chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: She got her vaccine, and said that she shot her at the top of her shoulder, and she was wondering why did she not give her the shot in hre muscle.  It hurt really bad.  Then it started to get very sore, and she didn't pay much attention to it as she felt she would get a sore arm.  She had things to do and as the day went on it got sorer and sorer and put a heating pad on it and rubbed it. The next day she went to pick up something with both her hands and the left hand could not hold onto it.  She felt that the arm was sore, but the pain was starting to move up and down the arm.  The pain was spreading around her arm and going into her back and stuff.  It got worse and then by the following Wednesday and was getting orange juice as she was starting to feel sick, and started having headaches where her head was killing her and started to take aspirin.  She continued to have the headaches regularly.  She was in store on Wednesday and went to get the juice from the lady and it dropped it.  Her chest was then starting to hurt, and the pain was on the left side which scared her.  She felt that maybe she was having a heart attack.  She went to the hospital that was close to store and felt that she was dying.  She made it over to the clinic and told them she thought she was having a heart attack as she was in so much pain.  She said she could deal with the pain if they told her that it was not a heart attack.  They did blood work, EKG's and other tests and told her that it was not a heart attack.  The pain was still there, but since she was ruled out for the heart attack the fear went away, but the pain was still there.  She then figured it was from the shot for sure and said that there would be no more.  She then started to use Voltaren and the heating pad and went on to sleep. She was given some Tylenol at the hospital to take for the pain.  She was told to rub it, massage it and to get moving it.  The pain did not go away and it feels like it inside her arm, and it just hurts up and down the arm and at times cannot grab things like she used to.  The muscles got a little bit better, but she still has the pain going inside her arm, and she still has it.  The muscle has relaxed and are not hurting as much and has the pain going up and down the arm into her shoulder.  She does not what else to do, and cannot take all of the pain pills and is dealing with it, rubbing it and trying not to move it a certain way so that she won't aggravate the pain by doing that motion.  She took all the COVID vaccines and never had any problems with them.  Pain medicines make her throw up, but this is a pain that is bothering her that she does not have the control with her hands and be able to do everything that she used to do.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, PNC20
Symptoms: Coagulation factor, Contusion, Full blood count, Induration, Liver function test
Clinical narrative: Bruising and induration persistent for 2 weeks after vaccination
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Throat irritation
Clinical narrative: App. 30 mins after vaccine was given pt. experienced a "faint" feeling with some dizziness.   She described an itchy feeling in her throat.  Vitals were stable.  Benadryl administered for precaution.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Morning after shot, while getting dressed, I fainted I had previously fainted after a Moderna shot, in 2021, and decided Pfizer might not have same effect since it had not the previous years, 7/10/22 and 2023
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired on 9/8/2024.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLUC4, PNC15, RV5
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Seizure
Clinical narrative: Pt received vaccines.  The following morning awoke normally app. 30 minutes later had a seizure which lasted only a few minutes.  There was NO reported fever or illness.  Patient was taken to ER.  CT scans were normal.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was to get Meningococcal Dose #1, was given Men B instead by accident. There were no symptoms reported  or noted at the time of the vaccine, and none reported by mother after the error was found
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron increased
Clinical narrative: Elevated Iron Level
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site pain, Joint range of motion decreased
Clinical narrative: Flu shot administered in right upper arm. 12 hours later pain in right shoulder at injection site causing reduced range of motion with moderate discomfort. Please note the flu vaccine was a trivalent but there is not an option above.
Age: 48.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: No adverse event
Clinical narrative: Patient requested to receive a flu shot and received a flu shot and a Covid shot. As of submission of this form, patient reports no adverse event.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PATIENT STATES SHE HAD A FEVER OF 103 FOR 4 HOURS THE NIGHT AFTER HER VACCINATION.  FEVER LASTED 3 TO 4 HOURS.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given instead of adult
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site in left arm reacted like a bee sting, meaning it became enflamed  (very red)  bigger than the size of my fist two days after the injection 9/7/24 (I did take a photo).it was hot to the touch and still is (9/9/24) but it is reducing in size, It was also itchy so I applied an anti itch spray which helped (itch now gone)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on face, neck, chest, arms, and thighs a few days after receiving vaccine.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Headache, Hyperhidrosis, Nausea
Clinical narrative: Patient stated that the day after she got the flu vaccine, she experienced nausea, headache, massive sweating and very weak which lasted for 3 days, the she is getting better, today patient feels much better, no more sweating or headache but still weak. I advised patient to contact his PCP to make sure she gets checked out.
