chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Dyspnoea
Clinical narrative: One to two hours after the vaccine she started to have L upper arm and L axilla with pain, swelling and erythema.  Later that evening, Mom is unclear of time she started to have belly pain, diarrhea, fever.  They gave her some tylenol and Ibuprofen then she went to sleep. Next morning she still had fever, diarrhea and L upper arm  pain, redness and swelling. That morning (11/16/24) she said told mom that last night she felt shortness of breath.  Morning of 11/16/24, shortness of breath not present; it has resolved. She never had cough, wheeze, retraction, lip/tongue swelling,  eyelid swelling, full body itch, full body rashes nor hives.  At some point L upper arm also itched. She was seen in UC on 11/16/24 only symptom seen on exam was L upper arm and L axilla with swelling and hurts. The L upper arm and axilla was not red, not itchy.  No other symptoms. No cough, wheeze, lip/tongue nor eyelid swelling, no body itch, no rash /hive.  No short of breath feeling.  No trouble talking. She was sitting up and talking well.  Pulse oximeter normal at 98%. Since no Benadryl was tried yet Bendaryl was recommended and antibiotics (Keflex) was started to cover for potential cellulitis of L upper arm. Mom agreed to plan.  ER precaution told: hive, rash, lip/tongue/ mouth swelling, shortness of breath, wheeze, trouble breathing or any breathing or airway compromise.  Otherwise a follow up was booked for 2 days later as follow up to see if needed more treatment (example but not limited to steroids)
Age: 8.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Abdominal pain, Axillary pain, Diarrhoea, Dyspnoea, Erythema
Clinical narrative: One to two hours after the vaccine she started to have L upper arm and L axilla with pain, swelling and erythema.  Later that evening, Mom is unclear of time she started to have belly pain, diarrhea, fever.  They gave her some tylenol and Ibuprofen then she went to sleep. Next morning she still had fever, diarrhea and L upper arm  pain, redness and swelling. That morning (11/16/24) she said told mom that last night she felt shortness of breath.  Morning of 11/16/24, shortness of breath not present; it has resolved. She never had cough, wheeze, retraction, lip/tongue swelling,  eyelid swelling, full body itch, full body rashes nor hives.  At some point L upper arm also itched. She was seen in UC on 11/16/24 only symptom seen on exam was L upper arm and L axilla with swelling and hurts. The L upper arm and axilla was not red, not itchy.  No other symptoms. No cough, wheeze, lip/tongue nor eyelid swelling, no body itch, no rash /hive.  No short of breath feeling.  No trouble talking. She was sitting up and talking well.  Pulse oximeter normal at 98%. Since no Benadryl was tried yet Bendaryl was recommended and antibiotics (Keflex) was started to cover for potential cellulitis of L upper arm. Mom agreed to plan.  ER precaution told: hive, rash, lip/tongue/ mouth swelling, shortness of breath, wheeze, trouble breathing or any breathing or airway compromise.  Otherwise a follow up was booked for 2 days later as follow up to see if needed more treatment (example but not limited to steroids)
Age: 8.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Oedema peripheral
Clinical narrative: One to two hours after the vaccine she started to have L upper arm and L axilla with pain, swelling and erythema.  Later that evening, Mom is unclear of time she started to have belly pain, diarrhea, fever.  They gave her some tylenol and Ibuprofen then she went to sleep. Next morning she still had fever, diarrhea and L upper arm  pain, redness and swelling. That morning (11/16/24) she said told mom that last night she felt shortness of breath.  Morning of 11/16/24, shortness of breath not present; it has resolved. She never had cough, wheeze, retraction, lip/tongue swelling,  eyelid swelling, full body itch, full body rashes nor hives.  At some point L upper arm also itched. She was seen in UC on 11/16/24 only symptom seen on exam was L upper arm and L axilla with swelling and hurts. The L upper arm and axilla was not red, not itchy.  No other symptoms. No cough, wheeze, lip/tongue nor eyelid swelling, no body itch, no rash /hive.  No short of breath feeling.  No trouble talking. She was sitting up and talking well.  Pulse oximeter normal at 98%. Since no Benadryl was tried yet Bendaryl was recommended and antibiotics (Keflex) was started to cover for potential cellulitis of L upper arm. Mom agreed to plan.  ER precaution told: hive, rash, lip/tongue/ mouth swelling, shortness of breath, wheeze, trouble breathing or any breathing or airway compromise.  Otherwise a follow up was booked for 2 days later as follow up to see if needed more treatment (example but not limited to steroids)
Age: 8.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Pyrexia
