chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: given an expired act-hib vaccine with no reported adverse event; Initial information received on 01-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 15 months old female patient who was administered expired HIB (PRP/T) Vaccine [ACT-HIB] 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, HIB VACCINE CONJ (TET TOX), Pertussis Vaccine Acellular 5-Component, Polio Vaccine INACT 3V (MRC 5), Tetanus Vaccine Toxoid (Pentacel); and Pneumococcal Vaccine (Pneumococcal Vaccine); both for Prophylactic vaccination.  On 01-Apr-2024, the patient had received 0.5 ml (dose: 4) of suspect HIB (PRP/T) Vaccine (lot UJ863AA, frequency: once, strength: standard, expiration date: 25-Mar-2024) via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Swollen, bruised, red lump on R thigh
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Balance disorder, Blood pressure fluctuation, Blood test normal, Brain fog
Clinical narrative: Nervous system constant shooting systematically through my body. Muscles cramps.  Body shaking, heart banging in chest with blood pressure up and down, EXHAUSTION,  blood pulse in head, tinnitus much louder, ANXIETY in core, left 3 small toes numb and soles of both feet numb. brain fog, brain working at 60%, vision not like before vaccine. Off balance
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac stress test, Computerised tomogram head normal, Condition aggravated, Electrocardiogram ambulatory, Fatigue
Clinical narrative: Nervous system constant shooting systematically through my body. Muscles cramps.  Body shaking, heart banging in chest with blood pressure up and down, EXHAUSTION,  blood pulse in head, tinnitus much louder, ANXIETY in core, left 3 small toes numb and soles of both feet numb. brain fog, brain working at 60%, vision not like before vaccine. Off balance
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Head discomfort, Hypoaesthesia, Nervous system disorder, Palpitations, Tinnitus
Clinical narrative: Nervous system constant shooting systematically through my body. Muscles cramps.  Body shaking, heart banging in chest with blood pressure up and down, EXHAUSTION,  blood pulse in head, tinnitus much louder, ANXIETY in core, left 3 small toes numb and soles of both feet numb. brain fog, brain working at 60%, vision not like before vaccine. Off balance
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor, Ultrasound Doppler, Visual impairment
Clinical narrative: Nervous system constant shooting systematically through my body. Muscles cramps.  Body shaking, heart banging in chest with blood pressure up and down, EXHAUSTION,  blood pulse in head, tinnitus much louder, ANXIETY in core, left 3 small toes numb and soles of both feet numb. brain fog, brain working at 60%, vision not like before vaccine. Off balance
Age: 11.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMRV, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Patient started with a splotchy red rash on her R upper chest, L cheek and R arm.  Rash was not itchy or painful and resolved in a few minutes after it started.  Patient denied any difficulty breathing, difficulty swallowing, abdominal pain or nausea.  Rash was not raised or warm to touch.  Patient denied feeling any dizziness
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: left thigh erythema 3 cm, no induration. Advised to do warm compresses, Motrin 3 times a day for 2 days , monitor, signs alarm given
Age: 7.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Blepharospasm, Facial asymmetry, Ocular hyperaemia
Clinical narrative: Patient arrived in the clinic on 04/01/2024  accompanied by her mother after receiving  mmrv ,hepb,polio,tdap, and influenza vaccines on 03/28/24 stating that "her child has been experiencing right eye twitching /redness and  crooked smile for two days .she declines any nausea /vomiting, pain and  fever. Writer assessed patient  and vital signs are as follows (Bp 114/64 right arm) respiration 18 unlabored ,Hr 80bpm and axillary temp 98.6.writer referred patient to urgent care for further evaluation and notified supervisor
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: My left arm began hurting shortly after the shot, it is an unbearable pain that shots through my arm and has been happening everyday for the last 3 years. I have had injections and take pain medicine multiple times a day and I also use cool and heat to help with the pain that basically last all day long and have tried therapy and nothing works
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood test normal, Condition aggravated, Dizziness
