chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: overdose/mistakenly administered the Engerix-B 20 mcg; mistakenly administered the Engerix-B 20 mcg dose to a 16 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 16-year-old male patient who received HBV (Engerix B adult) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis.   On 20-FEB-2024, the patient received the 3rd dose of Engerix B adult 20 ug. On 20-FEB-2024, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: overdose/mistakenly administered the Engerix-B 20 mcg) and adult product administered to child (Verbatim: mistakenly administered the Engerix-B 20 mcg dose to a 16 year old patient). The outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 11-MAR-2024 The pharmacist mistakenly administered the Engerix-B 20 mcg (Engerix B adult) to a 16-year-old patient, which led to an accidental overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart issues; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was administered vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced heart issues (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of heart issues was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART PROBLEMS; This spontaneous report received from a J&J managed social media site concerned a patient of unspecified age and sex, reporting self The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced heart problems.(Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was non-serious.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Twinrix on 8/18/2023 and never received the next doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix on 18 August 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Twinrix on 8/18/2023 and never received the next doses). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAR-2024 The registered pharmacist reported the patient never received next doses. The patient came in today (day of reporting) and was over due and was expecting the healthcare professional to remind of the next dose and that did not happen. The registered pharmacist was unsure on the timing between the second and third doses and confirmed this was intended for the Twinrix standard series. Pharmacist inquired how to procced with the Twinrix series. Till the time of reporting, the patient did not receive 2 dose of Twinrix, which led to incomplete course of vaccination.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Additional 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old patient who received Herpes zoster (Shingrix) (batch number J743F, expiry date 11-DEC-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 04-DEC-2018) and Shingrix (received 2nd dose on 28-FEB-2019).   On 22-JAN-2024, the patient received the 3rd dose of Shingrix. On 22-JAN-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Additional 3rd dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-MAR-2024 The pharmacist reported a patient received Shingrix but they recently discovered that patient already received 1st dose and 2nd dose, so the last one was an inadvertent 3rd dose, which led to extra dose administered. The reporter consented to follow up.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Headache, Influenza virus test negative, SARS-CoV-2 test negative
Clinical narrative: Several hours after receiving HPV vaccine, she experienced headache, dizziness, fatigue and blurred vision. This persisted through recheck office exam 03/25/2024
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Vision blurred
Clinical narrative: Several hours after receiving HPV vaccine, she experienced headache, dizziness, fatigue and blurred vision. This persisted through recheck office exam 03/25/2024
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: While reviewing immunizations, the patient's parent realized that vaccinations received in September 2023 (12 month visit) at outside facility had not been accounted for. Record request was sent and reviewed. Documentation showed that the patient had received PROQUAD and INFLUENZA at outside clinic in September 2023.  Both vaccinations were given in this clinic in January 2024 also. Dr. discussed with parents that vaccinations had been duplicated due to incomplete vaccination record at time of administration. All concerns were addressed by physician.
Age: 3.0
Sex: F
Vaccine: COVID19, DTAP, FLUC4
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: gave covid 19 pfzier 6m-4y without diluting as indicated and gave 0.3ml resulting in higher than indicated dose.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic valve incompetence, Cardiovascular evaluation, Condition aggravated, Echocardiogram abnormal, Palpitations
Clinical narrative: Shortly after first dose, noticed palpitations with exercise, shortly after second dose, noticed and increase of palpitations throughout the day at rest and with every day activities. Had a cardiac workup and an echocardiogram which showed the regurgitation and borderline pulmonary hypertension. Treatment of hypertension with Amlodipine 5mg has treated the tricuspid regurgitation and pulmonary hypertension.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary hypertension, Tricuspid valve incompetence
Clinical narrative: Shortly after first dose, noticed palpitations with exercise, shortly after second dose, noticed and increase of palpitations throughout the day at rest and with every day activities. Had a cardiac workup and an echocardiogram which showed the regurgitation and borderline pulmonary hypertension. Treatment of hypertension with Amlodipine 5mg has treated the tricuspid regurgitation and pulmonary hypertension.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Tenderness
Clinical narrative: Patient developed symptoms of shingles immediately after vaccine administered. Patient's left side of body extremely tender to touch, no rash has developed though. Physician called today to inform us that the patient came into an office visit presenting with signs/symptoms of shingles.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Left are injection site red, and swelling. Hives spread above and below injection site, and itching all around the red area of hives.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: bilateral tinnitus
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient did not suffer any adverse events at all, however we are following protocol due to her getting 2nd vaccine a month early.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic valve replacement, Asthenia, Atrial fibrillation, Balance disorder, Burning sensation
