chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Pruritus, Rash
Clinical narrative: no adverse event until the last:  full body rash, itching, very uncomfortable, no diabetic reaction
Age: 67.0
Sex: F
Vaccine: RSV, FLU4, RSV
Symptoms: Anaphylactic reaction
Clinical narrative: Constricted Throat, shallow breathing,  shakes,  teeth shattering ,  I  Injected myself with Auvi-Q at around 3pm,  symptoms subsided for about 20 minutes then came raging back and my husband  drove me to ER at 4pm.  At ER they gave me DiphenhydrAMINE, famotidine, MethylPREDNISolone sodium succ
Age: 67.0
Sex: F
Vaccine: RSV, FLU4, RSV
Symptoms: Chills, Hypopnoea, Throat tightness, Tremor
Clinical narrative: Constricted Throat, shallow breathing,  shakes,  teeth shattering ,  I  Injected myself with Auvi-Q at around 3pm,  symptoms subsided for about 20 minutes then came raging back and my husband  drove me to ER at 4pm.  At ER they gave me DiphenhydrAMINE, famotidine, MethylPREDNISolone sodium succ
Age: 22.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Injection site pain, Pain
Clinical narrative: muscle pain in left arm at injection site for at least two days; hurts especially to raise arm above 90 degrees
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Myalgia
Clinical narrative: widespread muscle aches, mild fatigue; both starting late that day or the day after, and continued for two days
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Premature delivery, Preterm premature rupture of membranes, Thrombosis
Clinical narrative: I ended up being hospitalized for Preterm Premature Rupture of Membranes from March 17-April 17, 2024. then proceeded to give birth to a preterm (29weeks 4 days) baby who had 79 day long NICU stay, respiratory issues, a nevus growth on her forehead, and a coloboma in her left eye. Following birth, I ended up being hospitalized again (April 24April 25, 2024) because I developed a blood clot in my left leg, despite being healthy after birth/in general, with no underlying problems with my health or birthing experience.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: August 30: 2? diameter raised hot red welt at injection site,. Developed tachycardia of duration about 10 minutes at 11:30 PM . August 31 I had a cluster headache involving right temple, right eye, right nasal sinuses, right ear , right side of throat and right Temporomandibular joint  from 5 am to 12:15 PM.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Urticaria
Clinical narrative: August 30: 2? diameter raised hot red welt at injection site,. Developed tachycardia of duration about 10 minutes at 11:30 PM . August 31 I had a cluster headache involving right temple, right eye, right nasal sinuses, right ear , right side of throat and right Temporomandibular joint  from 5 am to 12:15 PM.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Hyperaesthesia teeth, Toothache
Clinical narrative: On 8/31/2024, approximately 3 days after my Covid 19 (new) vaccine, I noticed pain in my teeth while chewing. I initially passed it off as a sensitive tooth. But it persisted throughout the day. The pain has sometimes lessened but returns. It seems to appear in my lower teeth and jaw bone frequently. But I sometimes feel it in my cheeks and upper teeth as well. It can be a sharp pain or dull ache. I am writing this the morning of 09/01/2024 and I feel it just as sharply as yesterday. I am treating it with Tylenol and Ibuprophen which seems to help some. I was unable to sleep well with the pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears and buzzing sound
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: ITCHY, HOT, RED , PAINFUL AROUND SITE OF INJECTION, HURT TO TOUCH
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Angiogram normal, Back pain, Computerised tomogram normal, Diplopia, Dizziness
Clinical narrative: 48 hours after I had this vaccine, I had double vision and dizziness...I was admitted to the Hospital on stroke protocall...I was Given a Cat Scan, MRI, MRA and heart diagnosis...all were negative and they have no eviidence of what my probem is...I also have a very sore upper back issue on the side the shot was given...all of this has been going on for two weeks with no improvement..