Clinical narrative: She got her vaccine, no reaction immediately, about 30 minutes after her tongue started to swell, lips started to swell and she took Benadryl as she has had reactions similar to this in the past with other medicines and also to a recent development of fresh lemons.  It plateued and then started going away about another 30  minutes.  She did not have any other problems with that reaction and took another Benadryl at night as a precaution.  For the following week she had some upper respiratory symptoms, congestion, fatigue and some head pressure.  She figured those were normal reactions, except the head pressure.  She has had this pressure ever since she started the COVID vaccines, but did not persist with the latest one.  It is short of a headache and the dizziness.  Then on Saturday 10/28/23, she started getting very severe leg and joint pains on the right side.  The right leg, right hip and right knee.  Then Sunday, 10/29/23 she had episodes of very shooting sharp pain on the right side of her pain that she thought was going into some kind of migraine, but she does not normally get them like that.  She then took at 1:00 Ondansetrone/Zofran, and then took another one later that day, which resolved the pain in her head.  The leg and joint pain continued.  On Saturday 11/4/23 the pain increased and it started to spread to her left hip and left knee also.  The worst pain during November and December was the hip pain.  She had never had the arthritic pain like that, and felt it was a significant arthritis flare up.  She felt that it was going to get better with time, and it did not.  The pain was not as bad during the day and once she got moving she was able to walk, but at night it seemed to worsen.  In January and February it started to move away from her hips and into her knees and feet.  It looked like it started to improve in February and then it just flared up again.  She has been back to her doctor, not much they can do with the arthritis, but she does have a referral for PT.  X-rays showed arthritis in her knees, blood work did not show anything.  Walking is her main exercises, and her walking is limited and cannot walk long distances, and has locking feelings and walks less.  She does take a gentle care yoga class on Zoom which has helped, but she is still dealing with mobility issues in both knees and legs.   She may have to get checked out by an orthopedist as well.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Headache, Lip swelling, Mobility decreased
Clinical narrative: She got her vaccine, no reaction immediately, about 30 minutes after her tongue started to swell, lips started to swell and she took Benadryl as she has had reactions similar to this in the past with other medicines and also to a recent development of fresh lemons.  It plateued and then started going away about another 30  minutes.  She did not have any other problems with that reaction and took another Benadryl at night as a precaution.  For the following week she had some upper respiratory symptoms, congestion, fatigue and some head pressure.  She figured those were normal reactions, except the head pressure.  She has had this pressure ever since she started the COVID vaccines, but did not persist with the latest one.  It is short of a headache and the dizziness.  Then on Saturday 10/28/23, she started getting very severe leg and joint pains on the right side.  The right leg, right hip and right knee.  Then Sunday, 10/29/23 she had episodes of very shooting sharp pain on the right side of her pain that she thought was going into some kind of migraine, but she does not normally get them like that.  She then took at 1:00 Ondansetrone/Zofran, and then took another one later that day, which resolved the pain in her head.  The leg and joint pain continued.  On Saturday 11/4/23 the pain increased and it started to spread to her left hip and left knee also.  The worst pain during November and December was the hip pain.  She had never had the arthritic pain like that, and felt it was a significant arthritis flare up.  She felt that it was going to get better with time, and it did not.  The pain was not as bad during the day and once she got moving she was able to walk, but at night it seemed to worsen.  In January and February it started to move away from her hips and into her knees and feet.  It looked like it started to improve in February and then it just flared up again.  She has been back to her doctor, not much they can do with the arthritis, but she does have a referral for PT.  X-rays showed arthritis in her knees, blood work did not show anything.  Walking is her main exercises, and her walking is limited and cannot walk long distances, and has locking feelings and walks less.  She does take a gentle care yoga class on Zoom which has helped, but she is still dealing with mobility issues in both knees and legs.   She may have to get checked out by an orthopedist as well.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Respiratory tract congestion, Swollen tongue, X-ray abnormal
