chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, UNK, UNK
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Inbound call from HCP regarding GARDASIL 9. HCP states that she gave the first dose of GARDASIL 9 to her 18 year old male patient on Tuesday 6MAY2025 and the patient experienced immediate syncope. The patient then laid down and the syncope resolved w; This spontaneous report was received from a Nurse Practitioner and refers to a 18-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 06-May-2025, the patient started therapy with Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (TDAP), (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot number, and expiration date were not reported), as prophylaxis. The patient started therapy with meningococcal vaccine (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot number, and expiration date were not reported), as prophylaxis; it was reported that the patient did not experience any immediate symptoms with those vaccines. On the same date, a few minutes after, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) lot #Y007197, expiration date: 18-Aug-2026, 0.5ml, administered by Intramuscular route, first dose, (strength, frequency, vaccination scheme, and anatomical location were not reported), as Human Papillomavirus (HPV) prevention.  On the same date, the patient experienced immediate syncope. The patient then laid down and the syncope resolved within 15 minutes. The patient sought medical attention and had been treated for the event.  The causal relationship between the event syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) was reported as related, but unknown with the other suspect vaccines.   Upon internal review, the event was determined to be important medical event.  This is one of four reports from the same reporter.
Age: 1.08
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report TE where one patient received a dose of VARIVAX after stored improperly; This spontaneous report was received from 09-MAY-2025 and refers to a 13-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 09-MAY-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z002625, expiration date: 09-JAN-2027), dose: 0.5 mL (route and dose number were not reported) and with sterile diluent (MERCK STERILE DILUENT), 0.5 mL (route, dose number, lot # and expiration date were not reported) for prophylaxis (Product storage error).  The administered dose of the vaccine experienced a temperature excursion 7.1 Fahrenheit for 1-hour hour with no previous excursions. There was no adverse effect reported.
Age: 36.0
Sex: M
Vaccine: TYP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administered typhim vi subcutaneously instead of the recommended intramuscular route with no reported ae; Initial information received on 12-May-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 36 years old male patient who was administered Typhoid Vi Polysaccharide Vaccine [Typhim Vi] subcutaneously instead of the recommended intramuscular route 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Tdap) and Tetanus Vaccine (Tetanus B) for Immunisation.  On 12-May-2025, the patient received 0.5ml (once) dose of suspect Typhoid Vi Polysaccharide Vaccine, Solution for injection, Strength standard, lot X1A271M and expiry date 31-Mar-2026 for immunization via subcutaneous route in the left triceps instead of the recommended intramuscular route with no reported adverse event (incorrect route of product administration) (Latency same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 years old received Daptacel on not approved age group with no reported adverse event; Initial information received on 13-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7-year-old female patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] to not approved age group 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 06-May-2025, the 7 years old patient received a 0.5 (ml) dose (dose 5) of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection strength: standard, frequency: once of lot 3CA20C1 and expiry date: 28-Feb-2026 via intramuscular route in the left arm for Immunization to not approved age group with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  Reportedly, She further asked if a Tdap (Tetanus, Diphtheria, and acellular Pertussis) would have to be given.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Blood test normal, Computerised tomogram normal, Dizziness, Fatigue
Clinical narrative: Within 10 minutes pain going up left arm into head. Headache. Headache 24 hours per day every day since then. Bouts of lightheadedness, constant fatigue,  food sensitivities including dairy and gluten, muscle spasms in right pointer finger and calfs, whole body pain. Constant migraines with aura (no previous migraines). Sensitivity to sound, ringing in the ears, light sensitivity, slow heart rate, low blood pressure, Dysautonomia
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Gluten sensitivity, Headache, Heart rate decreased, Hyperacusis, Hypotension
Clinical narrative: Within 10 minutes pain going up left arm into head. Headache. Headache 24 hours per day every day since then. Bouts of lightheadedness, constant fatigue,  food sensitivities including dairy and gluten, muscle spasms in right pointer finger and calfs, whole body pain. Constant migraines with aura (no previous migraines). Sensitivity to sound, ringing in the ears, light sensitivity, slow heart rate, low blood pressure, Dysautonomia
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Migraine with aura, Milk allergy, Muscle spasms, Pain
