chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: mixed PENTACEL with the wrong diluent, instead of the Act-Hib component with no reported adverse event; Initial information received on 27-Aug-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves 4 years old male patient and reporter reported that diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was mixed with the wrong diluent, instead of the ACT-HIB component 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) (Prevnar 20); Hepatitis a vaccine (Hepatitis A); and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) (Proquad) all for Immunization.  On 26-Aug-2024, reporter reported that diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection with 0.5 ml dose  (lot UK017AA and expiry date: 30-Jun-2025), was mixed with the wrong diluent, instead of the ACT-HIB component and administered via intramuscular route in the left thigh for immunization with no reported adverse event (product preparation error) (latency - same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: inappropriate use due to administration of acthib that was reconstituted with sterile water instead of the recommended diluent with no reported adverse event; Initial information received on 29-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who had inappropriate use due to administration of HIB (PRP/T) Vaccine [ACT-HIB] that was reconstituted with sterile water instead of the recommended diluent 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 Hepatitis a vaccine (Hepatitis A) for Immunisation; and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (DTaP vaccine) for Immunisation.  On 28-Aug-2024, the patient received a  dose of 0.5 ml of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UK036AA, Expiry date: 30-Jun-2025, frequency:once, strength : standard) via intramuscular route in left lower thigh for Immunization and inappropriate use due to administration of acthib that was reconstituted with sterile water instead of the recommended diluent with no reported adverse event (product preparation error) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: inappropriate use due to pentacel and vaxelis being administered at the same day/time resulting to patient receiving DTAP-IPV-HIB components with no reported adverse event; Initial information received on 29-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old female patient with inappropriate use due to Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] And Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) being administered at the same day/time resulting to patient receiving dtap-ipv-hib components 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) (Prevnar 20) and Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for Immunisation.  On 29-Aug-2024, the patient received suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine,  0.5 ml (1x) (once), Suspension for injection lot UJ985AA expiry date- 14-Feb-2025 via intramuscular route in the left thigh and VAXELIS not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation) (strength unknown) being administered at the same day/time resulting to patient receiving dtap-ipv-hib components with no reported adverse event (extra dose administered) (latency same day).  Reportedly, Nurse also confirmed that it was supposed to be Varicella to be administered but they have given the VAXELIS instead   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: 1.5
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: inappropriate use due to pentacel and vaxelis being administered at the same day/time resulting to patient receiving DTAP-IPV-HIB components with no reported adverse event; Initial information received on 29-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old female patient with inappropriate use due to Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] And Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) being administered at the same day/time resulting to patient receiving dtap-ipv-hib components 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) (Prevnar 20) and Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for Immunisation.  On 29-Aug-2024, the patient received suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine,  0.5 ml (1x) (once), Suspension for injection lot UJ985AA expiry date- 14-Feb-2025 via intramuscular route in the left thigh and VAXELIS not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation) (strength unknown) being administered at the same day/time resulting to patient receiving dtap-ipv-hib components with no reported adverse event (extra dose administered) (latency same day).  Reportedly, Nurse also confirmed that it was supposed to be Varicella to be administered but they have given the VAXELIS instead   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.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: the pharmacist looked at me and she said you are not a candidate for shingles shot; This spontaneous report was received from a consumer concerning a female patient of unknown age. Patient's concurrent conditions included asthma and high blood pressure. Patient's concomitant therapies and pertinent medical history were not provided.  On an unknown date, the patient was prescribed with zoster vaccine live (ZOSTAVAX) (reported as shingles vaccine) subcutaneous injection, for prophylaxis (strength, dose, frequency, lot #, expiry date, route of administration, and anatomical location were not provided), however the pharmacist told her that she was not a candidate because of her age (inappropriate prescribing).