Clinical narrative: One to two hours after the vaccine she started to have L upper arm and L axilla with pain, swelling and erythema.  Later that evening, Mom is unclear of time she started to have belly pain, diarrhea, fever.  They gave her some tylenol and Ibuprofen then she went to sleep. Next morning she still had fever, diarrhea and L upper arm  pain, redness and swelling. That morning (11/16/24) she said told mom that last night she felt shortness of breath.  Morning of 11/16/24, shortness of breath not present; it has resolved. She never had cough, wheeze, retraction, lip/tongue swelling,  eyelid swelling, full body itch, full body rashes nor hives.  At some point L upper arm also itched. She was seen in UC on 11/16/24 only symptom seen on exam was L upper arm and L axilla with swelling and hurts. The L upper arm and axilla was not red, not itchy.  No other symptoms. No cough, wheeze, lip/tongue nor eyelid swelling, no body itch, no rash /hive.  No short of breath feeling.  No trouble talking. She was sitting up and talking well.  Pulse oximeter normal at 98%. Since no Benadryl was tried yet Bendaryl was recommended and antibiotics (Keflex) was started to cover for potential cellulitis of L upper arm. Mom agreed to plan.  ER precaution told: hive, rash, lip/tongue/ mouth swelling, shortness of breath, wheeze, trouble breathing or any breathing or airway compromise.  Otherwise a follow up was booked for 2 days later as follow up to see if needed more treatment (example but not limited to steroids)
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: One day after vaccination, I noticed distortion in high frequency sounds ( piano or violin music, television). Two days after vaccination, I began experiencing tinnitus. The tinnitus manfests as a loud, constant ringing in both ears.
Sex: U
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: none stated
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pyrexia
Clinical narrative: 5 dats After receiving a shingle vaccine I had my first bout of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: 5 dats After receiving a shingle vaccine I had my first bout of shingles). The patient was treated with calamine, menthol, phenol, zinc oxide (Calamine). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-NOV-2024 This case was reported by a patient via interactive digital media. The reporter reported that five days after receiving a Shingles vaccine had a first bout of shingles. Started a small, thought spider bites, did not diagnose in time and it spread all up and down side. Too late to get the antiviral, it was occurred 5 times sine, got antiviral once, other times not available. Best remedy was the Calamine so fat but headache and fever. The reporter was ask any suggestion, relief, ideas very much appreciated.
Sex: F
Vaccine: MENB
Symptoms: Syringe issue, Underdose
Clinical narrative: second dose of Bexsero to a patient, 2 to 3 drops of prepared vaccine leaked from the syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 40-year-old female patient who received Men B NVS (Bexsero) (batch number 2X9SS, expiry date 31-JAN-2026) for prophylaxis.   On 06-NOV-2024, the patient received the 2nd dose of Bexsero. On 06-NOV-2024, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: second dose of Bexsero to a patient, 2 to 3 drops of prepared vaccine leaked from the syringe). The outcome of the incomplete dose administered 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: 06-NOV-2024 The reporter reported that during the administration of a second dose of Bexsero to a patient, 2 to 3 drops of prepared vaccine leaked from the syringe which led to, incomplete dose administered.  Thy requested data about if the dose needed to be repeated and gave data on patient and event. The vaccine administration facility was the same as primary reporter.
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cerebral haemorrhage, Dysstasia, Gait disturbance, Malaise, Mobility decreased
Clinical narrative: She said she was not feeling well when she went to bed on 10/1/24. The following morning, she was unable to raise herself up to get out of bed. Since that time she has not been able to stand, sit, walk, or turn herself in bed without help. Had to call EMT several times to help lift her, including help getting her in/out of vehicle. On Oct. 6th, had EMT to take her to hospital, they diagnosed her with Adverse Vaccination Symptoms, said she should improve in few days. On Oct 8th, took her back to Clinic to see Dr, the physician who gave her the Covid and flu vaccines at the same time on Oct 1st. He immediately had her admitted back at hospital for further care. After being back at hospital for a couple of weeks she was sent to rehab hospital. After being thre for approx two weeks she was sent to Nursing & Rehab, where she still resides as of 12/6/24. These shots caused her to have mini-strokes and brain bleeding.