Clinical narrative: Within 10 minutes pain going up left arm into head. Headache. Headache 24 hours per day every day since then. Bouts of lightheadedness, constant fatigue,  food sensitivities including dairy and gluten, muscle spasms in right pointer finger and calfs, whole body pain. Constant migraines with aura (no previous migraines). Sensitivity to sound, ringing in the ears, light sensitivity, slow heart rate, low blood pressure, Dysautonomia
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Photophobia, Tinnitus
Clinical narrative: Within 10 minutes pain going up left arm into head. Headache. Headache 24 hours per day every day since then. Bouts of lightheadedness, constant fatigue,  food sensitivities including dairy and gluten, muscle spasms in right pointer finger and calfs, whole body pain. Constant migraines with aura (no previous migraines). Sensitivity to sound, ringing in the ears, light sensitivity, slow heart rate, low blood pressure, Dysautonomia
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Dysarthria, Feeling abnormal, Impaired work ability, Laboratory test
Clinical narrative: I didn?t WANT to get this Vax. But, as a CCMA at an Internal Medicine practice, also in another area, I was UNDERSTOOD That we were to all get  it. I?m a single Mom. Since I had drug allergies, I had to wait the 15 minutes following each time I went. Within  2 hours, I felt very ill, after the first vax on 01/08/2021. I understand the science behind how my cells were doing what they allegedly were supposed to do. Within a week, I began to have an intermittent tremor, causing difficulty to sleep chart when rooming patients. The P.A. whom I was working with,  had been causing a lot of stress for me. She  couldn?t keep a MA because of how difficult she was. So in Feb 11, 2021,  by then I?d developed trouble speaking, finding words, ?spacing out?, life became difficult.  I was hospitalized on 07/09/2021. I thought I was having a stroke in the middle of clinic.  It was terrifying! I have documentation, pictures, I even LOST THE JOB THST I GOT VACCINATED FOR!! They fired me. My life has been garbage since. I?d love to tell you the whole story.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of employment, Malaise, Stress at work, Tremor
Clinical narrative: I didn?t WANT to get this Vax. But, as a CCMA at an Internal Medicine practice, also in another area, I was UNDERSTOOD That we were to all get  it. I?m a single Mom. Since I had drug allergies, I had to wait the 15 minutes following each time I went. Within  2 hours, I felt very ill, after the first vax on 01/08/2021. I understand the science behind how my cells were doing what they allegedly were supposed to do. Within a week, I began to have an intermittent tremor, causing difficulty to sleep chart when rooming patients. The P.A. whom I was working with,  had been causing a lot of stress for me. She  couldn?t keep a MA because of how difficult she was. So in Feb 11, 2021,  by then I?d developed trouble speaking, finding words, ?spacing out?, life became difficult.  I was hospitalized on 07/09/2021. I thought I was having a stroke in the middle of clinic.  It was terrifying! I have documentation, pictures, I even LOST THE JOB THST I GOT VACCINATED FOR!! They fired me. My life has been garbage since. I?d love to tell you the whole story.
Sex: M
Vaccine: CHOL
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Bedridden, Death, Injection site bruising, Malaise
Clinical narrative: My father was complaining about pain in his arm within an hour of taking his vaccine, was complaining about not feeling well within 4-5 hours after, was vomiting continuously within 15 hours of getting his vaccine, and was dead within 60 hours. He was bed ridden for the two days following the vaccine and stayed that way until he passed in the early hours of November 21st. On the second day of severe illness he contacted the transplant department of hospital (they were the doctors that made this vaccine mandatory for further treatment) and they assured him it was normal for adverse reactions to pass after 48 hours and due to that he decided to wait it out instead of going to the hospital. He died in his bed that night. He had a bruise in his right deltoid where he got the vaccine at the time of his death.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: My father was complaining about pain in his arm within an hour of taking his vaccine, was complaining about not feeling well within 4-5 hours after, was vomiting continuously within 15 hours of getting his vaccine, and was dead within 60 hours. He was bed ridden for the two days following the vaccine and stayed that way until he passed in the early hours of November 21st. On the second day of severe illness he contacted the transplant department of hospital (they were the doctors that made this vaccine mandatory for further treatment) and they assured him it was normal for adverse reactions to pass after 48 hours and due to that he decided to wait it out instead of going to the hospital. He died in his bed that night. He had a bruise in his right deltoid where he got the vaccine at the time of his death.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site reaction, Muscle swelling, Nausea
Clinical narrative: Headache rated 6/10, with nausea, mild swelling of L deltoid muscle.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Pruritus, Swelling
Clinical narrative: Swelling of arm @ injection site, swelling into chest wall & into hand.   Patient reports with a reaction to the pneumonia vaccine (5/12/2025). Saw her PCP and was given a pneumonia vaccine last week. She has developed redness on her left arm. The swelling and redness has increased. Arm has been itchy and she is having pain. It's trending a little worse with time. She has tried Advil and took some Benadryl. Denies fever and chills.  Patient reports further spread of redness today (5/13/2025), so I'm sending in a prescription to start her on Keflex.
