chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: FLU3, PNC21, VARZOS
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Almost immediately after receiving 3 vaccinations patient stated he wanted to remain seated for a few minutes.  He appeared to be light headed and dizzy and stated that this sometimes occurs after receiving vaccines.  Pharmacist stayed with patient and fanned him to help him stay cool.  Patient was taking deep breaths.  Pharmacist sent work associate to get patient a bottle of cold water to try to cool patient down.  Patient took a sip of water and immediately passed out.  This was approximately 5-8 minutes after vaccinations completed.  Pharmacist was standing in front of patient and his head fell into pharmacist.   Patient was unconscious for approximately 30 seconds.  Pharmacist called for associate assistance and off duty EMT shopping in store came to assist.  Local emergency assistance was called and arrived at pharmacy in about 10 minutes.  Patient's blood pressure was monitored and EKG was taken.   EMT staff stated at first patient blood pressure appeared low but within about 5 minutes returned to normal. Exact pressure was not provided to pharmacist.  EMT stated ekg appeared to be abnormal possibly indicating atrial fibrillation.  Patient refused to go to hospital and left on own approximately 40 minutes after receiving vaccines.  Pharmacy staff checked on patient later same day and following day and patient reports feeling fine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Significant Dermatographia. I thought it was an allergic reaction at first.
Age: 92.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: large, red, hot to touch area and swelling around injection site.  patient was advised to see dr.  patient given cephalexin 500mg capsules for 1 week , no further problems reported
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: first sign of tinnitus after 14-30 days
Age: 71.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Medication was already constituted but was accidently reconstituted by adding 0.7 ml of sterile diluent before administration in which 1.3 ml was given to the patient. The full amount of the 0.5ml of Menquadfi was delivered in addition to the 0.7 ml of sterile diluent.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Patient was administered an additional dose of tdap and varicella. The first doses of tdap and varicella were initially administered 1/29/25. Due to an error of verification from a medical assistant, the patient received another dose of tdap and varicella on 2/4/25. Patients mother reported patient to have fever as a side effect which occurred 2/4/25. Patients mother reported fever to last only 3 days. Patients mother gave tylenol to help with fever. Patients mother reported patient to have overcome fever.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received an accidental second dose of this vaccination. Patient received the first dose on 10/10/2023, and the accidental second dose was given 2/10/2025. Per staff working that day, the first dose was not visible in our state immunization registry, making it appear as though she was due for this dose.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cancer surgery, Chemotherapy, Haematuria, Ureteric cancer
Clinical narrative: Pt had bloody urine.  Went to ER. Diagnosed with ureter high grade cancer needing chemo and surgery.  I work at a cancer hospital and I've seen a large rise in cancer after people are taking the covid shots
Age: 4.0
Sex: F
Vaccine: FLU3, HEP, HEPA, MMRV
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Patient was administered an additional dose of MMRV and hep B. The first doses of MMR and varicella were initially administered 1/29/25. Due to an error of verification from a medical assistant, the patient received another dose of MMRV and hep B on 2/4/25. Patients mother reported patient to have fever as a side effect which occurred 2/4/25. Patients mother reported fever to last only 3 days. Patients mother gave Tylenol to help with fever. Patients mother reported patient to have overcome fever.
Age: 84.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Biopsy prostate abnormal, Bone cancer, Bone scan abnormal, Cachexia, Death
Clinical narrative: "turbo" prostate & bone cancer - hormone therapy from 2022-2023 (about 10 months) - severe pain, wasting away (lost over 100 pounds), muscle loss, rapid mental decline, personality changes
Age: 84.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Mental impairment, Muscle atrophy, Pain, Personality change, Positron emission tomogram prostate
Clinical narrative: "turbo" prostate & bone cancer - hormone therapy from 2022-2023 (about 10 months) - severe pain, wasting away (lost over 100 pounds), muscle loss, rapid mental decline, personality changes
Age: 84.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Prostate cancer, Prostatic specific antigen increased, Weight decreased
Clinical narrative: "turbo" prostate & bone cancer - hormone therapy from 2022-2023 (about 10 months) - severe pain, wasting away (lost over 100 pounds), muscle loss, rapid mental decline, personality changes
Age: 38.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Within 24 hours, my right arm at the vaccination site was inflamed, red, hot to the touch and very itchy.
