chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient stated she had received the vaccine intramuscularly with no reported adverse event; Initial information received on 26-Aug-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves 35 years old female patient had received the Yellow Fever Vaccine - [YF-VAX] intramuscularly 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 Influenza vaccine (Influenza) for Immunisation.   On 26-Aug-2024, the patient received 0.5 ml dose of suspect Yellow Fever Vaccine - (Solution for injection) lot UK065AB and expiry date: 31-Jul-2025 via intramuscular route in left deltoid for Prophylactic vaccination (Immunization) and patient stated she had received the vaccine intramuscularly with no reported adverse event (incorrect route of product administration) (latency: same day).  Reportedly,Pharmacy mentioned that Yf-Vax was administered to a patient via Intramuscular route instead of subcutaneously  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 and Regulatory Authority 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.  Additional information was received on 26-Aug-2024.Patient age, batch number, concomitant medication, event onset date were updated. Text amended accordingly.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccine was administered post-excursion to the patient with no reported adverse event; Initial information received on 27-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 12 years old male patient where Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] was administered post-excursion to the patient 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 HPV vaccine VLP rL1 4v (yeast) (Gardasil) for Immunisation.  On 20-Aug-2024, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (strength- standard) (lot- U8113CA and expiry date- 30-SEP-2027) via intramuscular route in the left deltoid for Immunisation (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: she administered a fourth dose to a five-year-old child accidentally with no reported adverse event; Medical assistant called to say that she administered a fourth dose to a five-year-old child accidentally with no reported adverse event; Initial information received on 27-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 5 years old male patient who got administered a fourth dose of HIB (PRP/T) Vaccine [ACT-HIB] to a five-year-old child accidentally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Jul-2021, the patient received a dose 3 of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site. On 27-Aug-2024 he also received 0.5 ml dose 4 of vaccine (lot no- UK021AA and expiry date- 28-FEB-2025) via unknown route in unknown administration site (strength: not provided) for Immunisation (product administered to patient of inappropriate age) and (extra dose administered) (latency- same day).  Reportedly, Reporter mentioned that the child and the mother were both seen by the prescriber and reported that both were feeling good.  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: 6.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered, Wrong product administered
Clinical narrative: never reconstituted the powder to activate and patients just received straight up IPVand DTAP and not the HIB part with no reported adverse event; supposed to have a DTAP but they grab a combination which is PENTACEL (DTAP-IPV-Hib) with no adverse event; Initial information received on 28-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case-2024SA254058  This case involves a 6 years old male patient for whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was never reconstituted the powder to activate and just received straight up ipv and dtap and not the hib part and supposed to have a dtap but they grab a combination which is pentacel (dtap-ipv-hib) with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO VACCINE) for Immunisation.    On 27-Aug-2024 the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection with dose 0.5 ml (x1) (once), expiry-30-Apr-2025 lot UK022AA via intramuscular route in the right deltoid but was never reconstituted the powder to activate and patients just received straight up ipv and dtap and not the hib part (single component of a two-component product administered) and supposed to have a dtap but they grab a combination which is pentacel (dtap-ipv-hib) with no adverse event (wrong product administered) (latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA254058:
Age: 8.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered, Wrong product administered
Clinical narrative: never reconstituted the powder to activate and patients just received straight up IPVand DTAP and not the HIB part with no reported adverse event; supposed to have a dtap but they grab a combination which is pentacel (dtap-ipv-hib) with no adverse event; Initial information received regarding an unsolicited valid non-serious case received from a nurse on 28-Aug-2024 and live follow up received on same date both were processed together.  This case is linked to case- 2024SA254317  This case involves a 8 years old male patient for whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was never reconstituted the powder to activate and just received straight up ipv and dtap and not the hib part and and supposed to have a dtap but they grab a combination which is pentacel (dtap-ipv-hib) with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO VACCINE) for Immunisation.    On 27-Aug-2024 the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection with dose 0.5 ml (x1) (once), expiry-30-Apr-2025 lot UK022AA via intramuscular route in the right deltoid but was never reconstituted the powder to activate and patients just received straight up ipv and dtap and not the hib part (single component of a two-component product administered) and supposed to have a dtap but they grab a combination which is pentacel (dtap-ipv-hib) with no adverse event (wrong product administered) (latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA254317:
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error, Single component of a two-component product administered
Clinical narrative: second excursion was 19 hours and 15 mins., Temperature 68 degrees, cause of the excursion was due to the vaccine being left out with no reported adverse event; lyophilized powder of the pentacel was not administered, not mixing the Acthib portion of the vaccine with no reported adverse event; Initial information received on 28-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 months old male patient where second excursion was occurred for 19 hours and 15 mins at temperature 68 degrees and cause of the excursion was due to the diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] being left out with no reported adverse event and lyophilized powder of the pentacel was not administered, not mixing the acthib portion of the vaccine 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 Rotavirus vaccine live oral 1v (Rotarix) for Immunisation.  On 27-Aug-2024, the patient received 0.5 ml dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot- UK024AA and expiry date- 30-APR-2025) via intramuscular route in the lateral side of left thigh (strength: not provided) for Immunisation (single component of a two-component product administered) (latency- same day).  On an unknown date, the second excursion was 19 hours and 15 mins, temperature 68 degrees, cause of the excursion was due to the vaccine being left out with no reported adverse event (product storage error) (unknown latency).  Reportedly, Did it occur due to a human error? YES, Does extended stability data cover the excursion: YES, Product used : Used, First time product used : No  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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: administered the liquid part of the vaccine (DTAP/POLIO) but it was not given/reconstituted with the HIB powder with no reported adverse event; Initial information received on 28-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who was administered the liquid part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (dtap/polio) but it was not given/reconstituted with the hib powder with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2024, the patient received the liquid part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection, expiry date-30-Apr-2025 lot UK024AA via unknown route in unknown administration site for immunization (strength, dose unknown), but it was not given/reconstituted with the hib powder with no reported adverse event (single component of a two-component product administered) (same day latency).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Lip swelling, Pruritus
Clinical narrative: redness on my palms and feet; itching on palms and feet; Swelling of the lips; This spontaneous case initially received on 22-Aug-2024, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had Shell allergy, high cholesterol. It was reported that patient could not find any contraindication related to shell allergy.  Associated product quality complaint was selected as No.  Administration of company suspect drugs: On 21-Aug-2024, the patient received Afluria (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: Not reported, Lot number: AW1610A.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 21-Aug-2024, the patient experienced redness on my palms and feet (outcome: Not Reported), itching on palms and feet (outcome: Not Reported), Swelling of the lips (outcome: Not Reported). The events started 10-12 hours after vaccination  Afluria (TIV) action taken: Not Applicable Treatment medication: Benadryl 50 mg  Reporter assessment:  The reporter did not provide a causality assessment and seriousness for the events was reported as non-serious; Reporter's Comments: The events are considered related to the administration of Afluria (TIV) due to close temporal relationship.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal discomfort, Dizziness, Tinnitus
Clinical narrative: Patient was fine after receiving shots then after I returned from getting his vaccination record from the printer his mom said he said his stomach was feeling weird.  He had gotten up from the vaccine chair (where I asked him to wait) and was standing when this was reported.  I had him sit back down in the chair and put the safety bar in front of him.  I asked him what he was feeling and he replied he was dizzy.  I had him lean back against the wall to rest his head.  I offered water and/or crackers and he did say ok to water.  I gave him the water and asked if he was feeling any better.  He reported that his ears were ringing.  He asked if he could lay on the exam table and I helped him over to the table.  Rested and started drinking the water.  After a few minutes his color in his face returned and he said he was feeling better.  I had him stay laying down a few more minutes then had him sit upright for a couple minutes then had him stand for a couple minutes before trying to walk.  He left ambulatory beside his mother stating he felt fine at 5:07.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9, TDAP
Symptoms: Fall, Loss of consciousness, Pallor, Syncope, Vomiting
Clinical narrative: After receiving HPV, Tdap, and flu vaccine, within a few minutes after vaccination , patient was standing in exam room and fainted post vaccine, falling forward face down by exam table. Mother reported patient lost consciousness for a couple seconds and once patient was conscious, he threw up twice. Patient was pale in color, assisted to exam table by LVN, placed in supine position with legs elevated. Once blood pressure was stable, patient was able to sit up and tolerated 10 oz of water by mouth. patient was alert and oriented, answering questions and behaving normal.
