chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: FLU4, HEP, TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: He said he got heplisav b, flu and boostrix vaccines on 2/26/24. He had fever and muscle ache for a few days but then after 7-10 days he was was not able to walk and very weak and then was hospitalized for 6 days. He did received IVIG treatment and was diagnosis as guillain barre sydrome due to getting  multiple vaccines.  Because to the condition he had to stop work and was in rehab hospital for 21 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Photopsia, Pupil dilation procedure, Slit-lamp examination, Visual impairment, Vitreous floaters
Clinical narrative: Flashing lights in right eye and dark spots initially in the morning upon waking, then followed by grey patch when moving eye/driving noted around noon and still there later that day?. Continues Monday morning and went to eye dr. Told it was a vitreous floater- larger one? haven?t had these before ?. Maybe a very small black speck once or twice in the past.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest X-ray, Echocardiogram normal, Feeling cold, Pain
Clinical narrative: Very cold and achy 1st & 2nd  day and night.  On the 3rd day I had a routine Calcium Artery Scan. Found a pericardial effusion and an elevated high sensitivity-CRP of 9.2
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion
Clinical narrative: Very cold and achy 1st & 2nd  day and night.  On the 3rd day I had a routine Calcium Artery Scan. Found a pericardial effusion and an elevated high sensitivity-CRP of 9.2
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Joint swelling, Rash
Clinical narrative: Quadracel was administered in  left deltoid, a few hours later patient reported mild pain, swelling around injection site. The following morning  redness, increased swelling and pain, and a mass around injection site and a scattered, nontender, nonpruritic, fine skin  to light pink maculopapular rash limited to patients trunk. Symptoms improved with administration of cool compresses, Motrin, and Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: Quadracel was administered in  left deltoid, a few hours later patient reported mild pain, swelling around injection site. The following morning  redness, increased swelling and pain, and a mass around injection site and a scattered, nontender, nonpruritic, fine skin  to light pink maculopapular rash limited to patients trunk. Symptoms improved with administration of cool compresses, Motrin, and Benadryl.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac operation, Cardioversion, Eye disorder, Tinnitus
Clinical narrative: AFIB- Started May 5, 2021. Still in treatment at Clinic. Tinnitus- No treatment
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Vitiligo
Clinical narrative: I started experiencing Vitiligo after receiving the Pfizer booster. I never had any Vitiligo/pigmentation issues previously. Vitiligo has been spreading ever since.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Developed tinnitus after second dose of Pfizer booster. Don't know which version of Pfizer but it was the initial one that was initialing being used.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Decreased appetite, Headache, Mobility decreased, Musculoskeletal disorder, Nausea
Clinical narrative: Nausea, headache, fever, inoperable arm, full body nervous system distress, no appetite, no sleep,  54 hours in bed.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nervous system disorder, Pyrexia, Sleep disorder
Clinical narrative: Nausea, headache, fever, inoperable arm, full body nervous system distress, no appetite, no sleep,  54 hours in bed.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Brain fog, Burning sensation, Chills, Dizziness
Clinical narrative: Immediate side effects after the shot: burning sensation, dizziness. Increase in symptoms over the next 36 hours, occurring in waves: nausea, lightheadedness, noise sensitivity, fatigue, aches, pain at old injury sites, excessive thirst. Extreme cold and chills while sleeping, while also sweating. Throbbing headache, then extreme body heat. These symptoms subsided over the next 2 days. But over the following weeks brain symptoms increased: brain fog, overwhelm, extreme noise sensitivity, trouble falling asleep. These symptoms have persisted to date.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Fatigue, Feeling cold, Feeling hot, Headache
Clinical narrative: Immediate side effects after the shot: burning sensation, dizziness. Increase in symptoms over the next 36 hours, occurring in waves: nausea, lightheadedness, noise sensitivity, fatigue, aches, pain at old injury sites, excessive thirst. Extreme cold and chills while sleeping, while also sweating. Throbbing headache, then extreme body heat. These symptoms subsided over the next 2 days. But over the following weeks brain symptoms increased: brain fog, overwhelm, extreme noise sensitivity, trouble falling asleep. These symptoms have persisted to date.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Hyperhidrosis, Immediate post-injection reaction, Initial insomnia, Nausea