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: *Inadvertently given Tdap vaccine rather than Dtap appropriate for her age. Parents notified.  This is the child's 4th dose. CDC says this would be considered invalid and the child would need to be immunized with Dtap.  Immunize site  states "Tdap given to a child younger than age 7 years as either dose 4 or 5 can be counted as valid for Dtap dose 4 or 5."
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Angiogram normal, Discomfort, Electromyogram abnormal, Injected limb mobility decreased, Magnetic resonance imaging normal
Clinical narrative: Patient had unusual pain in her right arm following the HPV vaccine along with decreased mobility. This lasted for approximately 4-6 weeks. I thought it was just vaccine soreness and as we were getting ready to follow up to check on this, the pain and mobility issues began to subside so we did not schedule. She did continue to complain of a muscle spasm in her neck with discomfort. We mentioned this at her 2023 well child visit, but the doctor said it was probably just from her looking down at her phone or something. Late fall (2023), we noticed drooping in her shoulder. Unaware of what it was from or what was wrong, we started off with a chiropractor (2 visits). This was of zero benefit so we started OMT in January 2024. After a few sessions, the doctor determined it was in fact her trap muscle vs an alignment issue. We were referred to a local orthopedic doctor (Dr) who then referred us for the first of 2 EMGs. This concluded her spinal accessory nerve was not functioning. We attempted physical therapy with nerve stimulation, but nothing was helping. At this point, we were starting into summer of 2024. An MRI was ordered to confirm no tumors or masses compressing the nerve, there was not. We were then referred to an orthopedic doctor specializing in brachial plexus (Dr). We had a second EMG completed. He sent us to hospital for a neurography to check for hour glass constrictions in her nerve. The radiologist concluded it had most likely been to long to see the constrictions. Dr felt confident her diagnosis was Parsonage Turner Syndrome due to her HPV vaccine (autoimmune response), but we needed to do our due diligence and rule everything out. She had a group of vessels noted on the neurography so we were referred to a neurosurgeon and had an angiogram completed to see if that was an issue. This was determined to be nothing and not contributory at all. At this point, it was November of 2024. Dr determined she would not recover at all due to the extensive and severe muscle deterioration in her trapezius and sternocleidomastoid muscles. It was causing pronounced muscle weakness and scapular winging which in turn caused forward shoulder rotation. She was experiencing a lot of stiffness, pain, and discomfort. Since her scapula had very little support due to trap muscle deterioration, she had to have a triple muscle transfer on 1/13/25. We were informed she would never recover and this was strictly a surgery to help deal with the damage. She will have lifelong damage and complications.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Magnetic resonance neurography, Muscle atrophy, Muscle disorder, Muscle spasms, Muscular weakness
Clinical narrative: Patient had unusual pain in her right arm following the HPV vaccine along with decreased mobility. This lasted for approximately 4-6 weeks. I thought it was just vaccine soreness and as we were getting ready to follow up to check on this, the pain and mobility issues began to subside so we did not schedule. She did continue to complain of a muscle spasm in her neck with discomfort. We mentioned this at her 2023 well child visit, but the doctor said it was probably just from her looking down at her phone or something. Late fall (2023), we noticed drooping in her shoulder. Unaware of what it was from or what was wrong, we started off with a chiropractor (2 visits). This was of zero benefit so we started OMT in January 2024. After a few sessions, the doctor determined it was in fact her trap muscle vs an alignment issue. We were referred to a local orthopedic doctor (Dr) who then referred us for the first of 2 EMGs. This concluded her spinal accessory nerve was not functioning. We attempted physical therapy with nerve stimulation, but nothing was helping. At this point, we were starting into summer of 2024. An MRI was ordered to confirm no tumors or masses compressing the nerve, there was not. We were then referred to an orthopedic doctor specializing in brachial plexus (Dr). We had a second EMG completed. He sent us to hospital for a neurography to check for hour glass constrictions in her nerve. The radiologist concluded it had most likely been to long to see the constrictions. Dr felt confident her diagnosis was Parsonage Turner Syndrome due to her HPV vaccine (autoimmune response), but we needed to do our due diligence and rule everything out. She had a group of vessels noted on the neurography so we were referred to a neurosurgeon and had an angiogram completed to see if that was an issue. This was determined to be nothing and not contributory at all. At this point, it was November of 2024. Dr determined she would not recover at all due to the extensive and severe muscle deterioration in her trapezius and sternocleidomastoid muscles. It was causing pronounced muscle weakness and scapular winging which in turn caused forward shoulder rotation. She was experiencing a lot of stiffness, pain, and discomfort. Since her scapula had very little support due to trap muscle deterioration, she had to have a triple muscle transfer on 1/13/25. We were informed she would never recover and this was strictly a surgery to help deal with the damage. She will have lifelong damage and complications.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Neuralgic amyotrophy, Pain, Pain in extremity
