chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.83
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient presented with mother to receive the Pfizer Covid 23-24 vaccine.  Writer verified patient's first and last name, DOB.  Pre-vaccination checklist was reviewed with mother.  Mother denied any significant health history, any reactions to prior Covid vaccines, or  other types of vaccines received.  Mother denied known allergy to Benadryl or Epinephrine.  Writer administered the vaccine in patient's left vastus lateralis but then realized she had administered the 12 year + vaccine, not the 6mo - 4yr vaccine. Writer informed Charge RN who contacted Dr., attending provider for the Peds Immunization Clinics.  Writer advised parents that patient had been given the wrong dose vaccine for his age and answered their questions.  Parents spoke to Dr. over the phone to have their questions answered and concerns addressed.  Parents reported to writer and charge RN Dr. advised that patient may experience more acute and/or hyper side effects from the vaccine such as fever.  Patient and parents remained in the observation area for approximately 20 minutes.  No acute side effects noted during this time.
Age: 67.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Dizziness, Fall, Immediate post-injection reaction
Clinical narrative: Patient was feeling a little dizzy and light-headed immediately after the vaccinations and sat down for around 10-15 minutes and had a piece of candy before she tried to head out of the store. Patient made it about 20 feet before she fell down from feeling faint. The patient never lost consciousness and did not hit her head during the fall do to her partner kind of holding her up breaking her fall. Patient was immediately attended to by one of the pharmacist's on duty. Patient's legs were elevated and an ice pack was placed on patient's head. After laying on the ground for about 30 seconds, patient was already saying she was feeling better. EMS was called immediately after she fell and paramedics came on scene to make sure she was okay and to check her blood pressure. Patient and paramedics determined that she did not need to be taken to the hospital and patient left under her own power with her significant other.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine on 10/26/2023 and discovered on 11/8/2023 that patient received a Pfizer COVID-19 vaccine for 6m-4yr that was diluted with expired normal saline.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Dizziness, Hot flush, Injection site erythema
Clinical narrative: First original shots were pfizer.  two shots were  pfizer, then the bivalent.  Had no issues whatsoever.    Yesterday was "Moderna Spikevax" but didn't see this option on above list.  Not updated?   Had hot flash about 15 minutes after shot.   By supper became stuffy, during night work up with scratchy throat. Over night had bad chills.   Alot of pain in left arm.  Shot site is very red, swollen, hard, hot.  This lump is about 2 1'2 inches in diameter.   Shot yesterday morning, today general unwell feeling: ache, dizzy, weak.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Injection site warmth, Interchange of vaccine products
Clinical narrative: First original shots were pfizer.  two shots were  pfizer, then the bivalent.  Had no issues whatsoever.    Yesterday was "Moderna Spikevax" but didn't see this option on above list.  Not updated?   Had hot flash about 15 minutes after shot.   By supper became stuffy, during night work up with scratchy throat. Over night had bad chills.   Alot of pain in left arm.  Shot site is very red, swollen, hard, hot.  This lump is about 2 1'2 inches in diameter.   Shot yesterday morning, today general unwell feeling: ache, dizzy, weak.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Nasal congestion, Pain, Pain in extremity, Sleep disorder
Clinical narrative: First original shots were pfizer.  two shots were  pfizer, then the bivalent.  Had no issues whatsoever.    Yesterday was "Moderna Spikevax" but didn't see this option on above list.  Not updated?   Had hot flash about 15 minutes after shot.   By supper became stuffy, during night work up with scratchy throat. Over night had bad chills.   Alot of pain in left arm.  Shot site is very red, swollen, hard, hot.  This lump is about 2 1'2 inches in diameter.   Shot yesterday morning, today general unwell feeling: ache, dizzy, weak.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat irritation
Clinical narrative: First original shots were pfizer.  two shots were  pfizer, then the bivalent.  Had no issues whatsoever.    Yesterday was "Moderna Spikevax" but didn't see this option on above list.  Not updated?   Had hot flash about 15 minutes after shot.   By supper became stuffy, during night work up with scratchy throat. Over night had bad chills.   Alot of pain in left arm.  Shot site is very red, swollen, hard, hot.  This lump is about 2 1'2 inches in diameter.   Shot yesterday morning, today general unwell feeling: ache, dizzy, weak.