Sex: U
Vaccine: MENB
Symptoms: Syringe issue
Clinical narrative: when she was screwing the cap off the syringe, the entire glass tip of the syringe broke off; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Lot number: GX1463, Expiration Date: 30Jun2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), described as "when she was screwing the cap off the syringe, the entire glass tip of the syringe broke off".  Additional information: The reporter went out and took out a pre-filled syringe from the TRUMENBA box and it was faulty. When she was screwing the cap off the syringe, the entire glass tip of the syringe broke off. The syringe was not administered to any patient.   The reporter considered "when she was screwing the cap off the syringe, the entire glass tip of the syringe broke off" not related to meningococcal group b Rlp2086. Causality for "when she was screwing the cap off the syringe, the entire glass tip of the syringe broke off" was determined associated to device constituent of meningococcal group b Rlp2086 (malfunction).
Sex: M
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: bust opened on him; when he tried to administered one of the vaccine, bust opened on him when he tried to pressed the plunger down to the bottom/No patient missed anything; The whole bottom of it just cracked open; This is a spontaneous report received from a Pharmacist.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: LN5486, Expiration Date: Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), described as "bust opened on him"; DEVICE LEAKAGE (non-serious), described as "when he tried to administered one of the vaccine, bust opened on him when he tried to pressed the plunger down to the bottom/No patient missed anything"; DEVICE BREAKAGE (non-serious), described as "The whole bottom of it just cracked open". The action taken for rsv vaccine prot.subunit pref 2v was unknown.  Additional information: The pharmacist stated that when he tried to administered one of the vaccine, bust opened on him when he tried to pressed the plunger down to the bottom. This happened while he tried to press the plunger down to the bottom. The whole bottom of it just cracked open. So, he still had the vial in the box and done hundreds of these and that was the first time. Patient did not miss anything. Everything was fine. They just pulled down another vial; they had some spares. So, everything was good. When probed for the lot number for the syringe, reporter stated, they did not have a syringe, it busted before. The sample of the product was available to be returned; but it was a broken vial inside the box that it came in.  Causality for "bust opened on him", "when he tried to administered one of the vaccine, bust opened on him when he tried to pressed the plunger down to the bottom/no patient missed anything" and "the whole bottom of it just cracked open" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 27.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Urticaria
Clinical narrative: Hives all over body
Age: 66.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Disorientation, Dizziness, Fall, Gaze palsy, Hyperhidrosis
Clinical narrative: Patient received his Fluzone HD, which was the first time he was receiving the HD, previously he has always received the regular dose flu shot.  He also received the Spikevax '24-25.  After vaccination, he was alert and conversive.  We talked in the vaccination room for about 1 minute after he received his vaccinations.  I opened the door for him and let him know that it would be a few minutes before calling his wife for her vaccinations.  Approximately 5-10 minutes after leaving the vaccination room, there was a call for a pharmacist as there was a patient having a vaccine reaction on the bench.  When I arrived by his side, the patient's wife was supporting him on the bench, calling his name but the patient wasn't responsive at that time.  I helped to steady the patient as he was sliding down on the bench.  His eyes had an upward stare.  He kept sliding on the bench and wasn't responding so the patient's wife and I lowered him to the ground.  The patient's head was protected at all times by his wife.  Once on the ground, both his wife and I kept calling his name and rubbing his shoulders to arouse the patient.  He finally responded in a startled fashion.  He didn't know where he was for a few seconds and was sweating.  I observed the patient having nystagmus as he was reporting that he was dizzy. He became more conversant over time, but continued to be sweaty, dizzy, nauseated and shaky.  He has never had any vaccine reactions to any vaccines in the past.  He seemed to be nervous with the number of staff that responded and was shaking his legs.  His wife indicated that he has never had any seizures before. I asked him if he was controlling the shaking of his legs and he said that he was and was just nervous about what was happening to him.  I provided the patient with a bag in case he vomited, a cold/damp paper towel for the back of his neck to help with the nausea as well as a paper-towel covered ice pack for further cooling affect.  The patient and the patient's wife discussed that he would feel better going to the ER to be evaluated.  A coach brought a motorized cart over.  We assisted him to the cart as he was coherent at that time.  His wife went to the car to bring it to the front of the store.  A couple of supervisors and I walked along with him to the entrance ensuring his safety.  I continued applying the ice pack as the patient indicated that it was helping him.  He continued to remain sweaty as he drove the cart to the front of the store.  I provided the patient' wife with the NDC, lot number and expiration dates of both vaccines as requested.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Nausea, Nervousness, Nystagmus, Staring, Tremor
