chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Ocular hyperaemia, Pain in jaw, Rash
Clinical narrative: high BP; high HR; palm rash; cough; jaw pain; then lock jaw; blood shot eyes; joint aches; blisters; The initial case was missing the following minimum criteria: No Specified AE. Upon receipt of follow-up information on 20Dec2024, this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Feb2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2013 (unspecified if ongoing). There were no concomitant medications. The following information was reported: HYPERTENSION (hospitalization, medically significant), outcome "recovered", described as "high BP"; HEART RATE INCREASED (hospitalization, medically significant), outcome "recovered", described as "high HR"; RASH (hospitalization, medically significant), outcome "recovered", described as "palm rash"; COUGH (hospitalization, medically significant), outcome "recovered"; PAIN IN JAW (hospitalization, medically significant), outcome "recovered", described as "jaw pain"; TRISMUS (hospitalization, medically significant), outcome "recovered", described as "then lock jaw"; OCULAR HYPERAEMIA (hospitalization, medically significant), outcome "recovered", described as "blood shot eyes"; ARTHRALGIA (hospitalization, medically significant), outcome "recovered", described as "joint aches"; BLISTER (hospitalization, medically significant), outcome "recovered", described as "blisters". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; Heart rate: High. Therapeutic measures were taken as a result of hypertension, heart rate increased, rash, cough, pain in jaw, trismus, ocular hyperaemia, arthralgia, blister. Clinical course: The patient reported that she received a dose of the Comirnaty (2023-2024) vaccine on Feb2024 and she developed symptoms that required hospitalization due to the severe reaction to the vaccine. The patient experienced adverse event after taking a Pfizer product. The patient taking was not taking any other medications within 2 weeks prior to the event onset.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Trismus
Clinical narrative: high BP; high HR; palm rash; cough; jaw pain; then lock jaw; blood shot eyes; joint aches; blisters; The initial case was missing the following minimum criteria: No Specified AE. Upon receipt of follow-up information on 20Dec2024, this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Feb2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2013 (unspecified if ongoing). There were no concomitant medications. The following information was reported: HYPERTENSION (hospitalization, medically significant), outcome "recovered", described as "high BP"; HEART RATE INCREASED (hospitalization, medically significant), outcome "recovered", described as "high HR"; RASH (hospitalization, medically significant), outcome "recovered", described as "palm rash"; COUGH (hospitalization, medically significant), outcome "recovered"; PAIN IN JAW (hospitalization, medically significant), outcome "recovered", described as "jaw pain"; TRISMUS (hospitalization, medically significant), outcome "recovered", described as "then lock jaw"; OCULAR HYPERAEMIA (hospitalization, medically significant), outcome "recovered", described as "blood shot eyes"; ARTHRALGIA (hospitalization, medically significant), outcome "recovered", described as "joint aches"; BLISTER (hospitalization, medically significant), outcome "recovered", described as "blisters". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; Heart rate: High. Therapeutic measures were taken as a result of hypertension, heart rate increased, rash, cough, pain in jaw, trismus, ocular hyperaemia, arthralgia, blister. Clinical course: The patient reported that she received a dose of the Comirnaty (2023-2024) vaccine on Feb2024 and she developed symptoms that required hospitalization due to the severe reaction to the vaccine. The patient experienced adverse event after taking a Pfizer product. The patient taking was not taking any other medications within 2 weeks prior to the event onset.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Encephalopathy, Neuropathy peripheral
Clinical narrative: neurological symptoms such as neuropathy; Encephalopathy; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ENCEPHALOPATHY (disability, medically significant) with onset Feb2022, outcome "unknown"; NEUROPATHY PERIPHERAL (disability, medically significant), outcome "not recovered", described as "neurological symptoms such as neuropathy". Therapeutic measures were taken as a result of encephalopathy, neuropathy peripheral. Clinical course: Patient had covid booster in Dec2021, experienced onset of Encephalopathy in Feb2022. Need cane to walk and hearing aids. Been experiencing neurological symptoms such as neuropathy, robotic voice, cognitive issues, etc since onset. Difficulty maintaining adequate work and unable to drive due to coordination issues for over a year.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400332243 same reporter/ product, different patient/ events;
Age: 62.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient experienced tired on the first day. patient came back 3 days later and there was swelling and redness at injection site and then pt experiences pain that is spreading to the neck, back and hand. recommended pt to visit emergency to have treatment asap
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No actual adverse event.  Pt was administered a Flu vaccine inadvertently because the pt stated that she had not received the flu vaccine yet, but once documented it was found that a flu vaccine had been given by another facility.  Pt states that she believes it was Covid vaccine that she received 2 months prior and not a flu vaccine.  Pt stated she would follow up with that other provider.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Injection site developed with a rash the size of a silver dollar to extending 5 inches in length and 3 inches in width. It was swollen and was heated to the touch.