Clinical narrative: Immediate side effects after the shot: burning sensation, dizziness. Increase in symptoms over the next 36 hours, occurring in waves: nausea, lightheadedness, noise sensitivity, fatigue, aches, pain at old injury sites, excessive thirst. Extreme cold and chills while sleeping, while also sweating. Throbbing headache, then extreme body heat. These symptoms subsided over the next 2 days. But over the following weeks brain symptoms increased: brain fog, overwhelm, extreme noise sensitivity, trouble falling asleep. These symptoms have persisted to date.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Thirst
Clinical narrative: Immediate side effects after the shot: burning sensation, dizziness. Increase in symptoms over the next 36 hours, occurring in waves: nausea, lightheadedness, noise sensitivity, fatigue, aches, pain at old injury sites, excessive thirst. Extreme cold and chills while sleeping, while also sweating. Throbbing headache, then extreme body heat. These symptoms subsided over the next 2 days. But over the following weeks brain symptoms increased: brain fog, overwhelm, extreme noise sensitivity, trouble falling asleep. These symptoms have persisted to date.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired on 5/2/2024.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Rash macular, Rash vesicular
Clinical narrative: About 4 hours later a small rash with some swelling developed below the site of injection. 2 days after injection, the rash became larger and very painful when touched. Rash appears very similar to the shingles I had last fall on my lower back (red blotches).
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac monitoring, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: I had heart related issues. Specifically, it felt like my heart was skipping a beat or the beat was off time / delayed. I wore an Holter monitor and got an echocardiogram. They found premature ventricular complexes and premature arterial complexes.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Infant irritability, Pyrexia
Clinical narrative: Fever of >100 degrees Fahrenheit beginning the evening of 05/05/2024 and lasting through date of VAERS report on 05/05/2024. Fever has been consistently over 100*F. 160mg/5mL Infant Tylenol given 2-3x per day (5mL dose per patient weight). Accompanying irritability.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site urticaria, Urticaria
Clinical narrative: Hives around injection site and on legs and back, redness of cheeks. Redness of cheeks resolved spontaneously. Seen in the office 24 hours later and started on oral benadryl.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Injection site pain, Pruritus, Pyrexia, Rash
Clinical narrative: During the injection method,  there was moderate pain at the site which resolved after 2 to 3 hours. In the evening on the day of vaccination, I started getting itching throughout the body along with fever and chills which lasted for about one day. I waited for the symptoms to resolve. The itching then resulted into red pinpoint spots throughout the body especially in the neck, chest, thigh and hands. I used antiallergy medicine I was carrying from (my home country as I am a foreign national) - levocetrizine which helped to manage the symptoms. The rashes took almost 5 to 6 days to disappear when counting from the first day of vaccination. The itching from vaccination still persists and has not resolved. Today is the 10th day following vaccination - 5th May 2024, and the itching persists. It is severe in intensity and worsens at night not allowing me to sleep at night.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Rash erythematous, Sleep disorder
Clinical narrative: During the injection method,  there was moderate pain at the site which resolved after 2 to 3 hours. In the evening on the day of vaccination, I started getting itching throughout the body along with fever and chills which lasted for about one day. I waited for the symptoms to resolve. The itching then resulted into red pinpoint spots throughout the body especially in the neck, chest, thigh and hands. I used antiallergy medicine I was carrying from (my home country as I am a foreign national) - levocetrizine which helped to manage the symptoms. The rashes took almost 5 to 6 days to disappear when counting from the first day of vaccination. The itching from vaccination still persists and has not resolved. Today is the 10th day following vaccination - 5th May 2024, and the itching persists. It is severe in intensity and worsens at night not allowing me to sleep at night.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: full body rash, itching. patient taking prednisone to help itching; calling primary care md in the morning
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Injection site pain, Neck pain
Clinical narrative: Tdap Vaccine (not sure whether Adacel or Boostrix) Shot on Friday. Pain near injection site. Saturday intense pain at injection site, Loss of energy. Sunday, today, pain at injection site no longer intense, but now pain in lower back near right kidney, and pain on right side lower neck, still lack of energy.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: moderate-severe dermatitis in hands. pimecrolimus ointment, steroid ointments. dermatologist wanted to do patch testing but since there is not a patch test to test if it is from covid vaccine, I deferred.