Age: 67.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Body temperature increased, Internal haemorrhage, Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: Swelling in the left shoulder, Temp - 103 internal bleeding of my arm (shoulder to wrist) intense pain & stiffness.  Emergency room visit 2xs.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Choking, Cough, Dyspnoea, Fatigue
Clinical narrative: Left arm pain, redness and swelling at site and pain to elbow. I had fatigue. Pain in arm lasted 3 to 3 1/2. I had muscle pain and more joint pain at 6 am 3-8 I woke up coughing and coking had so much mucus thought I would choke and couldn't get breath, lasted 2 hours then went back to bed. Monday at 4AM on 10th woke up choking with mucus again couldn't get breath and coughing.   I had the RSV shot 3-6-25. My left arm hurt, got swollen and felt warm. Continued til Tuesday 3-11. It still feels like my upper left arm is swollen or has a knot. I felt fatigued for a long time and muscle and joint pain. I woke up coughing and choking Saturday 3-8. I had so much mucus I thought I would choke to death - I couldn't breath for choking. That lasted 2 hours then I went back to bed after coughing up the mucus. Then Monday 3-10 at 4AM I woke up choking with mucus again and couldn't get breath - coughing so hard, spitting up mucus. I've had lots of mucus since shot. My left arm hurt clear to elbow. I did not go to hospital or doctor - I just got up and coughed it out. I should have never let my doctor talk us in to this RSV shot. It compromises your immune system for 3 weeks and is not very effective. It's useless! You are supposed to only get one shot ever but then I read only good for 18 months or 2 years. I received no written information from my doctor so went in next day 3-7 and asked for some printed information on this shot and found out it was Pfizer.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Left arm pain, redness and swelling at site and pain to elbow. I had fatigue. Pain in arm lasted 3 to 3 1/2. I had muscle pain and more joint pain at 6 am 3-8 I woke up coughing and coking had so much mucus thought I would choke and couldn't get breath, lasted 2 hours then went back to bed. Monday at 4AM on 10th woke up choking with mucus again couldn't get breath and coughing.   I had the RSV shot 3-6-25. My left arm hurt, got swollen and felt warm. Continued til Tuesday 3-11. It still feels like my upper left arm is swollen or has a knot. I felt fatigued for a long time and muscle and joint pain. I woke up coughing and choking Saturday 3-8. I had so much mucus I thought I would choke to death - I couldn't breath for choking. That lasted 2 hours then I went back to bed after coughing up the mucus. Then Monday 3-10 at 4AM I woke up choking with mucus again and couldn't get breath - coughing so hard, spitting up mucus. I've had lots of mucus since shot. My left arm hurt clear to elbow. I did not go to hospital or doctor - I just got up and coughed it out. I should have never let my doctor talk us in to this RSV shot. It compromises your immune system for 3 weeks and is not very effective. It's useless! You are supposed to only get one shot ever but then I read only good for 18 months or 2 years. I received no written information from my doctor so went in next day 3-7 and asked for some printed information on this shot and found out it was Pfizer.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Secretion discharge
Clinical narrative: Left arm pain, redness and swelling at site and pain to elbow. I had fatigue. Pain in arm lasted 3 to 3 1/2. I had muscle pain and more joint pain at 6 am 3-8 I woke up coughing and coking had so much mucus thought I would choke and couldn't get breath, lasted 2 hours then went back to bed. Monday at 4AM on 10th woke up choking with mucus again couldn't get breath and coughing.   I had the RSV shot 3-6-25. My left arm hurt, got swollen and felt warm. Continued til Tuesday 3-11. It still feels like my upper left arm is swollen or has a knot. I felt fatigued for a long time and muscle and joint pain. I woke up coughing and choking Saturday 3-8. I had so much mucus I thought I would choke to death - I couldn't breath for choking. That lasted 2 hours then I went back to bed after coughing up the mucus. Then Monday 3-10 at 4AM I woke up choking with mucus again and couldn't get breath - coughing so hard, spitting up mucus. I've had lots of mucus since shot. My left arm hurt clear to elbow. I did not go to hospital or doctor - I just got up and coughed it out. I should have never let my doctor talk us in to this RSV shot. It compromises your immune system for 3 weeks and is not very effective. It's useless! You are supposed to only get one shot ever but then I read only good for 18 months or 2 years. I received no written information from my doctor so went in next day 3-7 and asked for some printed information on this shot and found out it was Pfizer.
