chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Pt said vaccine exacerbated her asthma and flared cellulitis on akles, legs and arms-Mild
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Dizziness, Fatigue, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Additional Details: patient recieved 3 vaccines on the same day, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: glaxosmithline; LotNumber: 55th4; Route: left deltoid; BodySite: arm; Dose: ; VaxDate: 04/14/2025, VaccineTypeBrand: bostrix tdap vaccine; Manufacturer: glaxosmithline; LotNumber: dy3k7; Route: left deltoid; BodySite: arm; Dose: ; VaxDate: 04/14/2025
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Lethargy
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Additional Details: patient recieved 3 vaccines on the same day, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: glaxosmithline; LotNumber: 55th4; Route: left deltoid; BodySite: arm; Dose: ; VaxDate: 04/14/2025, VaccineTypeBrand: bostrix tdap vaccine; Manufacturer: glaxosmithline; LotNumber: dy3k7; Route: left deltoid; BodySite: arm; Dose: ; VaxDate: 04/14/2025
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Additional Details: daughter called saying dad got shot then was sick and feverish. i told her he might feel slightly ill for a few days and if not better to get scene.
Age: 75.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: Capvaxive; Manufacturer: Merck; LotNumber: y019157; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 04/19/2025
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Additional Details: Patient was having severe nausea and sweating and faigue... stay with us for min 20 min and we walked pt to the after 20, 25 min resting in the pharmacy, Other Vaccines:  VaccineTypeBrand: Havrix; Manufacturer: Glaxosmithkline; LotNumber: 2345B; Route: intramuscular; BodySite: left upper arm; Dose: ; VaxDate: UNKNOWN
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Additional Details: Patient was having severe nausea and sweating and faigue... stay with us for min 20 min and we walked pt to the after 20, 25 min resting in the pharmacy, Other Vaccines:  VaccineTypeBrand: Havrix; Manufacturer: Glaxosmithkline; LotNumber: 2345B; Route: intramuscular; BodySite: left upper arm; Dose: ; VaxDate: UNKNOWN
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Hypotension, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Collapse without loss of consciousness-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tinnitus-Medium, Systemic: Weakness-Severe, Additional Details: Possible vagal reactions vs vaccine reaction. No prior adverse events with vaccination. 1st time receiving Prevnar 20.
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Syncope, Tinnitus
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Collapse without loss of consciousness-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tinnitus-Medium, Systemic: Weakness-Severe, Additional Details: Possible vagal reactions vs vaccine reaction. No prior adverse events with vaccination. 1st time receiving Prevnar 20.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: little pain initially, then a lot of itching, area is red, a little bruised, possibly from scratching. Informed pt to take benadryl and ice the area for relief, she will follow up with md in the next day or 2 if it worsens or stays the same
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: little pain initially, then a lot of itching, area is red, a little bruised, possibly from scratching. Informed pt to take benadryl and ice the area for relief, she will follow up with md in the next day or 2 if it worsens or stays the same
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Redness swelling further down away from injection site on left arm-Medium
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Severe, Systemic: Weakness-Severe, Additional Details: patient complaining arm is severely bothering him. It is swollowen, hot to touch and very painful. , Other Vaccines:  VaccineTypeBrand: Prevnar 20; Manufacturer: Pfizer; LotNumber: lx4483; Route: Im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Severe, Systemic: Weakness-Severe, Additional Details: patient complaining arm is severely bothering him. It is swollowen, hot to touch and very painful. , Other Vaccines:  VaccineTypeBrand: Prevnar 20; Manufacturer: Pfizer; LotNumber: lx4483; Route: Im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Flushing, Headache, Hyperhidrosis, Hypertension
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Additional Details: Patient came to the pharmacy next day to report rash over body and arms but not at injection site., Other Vaccines:  VaccineTypeBrand: shingrix (10-ok) kit; Manufacturer: glaxosmithkline; LotNumber: 55th4; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: prevnar 20; Manufacturer: wyeth/pfizer; LotNumber: ln4927; Route: im; BodySite: righ arm; Dose: ; VaxDate: UNKNOWN
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Insomnia, Rash
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Additional Details: Patient came to the pharmacy next day to report rash over body and arms but not at injection site., Other Vaccines:  VaccineTypeBrand: shingrix (10-ok) kit; Manufacturer: glaxosmithkline; LotNumber: 55th4; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: prevnar 20; Manufacturer: wyeth/pfizer; LotNumber: ln4927; Route: im; BodySite: righ arm; Dose: ; VaxDate: UNKNOWN