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Eye pruritus, Eye swelling, Lip swelling, Pharyngeal swelling, Swollen tongue
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Throat tightness, Urticaria
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abdominal pain, Anaphylactic reaction, Arthralgia, Asthenia, Autoimmune disorder
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Bell's palsy, Blood disorder, Cardiac disorder, Cerebrovascular accident, Chest discomfort
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Chest pain, Chills, Confusional state, Dermatitis allergic, Diarrhoea
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Dysphagia, Dyspnoea, Eye swelling, Fatigue
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Flushing, Headache, Hyperhidrosis, Hypertension, Hyperventilation
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Hypoaesthesia, Hypotension, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site swelling, Insomnia, Lethargy, Lymphadenopathy, Mouth swelling
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Multisystem inflammatory syndrome in adults, Myocardial infarction, Nausea, Nervous system disorder, Pain
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Paraesthesia, Pruritus, Pyrexia, Rash, Seizure
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Swelling face, Swollen tongue, Syncope, Tachycardia, Throat tightness
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Tinnitus, Tremor, Unresponsive to stimuli, Visual impairment, Vomiting
Clinical narrative: Hives, swollen/itchy eyes, swollen libs, swollen tongue,  swollen/closing throat
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Patient report weakness in left arm
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Headache, Pyrexia, Swelling
Clinical narrative: HEADACHE, FEVER, REDNESS AND SWELLING SINCE MAY 1ST WHEN SHE HAD A VACCINE
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Sleep disorder, Tinnitus
Clinical narrative: Tinnitus, left ear; constant and worsening (louder). Impact on sleep in particular and quality of life.  No treatment.
Age: 60.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Chills, Headache, Pain, Pyrexia, Throat irritation
Clinical narrative: Headache, chills, body aches, scratchy throat, low grade fever.  Still after 48 hours
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Immediate post-injection reaction, Lip haemorrhage, Lip injury, Lip operation
Clinical narrative: IMMEDIATELY PASSED OUT, HIT BOTTOM LIP ON PHARMACY COUNTER WHILE FALLING.  BLED FOR AN HOUR EVEN THOUGH ICE WAS APPLIED.  I WENT TO A PLASTIC SURGEON TO HAVE SCAR REMOVED FROM MY LIP AND WAS TOLD BY THE DOCTOR THAT MY INSURANCE WOULD NOT COVER THE REPAIR.  THEREFORE, I HAVE A BULGING SCAR ON MY BOTTOM LIP RESULTING FROM THE FALL. MY LIP IS ALSO VERY TENDER ON THE SCAR AND IT CAUSES PAIN FOR ME TO DRINK FROM A GLASS CUP OR THROUGH A STRAW.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip pain, Loss of consciousness, Loss of personal independence in daily activities, Oral mucosal scar
Clinical narrative: IMMEDIATELY PASSED OUT, HIT BOTTOM LIP ON PHARMACY COUNTER WHILE FALLING.  BLED FOR AN HOUR EVEN THOUGH ICE WAS APPLIED.  I WENT TO A PLASTIC SURGEON TO HAVE SCAR REMOVED FROM MY LIP AND WAS TOLD BY THE DOCTOR THAT MY INSURANCE WOULD NOT COVER THE REPAIR.  THEREFORE, I HAVE A BULGING SCAR ON MY BOTTOM LIP RESULTING FROM THE FALL. MY LIP IS ALSO VERY TENDER ON THE SCAR AND IT CAUSES PAIN FOR ME TO DRINK FROM A GLASS CUP OR THROUGH A STRAW.