Age: 84.0
Sex: F
Vaccine: COVID19, PNC20, VARZOS
Symptoms: Feeding disorder, Pain in extremity, Skin warm
Clinical narrative: Patient is hot Patient can not eat Arm is sore
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: patient fainted 5 mins after vaccine was given
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Haematochezia
Clinical narrative: After first dose of Rotateq, mom states that child had blood in his stool
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematemesis
Clinical narrative: After second dose of Rotateq, child had blood in vomit. Second time having rotateq but had a similar reaction with first dose and have blood in his stool
Age: 78.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient got Arexvy in October of 2023 but this was unknown to pharmacy and patient had forgotten. Presented at pharmacy on 5/14/25 wanting Arexvy vaccine and it was administered after patient verbally stated they had never received one. Discovered after the fact that dose in May was a duplication of the single-dose series. Patient does not report any unexpected side effects at this time.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Rash with raised red bumps on both arms.  Patient called the pharmacy and explained her reaction to me.  I advised she take Diphenhydramine orally and apply Hydrocortisone 1% cream topically.  I called her the next morning and she said her rash was just about completely resolved.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pain in extremity, Product administered at inappropriate site, Weight bearing difficulty
Clinical narrative: Vaccine given in shoulder.  Several hours later began experiencing pain in right arm up to neck.  Could not raise arm without extreme pain.  Cannot lift anything.
Age: 50.0
Sex: F
Vaccine: PNC21, TDAP, VARZOS
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Drug withdrawal syndrome, Fatigue
Clinical narrative: Patient reports that when she woke up on 5/7/2025 (day following her injections) she was weak, had body aches, throwing up with stomach cramps, did not eat for 2 days, fatigue, with a headache. Patient also reports that she was unable to get up to take her medication and had a gabapentin withdrawal.
Age: 50.0
Sex: F
Vaccine: PNC21, TDAP, VARZOS
Symptoms: Headache, Pain, Vomiting
Clinical narrative: Patient reports that when she woke up on 5/7/2025 (day following her injections) she was weak, had body aches, throwing up with stomach cramps, did not eat for 2 days, fatigue, with a headache. Patient also reports that she was unable to get up to take her medication and had a gabapentin withdrawal.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Serious body pain (joints & muscles), moderate headache, mild pain/swelling at injection site.
Age: 1.25
Sex: F
Vaccine: PNC20
Symptoms: Agitation, Erythema, Injection site cellulitis, Pyrexia, Swelling
Clinical narrative: 5/12/25 -Received Shot - Had Normal redness and swelling. 5/13/25 woke up with a different redness/ swelling pattern in the same area I, the parent, Circled said "swollen area" for observation. Child was not bothered.  Same day after dinner,  baby spiked a fever of 101.6 and was agitated as expected- Administered Tylenol for fever. 5/14- I noticed at her first diaper change upon waking up- the swollen area doubled in size, and was now spreading toward her groin.
Age: 1.25
Sex: F
Vaccine: PNC20
Symptoms: Ultrasound scan
Clinical narrative: 5/12/25 -Received Shot - Had Normal redness and swelling. 5/13/25 woke up with a different redness/ swelling pattern in the same area I, the parent, Circled said "swollen area" for observation. Child was not bothered.  Same day after dinner,  baby spiked a fever of 101.6 and was agitated as expected- Administered Tylenol for fever. 5/14- I noticed at her first diaper change upon waking up- the swollen area doubled in size, and was now spreading toward her groin.
Age: 65.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient received MenQuadfi/Bexsero on 03/13/25 while inpatient hospital. HCP referred patient to another facility on 04/23/25 for completion doses of MenQuadfi/Trumenba and they were administered on 05/13/25  at home with nursing.