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: pt reports injection site pain in her left arm after flu vaccine on 12/13/2024. It is much more painful than flu shots she has received in the past. There is no swelling or redness. She reports aching. I suspect that it was injected into the SQ based on where is is indicating (she is pointing to the posterior mid upper arm, triceps region rather than deltoid), although it is possible it hit a nerve or bone. We use a 1inch needle so SQ is likely than bone. I recommended NSAIDs and APAP.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Endotracheal intubation, Guillain-Barre syndrome, Headache, Immunoglobulin therapy
Clinical narrative: one week after vaccine developed fever, myalgias, headache, nausea, one week after (about 2 weeks post vaccination) while traveling developed Gullian-Barre with respiratory failure, required tracheostomy, intubated in ICU 4 weeks, treated plasmapheresis, IVIG; symptoms mostly resolved now
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Intensive care, Myalgia, Nausea, Plasmapheresis, Pyrexia
Clinical narrative: one week after vaccine developed fever, myalgias, headache, nausea, one week after (about 2 weeks post vaccination) while traveling developed Gullian-Barre with respiratory failure, required tracheostomy, intubated in ICU 4 weeks, treated plasmapheresis, IVIG; symptoms mostly resolved now
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Respiratory failure, Tracheostomy
Clinical narrative: one week after vaccine developed fever, myalgias, headache, nausea, one week after (about 2 weeks post vaccination) while traveling developed Gullian-Barre with respiratory failure, required tracheostomy, intubated in ICU 4 weeks, treated plasmapheresis, IVIG; symptoms mostly resolved now
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client did not receive age appropriate vaccine. Moderna ( Spikevax )12 + administered instead of Moderna 6 mo -11 yo vaccine
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Extra dose administered, Nausea, Pyrexia
Clinical narrative: Patient given Covid Vaccine instead of Pneu. (Capvaxine). Patient had his last covid shot 09/19/2024. Patient started running a high fever and chills around 2:30Am on 12/27/2024. He became dizzy and his vision was blurry. Patient also felt nausea. Patient said that he was feeling better arouond 6:30pm on 12.27.2024
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Wrong product administered
Clinical narrative: Patient given Covid Vaccine instead of Pneu. (Capvaxine). Patient had his last covid shot 09/19/2024. Patient started running a high fever and chills around 2:30Am on 12/27/2024. He became dizzy and his vision was blurry. Patient also felt nausea. Patient said that he was feeling better arouond 6:30pm on 12.27.2024
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient came in the morning after injection and stated her are swelled, redness around the injection site  and warm to touch.  She also stated she felt liquid running down her arm at the time of injection but didn't think it was blood.
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second dose of Prevnar 20
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED FLU SHOT AT OUR LOCATION ON 10/17/24. PATIENT DID NOT DISCLOSE THEY RECEIVED A FLU SHOT AT THEIR PROVIDER'S OFFICE IN SEPTEMBER. PATIENT DID NOT REPORT ANY NEGATIVE EFFECTS FROM THIS EVENT.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: Day 1: Sore throat and some nasal congestion. Day 2: More congestion, fatigue, headache, slight fever, some coughing. Day 3: Increased in strength of all symptoms.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Day 1: Sore throat and some nasal congestion. Day 2: More congestion, fatigue, headache, slight fever, some coughing. Day 3: Increased in strength of all symptoms.