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Transient ischaemic attack
Clinical narrative: She said she was not feeling well when she went to bed on 10/1/24. The following morning, she was unable to raise herself up to get out of bed. Since that time she has not been able to stand, sit, walk, or turn herself in bed without help. Had to call EMT several times to help lift her, including help getting her in/out of vehicle. On Oct. 6th, had EMT to take her to hospital, they diagnosed her with Adverse Vaccination Symptoms, said she should improve in few days. On Oct 8th, took her back to Clinic to see Dr, the physician who gave her the Covid and flu vaccines at the same time on Oct 1st. He immediately had her admitted back at hospital for further care. After being back at hospital for a couple of weeks she was sent to rehab hospital. After being thre for approx two weeks she was sent to Nursing & Rehab, where she still resides as of 12/6/24. These shots caused her to have mini-strokes and brain bleeding.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Chest discomfort, Chest pain, Fatigue, Inappropriate schedule of product administration, Muscle tightness
Clinical narrative: Chest and rib cage tightness. Went to emergency room due to chest pain which subsided after a couple hours. Extreme fatigue, aches and soreness. Also concerned 3 shots were given at same visit. Two in the right arm and 1 in the left arm. Is this protocol.  It was not explained to us when to come back, which now alarms me, that 3 doses were given at the same time. We also were unaware (according to records) the patient received a first dose in 11/2019. We thought on 12/4/2024 we were getting the first dose. This could have been a translation issue.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain
Clinical narrative: Chest and rib cage tightness. Went to emergency room due to chest pain which subsided after a couple hours. Extreme fatigue, aches and soreness. Also concerned 3 shots were given at same visit. Two in the right arm and 1 in the left arm. Is this protocol.  It was not explained to us when to come back, which now alarms me, that 3 doses were given at the same time. We also were unaware (according to records) the patient received a first dose in 11/2019. We thought on 12/4/2024 we were getting the first dose. This could have been a translation issue.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cholecystectomy, Cholelithiasis, Computerised tomogram, Scan with contrast
Clinical narrative: Developed stomach pain and diagnosed with gallstones and eventual gallbladder had to be removed
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Developed stomach pain and diagnosed with gallstones and eventual gallbladder had to be removed
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 9/25 pt received diluted dose of Covid 19 vaccine. Single dose of 5-11yr vaccine diluted with 1.1 ml of NS, pt received 0.3ml IM injection of diluted dose. Dr notified, and aware. Called Mom and explained the error, offered to administer correct dose, Mom declined, explained pt hates shots and Mom aware dose doesn't count as 24-25 Covid vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, Tinnitus
Clinical narrative: Roughly four years ago, I noticed a mild ringing in my ears, where the cause was unknown, but possibly due to a vaccine. After this most recent Covid vaccine, I didn?t feel well for about two days after, which I expected. About five days later, I noticed the tinnitus (in both ears) was noticeably louder. It?s very bothersome and difficult ignore.
Age: 64.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized redness, swelling, itching at injection site. Patient noted this on the morning of 12/5/2024. This writer advised patient to apply ice, use over-the-counter Tylenol or Advil and Benadryl only as directed. Advised patient to go immediately to the Emergency Room if swelling and/or itching progress to throat, face, mouth or if redness and swelling increases in size and does not respond to OTC medications. Scheduled patient for office visit with provider on 12/6/24. This writer called the patient this morning to reassess, patient states swelling and redness has improved. Itching is essentially the same.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction occurred.  Patient was given a COVID 5-11 vaccine that was expired by 2 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccines (Oct 30, 2024) in both thigs but only the right tight present large swelling  (~10 cm diameter of edema and erythema in the right tight where the DTaP + IPV was injected IM it started the day before and became more severe in the following 3-4 days and start resolving by day 10. As it now (December 2024) the swelling subsided but she has now a brown mark ~10 cm diameter. As her patient complain of her leg being in pain we gave her Ibuprofen for 2 days.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse events
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient received a work required flu vaccine. She declined the high dose. She states that two days after receiving the vaccine, she had a bad headache, nausea and vomiting.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The day following injection, pt developed redness to L deltoid that continued to grow over time with redness, tenderness to palpation and warmth. Pt also developed frontal headache that has been persistent and not improving with motrin. No fevers, nausea or vomiting. Mom reports that pt had a similar reaction in his leg when he was 2 years old after receiving TDaP instead of DTaP.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Vomiting
Clinical narrative: Multiple episodes of vomiting, began sometime very early this morning 12/6 through now.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pain
Clinical narrative: Pt received Spikevax 12year+ dose instead of 6m-11year dose. Per father, pt had headache, general body aches and stomachache x 1 days. Was back to baseline within 24 hours with no further concerns. Pt did receive 2024-2025 flu vaccine at same time.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Disorientation, Dizziness, Feeling of body temperature change, Hypertension
Clinical narrative: Light headed, memory loss, disorientation, hot and cold, and high blood pressure
Age: 44.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Influenza vaccine intended but high dose influenza vaccine administered.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Meningococcal conjugate MCV4P intended but meningococcal B administered. Patient to have follow up appointment to receive Menactra.