Clinical narrative: She got her vaccine, no reaction immediately, about 30 minutes after her tongue started to swell, lips started to swell and she took Benadryl as she has had reactions similar to this in the past with other medicines and also to a recent development of fresh lemons.  It plateued and then started going away about another 30  minutes.  She did not have any other problems with that reaction and took another Benadryl at night as a precaution.  For the following week she had some upper respiratory symptoms, congestion, fatigue and some head pressure.  She figured those were normal reactions, except the head pressure.  She has had this pressure ever since she started the COVID vaccines, but did not persist with the latest one.  It is short of a headache and the dizziness.  Then on Saturday 10/28/23, she started getting very severe leg and joint pains on the right side.  The right leg, right hip and right knee.  Then Sunday, 10/29/23 she had episodes of very shooting sharp pain on the right side of her pain that she thought was going into some kind of migraine, but she does not normally get them like that.  She then took at 1:00 Ondansetrone/Zofran, and then took another one later that day, which resolved the pain in her head.  The leg and joint pain continued.  On Saturday 11/4/23 the pain increased and it started to spread to her left hip and left knee also.  The worst pain during November and December was the hip pain.  She had never had the arthritic pain like that, and felt it was a significant arthritis flare up.  She felt that it was going to get better with time, and it did not.  The pain was not as bad during the day and once she got moving she was able to walk, but at night it seemed to worsen.  In January and February it started to move away from her hips and into her knees and feet.  It looked like it started to improve in February and then it just flared up again.  She has been back to her doctor, not much they can do with the arthritis, but she does have a referral for PT.  X-rays showed arthritis in her knees, blood work did not show anything.  Walking is her main exercises, and her walking is limited and cannot walk long distances, and has locking feelings and walks less.  She does take a gentle care yoga class on Zoom which has helped, but she is still dealing with mobility issues in both knees and legs.   She may have to get checked out by an orthopedist as well.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, IPV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: The patient was seen at the Clinic for a routine school physical and catch-up immunizations to begin first grade in County Public Schools. The patient is uninsured and was referred by the school system to the clinic. Upon review of vaccination records, the clinic pharmacist declared that the patient required DTaP, Varicella, and IPV vaccines. An overseen pharmacy student used a DTaP-IPV (Kinrix) combination instead of a stand-alone DTaP. The patient received two doses of the Polio vaccine. The patient stayed for 15 minutes post-vaccination and stated she felt fine. The staff pharmacist checked in with her parent/guardian before they left and assessed that the patient did not observe any reaction during observation. After the double dose was identified, the lead nurse practitioner of the site contacted the parent/guardian and informed them that they'd received two doses of IPV instead of the one that was needed. The parent/guardian was alerted that if any reaction occurred, to seek medical attention immediately.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: HIB vaccine given was expired. Expiration date was 3/15/24. Given 4/3/24.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: DHI given for 4th dose of Dtap, only licensed for doses 1 thru 3
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: vaccine expired 3/22/24, was given out dated 3/28/24, no signs or symptoms or treatment
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Additional dose of Hep B was administered due to this communication gap between birth hospital and pediatrician office. At initial appointment on 3/25/24, discharge paperwork brought in by Mother of Patient from Birth hospital showed Hepatitis B vaccine was declined after delivery. Mother of Patient reported she did decline it at birth hospital but agreed for patient to receive it during appointment on 3/25/24 after explanation of benefits/safety/risks. Discharge summary was later forwarded from Birth hospital after date of initial appointment shows that Hep B vaccine was administered at the time of discharge on 3/20/24 when mom had agreed for vaccine. Called Birth hospital and confirmed that Hep B was given just prior to discharge on 3/20/24, after discharge summary had been printed for Mother of Patient. After this information was received, Physician to Mom that an additional dose of Hep B was administered due to this communication gap between birth hospital and pediatrician office and will not harm the baby.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lip swelling, Peripheral swelling, Pyrexia, Swollen tongue