Age: 1.0
Sex: M
Vaccine: PNC15, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: TDAP  was given in lieu of the needed DTAP.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Vaqta Hepatitis A vaccine (5/14/25) that expired on 5/11/25, 3 days out of date. No reactions noted at this time, no plans to have pt return for redose at this time.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event, no treatment needed, outcome good.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cranial nerve paralysis, Dysarthria, Magnetic resonance imaging head normal, Pulmonary function test, Scan with contrast normal
Clinical narrative: She had the 2nd vaccine a month later. 3 months after the 1st  vaccine (reported info above)  and 2 months after the 2nd vaccine booster (info available in her medical record), she had sudden onset of dysarthria. Has had full neurological work up and no progression or improvement. Idiopathic cranial nerve palsy is diagnosis at this time, but due to proximity of the vaccines to this neurological condition, M.D. felt obligated to report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swallow study
Clinical narrative: She had the 2nd vaccine a month later. 3 months after the 1st  vaccine (reported info above)  and 2 months after the 2nd vaccine booster (info available in her medical record), she had sudden onset of dysarthria. Has had full neurological work up and no progression or improvement. Idiopathic cranial nerve palsy is diagnosis at this time, but due to proximity of the vaccines to this neurological condition, M.D. felt obligated to report.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Measles antibody, Rash, Urticaria
Clinical narrative: Developed extensive urticarial rash on trunk, face, extremities on 4/17/25. Seen at ED on 4/18/25. Seen for follow-up in office on 4/25/25.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Dyspnoea, Nausea
Clinical narrative: Client reports that 4 hours after taking dose 1 he experienced SOB that felt like "my lungs were being folded" and some nausea. Client called requesting for advice on the following day. At time of call, symptoms had resolved and client was instructed to discontinue this medication. Client was instructed to seek emergency medical care if he experienced further symptoms of allergic reaction.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Hot flush, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 1 inch raised welp located at the site of administration Tender to touch Slight swelling Hot flashes Feels bad in general nausea
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Urticaria
Clinical narrative: 1 inch raised welp located at the site of administration Tender to touch Slight swelling Hot flashes Feels bad in general nausea
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC20, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: office called to state they gave the patient an expired dose of Pedvaxhib vaccine -expired on 5/10/25.  No AE at this time.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: extreme rash on left arm
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Rash on right leg about 1-1.5 hours following immunizations.  Video provided by mother shows 3-4 small erythematous papules to right lower leg.
Age: 60.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Arthralgia, Cellulitis, Chills, Erythema, Injection site erythema
Clinical narrative: Patient reported on 5/13/25 that her left shoulder was swollen, painful, red and itchy. Triage nurse spoke with the patient and the patient explained the area was warm to the touch, even more swollen and painful and had chills the previous day. The nurse recommended the patient to visit out urgent care clinic. Patient visited the urgent care clinic and was evaluated. The findings was a 7X8 cm area of slightly raised, erythematous ovular shaped nonindurated skin at the left deltoid, minimally tender. DDX: delayed hypersensitivity reaction, cellulitis. Antihistamine was recommended over the next few days and if it did not resolve the patient was instructed to return for reconsideration of antibiotics.
Age: 60.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site pain, Injection site swelling, Joint swelling, Pruritus, Skin warm
Clinical narrative: Patient reported on 5/13/25 that her left shoulder was swollen, painful, red and itchy. Triage nurse spoke with the patient and the patient explained the area was warm to the touch, even more swollen and painful and had chills the previous day. The nurse recommended the patient to visit out urgent care clinic. Patient visited the urgent care clinic and was evaluated. The findings was a 7X8 cm area of slightly raised, erythematous ovular shaped nonindurated skin at the left deltoid, minimally tender. DDX: delayed hypersensitivity reaction, cellulitis. Antihistamine was recommended over the next few days and if it did not resolve the patient was instructed to return for reconsideration of antibiotics.