Clinical narrative: Patient had unusual pain in her right arm following the HPV vaccine along with decreased mobility. This lasted for approximately 4-6 weeks. I thought it was just vaccine soreness and as we were getting ready to follow up to check on this, the pain and mobility issues began to subside so we did not schedule. She did continue to complain of a muscle spasm in her neck with discomfort. We mentioned this at her 2023 well child visit, but the doctor said it was probably just from her looking down at her phone or something. Late fall (2023), we noticed drooping in her shoulder. Unaware of what it was from or what was wrong, we started off with a chiropractor (2 visits). This was of zero benefit so we started OMT in January 2024. After a few sessions, the doctor determined it was in fact her trap muscle vs an alignment issue. We were referred to a local orthopedic doctor (Dr) who then referred us for the first of 2 EMGs. This concluded her spinal accessory nerve was not functioning. We attempted physical therapy with nerve stimulation, but nothing was helping. At this point, we were starting into summer of 2024. An MRI was ordered to confirm no tumors or masses compressing the nerve, there was not. We were then referred to an orthopedic doctor specializing in brachial plexus (Dr). We had a second EMG completed. He sent us to hospital for a neurography to check for hour glass constrictions in her nerve. The radiologist concluded it had most likely been to long to see the constrictions. Dr felt confident her diagnosis was Parsonage Turner Syndrome due to her HPV vaccine (autoimmune response), but we needed to do our due diligence and rule everything out. She had a group of vessels noted on the neurography so we were referred to a neurosurgeon and had an angiogram completed to see if that was an issue. This was determined to be nothing and not contributory at all. At this point, it was November of 2024. Dr determined she would not recover at all due to the extensive and severe muscle deterioration in her trapezius and sternocleidomastoid muscles. It was causing pronounced muscle weakness and scapular winging which in turn caused forward shoulder rotation. She was experiencing a lot of stiffness, pain, and discomfort. Since her scapula had very little support due to trap muscle deterioration, she had to have a triple muscle transfer on 1/13/25. We were informed she would never recover and this was strictly a surgery to help deal with the damage. She will have lifelong damage and complications.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Posture abnormal, Tendon transfer, Winged scapula
Clinical narrative: Patient had unusual pain in her right arm following the HPV vaccine along with decreased mobility. This lasted for approximately 4-6 weeks. I thought it was just vaccine soreness and as we were getting ready to follow up to check on this, the pain and mobility issues began to subside so we did not schedule. She did continue to complain of a muscle spasm in her neck with discomfort. We mentioned this at her 2023 well child visit, but the doctor said it was probably just from her looking down at her phone or something. Late fall (2023), we noticed drooping in her shoulder. Unaware of what it was from or what was wrong, we started off with a chiropractor (2 visits). This was of zero benefit so we started OMT in January 2024. After a few sessions, the doctor determined it was in fact her trap muscle vs an alignment issue. We were referred to a local orthopedic doctor (Dr) who then referred us for the first of 2 EMGs. This concluded her spinal accessory nerve was not functioning. We attempted physical therapy with nerve stimulation, but nothing was helping. At this point, we were starting into summer of 2024. An MRI was ordered to confirm no tumors or masses compressing the nerve, there was not. We were then referred to an orthopedic doctor specializing in brachial plexus (Dr). We had a second EMG completed. He sent us to hospital for a neurography to check for hour glass constrictions in her nerve. The radiologist concluded it had most likely been to long to see the constrictions. Dr felt confident her diagnosis was Parsonage Turner Syndrome due to her HPV vaccine (autoimmune response), but we needed to do our due diligence and rule everything out. She had a group of vessels noted on the neurography so we were referred to a neurosurgeon and had an angiogram completed to see if that was an issue. This was determined to be nothing and not contributory at all. At this point, it was November of 2024. Dr determined she would not recover at all due to the extensive and severe muscle deterioration in her trapezius and sternocleidomastoid muscles. It was causing pronounced muscle weakness and scapular winging which in turn caused forward shoulder rotation. She was experiencing a lot of stiffness, pain, and discomfort. Since her scapula had very little support due to trap muscle deterioration, she had to have a triple muscle transfer on 1/13/25. We were informed she would never recover and this was strictly a surgery to help deal with the damage. She will have lifelong damage and complications.