Clinical narrative: lip and tongue swelling, leaden/heavy arms with swelling of digits, fever
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Bell's palsy, Eyelid function disorder, Facial nerve disorder, Facial paralysis
Clinical narrative: I thought I had pink eye or a stye or conjuctivitis. Then they said Bells Palsy with a brain aneurism. Then they diagnosed me with 7th Nerve Palsy. I saw several doctors. I have a lot of headaches on the left side. everything has "dropped" on th eleft side. I am losing hair. Facial paralysis. I did NOT have a stroke.  Then an eye Dr,  Dr (eye disease specialist) and I have an eye surgery with Dr on  08/08/2024. I have not been able to work. The nerves and muscles no longer work on the left side of my face. I cant open and close my eyelids.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Impaired work ability, Intracranial aneurysm, Laboratory test, Muscle disorder
Clinical narrative: I thought I had pink eye or a stye or conjuctivitis. Then they said Bells Palsy with a brain aneurism. Then they diagnosed me with 7th Nerve Palsy. I saw several doctors. I have a lot of headaches on the left side. everything has "dropped" on th eleft side. I am losing hair. Facial paralysis. I did NOT have a stroke.  Then an eye Dr,  Dr (eye disease specialist) and I have an eye surgery with Dr on  08/08/2024. I have not been able to work. The nerves and muscles no longer work on the left side of my face. I cant open and close my eyelids.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was due for Tdap vaccine and received Infanrix when he should have received Boostrix. Error was found during vaccine documentation. RN spoke with Vaccine Coordinator who stated Infanrix immunization counted towards vaccine requirement and patient would not need an additional vaccine. RN contacted mother of patient and informed her that the patient received an infant dose of the vaccine instead of the adolescent dose, but no further immunization is needed and patient is vaccinated. Patient did not present any adverse symptoms and no further treatment is needed at this time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Pruritus
Clinical narrative: Three hours after vaccination patient developed chills. This progressed to dry heaving and sweats, as well as dizziness. Slight headache. No associated abdominal pain or diarrhea. One night of itching without rash on the fourth night. No local injection site reaction.  Symptoms resolved after two weeks.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching
Clinical narrative: Three hours after vaccination patient developed chills. This progressed to dry heaving and sweats, as well as dizziness. Slight headache. No associated abdominal pain or diarrhea. One night of itching without rash on the fourth night. No local injection site reaction.  Symptoms resolved after two weeks.
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Cardiac monitoring, Cerebrovascular accident, Computerised tomogram, Confusional state, Dysarthria
Clinical narrative: Brain bleed (intracranial hemorrhage). Checked in ER after confusion, starting to slur speech. Sent to ICU for stroke treatment. Eventually moved to Progressive care, then rehabilitation.
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Haemorrhage intracranial, Intensive care, Ultrasound scan, X-ray
Clinical narrative: Brain bleed (intracranial hemorrhage). Checked in ER after confusion, starting to slur speech. Sent to ICU for stroke treatment. Eventually moved to Progressive care, then rehabilitation.
Age: 40.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Date 1/4/24 New employee called employee health office reported injection site red and swollen location upper back right arm at SQ injection site.  Advised to use cool wet compress to arm and Tylenol for discomfort and continue to monitor. 1/30/24 Employee called said right arm at injection site was like a small scar red/dark brown area. She stated she had an appointment with family provider next week. I advised for her to ask provider going forward if she would recommend for her to receive 2nd dose of varicella. 2/8/24 I received note from provider NP she should not receive this vaccine in the future .