Age: 7.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Wrong product administered
Clinical narrative: Pt is adopted and has 2 numbers the numbers pulled the day of Well Child is child's Legal name, numbers #(redacted), and was not merged with old number# (redacted), after to name change. Pt has had legal name change for 3 years per patient's mother. Wrong immunizations given related to incorrect information in database with legal name.  Attempted to call help desk times 2 unable to get through related to "in a staff meeting"
Age: 11.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient administered COVID vaccine for greater than or equal to 12 years old when patient is 11 years old.
Age: 93.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Death
Clinical narrative: Client died 19 days post immunization.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Adverse reaction, Injection site reaction
Clinical narrative: Received shorts on left and right thigh and spots showed reaction. Reported to doctor and reaction spreader over body and still exist
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: According to guidelines, patient (15 y/o) should have received Fluzone instead of Flublock.  No adverse reactions noted.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site mass, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Continued bleeding from site for 15 minutes. Area of left arm just above elbow became swollen and painful for a week or so. Occasionally whole arm ached. This continued for a few weeks then only ached periodically. Has now seemed to have stopped.but still feel a lump in the arm above the elbow.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Facial pain, Laboratory test, Neck pain, Pain, Paranasal sinus discomfort
Clinical narrative: Sinus pain, sinus pressure, pain under ear radiating to face, teeth, started a day or two after vaccine at night's with very sharp pains, and after 2 weeks turned to sustain pain throughout the day.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Sinus pain, Toothache
Clinical narrative: Sinus pain, sinus pressure, pain under ear radiating to face, teeth, started a day or two after vaccine at night's with very sharp pains, and after 2 weeks turned to sustain pain throughout the day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: NEXT DAY RED RASH COVERING UPPER LEFT ARM, WARM TO TOUCH
Age: 1.83
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Kinrix at the age of 1, but she was not eligible to receive that combination yet due to her age. Patient did not have any side effects from the injections.
Age: 3.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Had pain of the left arm from the time of the injection for about 24 hours. About 24 hours after the injection, he developed redness of the left arm from the shouler to the elbow and significant swelling (double the size of the other arm), very warm to the touch. He also had a temperature of 101 and achiness in his legs. He was given a dose of Ibuprofen and symptoms did not improve. I brought him to the pediatrician for futher evaluation about 24 hours after the injection.
Age: 3.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Had pain of the left arm from the time of the injection for about 24 hours. About 24 hours after the injection, he developed redness of the left arm from the shouler to the elbow and significant swelling (double the size of the other arm), very warm to the touch. He also had a temperature of 101 and achiness in his legs. He was given a dose of Ibuprofen and symptoms did not improve. I brought him to the pediatrician for futher evaluation about 24 hours after the injection.
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus
Clinical narrative: Exactly one week after having the vaccine I found a very red, large  circle with an itchiness sensation. Surprised it had taken a week for such reaction I reported it to the pharmacy where I had had the vaccine.  Was told to apply hot compresses and that it was a natural reaction.  The following day the circle had grow (took photos was very concerned as to the extent of the reaction after one week.  Did phone my  Dr. and reported the situation.  Did not have a fever. Just the very large red circle that begun to extend to the underarm.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Chest pain, Pruritus, Rash, Swelling
Clinical narrative: Patient was given Varicella vaccine (patient had prior Varicella vaccines 3/9/2018 and 10/13/2018) and Depo-Provera  in Right arm around the same time at visit at 12:30 pm. Patient was feeling well when she left the clinic and returned around 1:00 pm with swelling, itching, rash, and tongue swelling. Patient was given Benadryl to see if symptoms improved. Patient was monitored by MA every 5 minutes. Symptoms worsened with stomach aches, chest pain, and more swelling . Patient placed on pulse ox and monitored. Epi pen dose given at 1:19 pm and ambulance was called patient taken to ER for further workup.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Swollen tongue
Clinical narrative: Patient was given Varicella vaccine (patient had prior Varicella vaccines 3/9/2018 and 10/13/2018) and Depo-Provera  in Right arm around the same time at visit at 12:30 pm. Patient was feeling well when she left the clinic and returned around 1:00 pm with swelling, itching, rash, and tongue swelling. Patient was given Benadryl to see if symptoms improved. Patient was monitored by MA every 5 minutes. Symptoms worsened with stomach aches, chest pain, and more swelling . Patient placed on pulse ox and monitored. Epi pen dose given at 1:19 pm and ambulance was called patient taken to ER for further workup.