Age: 17.0
Sex: F
Vaccine: HEP, HPV9, MENB
Symptoms: Chills, Deafness, Dizziness, Dyspnoea, Exercise tolerance decreased
Clinical narrative: 8/27/24-Vaccinated. Upon standing from the table she felt lightheaded. Then she couldn't hear and was seeing spots and had to lay down in the waiting room until it passed. That night, while trying to sleep she experience fever, body aches, chills and heart palpitations. 8/28/24-she continued to feel those symptoms throughout the day. By that evening the fever and body aches were gone but she noticed her heart rate was high. Resting was 90-100 (uncommon for her). When she would sit up in bed or stand it would rise to 120 or higher. 8/29/24-I spoke with the pediatrician. They advised this was just an immune response and shouldn't last long. They advised her to increase salt and fluid intake. She began taking 1 gram of salt 3 times a day and increasing fluids. 8/30/24- I contacted the pediatrician again before the weekend to see how long these symptoms should last. Her heart rate was rising to 154 while just walking across a room. She couldn't stand in the shower without getting lightheaded and having to sit down. They suggested she continue fluid and salt over the weekend. Her resting heart rate started to return to somewhat normal (80-90) but anytime she would do anything slightly physical her heart would rise, she would get lighthead, shaky and dizzy and have to sit down. We continued increased salt and fluids throughout the next week. She was still not able to participate in workouts because her heart rate would spike and she would get lightheaded. 9/4/24 I contacted the pediatrician again because the school nurse called to say that pt got lightheaded and had to sit in the weight room with a heartrate of 187. The doctor gave us a form for pt to self administer salt pills at lunch to help alleviate the issues in weight room. 9/9/24-Pt had to sit out of workouts again as her heart rate spiked to 190 after one set of warm up stretches. She has also started to experience trouble breathing when her heart rate is elevated. I have requested a follow up appointment with her pediatrician as these side effects are not going away after 2 weeks.
Age: 17.0
Sex: F
Vaccine: HEP, HPV9, MENB
Symptoms: Heart rate increased, Immune system disorder, Pain, Palpitations, Pyrexia
Clinical narrative: 8/27/24-Vaccinated. Upon standing from the table she felt lightheaded. Then she couldn't hear and was seeing spots and had to lay down in the waiting room until it passed. That night, while trying to sleep she experience fever, body aches, chills and heart palpitations. 8/28/24-she continued to feel those symptoms throughout the day. By that evening the fever and body aches were gone but she noticed her heart rate was high. Resting was 90-100 (uncommon for her). When she would sit up in bed or stand it would rise to 120 or higher. 8/29/24-I spoke with the pediatrician. They advised this was just an immune response and shouldn't last long. They advised her to increase salt and fluid intake. She began taking 1 gram of salt 3 times a day and increasing fluids. 8/30/24- I contacted the pediatrician again before the weekend to see how long these symptoms should last. Her heart rate was rising to 154 while just walking across a room. She couldn't stand in the shower without getting lightheaded and having to sit down. They suggested she continue fluid and salt over the weekend. Her resting heart rate started to return to somewhat normal (80-90) but anytime she would do anything slightly physical her heart would rise, she would get lighthead, shaky and dizzy and have to sit down. We continued increased salt and fluids throughout the next week. She was still not able to participate in workouts because her heart rate would spike and she would get lightheaded. 9/4/24 I contacted the pediatrician again because the school nurse called to say that pt got lightheaded and had to sit in the weight room with a heartrate of 187. The doctor gave us a form for pt to self administer salt pills at lunch to help alleviate the issues in weight room. 9/9/24-Pt had to sit out of workouts again as her heart rate spiked to 190 after one set of warm up stretches. She has also started to experience trouble breathing when her heart rate is elevated. I have requested a follow up appointment with her pediatrician as these side effects are not going away after 2 weeks.