Age: 1.58
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: An additional dose was given. PCP was informed what happened.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Head discomfort, Headache, Hyperacusis, Photophobia
Clinical narrative: The day after the second vaccination, I woke up with extreme sensitivity to light in my left eye and to sound in my left ear. It was extremely painful. The pain was about the size of a CD on the left side of my head. It felt as though my skull was swelling and might explode. I was also off balance and had a tremor in my left hand. This lasted for weeks and then gradually became less. The light and sound sensitivity flares up from time to time - maybe once a month or so. The balance problems and tremor remain.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: The day after the second vaccination, I woke up with extreme sensitivity to light in my left eye and to sound in my left ear. It was extremely painful. The pain was about the size of a CD on the left side of my head. It felt as though my skull was swelling and might explode. I was also off balance and had a tremor in my left hand. This lasted for weeks and then gradually became less. The light and sound sensitivity flares up from time to time - maybe once a month or so. The balance problems and tremor remain.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Dementia, General physical health deterioration, Wheelchair user
Clinical narrative: Several months after her one and only Pfizer Covid shot & its booster 2 weeks later, my Mom's issues from old age accelerated rapidly. She became wheelchairbound instead of using a walker, with fast-onset dementia, culminating in a series of small strokes beginning 8/12/22, leading to her death on 8/29/22. I have video of the balcony visits' allowed during Covid before the vaccine rollout, and you can see, although elderly, she was cognizant and present in mind. Several months after the shot/booster, she was declining in an unnatural and alarming way.
Sex: M
Vaccine: MMRV
Symptoms: Amblyopia, Autism spectrum disorder, Behaviour disorder, Blood bilirubin increased, Delayed dark adaptation
Clinical narrative: I don't remember which shots. But the nurse took patient from me - after he had latched on perfectly and fed, and the nurse said how cute he was - to give him his shots'. They were the newborn shots required on 11/04/04. About 20 - 30 minutes later she ran into my room breathless, said he had trouble breathing, had bilirubin and had been moved to the ICU, and was there until 11/09/2004. He had eye issues & surgeries ages 18 months & 5 years, sleeping issues, darkness issues, behavioral issues, learning issues, and was finally diagnosed at age 5 1/2 with moderate/severe autism by Dr Health Clinic.
Sex: M
Vaccine: MMRV
Symptoms: Dyspnoea, Eye disorder, Eye operation, Intensive care, Learning disorder
Clinical narrative: I don't remember which shots. But the nurse took patient from me - after he had latched on perfectly and fed, and the nurse said how cute he was - to give him his shots'. They were the newborn shots required on 11/04/04. About 20 - 30 minutes later she ran into my room breathless, said he had trouble breathing, had bilirubin and had been moved to the ICU, and was there until 11/09/2004. He had eye issues & surgeries ages 18 months & 5 years, sleeping issues, darkness issues, behavioral issues, learning issues, and was finally diagnosed at age 5 1/2 with moderate/severe autism by Dr Health Clinic.