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect dose administered
Clinical narrative: Patient administered polio immunization after 10 doses already administered from vial
Age: 11.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: No signs or symptoms of adverse events.
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: There was another full dose of the IPV in the vial, the Medical assistant was not aware there was an extra dose in the vial. Medical assistant found out about it because there was no more IPV on the inventory.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Given dose #3 inadvertently. Patient doing well, no adverse outcome.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Gait inability, Pain in extremity, Scan abnormal
Clinical narrative: Pt stated that in 2022 after receiving the covid shot he was diagnosed with a blood clot. He states about 10 hours after the vaccine he had so much pain in his leg that he was unable to walk and went to the ER which is where he was diagnosed with a DVT.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received TDaP and Menquadfi vaccinations. Patient was checking out with mother and had a syncopal episode. Patient did loose consciousness for a few seconds. When she "came to" she was aware of her surroundings. Patient was evaluated by one of our pediatricians (on the floor where syncopal episode occurred) after a few minutes, patient was transferred to patient room where she was given a neurological exam as well as had her vitals check. All WNL. Patient rested laying down with head slightly elevated for 25-30 minutes and was again evaluated by our pediatrician.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient registered online for a Moderna COVID vaccine.  She arrived at the appt time on 11/19/24.  She was signed out at the register at which time the clerk told her she signed up for a COVID shot.  I prepared and administered the COVID vaccination after which she asked about program which is only given for Influenza shots.  When told she received a Moderna vaccine, she said she already had that a few weeks ago.  Upon further questioning, she revealed she received the Moderna at another pharmacy (on 10/21/24 per system) so this would be a duplicate/double vaccination.  She was very confused, admitted she did sign up for Moderna but meant to get a Flu shot. I advised her to notify us or her doctor if she experienced any unexpected reactions.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion, Hypotension, Laboratory test, Loss of consciousness
Clinical narrative: Passed out; low blood.pressure; Pacemaker installed 6/5/21; hospitalized on 1/26.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: After vaccination at 11:45 am the baby broke out in rash of little red bumps on chest and stomach. Benadryl 6.25 mg was given in the office at 12:00 pm.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was 5 years old and did not need a second dose of Moderna
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Aldolase, Anti-cyclic citrullinated peptide antibody, Arthralgia, Blood creatine phosphokinase, C-reactive protein
Clinical narrative: Severe joint pain, multiple joints (hands, wrists, shoulders, feet, knees, low back, cervical spine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cystatin C, EGFR status assay, Metabolic function test, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Severe joint pain, multiple joints (hands, wrists, shoulders, feet, knees, low back, cervical spine.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child was administered the 12+ Pfizer 24/25 instead of the appropriate 5-11 yr formulation. No reactions noted.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient noticed stiffness in arm, worse than normal shots.  After a few weeks passed pain progressed with movement-sharp pain.  Patient went to see physician-X-ray done, oral steroids given.  Steroids helped with the pain temporarily, but did not go away.  Referred to ortho.  Patient received a steroid shot at ortho appointment and referred to physical therapy.  Patient is still experiencing limited movement and pain when using left arm.  Patient stated flu shot was administered approximately one of her finger widths down from the top of her shoulder.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Patient noticed stiffness in arm, worse than normal shots.  After a few weeks passed pain progressed with movement-sharp pain.  Patient went to see physician-X-ray done, oral steroids given.  Steroids helped with the pain temporarily, but did not go away.  Referred to ortho.  Patient received a steroid shot at ortho appointment and referred to physical therapy.  Patient is still experiencing limited movement and pain when using left arm.  Patient stated flu shot was administered approximately one of her finger widths down from the top of her shoulder.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Anticonvulsant drug level therapeutic, Computerised tomogram head normal, Condition aggravated, Electroencephalogram normal, Eye movement disorder