Age: 17.0
Sex: F
Vaccine: HEP, HPV9, MENB
Symptoms: Tremor, Visual impairment
Clinical narrative: 8/27/24-Vaccinated. Upon standing from the table she felt lightheaded. Then she couldn't hear and was seeing spots and had to lay down in the waiting room until it passed. That night, while trying to sleep she experience fever, body aches, chills and heart palpitations. 8/28/24-she continued to feel those symptoms throughout the day. By that evening the fever and body aches were gone but she noticed her heart rate was high. Resting was 90-100 (uncommon for her). When she would sit up in bed or stand it would rise to 120 or higher. 8/29/24-I spoke with the pediatrician. They advised this was just an immune response and shouldn't last long. They advised her to increase salt and fluid intake. She began taking 1 gram of salt 3 times a day and increasing fluids. 8/30/24- I contacted the pediatrician again before the weekend to see how long these symptoms should last. Her heart rate was rising to 154 while just walking across a room. She couldn't stand in the shower without getting lightheaded and having to sit down. They suggested she continue fluid and salt over the weekend. Her resting heart rate started to return to somewhat normal (80-90) but anytime she would do anything slightly physical her heart would rise, she would get lighthead, shaky and dizzy and have to sit down. We continued increased salt and fluids throughout the next week. She was still not able to participate in workouts because her heart rate would spike and she would get lightheaded. 9/4/24 I contacted the pediatrician again because the school nurse called to say that pt got lightheaded and had to sit in the weight room with a heartrate of 187. The doctor gave us a form for pt to self administer salt pills at lunch to help alleviate the issues in weight room. 9/9/24-Pt had to sit out of workouts again as her heart rate spiked to 190 after one set of warm up stretches. She has also started to experience trouble breathing when her heart rate is elevated. I have requested a follow up appointment with her pediatrician as these side effects are not going away after 2 weeks.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphonia, Dyspnoea, Heart rate increased, Hypersensitivity, Syncope
Clinical narrative: Inadvertently administered Varicella vaccine 1 day earlier outside of the 4 day grace period.  Presented no symptoms during 15 -minute wait, also contacted mother at 11:35 a.m,   Pt not presenting with any symptoms.  Informed mother that today's dose is invalid and rescheduled to return in 1 month to re-vaccinate.  Informed mother if patient complains of shortness of breath, allergic reaction, hoarseness, rapid heart rate, fainting to go to nearest emergency room.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Caller reporting that a dose of PROQUAD was administered after its labeled expiration date. Product has not undergone a temperature excursion. Date expired: 8/15/2024, date administered: 8/21/2024. No additional AE, no PQC. No additional information.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant medication, past drug reactions or allergies were not reported.  On 21-AUG-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin [rHA]) (PROQUAD) injection, administered as prophylaxis (lot number X011437 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date reported and validated as 15-AUG-2024) (expired product administered) (strength, dose number, dose quantity, route of administration, and anatomical site of application were not provided). It was also reported that the product has not undergone a temperature excursion. No additional adverse events were reported.
Age: 35.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No aditional AE; Inbound call from HCP calling to report accidental co-administration of PROQUAD and VARIVAX.  Caller confirmed administration date of 4-SEP-2024.  Confirmed no symptomatic adverse events were reported.  No additional information available at this tim; The patient is 35 years old; This spontaneous report was received from a Medical Assistant, regarding a 35-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 04-SEP-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, at a dose of 0.5 milliliters (ml), once, administered for prophylaxis (lot number was reported as "9/24/2025", expiration date reported as: 24-SEP-2025, vaccination scheme and site of vaccination were not provided) (inappropriate age at vaccine administration), co-administered with varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 ml, once, administered for prophylaxis (lot #W031815, expiration date: 05-OCT-2024, vaccination scheme, and site of vaccination were not provided) (Inappropriate schedule of product administration). It was confirmed no symptomatic adverse events were reported.
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; HCP called to report that a pediatric patient was administered GARDASIL 9 at 8 years old; This spontaneous report was received from other Health Professional regarding a 8-year-old female patient.   Her medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 19-AUG-2024, while the patient was still 8-years-old, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; lot number X025115 has been verified to be a valid number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) [GARDASIL 9], expiration date 19-MAY-2026) (Product administered to patient of inappropriate age).  No additional adverse events were reported for the patient.