Clinical narrative: Patient received his Fluzone HD, which was the first time he was receiving the HD, previously he has always received the regular dose flu shot.  He also received the Spikevax '24-25.  After vaccination, he was alert and conversive.  We talked in the vaccination room for about 1 minute after he received his vaccinations.  I opened the door for him and let him know that it would be a few minutes before calling his wife for her vaccinations.  Approximately 5-10 minutes after leaving the vaccination room, there was a call for a pharmacist as there was a patient having a vaccine reaction on the bench.  When I arrived by his side, the patient's wife was supporting him on the bench, calling his name but the patient wasn't responsive at that time.  I helped to steady the patient as he was sliding down on the bench.  His eyes had an upward stare.  He kept sliding on the bench and wasn't responding so the patient's wife and I lowered him to the ground.  The patient's head was protected at all times by his wife.  Once on the ground, both his wife and I kept calling his name and rubbing his shoulders to arouse the patient.  He finally responded in a startled fashion.  He didn't know where he was for a few seconds and was sweating.  I observed the patient having nystagmus as he was reporting that he was dizzy. He became more conversant over time, but continued to be sweaty, dizzy, nauseated and shaky.  He has never had any vaccine reactions to any vaccines in the past.  He seemed to be nervous with the number of staff that responded and was shaking his legs.  His wife indicated that he has never had any seizures before. I asked him if he was controlling the shaking of his legs and he said that he was and was just nervous about what was happening to him.  I provided the patient with a bag in case he vomited, a cold/damp paper towel for the back of his neck to help with the nausea as well as a paper-towel covered ice pack for further cooling affect.  The patient and the patient's wife discussed that he would feel better going to the ER to be evaluated.  A coach brought a motorized cart over.  We assisted him to the cart as he was coherent at that time.  His wife went to the car to bring it to the front of the store.  A couple of supervisors and I walked along with him to the entrance ensuring his safety.  I continued applying the ice pack as the patient indicated that it was helping him.  He continued to remain sweaty as he drove the cart to the front of the store.  I provided the patient' wife with the NDC, lot number and expiration dates of both vaccines as requested.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient received his Fluzone HD, which was the first time he was receiving the HD, previously he has always received the regular dose flu shot.  He also received the Spikevax '24-25.  After vaccination, he was alert and conversive.  We talked in the vaccination room for about 1 minute after he received his vaccinations.  I opened the door for him and let him know that it would be a few minutes before calling his wife for her vaccinations.  Approximately 5-10 minutes after leaving the vaccination room, there was a call for a pharmacist as there was a patient having a vaccine reaction on the bench.  When I arrived by his side, the patient's wife was supporting him on the bench, calling his name but the patient wasn't responsive at that time.  I helped to steady the patient as he was sliding down on the bench.  His eyes had an upward stare.  He kept sliding on the bench and wasn't responding so the patient's wife and I lowered him to the ground.  The patient's head was protected at all times by his wife.  Once on the ground, both his wife and I kept calling his name and rubbing his shoulders to arouse the patient.  He finally responded in a startled fashion.  He didn't know where he was for a few seconds and was sweating.  I observed the patient having nystagmus as he was reporting that he was dizzy. He became more conversant over time, but continued to be sweaty, dizzy, nauseated and shaky.  He has never had any vaccine reactions to any vaccines in the past.  He seemed to be nervous with the number of staff that responded and was shaking his legs.  His wife indicated that he has never had any seizures before. I asked him if he was controlling the shaking of his legs and he said that he was and was just nervous about what was happening to him.  I provided the patient with a bag in case he vomited, a cold/damp paper towel for the back of his neck to help with the nausea as well as a paper-towel covered ice pack for further cooling affect.  The patient and the patient's wife discussed that he would feel better going to the ER to be evaluated.  A coach brought a motorized cart over.  We assisted him to the cart as he was coherent at that time.  His wife went to the car to bring it to the front of the store.  A couple of supervisors and I walked along with him to the entrance ensuring his safety.  I continued applying the ice pack as the patient indicated that it was helping him.  He continued to remain sweaty as he drove the cart to the front of the store.  I provided the patient' wife with the NDC, lot number and expiration dates of both vaccines as requested.
