chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Mucous stools, Musculoskeletal stiffness, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: An hour after the shot I felt extreme fatigue/ ?wiped out,? upon waking next morning severe aching pain stiffness and tingling in entire left arm, about 24 hours after, I felt like my throat closed up to half its usual width and got scratchy, food was catching, felt like a sinus infection was coming on. The next day my I lost my voice and only squeaks came out for the next 2.5 days. I had flu symptoms and missed two days of work. This segued into severe headache and upper respiratory congestion, stomach pains and nausea with diarrhea, mucous-covered stool and constipation. Two nosebleeds over this time.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Throat tightness, Upper respiratory tract congestion
Clinical narrative: An hour after the shot I felt extreme fatigue/ ?wiped out,? upon waking next morning severe aching pain stiffness and tingling in entire left arm, about 24 hours after, I felt like my throat closed up to half its usual width and got scratchy, food was catching, felt like a sinus infection was coming on. The next day my I lost my voice and only squeaks came out for the next 2.5 days. I had flu symptoms and missed two days of work. This segued into severe headache and upper respiratory congestion, stomach pains and nausea with diarrhea, mucous-covered stool and constipation. Two nosebleeds over this time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Computerised tomogram head, Facial paralysis, Fatigue, Oral herpes
Clinical narrative: pt states that she was extremely tired after getting the vaccine.  The next day she began running a fever, developed fever blisters on her lips and she slept the entire day. After about 24 hours, the right side of her face became swollen and had fallen. She tried to drink water but it came out of mouth because the entire right side of face was drooping. She went back to bed and slept. The next morning, the right side of her face was still swollen but not as swollen as the day before.  A couple of days later, she noticed the right side of her face on her cheeks, she was developing a rash and/or hives. Her chin had dimples in it and her neck looked like chicken skin as her skin was just hanging. She contacted her PCP and was seen right away. She was prescribed Valtrex for the fever blisters.  The next morning, her right cheek was still red with rash and was worse. She went back to her PCP.  She was prescribed more Valtrex and steroids. She was told if gets any worse to go to the ER. By Feb 3rd she went to ER. They did CT scan. She was diagnosed with Bells Palsy associated with the vaccine. She was told keep using the meds prescribed by PCP and to follow up with PCP next day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous, Skin atrophy, Somnolence
Clinical narrative: pt states that she was extremely tired after getting the vaccine.  The next day she began running a fever, developed fever blisters on her lips and she slept the entire day. After about 24 hours, the right side of her face became swollen and had fallen. She tried to drink water but it came out of mouth because the entire right side of face was drooping. She went back to bed and slept. The next morning, the right side of her face was still swollen but not as swollen as the day before.  A couple of days later, she noticed the right side of her face on her cheeks, she was developing a rash and/or hives. Her chin had dimples in it and her neck looked like chicken skin as her skin was just hanging. She contacted her PCP and was seen right away. She was prescribed Valtrex for the fever blisters.  The next morning, her right cheek was still red with rash and was worse. She went back to her PCP.  She was prescribed more Valtrex and steroids. She was told if gets any worse to go to the ER. By Feb 3rd she went to ER. They did CT scan. She was diagnosed with Bells Palsy associated with the vaccine. She was told keep using the meds prescribed by PCP and to follow up with PCP next day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Urticaria
Clinical narrative: pt states that she was extremely tired after getting the vaccine.  The next day she began running a fever, developed fever blisters on her lips and she slept the entire day. After about 24 hours, the right side of her face became swollen and had fallen. She tried to drink water but it came out of mouth because the entire right side of face was drooping. She went back to bed and slept. The next morning, the right side of her face was still swollen but not as swollen as the day before.  A couple of days later, she noticed the right side of her face on her cheeks, she was developing a rash and/or hives. Her chin had dimples in it and her neck looked like chicken skin as her skin was just hanging. She contacted her PCP and was seen right away. She was prescribed Valtrex for the fever blisters.  The next morning, her right cheek was still red with rash and was worse. She went back to her PCP.  She was prescribed more Valtrex and steroids. She was told if gets any worse to go to the ER. By Feb 3rd she went to ER. They did CT scan. She was diagnosed with Bells Palsy associated with the vaccine. She was told keep using the meds prescribed by PCP and to follow up with PCP next day.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: No adverse event, Off label use
Clinical narrative: Dr. ordered the vaccines for this patient and they were administered in the office as ordered.  Dr. discussed with the mother at the time of the visit that he wanted the Rotavirus to be administered in light of patient's many complex medical issues that include gastrointestinal issues.  There was no adverse effect.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Sleep disorder, Swelling
Clinical narrative: Right upper arm pain that radiates circumferentially and down arm. Patient reports pain at the site was severe. Developed swelling for about a week. Unable to lift weights with right arm, cannot sleep on right side due to pain.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Lichen planopilaris, Scar
Clinical narrative: Systemic: Hair Loss and scarring on scalp-Medium, Additional Details: Patient stated that she has been diagnosed with Lichen planopilaris and the only thing she has in common with the other people that has this is that they received the COVID-19 shot
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Axillary mass, Fatigue, Lethargy, Pyrexia
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: lump under arm/upset stomach-Severe