Age: 12.0
Sex: U
Vaccine: COVID19, FLU3, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna 6m-11year old formula was given to 12 year old Patient No complants. Parent was informed
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Exposure during pregnancy, Injection site pain, Skin warm, Vomiting
Clinical narrative: Hot to the touch; some vomiting; pain at the injection site; Shortness of breath; This is a spontaneous report received from an Other HCP from a sales representative.  A 26-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Nov2024 as dose 1, single (Lot number: LG9827) at the age of 26 years, in right deltoid for maternal immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "heart murmur" (unspecified if ongoing); "fibroids" (unspecified if ongoing); "herniated discs" (unspecified if ongoing). Date of last menstrual period: 09Mar2024. The patient was 32 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12Jan2025. Concomitant medication(s) included: IRON; VITAMINS NOS. Past drug history included: Amoxicillin, reaction(s): "Hypersensitivity". The following information was reported: FEELING HOT (non-serious) with onset 19Nov2024, outcome "recovered" (20Nov2024), described as "Hot to the touch"; DYSPNOEA (non-serious) with onset 19Nov2024, outcome "recovered" (20Nov2024), described as "Shortness of breath"; VACCINATION SITE PAIN (non-serious) with onset 19Nov2024, outcome "recovered" (20Nov2024), described as "pain at the injection site"; VOMITING (non-serious) with onset 19Nov2024, outcome "recovered" (20Nov2024), described as "some vomiting". It was unknown if therapeutic measures were taken as a result of feeling hot, vomiting, vaccination site pain, dyspnea.  Additional Information: The patient did not receive any other vaccines on the same date and within 4 weeks prior to the suspect vaccine.   No follow-up attempts are possible.
Age: 45.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: extreme redness at injection site as well as pain that lasted a week; extreme redness at injection site as well as pain that lasted a week; This is a spontaneous report received from a Physician from a sales representative.  A 45-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Nov2024, outcome "recovered" (Dec2024) and all described as "extreme redness at injection site as well as pain that lasted a week". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site pain.  Additional information: Reported event: Patient experienced extreme redness at injection site as well as pain that lasted a week. No known allergies reported. The patient was not received any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient was not received any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. It was unknown that the patient was taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: PNC20
Symptoms: Ageusia, Dysgeusia
Clinical narrative: lost his sense of taste; food tastes funny; This is a spontaneous report received from an Other HCP, Program ID.  A 72-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Feb2023 as dose number unknown 0.5 ml, single (Batch/Lot number: unknown) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset Jan2024, outcome "unknown", described as "food tastes funny"; AGEUSIA (non-serious) with onset Jan2024, outcome "unknown", described as "lost his sense of taste".  Additional information: patient reported since Jan2024 he had lost his sense of taste. patient stated that food tastes funny. patient stated that to his knowledge he never had covid.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feel really bad; This is a spontaneous report received from an Other HCP, Program ID.  A 43-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Aug2024 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete: unknown manufacturer), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2024, outcome "unknown", described as "feel really bad".  Additional information: patient reports that whenever they get the vaccine it makes them feel really bad. no further information provided.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site pain
Clinical narrative: still experiencing pain from the administration of adacel; Initial information received on 23-Dec-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 29 years old female patient who is still experiencing pain from the administration of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Polio vaccine inact 3v (Vero) (Ipol) for Immunisation.  On 30-Nov-2024, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (strength not reported) (lot U8264AA; Expiry date: 31-Aug-2026) via intramuscular route in the left arm for Immunization.  On an unknown date the patient still experiencing pain from the administration of adacel (vaccination site pain) (unknown latency).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (still experiencing pain from the administration of adacel).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event still experiencing pain from the administration of adacel.