Age: 77.0
Sex: F
Vaccine: COVID19, RSV, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient didn't have any adverse reactions but she previously had arexvy in september 2023
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This patient who is 11 received Flublok which is only indicated in individuals 18 and over. I spoke with the mother 9/4 as well as the pediatrician. I have been unable to reach the mother or father since then. Sanofi Pasteur representative indicated that no adverse outcomes would be expected and that this should be considered a regular flu vaccine.
Age: 81.0
Sex: M
Vaccine: COVID19, RSV, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient didn't have any adverse reaction but he did receive arexvy in september 2023 and abrysvo in october 2023 before getting abrysvo again in august 2024
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash not severe
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain fog, Chills, Headache, Myalgia, Pain
Clinical narrative: Aches, Chills, Fever, Headache, Brain Fog, Muscle Soreness
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Aches, Chills, Fever, Headache, Brain Fog, Muscle Soreness
Age: 59.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was told by his doctor to get the RSV due to his daughter being pregnant. The patient was only 59 at the time and not eligible to receive this vaccine under the pharmacy's STANDING ORDER. The patient's doctor did not give him a patient specific Rx. The patient has been counseled that he was not eligible to receive it due to the fact that he was not yet 60. He was counseled that at this time the cdc recommends only 1 dose per lifetime, but these recommendations may change in the future. Patient had no adverse event.
Age: 51.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Hypotonia, Unresponsive to stimuli
Clinical narrative: After receiving the 4th short, I was talking to the patient while he was seated. He just slumped in his chair and would not respond to me calling his name. I opened the door and ask my tech to call 911. The wife came in and we both called his name again and he responded and said her was ok but shaky. His wife said that he always faints when getting a shot but he answered no on the question on the VAR. Patient had also not eaten all day except for a donut and coffee. The EMS checked him out and said he was ok but suggested that the wife drive home. I had tried to talk him out of getting 4 shots at once, however he said he had to have them for process on 12th.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site mass
Clinical narrative: PATIENT HAS A BUMP ON HIS UPPER LEFT ARM. PATIENT STATED IT DOES NOT HURT, AND HE DOES NOT EVEN FEEL THAT THERE IS A BUMP. HE SAID THAT THE BUMP WAS THERE AFTER HE GOT HIS SHOTS LAST YEAR IN AUGUST 2023. HE GOT 2 VACCINES ON 08/23/2023, AREXVY ON HIS RIGHT ARM AND FLUAD QUAD ON HIS LEFT ARM
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Inflammation and redness around injection site. Has persisted for 2 days after injection, at time of reporting
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was administered Flublok Trivalent instead of Fluzone Trivalent which is approved for ages 6 months to 18 years.  Discovered at facility level, and informed mother.  No adverse side effects reported and she thanked us for telling her of the error.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Feeling abnormal, Wheezing
Clinical narrative: patient reports by the time she got to her car she was wheezing really bad and "felt like i had run a marathon"
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: patient reports by the time she got to her car she was wheezing really bad and "felt like i had run a marathon"
Age: 63.0
Sex: M
Vaccine: COVID19, PNC20, UNK
Symptoms: Hypoaesthesia
Clinical narrative: patient is complaining of numbness in right hand that started after receiving vaccinations on 9/2/2024
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient given wrong Flu shot based off patient age, was given Fluzone HD instead of FluBlock 18+
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient came asking for a Flu shot, not realizing she received one in July. We did not catch it and administered a second Fluad vaccine.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt inadvertently given extra dose of TDAP too early. Previously received does April 2024. No known adverse event at this time
Age: 12.0
Sex: M
Vaccine: MNQ, UNK, UNK
Symptoms: Influenza like illness, Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Flu/cold like symptoms--runny nose, sore throat, fever, nasal congestion
Age: 12.0
Sex: M
Vaccine: MNQ, UNK, UNK
Symptoms: Rhinorrhoea
Clinical narrative: Flu/cold like symptoms--runny nose, sore throat, fever, nasal congestion
Age: 82.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Pruritus
Clinical narrative: Patient states that in the evening after receiving immunizations, that he started having intense itching starting in his shins, he stated that is spread to his hip and back, but did not notice any hives, states that he took a claritin tablet and a prednisone tablet at the helped resolved his symptoms, states they came back the next day while he was playing golf and took another claritin tablet, which again helped with the itching.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Sleep disorder, Tic
Clinical narrative: Severe vomiting starting in the middle of the night after vaccination still ongoing now, and new onset tics - moving head quickly while awake and asleep.  Both ongoing.