Age: 65.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Respiratory arrest, Resuscitation, Seizure
Clinical narrative: The day after receiving both vaccinations, patient had a seizure, stopped breathing, required CPR, and was hospitalized for 2 days.  The patient's wife said they were not given a physiological reason as to why this happened to him.  He had never had a seizure before.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills
Clinical narrative: Significant chills.  Note that this was 8th COVID-19 vaccine - Initial 3 were Pfizer in 2021,  Remaining 4 were Moderna, two in 2022, 1 in 2023, one on 5/4/2024.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: The patient called on Friday 05/04/2024 and said that she wanted to report an injury that she had received when given a vaccination at our pharmacy.  She stated that she has had a painful reaction to a vaccination that was given on 04/12/2024.  She said that she still had a bump and the site was inflamed and she was still experiencing pain from the shot.  She said that what she thought she was experiencing was SIRVA.  She said that she was seeing a doctor soon for evaluation of the injury.  I told her that I was very sorry for the pain that she was experiencing and that we would file an incident report with agency and VAERs.
Age: 68.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: The pharmacist had vaccine recommendations to make to the patient who came in to pick up her medications today. Following their discussion, the patient stated that she had received 2 vaccines from our facility at the end of 2023 (Respiratory Syncytial Virus and Pneumococcal) and her arm was still sore since then, resulting in slight difficulty/pain when she moved it around.  She said she had been told at the time that it would go away after a couple of days, but it never did. I checked our records and saw that she had received the RSV vaccine and PCV20 vaccines on 11/27/2023, so I referred her to her doctor for further evaluation and said I would follow up with her in a couple of days.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Muscle spasms, Nausea, Pyrexia
Clinical narrative: I had a high fever (over 101 degrees Fahrenheit), experienced chills and muscle spasms, and was weak and nauseated. I needed help to put laundry in the washer and dryer. I could hardly sit up for longer than a few minutes.
Age: 72.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Dyspnoea, Fatigue, Pain in extremity, Vision blurred
Clinical narrative: couple days later, gradual increase of  tiredness, sore arm, blurred vision, difficulty breathing (NO RASH or NO FEVER) then patient admitted to the hospital 04/28/2024 and further evaluated at the hospital
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The patient missed her second and third dose; No additional AE; This spontaneous report was received from Pharmacist and refers to a 19-year-old female patient.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided.  On an unspecified date in 2020 (also reported as about 4 years ago), the patient was vaccinated with the first dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On unspecified dates, the patient missed her second and third doses (Missed dose). No additional adverse event.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: FBE called on behalf of HCP to report a patient who received GARDASIL in the past and has now developed HPV-16.; This spontaneous report was received from a physician via company representative, and refers to a female in her 30's. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2012 (also reported as about "12 years ago"), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date (also reported as recently), the patient was diagnosed with human papillomavirus (HPV) -16. At the reporting time, the outcome of the event was unknown.  The causal relationship between HPV-16 and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No reported signs/symptoms of adverse effects.; Caller stated that product was administered after a not supported excursion. No reported signs/symptoms of adverse effects.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-APR-2024, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X025342, which had been confirmed to be a valid lot number, expiration date reported and confirmed as 12-MAY-2025, administered for prophylaxis (strength, dose, route of administration, and anatomical location were not provided) after a not supported excursion (product storage error). No reported signs/symptoms of adverse effects (no adverse event). Limited information provided.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Caller is a nurse prescriber who reports expired MMR II was administered to one patient. Product expired 06-APR-2024 and the date of administration was 30-APR-2024.; This spontaneous report has been received from other health professional (nurse practitioner) referring a male patient of an unknown age.  The patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent.   On 30-APR-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, rHA, 0.5 mL, administered as prophylaxis (strength, and route of administration were not provided, lot # reported as W028732, which is a valid lot # for this vaccine, expiration date provided and validated to be on 06-APR-2024); therefore, expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered to one patient (expired product administered). No additional adverse event (AE) were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: The shot does not work/suspected vaccination failure; pain; shingles; 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: The shot does not work/suspected vaccination failure) (serious criteria GSK medically significant), pain (Verbatim: pain) (serious criteria other: Serious as per reporter) and shingles (Verbatim: shingles). The patient was treated with gabapentin (Gabapentine). The outcome of the vaccination failure was unknown and the outcome of the pain and shingles were not resolved.   