Clinical narrative: Patient received both the Covid vaccine and flu vaccine on 10/2/24.  The patient had a temperature around 100F after the vaccines.  The patient was reported to appear drowsy and "zoned out" after a community outing on 10/3/24.  The patient then experienced an unusual increase in seizure activity.  The patient usually experienced about 1-2 seizures per month but on the morning of 10/3/24 was reported to have about 15 seizures which lasted about 20 seconds and 2 minutes each.  The seizures were reported as violent with stiffening of the arms, thrashing and rapid eye movement which is her usual seizure activity.  In the emergency department, the patient did not have any witnessed seizures but her temp was noted to be 100F on 10/3/24 at 14:12.  Temp was down to 98.8F on 10/3/24 at 20:45.   A CT of the head without contrast did not show any acute abnormality.  Patient was given lorazepam and levetiracetam in the ED and then admitted to the hospital.   She was managed with her home antiepileptic agents with no seizures observed in the hospital. An EEG was performed which was considered unremarkable by the neurologist.  She was discharged on 10/5/24.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Seizure, Somnolence
Clinical narrative: Patient received both the Covid vaccine and flu vaccine on 10/2/24.  The patient had a temperature around 100F after the vaccines.  The patient was reported to appear drowsy and "zoned out" after a community outing on 10/3/24.  The patient then experienced an unusual increase in seizure activity.  The patient usually experienced about 1-2 seizures per month but on the morning of 10/3/24 was reported to have about 15 seizures which lasted about 20 seconds and 2 minutes each.  The seizures were reported as violent with stiffening of the arms, thrashing and rapid eye movement which is her usual seizure activity.  In the emergency department, the patient did not have any witnessed seizures but her temp was noted to be 100F on 10/3/24 at 14:12.  Temp was down to 98.8F on 10/3/24 at 20:45.   A CT of the head without contrast did not show any acute abnormality.  Patient was given lorazepam and levetiracetam in the ED and then admitted to the hospital.   She was managed with her home antiepileptic agents with no seizures observed in the hospital. An EEG was performed which was considered unremarkable by the neurologist.  She was discharged on 10/5/24.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Infection, Peripheral swelling
Clinical narrative: 3 DAYS AFTER VACCINATION PAIENTS ARM BECAME RED AND SWOLLEN. PATIENT WENT TO HER DOCTOR AND WAS TOLD SHE ACQUIRED AN INFECTION FROM THE INJECTION.
Age: 52.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Culture stool, Full blood count, Influenza virus test, Malaise, Psittacosis
Clinical narrative: Sick beginning Nov 22. No one's listened. Turned out to be parrot fever just found out yesterday.
Age: 52.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: SARS-CoV-2 test
Clinical narrative: Sick beginning Nov 22. No one's listened. Turned out to be parrot fever just found out yesterday.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: After giving vaccine, pt got up walked to the waiting room , and passed out. Mom lowered pt to the floor. Pt was waking up when I came to the side.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: pt came in pharmacy 12/6/24 reporting his left arm still sore sometimes from the vaccine. pt received 2 shots , the one on his right arm was fine, he received flu shot on his left arm. and the flu HD shot was the one that he complained about.
Age: 16.0
Sex: M
Vaccine: FLU3, MENB, MNQ
Symptoms: Blood test, Chills, Electroencephalogram, Headache, Intention tremor
Clinical narrative: The day after receiving the vaccines, he had fever (not measured), headache, and chills for 2 to 3 days.  He also began having an intention tremor (mainly with tensing or flexing of his muscles ) - more in left hand but has also involved his right hand.  At some point he also began having intermittent tremor in his feet.  These symptoms have been present for one year
Age: 16.0
Sex: M
Vaccine: FLU3, MENB, MNQ
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Pyrexia, Tremor
Clinical narrative: The day after receiving the vaccines, he had fever (not measured), headache, and chills for 2 to 3 days.  He also began having an intention tremor (mainly with tensing or flexing of his muscles ) - more in left hand but has also involved his right hand.  At some point he also began having intermittent tremor in his feet.  These symptoms have been present for one year
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity
Clinical narrative: arm pain still unresolved
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second flu shot in the same flu season, having also received one on 9/18/24.  Patient reports no adverse effects at this time, but counseling was provided and he was instructed to report any unusual events if they occur.