Age: 40.0
Sex: M
Vaccine: FLUC4, FLUC4, FLUC4
Symptoms: Extra dose administered
Clinical narrative: PATIENT GIVEN 2ND DOSE OF FLUCELVAX (INFLUENZA) VACCINE
Age: 40.0
Sex: M
Vaccine: FLUC4, FLUC4, FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: PATIENT GIVEN 2ND DOSE OF FLUCELVAX (INFLUENZA) VACCINE
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt came in for flu and RSV vaccines. Both vaccines went through insurance and were administered to the pt. Later on, we found out that pt had RSV vaccine last year. RSV vaccine according to the current guideline is only 1 shot per lifetime. Pt was informed that her administered vaccine was outside the guidelines. Pt indicated that he wants the vaccine because she has a high risk for getting rsv and this vaccine would give her more protection from getting the RSV infection.
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt came in for flu and RSV vaccines. Both vaccines went through insurance and were administered to the pt. Later on, we found out that pt had RSV vaccine last year. RSV vaccine according to the current guideline is only 1 shot per lifetime. Pt was informed that his administered vaccine was outside the guidelines. Pt indicated that he wants the vaccine because he has a history of leukemia cancer and this vaccine would give him more protection from getting the RSV infection.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient did not disclose she had already received a first dose last fall.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient wanted COVID vaccination
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dysphagia, Nausea, Rash, Swelling of eyelid
Clinical narrative: Multiple raised rashes over arms, legs, ankles, abdomen, chest, face. Swollen eye lids, difficulty swallowing, nausea, feeling faint. Symptoms started roughly 10 hrs after recieving.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash, Rash pruritic
Clinical narrative: GENERALIZED PRURITIC RASHES 2 DAYS AFTER VACCINATION. TREATED WITH BENADRYL 12.5 MG/5 ML 1.5 ML Q 8 HOURS FOR 7 DAYS, AND CALADRYL LOTION TID FOR 7 DAYS.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia, Rash
Clinical narrative: Second day had 102 fever with shivering chills, achy muscles, Fatigue, sore arm at injection site, third day had red rash all over trunk and welts on neck
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Second day had 102 fever with shivering chills, achy muscles, Fatigue, sore arm at injection site, third day had red rash all over trunk and welts on neck
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Back pain, Condition aggravated, Myalgia, Neck pain
Clinical narrative: Experiencing major muscle pain in back & neck! Started almost exactly 48 hours from the injection
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Bacillus test positive, Blood culture negative
Clinical narrative: Admit date: 9/3/2024  Discharge date: 9/5/24  Admitting Physician:   Attending Physician at the Time of Discharge:   Primary Care Physician:   Reason for Admission: Fatigue and Weakness secondary to COVID  Brief Summary of Hospital Stay: Patient is a 76 year old female who presented to clinic with complaitns of weakness, fatigue, loss of smell, loss of taste, cough, sore throat, and congestion. Patient's pmhx included paroxysmal afib on eliquis, CVA s/p PFO/ASD closure 2015 with residual right sided ataxia and weakness, HTN, SLE, RA, T2DM, anxiety, and insomnia. Patient proceeded to present to the ER with her complaints and was found to be covid positive without significant findings on any other lab work. Patient had a similar presentation with COVID the previous year. Patient's pain symptom was severe weakness and fatigue.  On the night of her admission it was reported she was acutely confused so the patient was reassessed and found to be answering questions a little slowly but without any other acute deficits on neurological exam and she was AOX3. Patient received Q4 Neuro checks from there and a set of labs which did not reveal an acute etiology for confusion including blood culture, morning labs including CBC which did not reveal an acute change.  During her stay she did have elevated blood pressure in the 170s and 180s which she received hydralazine PRN 5 then 10 mg for better blood pressure control. No other changes were made to her home medication regimen but we did consider holding methotrexate which she takes weekly. Should consider holding it on account of the acute COVID infection.  Patient developed hypokalemia during her stay which was repleted with oral potassium. Lowest recorded potassium on BMP was 3.3. Urinalysis was positive for 1-5000 gram negative bacilli but was not associated with significant symptoms or findings indicating an acute UTI and the low count as well.  PMR was consulted and assessed the patient's weakness as  requirinf IPR for recovery when medically stable. As we were not acutely managing the COVID with steroids or antivirals on account of no hypoxia or respiratory distress, she was deemed stable enough for IPR and discharged. Patient's other chronic issues were managed with her home medications which she was discharged with.  Discharged to Inpatient Rehab Facility.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Blood pressure increased, COVID-19, Condition aggravated, Confusional state