Age: 60.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: Patient reported on 5/13/25 that her left shoulder was swollen, painful, red and itchy. Triage nurse spoke with the patient and the patient explained the area was warm to the touch, even more swollen and painful and had chills the previous day. The nurse recommended the patient to visit out urgent care clinic. Patient visited the urgent care clinic and was evaluated. The findings was a 7X8 cm area of slightly raised, erythematous ovular shaped nonindurated skin at the left deltoid, minimally tender. DDX: delayed hypersensitivity reaction, cellulitis. Antihistamine was recommended over the next few days and if it did not resolve the patient was instructed to return for reconsideration of antibiotics.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was 7 years old at the time of receiving Infanrix. Patient should have received first dose of Tdap instead. No adverse event.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hip arthroplasty, Loss of consciousness
Clinical narrative: PASS OUT / LOSE CONSCIOUSNESS TWICE THE DAY OF THE VACCINE, AND THE NEXT DAY, AND THEN ONCE AGAIN AFTER A SURGERY
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Colleague was administered varicella vaccine despite having a previous immune titer on record. Call placed to candidate the following day confirming she had no reaction to recieving vaccine.
Age: 2.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave HPV9 to a child younger than 9years old which is outside the recommended age range.  Mother informed of error and Vaccine Information Sheet (VIS) on HPV9 given to mother.  Informed mother that IAP was calling CDC for information now and that HD would let her know what they said.  No adverse reaction noted during 45 min wait period after vaccine given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction on right thigh. Entirely thigh is swollen from hip to knee, especially outer thigh. Area is red, hard, and warm to touch and she reports it is itchy and doesn?t feel good.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Injection site reaction on right thigh. Entirely thigh is swollen from hip to knee, especially outer thigh. Area is red, hard, and warm to touch and she reports it is itchy and doesn?t feel good.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Injection site pain
Clinical narrative: Terrible pain at injection site. Approx. one year of extremely heavy bleeding during menstrual cycle. Went from having cramps maybe once a year during my period to having them every single month. 4 years later, the heavy bleeding has stopped, but my pain persists. I once had a healthy period, and I have not had the same periods ever since vaccination.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: Received vaccine 05/13/2025 in the AM. 05/14/2025 AM staff notified us she had area of redness, swelling, warmth, itching, and tenderness. Picture sent to primary care provider who ordered Augmentin 875/125 BID X 7 days.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Started getting seizures 3 months after receiving the vaccine
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient was inadvertently given 2 menquadfi 1 in left arm other in right arm
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Limb discomfort
Clinical narrative: On 05/09/2025 - Participant was vaccinated on the left arm at 1534. 10 minutes into the 15-minute observation period, at approximately 1544, participant reported a "heavy feeling" in their left arm as well as a "mild, sharp chest pain" that lasted 5-10 seconds and immediately disappeared after. Participant vitals were assessed by nurses and vitals were documented as followed: 99.1 F; 98% Oxygen Saturation; 110/75 Blood Pressure. Participant was monitored for additional 25 minutes and during the additional observation, the participant did not report any additional symptoms. Towards the end of the additional observation period, participant stated: "I am feeling fine, this is probably just my anxiety."
Age: 34.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Abdominal pain upper, Nausea, Pruritus, Sensation of foreign body, Urticaria
Clinical narrative: Patient was advised to remain in clinic 15-20 minutes post immunization. Patient presented to front desk at 4:11 PM stating she was feeling nauseous. RN brought patient back to room and patient verbalized nauseous and epigastric pain. Vaccine ordering provider notified by RN and provider assessed patient. VS taken - WNL. Patient seen by another provider for treatment. Patient's symptoms progressed to itchiness and hives on bilateral arms, bilateral hands, and chest around 4:35-4:40PM. Ice packs given for comfort. Oral Benadryl administered at 4:43 PM per provider's orders. Patient verbalized "feeling lump in throat". Patient alert and oriented x4 and ambulating independently. Oxygen saturation monitored continuously - between 95-100%. EMS/911 called and arrived at clinic around 4:55PM. Patient taken to hospital for further treatment and per chart review discharged to home.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema multiforme
Clinical narrative: Pt was diagnosed with erythema multiforme on 5/13.  Unknown if related to HPV vaccine on 5/2.  Provider and Parent wanted to report potential reaction
Age: 20.0
Sex: M
Vaccine: FLU3, HEPA, TDAP
Symptoms: Underdose