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Anaphylactic reaction, Hypersensitivity, Throat tightness
Clinical narrative: felt throat tighten and start to close; allergic reaction; Anaphylaxis; This serious case was reported by a consumer and described the occurrence of anaphylaxis in a 55-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included mast cell activation syndrome (had a MCAS).   On 31-AUG-2024, the patient received Boostrix. On 31-AUG-2024, less than a day after receiving Boostrix, the patient experienced anaphylaxis (Verbatim: Anaphylaxis) (serious criteria GSK medically significant and clinically significant/intervention required). On an unknown date, the patient experienced throat tightness (Verbatim: felt throat tighten and start to close) and allergic reaction (Verbatim: allergic reaction). The patient was treated with dexamethasone, acrivastine (Benadryl), epinephrine, cetirizine hydrochloride (Cetrizine) and famotidine (Pepcid). The outcome of the anaphylaxis was not resolved and the outcome of the throat tightness and allergic reaction were not reported.   The reporter considered the anaphylaxis, throat tightness and allergic reaction to be related to Boostrix.     The company considered the anaphylaxis, throat tightness and allergic reaction to be related to Boostrix.   Additional Information: GSK Receipt Date: 02-SEP-2024 The patient self-reported this case. The reporter reported that she went to emergency room for a tetanus booster as she had lapsed. She was given the vaccine and she left the hospital, she felt her throat tighten and started to close. She went back and admitted to emergency room again and given 10 milligrams of Dexamethasone, Benadryl and an Epinephrine injection. She was sent home 5 hours later. She returned to the emergency room yesterday (before the day of reporting) with rebound anaphylaxis and was treated with another 10 mgs of Dexamethasone and Epinephrine injection, Cetirizine and Pepcid. She found it very alarming that on GlaxoSmithKline Material Safety Data Sheet (MSDS) sheet next to reactions, it said, none known. She was sure GSK know that a small percentage of people had allergic reactions to vaccines, asked to acknowledge this. She did have MCAS which was on the rise. She would appreciate it if GSK did due diligence and acknowledged publicly and had healthcare providers remind patients that there could be an allergic reaction. Nobody had asked her to stick around to see if she had a reaction she just left. Things need to be changed and they would change in the upcoming year, she had no doubt. The GSK could be the ones who help start it. Meanwhile she had an allergic reaction to GSK vaccine and she wanted GSK to know.; Sender's Comments: Anaphylactic reaction is a listed event which is considered related to GSK vaccine Boostrix.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: she received one about 6 months ago when she was pregnant; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: she received one about 6 months ago when she was pregnant). The outcome of the vaccine exposure during pregnancy was not reported.   Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester 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: 29-AUG-2024 The pharmacist had a patient here who was looking to get the Boostrix vaccine, she received one about 6 months ago when she was pregnant.  The pharmacist reported that there was no record for like when the patient received it and she was trying to get through some immigration things where she needed proof of it, so they told her to get it again.  The pharmacist confirmed that the patient was not pregnant anymore.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received a first dose of Shingrix 2 years ago (no specific date), and they just came today on August 30th 2024 to get 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 61-year-old male patient who received Herpes zoster (Shingrix) (batch number E3XT9, expiry date 19-JUN-2026) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix 2 years ago on an unknown date).   On 30-AUG-2024, the patient received the 2nd dose of Shingrix. On 30-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received a first dose of Shingrix 2 years ago (no specific date), and they just came today on August 30th 2024 to get the second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 30-AUG-2024 The pharmacist reported that the patient received a first dose of Shingrix 2 years ago (no specific date), and they just came on the day of reporting to get the second dose.  The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: the pain of both is way better/ The first one was a breeze; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: the pain of both is way better/ The first one was a breeze). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR111721   Additional Information: GSK Receipt Date: 29-Aug-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine and the pain of both was way better. The first one was a breeze. The patient was told by primary care that it was a lifetime protection. For tolerance of 2nd dose refer case US2024AMR111721, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR111721:same reporter, same patient, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Feeling abnormal, Malaise, Mobility decreased, Spinal pain