It was unknown if the reporter considered the vaccination failure, pain and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, pain and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-APR-2024 The case was received from the patient via interactive digital media. The reporter reported he/she had a hope it was tail end of a current case of the shingles. The patients stated the shot did not work and had a breakout on the nerve that runs down the inside leg from the groin to ankle. The pain was severe and had lasted three weeks so far. The patient had taken the gabapentin but could not tell if it works or just, he/she was getting it. The patient did not know if he/she had the shingles when they appeared and stupidly thought that he/she had been bitten by something.  The patient waited too long to go to the doctor to get the antivirus medication, had only three days and had to ride it out.  The pain was serious pain. The patient had spoken to the many people who had gotten shingles after having the shot previously. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling in arm that lasted 7 days; This non-serious case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling in arm that lasted 7 days). The outcome of the swelling arm was resolved (duration 7 days).   The reporter considered the swelling arm to be related to Shingrix.     The company considered the swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-APR-2024 The nurse was reported that the patient was received the Shingrix vaccine and experienced swelling in arm that lasted 7 days. The healthcare reported her experience with Shingrix. She said she already reported the arm swelling to her primary care physician (PCP) at the time and the Primary care physician (PCP) reported the incident. The healthcare professional said the adverse event was resolved. She did not want to discuss the adverse event since it had already been reported. The reporter did not have batch/lot number and expiry date.  The reporter did not consent to follow up no contact detail available.
Sex: M
Vaccine: HEPA
Symptoms: Abdominal discomfort, Chest pain, Dyspnoea
Clinical narrative: difficulty breathing; chest pain; upset stomach; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of difficulty breathing in a male patient who received HAV (Havrix) for prophylaxis.   Concurrent medical conditions included alpha-gal allergy.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced difficulty breathing (Verbatim: difficulty breathing), chest pain (Verbatim: chest pain) and upset stomach (Verbatim: upset stomach). The outcome of the difficulty breathing, chest pain and upset stomach were not reported.   It was unknown if the reporter considered the difficulty breathing, chest pain and upset stomach to be related to Havrix.     It was unknown if the company considered the difficulty breathing, chest pain and upset stomach to be related to Havrix.   Additional Information: GSK Receipt Date: 22-APR-2024 This case was reported by patient's parent. The reporter reported that her son (patient) received the Havrix vaccine and has had difficulty breathing, chest pain and an upset stomach.  The reporter refused to provide any further information. No additional adverse event and PQC (product quality complaint) reported.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Temp excursion. Fridge malfunctioned in the middle of the night 4/17/24.; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Temp excursion. Fridge malfunctioned in the middle of the night 4/17/24.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 23-APR-2024  The fridge malfunctioned in the middle of the night 17-APR-2024.  The fridge hit lowest temp negative 10.3 Celsius outside normal range 9 hours 17 minutes and 30 seconds, in which Menveo was stored, which led to incorrect storage of drug.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Patient got pediarix instead of Infanrix; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 77J49, expiry date 09-FEB-2026) for prophylaxis.   On 18-APR-2024, the patient received Pediarix. On 18-APR-2024, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Patient got pediarix instead of Infanrix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 18-APR-2024 Pharmacist called regarding patient got Pediarix instead of Infanrix, patient got an extra polio and Hepatitis B which led to wrong vaccine administered. The reporter questioned was there any adverse reaction. He had completed schedule of Pediarix already.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix was administered using incorrect route, injected intramuscular; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was administered using incorrect route, injected intramuscular). The outcome of the subcutaneous injection formulation administered by other route 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: 23-APR-2024 The nurse called to report that the Priorix vaccine was administered using incorrect route and injected to intramuscular to four patients which led to Subcutaneous injection formulation administered by other route. The reporter did not consent to follow up.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Engerix B; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received HBV (Engerix B) (batch number CM294, expiry date 19-APR-2024) for prophylaxis.   On 22-APR-2024, the patient received Engerix B. On 22-APR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: received an expired dose of Engerix B). 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: 23-APR-2024 The nurse reported that yesterday (one day before the reporting day), the patient received the expired dose of Engerix B vaccine which led to expired vaccine used. This case has been linked to the case US2024052017 reported by the same reporter, different patient.; Sender's Comments:  US-GSK-US2024052017:Same reporter/2nd patient