Clinical narrative: Patient came into the office to discuss vaccines needed for his trip to (redacted). Dr. ordered him to have Vaqta (ped/adolescent), Adacel, & Flubok. It was later discovered that patient received Vaqta pediatric/adolescent 0.5mL instead of the Adult version which would be 1mL. We contacted the manufacturer who said this is an error and that dose not count for the patient and he would need to be revaccinated unless we wanted to do serology studies on the patient. I presented this to our vaccine director who instructed us to make the patient aware of what happen and revaccinate him with the correct dose. Patient has been contacted to received the correct dose of Vaqta.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Patient has red irritated mark on arm where vaccine was administered.  He stated that it has been over 3 weeks since vaccination and it is still irritated.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: Intermittent, diffuse hives all over body and face for 1 month
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Gait disturbance, Headache, Influenza virus test negative, Pain, Pain in extremity
Clinical narrative: 2-3 hours after the TDaP vaccine was given, patient started having a severe headache, body ache, bilateral thigh pain, which make it difficult for him to walk, and fever that rose as high as 105.1.    He experienced no local reaction in his Left deltoid region.  His parent took him to ED for evaluation on 5/14/25.   After tests were negative for Flu, Covid and UTI,  the ED staff diagnosed patient with a post-vaccine fever.    on 5/15/25 ,  I talked with his mother, who reported that fever had stopped after ER visit and that he was feeling better
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: 2-3 hours after the TDaP vaccine was given, patient started having a severe headache, body ache, bilateral thigh pain, which make it difficult for him to walk, and fever that rose as high as 105.1.    He experienced no local reaction in his Left deltoid region.  His parent took him to ED for evaluation on 5/14/25.   After tests were negative for Flu, Covid and UTI,  the ED staff diagnosed patient with a post-vaccine fever.    on 5/15/25 ,  I talked with his mother, who reported that fever had stopped after ER visit and that he was feeling better
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site urticaria, Pain
Clinical narrative: severe body ackes for two full days and nights, headache for one week, redness at injection site the turned to a large hive encompassing my left bicept for seven days, itching off and on for several days.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Injected limb mobility decreased, Joint range of motion decreased, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: Dead arm/weakness, immobile arm of injection, persistent pain, reduced range of motion, inflammation, impairment to quality of life. I went back to the doctor's office who gave the injection a month later (11/14/2022), they referred me to Physical Therapy. I did physical therapy on my arm/ shoulder from 11/17/2022-1/23/2023. I felt some relief after physical therapy with the occasional discomfort, pain and immobility. over the last two months 3/2025-5/2025 I have had severe immobility, and reduced range of motion effecting my daily activities and causing severe pain. On 5/15/2025 I went to an orthopedic doctor and they diagnosed me with SIRVA and suggested a cortisone shot. They administered the shot on 5/15/2025.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Pain in extremity, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: Dead arm/weakness, immobile arm of injection, persistent pain, reduced range of motion, inflammation, impairment to quality of life. I went back to the doctor's office who gave the injection a month later (11/14/2022), they referred me to Physical Therapy. I did physical therapy on my arm/ shoulder from 11/17/2022-1/23/2023. I felt some relief after physical therapy with the occasional discomfort, pain and immobility. over the last two months 3/2025-5/2025 I have had severe immobility, and reduced range of motion effecting my daily activities and causing severe pain. On 5/15/2025 I went to an orthopedic doctor and they diagnosed me with SIRVA and suggested a cortisone shot. They administered the shot on 5/15/2025.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Pain
Clinical narrative: patient stated that he's had a painful knott, he came to the pharmacy today 5/15/25 while he received his vaccine on 5/6/25. he was wondering if this should last this long, i told him no it should last no longer than 2-3 days. he said he will check with his dr
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Rash
Clinical narrative: Hep B injection given in right leg at time of birth.  Parents reported in a recent office visit for the patient, that vaccine has caused painful,  persistent subcutaneous bumps.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Haemorrhage, Muscle spasms
Clinical narrative: Healthy first pregnancy until fetus died. Went to hospital at 35 weeks and 2 days pregnant because abnormal bleeding and cramps. Tdap vaccine recieved at 32 weeks pregnant. At hospital found no heart beat. Expected delivery was January 23, 2025. Stillborn birth weight was 1701 grams.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pathology test, Stillbirth
Clinical narrative: Healthy first pregnancy until fetus died. Went to hospital at 35 weeks and 2 days pregnant because abnormal bleeding and cramps. Tdap vaccine recieved at 32 weeks pregnant. At hospital found no heart beat. Expected delivery was January 23, 2025. Stillborn birth weight was 1701 grams.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Asthenia, Blood glucose decreased, Blood urine present, Eye movement disorder