Age: 25.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Heart rate increased, Pain, Pyrexia
Clinical narrative: I had fever, body aches, extreme exhaustion in the week following the vaccine. In the month following I have had worsening increased heartrate, frequently above 100 bpm when at rest. Previously my awake resting heartrate was around 75 bpm. Minor exercise also elevates it to around 120 bpm.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Acute tinnitus in right ear
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Musculoskeletal disorder, Pain
Clinical narrative: Prevar, Flyuzone Trivalent was the shots, mother could not use her limbs right after the shots, and in intense pain
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract infection
Clinical narrative: Developed a respiratory infection; when I filled out weekly CDC follow up form it said I should complete this form though I doubt that there is any connection.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: EXTRA DOSE OF HIGH DOSE FLU SHOT GIVEN TO PATIENT. HE RECEIVED A DOSE 11/21/24 AND ANOTHER DOSE 12/19/24
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Supraventricular tachycardia
Clinical narrative: SVT, went to the ER and received adenosine and  2 sodium chloride.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Purpura, Rash
Clinical narrative: Pityriasis rosea?puritic rash began on upper torso then spread to both upper extremities as far as wrists, and both lower extremities just below knees.  ? Herald patch
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache Chills Fever Muscle aches
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Herpes zoster, Pain, Sleep disorder
Clinical narrative: I ha  They also told me to purchase Alocane Max, 4 % Lidocained the Vaccine on December 3, and on December 21, I had a pain filled sleepless night.  My husband took me to the MD Now Urgent Care Center where I was diagnosed with Shingles and given a 7 day Prescription for Valacyclovir. 1 Gram Tablet, 3 times/day.  I was also told to buy Alocane Max, 2% Lidocane Lotion and Calamine Lotion for the sores.  After 6 days I was still in a lot of pain, I couldn't sleep and lost my appitite.  This time I went to my Determologist and he wrote a Compounding Prescription for C-Lidocaine-10%/Prilocaine10% Cream.  I have used it the past 24 hours, and there is some improvement in the Pain Level and I have slept for more than an hour without waking up.  I will meet with my Determologist on Monday for follow up.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Duplicate flu vaccines given in 2024. One was given 9-8-24 and the other 12-2-24. No side effects or reports from the patient.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Mild case of shingles in same spot as Covid shot.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Anger, Appetite disorder, Blood test, Disturbance in attention
Clinical narrative: Extreme hyperactivity within one hour of taking the shot with inability to self-regulate, increase in behaviors, rash on arm (reported to Dr) within 2-3 days and worsening behavior, intrusive thoughts, inability to focus, rage, emotional dysregulation, elopement, change in appetite, and sudden change in behavior at school (unable to attend beginning Oct 11, 2024 and medically homebound since Oct 22, 2024), complaints of head pressure. Blood tests and exams show potential etiologies for encephalopathy and inflammation.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Emotional disorder, Head discomfort, Intrusive thoughts, Loss of personal independence in daily activities, Patient elopement
Clinical narrative: Extreme hyperactivity within one hour of taking the shot with inability to self-regulate, increase in behaviors, rash on arm (reported to Dr) within 2-3 days and worsening behavior, intrusive thoughts, inability to focus, rage, emotional dysregulation, elopement, change in appetite, and sudden change in behavior at school (unable to attend beginning Oct 11, 2024 and medically homebound since Oct 22, 2024), complaints of head pressure. Blood tests and exams show potential etiologies for encephalopathy and inflammation.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Psychomotor hyperactivity, Rash
Clinical narrative: Extreme hyperactivity within one hour of taking the shot with inability to self-regulate, increase in behaviors, rash on arm (reported to Dr) within 2-3 days and worsening behavior, intrusive thoughts, inability to focus, rage, emotional dysregulation, elopement, change in appetite, and sudden change in behavior at school (unable to attend beginning Oct 11, 2024 and medically homebound since Oct 22, 2024), complaints of head pressure. Blood tests and exams show potential etiologies for encephalopathy and inflammation.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: This was his second rsv shot, we checked state Records , no documentation, we checked active profile, no documentation, no duplicate dur message on rx , insurance did not flag as duplicate. Clinical services sent email that he did indeed receive an arexvy shot 9-15-2023
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Death
Clinical narrative: Resident expired 12/23/2024  unexpectedly
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Duplicate vaccine given; first dose given 12/2023.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient came into the pharmacy and said that she still has a lot of arm pain since receiving the flu vaccine 14 days ago.  It has lessened since receiving it but has not gone away.  She said when she was injected that she could feel the vaccine going in as if it had hit a nerve.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Gait disturbance, Headache, Nausea, Vomiting
Clinical narrative: On 12/28, pt reported Nausea and vomiting, headache, and difficulty walking and stated she had to see her doctor 3 times.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: headache, nausea, muscle/joint pain, fever, tired