Age: 4.0
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given an Adult dose of Hepatitis Vaqta-Adult instead of a pediatric dose.  No treatment was needed, follow up with patient per mother states no side effects.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Erythema, Malaise, Pruritus, Urticaria
Clinical narrative: The patient received these 2 vaccines and left the office with the parent.  The parent reports that while they were waiting in line at a fast food restaurant patient started complaining that he was not feeling well and felt dizzy.  Then Mom noticed a couple of red spots.  Mom returned to the office. At approximately 1225pm, patient was back in the office with hives on left arm, neck and trunk with itching.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itchiness of R Arm where vaccine was administered. Recommended to f/u with a medical provider  for further assessment.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The nurse drew an entire vaccine vial instead of administering 0.25 ml. The child had no effects following the vaccine being administered.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza, Injected limb mobility decreased
Clinical narrative: Flu symptoms for three days, missed work; loss of mobility in left arm for three days +
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Swelling, Syncope
Clinical narrative: fainting, shivering, mild fever, swelling
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Wrong product administered
Clinical narrative: Child was due for MCV4 vaccine and was given Meningococcal B vaccine.  Spoke with parent to review the incident.  Child is having no adverse effects other than injection site tenderness.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Echocardiogram, Pulmonary thrombosis, Thrombosis
Clinical narrative: Patient was admitted to Medical Center on 4/3/24 and was noted to have blood clots in both her lower extremities as well as both of her lungs per daughter.  Patient has a history of bilateral lower extremity edema and wears Circaid wraps to her bilateral legs to help with the swelling.  The day of the vaccine her vital signs were blood pressure: 124/68 pulse 64 respirations 20 pulse ox: 97% on room air.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Patient was admitted to Medical Center on 4/3/24 and was noted to have blood clots in both her lower extremities as well as both of her lungs per daughter.  Patient has a history of bilateral lower extremity edema and wears Circaid wraps to her bilateral legs to help with the swelling.  The day of the vaccine her vital signs were blood pressure: 124/68 pulse 64 respirations 20 pulse ox: 97% on room air.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Irritability, Mobility decreased, Pyrexia, Somnolence
Clinical narrative: The nurse gave the entire contents of the vial instead of the 0.25 ml. The child was sleepy and fussy about leg pain and had decreased ambulation for a day. He had low grade fever.
Age: 74.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient experiences redness and swelling at injection site.  She reports no discomfort or warmth to the area, and the size of the rash is the size of the silver dollar, but currently not spreading.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: Fever after being given the entire vial instead of the 0.25 ml dose.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The child was inadvertently given the entire contents of the vial instead of the 0.25 ml dose. No known effect of the higher dose
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna (Covid) Spikevax given and expired 4/3/2024
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Joint swelling, Vertigo
Clinical narrative: Swollen joints in my hands and knees and very dizzy, like vertigo. My doctor didnt have any advice on this. I had to get steroid shots in my knees to help.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Skin discolouration, Syncope
Clinical narrative: Patient fainted post immunization on the way out of the store.  His mother was with him and noticed a change in face color. They sat in the waiting room for a few minutes until he felt better. At that time, mom had declined medical help here at the pharmacy and with a call later in the evening had declined going to seek medical care at their provider.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Pyrexia, Vomiting
Clinical narrative: Fever and vomiting for 2 days after receiving the entire vial contents of the vaccine instead of the 0.25 ml.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The entire vial was given to the patient instead of the 05 ml dose. No known adverse reaction.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death after recent Covid infection
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pain at injection site, decreased range of motion
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV, PNC20
Symptoms: Injection site rash, Rash
Clinical narrative: Pt brought back in today 4/4/24 - Mother states noticed rash start to middle of low back/buttock area approx 630pm Monday evening (4/1/24) that she did not have prior to vaccine administrations. Yesterday rash started spreading to bilateral legs in spots.