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Magnetic resonance imaging normal
Clinical narrative: 48 hours after I had this vaccine, I had double vision and dizziness...I was admitted to the Hospital on stroke protocall...I was Given a Cat Scan, MRI, MRA and heart diagnosis...all were negative and they have no eviidence of what my probem is...I also have a very sore upper back issue on the side the shot was given...all of this has been going on for two weeks with no improvement..
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Patient reports hard lump at shot site, with redness. Said redness was a few inches at first, but improved to only be about a 1 inch square area around the shot site. No pain reported, just the redness and hard lump.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: PATIENT RECEIVED THE VACCINE AND HEADED HOME FINE. SPOUSE CALLED AND STATED SEVERAL HOURS LATER THAT THE PATIENT HAD A SEIZURE BUT REQUIRED NO MEDICAL TREATMENT
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Inflammation, Joint stiffness, Mobility decreased
Clinical narrative: In the past, the only reactions that I have had from a flu vaccine (which I get every year) have been a slightly sore arm at the injection site, a low grade fever (about 1 degree above my normal temperture) and a slight feeling of malaise.  But this vaccine seems to have triggered far more serious reactions. Starting about 30 hours after the vaccine was given, I began to experience an elevated temperature (nearly 3 degrees above my normal) plus any area of my body which, in the past, had sustained  trauma, injury or surgery felt extremely inflammed, painful and had restricted mobility and/or spasms: a) left knee felt as though it was on fire and throbbing.  I could not bend my leg (meniscus tear many yrs ago) b) left ankle felt stiff/sore c)  low back sore (had herniated disks) d) entire back area (shoulder blade location) and neck (had a number of disks fused years ago and still have ongoing issues) started to spasm--could not turn head  nor drink without using a straw--difficulty opening mouth enough to eat e) had rotator cuff surgery on R shoulder several years ago and -my R arm lost all range of motion--elbow bent at 90 degree angle--it was as though I had just had the surgery and my arm was in a sling--the pain from both the neck and shoulder was intense All symptoms slowly disappeared by that Monday morning (Aug. 26) with the fever dropping by 2 degrees but  arm, neck and shoulder issues reappeared Tues night and by Wednesday (28th) could not raise my head from a prone position without great pain.  Was finally able to see chiropractor on the 30th--still some neck sapasms and still unable to turn head.  Better by the 31st but still  not resolved.  Afraid of symptoms again reappearing. Today (9/01) still have very taut neck muscles and limited ROM in neck Used (and am still using) ice and heat as home treatments plus 2 homeeopathic remedies (arnica and bryonia) and a cream that my chiropractor had provided ahile ago.  I eventially used aspirin (29th) and then switched to acetaminophen(30th) for some pain relief.  Did several home tests at the onset of this ordeal to check for Covid to see if that might be a factor in the reactions I experienced--tests always negative.  Have always gotten annual flu vaccine with only mild discomfort. And I have had the senior version multiple times,  This is the first time that I have ever had a reaction this intense with ANY vaccine. Also--on the 26th, when the iniitial  symptoms began to abate, I went to pharmacy and spoke with one of the pharmacists.  I asked if this should be reported as an adverse event and on the 30th, asked the same of my chiropractor.  Both felt I should report.  Am assuming the vaccine was quadrivalent--my paperwork says Fluad 2024-2025   My normal temp is 96.7 degrees--when it was elevated by 3 degrees to 99.7 degrees I knew that I had a fever--using the usual baselin of 98.6 does not work for people who do not fit the presumed temperature norm--this is equivalent to feeling as if my temperature is over 101 degrees
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Muscle spasms, Muscle tightness, Musculoskeletal disorder, Neck pain, Pain