Age: 51.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction. Just medication administration error.  Menveo given instead of MMR
Age: 62.0
Sex: M
Vaccine: COVID19, FLU3, HEPAB, VARZOS
Symptoms: Alcohol use, Rash
Clinical narrative: Box 18 Patient arrives at the pharmacy on 12/4/24 and indicates that on 11/27/24 he was vaccinated in our pharmacy with 4 vaccines and then he had an alcoholic drink. At night he gets rash and takes Benadryl and Panadol. He had the rash for 2 days and it was gone.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Left arm pain that radiated to neck. Injection site and surrounding area red, tender and warm to touch. Symptomatic treatment including Tylenol and/or ibuprofen and applying ice to the site.
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Rash
Clinical narrative: I don't know what type of RSV vaccine it was.  I got a rash on my face arms chest
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of Hep A instead of the adult dose she should have been given.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, TDAP
Symptoms: Depressed level of consciousness, Hyperhidrosis, Pallor, Product administered to patient of inappropriate age
Clinical narrative: Patient received age appropriate Polio, Hepatitis B, and Tdap vaccines at a mobile vaccination event at his school. After the Tdap vaccine patient became pale and appeared to be sweaty. We safely moved the student to the floor and elevated his legs. Patient did not fully lose consciousness but was in and out. He was able to follow commands and had a rapid pulse. We had patient smell an alcohol pad and mother was also present. She then stated that he has fainted after vaccinations in the past. Patient sat 15 minutes with 3 nurses and was back to his baseline. Patient walked unassisted to the main office with his mother and his school nurse present
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: mother was holding child on side for vaccinations when mother grabbed needle from nurses hand and injected her child in  right thigh. she then proceeded to grab the second needle off the table and inject child with 2nd vaccination. it is unclear if vaccine were delivered correctly in the route( IM/SC).
Age: 53.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Ear infection, Feeling abnormal, Insomnia, Pyrexia
Clinical narrative: Immunization on 11/18, first signs of rash on face started 11/29-Day 11 post vaccination. The rash has continued and is now all over her body. The rash is red and raised, "sand paper" like texture. Baby is scratching, and miserable. Unable to sleep, decrease in appetite. On December 2nd, she developed a fever of 103.2F and mother brought her in to the doctor to be evaluated. It was determined that she had an ear infection (her first one ever) and that she was having a reaction or immune response to the MMR vaccine. The rash is still present today with minimal improvements (December 5, 2024)
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Immunization on 11/18, first signs of rash on face started 11/29-Day 11 post vaccination. The rash has continued and is now all over her body. The rash is red and raised, "sand paper" like texture. Baby is scratching, and miserable. Unable to sleep, decrease in appetite. On December 2nd, she developed a fever of 103.2F and mother brought her in to the doctor to be evaluated. It was determined that she had an ear infection (her first one ever) and that she was having a reaction or immune response to the MMR vaccine. The rash is still present today with minimal improvements (December 5, 2024)
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Asthenia, Chills, Lymphadenopathy, Skin discolouration
Clinical narrative: discoloration - black/blue, dark brown; jolting pain in the left elbow, teeth shaking, peeling of the left arm skin, swollen groin and left axillary glands with weakness.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Skin exfoliation, Swelling
Clinical narrative: discoloration - black/blue, dark brown; jolting pain in the left elbow, teeth shaking, peeling of the left arm skin, swollen groin and left axillary glands with weakness.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hyperhidrosis, Nausea, Pain
Clinical narrative: whole body aches, weakness, chills, sweats, nausea
Age: 62.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Electrocardiogram ST-T segment abnormal, Lung opacity, Pulmonary embolism, Pulmonary infarction, Syncope
Clinical narrative: November 25 fainted at home. Went to emergency room
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt given Shingrix vaccine not ordered by provider and outside recommended age range. Pt is 41 years of age.  No adverse reaction reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Injection site erythema, Peripheral swelling
Clinical narrative: Immediate burning, sure was red, arm continued to swell turning red, by 24 hrs, left arm was noticeably swollen, by that night, my left leg swelled, both arm and leg were red and hot to touch, my face and neck were swollen but not as noticeable as limbs, my right side swelled but nothing like the left side. There?s still the outline of the shot, tenderness and swelling today, 12/6/24. I stayed in bed, put cold compresses on my arm, took 1 extra dose of lasix a day, drank lots of water to flush myself out.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling, Swelling face, Tenderness