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Crying, Respiratory viral panel
Clinical narrative: Baby started crying inconsolably around 10:00pm on the day the vaccines were given. Mom gave Tylenol with no improvement. He was brought in for examination which did not reveal any signs of illness. Baby has been mildly constipation so a glycerin suppository was given in office along with Ibuprofen and Benadryl. He was monitored for 45min. Crying stopped and no distress 35minutes after the Ibuprofen and Benadryl were given.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient vaccine record reviewed. Records indicated patient needed second dose of MMR and first dose of varicella vaccine.  Administered MMRV (proquad) vaccine per protocol. Upon review of records I noticed patient had received MMRV (proquad) vaccine on 02/05/24.  There was no documentation on system that patient had received varicella vaccine on 02/05/24.  Second dose of varicella vaccine administered too soon for patient's age.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: The patient was given a Td vaccine after receiving a Tdap the day before.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid-related death
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Crying, Face injury, Fall, Myoclonus, Syncope
Clinical narrative: After immunizations were given, patient had a convulsive syncope event. He was sitting on the exam table post immunizations, within two minutes of completing immunizations, he fell face first onto the floor hitting his right side of his face, then began having myoclonic jerking movements that lasted around 15 seconds. He became responsive after the convulsions stopped, began to cry and speak with me and his mother. His vitals were stable after adverse event. He remained laying flat for around five minutes, then we transferred him to the exam table sitting upright. He was alert and oriented, and answered questions appropriately during evaluation. He was monitored for an additional 30 minutes, tolerated a popsicle and denied any further dizziness or symptoms associated. He was then sent home with his mother for continued observation.
Age: 42.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Axillary pain, Electrocardiogram normal, Feeling hot, Headache, Musculoskeletal chest pain
Clinical narrative: 10 min after vaccination, pt reported pain in left axillar region, extending to midline and down to bottom of rib cage over course of 10 min, then extended to left side of head, with feeling of warmth. Pain not reproducible or worsened with palpation.  Called paramedics after symptoms continued to progress after 10 minutes. We did vitals,  BP 125/75, HR 52?increased to 72, O2 sat 100% They evaluated the patient, determined that he needed further workup, and proceeded to load him into their ambulance.   Never had pain like this before, no history migraines.  Received MMR, varicella, hepatitis and possible other vaccines on Monday at PCP.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Tinnitus
Clinical narrative: Tinnitus left ear    Audio exam, mri,
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE reported; Medical assistant reports patient was accidently administered an expired dose of MMR II on Mar 19, 2024. Product expired on Feb 25, 2024. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC; Product dispensing error; This spontaneous report has been received from a medical assistant, referring to a 4-year-old male patient. The patient's concomitant medications included vaccination with varicella virus vaccine live (Oka/Merck) (VARIVAX) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX). The information regarding the patient's concurrent conditions or medical history was not reported.  On 19-MAR-2024, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II), administered once, intramuscularly, lot# W006738, expiry date: 25-FEB-2024 (dose and anatomical location were not reported) for prophylaxis (expired product administered). The error occurred during product dispensing (product dispensing error). No additional adverse events reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; The medical assistant is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (x024543   10/10/2025) Temperature: (-0.3; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 26-MAR-2024, the patient was vaccinated with improperly stored vaccine: varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X024543, expiration date: 10-OCT-2025, administered for prophylaxis (anatomical location, strength and route of administration were not provided) (temperature - 0.3 C, time frame: 4 hours 26 minutes) (product storage error). No previous temperature excursion. No additional adverse events were reported, no further information provided
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; patient received improperly stored vaccine; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 26-MAR-2024, the patient was vaccinated with improperly stored vaccine: varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X024543, expiration date: 10-OCT-2025, administered for prophylaxis (anatomical location, strength, and route of administration were not provided) (Product storage error). No additional adverse events were reported (temperature: - 0.3C, time frame: 4 hours 26 minutes). No previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; HBP called to report inadvertent administration of VARIVAX on 12MAR2024 after a temperature excursion.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 12-MAR-2024, the patient was vaccinated with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X017484, expiration date: 25-FEB-2025 (strength, dose, dose number, route, and anatomical location were not provided) for prophylaxis.   The temperature and Time frame was reported as: 6°F up to 14°F (9.9°F) for 0 hours 28 minutes 0 seconds and 14°F up to 46°F (21.6°F) for 0 hours 54 minutes 0 seconds. There was no previous temperature excursión.   No adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain
Clinical narrative: pain at the injection site; Flu-like symptoms; fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), influenza-like symptoms (Verbatim: Flu-like symptoms) and fatigue (Verbatim: fatigue). The outcome of the injection site pain, influenza-like symptoms and fatigue were resolved (duration 48 hrs).   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix. The reporter considered the influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the injection site pain and fatigue to be related to Shingrix. The company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAR-2024 The patient experienced pain at the injection site, fatigue and flu-like symptoms for 48 hours which completely resolved. The patient was aware these adverse events were likely to occur and was not concerned by them.