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: autistic; has a measles titer that was "flat" and not responsive; This spontaneous report was received from a pharmacist and refers to a 20-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date (the pharmacist stated that the patient received the vaccine when he was an infant), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (strength, dose, frequency, route, lot # and expiration date were not reported) and sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the pharmacist stated that the patient was an autistic male who had a measles titer that was "flat" and not responsive.   The outcome and the causality of the events was not provided.   Upon internal review, the event of autistic was determined to be medically significant.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient refused to speak with Rph and this is the information given
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Rash
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Mild, Additional Details: Patient reported developing a rash and swelling around site of injection. Rash and swelling is resolving with minimal effect on daily activity. Patient also reported having chills the day after injection which has gone away.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Severe, Systemic: Weakness-Medium, Other Vaccines:  VaccineTypeBrand: Heplisav-B; Manufacturer: Dynavax; LotNumber: 945661; Route: IM; BodySite: Right Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Myalgia
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: muscle aches and chills-Mild, Systemic: Headache-Mild, Additional Details: rash that started 3 days ago that got worse in the past 3 days
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: muscle aches and chills-Mild, Systemic: Headache-Mild, Additional Details: rash that started 3 days ago that got worse in the past 3 days
Age: 60.0
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, Additional Details: patient came 21 months later today 4/29/25 to report this, said very long needle was used which is not true as I am the administering immunizer pharmacist and used 1inch needle
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Tremor
Clinical narrative: Systemic: Chills-Mild, Systemic: Shakiness-Mild
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: pt has sore arm that she cannot sleep on and cannot fully raise her arm
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Other flu-like symptoms-Medium, Systemic: Headache-Medium
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Systemic: Fever-Severe
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Additional Details: The patient received Arexvy and Shingrix vaccines at the same time. The patient's wife called us 7 days later to inform us that he had become severely ill with chills, headaches, lethargy, and joint pain so severe he had difficulty walking. They had gone to his doctor and the doctor assessed that this was a result of the 2 vaccines being given together. Patient has still not recovered after 7 days., Other Vaccines:  VaccineTypeBrand: Arexvy (RSV); Manufacturer: GSK; LotNumber: 9SB34; Route: IM; BodySite: Right Deltoid; Dose: 1; VaxDate: 04/23/2025
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Malaise, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Additional Details: The patient received Arexvy and Shingrix vaccines at the same time. The patient's wife called us 7 days later to inform us that he had become severely ill with chills, headaches, lethargy, and joint pain so severe he had difficulty walking. They had gone to his doctor and the doctor assessed that this was a result of the 2 vaccines being given together. Patient has still not recovered after 7 days., Other Vaccines:  VaccineTypeBrand: Arexvy (RSV); Manufacturer: GSK; LotNumber: 9SB34; Route: IM; BodySite: Right Deltoid; Dose: 1; VaxDate: 04/23/2025
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Lethargy, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient reports that she experiences injection site pain every time she gets a vaccine. The pain feels as though she over worked her arm and it lasts about a week.
Age: 80.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient reported to pharmacy on Wednesday morning, April 30 and showed current RPh on duty arm; the right arm was red and felt warm per patient and swelling; did not notice any issues with left arm. Patient states some mild discomfort and swelling/ itching. Will let MD know at their current cardiology appointment later that day., Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GLAXOSMITHKLINE; LotNumber: 33FD3; Route: IM; BodySite: RIGHT DELTOID; Dose: 1; VaxDate: 04/23/2025
Age: 80.0
Sex: F
Vaccine: PNC21
Symptoms: Limb discomfort, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient reported to pharmacy on Wednesday morning, April 30 and showed current RPh on duty arm; the right arm was red and felt warm per patient and swelling; did not notice any issues with left arm. Patient states some mild discomfort and swelling/ itching. Will let MD know at their current cardiology appointment later that day., Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GLAXOSMITHKLINE; LotNumber: 33FD3; Route: IM; BodySite: RIGHT DELTOID; Dose: 1; VaxDate: 04/23/2025
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Hypersomnia, Influenza like illness, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Nausea-Mild, Additional Details: Patient reports feeling down after receiving the vaccine. She was sleeping around the clock, has flu like symptoms, nausea(couldn't eat), and her arm was sore.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Nausea-Mild, Additional Details: Patient reports feeling down after receiving the vaccine. She was sleeping around the clock, has flu like symptoms, nausea(couldn't eat), and her arm was sore.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: sewlling/redness around the injection site
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Lethargy, Pyrexia