Age: 71.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Blood pressure decreased, Hyperhidrosis, Nausea
Clinical narrative: patient stated that on 11/8/2023, approximately 20 hours after receiving both vaccinations that she experienced a severe drop in blood pressure along with sweating and nausea. she stated that she was able to lie down a while and after about 2 hours her blood pressure returned to normal and she is feeling much better, she did not have to seek medical attention
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: 11/1/2023: Patient right arm where vaccine site was given was swollen red and had a blister.  11/1/2023: Patient went to ER and received ibuprofen, Benadryl, Kenalog 1% cream, and clindamycin.  11/9/2023: Patient blister healed and no issues at this time.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Vomiting, lightheadness
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Angiogram pulmonary, Blood pressure increased, Chest X-ray, Computerised tomogram, Differential white blood cell count
Clinical narrative: Heart rate increased to 188 bpm.  Blood pressure was 188/102 (11/8/23 1:57 AM).  At my routine doctor appt (11 AM, 11/7/23) my blood pressure was 122/72 (I think). When I woke around 12:30 AM,  I was light headed, dizzy, had difficulty breathing in addition to the racing heart. At the ER, I was given benadryl and solu-medrol via IV.  Blood tests indicated D-dimer, so a chest x-ray and ct scan were done.  When my blood pressure had decreased, I was released from the ER (around 4 AM).
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Fibrin D dimer, Full blood count
Clinical narrative: Heart rate increased to 188 bpm.  Blood pressure was 188/102 (11/8/23 1:57 AM).  At my routine doctor appt (11 AM, 11/7/23) my blood pressure was 122/72 (I think). When I woke around 12:30 AM,  I was light headed, dizzy, had difficulty breathing in addition to the racing heart. At the ER, I was given benadryl and solu-medrol via IV.  Blood tests indicated D-dimer, so a chest x-ray and ct scan were done.  When my blood pressure had decreased, I was released from the ER (around 4 AM).
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Heart rate increased, Liver function test, Metabolic function test, Palpitations, Troponin
Clinical narrative: Heart rate increased to 188 bpm.  Blood pressure was 188/102 (11/8/23 1:57 AM).  At my routine doctor appt (11 AM, 11/7/23) my blood pressure was 122/72 (I think). When I woke around 12:30 AM,  I was light headed, dizzy, had difficulty breathing in addition to the racing heart. At the ER, I was given benadryl and solu-medrol via IV.  Blood tests indicated D-dimer, so a chest x-ray and ct scan were done.  When my blood pressure had decreased, I was released from the ER (around 4 AM).
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Pt reports waking up on Thurs morning after receiving vaccine on Tues evening with a numbness and weakness in right arm.. Came her today after contacting PCP but not seeing them last week.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Brain fog, Chills, Fatigue
Clinical narrative: Sharp pain, burning and itching at injection site, raised area larger than a quarter. Achy body, chills, sharp ?spikey? intermittent pain in joints, hands, abdomen. Significant fatigue. Brain fog.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Sharp pain, burning and itching at injection site, raised area larger than a quarter. Achy body, chills, sharp ?spikey? intermittent pain in joints, hands, abdomen. Significant fatigue. Brain fog.