Clinical narrative: Admit date: 9/3/2024  Discharge date: 9/5/24  Admitting Physician:   Attending Physician at the Time of Discharge:   Primary Care Physician:   Reason for Admission: Fatigue and Weakness secondary to COVID  Brief Summary of Hospital Stay: Patient is a 76 year old female who presented to clinic with complaitns of weakness, fatigue, loss of smell, loss of taste, cough, sore throat, and congestion. Patient's pmhx included paroxysmal afib on eliquis, CVA s/p PFO/ASD closure 2015 with residual right sided ataxia and weakness, HTN, SLE, RA, T2DM, anxiety, and insomnia. Patient proceeded to present to the ER with her complaints and was found to be covid positive without significant findings on any other lab work. Patient had a similar presentation with COVID the previous year. Patient's pain symptom was severe weakness and fatigue.  On the night of her admission it was reported she was acutely confused so the patient was reassessed and found to be answering questions a little slowly but without any other acute deficits on neurological exam and she was AOX3. Patient received Q4 Neuro checks from there and a set of labs which did not reveal an acute etiology for confusion including blood culture, morning labs including CBC which did not reveal an acute change.  During her stay she did have elevated blood pressure in the 170s and 180s which she received hydralazine PRN 5 then 10 mg for better blood pressure control. No other changes were made to her home medication regimen but we did consider holding methotrexate which she takes weekly. Should consider holding it on account of the acute COVID infection.  Patient developed hypokalemia during her stay which was repleted with oral potassium. Lowest recorded potassium on BMP was 3.3. Urinalysis was positive for 1-5000 gram negative bacilli but was not associated with significant symptoms or findings indicating an acute UTI and the low count as well.  PMR was consulted and assessed the patient's weakness as  requirinf IPR for recovery when medically stable. As we were not acutely managing the COVID with steroids or antivirals on account of no hypoxia or respiratory distress, she was deemed stable enough for IPR and discharged. Patient's other chronic issues were managed with her home medications which she was discharged with.  Discharged to Inpatient Rehab Facility.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Full blood count normal, Hypokalaemia, Hyporesponsive to stimuli
Clinical narrative: Admit date: 9/3/2024  Discharge date: 9/5/24  Admitting Physician:   Attending Physician at the Time of Discharge:   Primary Care Physician:   Reason for Admission: Fatigue and Weakness secondary to COVID  Brief Summary of Hospital Stay: Patient is a 76 year old female who presented to clinic with complaitns of weakness, fatigue, loss of smell, loss of taste, cough, sore throat, and congestion. Patient's pmhx included paroxysmal afib on eliquis, CVA s/p PFO/ASD closure 2015 with residual right sided ataxia and weakness, HTN, SLE, RA, T2DM, anxiety, and insomnia. Patient proceeded to present to the ER with her complaints and was found to be covid positive without significant findings on any other lab work. Patient had a similar presentation with COVID the previous year. Patient's pain symptom was severe weakness and fatigue.  On the night of her admission it was reported she was acutely confused so the patient was reassessed and found to be answering questions a little slowly but without any other acute deficits on neurological exam and she was AOX3. Patient received Q4 Neuro checks from there and a set of labs which did not reveal an acute etiology for confusion including blood culture, morning labs including CBC which did not reveal an acute change.  During her stay she did have elevated blood pressure in the 170s and 180s which she received hydralazine PRN 5 then 10 mg for better blood pressure control. No other changes were made to her home medication regimen but we did consider holding methotrexate which she takes weekly. Should consider holding it on account of the acute COVID infection.  Patient developed hypokalemia during her stay which was repleted with oral potassium. Lowest recorded potassium on BMP was 3.3. Urinalysis was positive for 1-5000 gram negative bacilli but was not associated with significant symptoms or findings indicating an acute UTI and the low count as well.  PMR was consulted and assessed the patient's weakness as  requirinf IPR for recovery when medically stable. As we were not acutely managing the COVID with steroids or antivirals on account of no hypoxia or respiratory distress, she was deemed stable enough for IPR and discharged. Patient's other chronic issues were managed with her home medications which she was discharged with.  