Sex: M
Vaccine: MMRV
Symptoms: Sleep disorder
Clinical narrative: I don't remember which shots. But the nurse took patient from me - after he had latched on perfectly and fed, and the nurse said how cute he was - to give him his shots'. They were the newborn shots required on 11/04/04. About 20 - 30 minutes later she ran into my room breathless, said he had trouble breathing, had bilirubin and had been moved to the ICU, and was there until 11/09/2004. He had eye issues & surgeries ages 18 months & 5 years, sleeping issues, darkness issues, behavioral issues, learning issues, and was finally diagnosed at age 5 1/2 with moderate/severe autism by Dr Health Clinic.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event at the time of administered
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16-SEP-2022, batch no XM22G with expiry date 31-AUG-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: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-FEB-2025 The pharmacist called to informed that till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. This case had been linked to the case US2025017230, reported by the same reporter.; Sender's Comments:  US-GSK-US2025017230:same reporter
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient complaing of pain and swollen at injection site (R) arm. MCV- L ARM- TDAP- L ARM HPV R ARM
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: patient has ongoing tinnitis (ringing in the ear) since vaccination. Provider has ruled out other causes. Believes it may be attributed to Covid vaccination.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nasopharyngitis, Sudden death
Clinical narrative: Patient had a cold.    We did not know that he had covid.     At that time we did  not have our own vehicle to go to hospital and people in the area did not want to  take a chance to transport us to the nearest hospital.   He just complaint that he had breathing difficulty and before I could call an ambulance, he suddenly passed away at home on 08/27/2022
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This spontaneous report received from a consumer concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid-19 prophylaxis. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot. (Dose series 1). Patient's spouse reported that way back during the days of Covid, the patient got the Johnson and Johnson vaccine and shortly, he got blood clot from it. The doctors said it was probably caused by the vaccine he took. The action taken with janssen covid-19 vaccine was not applicable.  The outcome of blood clot was not reported.  This report was serious (other medically important condition).; Sender's Comments: V0:Thrombosis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2025, the patient received the 1st dose of Shingrix. In JAN-2025, 1 day after receiving Shingrix, the patient experienced tiredness (Verbatim: tiredness). The outcome of the tiredness was resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.     It was unknown if the company considered the tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that she was vaccinated for the first of two shingles vaccines a couple of weeks ago.  The only issue she had was tiredness the following day.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: adjuvant only administered; only the adjuvant portion of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number G97Y2, expiry date 15-NOV-2026) for prophylaxis.   On 06-FEB-2025, the patient received Shingrix. On 06-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant only administered) and inappropriate dose of vaccine administered (Verbatim: only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-FEB-2025 The patient received only the adjuvant portion of Shingrix, which led inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: States a male patient received three doses of SHINGRIX; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 10th September 2020) and Shingrix (received 2nd dose of Shingrix vaccine on 17th November 2020).   On 10-FEB-2025, the patient received the 3rd dose of Shingrix. On 10-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: States a male patient received three doses of SHINGRIX). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-FEB-2025 The Healthcare professional was the reporter states that a male patient received three doses of Shingrix, extra dose, which led to extra dose administered. 1st dose was administered on 10-SEP-2020, 2nd dose was administered on 17-NOV-2020 and 3rd dose was received on 10-FEB-2025. No further information was provided including lot number, route or site of administration.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received 2-doses of HIB in the same day with no reported adverse event; received PENTACEL and ACTHIB at their appointment and they should have gotten DTAP and ACTHIB with no reported adverse event; Initial information received on 06-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who received 2-doses of hib in the same day with no reported adverse event and received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero) and hib (prp/t) vaccine [ACT-HIB] at their appointment and they should have gotten diphtheria, tetanus and acellular pertussis vaccine and hib (prp/t) vaccine [ACT-HIB] 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  (Pneumococcal Vaccine Conj 20V (CRM197).  On 30-Jan-2025, the patient received 0.5 mL of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in the right thigh, received 0.5mL dose of suspect hib (prp/t) vaccine, powder and solvent for solution for injection via unknown route in the left thigh,both for Prophylactic vaccination (Immunisation) and  received 2-doses of hib in the same day with no reported adverse event (extra dose administered) and received pentacel and acthib at their appointment and they should have gotten diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer, unknown formulation and acthib with no reported adverse event (wrong product administered) (latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  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: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Increased bronchial secretion, Myalgia, Oxygen saturation decreased