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Syringe issue
Clinical narrative: ONCE THE NEEDLE WAS INSERTED INTO THE PATIENT'S LEFT DELTOID, AND THE PLUNGER WAS PUSHED, THE VACCINE SPILLED OUT. NO VACCINE WAS ADMINISTERED DURING THIS ATTEMPT. NEW VACCINE WAS THEN ADMINISTERED WITHOUT ANY FURTHER ISSUES/CONCERNS.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood creatinine increased, Cardioversion, Electrocardiogram abnormal, Palpitations
Clinical narrative: Patient developed palpitations and went into Atrial Fibrillation with RVR requiring medications and later cardioversion. This also led to a drop in his kidney function.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Renal impairment
Clinical narrative: Patient developed palpitations and went into Atrial Fibrillation with RVR requiring medications and later cardioversion. This also led to a drop in his kidney function.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 31.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient got 2 vaccine on 8/7  around 5pm. On 8/8 patient experienced redness of the injection area and keep spreading on patient's arm. She also stated that the area is warm to touch. Patient call us on 8/9 to report the symptoms and was recommended by to attend urgent care due to potential allergy symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: Partial dose of vaccine was administered rather than full administration. this was caused by some fault in the needle used to inject. following cdc guideance last update 11/3/23, a second half dose was given to equal a full dose. this was all done on the same day. no negative outcome, side effects, or outcomes other wise noted as of the time of this report. Will be following up with pt on Monday.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formmulation administered
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Echocardiogram, Hypotension, Mobility decreased
Clinical narrative: Patient was leaving the store 10-15 minutes after his vaccine when he had to sit in the aisle. He was unable to get back up and emergency services were contacted. He was transported to Hospital and released three days later. He had low blood pressure but no other pertinent findings according to his wife.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red, raised area at injection site
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient received vaccination approximately 5-10 min after vaccine patient reported feeling nauseated. Upon observation patient was pale, diaphoretic and dizzy. Immediately laid patient on the ground and elevated legs.  Pulse ox was applied to patients finger with oxygen saturation at 90%. Mother reported patient had not eaten anything since lunch, provided waters and cracker to patient. Patient felt much better and symptoms resolved.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red, raise area at site of injeciton
Age: 74.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe pain in both arms unable to raised arms or lifting Continuos pain that does go away
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Fast heart rate of 137 during activity and rest 118. Large 6x6 in rash at injection site on left arm.  Extremely warm and itchy
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Electrocardiogram
Clinical narrative: The patient came in for a tetanus vaccination due to having been cut with a rusty fishing lure.  She tried to get it at her primary care physician's office but since they did not have epinephrine they recommended she come to the pharmacy. A representative from the physician's office called in advance to ask if we have the appropriate medication in the event that she has an anaphylactic reaction. After filling out the consent form, I administered the Boostrix vaccination in her left deltoid.  Within 10-20 seconds she conveyed she was feeling dizzy, after a few more seconds she said she felt like she was possibly feeling tightness in her chest and possible swelling of the throat. I then administered 0.3mg of epinephrine into her left thigh intramuscularly.  After about 30 - 45 seconds she began to feel better.  The other pharmacist called EMS and EMS arrived about 10 minutes later. They took her vitals and ran a 4-lead EKG. The patient left via EMS with her husband.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain, Skin discolouration, Swelling, Vaccination site bruising
Clinical narrative: When pt. got home after vaccine was given, the Left arm began to swell in the area the vaccine was given and became sore/painful. In 2 - 3 days, the area below axilla to elbow was discolored with black bruising. Quarter size bruise (yellow) noted 2" below shoulder. On 11/2/23 swelling , pain, and bruising noted. 11/7/23 no swelling, minimal pain, and decreased bruising noted.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site swelling
Clinical narrative: When pt. got home after vaccine was given, the Left arm began to swell in the area the vaccine was given and became sore/painful. In 2 - 3 days, the area below axilla to elbow was discolored with black bruising. Quarter size bruise (yellow) noted 2" below shoulder. On 11/2/23 swelling , pain, and bruising noted. 11/7/23 no swelling, minimal pain, and decreased bruising noted.