Clinical narrative: In the past, the only reactions that I have had from a flu vaccine (which I get every year) have been a slightly sore arm at the injection site, a low grade fever (about 1 degree above my normal temperture) and a slight feeling of malaise.  But this vaccine seems to have triggered far more serious reactions. Starting about 30 hours after the vaccine was given, I began to experience an elevated temperature (nearly 3 degrees above my normal) plus any area of my body which, in the past, had sustained  trauma, injury or surgery felt extremely inflammed, painful and had restricted mobility and/or spasms: a) left knee felt as though it was on fire and throbbing.  I could not bend my leg (meniscus tear many yrs ago) b) left ankle felt stiff/sore c)  low back sore (had herniated disks) d) entire back area (shoulder blade location) and neck (had a number of disks fused years ago and still have ongoing issues) started to spasm--could not turn head  nor drink without using a straw--difficulty opening mouth enough to eat e) had rotator cuff surgery on R shoulder several years ago and -my R arm lost all range of motion--elbow bent at 90 degree angle--it was as though I had just had the surgery and my arm was in a sling--the pain from both the neck and shoulder was intense All symptoms slowly disappeared by that Monday morning (Aug. 26) with the fever dropping by 2 degrees but  arm, neck and shoulder issues reappeared Tues night and by Wednesday (28th) could not raise my head from a prone position without great pain.  Was finally able to see chiropractor on the 30th--still some neck sapasms and still unable to turn head.  Better by the 31st but still  not resolved.  Afraid of symptoms again reappearing. Today (9/01) still have very taut neck muscles and limited ROM in neck Used (and am still using) ice and heat as home treatments plus 2 homeeopathic remedies (arnica and bryonia) and a cream that my chiropractor had provided ahile ago.  I eventially used aspirin (29th) and then switched to acetaminophen(30th) for some pain relief.  Did several home tests at the onset of this ordeal to check for Covid to see if that might be a factor in the reactions I experienced--tests always negative.  Have always gotten annual flu vaccine with only mild discomfort. And I have had the senior version multiple times,  This is the first time that I have ever had a reaction this intense with ANY vaccine. Also--on the 26th, when the iniitial  symptoms began to abate, I went to pharmacy and spoke with one of the pharmacists.  I asked if this should be reported as an adverse event and on the 30th, asked the same of my chiropractor.  Both felt I should report.  Am assuming the vaccine was quadrivalent--my paperwork says Fluad 2024-2025   My normal temp is 96.7 degrees--when it was elevated by 3 degrees to 99.7 degrees I knew that I had a fever--using the usual baselin of 98.6 does not work for people who do not fit the presumed temperature norm--this is equivalent to feeling as if my temperature is over 101 degrees
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: SARS-CoV-2 test negative, Trismus
Clinical narrative: In the past, the only reactions that I have had from a flu vaccine (which I get every year) have been a slightly sore arm at the injection site, a low grade fever (about 1 degree above my normal temperture) and a slight feeling of malaise.  But this vaccine seems to have triggered far more serious reactions. Starting about 30 hours after the vaccine was given, I began to experience an elevated temperature (nearly 3 degrees above my normal) plus any area of my body which, in the past, had sustained  trauma, injury or surgery felt extremely inflammed, painful and had restricted mobility and/or spasms: a) left knee felt as though it was on fire and throbbing.  I could not bend my leg (meniscus tear many yrs ago) b) left ankle felt stiff/sore c)  low back sore (had herniated disks) d) entire back area (shoulder blade location) and neck (had a number of disks fused years ago and still have ongoing issues) started to spasm--could not turn head  nor drink without using a straw--difficulty opening mouth enough to eat e) had rotator cuff surgery on R shoulder several years ago and -my R arm lost all range of motion--elbow bent at 90 degree angle--it was as though I had just had the surgery and my arm was in a sling--the pain from both the neck and shoulder was intense All symptoms slowly disappeared by that Monday morning (Aug. 26) with the fever dropping by 2 degrees but  arm, neck and shoulder issues reappeared Tues night and by Wednesday (28th) could not raise my head from a prone position without great pain.  Was finally able to see chiropractor on the 30th--still some neck sapasms and still unable to turn head.  Better by the 31st but still  not resolved.  Afraid of symptoms again reappearing. Today (9/01) still have very taut neck muscles and limited ROM in neck Used (and am still using) ice and heat as home treatments plus 2 homeeopathic remedies (arnica and bryonia) and a cream that my chiropractor had provided ahile ago.  