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Patient reported SEs after last Covid dose which were described as 'slept a lot, and felt like I had a fever.', Other Vaccines:  VaccineTypeBrand: Fluzone High-Dose Trivalent; Manufacturer: Sanofi-Pasteur; LotNumber: UT8463DA; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 09/07/2024
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Nausea-Medium
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: 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-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Small amount of redness and swelling below injection site.  No discharge. Pt not running a fever that she is aware of.  Counseled to take Tylenol, monitor for increase in swelling and redness and follow up with PCP.  Informed pt we would call and check on her this weekend.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Systemic: Unconstituted diluent-Mild
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Inbound call received from a nurse who said a patient received a dose of PROQUAD after it was improperly stored  after a Temperature excursion. The dose was administered on 10MAR2025, prior to the expiry date. No patient name or additional informatio; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 10-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) reconstituted with sterile diluent (BAXTER STERILE DILUENT), lot #X023316, expiration date: 19-Mar-2025, administered for prophylaxis (dose, route od administration and anatomical site of injection were not reported). The vaccine administered experienced a temprature excursion of -10.1C for 3 hours and 40 minutes (Product storage error).   No additional information was provided to further clarify the details, no previous temperature excursions and no additional adverse events were reported (no adverse events).  This case is non-valid due to no patients' identifiers.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Systemic: Herpes rash on abdomen and arm. Nerve pain-Severe, Additional Details: Patient developed a rash along abdomen and arm and is being treated for nerve pain and shingles by MD, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: glaxo smith kline biologicals; LotNumber: 55th4; Route: intra muscular; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Dysphagia, Eye swelling, Mouth swelling, Paraesthesia, Pruritus
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: Patient age 16 came in for  2nd of Priorix and Engerix vaccine. she stated on the Vaccine screening and consent form that she does get dizzy and faint after a vaccine. I had asked if this happened with the first two doses and she said no. After giving the vaccines i had patient sit down and wait and assessed her for any adverse effects. Patient started to get dizzy and looked pale. I took her blood pressure which was 106/63, patient also felt nauseous but felt better afterwards, Other Vaccines:  VaccineTypeBrand: Priorix MMR; Manufacturer: Glaxosmithkline; LotNumber: XX9N4; Route: Left upper Arm; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Engerix BPEdi; Manufacturer: Glaxosmithkline; LotNumber: 7nx57; Route: LEft Deltoid; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: SECOND DOSE OF RSV VACCINE ADMINISTERED. NOT NEEDED UNDER CURRENT RECOMMENDATIONS. NO ADVERSE REACTION REPORTED.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Burning sensation, Injection site indentation, Injection site pain, Rash
Clinical narrative: Patient is experiencing a sharp/dull pain and an indentation at injection site. Patient also has a rash that burns.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEP, HEPA, MMRV
Symptoms: Extra dose administered
Clinical narrative: Hep B was administered although it was already part of the pediarix combo vaccine.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Lip swelling, Urticaria
Clinical narrative: Hives and swelling to lip.  Put on Benadryl.  Still with some swelling to lip the next day.
Age: 0.67
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Injection given to left leg without incident. VIS given to mother.   Rechecked after 10 minutes at 150 pm and injection site red and irritated. No rash to site, or to chest, stomach,arms, legs or back.   Ice pack placed on leg will review with PCP.   Rechecked at 2 pm with PCP. Ok to watch for a few more minutes.   Rechecked at 212 pm. Site remains red. NO rash, trouble breathing, tongue swelling, lip swelling or other reaction.
Age: 41.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Pt experienced her upper Rt arm was slightly erythematic, distally swollen to her elbow, with lines of delineation. Patient showed me a picture of her arm the day after the vaccine, in which her whole upper extremity was erythematic, swollen and had a white poc mark where the injection was given
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not have an adverse reaction
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red thigh swollen and red. Prescribed ointment.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient had Kinrix ordered instead of Pediarix. Patient received Kinrix and had no adverse reaction noted while in office.  MA realized after administration, Pediarix should have been ordered instead.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness and swelling at injection site.  Redness and swelling has increased in size over the last 5 days
Age: 58.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine is supposed to be given subcutaneously but was given intramuscularly instead
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood gases abnormal, Full blood count abnormal, Metabolic function test abnormal, Seizure, Urine analysis abnormal
Clinical narrative: seizure occurred approx 3 hours post- vaccines, pt evaluated in ER
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Upon visit the vaccine was found in the refrigerator and should have been in the freezer. No issues or symptoms reported by patient.