Clinical narrative: He got his vaccine, had no initial reaction.  On Sunday he had warmth in the area of the vaccine, and tenderness in the arm.  On Monday, had warmth in the arm, more tenderness to hitting him hard and affecting the entire body with deep aches and pain.  Just feeling a system disorientation, weakness, fatigue.  He then started having a feeling of A-fib around 1:00 PM and never had chest pain or heart pain, just checked and noticed he was in A-fib for about the next 10-11 hours.  Then he took 3 Ibuprofen and tried to calm down, and reminded him a lot of fibromyalgia pain that he had in the past, and he felt like his body calmed down and didn't notice it ramping back up but then about 8:00 -9:00 PM he was back to normal rhythm.  He has some type of inflammation and has it where the arch of his foot starts to fill in and this is where he has the inflammation.  He did have an aortic valve replacement and most of his inflammation went away.  His feet burn and his butt burns and it feels like somebody is blowing up his feet with an air hose.  The circulation issues are better today in his feet and he knows first thing in the morning by how his arches feel.  He feels wobbly sometimes, but he can exercise and has to stop as his feet start hurting and they feel swollen by air and not water.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Exercise tolerance decreased, Fatigue, Inflammation, Pain
Clinical narrative: He got his vaccine, had no initial reaction.  On Sunday he had warmth in the area of the vaccine, and tenderness in the arm.  On Monday, had warmth in the arm, more tenderness to hitting him hard and affecting the entire body with deep aches and pain.  Just feeling a system disorientation, weakness, fatigue.  He then started having a feeling of A-fib around 1:00 PM and never had chest pain or heart pain, just checked and noticed he was in A-fib for about the next 10-11 hours.  Then he took 3 Ibuprofen and tried to calm down, and reminded him a lot of fibromyalgia pain that he had in the past, and he felt like his body calmed down and didn't notice it ramping back up but then about 8:00 -9:00 PM he was back to normal rhythm.  He has some type of inflammation and has it where the arch of his foot starts to fill in and this is where he has the inflammation.  He did have an aortic valve replacement and most of his inflammation went away.  His feet burn and his butt burns and it feels like somebody is blowing up his feet with an air hose.  The circulation issues are better today in his feet and he knows first thing in the morning by how his arches feel.  He feels wobbly sometimes, but he can exercise and has to stop as his feet start hurting and they feel swollen by air and not water.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Peripheral vascular disorder, Sensory disturbance, Skin warm, Tenderness
Clinical narrative: He got his vaccine, had no initial reaction.  On Sunday he had warmth in the area of the vaccine, and tenderness in the arm.  On Monday, had warmth in the arm, more tenderness to hitting him hard and affecting the entire body with deep aches and pain.  Just feeling a system disorientation, weakness, fatigue.  He then started having a feeling of A-fib around 1:00 PM and never had chest pain or heart pain, just checked and noticed he was in A-fib for about the next 10-11 hours.  Then he took 3 Ibuprofen and tried to calm down, and reminded him a lot of fibromyalgia pain that he had in the past, and he felt like his body calmed down and didn't notice it ramping back up but then about 8:00 -9:00 PM he was back to normal rhythm.  He has some type of inflammation and has it where the arch of his foot starts to fill in and this is where he has the inflammation.  He did have an aortic valve replacement and most of his inflammation went away.  His feet burn and his butt burns and it feels like somebody is blowing up his feet with an air hose.  The circulation issues are better today in his feet and he knows first thing in the morning by how his arches feel.  He feels wobbly sometimes, but he can exercise and has to stop as his feet start hurting and they feel swollen by air and not water.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: He got his vaccine, had no initial reaction.  On Sunday he had warmth in the area of the vaccine, and tenderness in the arm.  On Monday, had warmth in the arm, more tenderness to hitting him hard and affecting the entire body with deep aches and pain.  Just feeling a system disorientation, weakness, fatigue.  He then started having a feeling of A-fib around 1:00 PM and never had chest pain or heart pain, just checked and noticed he was in A-fib for about the next 10-11 hours.  Then he took 3 Ibuprofen and tried to calm down, and reminded him a lot of fibromyalgia pain that he had in the past, and he felt like his body calmed down and didn't notice it ramping back up but then about 8:00 -9:00 PM he was back to normal rhythm.  He has some type of inflammation and has it where the arch of his foot starts to fill in and this is where he has the inflammation.  He did have an aortic valve replacement and most of his inflammation went away.  His feet burn and his butt burns and it feels like somebody is blowing up his feet with an air hose.  The circulation issues are better today in his feet and he knows first thing in the morning by how his arches feel.  He feels wobbly sometimes, but he can exercise and has to stop as his feet start hurting and they feel swollen by air and not water.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Bell's palsy, Chronic sinusitis, Nerve compression
Clinical narrative: Patient began to exhibit signs of "Bells Palsy" on the evening of 3/21/2024 (same day as vaccination). He did seek medical attention with his PCM and the treatment was a Medrol Dose Pak. Symptoms as of today (3/26/2024) is beginning to resolve a little,
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: Patient received dose #4 in series when series was really complete at dose #3 (dose #4 was not necessary)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: "full body, head to toe nerve pain," self treating at home with pain medicine, starting day after vaccine
Age: 49.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Patient began having redness, heat to the touch and a small bump the day after her vaccine. One more day later, she began to have pain at the site of injection which has gotten worse. Today, 3 days after the vaccine, patient started taking an anti-inflammatory for pain and has been instructed to add an antihistamine. If symptoms do not resolve, patient should contact her primary care.