I eventially used aspirin (29th) and then switched to acetaminophen(30th) for some pain relief.  Did several home tests at the onset of this ordeal to check for Covid to see if that might be a factor in the reactions I experienced--tests always negative.  Have always gotten annual flu vaccine with only mild discomfort. And I have had the senior version multiple times,  This is the first time that I have ever had a reaction this intense with ANY vaccine. Also--on the 26th, when the iniitial  symptoms began to abate, I went to pharmacy and spoke with one of the pharmacists.  I asked if this should be reported as an adverse event and on the 30th, asked the same of my chiropractor.  Both felt I should report.  Am assuming the vaccine was quadrivalent--my paperwork says Fluad 2024-2025   My normal temp is 96.7 degrees--when it was elevated by 3 degrees to 99.7 degrees I knew that I had a fever--using the usual baselin of 98.6 does not work for people who do not fit the presumed temperature norm--this is equivalent to feeling as if my temperature is over 101 degrees
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Enema administration, Gastrointestinal surgery, Intussusception, Treatment failure
Clinical narrative: Patient administered RotaTeq virus at 2 month well child visit per protocol. Within one week for administration she developed intussusception requiring surgical correction (air enema did not resolve is intussusception). She was hospitalized due to this adverse event.
Age: 79.0
Sex: M
Vaccine: FLUA4, FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 seasonal flu shots within 30 days. No adverse reactions reported.
Age: 44.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient accidentally received a third dose of the MPOX vaccine after patient's record was read incorrectly. The pt did not report any adverse affects at the time of the incident.
Age: 65.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: patient had a lot of redness, ithcing, swelling at site
Age: 76.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLUA4
Symptoms: Pain in extremity
Clinical narrative: patient came back to pharmacy saying her left arm hurt. patient was advised ibuprofen or acetaminophen if needed to help subside pain. No redness present on the skin or arm. Patient advised to seek medical care and assessment from a doctor. She declined stated not going.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diplopia, Headache, Lethargy, Myalgia
Clinical narrative: Headache, 101.4 F fever, muscle and joint ache, double vision for one day, lethargy
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, 101.4 F fever, muscle and joint ache, double vision for one day, lethargy
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Decreased interest, Disturbance in attention, Fatigue, Injection site pain
Clinical narrative: I had the Vaccination at Pharmacy. Adverse symptoms: Mild itching on my limbs, which spread to my body. This ceased overnight. General feeling of energy loss and inability to concentrate for any length of time and overall tiredness. The following day I was generally lacking in energy and overall disinterest, generally feeling unwell. The third day these conditions tempered, but i was still recovering. The injection site was sore but nothing more that these types of vaccinations cause.
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Malaise, Pruritus
Clinical narrative: I had the Vaccination at Pharmacy. Adverse symptoms: Mild itching on my limbs, which spread to my body. This ceased overnight. General feeling of energy loss and inability to concentrate for any length of time and overall tiredness. The following day I was generally lacking in energy and overall disinterest, generally feeling unwell. The third day these conditions tempered, but i was still recovering. The injection site was sore but nothing more that these types of vaccinations cause.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: seizure
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait inability, Headache, Mobility decreased
Clinical narrative: Initially had normal vaccine effects (fatigue, myalgias,headache, chills etc). Then 2 days after vaccine developed severe vertigo with nystagmus and vomiting to the point where patient was not able to walk or get out of bed.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nystagmus, Vertigo, Vomiting
Clinical narrative: Initially had normal vaccine effects (fatigue, myalgias,headache, chills etc). Then 2 days after vaccine developed severe vertigo with nystagmus and vomiting to the point where patient was not able to walk or get out of bed.