Clinical narrative: Spike in HR into 140-150s, fever ranging from 101-103, severe difficulties breathing that even breathing treatments and 4L of O2 are not able to bring her saturations above 90%, several seizures, shaking, muscle pain, copious secretions - all of these began roughly 16 hours after vaccine, she was perfectly healthy with zero symptoms beforehand
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Seizure, Tremor
Clinical narrative: Spike in HR into 140-150s, fever ranging from 101-103, severe difficulties breathing that even breathing treatments and 4L of O2 are not able to bring her saturations above 90%, several seizures, shaking, muscle pain, copious secretions - all of these began roughly 16 hours after vaccine, she was perfectly healthy with zero symptoms beforehand
Sex: U
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: muscle ache after administering Arexvy; This non-serious case was reported by a physician via sales rep and described the occurrence of muscle pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscle pain (Verbatim: muscle ache after administering Arexvy). The outcome of the muscle pain was not reported.   It was unknown if the reporter considered the muscle pain to be related to Arexvy.     It was unknown if the company considered the muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-DEC-2024 The physician reported that a patient received Arexvy vaccine and experienced muscle pain. The doctor got Arexvy vaccine and that said similar adverse event to Shingrix muscle aches. She said checks/makes sure patient get vaccines wants her to have health care professional guide.  The doctor had patient who was copay too high on Arexvy.  Gave co-pay card and she was going to call patient to came get it.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Night sweats, Pain in extremity
Clinical narrative: reports beginning to feel, "not well"; sore arm; feel, "not well" specifically, feeling "hot and cold. don't know whether cold... mainly cold" (later described as chills); feeling "extreme tiredness/"too tired; night sweats; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (night sweats), MALAISE (reports beginning to feel, "not well"), PAIN IN EXTREMITY (sore arm), CHILLS (feel, "not well" specifically, feeling "hot and cold. don't know whether cold... mainly cold" (later described as chills)) and FATIGUE (feeling "extreme tiredness/"too tired) in a 95-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Feb-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Feb-2025, the patient experienced NIGHT SWEATS (night sweats), PAIN IN EXTREMITY (sore arm), CHILLS (feel, "not well" specifically, feeling "hot and cold. don't know whether cold... mainly cold" (later described as chills)) and FATIGUE (feeling "extreme tiredness/"too tired). On 03-Feb-2025, the patient experienced MALAISE (reports beginning to feel, "not well"). At the time of the report, NIGHT SWEATS (night sweats), PAIN IN EXTREMITY (sore arm), CHILLS (feel, "not well" specifically, feeling "hot and cold. don't know whether cold.. mainly cold" (later described as chills)) and FATIGUE (feeling "extreme tiredness/"too tired) had not resolved and MALAISE (reports beginning to feel, "not well") outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no relevant medical history within the past 4 weeks. No concomitant medications were provided. Following the vaccination, patient experienced armed soreness from Saturday through Monday. On Monday, she began to feel unwell, describing sensations of alternating hot and cold, which was later identified as chills.  Although this feeling subsided that night, her condition had progressively worsened since then. Additionally, she was experiencing night sweats, necessitating a changed of bedsheets that morning, and expressed feelings of extreme fatigue, stating that she was too tired to visit a doctor. No treatment medication was provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child received covid vaccine on 2/12/25 when he had already gotten on 10/19/2024 Dr spoke to parent aware of additional vaccine site. No adverse effects reported today 2/13/25
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: red itchy rash to face, torso and bilateral arms
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: Patient and her mother came in for vaccines. The mother was to get RSV and the daughter Flu and Covid. I accidently gave the RSV to the daughter, who is 64. When I spoke to the daughter and told her what happened she was fine with it as she wanted to get the RSV vaccine anyway.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram head, Fall, Head injury, Seizure
Clinical narrative: HAD A SEIZURE AND FELL OF THE EXAM TABLE
Age: 36.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Wrong product administered
Clinical narrative: INCORRECT GIVEN IN THE SERIES.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: No significant adverse events, other than sore arm