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Chills, Decreased appetite, Dehydration
Clinical narrative: Member reported to 120 MDG for vaccination of anthrax. Symptoms reported as headache, nausea, massive cramping in gut. Progressively worsening to fatigue, no appetite, starting to progress into body aches around the entire system. Progressed to hot flashes, felt temperature rising, pt states he felt extremely dehydrated with adequate water intake, immediately progressed to chills, joint pain, swelling in left elbow and left shoulder, lower back pain bilaterally.  Did not take any medication or supplement. Member soaked to relieve some of the body pain. Pt began to feel a bit better Fri, and felt better Sat.
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Feeling hot, Gastrointestinal pain, Headache, Hot flush
Clinical narrative: Member reported to 120 MDG for vaccination of anthrax. Symptoms reported as headache, nausea, massive cramping in gut. Progressively worsening to fatigue, no appetite, starting to progress into body aches around the entire system. Progressed to hot flashes, felt temperature rising, pt states he felt extremely dehydrated with adequate water intake, immediately progressed to chills, joint pain, swelling in left elbow and left shoulder, lower back pain bilaterally.  Did not take any medication or supplement. Member soaked to relieve some of the body pain. Pt began to feel a bit better Fri, and felt better Sat.
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Joint swelling, Nausea, Pain
Clinical narrative: Member reported to 120 MDG for vaccination of anthrax. Symptoms reported as headache, nausea, massive cramping in gut. Progressively worsening to fatigue, no appetite, starting to progress into body aches around the entire system. Progressed to hot flashes, felt temperature rising, pt states he felt extremely dehydrated with adequate water intake, immediately progressed to chills, joint pain, swelling in left elbow and left shoulder, lower back pain bilaterally.  Did not take any medication or supplement. Member soaked to relieve some of the body pain. Pt began to feel a bit better Fri, and felt better Sat.
Age: 0.75
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Rota #3 given at 9 months of age. Rota is not indicated after 8 months of age. No adverse outcome for the patient.
Age: 63.0
Sex: F
Vaccine: PNC13, RSV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site reaction, Injection site scar
Clinical narrative: On the evening of the injections the site became warm, swollen and reddened. Thirty six hours after the injections I began experiencing chills and muscle aches. The arm of the injection site was tender and continued to be warm, swollen and reddened. The chills and muscle aches subsided after twenty four hours. The area surrounding the injection sites continued to be reddened, similar to a sunburn. Over the course of a week the skin at site of the injections peeled and flaked off. At 24 days post injection the site remains reddened, mottled and almost has the appearance of a scar. The site remains slightly tender to touch.
Age: 63.0
Sex: F
Vaccine: PNC13, RSV
Symptoms: Injection site swelling, Injection site warmth, Livedo reticularis, Myalgia, Skin exfoliation
Clinical narrative: On the evening of the injections the site became warm, swollen and reddened. Thirty six hours after the injections I began experiencing chills and muscle aches. The arm of the injection site was tender and continued to be warm, swollen and reddened. The chills and muscle aches subsided after twenty four hours. The area surrounding the injection sites continued to be reddened, similar to a sunburn. Over the course of a week the skin at site of the injections peeled and flaked off. At 24 days post injection the site remains reddened, mottled and almost has the appearance of a scar. The site remains slightly tender to touch.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: Red area, celulitis.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Red area, celulitis.