Age: 10.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: Vaccine was administered via Intramuscular when it should have been Subcutaneous resulting in an administration error.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Rash, Rash macular
Clinical narrative: Diffuse blanching macular rash on the face, chest, abdomen, back arms, and legs. Spares palms and soles. No mucosal invovlement.
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt come in for a flu vaccine, patient received flu vaccine, but did not get the one that was appropriate for her age. Due to being 64, she should have received regular flu quad vaccine, but was given fluad quad instead.  PT waited 15 after vaccine, no adverse reactions observed.    Attempted to contact patient about the mix up, no contact information has been given to us. As of today, there has been no attempted contact from the patient to report any adverse reactions for the vaccine.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Aphthous ulcer, Decreased appetite, Fatigue, Feeling abnormal, Oral herpes
Clinical narrative: Patient received RSV (arexvy) and Moderna covid vaccine both in left deltoid on 10/25/23 around 11am.  Patient states around 10pm on 10/25/23 she had a sore arm, felt achy, tired, vomited, had no appetite, fever of 103, and cold sores on both upper and bottom lips and canker sores inside her mouth.  The 103 fever lasted for 2 days and then 102 fever for 1 day.  As of today, 11/9/23 she states she is still recovering and does not feel back to normal as of yet.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Patient received RSV (arexvy) and Moderna covid vaccine both in left deltoid on 10/25/23 around 11am.  Patient states around 10pm on 10/25/23 she had a sore arm, felt achy, tired, vomited, had no appetite, fever of 103, and cold sores on both upper and bottom lips and canker sores inside her mouth.  The 103 fever lasted for 2 days and then 102 fever for 1 day.  As of today, 11/9/23 she states she is still recovering and does not feel back to normal as of yet.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient had received flu immunization on 10/7/23. Patient came to clinic for flu immunization on 11/7/23. Patient received flu immunization in error. Provider was notified. Patient's parent was also notified of error.
Age: 59.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received Fluad, instead of age appropriate dose of  Flu Quad. Pt was observed for 15 mins following vaccination. No adverse reactions, noted.  Left a message for Pt to call, to discuss med error. No response as of yet.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Hordeolum, Injection site pain, Lymphadenopathy, Ocular discomfort
Clinical narrative: Pressure behind eyes - 7 days Headache - 7 days Stye in eye - 4 days swollen lymph nodes, neck - 2 weeks "necklace" rash - 3 inches around - around neck - 2 weeks hives from neck to ankles - 4 weeks soreness at injection site - 1 day  Took NSAID (Advil)
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Urticaria
Clinical narrative: Pressure behind eyes - 7 days Headache - 7 days Stye in eye - 4 days swollen lymph nodes, neck - 2 weeks "necklace" rash - 3 inches around - around neck - 2 weeks hives from neck to ankles - 4 weeks soreness at injection site - 1 day  Took NSAID (Advil)
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Hallucination, Screaming, Sleep disorder
Clinical narrative: Progressive confusion, hallucinations, waking up screaming.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The administered vaccine expired July 15 2023, upon calling the manufacturer the representative stated that according to the stability data they have for MMR II with the above expiration date, the dose is still stable and the patient doesn't need to repeat the dose.  Further, upon talking to the patient, she is not experiencing or has experienced any side effects as of now.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Mis-read patients date of birth, patient was then given the high dose vaccine with thought of him being 65. Patient has no adverse effects to this injection.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Hypoaesthesia
Clinical narrative: Vaccine was given on 10/19/23 around 12;30 pm. shortley after pt began having numbness to the left side of his face, some numbness in left arm,  left eye swelling. He called the pharmacy and then came to our office. He arrived at our office around 3pm and we assessed him and gave him a dose of IM steroids.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Vomiting
Clinical narrative: About 11 hours after shot:  severe vomiting for over an hour,  severe chills, fever 99.6 18 hours after shot continuing through the next day,  sore left shoulder
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC15, VARCEL
Symptoms: Wrong product administered
Clinical narrative: A varicella and a proquad (MMR/Varicella) were given together instead of an MMR.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; a patient was inadvertently administered  a second dose ( 10/10/2023) of PROQUAD two weeks after the first dose 09/26/2023; This spontaneous report was received from a medical assistant (other health professional) and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-SEP-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: rHA) (PROQUAD) injection, 0.5ml/series, lot #W038809, expiration date: 04-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). On 10-OCT-2023 (two weeks after the first dose), the patient was inadvertently administered a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: rHA) (PROQUAD) injection, 0.5ml/series, lot #W038809, expiration date: 04-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration). There were no symptomatic adverse events (AEs)/additional AEs/product quality complaints (PQCs) reported.