Clinical narrative: The morning following his immunizations he began experiencing a stomach ache. He ate a normal breakfast. He had no fever and no vomiting. He was laying down on the couch because he felt ill. Mother runs a daycare and when a daycare aide was asked to check on him she immediately notified mother something was wrong. Mother found him frothing at the mouth and without strength when trying to stand him up. His eyes rolled back into his head and he was shaking rhythmically. No bladder or bowel incontinence. Felt very tired afterwards. Felt fine when in the Emergency Department and has been at baseline since then.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Fatigue, Foaming at mouth, Full blood count normal, Malaise, Metabolic function test normal
Clinical narrative: The morning following his immunizations he began experiencing a stomach ache. He ate a normal breakfast. He had no fever and no vomiting. He was laying down on the couch because he felt ill. Mother runs a daycare and when a daycare aide was asked to check on him she immediately notified mother something was wrong. Mother found him frothing at the mouth and without strength when trying to stand him up. His eyes rolled back into his head and he was shaking rhythmically. No bladder or bowel incontinence. Felt very tired afterwards. Felt fine when in the Emergency Department and has been at baseline since then.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Tremor
Clinical narrative: The morning following his immunizations he began experiencing a stomach ache. He ate a normal breakfast. He had no fever and no vomiting. He was laying down on the couch because he felt ill. Mother runs a daycare and when a daycare aide was asked to check on him she immediately notified mother something was wrong. Mother found him frothing at the mouth and without strength when trying to stand him up. His eyes rolled back into his head and he was shaking rhythmically. No bladder or bowel incontinence. Felt very tired afterwards. Felt fine when in the Emergency Department and has been at baseline since then.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Skin warm
Clinical narrative: Sore. And warm
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Expired product administered
Clinical narrative: pt was given an expired vaccine.  provider was then notified. then I notified the patient.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: HCP reports she has a 38 year old patient who previously received 2 doses of the GARDASIL series about 18-20 years ago. The patient missed her 3rd dose of GARDASIL and did not complete the vaccine series. No further details. No additional AE/ No PQC.; No additional AE; This spontaneous report was received from a healthcare professional (reported as a certified midwife) regarding a 38-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On unknown dates (reported as about 18-20 years ago), the patient was vaccinated with the first and second doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), administered as prophylaxis (strengths, doses, routes of administration, anatomical sites of injection, lot numbers and expiration dates were not reported for any dose).  The reporter stated that the patient missed her third dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) and did not complete the vaccine series (Inappropriate schedule of product administration). No additional adverse events were reported.
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other AE; patient who received a 3rd dose of MMR-II yesterday (13MAY2025) and  should've only received two doses.; This spontaneous report has been received from a consumer or other non-health professional regarding to a 11-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 17-APR-2025, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), then on 13-MAY-2025, then on an unspecified date in 2025, she received the second dose, both at a dose of 0.5 milliliter as prophylaxis (vaccination scheme, route of administration, anatomical site of injection, lot number and  expiration date were not reported). On 13-MAY-2025, the patient received the third dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Extra dose administered) at a dose of 0.5 ml, as prophylaxis, lot number y018154 which had been verified to be an invalid number (vaccination scheme, route of administration, and anatomical site of injection, were not reported). No additional adverse events were reported in the patient.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: She is 47 years old  and yesterday, 04-May-2025, she received priorix subcutaneously; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received MMR (Priorix) for prophylaxis.   On 04-MAY-2025, the patient received Priorix (subcutaneous). On 04-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: She is 47 years old  and yesterday, 04-May-2025, she received priorix subcutaneously). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 05-MAY-2025 The reporter was the husband.  The patient was the reporter's wife, and She was 47 years old.  The reporter did not want to share her exact date of birth or her MD contact information.  He did give permission for GSK to contact him via letter but did not want to provide his email address.  Consumer reported that yesterday, 04-May-2025, she received Priorix subcutaneously, which led to Inappropriate age at vaccine administration. Reporter did not have access to the lot number because the paperwork she was given did not include the lot number. The reporter was not certain if his wife had prior MMR injections in the past as a child; he assumes that she did. However, she was going to be traveling internationally soon and so it was recommended she receive a Priorix dose prior to travel.; Sender's Comments:  US-GSK-US2025055147:same reporter,different patient 1 of 2 report