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of expired Engerix B; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 9-year-old male patient who received HBV (Engerix B) (batch number CM294, expiry date 19-APR-2024) for prophylaxis.   On 22-APR-2024, the patient received Engerix B. On 22-APR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of expired Engerix B). 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: 23-APR-2024 The nurse reported that yesterday (day before reporting), the patient received an expired dose of Engerix B vaccine, which led to an expired vaccine used. This case has been linked to the case US2024052016 reported by the same reporter, different patient.; Sender's Comments:  US-GSK-US2024052016:Same reporter/2nd patient
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early Dose/Havrix at 7 week timeframe after 1st 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 11-year-old male patient who received HAV (Havrix) (batch number X2233, expiry date 14-NOV-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX).   On 11-APR-2024, the patient received the 2nd dose of Havrix. On 11-APR-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Early Dose/Havrix at 7 week timeframe after 1st dose.). The outcome of the drug dose administration interval too short 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: 23-APR-2024 The licensed practice nurse reported that the patient received the Havrix vaccine at 7 week timeframe after 1st dose instead of at the 6 month point.  The patient received 2nd dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: they accidentally administered an expired dose of Infanrix to a patient, the vaccine expired 2 days ago on April 21st 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   Previously administered products included Pediarix (unknown dose received on 9th March 2023 batch number N7HL3, expiration date April 15th 2024), Pediarix (unknown dose received on 9th May 2023, batch number 9552X, expiration date October 26th 2024) and Pediarix (unknown dose received on 10th July 2023, batch number 25L32, expiration date July 10th 2023).   On 23-APR-2024, the patient received the 1st dose of Infanrix. On 23-APR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: they accidentally administered an expired dose of Infanrix to a patient, the vaccine expired 2 days ago on April 21st 2024). 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: 23-APR-2024 The reporter mentioned that they accidentally administered an expired dose of Infanrix to a patient.  The vaccine expired 2 days ago.  The patient received 3 prior DTaP doses. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient had received an expired dose of Infanrix vaccine, which had led to expired vaccine used
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received the first dose of SHINGRIX on April 7, 2023, and never received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: The patient received the first dose of SHINGRIX on April 7, 2023, and never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2024 The reporter was the son of the patient.   The patient never received the second dose of Shingrix. The reporter consented to follow up. The reporter was not sure if the patient would consent to healthcare professional follow up but provided the contact information for the patient. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2024053393 and US2024053399, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024053393:same reporter/ Different patient US-GSK-US2024053399:Same reporter / different patient
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given Adacel due to injury and the Adacel was found to have been stored at temperature of greater than 26 degree Celsius with no reported adverse event; Patient was given Adacel due to injury and the Adacel was found to have been stored at temperature of greater than 26 degree Celsius with no reported adverse event; Initial information received on 25-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 28 years old female patient (167 cm and 278 kg) who experienced patient was given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] due to injury and the adacel was found to have been stored at temperature of greater than 26 degree celsius with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Feb-2024, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (lot U7948BA and expiry date not reported) via intramuscular route in the right deltoid for Prophylactic vaccination and due to injury and the adacel was found to have been stored at temperature of greater than 26 degree celsius with no reported adverse event(poor quality product administered) (latency: same day) (product storage error) (unknown latency).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Exposure during pregnancy