Age: 1.08
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Accidental exposure to product
Clinical narrative: No AE; Nurse calling to report adverse event regarding the inadvertent administration of PROQUAD with VARIVAX to a one year old patient.  Nurse stated that the patient involved was scheduled to be administered MMR II and VARIVAX at their appointment, but th; Nurse calling to report adverse event regarding the inadvertent administration of PROQUAD with VARIVAX to a one year old patient.  Nurse stated that the patient involved was scheduled to be administered MMR II and VARIVAX at their appointment, but th; Nurse calling to report adverse event regarding the inadvertent administration of PROQUAD with VARIVAX to a one year old patient.  Nurse stated that the patient involved was scheduled to be administered MMR II and VARIVAX at their appointment, but th; Information has been received from a registered nurse, referring to a 13-month-old (also reported as 1 year old) male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) and hepatitis a vaccine inact (HAVRIX).   On 24-OCT-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) "two dose series", 0.5 milliliters, lot # W036939, expiration date: 19-MAY-2024, administered subcutaneously in the right thigh for prophylaxis (strength was not provided); and with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), "two dose series",0.5 milliliters,  lot # X001000, expiration date: 09-JAN-2025, administered subcutaneously in the left thigh for prophylaxis (strength was not provided).  The nurse stated that the patient involved was scheduled to be administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) at their appointment; however, the nurse inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) to the patient on the same day (24-OCT-2023). The nurse stated that this event was due to an error in processing by the nurse while preparing the vaccines to be administered. Nurse confirmed that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not administered to the patient. It was additional confirmed that had not received any report of medical concerns or symptoms by the patient's family at this time.
Sex: F
Vaccine: HPV9
Symptoms: Nervous system disorder, Seizure
Clinical narrative: CNS effects with uncontrolled seizures; This spontaneous report was received from a pharmacist via company representative and referred to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, vaccination scheme, anatomical location and route of administration were not provided).  On an unknown date, the patient experienced central nervous system (CNS) effects with uncontrolled seizures. At the time of reporting, the outcome of the event was not known.   The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the event was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE and no PQC; HBP calling to report an adverse event for PROQUAD.  Caller states a 15 year old patient was administered their second dose of PROQUAD on 10/31/2023.  The first dose was on 10/10/2009.  No symptoms or further details provided.  No other AE and no PQC; This spontaneous report as received from an administrator and refers to a 15-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 10-OCT-2009, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided). On 31-OCT-2023 the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # X011979 and expiration date 18-JUL-2024, for prophylaxis (exact dose, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event)
Sex: U
Vaccine: PNC15
Symptoms: Product storage error
Clinical narrative: HCP called to report Administered supported TE for VAXNEUVANCE.   No Previous Excursions VAXNEUVANCE LOT #: X005583  EXP: 12/10/20245 42 Hours 5 Minutes 0 Seconds @ 33.9F. Associated AE Cases: 02503187 // 02503224. No PQC.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 01-NOV-2023, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot # X005583, expiration date 10-DEC-2024 (dose and route of administration not reported) for prophylaxis (product storage error).  The vaccine underwent a temperature excursion of 33.9 degrees Fahrenheit for 42 hours and 5 minutes.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired MMRII was administered to a patient on 11/3/2023, and it expired on 10/15/2023; This spontaneous report was received from a nurse referring to a 21-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditio9ns and concomitant medications were not reported.       On 03-NOV-2023, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 mL/once, recombinant Human albumin (rHA) lot # W034714 expiration date reported as "15-OCT-2023", but upon internal determination established as 18-OCT-2023, for prophylaxis (strength, route of administration and anatomical location were not reported) (expired product administered). It was confirmed that no temperature excursion on this product. It was also confirmed that no side effects symptoms were reported and no additional adverse event (AE).