Age: 18.0
Sex: U
Vaccine: MMR, MNQ, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: syncope; extreme paleness, sweating, light headedness, dizziness, loss of consciousness
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Pain in extremity
Clinical narrative: After administration, noticed that the vaccine was beyond use date by 6 days.  The expiration on the vial was 5/4/24.  However, the vaccine was previously frozen and had a 10 week use by date from when it was thawed.  The beyond use date was March 15 2024.  Pfizer contacted and no data as to whether dose would be effective or not.  Patient notified who reported some short lived chills and sore arm but no other adverse effects.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Hypersensitivity, Internal haemorrhage, Orthosis user
Clinical narrative: allergic reaction, loss of blood internally, knee started having issues; still having issues over the course of 3 years with knee, having to wear knee brace-taking tylenol for knee
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Musculoskeletal discomfort, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: Patient stated that he has been experiencing weakness and stiffness in his left shoulder since receiving his Shingles vaccine in that left arm on 12/19/23. Patient reported that the vaccine felt OK while it was given, but after the vaccine was administered, he noticed the bandage was higher up on his arm than he thought it should be. Over the next 3 to 5 days, the patient felt that something was not right with his shoulder. At the 30 to 45 day mark, his shoulder still didn't feel normal. Patient has been experiencing stiffness and weakness in his left shoulder. He stated he has been doing stretching on that shoulder at home and has regained about 75 to 80 percent of his shoulder strength back.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes virus test, Metabolic function test, Pyrexia, Urticaria, Varicella virus test
Clinical narrative: Fever for over 9 days up to 103.7, severe hives covering entire body including in mouth and in throat
Age: 58.0
Sex: M
Vaccine: FLU4, PNC20, TDAP, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient called the pharmacy on 3/26/24 complaining about pain in his left arm where he received the 4 aforementioned vaccines in November. He reported that he has not had relief even though he received the vaccine 4 months ago. He was seen by his PCP who encouraged him to reach out to the pharmacy and get an MRI.
Age: 76.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site erythema, Injection site reaction, Injection site scab, Skin wound
Clinical narrative: Patient had a small wound about the size of a quarter develop in skin located at injection site of RSV vaccine in left deltoid.  Redness still persisting and wound is scabbed over about the size of a dime now and healing as of 3-26-24 over a month since vaccine administration.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ascites, Blood test, Condition aggravated, Dressler's syndrome, Ultrasound abdomen
Clinical narrative: Recurrence of Dressler's Syndrome (Autoimmune). abdominal fluid retention (ascites).
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Gave Infanrix instead of Boostrix
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Infanrix was given instead of Boostrix
Age: 26.0
Sex: F
Vaccine: COVID19, HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse reaction. Vaccine that wa sgiven is for patient 06 months to 11 years old and patient is 26 years old.
Age: 1.08
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Infanrix given was expired.  Expiration date was 03/03/24.  No symptoms or signs of any other adverse reaction.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Infanrix was given instead of Boostrix
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 65.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Atrial fibrillation, Cardiac function test, Laboratory test
Clinical narrative: First time (and only time) atrial fibrillation (AF) with rapid ventricular response.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Arm was sore after vaccine and is still sore months later. Verified with patient that there was no shoulder pain or shoulder involvement, just muscle pain at injection site still.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: vaccine expired on 3/25/2024
Age: 85.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: The patient called at 10:41am and said that she woke up with a rash and hives. It was on her legs, arms and trunk. She was itching and had whelps. She called me back at 2:50pm and said the she was doing better after taking Benadryl, per my recommendation.
Age: 15.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient recently moved here and her vaccines were all kind of messed up. I did go and speak with her primary care provider to discuss and to verify what she wanted me to give to the patient as I was unsure and I gave the ones that she said to give, which were given. Patient was not due for Tdap as it was administered 1 month prior on 2/13/24.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: cellulitis that started 3 days after injection. pt went to family care nurse practitioner and received bactrim for cellulitis
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given an adult dose of Hepatitis A instead of pediatric dose.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient came to pharmacy 3/26/24 reported sore arm, redness, swollen at the injection site no itching or rash  , upon looking at the injection site seems like common adverse reaction after vaccination, patient mentioned that she was seen by the primary care provider earlier same day of reporting symptoms. Patient was advised to use ice packs to help with soreness and Ibuprofen to reduce the redness and swelling and also to follow up again with PCP  in case of symptoms did not improve or upon seeing  a new symptoms.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Internal haemorrhage, Platelet count decreased
Clinical narrative: Internal bleeding.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lip and/or oral cavity cancer, Neoplasm, Oral lichen planus, Radiotherapy
Clinical narrative: Patient developed lichen planus (mouth fungus). Antibiotics were prescribed. Around July of 2024, a cancer tumor had developed in the right side of her mouth.  The surgical procedure was not a good option, so radiation therapy was suggested. The first treatment was too uncomfortable, so she discontinued the treatments.  Non-invasive treatments were available in her area, but a family member would not agree to take her to receive them.