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Systemic: Stroke-Severe, Additional Details: Patient states he suffered a triple massive stroke
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: On 1/25/25, pt was seen at clinic for TB reading. During visit, pt reported pain, swelling, redness below injection site of shingrix vaccine (received 1/22/25). Bruising noted at injection site. Pt noticed symptoms one day after receiving injection. Pt advised to ice the area and schedule follow-up appointment with PCP or clinic for further management
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Autoimmune disorder, Skin discolouration, Stress, Vitiligo
Clinical narrative: Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Additional Details: Patient discovered discolored patch of skin on right side of abdomen about 2 weeks after receiving vaccination. After a stressful event, discoloration spread all over body. She visited a dermatologist and was diagnosed with vitiligo. Dermatologist suspects it was triggered by vaccination.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: flulaval; Manufacturer: gsk; LotNumber: 72415; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Other Vaccines:  VaccineTypeBrand: spikevax; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Fatigue, Influenza, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: fatigue and arm soreness-Mild, Additional Details: similar feeling to the flu, had fallen getting out of her car. patient was able to recover normally that day.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: fatigue and arm soreness-Mild, Additional Details: similar feeling to the flu, had fallen getting out of her car. patient was able to recover normally that day.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Lethargy, Mobility decreased
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Cold Symptoms-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient reported experiencing cold symptoms after 3rd dose and being in bed for about a week after with no energy and hard to move.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Cold Symptoms-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient reported experiencing cold symptoms after 3rd dose and being in bed for about a week after with no energy and hard to move.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Patient stated he felt like he had the flu for 3 days-Severe, Additional Details: Patient reported swelling, soarness, and pain at the injection site.  He says i lasted for 3 days and he felt like he had the flu. Patient stated he lives in a retirement center and Pharmacy came to administer the vaccine.
Age: 67.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Nausea-Medium, Additional Details: Also Sore Throat reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Pain radiating up neck from sight of injection-Severe
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site cyst, Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: cyst formed at injection site because vaccine was given below deltoid-Medium
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: Systemic: patient states no symptoms that correlate w/ vaccine-Mild, Additional Details: Patient reports pain in back of neck, other than that no symptoms reported
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: underarm swelling for months afterward-Medium
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: underarm swelling for months afterward-Medium
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: complained of mild pain at injection site, but has returned for 2 other vaccines (covid and RSV)  since the flucelvax. She did not mention the pain until returning for the 2nd vaccine. She said the pain is mild and not restricting any activity. No redness, bruising, swelling on the arm at all. She did not seem concerned at all, but we thought it should be reported as an adverse event.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient is stating that he is experiencing a "coming and going" pain in his bicep. He also stated that about 5-6 weeks after the injection he starting experiencing nexk pain/stiffness in his neck.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Additional Details: PATIENT SAYS HE EXPERIENCED MILD ACHES AND LOW GRADE FEVER W/ NOVOVAX. ALTHOUGH HER HAD SIDE EFFECTS, THEY WERE ABOUT 20% OF WHAT SIDE EFFECTS WERE W/ MODERNA. WHEN HE WAS VACCINATED WITH MODERNA HE HAD 101 DEGREE FEVER AND CHILLS.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Bacterial infection, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: 1/29 patient came in to inform us of the situation.  Her arm looks red and possible dead skin.  complained of pain and red striking down arm the next day after vaccine.  Went to patient first, states bacterial infections.  Has gone several times for treatment.  still hurts from today.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: 1/29 patient came in to inform us of the situation.  Her arm looks red and possible dead skin.  complained of pain and red striking down arm the next day after vaccine.  Went to patient first, states bacterial infections.  Has gone several times for treatment.  still hurts from today.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Presyncope, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt vasovagaled while in chair during flu vaccine and TB administration.  Brief LOC for 5-10 seconds.  Pt woke up and vital signs were monitored for 15 minutes.  No injury noted and pt did not fall out of chair.  Pt reported history of vasovagal during procedures in past.  Did not disclose this prior to shot.  Pt Discharged home in stable condition. , Other Vaccines:  VaccineTypeBrand: PPD test; Manufacturer: Sanofi Pasteur; LotNumber: 3CA4BC1; Route: ID; BodySite: Left lower forearm; Dose: 1; VaxDate: 01/08/2025
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Muscle tightness, Myalgia, Neuralgia, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: says her muscle "seized" when walking, muscle and nerve pain-Medium, Additional Details: patient said sore muscles, nerve pain and while walking felt like her muscles were seizing. she said slight fever she used tylenol and ibuprofen along with cold compresses. Also complained of back spasms.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: says her muscle "seized" when walking, muscle and nerve pain-Medium, Additional Details: patient said sore muscles, nerve pain and while walking felt like her muscles were seizing. she said slight fever she used tylenol and ibuprofen along with cold compresses. Also complained of back spasms.