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Lymphadenopathy, Paraesthesia oral
Clinical narrative: SWOLLEN LYMPH NODES, TINGLING TONGUE (PT GOT NEW 2024-2025 FLUAD TRIVALENT VACCINE)
Age: 74.0
Sex: F
Vaccine: PPV, RSV
Symptoms: Dizziness, Erythema, Nausea, Peripheral swelling
Clinical narrative: redness and swelling in the arm, mild nausea and dizziness,
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Injection site pain, Pyrexia
Clinical narrative: Severe watery diarrhea about 4 to 5 hours after the latest moderna KP.2 vaccine was administered and continued for 2 to 3 hours multiple times. Soreness of the injection site, fever and chills 6 to 7 hours after the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Allergy test, Antibody test, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram pelvis
Clinical narrative: Nerve pain in chest with no cardiac origin determined after multiple ER visits and a full cardiac work up by a cardiologist. Dizziness and vertigo with no verified neurological origin determined after multiple primary care visits, labs, specialist, and a full work up by a neurologist.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram thorax, Dizziness, Electrocardiogram, Full blood count, Magnetic resonance imaging head
Clinical narrative: Nerve pain in chest with no cardiac origin determined after multiple ER visits and a full cardiac work up by a cardiologist. Dizziness and vertigo with no verified neurological origin determined after multiple primary care visits, labs, specialist, and a full work up by a neurologist.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Metabolic function test, Neuralgia, Oesophagogastroduodenoscopy, Vertigo
Clinical narrative: Nerve pain in chest with no cardiac origin determined after multiple ER visits and a full cardiac work up by a cardiologist. Dizziness and vertigo with no verified neurological origin determined after multiple primary care visits, labs, specialist, and a full work up by a neurologist.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Paraesthesia
Clinical narrative: Tingling sensation up and down 10-15 minutes after vaccination.  Since then it's an every day thing according to patient, tingling electricity on and off for 10-20, to 30 times a day until now--that's almost 1 and 1/2 months (reported to me on 8/31/24 when the patient stopped by the pharmacy.  He's also having a triggered pressure-- feels muscle tightness on the vaccinated arm, it feels tensed.  He's visited Dr., internal medicine, and the patient's now waiting for an appointment with neurologist mid September.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: Patient recevied a 2nd dose of the seasonal tri-valent 2024-2025.  She got her first shot on 7/27/24 and another on 8/31/24.  The patient was called and is not experiencing any side effects.  She did not remember that she got it on 7/27 so when asked if she wanted a flu shot she replied yes and the shot was administered.
Age: 54.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: I administered two vaccines into pt.'s left deltoid muscle, first Fluzone and second, an inch apart, Shingrix. Approximately a minute after administering Shingrix, pt. said he felt like he was going to pass out. He moved from the chair in which he was sitting to the couch. Before he could lay down, he experienced a syncopal episode. I placed him in recovery position, check his respiratory rate, and pulse, and then left the vaccination room to ask a technician to call for an ambulance and to inform his wife. Upon entering the room, pt. was awake. I provided him with water. He refused medical assistance. He then disclosed to me that he had not eaten or drank water, and that he fainted last year from receiving a vaccine after not eating or drinking water.
Age: 63.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Extra dose administered
Clinical narrative: Patient received two flu shots, one week apart.