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX  x006983   3/7/2025 Temperature and Time frame: -9.2C; This spontaneous report was received from a registered nurse and refers to a. patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #x006983, expiration date: 07-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine udnerwent temperature excursion in -9.2 degree Ceslius fo 1 hour 7 minutes and in -11.2 degree Celsius for 31 minutes (Product storage error). No additional adverse event was reported.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Drug ineffective
Clinical narrative: PATIENT WAS VACCINATED USING FLUMIST AS A CHILD IN HER DOCTOR''S OFFICE. HER DOCTOR LATER TOLD HER THE VACCINATION NO LONGER WORKS.; Patient was vaccinated using FluMist as a child in her doctor's office. Her doctor later told her the vaccination no longer works.; A spontaneous report has been received from a consumer. The report concerns a female patient of ethnic origin (age 8 years).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown) once/single administration, via unk route, on an unknown date. The patient received Flumist (influenza vaccine live reassort 3v) (batch number Unknown) once/single administration, via unk route, on an unknown date.     No malfunction has been reported for FLUMIST.   No malfunction has been reported for FLUMIST.    The report described lack of effect for Flumist and Flumist. The reported term was "patient was vaccinated using flumist as a child in her doctor''s office. her doctor later told her the vaccination no longer works." (Preferred term: Drug ineffective).     It is unknown if any action was taken with Flumist (influenza vaccine live reassort 3v) and Flumist (influenza vaccine live reassort 3v).     The patient recovered from the event(s) on an unspecified date.     The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction 06-Nov-2023: Valid nullflavors added to all reporters. Reporter Name of vaccination Facility added on product and dosing. Narrative updated.    Minor correction 09-Nov-2023: Valid nullflavors added to event. Narrative updated.
Sex: U
Vaccine: FLUX, RSV
Symptoms: Diplopia, Guillain-Barre syndrome
Clinical narrative: Guillen Barre symptoms; diplopia; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On an unknown date, the patient received Arexvy and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving Arexvy and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced guillain barre syndrome (Verbatim: Guillen Barre symptoms) (serious criteria GSK medically significant) and diplopia (Verbatim: diplopia). The outcome of the guillain barre syndrome and diplopia were not resolved.   The reporter considered the guillain barre syndrome and diplopia to be possibly related to Arexvy.     The company considered the guillain barre syndrome and diplopia to be possibly related to Arexvy.   Additional Information: GSK receipt date: 02-NOV-2023 The physician thought that patient was experiencing Guillen Barre symptoms and diplopia. The physician thought it could be Arexvy causing the symptoms. It was unknown if the reporter considered the guillain barre syndrome and diplopia to be related to Flu vaccine. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Ear pain, Giant cell arteritis, Headache, Pain, Tenderness
Clinical narrative: pain on side of head between temple and ear throbbing; hurts to touch as if was hit or banged with something; laying on a pillow hurts; This non-serious case was reported by a consumer via patient support programs and described the occurrence of temporal arteritis in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included gout. Previously administered products included Allopurinol.   On 28-OCT-2023 12:45, the patient received Arexvy. On 28-OCT-2023, several hours after receiving Arexvy, the patient experienced temporal arteritis (Verbatim: pain on side of head between temple and ear throbbing), tenderness (Verbatim: hurts to touch as if was hit or banged with something) and pain (Verbatim: laying on a pillow hurts). The outcome of the temporal arteritis, tenderness and pain were not resolved.   It was unknown if the reporter considered the temporal arteritis, tenderness and pain to be related to Arexvy.     It was unknown if the company considered the temporal arteritis, tenderness and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 The patient reported that pain started a few hours after shot received and had continued since. The patient stated that he knew headache was a mentioned side effect but the sore to touch area that felt as if he was struck by something was very strange. The patient stated that it hurted to touch area and laying on a pillow hurted. Unlike any headache he ever had pain on side of head between temple and ear throbbing ache but strangely hurts to touch as if was hit or banged with something. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine was mixed incorrectly; Patient given just adjuvent; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine was mixed incorrectly) and inappropriate dose of vaccine administered (Verbatim: Patient given just adjuvent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date - 01-NOV-2023 The nurse reported that the Shingrix vaccine was mixed incorrectly and just given adjuvant which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: his arm hurt 2 days after having been vaccinated; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 2 days after receiving Arexvy, the patient experienced pain in arm (Verbatim: his arm hurt 2 days after having been vaccinated). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date 31 Oct 2023: The patient stated that his arm hurt 2 days after having been vaccinated. The reporter did not consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Erythema, Fatigue, Feeling abnormal, Flushing, Hypersomnia
Clinical narrative: sore red enlarging round raided spot on my arm; sore red enlarging round raided spot on my arm; sore red enlarging round raided spot on my arm; horrid fatigue; I napped and napped again and turned in at 6 pm and slept until 6 am; felt flushed off and on; This non-serious case was reported by a consumer and described the occurrence of localized erythema in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Shingles vaccine (only vaccine patient have ever had a reaction to were the shingles where it was a horrid arm experience).   On 20-OCT-2023, the patient received Arexvy. In OCT-2023, 24 hrs after receiving Arexvy, the patient experienced fatigue (Verbatim: horrid fatigue), sleep excessive (Verbatim: I napped and napped again and turned in at 6 pm and slept until 6 am) and feeling abnormal (Verbatim: felt flushed off and on). On 21-OCT-2023, the patient experienced localized erythema (Verbatim: sore red enlarging round raided spot on my arm), pain localized (Verbatim: sore red enlarging round raided spot on my arm) and local swelling (Verbatim: sore red enlarging round raided spot on my arm). In OCT-2023, the outcome of the fatigue, sleep excessive and feeling abnormal were resolved (duration 48 hrs). The outcome of the localized erythema, pain localized and local swelling were resolved (duration 48 hrs).   It was unknown if the reporter considered the localized erythema, pain localized, local swelling, fatigue, sleep excessive and feeling abnormal to be related to Arexvy.     It was unknown if the company considered the localized erythema, pain localized, local swelling, fatigue, sleep excessive and feeling abnormal to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2023 The patient self-reported this case. The patient wanted to report that the day after he/she had the RSV (Arexvy vaccine) he/she developed a huge sore red enlarging round raided spot on his/her arm. Also, about 24 hours after patient had such horrid fatigue and he/she napped and napped again and turned in at 6 pm and slept until 6 am. The patient felt flushed off and on. Less than a week after receiving Arexvy, the patient experienced feeling abnormal. About 48 hours after the vaccine patient felt more back to normal in Oct-2023. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Pain, Swelling
Clinical narrative: sore red enlarging round raided spot on my arm; sore red enlarging round raided spot on my arm; sore red enlarging round raided spot on my arm; horrid fatigue; I napped and napped again and turned in at 6 pm and slept until 6 am; felt flushed off and on; This non-serious case was reported by a consumer and described the occurrence of localized erythema in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Shingles vaccine (only vaccine patient have ever had a reaction to were the shingles where it was a horrid arm experience).   On 20-OCT-2023, the patient received Arexvy. In OCT-2023, 24 hrs after receiving Arexvy, the patient experienced fatigue (Verbatim: horrid fatigue), sleep excessive (Verbatim: I napped and napped again and turned in at 6 pm and slept until 6 am) and feeling abnormal (Verbatim: felt flushed off and on). On 21-OCT-2023, the patient experienced localized erythema (Verbatim: sore red enlarging round raided spot on my arm), pain localized (Verbatim: sore red enlarging round raided spot on my arm) and local swelling (Verbatim: sore red enlarging round raided spot on my arm). In OCT-2023, the outcome of the fatigue, sleep excessive and feeling abnormal were resolved (duration 48 hrs). The outcome of the localized erythema, pain localized and local swelling were resolved (duration 48 hrs).   