Age: 38.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Nurse (RN) inadvertently administered a pediatric dose of Hepatitis A vaccine to the client. Client was made aware after event and declined a repeat dose at this time.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Herpes zoster reactivation, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Resident developed a reactivation of Herpes Zoster 7 days after administration of the vaccine around left eye, forehead, temple and into scalp mid-way. Left eye with extensive redness and tearing, no visible lesion on the cornea at this time. Previously resident only developed Shingles on her sacral area for every outbreak. Reactivated outbreak new location and much more severe. On 9/3/2024 started on Valacyclovir 1gm BID for 7 days and Acyclovir ointment TID for 7 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Resident developed a reactivation of Herpes Zoster 7 days after administration of the vaccine around left eye, forehead, temple and into scalp mid-way. Left eye with extensive redness and tearing, no visible lesion on the cornea at this time. Previously resident only developed Shingles on her sacral area for every outbreak. Reactivated outbreak new location and much more severe. On 9/3/2024 started on Valacyclovir 1gm BID for 7 days and Acyclovir ointment TID for 7 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: BODY RASH
Age: 56.0
Sex: F
Vaccine: COVID19, UNK, VARZOS
Symptoms: Mechanical ventilation, Swollen tongue
Clinical narrative: Patient woke up in the night at 3am with tongue swelling.  She took a benadryl tablet and went to General Hospital.  She had to be put on a ventilator shortly after arriving and was on it for 3 days.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient above mentioned received a MMRV instead of single Varicella. Wrong syringe was taken. I had two trays with two live vaccines labeled (sibling was also getting vaccinated). For some reason, when I finished vaccinating the patient I noticed the one I used had the MMRV label instead of the Varicella. Pt received and extra dose of MMR vaccine. I talked to the provider and report was filled out.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia
Clinical narrative: Patient states that both of her feet became numb on Friday night (two days after her shot).  The right foot remained numb for about 4 hours and the left foot did not resolve until the next morning.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient got two fluad vaccines on 2 separate dates: 8/7/24 and 9/3/24.
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had received original RSV dose on 9/27/2023. which was discovered after administration.  This vaccine only requires a single dose and there is no indication for a 2nd dose.  Discussed with patient before she left and advised her to notify us with any adverse reactions
Age: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: About 5 or 10 minutes after the vaccine was given the patient began to feel dizzy and fell and hit his head.  He sat for about 20-30 minutes before requesting an ambulance.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Cough
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vision blurred
Clinical narrative: 15 minutes after receiving Pfizer Comirnaty vaccine, patient complained of stiffness on both sides of neck between shoulder and jaw and said his vision was unclear. 45 min after vaccine, patient said his vision was better and stiffness less.  He said he would followup with his physician.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: I have general Osteoarthritis in various joints. The morning after the vaccine around 4 am I awoke with significant pain in my left elbow joint.  I have never had pain in my left elbow joint before so this was totally new and appeared to be "out of the blue." I suspected perhaps it was from my immune system kicking up with the vaccine. I also got flu shot at the same time in right arm, but that is not new, I did the two together last year as well with no reaction. I took an Aleve and one 325 mg aspirin but couldn't get back to sleep. The pain continued throughout the day and I had to ice my elbow, rest, and take Aleve again. I'm writing this the day of event.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neuralgia, Pain
Clinical narrative: PATIENT HAD SORENESS AT INJECTION SITE IN DELTOID BUT WAS ADDITIONALLY HAVING STINGING AND STABBING NERVE PAIN UNDERNEATH THE TRICEP EVERY 15 MINUTES FOR THE FIRST DAY AFTER RECEIVING THE VACCINE.  IT WORSENED WHEN PATIENT WOULD LIFT HER ARM. PAIN IS THE SAME BUT NOT OCCURRING AS OFTEN ON THIRD DAY AFTER VACCINE.  PATIENT DOES HAVE AN APPOINTMENT PLANNED WITH HER PHYSICIAN ON 9/5/24 AND SHE WILL DISCUSS SIDE EFFECTS WITH PROVIDER DURING HER APPOINTMENT.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Immediate post-injection reaction, Limb discomfort, Paraesthesia
Clinical narrative: Immediately after vaccination patient felt tingling and heaviness in left arm.  After walking around both arms and legs felt heavy and he had difficulty breathing.  Patient went to a local emergency room.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: (patient has had moderna only prior to this event) Immediately after administering the vaccine, the patient began to sweat and feel nausea. Pharmacist administered 25 mg diphenhydramine to patient and provided water as well as a snack. Pharmacist stayed with patient for the next 15 minutes while patient returned to normal feeling.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no side effects. patient was under 18. Flublok trivalent 2024-25 is for patients 18 and up. Patient's mother says the patient has not experienced any side effects from receiving the flublok vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: STILL WAITING IF THERE IS ANY ADVERSE EVENT