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event
Clinical narrative: pt didn't present any symptoms and didn't need any treatment.
Age: 1.25
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: THERE WERE NO ADVERSE EVENTS.  TYPHOID VI VACCINE WAS GIVEN OUTSIDE OF THE APPROVED AGE RANGE.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine administered (DTAP+IPV+Hib). No adverse outcome. Patient to be re-immunized.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given was expired, no adverse s/s noted
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given was expired, it had expired on 3/22, no adverse s/s noted after administration
Age: 1.08
Sex: M
Vaccine: UNK
Symptoms: Rash morbilliform
Clinical narrative: Measles like rash
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that unknown number of patients possibly received improperly stored vaccines yesterday.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) GARDASIL 9 x; This spontaneous report was received from medical assistant on 30-JAN-2024, and follow-up has been received from a practice manager on 21-FEB-2024. This report refers to a 16-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JAN-2024, the patient was vaccinated with improperly stored, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, intramuscularly, in the left deltoid, lot #x019863, expiration date: 14-FEB-2025, administered for prophylaxis (strength was not provided); with a influenza vaccine inact split 3 (FLULAVAL), intramuscularly, in the right deltoid, lot #23G34, expiration date: 27-JUN-2024, (strength, formulation, and indication were not provided); and with a meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), lot #U7945BA, expiration date: 20-MAR-2026, administered intramuscularly, in the left deltoid, (strength, formulation, and indication were not provided). Those vaccines underwent temperature excursion on 29-JAN-2024 in 29.5 Farenheit for 19 hours 15 minutes (Product storage error). It was also reported that refrigerator temperature out of range, which was discovered an the end of a day. No adverse event was reported (no adverse event).
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE.; HCP reporting 14 year old patient received 1st dose of PROQUAD on 2/7/2024.; This spontaneous report was received from the customer and refers to a 14-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-FEB-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, frequency, strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse event (AE) was reported.  Lot # is being requested and will be submitted if received.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; Office manager calling on behalf of physician to report that a 4 year old patient was accidently administered both PROQUAD and VARIVAX today, 08-MAR-2024. Office manger explained that the nurse meant to administer PROQUAD, but did not realize that PR; This spontaneous report was received from an office manager concerning a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-MAR-2024, the patient was accidentally vaccinated with both varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # X023717, expiry date: 26-SEP-2025), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection (lot # X024913, expiry date: 14-APR-2024), both administered for prophylaxis (strength, dose, anatomical location and route of administration were not provided). It was reported that the nurse meant to administer measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), but did not realize that it contained varicella so she also gave the patient varicella virus vaccine live (oka/merck) (VARIVAX) (Accidental overdose). No adverse events were reported.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AEs; Caller reported VARIVAX was administered to a pregnant patient.; This spontaneous report was received from nurse and refers to a 23-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-MAR-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, administered subcutaneously in the right arm for immunisation, valid lot # X017485 with expiration date 25-JUN-2025 (strength and expiry date were not provided). On 08-MAR-2024, the patient was vaccinated with sterile diluent (STERILE DILUENT) solution for injection/infusion, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); diluted in sterile diluent solution for injection/infusion 0.5 ml (strength, lot #, expiry date and route of administration) as prophylaxis.   It was reported that the varicella virus vaccine live (oka/merck) (VARIVAX) was administered to a pregnant patient (exposure during pregnancy). Date of the last menstrual period (LMP) was on 13-JAN-2024. Due date of pregnancy was estimated as 19-OCT-2024. No treatment given. No additional adverse event reported (no adverse event).
Age: 35.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; a 35 year old male patient was administered the PROQUAD vaccine outside of the PI.; This spontaneous report was received from an other health professional (HCP) (medical assistant) and refers to a 35-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-MAR-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, administered for prophylaxis (lot #, expiry date, therapy type, and route of administration were not provided).   Suspect vaccine was administered outside of the package insert (PI) (product administered to patient of inappropriate age). HCP did not report any side effects from the administration of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine. HCP provided limited pertinent information and had no further clarifications. Permission was provided to follow up with the HCP. No additional adverse event (AE) reported (no adverse event).  Lot # is being requested and will be submitted if received.