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest discomfort, Chest pain, Headache, Neck pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: back/neck pain-Severe, Systemic: Headache-Severe, Additional Details: pt experencied chest pain,neck and back pain along with headache with few minutes of vaccination. EMS was called and pt was taken to hospital
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Pt states having a rash and hives and that the injection site was raised as well. Resolved in 2 days
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Pt states having a rash and hives and that the injection site was raised as well. Resolved in 2 days
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Tachycardia
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Tachycardia-Severe
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Additional Details: Patient states the rash is cleared up mostly now. Did present with this before and went to the Emergency room, but did not go to emergency room this time. Patient is nit certain vaccine caused reaction, speculates it could also be due to cold weather, Other Vaccines:  VaccineTypeBrand: FLUCELVAX TRIVAL 2024-2025; Manufacturer: ; LotNumber: 946619; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 01/08/2025
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Pain in injection site for 24 hours controlled by an ice pack. Patient recovering almost to normal today on 1/31/25. Spoke with pt's Mom who checked in on her son and reported back to me., Other Vaccines:  VaccineTypeBrand: bexsero; Manufacturer: glaxosmithkline; LotNumber: 55n34; Route: im; BodySite: r deltoid; Dose: ; VaxDate: UNKNOWN
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: Fluzone High-Dose; Manufacturer: ; LotNumber: U8532BA; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Seizure
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Additional Details: while not disclosed before vaccine administration, patient did say she has a neurological disorder, traumatic brain injury and has had absence seizures in the past.  patient states she has not had an adverse reaction to vaccines previously but has had adverse reactions after blood draw .  ambulance was called and patient taken to hospital for further evalation.  patient was able to stand on own and speak when she left.  patients mother was called by the patient to notify family
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Additional Details: while not disclosed before vaccine administration, patient did say she has a neurological disorder, traumatic brain injury and has had absence seizures in the past.  patient states she has not had an adverse reaction to vaccines previously but has had adverse reactions after blood draw .  ambulance was called and patient taken to hospital for further evalation.  patient was able to stand on own and speak when she left.  patients mother was called by the patient to notify family
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Fever-Mild
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Pattient checked in for Tdap, Flu, and Covid Vaccines. After the Flu and Tdap was administered, patient mentioned he may have had a fainting adverse reaction after receiving Tetanus vaccine in the past. The Covid vaccine was suspended to monitor for any reaction. Patient suddenly clenched his fists, shook and pushed his head backward against the wall of the immunization room. I called out for help and got the minute clinic nurse practitioner. Patient was confused, sweating and fainting., Other Vaccines:  VaccineTypeBrand: FLUCELVAX; Manufacturer: SEQIRUS; LotNumber: 391416; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Pattient checked in for Tdap, Flu, and Covid Vaccines. After the Flu and Tdap was administered, patient mentioned he may have had a fainting adverse reaction after receiving Tetanus vaccine in the past. The Covid vaccine was suspended to monitor for any reaction. Patient suddenly clenched his fists, shook and pushed his head backward against the wall of the immunization room. I called out for help and got the minute clinic nurse practitioner. Patient was confused, sweating and fainting., Other Vaccines:  VaccineTypeBrand: FLUCELVAX; Manufacturer: SEQIRUS; LotNumber: 391416; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient has a history of fainting from receiving flu shot in the past (2 years prior). She regain conciousness within 2 minutes of fainting and did not need to seek immediate medical attention
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient has a history of fainting from receiving flu shot in the past (2 years prior). She regain conciousness within 2 minutes of fainting and did not need to seek immediate medical attention
Age: 1.17
Sex: U
Vaccine: PNC20
Symptoms: Erythema, Swelling
Clinical narrative: Red, raised swollen Size 5inches x 3 Oval shape
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood glucose went up 10-20 points fasting after the vaccine and haven't returned to pre vaccine range.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave patient covid vaccine on right arm, no reactions, covid -19 is for 12 years of age or older and patient is not of age for dosage.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain
Clinical narrative: Patient reported shoulder and neck pain today while doing a medication review with him. He is still experiencing some occasional pain
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; Medical assistant calling to report the inadvertent administration of an expired dose of GARDASIL 9 to a patient on 02/04/2025.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-FEB-2025, the patient was vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W028573, expiration date: 06-JAN-2025, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) inadvertently by health professional (Expired product administered). No symptoms reported and no additional details provided. No other adverse event (no AE).