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Syncope
Clinical narrative: patient returned to pharmacy counter 5 min after receiving vaccine. patient was syncope for 10 seconds. off duty paramedic assisted pharmacist on scene. Patient woke up and was alert & oriented and breathing normally. skin color returned to normal. EMS was called. EMS arrived and transported patient to local hospital for further evaluation. No treatment was given on site at pharmacy
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Eye swelling, Oral mucosal eruption, Rash, Respiratory tract congestion
Clinical narrative: Coughing, congestion, rash around mouth and back of neck, swelling of face and eyes.  All happened within 30 minutes of receiving MMR
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: Coughing, congestion, rash around mouth and back of neck, swelling of face and eyes.  All happened within 30 minutes of receiving MMR
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Left shoulder start hurting 2nd vaccine never stop. Now August 2024 Dr game me meds for pain -  January 25, 2024 (MMR - Shingles injection 2nd injection March 22, 2024. Left shoulder starting to hurt more through left arm down to hand and fingers. Called doctor  sore fingers went to urgent care x-rays - meds - MRI.
Sex: M
Vaccine: HEP, HEP
Symptoms: Death, Life support, Pulse absent, Resuscitation, Unresponsive to stimuli
Clinical narrative: Infant fed normally that afternoon and evening.  He last fed at 1 am and parents put him down to sleep.  They woke up at 7 am to find infant unresponsive, dusky, purple color and pulseless.  They took him to ER where CPR was initiated but patient remained in asystole.  Time of death was called at 0812 per ER records.
Sex: M
Vaccine: HEP, HEP
Symptoms: Cardiac arrest, Death, Pulse absent, Resuscitation, Skin discolouration
Clinical narrative: Infant fed normally that afternoon and evening.  He last fed at 1 am and parents put him down to sleep.  They woke up at 7 am to find infant unresponsive, dusky, purple color and pulseless.  They took him to ER where CPR was initiated but patient remained in asystole.  Time of death was called at 0812 per ER records.
Sex: M
Vaccine: HEP, HEP
Symptoms: Unresponsive to stimuli
Clinical narrative: Infant fed normally that afternoon and evening.  He last fed at 1 am and parents put him down to sleep.  They woke up at 7 am to find infant unresponsive, dusky, purple color and pulseless.  They took him to ER where CPR was initiated but patient remained in asystole.  Time of death was called at 0812 per ER records.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid infection after vaccination
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: covid infection after vaccination
Sex: F
Vaccine: RSV, RSV
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiffness in her face and hands/Muscle stiffness/felt stiff all over; muscle pain; patient has myotonia, a muscle disease she has had her entire life/something set it off; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 77-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Aug2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Paramyotonia" (ongoing); "myotonia" (ongoing), notes: lack of muscle relax. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, for immunization, reaction(s): "no issues". The following information was reported: MYALGIA (non-serious) with onset Aug2024, outcome "unknown", described as "muscle pain"; MYOTONIA (non-serious) with onset Aug2024, outcome "unknown", described as "patient has myotonia, a muscle disease she has had her entire life/something set it off"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Aug2024, outcome "unknown", described as "stiffness in her face and hands/Muscle stiffness/felt stiff all over". Therapeutic measures were taken as a result of musculoskeletal stiffness, myotonia. Additional information: patient said she got the RSV vaccine 2 and a half weeks ago she wanted to know what the side effects are. She has underlying muscle disease and she felt stiff all over. She mentioned that she has been experiencing muscle stiffness and muscle pain since receiving the vaccine. These are symptoms she had experienced previously due to paramyotonia, but she noted that she had not experienced them for a long time until she took the vaccine. She mentioned that certain things trigger her condition, such as medicine, food, stress, etc. She described her experience as a "horrible situation" and wants to confirm if muscle stiffness and muscle pain are listed adverse events of the vaccine. The patient has myotonia, a muscle disease she has had her entire life. Certain factors can trigger her condition. She believed her mistake was taking a vaccine. After receiving the flu vaccine with no issues, she then took the RSV vaccine. She mentioned that she is experiencing stiffness in her face and hands, which are the usual symptoms she gets from her muscle disease. However, something set it off, and she doesn't know what to do at this point. She mentioned that she is taking Baclofen as a muscle relaxer.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: RSV, RSV