Sex: M
Vaccine: VARZOS
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: patient was prescribed medication off label for Ulcerative Colitis/shingrix prescribed to a under age patient; This non-serious case was reported by a consumer via patient support programs and described the occurrence of drug prescription issue in a 26-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug prescription issue (Verbatim: patient was prescribed medication off label for Ulcerative Colitis/shingrix prescribed to a under age patient). The outcome of the drug prescription issue was unknown.   Additional Information: GSK Receipt date: 28-MAR-2024 The patient was self-reported. The patient was prescribed medication off label for Ulcerative Colitis, patient did not fall under the FDA approved age for vaccine which led to drug prescription issue. At the time of reporting the patient had not started the vaccine.
Sex: U
Vaccine: HEP, HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: anti hbs serologic testing; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of therapy non-responder in a adult patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Engerix B and Heplisav b. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapy non-responder (Verbatim: anti hbs serologic testing). The outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAR-2024 The reporter reported that one of their patient who was not on pre-dialysis or dialysis had Engerix-B and Heplisav-B on unspecified dates and did not show immunity after anti-HBs serologic testing which led to therapy non-responder. The nurse was not willing to provide any additional patient-specific information or medical history.  No product quality compliant additional adverse event reported. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: injection site pain; joint pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site pain) and joint pain (Verbatim: joint pain). The outcome of the injection site pain and joint pain were not resolved.   It was unknown if the reporter considered the injection site pain and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site pain and joint pain to be related to Arexvy.   Additional Information: GSK Receipt date: 22-MAR-2024 This case was reported by patient via (Open field AE monitoring) interactive digital media. The patient stated that how long would the joint pain and injection site pain remained and he/she had both types of pain for over two (illegible).
Sex: U
Vaccine: RSV
Symptoms: Fall, Gait disturbance, Mobility decreased
Clinical narrative: Difficulty lifting my legs and hips to walk; Difficulty lifting my legs and hips to walk; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of movement disorder in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced movement disorder (Verbatim: Difficulty lifting my legs and hips to walk) and walking difficulty (Verbatim: Difficulty lifting my legs and hips to walk). The outcome of the movement disorder and walking difficulty were not reported.   It was unknown if the reporter considered the movement disorder and walking difficulty to be related to Arexvy.     It was unknown if the company considered the movement disorder and walking difficulty to be related to Arexvy.   Additional Information: GSK Receipt date: 22-MAR-2024 This case was reported by patient via interactive digital media. The patient could not up the next day, difficulty lifting his/her legs and hips to walk (actually fell trying to walk up a curb). Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Body temperature decreased, Chills
Clinical narrative: Shivers; temperature has gone down to the 20s.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced shivers (Verbatim: Shivers) and body temperature decreased (Verbatim: temperature has gone down to the 20s.). The outcome of the shivers and body temperature decreased were not reported.   It was unknown if the reporter considered the shivers and body temperature decreased to be related to Arexvy.     It was unknown if the company considered the shivers and body temperature decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024. This case was reported by a patient via interactive digital media. The patient received Arexvy vaccine and experienced the shivers and the temperature had gone down to the 20s. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Malaise, Pain