Age: 9.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: The nurse is reporting that unknown number of patients received improperly stored vaccines.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PEDVAX x017448  11/7/2025 VAXELIS  u7907aa; No additional AEs were reported; This spontaneous report was received from a nurse concerning unspecified number of patients of 9 years-old male patient. Patients' concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 16-JAN-2025, the patient  was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #x017448 with expiration date: 07-NOV-2025, in his right deltoid and administered for prophylaxis (strength, dose, and anatomical location were nor reported).  The vaccines were stored at a temperature of 33 degrees Fahrenheit for a time frame of 76 hours. There was no previous temperature excursions.  No additional adverse events were reported.  This case was previously considered as non valid, but upon follow up information received from the reporter on 03-FEB-2025, this case became valid.  This is one of the 2 reports from the same reporter.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; a 12-month year old child was administered VARIVAX intradermally; This spontaneous report was received from a medical assistant, referring to a 12-month-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 04-FEB-2025, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y011019, expiration date: 18-JUN-2026, administered intradermally for prophylaxis (dose and strength not provided) (product use issue), diluted with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose description, lot #, expiry date, and indication were not provided). No adverse side effects were reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported.; HCP called to report that an expired dose of VAQTA (expiry 10/1/2024) was inadvertently administered to a patient today, 2/5/2025.  Potency was not supported by the post expiry memo.  No adverse effects were reported. Consent to contact is yes. No ad; This spontaneous report as received from a registered nurse refers to a 41-year-old patient. On 05-FEB-2025, the patient was inadvertently vaccinated with an expired dose of  hepatitis a vaccine, inactivated (VAQTA) lot # X006702, expiration date: 01-OCT-2024, 0.5 mL for prophylaxis. No adverse event was reported.
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Nurse called to report a Patient was given a dose of PROQUAD on 12/31/2024 and another dose on 2/4/2025. Patient received her 1st dose at normal dosing schedule on unknown date, however received 3 doses in total accidentally; This spontaneous report was received from nurse and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 31-DEC-2024, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 04-FEB-2025, the patient was vaccinated with the third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection 0.5 milliliter, lot # Y017206 with expiration date of 13-APR-2026, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (extra dose administered).  No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: aMedical Assistant calling to report adverse event regarding MMR II and VARIVAX.  Medical Assistant stated that a patient was administered doses of MMR II and VARIVAX after the vaccines have been reconstituted and drawn into a syringe and left out at; any medical concerns or symptoms after the administration of the improperly stored vaccines/No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of a not reported age or gender.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On an unknown date (reported as 27-JAN-2026 conflicting information), the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 ml / two dose series, lot# reported as Y000224 (which upon internal validation was found as valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)),  expiration date reported as: 03-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml / two dose series, lot #Y011019, expiration date: 18-JUN-2026, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion for over 1 hour and 30 minutes while unprotected from light.. Medical Assistant confirmed the patient involved has not reported any medical concerns or symptoms after the administration of the improperly stored vaccines.
Age: 20.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Caller stated that PROQUAD was accidentally administered to a 20 year old male patient instead of MMR II.; It was administered concomitantly with VARIVAX; No additional AE/no PQC; This spontaneous report was received from a registered nurse referring to a 20 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, route, lot number, expiration date and anatomical location were not provided) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot number, expiration date and anatomical location were not provided) for prophylaxis (wrong product administered).  It was also reported that It was administered also concomitantly varicella virus vaccine live (oka/merck)(VARIVAX) (accidental overdose).  No adverse events reported.  Additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: testing negative for chicken pox immunity; This spontaneous report was received from the patient's mother, concerning her daughter, a female patient of unknown age.   The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On an unknown date in 2011, the patient was vaccinated with two doses of with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient was given a third dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1st dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) due to receiving testing and testing negative for chicken pox immunity.  At the time of reporting, the outcome of the event testing negative for chicken pox immunity was not known.    The causal relationship between testing negative for chicken pox immunity and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: PNC15, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional adverse event was reported; then PREVNAR 20 was mistakenly administered on 2/3/2025 to the same patient at a different location; This spontaneous report was received from Other Health Professional and refers to a.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 23-OCT-2024, the patient was vaccinated with first dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 03-FEB-2025, the patient was mistakenly vaccinated with pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided) (Wrong product administered). No additional adverse event was reported.