Discharged to Inpatient Rehab Facility.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination abnormal, Oropharyngeal pain, Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Admit date: 9/3/2024  Discharge date: 9/5/24  Admitting Physician:   Attending Physician at the Time of Discharge:   Primary Care Physician:   Reason for Admission: Fatigue and Weakness secondary to COVID  Brief Summary of Hospital Stay: Patient is a 76 year old female who presented to clinic with complaitns of weakness, fatigue, loss of smell, loss of taste, cough, sore throat, and congestion. Patient's pmhx included paroxysmal afib on eliquis, CVA s/p PFO/ASD closure 2015 with residual right sided ataxia and weakness, HTN, SLE, RA, T2DM, anxiety, and insomnia. Patient proceeded to present to the ER with her complaints and was found to be covid positive without significant findings on any other lab work. Patient had a similar presentation with COVID the previous year. Patient's pain symptom was severe weakness and fatigue.  On the night of her admission it was reported she was acutely confused so the patient was reassessed and found to be answering questions a little slowly but without any other acute deficits on neurological exam and she was AOX3. Patient received Q4 Neuro checks from there and a set of labs which did not reveal an acute etiology for confusion including blood culture, morning labs including CBC which did not reveal an acute change.  During her stay she did have elevated blood pressure in the 170s and 180s which she received hydralazine PRN 5 then 10 mg for better blood pressure control. No other changes were made to her home medication regimen but we did consider holding methotrexate which she takes weekly. Should consider holding it on account of the acute COVID infection.  Patient developed hypokalemia during her stay which was repleted with oral potassium. Lowest recorded potassium on BMP was 3.3. Urinalysis was positive for 1-5000 gram negative bacilli but was not associated with significant symptoms or findings indicating an acute UTI and the low count as well.  PMR was consulted and assessed the patient's weakness as  requirinf IPR for recovery when medically stable. As we were not acutely managing the COVID with steroids or antivirals on account of no hypoxia or respiratory distress, she was deemed stable enough for IPR and discharged. Patient's other chronic issues were managed with her home medications which she was discharged with.  Discharged to Inpatient Rehab Facility.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: Admit date: 9/3/2024  Discharge date: 9/5/24  Admitting Physician:   Attending Physician at the Time of Discharge:   Primary Care Physician:   Reason for Admission: Fatigue and Weakness secondary to COVID  Brief Summary of Hospital Stay: Patient is a 76 year old female who presented to clinic with complaitns of weakness, fatigue, loss of smell, loss of taste, cough, sore throat, and congestion. Patient's pmhx included paroxysmal afib on eliquis, CVA s/p PFO/ASD closure 2015 with residual right sided ataxia and weakness, HTN, SLE, RA, T2DM, anxiety, and insomnia. Patient proceeded to present to the ER with her complaints and was found to be covid positive without significant findings on any other lab work. Patient had a similar presentation with COVID the previous year. Patient's pain symptom was severe weakness and fatigue.  On the night of her admission it was reported she was acutely confused so the patient was reassessed and found to be answering questions a little slowly but without any other acute deficits on neurological exam and she was AOX3. Patient received Q4 Neuro checks from there and a set of labs which did not reveal an acute etiology for confusion including blood culture, morning labs including CBC which did not reveal an acute change.  During her stay she did have elevated blood pressure in the 170s and 180s which she received hydralazine PRN 5 then 10 mg for better blood pressure control. No other changes were made to her home medication regimen but we did consider holding methotrexate which she takes weekly. Should consider holding it on account of the acute COVID infection.  Patient developed hypokalemia during her stay which was repleted with oral potassium. Lowest recorded potassium on BMP was 3.3. Urinalysis was positive for 1-5000 gram negative bacilli but was not associated with significant symptoms or findings indicating an acute UTI and the low count as well.  PMR was consulted and assessed the patient's weakness as  requirinf IPR for recovery when medically stable. As we were not acutely managing the COVID with steroids or antivirals on account of no hypoxia or respiratory distress, she was deemed stable enough for IPR and discharged. Patient's other chronic issues were managed with her home medications which she was discharged with.  Discharged to Inpatient Rehab Facility.