Clinical narrative: Immediate burning, sure was red, arm continued to swell turning red, by 24 hrs, left arm was noticeably swollen, by that night, my left leg swelled, both arm and leg were red and hot to touch, my face and neck were swollen but not as noticeable as limbs, my right side swelled but nothing like the left side. There?s still the outline of the shot, tenderness and swelling today, 12/6/24. I stayed in bed, put cold compresses on my arm, took 1 extra dose of lasix a day, drank lots of water to flush myself out.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Severe vomiting on the evening of vaccine administration 12/3/24, about 7 times. Went to ER. Given ondansetron and left taking good PO. Diarrhea, but no more vomiting, when I followed up with mother by phone later in the day 12/4/24
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Drug abuse, Drug screen positive, Fatigue, Flushing, Headache
Clinical narrative: 2 hours post vaccination pt complained of headache and fatigue pt was noted to have flushing to face and hives to bilat arms and neck.  Benadryl 50mg PO was given and medrol dose pack.  Due to behavior drug tox screen was also done and was found to have amphetamines, methamphetamines, bupinorphine and fentanyl in his symptoms, pt reported doing an unknown substance 4 days prior to this day.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: 2 hours post vaccination pt complained of headache and fatigue pt was noted to have flushing to face and hives to bilat arms and neck.  Benadryl 50mg PO was given and medrol dose pack.  Due to behavior drug tox screen was also done and was found to have amphetamines, methamphetamines, bupinorphine and fentanyl in his symptoms, pt reported doing an unknown substance 4 days prior to this day.
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event - duplicate flu shot
Age: 0.17
Sex: U
Vaccine: HEP, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a 2 month old was administered VAXELIS and RECOMBIVAXHB on the same day; No additional AE.; This spontaneous report was received from a medical assistant via company representative and refers to a 2-month-old patient of unknown gender.  The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated on the same day with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose, dose number, lot #, expiration date, site and route of administration were not provided) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) 0.5 milliliter (dose, dose number, lot #, expiration date, site and route of administration were not provided) for prophylaxis (overdose). There was no additional adverse event reported.   Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: HPV4
Symptoms: Acrochordon, Anogenital warts, Biopsy skin abnormal, Human papilloma virus test positive
Clinical narrative: skin tag is considered a genital wart; This spontaneous report has been received from a physician assistant, referring to a 28-year-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On unknown dates, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (dose, route of administration, anatomical location, lot# and expiry date were not reported. The patient completed the vaccination series (no further details provided).  On an unspecified date in 2024 (reported as "recently"), the patient had "breakthrough disease"; he saw a dermatologist and had a skin tag removal by the dermatologist. On an unknown date in 2024, skin tag testing was positive for 6 and 11 strains and negative for strain 18 of the human papillomavirus (HPV) virus, and after biopsy, skin tag was considered a genital wart.  The outcome of the event was unknown.  Causality assessment was not provided.  Lot# is being requested and will be submitted if received.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired drug administered; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 05-NOV-2024, the patient received Havrix (right thigh) .5 ml. On 05-NOV-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired drug administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-NOV-2024 The physician assistant reported that the patient received the Havrix vaccine, which was expired, which led to an expired vaccine used. No other condition reported. No other products were received by the patient.
Sex: U
Vaccine: UNK
Symptoms: Burning sensation, Pain
Clinical narrative: it hurts so bad; it burns; This non-serious case was reported by a pharmacist and described the occurrence of pain in a patient who received Flu Seasonal TIV Dresden (Fluarix 2008-2009 season) (batch number 72RF2) for prophylaxis.   On an unknown date, the patient received Fluarix 2008-2009 season. On an unknown date, an unknown time after receiving Fluarix 2008-2009 season, the patient experienced pain (Verbatim: it hurts so bad) and burning sensation (Verbatim: it burns). The outcome of the pain and burning sensation were unknown.   It was unknown if the reporter considered the pain and burning sensation to be related to Fluarix 2008-2009 season.     It was unknown if the company considered the pain and burning sensation to be related to Fluarix 2008-2009 season.   Additional Information: GSK Receipt Date: 07-NOV-2024  The pharmacist reported that they have been administering the Fluarix vaccine and many people are reporting that it hurts so bad during the injection, that it burns. The age range of the vaccinated persons were 38 to under 52 years old. This case was inked with US2024121095 and US2024121111, reported by same reporter.; Sender's Comments:  US-GSK-US2024121095:Same reporter; different patient US-GSK-US2024121111:Same reporter; different patient