Clinical narrative: Back pain; still to this day has extremely bad spinal pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of back pain in a child female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced back pain (Verbatim: Back pain) and pain in spine (Verbatim: still to this day has extremely bad spinal pain). The outcome of the back pain was resolved and the outcome of the pain in spine was not resolved.   It was unknown if the reporter considered the back pain and pain in spine to be related to Shingles vaccine.     It was unknown if the company considered the back pain and pain in spine to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-AUG-2024 The patient's parent reported this case. The reporter said that their extremely healthy athletic, organic fed child (patient) got Shingles (Shingrix) vaccination and laid on her bedroom floor for two full days deathly ill with terrible back pain. By the second night the reporter told her husband they were taking her to the emergency room (ER) as this was not right. She somewhat started to feel normal and recovered, but still to this day had extremely bad spinal pain.  The reporter no longer believed in vaccinations, but was super scared of what this one did to her healthy child because she was completely normal before and now was constant pain in her spine.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: urticaria; delayed type allergic reaction to the saponin used in Shingrix; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of urticaria 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 urticaria (Verbatim: urticaria) and delayed type hypersensitivity (Verbatim: delayed type allergic reaction to the saponin used in Shingrix). The outcome of the urticaria was not resolved and the outcome of the delayed type hypersensitivity was not reported.   It was unknown if the reporter considered the urticaria and delayed type hypersensitivity to be related to Shingrix.  It was unknown if the company considered the urticaria and delayed type hypersensitivity to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-AUG-2024 The reporter inquired that he/she was interested in getting their RSV vaccine, but need to know what sort of adjuvant was incorporated. The patient had a delayed type allergicreaction to the saponin used in Shingrix, experiencing urticaria that involved two visits to an emergency room. The reporter asked could they advise what sort of adjuvant, if any, was used in RSV vaccine, Abrysvo .
Sex: U
Vaccine: RSV
Symptoms: Injection site vesicles
Clinical narrative: get a blister at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site blisters in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site blisters (Verbatim: get a blister at the injection site). The outcome of the injection site blisters was not reported.   It was unknown if the reporter considered the injection site blisters to be related to Arexvy.     It was unknown if the company considered the injection site blisters to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-AUG-2024 This case was reported by a patient via interactive digital media. The reporter reported that the patient received the Arexvy vaccine and experienced blister at the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: the pain of both is way better; The second one I was laid up for 8 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of pain (1st dose received on an unknown date, refer case-US2024AMR108564).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: the pain of both is way better) and bedridden (Verbatim: The second one I was laid up for 8 hours). Rechallenge with Shingles vaccine was positive. The outcome of the pain was not reported and the outcome of the bedridden was resolved (duration 8 hrs).   It was unknown if the reporter considered the pain and bedridden to be related to Shingles vaccine.   It was unknown if the company considered the pain and bedridden to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR108564   Additional Information: GSK Receipt Date: 29-Aug-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine and the pain of both was way better. After the second one the patient was laid up for 8 hours but he/she would take that compared to the shingles. The patient was told by the primary care that it was a lifetime protection.; Sender's Comments:  US-GSK-US2024AMR108564:same reporter, same patient, 2nd dose
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Feeling Icky; Hurt Arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of feeling abnormal in a 16-year-old patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patients received Bexsero (unknown arm). In JUL-2024, an unknown time after receiving Bexsero, the patient experienced feeling abnormal (Verbatim: Feeling Icky) and pain in arm (Verbatim: Hurt Arm). The outcome of the feeling abnormal and pain in arm were unknown.   It was unknown if the reporter considered the feeling abnormal and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the feeling abnormal and pain in arm to be related to Bexsero and Bexsero 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: 27-AUG-2024 The nurse stated that when administering Bexsero to their 16 year old patients, most of the patients complained of a hurted arm and feeling icky after receiving the vaccine. The nurse reported that these adverse reactions happened in most of her patients (no patient demographics provided) and had been occurring the entire time they had been administering Bexsero (no time frame provided) and occurred as recent as last month in July 2024.  The reporter stated that they administer Menveo and Bexsero in different arms at the same office visit to these 16 year old patients and none complained about the arm the Menveo was administered in.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: itchy while rash was healing; she noticed a rash appearing; burning pain under affected arm/ pain and burning in the swollen areas; swelling at injection site; her arm became swollen, extending under her arm.; she experienced soreness at injection site.