Age: 0.5
Sex: U
Vaccine: PNC21
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE. No PQC.; HCP called to report that a 6 month old was inadvertently administered CAPVAXIVE on 02/04/2025. No additional information was provided. Caller did not provide full patient demographic information. Permission given to contact HCP. No additional AE. No; This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-FEB-2025, the patient was vaccinated with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE),  strength 168 microgram per milliliter (mcg/ml) injection, (valid lot number Y011819, expiration date: 01-OCT-2025 upon internal review (reported as 11-OCT-2025, conflicting information) administered for prophylaxis (dose, anatomical location, route of administration was not provided) (product administered to patient of inappropriate age).  No additional adverse event (AE).
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the 2nd dose yet; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2025 This case was reported by a patient via interactive digital media. The patient was enquiring whether he/she should start again from the 1st dose at this moment if he/she want to get shingrix or it was ok to get only 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I did get the 2 shot vaccine a few years ago and got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I did get the 2 shot vaccine a few years ago and got the shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JAN-2025 This case was reported by the patient via interactive digital media. The patient got the 2 shots of vaccine a few years ago and got the shingles last year and it was mild, so it helped. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose )and Shingles vaccine(2nd dose).
Sex: U
Vaccine: VARZOS
Symptoms: Diplopia, Vertigo
Clinical narrative: I developed vertigo and double vision, 6 weeks after my first Shingrix shot; I developed vertigo and double vision, 6 weeks after my first Shingrix shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced vertigo (Verbatim: I developed vertigo and double vision, 6 weeks after my first Shingrix shot) and double vision (Verbatim: I developed vertigo and double vision, 6 weeks after my first Shingrix shot). The outcome of the vertigo and double vision were not reported.   It was unknown if the reporter considered the vertigo and double vision to be related to Shingrix.     It was unknown if the company considered the vertigo and double vision to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2025  The reporter from digital media of GlaxoSmithKline that he/she received first dose of Shingrix vaccine and experienced vertigo and double vision in 6 weeks. The reporter asked that the Vertigo was known side effect of Shingrix. Two months had passed from first vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Scab, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles/shingles across my back, under my arm and across my chest; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles.shingles across my back, under my arm and across my chest). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter requested that change the advertising because it is deceptive. The reporter was 78 year old woman who has had both shingles shots and got shingles. Needless to say, the reporter and everyone to know was led to believe, through they advertising that, if you got both shingles shots, you would not got shingles. At first, the reporter thought it was just her. But every one told, about 25 people, all asked if the reporter had gotten the shots because if so, the reporter would not get shingles. It turns out that, if they did get shingles, supposedly they get a milder case So the reporter been through a Valtrex prescription and shingles across the patient back, under arm and across chest. Just as it was done scabbing 4 weeks ago and after the worst pain the patient had ever had, it was starting up again in distinct places. The reporter requested to please change there false advertising that leaves people thinking they would not get. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(1st dose) and Shingles vaccine(2nd dose)
Sex: U
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: feeling very sick after taking Arexvy; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness 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 sickness (Verbatim: feeling very sick after taking Arexvy). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Arexvy.     It was unknown if the company considered the sickness to be related to Arexvy.   Additional Information: GSK receipt date: 03-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she was feeling very sick after taking Arexvy vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: When I was given my first Shingrix shot, it was injected into my tricep; This non-serious case was reported by a consumer via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: When I was given my first Shingrix shot, it was injected into my tricep). The outcome of the vaccine administered at inappropriate site was unknown.   Additional Information: GSK Receipt Date: 02-FEB-2025 The reporter reported that when the patient was given my first Shingrix shot, it was injected into my tricep which led to vaccine administered at inappropriate site. The reporter asked should not the shot be injected into the deltoid.
Sex: U
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: skin reaction; This non-serious case was reported by a consumer and described the occurrence of skin reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin reaction (Verbatim: skin reaction). The outcome of the skin reaction was not resolved.   It was unknown if the reporter considered the skin reaction to be related to Shingrix.     It was unknown if the company considered the skin reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2025 The reporter reported that he/she just got the Shingrix vaccine.  He/she was not told that there were 2 shots. He/she had a skin reaction after the first dose which had not gone away.