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: stiffness in her face and hands/Muscle stiffness/felt stiff all over; muscle pain; patient has myotonia, a muscle disease she has had her entire life/something set it off; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 77-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Aug2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Paramyotonia" (ongoing); "myotonia" (ongoing), notes: lack of muscle relax. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, for immunization, reaction(s): "no issues". The following information was reported: MYALGIA (non-serious) with onset Aug2024, outcome "unknown", described as "muscle pain"; MYOTONIA (non-serious) with onset Aug2024, outcome "unknown", described as "patient has myotonia, a muscle disease she has had her entire life/something set it off"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Aug2024, outcome "unknown", described as "stiffness in her face and hands/Muscle stiffness/felt stiff all over". Therapeutic measures were taken as a result of musculoskeletal stiffness, myotonia. Additional information: patient said she got the RSV vaccine 2 and a half weeks ago she wanted to know what the side effects are. She has underlying muscle disease and she felt stiff all over. She mentioned that she has been experiencing muscle stiffness and muscle pain since receiving the vaccine. These are symptoms she had experienced previously due to paramyotonia, but she noted that she had not experienced them for a long time until she took the vaccine. She mentioned that certain things trigger her condition, such as medicine, food, stress, etc. She described her experience as a "horrible situation" and wants to confirm if muscle stiffness and muscle pain are listed adverse events of the vaccine. The patient has myotonia, a muscle disease she has had her entire life. Certain factors can trigger her condition. She believed her mistake was taking a vaccine. After receiving the flu vaccine with no issues, she then took the RSV vaccine. She mentioned that she is experiencing stiffness in her face and hands, which are the usual symptoms she gets from her muscle disease. However, something set it off, and she doesn't know what to do at this point. She mentioned that she is taking Baclofen as a muscle relaxer.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Additional AE/No PQC.; 12-month-old received both PROQUAD and VARIVAX on the same day; This spontaneous report was received from a registered nurse and refers to a 12-month-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 20-AUG-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 mL, lot number X009731 with expiration date 30-SEP-2024 and a dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot number X021931 with expiration date 29-AUG-2025 (dose, route and anatomical location were not reported) for prophylaxis (inappropriate schedule of product administration). No Additional adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Incorrect dose administered, Myalgia
Clinical narrative: Low fever (99.3); chills; body aches; Joint pain; Muscle pain; Inappropriate dose of vaccine administered; This non-serious case was reported by a consumer and described the occurrence of fever in a 56-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-AUG-2024, the patient received Shingles vaccine. On 13-AUG-2024, an unknown time after receiving Shingles vaccine, the patient experienced inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). On 14-AUG-2024, the patient experienced fever (Verbatim: Low fever (99.3)), chills (Verbatim: chills), general body pain (Verbatim: body aches), joint pain (Verbatim: Joint pain) and muscle pain (Verbatim: Muscle pain). On 14-AUG-2024, the outcome of the fever, chills, general body pain, joint pain and muscle pain were resolved. The outcome of the inappropriate dose of vaccine administered was not reported.   It was unknown if the reporter considered the fever, chills, general body pain, joint pain and muscle pain to be related to Shingles vaccine.     It was unknown if the company considered the fever, chills, general body pain, joint pain and muscle pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-AUG-2024 The patient self-reported this case for himself. The patient received Shingles vaccine. The patient had low fever (99.3), chills, body aches in joints and muscles. The patient reported that the symptoms were not treated. The patient received 50 mcg dose of Shingles vaccine which led to inappropriate dose of vaccine administered.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HBV (Engerix B Junior) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 16-AUG-2024, the patient received the 1st dose of Engerix B Junior. On 16-AUG-2024, an unknown time after receiving Engerix B Junior, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-AUG-2024 The nurse reported that, a dose of expired Energix-B was administered which led to expired vaccine used.  The expiration date was June 2024.  The nurse asked was there a great potential for potency loss, would the individual need re-vaccinated.  The nurse reported that was the first of the 3 dose series.  The nurse reported that the expiration date was June 2024 but upon checking in the batch number identifier, the expiration date was 12th May 2024 (as entered with the suspect vaccine). This case was linked with US2024104003, reported by same reporter.; Sender's Comments:  US-GSK-US2024104003:Same reporter/different patient
Sex: M
Vaccine: COVID19
Symptoms: Anti-glomerular basement membrane antibody, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody, Antinuclear antibody