It was unknown if the reporter considered the localized erythema, pain localized, local swelling, fatigue, sleep excessive and feeling abnormal to be related to Arexvy.     It was unknown if the company considered the localized erythema, pain localized, local swelling, fatigue, sleep excessive and feeling abnormal to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-OCT-2023 The patient self-reported this case. The patient wanted to report that the day after he/she had the RSV (Arexvy vaccine) he/she developed a huge sore red enlarging round raided spot on his/her arm. Also, about 24 hours after patient had such horrid fatigue and he/she napped and napped again and turned in at 6 pm and slept until 6 am. The patient felt flushed off and on. Less than a week after receiving Arexvy, the patient experienced feeling abnormal. About 48 hours after the vaccine patient felt more back to normal in Oct-2023. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Twinrix 8 months ago/Patient not received  2nd dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received the first dose of Twinrix 8 months ago (batch no.4KF75 and expiry date 03rd January 2025)).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Twinrix 8 months ago/Patient not received  2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date-31-Oct-2023 The health care professional asked how to proceed with patient vaccination. Till the time of reporting patient did not receive the 2nd dose of Twinrix which led to incomplete course of vaccination . The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Device connection issue, Needle issue, No adverse event, Underdose
Clinical narrative: there was leakage due to the needle not being attached securely; there was leakage due to the needle not being attached securely; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 08-SEP-2023, the patient received Bexsero. On 08-SEP-2023, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: there was leakage due to the needle not being attached securely) and needle leak (Verbatim: there was leakage due to the needle not being attached securely). The outcome of the accidental underdose and needle leak were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2023 The reporter reported that patient received the Bexsero and there was leakage due to the needle not being attached securely which led to accidental underdose and needle leak. No reactions reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Swelling
Clinical narrative: patient received the Shingrix vaccine and emailed her yesterday, 30/OCT/2023 reporting swelling under her left arm in the axillary region; This non-serious case was reported by a other health professional via call center representative and described the occurrence of local swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number TF3A9) for prophylaxis.   On 27-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 28-OCT-2023, 1 days after receiving Shingrix, the patient experienced local swelling (Verbatim: patient received the Shingrix vaccine and emailed her yesterday, 30/OCT/2023 reporting swelling under her left arm in the axillary region). The outcome of the local swelling was not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.     It was unknown if the company considered the local swelling to be related to Shingrix.   Additional Information: GSK receipt date: 31-OCT-2023 The nurse was reported on behalf of the patient. Reporter stated that the patient received Shingrix vaccine and emailed the reporter one day before the reporting day, reporting swelling under her left arm in the axillary region. Referred to health care professional for further information. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: female patient received by error Engerix-B pediatric formulation; Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 54-year-old female patient who received HBV (Engerix B pediatric) (batch number DD707) for prophylaxis.   On 27-SEP-2023, the patient received the 1st dose of Engerix B pediatric. On 27-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: female patient received by error Engerix-B pediatric formulation) and accidental underdose (Verbatim: Underdose). The outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK receipt date 1 November 2023: Clinic Administrator reported that an adult patient received by error Engerix-B pediatric formulation as a First dose and then an Engerix-B second adult dose on 31Oct 2023.  The patient did not received Engerix-B third dose yet. The reporter consented to follow up via email The adult patient received by error Engerix-B pediatric formulation which led to adult use of a child product and accidental underdose.