Age: 7.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE REACTION AT TIME OF VACCINE. PATIENT WAS GIVEN FLUBLOK BY MISTAKE.  NOTICED AT TIME OF PROCESSING IN THE PHARMACY WHEN INSURANCE BILLED.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, tender and hot skin below the area of the injection
Age: 85.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Rash, Sleep disorder
Clinical narrative: Patient describes a rash on his arm that keeps him up at night, and uses a cool compress to get back to sleep.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fall, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient was asked in the questionnaire and she states no reaction to any vaccine before. Patient wanted her husband to come with her to the immunization room just in case anything happens. Patient was given COVID vaccine first in the left arm, then 15 seconds later was administered the flu shot. One I put the band-aid on the patient fainted and dropped from the chair. I instantly made sure clothing was loose. Immediately started preparing the Epi-pen to inject the patient, patient gained consciousness within 15 seconds. Patient was able to breathe normally and stated she does not complain of any shortness of breath. Noticed patient's face turned pale. Advised the patient not to get the TDaP shot and postpone it to a later time. Patient stayed in store for 15 minutes and then left with her husband. Patient was doing fine and had no complains.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Full blood count, Metabolic function test, Thyroid function test, Ultrasound scan
Clinical narrative: Loss of menstrual cycle
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Lethargy, Pain
Clinical narrative: Chill, sweating, body aches, 99.1 fever, lethargy, headache.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Lethargy, Paraesthesia, Swelling face
Clinical narrative: July 2023...numbness...tingling arms face swelling face ..weakness..lethargy...
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Periorbital swelling, Swelling face
Clinical narrative: July 2023...numbness...tingling arms face swelling face ..weakness..lethargy...
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Decreased appetite, Injection site induration, Injection site rash, Injection site swelling, Mobility decreased
Clinical narrative: the evening after shingles shot and Sunday upper arm got swollen and hard as a rock, rash spread farther than upper arm, sore muscles and difficult movement throughout body, appetite loss, fever of 100.1; fever resolved Wednesday (8/28), remained sore until Friday (8/30) no meds needed, patient reports she simply rode it out and has since recovered
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Myalgia, Pain, Rash
Clinical narrative: the evening after shingles shot and Sunday upper arm got swollen and hard as a rock, rash spread farther than upper arm, sore muscles and difficult movement throughout body, appetite loss, fever of 100.1; fever resolved Wednesday (8/28), remained sore until Friday (8/30) no meds needed, patient reports she simply rode it out and has since recovered
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles on face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included facial herpes zoster (had shingles on face).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on face). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-AUG-2024 This case was self-reported by patient. This case was reported by the patient via interactive digital media. The vaccine did not help to the patient. The patient had the shingles on face, patient waited three months, got the vaccine, shingles returned, patient said need to took medicines forever. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles/It is a horrible virus; Pain; Blister; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles/It is a horrible virus), pain (Verbatim: Pain) and blister (Verbatim: Blister). The outcome of the vaccination failure, shingles, pain and blister were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles, pain and blister to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-AUG-2024 This case was reported by a patient via interactive digital media. The reporter reported that it was a horrible virus. The patient had developed pain and blisters along with other symptoms were not fun. The patient had it (shingles) for the 2nd time, even after getting the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for Shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Age: 4.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong drug; This non-serious case was reported by a nurse via patient support programs and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received Men B NVS (Bexsero) (batch number A2JX7) for prophylaxis.   On 19-AUG-2024, the patient received Bexsero .5 ml. On 19-AUG-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong drug). 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: 19-AUG-2024 The 4 year of patient had Bexsero (Wrong drug), which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: HEPA
Symptoms: Headache
Clinical narrative: Pain at back of head; This non-serious case was reported by a consumer and described the occurrence of headache in a 29-year-old female patient who received HAV (Havrix 1440) for prophylaxis.   On 19-SEP-2023, the patient received Havrix 1440. In SEP-2023, an unknown time after receiving Havrix 1440, the patient experienced headache (Verbatim: Pain at back of head). The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to Havrix 1440.     It was unknown if the company considered the headache to be related to Havrix 1440.   Additional Information: GSK Receipt Date: 21-AUG-2024 The patient experienced pain at back of head.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Peripheral swelling