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Fever and chills 12 hours.  Extreme fatigue 2 days.  Loss of appetite.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: right shoulder pain
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: pt says the injection really hurt when it was given. Later that day the pain in the right arm became worse. He went to his PCP Dr and was given Naproxen and was referred to ortho Dr. Ortho doctor gave him steroid shot and prescribed PT. He is still in physical therapy but continues to have pain. He will see the doctor again in a couple of weeks and is hoping he will help him find a way to help with the pain as he continues to suffer.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted immediately after receiving influenza and HPV vaccines.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal disorder, Anti-melanoma differentiation-associated protein 5 antibody positive, Autoimmune disorder, Fatigue, Liver disorder
Clinical narrative: I just started not feeling well after the vaccine and it just got worse over the year.  Extreme tiredness, muscle pain and weakness, I had rash on face and neck, can not be out in the sun, different organs were affected at different times (Adrenal glands, kidney, liver, lung nodules).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness, Myalgia, Photosensitivity reaction, Pulmonary mass
Clinical narrative: I just started not feeling well after the vaccine and it just got worse over the year.  Extreme tiredness, muscle pain and weakness, I had rash on face and neck, can not be out in the sun, different organs were affected at different times (Adrenal glands, kidney, liver, lung nodules).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Renal disorder
Clinical narrative: I just started not feeling well after the vaccine and it just got worse over the year.  Extreme tiredness, muscle pain and weakness, I had rash on face and neck, can not be out in the sun, different organs were affected at different times (Adrenal glands, kidney, liver, lung nodules).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure immeasurable, Death, Dyspnoea, Pulse abnormal
Clinical narrative: on 02/06/2025 At around 620, routine rounds made and shortness of breath noted. LN tried to obtain BP but unable to obtain. Pulse very faint and respiration at 12. Within minutes, resident was gasping for air. RN in the building called to assess resident and no vitals signs observed. Resident Expired. Son arrived and Hospice was called to send RN.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Patient came to pharmacy on 2/7/25 complaining of itching on arm and a reddish (not bumpy) rash on area of injection site.  The size of the rash is oval and 6 inches long protruding from injection site  and down.  She reported no sign of systemic side effects such as shortness of breath or wheezing.   I advised her to call her doctor for approval for a second dose.  Based on my  professional judgment, I told her she should not get the second dose due to allergic reaction.  I told her to let her know if the itching get worse or if the rash is spreading.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pruritus, Pyrexia, Rash
Clinical narrative: High fever 103.9, rash to torso, itching, increased fatigue
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Patient received vaccine and began experiencing arm/shoulder pain. Patient endorses persistent soreness that worsened over 3 weeks; patient unable to lift arm without assistance. Patient has taken Advil and rested arm/shoulder without relief. Patient was evaluated by PCP 2/7 for ongoing pain and was prescribed naproxen and referred to sports medicine.
Age: 29.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Discomfort, Erythema, Pruritus, Swelling
Clinical narrative: Swelling, itching, pressure build up under the skin. Redness
Age: 29.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Swelling, itching, pressure build up under the skin. Redness
Age: 29.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction, Skin irritation
Clinical narrative: Swelling, itching, pressure build up under the skin. Redness
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Cleared by doctor
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Cleared by doctor
Age: 27.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction, Skin irritation
Clinical narrative: Cleared by doctor
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Cough, Dizziness, Immune system disorder, Nausea
Clinical narrative: Patient was a healthy girl and  in one point in the middle of January she started to feel weak, and then I noticed that her immune system wasn?t  strong  like before, because she started to have symptoms as a sick person that last longer and  harder,  and then she start to have dizzy symptoms and  a sensation of throwing up , also vertigo and then she started with a cough That didn?t go away and she feel weak and she want to stay in bed . For like three weeks she started with all the symptoms, some go away, but then come back sometime that you have both in the same  time, and the only event that I recall that was different than normal routine was that vaccine that she take on January. I went to the doctor on February 12 and I report that to them and they don?t consider my observation and they want to give her medication for Her dizziness.. I refuse that treatment because they don?t know the cause of what happens to her they they don?t consider my opinion about all this symptom that  starting after the vaccine or like a week or two weeks after the vaccine , so I don?t know if this is a side effect of the vaccine, but I think is good to report this .  Thanks