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache, nausea, muscle/joint pain, fever, tired
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: The patient received a Fluad shot, but afterwards said he already had a flu shot this year on November 11, 2024
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Magnetic resonance imaging normal, Mobility decreased, Neck pain, Pain
Clinical narrative: Woke up two weeks after first dose of vaccine and could hardly move due to severe neck and arm pain.  Went to the doctor the following Monday and received a steroid shot and was put on a steroid pack. Doctor thought I may have a slipped disc.  Proceeded to get second dose of vaccine and the same thing happened again only the pain was extensively worse. Ended up getting another steroid shot in the shoulder and also had a MRI which showed nothing was wrong. Have continued with severe shoulder/arm pain that also radiates down entire right side.  Over next several months, health continued to decline.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Woke up two weeks after first dose of vaccine and could hardly move due to severe neck and arm pain.  Went to the doctor the following Monday and received a steroid shot and was put on a steroid pack. Doctor thought I may have a slipped disc.  Proceeded to get second dose of vaccine and the same thing happened again only the pain was extensively worse. Ended up getting another steroid shot in the shoulder and also had a MRI which showed nothing was wrong. Have continued with severe shoulder/arm pain that also radiates down entire right side.  Over next several months, health continued to decline.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received 1st rsv vaccine on 9/25/23.  Patient received the same vaccine again on 12/27/24. The 2nd vaccine was not appropriate given guidelines
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion, Dyspnoea, Fatigue, Myocarditis
Clinical narrative: Lots of breath. Severely tired. Had to have Pacemaker put in.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: There is severe pain on the left side of my shoulder down to my hand. I cannot move as I want . This happens after I took the COVID injection
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: patient came into today with a red 2 inch circular area on left deltoid, slightly raised with a small circle resembling the inject safe bandaid used for immunization, stated she had headache and felt achy in her bones.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Behaviour disorder, Blood immunoglobulin G, Brain fog, Cerebral haemorrhage
Clinical narrative: Fatigue, brain fog, rapid heartbeat, heart palpitations if engaging in strenuous exercise, depression, anxiety, behavioral disorder (crowding myself with things); Hyperbaric oxygen therapy, supplements (nattokinase, LDN, curcumin, quercetin), nicotine patches; I still don't feel better
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Heart rate increased, Magnetic resonance imaging head abnormal, Palpitations
Clinical narrative: Fatigue, brain fog, rapid heartbeat, heart palpitations if engaging in strenuous exercise, depression, anxiety, behavioral disorder (crowding myself with things); Hyperbaric oxygen therapy, supplements (nattokinase, LDN, curcumin, quercetin), nicotine patches; I still don't feel better
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest X-ray, Dyspnoea, Infection, Influenza like illness
Clinical narrative: Caused a infection that was flu like and had a severe breathing episode where I could barely breathe. Hospital said it was an infection that lead to pneumonia. It wasn't COVID or the flu. Not contagious they said
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza virus test negative, Pneumonia, SARS-CoV-2 test negative
Clinical narrative: Caused a infection that was flu like and had a severe breathing episode where I could barely breathe. Hospital said it was an infection that lead to pneumonia. It wasn't COVID or the flu. Not contagious they said
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Back pain, Musculoskeletal stiffness, Pain
Clinical narrative: Patient reports that after getting the vaccine her shoulder has become stiff and there is pain that has radiated towards her back.  Patient reported that right after getting vaccine she did a lot of yard work clearing leaves and that she does not know if the stiffness and pain in her back is still from the vaccine or her yard work. It was recommended that she gets her shoulder checked out by her PCP.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: High fever of 104 started 0600 December 28th a.m. in addition to rash that started on face then spread to neck then chest and back then extremities, rash started with fever.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: Localized hives developed about 1 inch below injection site (not including injection site) about 26 hours post injection.  Treated so far with a couple dose of oral antihistamine and topical antihistamine due to the hives increasing in size. No anaphylactic symptoms.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: Fever, body aches, migraine
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Computerised tomogram normal, Fontanelle bulging, Lethargy, Lumbar puncture, Mental status changes
Clinical narrative: Child had bulging fontanelle, lethargy and change in mental status, and projectile vomiting within 24 hours of receiving the vaccines. Parents brought child to the ER with concerns. No viral or bacterial infection was found in the infant's spinal fluid, CT scan came back normal. It was ruled as an adverse reaction.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Vomiting projectile
Clinical narrative: Child had bulging fontanelle, lethargy and change in mental status, and projectile vomiting within 24 hours of receiving the vaccines. Parents brought child to the ER with concerns. No viral or bacterial infection was found in the infant's spinal fluid, CT scan came back normal. It was ruled as an adverse reaction.