Clinical narrative: sick; quite a bit of pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In MAR-2024, the patient received Arexvy. In MAR-2024, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: sick) and pain (Verbatim: quite a bit of pain). The outcome of the sickness and pain were not reported.   It was unknown if the reporter considered the sickness and pain to be related to Arexvy.     It was unknown if the company considered the sickness and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The case was received from the patient via interactive digital media. The reported that patient had the vaccine 3 full days ago and patient had been sick with quit a bit of pain.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Cold sweat, Nausea
Clinical narrative: cold sweat; blisters; Nauseated; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sweat in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cold sweat (Verbatim: cold sweat), blister (Verbatim: blisters) and nausea (Verbatim: Nauseated). The outcome of the cold sweat, blister and nausea were not reported.   It was unknown if the reporter considered the cold sweat, blister and nausea to be related to Shingrix.   It was unknown if the company considered the cold sweat, blister and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-Mar-2024 The patient believed he/she got Shingrix and need to know if it was contagious. The temperature was 71 and the patient was in a cold sweat. The patient had blisters on him/her. The patient was nauseated and live alone with no one to help him/her. The patient asked that what he/she could do to help himself/herself.
Age: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong age administration/Kinrix given to a 7-month-old instead of the approved age group 4 - 6 years; Kinrix given to a 7-month-old instead of the approved age group 4 - 6 years/has 2 Dtaps and 2 IPV doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2TP74, expiry date 10-JUN-2024) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age administration/Kinrix given to a 7-month-old instead of the approved age group 4 - 6 years) and inappropriate schedule of vaccine administered (Verbatim: Kinrix given to a 7-month-old instead of the approved age group 4 - 6 years/has 2 Dtaps and 2 IPV doses). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-MAR-2024 and 22-MAR-2024 The medical assistant reported that the kinrix vaccine was given at 7 months of age instead of the approved age group of 4-6 years old and with this last Kinrix shot, the baby had 2 Dtaps and 2 IPV doses, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The vaccine administration facility was the same as the primary reporter. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient receiving Abrysbo, Pfizer vaccine as Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 79-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number J7G32, expiry date 09-MAY-2026) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: patient receiving Abrysbo, Pfizer vaccine as Arexvy). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 22-MAR-2024 The reporter called wanting to know if there was information on having a patient receiving Abrysbo, Pfizer vaccine as Arexvy which led to Wrong vaccine administered. 4 months later receiving Arexvy the patient has had no adverse event or symptoms. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; inadvertent administration of VARIVAX on 29-MAR-2024 after a temperature excursion.; This spontaneous report has been received from Other Health Professional (nurse), referring to a patient of an unknown age and gender.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 29-MAR-2024, the patient was inadvertent vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered as prophylaxis (strength, dose, route and anatomical location of administration were not provided; lot # reported as X023717, which is a valid lot # for this vaccine, expiration date provided and validated to be on 26-SEP-2025) after a temperature excursion that occurred on that date (product storage error). The temperature of the vaccine administered was reported as 70 Fahrenheit (F) during a time frame of 16 hours 0 minutes 0 seconds. There were not previous temperature excursions reported. No additional adverse event (AE) or product quality complaints (PQC) (no adverse event).
Sex: U
Vaccine: RSV
Symptoms: Nasopharyngitis
Clinical narrative: cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cold (Verbatim: cold). The outcome of the cold was not reported.   It was unknown if the reporter considered the cold to be related to Arexvy.     It was unknown if the company considered the cold to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The case was received from the patient via (Open field AE monitoring) interactive digital media.   The patient was not sure if he or she had a reaction or cold after receiving Arexvy vaccine. The follow-up could not be possible as no contact details were provided.