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Vertigo
Clinical narrative: Patient was a healthy girl and  in one point in the middle of January she started to feel weak, and then I noticed that her immune system wasn?t  strong  like before, because she started to have symptoms as a sick person that last longer and  harder,  and then she start to have dizzy symptoms and  a sensation of throwing up , also vertigo and then she started with a cough That didn?t go away and she feel weak and she want to stay in bed . For like three weeks she started with all the symptoms, some go away, but then come back sometime that you have both in the same  time, and the only event that I recall that was different than normal routine was that vaccine that she take on January. I went to the doctor on February 12 and I report that to them and they don?t consider my observation and they want to give her medication for Her dizziness.. I refuse that treatment because they don?t know the cause of what happens to her they they don?t consider my opinion about all this symptom that  starting after the vaccine or like a week or two weeks after the vaccine , so I don?t know if this is a side effect of the vaccine, but I think is good to report this .  Thanks
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic cirrhosis, Platelet count decreased, Transfusion, Vascular graft
Clinical narrative: Two doses were received.  First on 2/20/2021, second on 3/20/2021.  Blood platelets were normal until CBC on 9/13/2021.  They remain low (between 135 and 93)  All were within normal range as of 08/31/2021.  Additional vaccinations were done on 10/12/2021 & 4/27/2022
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Headache
Clinical narrative: Chills, muscle pain, body aches, joint pain, headache, fever, fatigue, pain at injection site - about 12 hours after second dose and lasted for 24 hours. Pain/tenderness in right armpit, swollen lymph node in right armpit- about 48 hours after the second dose lasting over 24 hours.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lymphadenopathy, Myalgia, Pain, Pyrexia
Clinical narrative: Chills, muscle pain, body aches, joint pain, headache, fever, fatigue, pain at injection site - about 12 hours after second dose and lasted for 24 hours. Pain/tenderness in right armpit, swollen lymph node in right armpit- about 48 hours after the second dose lasting over 24 hours.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: This was patient's 2nd time receiving the same vaccine and guideline recommends only 1.  The first vaccine was on 9/13/24 and the second on 2/11/25. Patient is having no symptoms.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chest discomfort, Decreased appetite, Dizziness, Ileus paralytic
Clinical narrative: Sequentially related symptoms and duration of same: sore throat (two days), nausea and retching (8 hours), chest tightness (two days), wheezing (one day), paralytic ileum with significant right upper quadrant colicky pain along with inability to pass gasses either upward or downward the GI tract (three days), lightheadedness (3 days), anorexia (three days.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Wheezing
Clinical narrative: Sequentially related symptoms and duration of same: sore throat (two days), nausea and retching (8 hours), chest tightness (two days), wheezing (one day), paralytic ileum with significant right upper quadrant colicky pain along with inability to pass gasses either upward or downward the GI tract (three days), lightheadedness (3 days), anorexia (three days.
Age: 18.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt called clinic on 2/11/25 around 8/8:30 a.m. to report "left arm soreness at injection site, restricted movement of left arm, and left arm numbness." Pt stated she did not have numbness or tingling in her lower extremities or right arm. Encouraged pt to monitor site as all symptoms should resolve within 1-2 days but encouraged her to follow up with ER if symptoms did not resolve or if they worsened. I called pt to check on her on 2/11/25 around 4:30 p.m. and on 2/13/25 around 1:00 p.m. but pt did not answer her phone.
Age: 1.08
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Multiple people administering vaccines. Patient received Proquad (unclear of lot and administration site), MMR II, and varicella vaccine on 1/30/2025. No adverse reactions noted.
Age: 73.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Fall, Head injury
Clinical narrative: after getting the vaccines, the patient walked to the bathroom, then came back to the pharmacy saying she fell forward and hit her head on the bathroom door.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient received vaccine @2:45 pm in our clinic.   Patient returned to clinic @ 4:33 pm complaining of bilateral facial numbness, assessed by physician on site at 4:35 pm  Vitals were taken on the patient BP 157/88 PULSE 107 Resp : 20 o2 sat. 99%.  At 4:42 BP re-asessed BP: 147/85 ,4:47 pm,Doctor  ordered epi-pen 0.3 mg injection and administered at 4:52.  Vital signs re-asessed at 5:02 BP 147/76 PULSE 104 02 sat 94% reaassess in 10 min.   At 5:12 pm BP 136/73 PLUSE 100  Resp: 21 02 SAT 97%.  Patient feeling numbness resolved  and discharged home.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient stated that she experienced body aches, chills and sweating on the day of the vaccination 2/10/25. She reported to the pharmacy today 2/13/25,  her injection arm is still red (complete upper arm) and still feeling achy.