Age: 68.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Computerised tomogram, Full blood count, Headache, Metabolic function test, Vomiting
Clinical narrative: Recurrent headaches which are resistant to medication starting 2-3 weeks after vaccination.  They last for approximately a month.  I have had these from the first COVID vaccination through this one, with the exception of #7 (out of 8).  #1-6 were Pfizer, #7 was Moderna (switched to see if the headaches were specific to Pfizer).  No headaches following #7, but the headaches started 12/6 and are continuing, with one severe enough to send me to the emergency room.  I had headaches from age 4 through approximately age 55 - always treatable with aspirin or ibuprofen if started early, or terminated with vomiting if I didn't catch them early enough.  They ended at menopause - for more than a decade until the first COVID vaccination.  Because they didn't start immediately after vaccination, it took me a while to realize the connection.  Unlike my prior headaches (likely migraines), these new headaches are resistant to nearly all medications, and have persisted through at least 5 bouts of vomiting.  They are still primarily (but not exclusively) in the location of the headaches I had through menopause.  Unlike my prior headaches, these are nearly constant for around a month.  Prior to going to the ER, I tried ibuprofen, aspirin, acetaminophen, oxycodone, and tramadol.  At the ER they administered droperidol (no response) and diphenhydrAMINE, keTORolac, and prochlorperazine, which finally ended the headache.  Since then I have had headaches approximately half of the days and have used diphenhydramine, prochlorperazine, acetaminophen, and gabapentin.  I currently still have a headache (12/29/2024)
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Groin pain, Inflammation
Clinical narrative: Approximately 1 week after vaccination, I experienced inflammation and possible infection of lower urinary tract and/or prostate area.  I travelled out of the country so did not have access to medical care.  Still experience ing  pain in groin,  slight elevated temperature, but urine is clear ( not cloudy or any sign of blood).  Pain in oerineum area as well.  Never experienced this.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient stated injection on 12/21/24 was painful, his arm was sore almost immediately after vaccination, and it has been getting worse over the last 8 or so days. He said it is very sore and now he can almost not lift up his arm. He has been taking ibuprofen for the last three days (including today) with little effect on his symptoms. No other symptoms present, no fever or chills. He plans to go to the emergency room this afternoon for evaluation.
Age: 11.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: on 11/7/2024 patient due for Meningitis, Flu, and Tdap. Menquadi, Fluzone, & Pediarix administered. Patient had no problems at time of administration or until discovery of error on 12/13/2024 when notified. Notified the State and spoke with (Redacted). Patient does not need Tdap repeated.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Posterior capsule opacification
Clinical narrative: R eye posterior  capsular opacification
Sex: U
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Cough, Influenza virus test negative, Laboratory test normal, SARS-CoV-2 test negative
Clinical narrative: Persistent unproductive cough that can be severe especially when talking. This has happened about 7 times out of 10 flu vaccinations. Lasts for over a month typically. Severe enough that I will not be taking flu shot regularly unless my health declines.
Age: 85.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient had a local reaction on the right arm to the Fluad flu shot. She had dark bruising on her arm. There was no inflammation, redness or swelling. Vaccination location was correct based on observation of the site of reaction. Patient did not have decreased movement of arm but did have pain in arm for up to 2 weeks after vaccination. No reaction on left arm.
Age: 69.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of the Prevnar 20 which is only a 1 shot series. He received one on 10/04/2023 and 12/23/2024
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Cardiac monitoring, Central nervous system lesion, Computerised tomogram normal, Echocardiogram normal, Embolic stroke
Clinical narrative: Embolic stroke;
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: Embolic stroke;
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Influenza like illness, Oropharyngeal pain, Pain
Clinical narrative: Flu like symptoms, sore throat, body aches, headaches, chills
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Vaccination error. Patient has already received RSV vaccine in January 2024. Patient thought this was a yearly vaccine and we didn't realize he had already received it.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient didn't have adverse effects but was given Arexvy for the second time accidentally. He is aware and didn't experience any adverse effects.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Nodule, Pain in extremity
Clinical narrative: pt stated approximately 3 weeks after receiving flu shot he had a knot in his arm and pain, went to doctor and they told him the shot possibly hit a tendon, gave him at home exercises to try and work it out but did not help, pt started physical therapy 12/27/24 for issue per conversation 12/29/24 345pm
Age: 65.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash pruritic
Clinical narrative: Entire arm below the injection site was red, swollen, and warm to the touch. Patient reported itchy rash appeared the evening of the injection. Injection site its self was not red or raised. Recommended ice pack and hydrocortisone cream for itching. Recommended to see PCP if symptoms get worse.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Developed Gillian Barre Syndrome