Age: 10.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; Proquad and MMR administered with interval less than 1 month; Improper storage of product in use; This spontaneous report was received from an other health professional (nurse practitioner) and refers to a 10-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 25-OCT-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided). On 22-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II) subcutaneous injection, lot #W031980, expiration date: 06-OCT-2024, administered subcutaneously for prophylaxis (exact dose and anatomical location were not provided). Vaccines were administered with interval less than 1 month (inappropriate schedule of product administration).  Administered doses of vaccines were exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset dates: 25-OCT-2023 and 22-NOV-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 35.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of PROQUAD instead of MMR-II; administration of PROQUAD instead of MMR-II to a 35 year old female; No additional AE; This spontaneous report was received from a Medical Assistant and refers to a 35-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided); instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (wrong product administered, product administered to patient of inappropriate age). No additional adverse events reported.  Lot # is being requested and will be submitted if received
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AEs were reported; an adult patient received a pediatric dose of VAQTA; an adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 18-MAR-2024, an adult patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, 0.5 milliliter, once, lot # reported and confirmed as: 1989614, expiration date reported and confirmed as: 23-AUG-2024, administered for prophylaxis by a health professional (site and route of administration were not provided) (incorrect dose administered; product administered to patient of inappropriate age). There was no additional adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP did not report any side effects from the administration of the expired PROQUAD; patient was inadverntly administered an expired; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-MAR-2024, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot #W029550 was valid, expiration date 14-MAR-2024, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). HCP did not report any side effects from the administration of the expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine (No adverse event). No product quality complaint (PQC).
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous report was split from a legal case (2403USA000091), received from physician and referred to a 2-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were captured in 2403USA000091.  On 30-AUG-2009, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (unspecified formulation, captured as intramuscular injection) (manufacturer unknown) (captured as VAQTA) for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 15-JUL-2009, the patient was vaccinated with the second dose (inappropriate schedule of vaccine administered), on 16-FEB-2011, the patient was vaccinated with the third dose (extra dose administered).; Sender's Comments:  US-009507513-2403USA000091:
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This spontaneous report was split from a legal case (2403USA000091) and received from physician and referred to a 4-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were captured in 2403USA000091.  On 13-APR-2007, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (unspecified formulation, captured as intramuscular injection) (manufacturer unknown) (captured as RECOMBIVAX HB) for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 15-JUN-2007, the patient was vaccinated with the second dose (inappropriate schedule of vaccine administered). On 16-AUG-2007, the patient was vaccinated with the third dose (inappropriate schedule of vaccine administered).; Sender's Comments:  US-009507513-2403USA000091:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; received a dose of VAQTA one month before their doses were due.; This spontaneous report was received from an office manager and refers to a 10-year-old patient of unknown gender.  The patient's medical, concurrent conditions, previous drug allergies and reactions and concomitant therapies were not reported.  On 09-OCT-2023, the patient was vaccinated with the primary regimen of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 08-MAR-2024 (also reported as about 1 month prior to the booster due date), the patient was vaccinated with the booster dose of hepatitis a vaccine, inactivated (VAQTA) (inappropriate schedule of vaccine administered). No additional adverse events were reported.  This is one of 4 reports from the same reporter.; Sender's Comments:  US-009507513-2403USA007673:
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: No additional AE reported; adult patient who received a dose of MMR-II / patient is over 40 years old; This spontaneous report was received from Pharmacist and refers to an adult patient (reported as over 40-years-old) of unknown gender.  The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On 14-MAR-2023, the patient (over 40-years-old), was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: shingles / suspected vaccination failure; shingles; c19 (covid 19); 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: shingles / suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and covid-19 (Verbatim: c19 (covid 19)). The outcome of the vaccination failure was unknown and the outcome of the shingles and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-Mar-2024 This case was reported by a patient's friend via (social media) interactive digital media. Reporter stated that, a healthy friend (patient) got the shot and ended up with shingles. Not happy and stated would never get another and to top it off still got c19 (covid 19). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the 2 new shot series and a year later got shingles not too bad / Suspected vaccination failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of no adverse event (got old vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the 2 new shot series and a year later got shingles not too bad / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 2 weeks).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2024 This case was reported by the patient via (social media) interactive digital media. The patient got the old vaccine and also got the 2 new shot series and a year later got shingles not too bad had them for two weeks. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.