Age: 29.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Weight decreased
Clinical narrative: DONOR PHONED CENTER WITH C/O RIGHT ARM PAIN AT INJECTION AND TENDER TO TOUCH SITE WITH SWELLING, C/O SHOOTING PAIN DOWN BOTH ARMS WITH NUMBNESS AND BODY ACHES, DONOR INSTRUCTED TO SEEK MEDICAL ATTENTION
Age: 29.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: DONOR PHONED CENTER WITH C/O RIGHT ARM PAIN AT INJECTION AND TENDER TO TOUCH SITE WITH SWELLING, C/O SHOOTING PAIN DOWN BOTH ARMS WITH NUMBNESS AND BODY ACHES, DONOR INSTRUCTED TO SEEK MEDICAL ATTENTION
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: The NP told the field employee that she had received GARDASIL 4-Valent in the past and recently received GARDASIL 9 doses.  No additional AEs were reported. No f; No additional AEs were reported; This spontaneous report was received from a Nurse practitioner (NP) via field employee reporting on themselves ( unknown age and gender). The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On an unknown date (reported as in the past), the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, frequency, lot#, and expiration date were not reported) for prophylaxis and recently received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, frequency, lot#, and expiration date were not reported) for prophylaxis (interchange of vaccine products). No additional Adverse Events were reported (no adverse event).
Sex: M
Vaccine: RV5
Symptoms: Colonoscopy, Diarrhoea
Clinical narrative: 2-month-old boy had diarrhea for about a month; This spontaneous report has been received from a physician via a company representative, referring a 2-months-old male patient. Information regarding medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were unknown by the reporter.  On an unknown date in 2024, the patient received rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) for prophylaxis (formulation, strength, dose, scheme, route of administration, lot number and expiration date were unknown by the reporter).  On an unknown date in 2024, after he was vaccinated, the patient had diarrhea for about a month (Therefore, considered as recovered) and underwent colonoscopy (results were not provided). No additional information provided.   Causal relationship between the suspect vaccine and the event was not provided.
Age: 40.0
Sex: M
Vaccine: FLUC4, FLUC4, FLUC4
Symptoms: Extra dose administered
Clinical narrative: no adverse event to note. Patient accidentally filled out form and got the same flu shot within a month of each other.
Age: 40.0
Sex: M
Vaccine: FLUC4, FLUC4, FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: no adverse event to note. Patient accidentally filled out form and got the same flu shot within a month of each other.
Age: 64.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19
Symptoms: Urticaria
Clinical narrative: Large hives all over body. Began the on lower legs and moved up covering arms, stomach, chest and back
Age: 64.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19
Symptoms: Headache, Injection site erythema, Pruritus, Rash, Urticaria
Clinical narrative: Large hives all over body. Began the on lower legs and moved up covering arms, stomach, chest and back
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This non-serious case was reported by a consumer and described the occurrence of rash in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure and breast cancer. Concomitant products included carvedilol (Coreg) and tamoxifen citrate.   On 26-AUG-2024, the patient received Shingles vaccine. On 26-AUG-2024, less than a day after receiving Shingles vaccine, the patient experienced rash (Verbatim: Rash). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     It was unknown if the company considered the rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-AUG-2024 The patient had rash and the symptoms were treated.