Age: 70.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second dose of the arexvy (rsv) vaccine. The CDC only recommends 1 dose of this vaccine at this time.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Hypoaesthesia, Paraesthesia
Clinical narrative: patient has tingling , numbness like ant crawling the whole right arm that last 30 seconds and then stop and then start again every 15 minutes. It started 2 weeks after getting the shingrix vaccines.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Ocular discomfort, Swelling face
Clinical narrative: I took 1 Benadryl 25mg 45 minutes before vaccination.  Reactions were red cheeks slightly swollen cheeks, and pressure behind left eye.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Seizure
Clinical narrative: Less than one week from my 2024 covid booster I was hospitalized for seizures. Doctors have not determined a cause and I've never had health issues before.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Other Vaccines:  VaccineTypeBrand: engerix b; Manufacturer: GSK; LotNumber: 4T39P; Route: IM; BodySite: Lt deltoid; Dose: 1; VaxDate: 11/25/2024
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Myalgia, Night sweats, Pyrexia
Clinical narrative: significant injection site soreness; Fever; muscle pain; night sweats; Site soreness has discolored his arm in a 2.5 centimeter circle; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension and barrett's esophagus. Concomitant products included lisinopril and omeprazole.   On 25-NOV-2024, the patient received the 2nd dose of Shingrix (unknown arm). In NOV-2024, an unknown time after receiving Shingrix, the patient experienced injection site discoloration (Verbatim: Site soreness has discolored his arm in a 2.5 centimeter circle) and night sweat (Verbatim: night sweats). On 25-NOV-2024, the patient experienced injection site pain (Verbatim: significant injection site soreness), fever (Verbatim: Fever) and muscle pain (Verbatim: muscle pain). The outcome of the injection site pain, fever and muscle pain were resolving and the outcome of the injection site discoloration and night sweat were not reported.   It was unknown if the reporter considered the injection site pain, injection site discoloration, fever, muscle pain and night sweat to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site discoloration, fever, muscle pain and night sweat to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-NOV-2024 The patient self-reported this case for himself.  The patient said he was healthy. He received a dose of Shingrix and experienced fever, significant injection site soreness and muscle pain. The patient said that site soreness had discolored his arm in a 2.5-centimeter circle.  The patient developed a fever 12 hours after injection.  Second day, he experienced more fever resulting in night sweats. Less than a week after received Shingrix, the patient experienced night sweat. Less than a day after received Shingrix, the patient experienced injection site pain and muscle pain. The symptoms were treated.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient never receives indicated 2nd dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient never receives indicated 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-NOV-2024 The physician asked about the efficacy of only 1 dose of shingrix. The patient never received indicated 2nd dose. No other information was provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first SHINGRIX dose in November 2023. He has not yet had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 01-NOV-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first SHINGRIX dose in November 2023. He has not yet had the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-DEC-2024 The patient received his first Shingrix dose in November 2023.  He had not yet had the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 40-year-old male patient who received HBV (Engerix B) (batch number AX2D5, expiry date 07-DEC-2024) for prophylaxis.   On 09-DEC-2024, the patient received Engerix B. On 09-DEC-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-DEC-2024 The reporter reported that an expired dose of Engerix-B was administered to a patient, which led to expired vaccine used. The reporter consented to follow up.
Age: 39.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL was administered post-excursion with no reported adverse event; Initial information received on 20-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to US-SA-2024SA380129.  This case involves 39 years old male patient who was administered IPV (VERO) [IPOL] post-excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis a vaccine inact (Havrix) for Immunisation; Diphtheria vaccine toxoid, Tetanus vaccine toxoid (Tenivac) for Immunisation; Influenza vaccine inact split 3v (Flulaval) for Immunisation; and Elasomeran (Spikevax) for COVID-19 immunisation.  On 18-Dec-2024, the patient was administered a standard dose 2 (0.5 ml once) of suspect IPV (VERO) Suspension for injection (lot W1C741M, expiry date- 17-NOV-2025) via intramuscular route in unknown administration site for Immunization; post-excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Nurse/vaccine manager called to report a temperature excursion for Punctured IPOL, Reason: Unknown Max/low temperature reached & Duration: Unit 1 max: she said max temperature stayed at normal range; Low: 1.81°C, for 7 minutes, unit 2:- Max: she said stayed at normal range- 19Dec2024: Low:1.75°C for 4 minutes- 18Dec2024: Low: 1.75°C for 4 minutes. Previous Excursion-None. Human error-  Unknown. Treatment: None  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-2024SA380129:02350498