Clinical narrative: Nausea; fatigue; Headache; swollen arm; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included amlodipine, levothyroxine, liothyronine, rosuvastatin, lamotrigine and duloxetine.   On 20-AUG-2024, the patient received the 1st dose of Shingrix (left arm). On 20-AUG-2024, less than a day after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), fatigue (Verbatim: fatigue), headache (Verbatim: Headache) and swelling arm (Verbatim: swollen arm). The outcome of the nausea was not resolved and the outcome of the fatigue, headache and swelling arm were resolving.   The reporter considered the nausea, fatigue, headache and swelling arm to be related to Shingrix.     The company considered the nausea, fatigue, headache and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-AUG-2024 The pharmacist reported that the patient received first dose of Shingrix. The patient had nausea and fatigue afternoon after vaccine.  The patient had headache, swollen arm, and at the time of reporting the patient was nauseous the day after administration.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Immediate post-injection reaction, Rash, Swelling
Clinical narrative: shortness of breath; swelling; Rash; This non-serious case was reported by a pharmacist and described the occurrence of shortness of breath in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shortness of breath (Verbatim: shortness of breath), swelling (Verbatim: swelling) and rash (Verbatim: Rash). The outcome of the shortness of breath, swelling and rash were not reported.   It was unknown if the reporter considered the shortness of breath, swelling and rash to be related to Shingrix.   It was unknown if the company considered the shortness of breath, swelling and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-AUG-2024 The reporter reported that, a similar case was reported involving a patient who had an adverse reaction to Shingrix. The reaction included shortness of breath, swelling, and a rash shortly after vaccination. The case was linked with case US2024AMR096059, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR096059:same reporter, different patient
Sex: U
Vaccine: VARZOS
Symptoms: Dry skin, Sensitive skin
Clinical narrative: facial skin has rough patches; sensitive to touch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rough facial skin in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rough facial skin (Verbatim: facial skin has rough patches) and touch sensitivity increased (Verbatim: sensitive to touch). The outcome of the rough facial skin and touch sensitivity increased were not reported.   It was unknown if the reporter considered the rough facial skin and touch sensitivity increased to be related to Shingles vaccine.     It was unknown if the company considered the rough facial skin and touch sensitivity increased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-AUG-2024 This case was reported by patient itself. The patient received shingles shot last year and noticed facial skin has rough patches on forehead and along jaw line. A couple spots along jawline were very rough and sensitive to the touch. The patient reported he/she never had skin issues in life, no acne nothing till received shot.
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: felt like I had a cold; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID 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 cold (Verbatim: felt like I had a cold). The outcome of the cold was not resolved.   It was unknown if the reporter considered the cold to be related to Shingrix.     It was unknown if the company considered the cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-AUG-2024 The patient received Shingrix vaccine around a month or month and a half ago (no date given). The reporter reported, the patient felt like had a cold after getting vaccine, it ruined the patient vacation, it was worse than the COVID shot. The reporter asked if the second shot would be the same. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: we administered Engerix-B, but it was a half mL; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 68-year-old female patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   Previously administered products included Heplisav B (received 1st dose of Heplisav B).   On 20-AUG-2024, the patient received the 2nd dose of Engerix B. On 20-AUG-2024, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: we administered Engerix-B, but it was a half mL). The outcome of the underdose 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: 20-AUG-2024 The nurse called and informed that they administered the adult patient 2nd dose of Engerix-B vaccine but it was a half ml, which led to underdose. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: patient was administered the Shingrix vaccine, but sterile diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number J327J, expiry date 19-JUN-2026) for prophylaxis.   On 20-AUG-2024, the patient received the 2nd dose of Shingrix. On 20-AUG-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient was administered the Shingrix vaccine, but sterile diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   Additional Information: GSK receipt date: 20-AUG-2024  A nurse called to inform that earlier that day (on the day of reporting) a patient was administered the Shingrix vaccine, but sterile diluent  was used to reconstitute Shingrix, which led to wrong solution used and inappropriate dose administered.  According to reporter, the sterile diluent was sterile water.  Also, it was the second dose of Shingrix for that patient. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 68.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Crying, Injection site pain, Tremor