Clinical narrative: ANCA-associated vasculitis following COVID-19 vaccination; This is a literature report for the following literature source(s).  A 23-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (medically significant), 14 days after the suspect product(s) administration, outcome "unknown", described as "ANCA-associated vasculitis following COVID-19 vaccination". The symptoms and clinical findings included Acute kidney injury (AKI), weakness, fatigue and weight loss and affected organs included kidney: crescentic glomerulonephritis. The patient underwent the following laboratory tests and procedures: Anti-glomerular basement membrane antibody: Positive; Antineutrophil cytoplasmic antibody: Positive; Antinuclear antibody: Positive.; Sender's Comments: Given the compatible time association, the reasonable possibility that the reported event is related to BNT162b2 administration cannot be completely excluded. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 40.0
Sex: M
Vaccine: HPV9, VARZOS
Symptoms: Injection site pain, Laboratory test
Clinical narrative: Right arm pain at injection site (right deltoid), present constantly through at least 8/30/2024.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Approximately 65 hours post-vaccination with the Moderna 2024-2025 COVID-19 vaccine, multiple itchy hives appeared on the left upper arm and forearm, with one possible lesion on the back. The hives persisted for four days, with a reduction in size and intensity starting on day two. No systemic symptoms were observed.
Age: 1.75
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Gait disturbance, Injection site pain
Clinical narrative: Pain at injection site - difficulty walking/limping on right leg after PCV 20 vaccine was given in this leg the day before. On examination, the injection site looked normal with no signs of infection/abscess.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024  The patient developed shingles after receiving the vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine Shingrix. Herpes zoster  is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Arthropod bite, Herpes zoster, Neuralgia, Ophthalmic herpes zoster, Pain
Clinical narrative: Suspected vaccination failure; Shingles in right eye; Shingles all around the right side of my forehead and; spider bit in eyebrow; painful case of shingles; hitting the tri nerve in the face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In JUN-2024, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in right eye) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: Shingles all around the right side of my forehead and), insect bite nos (Verbatim: spider bit in eyebrow), pain (Verbatim: painful case of shingles) and nerve pain (Verbatim: hitting the tri nerve in the face). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster, facial herpes zoster, insect bite nos, pain and nerve pain were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, facial herpes zoster, insect bite nos, pain and nerve pain to be related to Shingrix.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix. It was unknown if the company considered the facial herpes zoster, insect bite nos, pain and nerve pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 The patient daughter was the reporter. The patient had the vaccines for Shingles. In June this year a spider bit the patient in the eyebrow, hitting the tri nerve in the face and ended up with the most painful case of shingles in patient right eye and all around the right side of forehead and throughout the scalp.  There are many different variants of the shingles virus and the vaccine does not help.  The reporter reported that not kidding, that is what patient was told at the emergency room. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccine schedule, clinical description, medical history and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles in right eye; Shingles all around the right side of my forehead and; spider bit in eyebrow; painful case of shingles; hitting the tri nerve in the face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In JUN-2024, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in right eye) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: Shingles all around the right side of my forehead and), insect bite nos (Verbatim: spider bit in eyebrow), pain (Verbatim: painful case of shingles) and nerve pain (Verbatim: hitting the tri nerve in the face). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster, facial herpes zoster, insect bite nos, pain and nerve pain were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, facial herpes zoster, insect bite nos, pain and nerve pain to be related to Shingrix.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix. It was unknown if the company considered the facial herpes zoster, insect bite nos, pain and nerve pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 The patient daughter was the reporter. The patient had the vaccines for Shingles. In June this year a spider bit the patient in the eyebrow, hitting the tri nerve in the face and ended up with the most painful case of shingles in patient right eye and all around the right side of forehead and throughout the scalp.  There are many different variants of the shingles virus and the vaccine does not help.  The reporter reported that not kidding, that is what patient was told at the emergency room. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccine schedule, clinical description, medical history and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.