Clinical narrative: she was pregnant,received MENQUADFI with no reported adverse event; Initial information received on 25-Apr-2024 regarding an unsolicited valid non-serious case received via nurse.  This case involves a 17-year-old female patient, she was pregnant, received menquadfi with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date is 17-Jun-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 23-Apr-2024, the patient received a 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength, expiry date: unknown) (lot: U7945BA) via intramuscular route in unknown administration site for immunisation (exposure during pregnancy) (latency: same day).  Additionally, at time of reporting, the pregnancy was still ongoing.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ActHib administered to the patient, after it was expired with no reported adverse event; Initial information received on 25-Apr-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 16 months old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB], after it was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination.  On 25-Apr-2024, the patient was administered an expired dose of 0.5 mL of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ854AA, expiry- 15-MAR-2024) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: F
Vaccine: TD, TDAP
Symptoms: No adverse event
Clinical narrative: had Adacel vaccine and was administered tenivac two weeks later with no adverse event; Initial information received on 25-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 47 years old female patient who had Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] and was administered Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] two weeks later with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient received 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7679AA) (Expiry date: 25-Mar-2025) (Strength: standard) (Frequency: once) via intramuscular route in the left arm for immunization.  On an unknown date,  the patient had received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] and was administered Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] two weeks later with no adverse event (extra dose administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Skin warm, Tenderness
Clinical narrative: Hard lump in arm very painful and hot to touch. Bright red. Larger than an egg. Even protrudes from my arm a bit
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Hearing aid user, Magnetic resonance imaging ear, SARS-CoV-2 test negative
Clinical narrative: I had no immediate adverse effects to the vaccine. This was my third vaccine. I believe they called it a booster. My first two were Moderna, administered in January and February 2021. This was Pfizer. Eight weeks after receiving the vaccine, I developed severe vertigo, tinnitus, and sudden hearing loss in my left ear. I was given a PRC Covid test, whidh was negative. I was given a hearing test, and prescribed a course of Prednisone. I have had severe hearing loss in my left ear ever since, and wear hearing aids. They do not help as much as I would have hoped. I have permanent hearing loss.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus, Vertigo
Clinical narrative: I had no immediate adverse effects to the vaccine. This was my third vaccine. I believe they called it a booster. My first two were Moderna, administered in January and February 2021. This was Pfizer. Eight weeks after receiving the vaccine, I developed severe vertigo, tinnitus, and sudden hearing loss in my left ear. I was given a PRC Covid test, whidh was negative. I was given a hearing test, and prescribed a course of Prednisone. I have had severe hearing loss in my left ear ever since, and wear hearing aids. They do not help as much as I would have hoped. I have permanent hearing loss.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Large 4-inch diameter red, raised, itchy, painful reaction at the injection site, fever, chills, loss of appetite, extreme fatigue
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Large 4-inch diameter red, raised, itchy, painful reaction at the injection site, fever, chills, loss of appetite, extreme fatigue
Age: 0.75
Sex: M
Vaccine: DTAPIPV, PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: infant was mistakenly given wrong vaccine. No adverse reactions reported by parent.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Fall, Head injury, Muscle rigidity
Clinical narrative: After vaccines administered child was sitting at table 5 mins into monitoring, child seen falling to floor with ridget limbs and jerking for 5 to 10 seconds hit left side of head on bookshelfs. School nurse notify immediately and she notified partents. Placed called to Dr. 3pm orders given to have child seen in E.R. for evaluation and Ct of head. Nurse notified of orders given by Dr. Nurse contacted mother and mother stated father was on his way to pick her and transport her by PMV to E.R. LVN
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, PNC20, RV5
Symptoms: Cyanosis, Influenza virus test negative, Pyrexia, SARS-CoV-2 test negative, Seizure
Clinical narrative: IPV Sanofi: WAC751M: RT thigh IM fever, blue discoloration to hands, ankle, lips per mom had a 4-5 minute seizure event febrile to 103 in ED  fever started at 1630 on 3-5-2024
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incontinence, Lethargy
Clinical narrative: Reported Symptoms: 10024264:LETHARGY; 100048555:INCONTINENCE NOS; Narrative: reports extreme lethargy and incontinence after administration of COVID vaccine; was taken to hospital Other: Relevant HX:  Other: lethargy and incontinence