Clinical narrative: Extreme pain upon injection; Yell after injection; Shaken up after the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GE3S7, expiry date 13-OCT-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number e3xt9, expiry date 19-JUN-2026) for prophylaxis.   On 20-AUG-2024, the patient received Arexvy and Shingrix. On 20-AUG-2024, less than a day after receiving Arexvy and Shingrix, the patient experienced injection site pain (Verbatim: Extreme pain upon injection), crying (Verbatim: Yell after injection) and tremor (Verbatim: Shaken up after the vaccine). The outcome of the injection site pain, crying and tremor were unknown.   It was unknown if the reporter considered the injection site pain, crying and tremor to be related to Arexvy and Shingrix.     It was unknown if the company considered the injection site pain, crying and tremor to be related to Arexvy and Shingrix.   Additional Information: GSK receipt date: 20-AUG-2024 The Caller reported to have a patient that was supposed to received Arexvy and Shingrix vaccines, so the health care provider reconstitute both, each in different syringes.  The health care provider administer one of this and it cause an extreme pain upon the injection, so they did not administer the second vaccine. As the health care provider didn't label the vaccines, they need to know if we have any information on how to difference the vaccines once their were reconstitute, this in order to know witch vaccine the patient received The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of Shingrix given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) (batch number 33L2J, expiry date 15-MAY-2026) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2022) and Shingrix (2nd dose received in 2022).   On 07-JUN-2024, the patient received the 3rd dose of Shingrix. On 07-JUN-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose of Shingrix given). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 21-AUG-2024 Pharmacist called to report a third dose was given to a patient because patient did not remember she was already vaccinated with the complete two dose series of Shingrix which led to extra dose administered. Pharmacist did not have exact vaccination dates for the first and second doses, only reported these doses were given in 2022.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the first dose for Shingrix in 2022 and then the second dose was administered June 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 49e83) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on 2022).   On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On 11-JUN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose for Shingrix in 2022 and then the second dose was administered June 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-Aug-2024 The reporter reported that the patient received the first dose for Shingrix in 2022 and then the second dose was administered June 2024. The reporter stated that there was no exact vaccination date for the first dose reported. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose not receive yet; 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 44-year-old female patient who received HBV (Engerix B adult) (batch number 2793Z) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B (1st dose received in 9th January 2022 batch number N4GA4).   On 18-FEB-2022, the patient received the 2nd dose of Engerix B adult. On an unknown date, the patient did not receive the 3rd dose of Engerix B adult. On 18-FEB-2022, an unknown time after receiving Engerix B adult and not applicable after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: 3rd dose not receive yet). The outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 21-AUG-2024 Till the time of reporting, the patient did not receive 3rd dose of Engerix-B which led to incomplete course of vaccination. The patient received 2nd dose of Engerix-B, later than the recommended interval, which led to lengthening of vaccinations schedule. The patient received Twinrix on 22nd January 2024 (lot number H7RF2). This shot was administered in another location.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: vaccine expired on "7/31/2024, and I gave it on 8/1/202; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   On 01-AUG-2024, the patient received Bexsero. On 01-AUG-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: vaccine expired on "7/31/2024, and I gave it on 8/1/202). 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: 21-AUG-2024 The Registered Nurse called to inform that a dose of Bexsero that was outdated by one day was administered, which led to expired vaccine used. Consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter
Age: 75.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old female patient who received HBV (Engerix B) (batch number ZY7D9, expiry date 12-AUG-2024) for prophylaxis.   On 21-AUG-2024, the patient received Engerix B. On 21-AUG-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of expired dose.). 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: 21-AUG-2024 The patient was administered an expired vaccine, if it was like 8 days expired, and wanted know if the patient requires to be revaccinated. Consented to follow up.