY-2024 Clinical Director reported that a Medical Assistant administered a dose of the liquid CYW-135 conjugate portion of Menveo without reconstituting with the lyophilized meningococcal A portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter
Age: 17.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No other AE; inadvertent administration of PROQUAD and VARIVAX to a patient on the same day on 05/14/2024.  Patient was supposed to receive the MMR II and VARIVAX; inadvertent administration of PROQUAD and VARIVAX to a patient on the same day on 05/14/2024.  Patient was supposed to receive the MMR II and VARIVAX; Vaccine administered to a 17 year old patient; This spontaneous report was received from a medial assistant and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (exact dose, route of administration, vaccination site, lot # and expiration date were not provided) administered for prophylaxis.  On 14-MAY-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X020565, expiration date reported as and upon internal review confirmed as: 03-FEB-2025 (exact dose, route of administration and vaccination site were not provided) administered for prophylaxis. On the same day, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X018952 and expiration date reported as and upon internal review confirmed as: 13-JUL-2025 (exact dose, route of administration and vaccination site were not provided) administered for prophylaxis (accidental overdose) (product administered to patient of inappropriate age).  On 14-MAY-2024, there was an inadvertent administration of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX). The patient was supposed to receive the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (wrong product administered). No symptoms were reported. No Additional details were provided. No other adverse event AE and no product quality complaint (PQC) was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of MMR-II expired on 4/6/2024 and was administered on 5/21/2024; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.      On 21-MAY-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA, Injection,  lot # W022943, expiration reported as 06-APR-2024 for prophylaxis (dose, dose number, route, and route of administration were not provided).  The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had no temperature excursions prior to administration. No additional AE reported.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: syringes breaking; No AE reported; This spontaneous report has been received from a health business professional (HBP) via a company representative. No patient was involved.   The doctors had several instances of syringes from  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 ml syringe breaking (Syringe issue) in the past couple of weeks (batch# 0001716939, lot #Y002963 has been verified to be a valid lot number, expiration date 04-OCT-2026). The break was occurring at the top of the glass where the plastic plunger went into the syringe. One of the boxes also had several syringes broken during shipment. At the time of reporting, the reporter did not have the broken syringes because they had already disposed them. If possible, they would get pictures of any syringes that broke in the future.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; inadvertently administered VARIVAX after the temperature excursion occurred; This spontaneous report was received from a pharmacy manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions were not reported and concomitant therapies were not reported.  On 21-MAY-2024 at 10:30am, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number X010526 with expiration date: 11-APR-2025, that has been verified to be valid, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).   On an unknown date, the vaccine had a temperature excursion of -4C, for a time range of 21 Hours 30 Minutes 0 Seconds. No additional adverse events or product quality complaint were reported. No previous temperature excursion reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP calling to report that patient received inappropriately stored VARIVAX.; This spontaneous report has been received from a medical assistant, regarding to a 1 years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 21-MAY-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number: X026789, which was determined to be valid, with an expiration date on 14-NOV-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered dose was stored at a temperature of 19.8 degrees Fahrenheit (F), during a time frame of 15 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received inappropriately stored VARIVAX; This spontaneous report has been received from a medical assistant concerning to a 01-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 23-MAY-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, single dose, lot number X026789 that was verified to be a valid lot number (expiration date reported and validated as 14-NOV-2025) as prophylaxis (strength, specific dose, scheme, route, and anatomical location of administration were not provided) (product storage error). The dose was exposed to a temperature of 19.8 F, for 20 hours 15 minutes. There were no previous temperature excursions (TE). No adverse effects were reported (no adverse event).
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of inappropriate dose of vaccine administered in a 36-year-old female patient who received HBV (Engerix B) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 05-MAY-2024, the patient received Engerix B. On 05-MAY-2024, an unknown time after receiving Engerix B, the patient experienced inappropriate dose of vaccine administered (Verbatim: Wrong dose). The outcome of the inappropriate dose of vaccine administered was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2024 This report was submitted via the online direct entry reporting system. The patient received wrong dose of Engerix-B , which led to inappropriate dose of vaccine administered.