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-AUG-2024, the patient received the 1st dose of Shingrix (left arm). On 15-AUG-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: she experienced soreness at injection site.). On 16-AUG-2024, the patient experienced injection site swelling (Verbatim: swelling at injection site) and extensive swelling of vaccinated limb (Verbatim: her arm became swollen, extending under her arm.). On 23-AUG-2024, the patient experienced pain burning (Verbatim: burning pain under affected arm/ pain and burning in the swollen areas) and rash (Verbatim: she noticed a rash appearing). On 27-AUG-2024, the patient experienced pruritus (Verbatim: itchy while rash was healing). The outcome of the injection site pain, injection site swelling, extensive swelling of vaccinated limb, pain burning, pruritus and rash were resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, extensive swelling of vaccinated limb, pain burning, pruritus and rash to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, extensive swelling of vaccinated limb, pain burning, pruritus and rash to be related to Shingrix.   Additional Information: GSK receipt date: 29-AUG-2024 The patient reported that she received her first Shingrix dose and the day of the vaccination she experienced soreness at injection site.  The following day her arm became swollen, extending under her arm.  She experienced pain and burning in the swollen areas.   8 days after the vaccination she noticed a rash appearing on the side of the injected arm which lasted a few days. All symptoms were now (at the time of reporting) resolved. Consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: itchy while rash was healing; she noticed a rash appearing; burning pain under affected arm/ pain and burning in the swollen areas; swelling at injection site; her arm became swollen, extending under her arm.; she experienced soreness at injection site.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-AUG-2024, the patient received the 1st dose of Shingrix (left arm). On 15-AUG-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: she experienced soreness at injection site.). On 16-AUG-2024, the patient experienced injection site swelling (Verbatim: swelling at injection site) and extensive swelling of vaccinated limb (Verbatim: her arm became swollen, extending under her arm.). On 23-AUG-2024, the patient experienced pain burning (Verbatim: burning pain under affected arm/ pain and burning in the swollen areas) and rash (Verbatim: she noticed a rash appearing). On 27-AUG-2024, the patient experienced pruritus (Verbatim: itchy while rash was healing). The outcome of the injection site pain, injection site swelling, extensive swelling of vaccinated limb, pain burning, pruritus and rash were resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, extensive swelling of vaccinated limb, pain burning, pruritus and rash to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, extensive swelling of vaccinated limb, pain burning, pruritus and rash to be related to Shingrix.   Additional Information: GSK receipt date: 29-AUG-2024 The patient reported that she received her first Shingrix dose and the day of the vaccination she experienced soreness at injection site.  The following day her arm became swollen, extending under her arm.  She experienced pain and burning in the swollen areas.   8 days after the vaccination she noticed a rash appearing on the side of the injected arm which lasted a few days. All symptoms were now (at the time of reporting) resolved. Consented to follow up.
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: gave her 75 year old husband 1st dose of Bexsero; received 2nd dose 1 month apart in 2023; HCP wanted him to get 3 doses due to his spleen being removed; 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 75-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient did not receive the 3rd dose of Bexsero and the patient received the 2nd dose of Bexsero and the 1st dose of Bexsero. On an unknown date, not applicable after receiving Bexsero and Bexsero and an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: gave her 75 year old husband 1st dose of Bexsero), inappropriate age at vaccine administration (Verbatim: received 2nd dose 1 month apart in 2023) and incomplete course of vaccination (Verbatim: HCP wanted him to get 3 doses due to his spleen being removed). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and incomplete course of vaccination 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: 29-AUG-2024 The reporter was the wife of the patient. The reporter stated that she was having a hard time finding a pharmacy to give her 75 year old husband Bexsero. The reporter stated they knew the indicated age was between 10 and 25 years old but his healthcare professional (HCP) wanted him to get 3 doses due to his spleen being removed. The patient received Bexsero dose 1 in 2023 (no date provided) and dose 2 about a month later in 2023. The reporter also mentioned that he was supposed to get Bexsero shots yearly. A 75 years old patient received 1st and 2nd dose Bexsero which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive 3rd dose of Bexsero vaccine, which led to incomplete course of vaccination. Education provided per PI, Offered PI Medical disclaimer and MI phone number provided. Referred them to HCP. The reporter did not want to give HCP consent. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: experiencing swollen lymph nodes; This non-serious case was reported by a consumer via call center representative and described the occurrence of swollen lymph nodes in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 07-AUG-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced swollen lymph nodes (Verbatim: experiencing swollen lymph nodes). The outcome of the swollen lymph nodes was not resolved.   It was unknown if the reporter considered the swollen lymph nodes to be related to Shingles vaccine.     It was unknown if the company considered the swollen lymph nodes to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-AUG-2024 Consumer was the reporter. The reporter stated that she received her first dose of Shingrix and was experiencing swollen lymph nodes. As of 30 August 2024 this condition had not resolved. No further information was known such as demographics, date of birth, site of injection, or any medical conditions. The consumer declined to provide any personal information.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 3rd dose; Late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 12-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included PEDIARIX (1st dose received on 26 September 2023).   On 26-AUG-2024, the patient received the 3rd dose of Pediarix. On 06-AUG-2024, the patient received the 2nd dose of Pediarix. On 06-AUG-2024, not applicable after receiving Pediarix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On 26-AUG-2024, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose). The outcome of the drug dose administration interval too short was unknown and the outcome of the drug dose administration interval too long was not reported.   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: 30-AUG-2024 The patient received 3rd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose received late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 16-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix (received 2nd dose on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 3rd dose received late). The outcome of the incomplete course of vaccination 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: 30-AUG-2024 Pharmacist requested data on the administration of Twinrix to a 16 year old patient who had 2 previous doses. HCP stated that MD wrote prescription for 1 dose of Twinrix since patient has already had 2 prior doses in another country.  At the time of the call, the Twinrix vaccine had not been administered.  Till the time of reporting, the patient did not receive 3rd dose of Shingrix, which led to incomplete course of vaccination.
Age: 40.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received late; 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 40-year-old male patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 14th March 2024, lot number 797F9, expiration date 20 December 2025..).   On 28-AUG-2024, the patient received the 2nd dose of Twinrix. On 28-AUG-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2024 Pharmacist reported 40 year old male patient received first Twinrix dose on 14 March 2024 and did not receive second dose until 28 August 2024. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not receive second dose yet; This non-serious case was reported by a pharmacist 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 on 21-OCT-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: patient did not receive second dose yet). The outcome of the incomplete course of vaccination was not reported.   Additional Information: GSK receipt date: 30-AUG-2024 The HCP (Healthcare professional) was the reporter. The reporter stated that the patient had received 1st dose of Shingrix vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further information was known. The reporter consented to the follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm, Fatigue, Paraesthesia
Clinical narrative: began experiencing paresthesia on her nose and the lower left quadrant of her chin; At the same time, she experienced bilateral blepharospasms which seems to be escalating at this time; She experienced fatigue for about 24 hours after the shot and it resolved; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial paresthesia in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-JUL-2024, the patient received the 1st dose of Shingrix. On 24-JUL-2024, 24 hrs after receiving Shingrix, the patient experienced fatigue (Verbatim: She experienced fatigue for about 24 hours after the shot and it resolved). On 16-AUG-2024, the patient experienced facial paresthesia (Verbatim: began experiencing paresthesia on her nose and the lower left quadrant of her chin) and blepharospasm (Verbatim: At the same time, she experienced bilateral blepharospasms which seems to be escalating at this time). On 25-JUL-2024, the outcome of the fatigue was resolved.  On 23-AUG-2024, the outcome of the facial paresthesia was resolved. The outcome of the blepharospasm was not resolved.   It was unknown if the reporter considered the facial paresthesia, fatigue and blepharospasm to be related to Shingrix.     It was unknown if the company considered the facial paresthesia, fatigue and blepharospasm to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-AUG-2024 The patient reported that she received her first Shingrix vaccination on July 24, 2024. She experienced fatigue for about 24 hours after the shot and it resolved. About 2 weeks ago she began experiencing paresthesia on her nose and the lower left quadrant of her chin. The paresthesia persisted intermittently for about a week. At the same time, she experienced bilateral blepharospasms which seems to be escalating at this time.