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was supposed to be getting a tdap and a dtap was entered into the system by a student of Dr.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Upon visit the vaccine was in the freezer and should have been in the refrigerator.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: Patient stated she a dime size red area appeared around the site of injection approximately 2 days after she received the vaccine. On the third day, the red area was twice the size and hot to the touch. Patient also experienced flu like symptoms for about four days. Patient took Benadryl last night but she stated she did not think it helped.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Crying, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed adverse symptoms approx. 1 hour after administration. became inconsolable and had radiating heat, swelling, and pain at injection site. patient given tylenol upon onset of symptoms without improvement after 10min. patient taken by mom to ED. Father notified this clinic
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Culture wound, Skin lesion, Skin ulcer
Clinical narrative: Ulcerated skin lesion developed within 48hrs of receiving the Prevnar 20 vaccine in left thigh.  Skin culture obtained. Started Mupirocin Ointment. Consider oral antibiotics if not improving.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Malaise, Myalgia, Oropharyngeal discomfort
Clinical narrative: On day of injection, mild to moderate soreness at injection site. No erythmea or nother symptoms. Next morning, slight throat discomfort, which intensified over the next 24 hours. Overnight, symptoms included severe sore throat, inflammed pharynx, slight green phlegm (to the point of raspy breathing), no fever (97.1),  there was chills/shivering, no shortness of breath, there was malaise and moderate diffuse myalgia.  Symptoms improved vastly within about 6 hours of peak with supportive care and rest at home.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pharyngeal inflammation, Sputum discoloured
Clinical narrative: On day of injection, mild to moderate soreness at injection site. No erythmea or nother symptoms. Next morning, slight throat discomfort, which intensified over the next 24 hours. Overnight, symptoms included severe sore throat, inflammed pharynx, slight green phlegm (to the point of raspy breathing), no fever (97.1),  there was chills/shivering, no shortness of breath, there was malaise and moderate diffuse myalgia.  Symptoms improved vastly within about 6 hours of peak with supportive care and rest at home.
Sex: M
Vaccine: PNC21
Symptoms: Injection site pain, Lethargy, Pyrexia, Sinus headache
Clinical narrative: about 8 hours after vaccination he began to have what he described as mild to moderate non-serious adverse reactions of sinus headache, pain at injection site; pain at injection site; feeling feverish but no fever; lethargy; This spontaneous report was received from a physician and refers to a 70-year-old male patient.   The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.   On 01-May-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection, 0.5 mL, administered as prophylaxis (strength, Lot No., expiration date, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided). On the same date (01-May-2025, reported as about 8 hours after vaccination) he experienced as mild to moderate non-serious adverse reactions of sinus headache, pain at injection site (vaccination site pain), feeling feverish but no fever (pyrexia) and lethargy.  At the reporting time, the patient was recovering from all the events  The causal relationship between all the events with the suspect vaccine was not reported.
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; A nurse called to report a 15 year old patient received an expired dose of GARDASIL 9 ON 01MAY2025. The caller declined to answer any additional questions. No additional information provided. No additional AE reported. No PQC.; This spontaneous report was received from a nurse and refers to a 15-year-old patient of unknown gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 01-May-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), lot #X019625, expiration date: 23-Apr-2025, administered for prophylaxis (dose, route of administration and anatomical site of injection) (expired product administered).  No additional information and no additional adverse events were provided (no adverse event).
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster, Sensory disturbance
Clinical narrative: got shingles 2 weeks later. I refused the 2nd shot. In my eye, temple, head area.; had nerve sensations for months after; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: got shingles 2 weeks later. I refused the 2nd shot. In my eye, temple, head area.) (serious criteria GSK medically significant) and sensory disturbance (Verbatim: had nerve sensations for months after). The outcome of the ophthalmic herpes zoster was not reported and the outcome of the sensory disturbance was resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster and sensory disturbance to be related to Shingles vaccine.     The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the sensory disturbance to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that had the first shot, got shingles 2 weeks later. The reporter refused the 2nd shot, the patient had experienced in his/her eye, temple, head area. The patient lived on the couch over 2 months and had to see doctor and eye doctor. The patient looked like a monster, even after the poxs were gone the patient had nerve sensations for months after.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: left arm and complains of worse pain than last year; This non-serious case was reported by a contact via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number T75MP) for prophylaxis.   On 20-SEP-2024, the patient received FluLaval 2024-2025 season (intramuscular, left arm). On 20-SEP-2024, less than a day after receiving FluLaval 2024-2025 season, the patient experienced pain in arm (Verbatim: left arm and complains of worse pain than last year). The outcome of the pain in arm was not resolved.   The reporter considered the pain in arm to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     The company considered the pain in arm to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 21-MAR-2025 Reporter reported that she had patient that received Flulaval on 20th September 2024 in the left arm and complained of worse pain than last year.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Pain in extremity, X-ray limb normal
Clinical narrative: left arm and pain; shoulder pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received belimumab (Benlysta) (batch number Unknown) for systemic lupus erythematosus.   Co-suspect products included Flu unspecified (Flu vaccine) for flu prevention.   On an unknown date, the patient started Benlysta. In NOV-2024, the patient received Flu vaccine. In DEC-2024, an unknown time after receiving Benlysta and Flu vaccine, the patient experienced pain in arm (Verbatim: left arm and pain) and shoulder pain (Verbatim: shoulder pain). The action taken with Benlysta and Flu vaccine was unknown. The outcome of the pain in arm and shoulder pain were not resolved.   It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Benlysta and Flu vaccine.     Linked case(s) involving the same patient:  US2020237640   GSK receipt date: 07-APR-2025 This case was received from Consumer. Caller was the patient and experienced user of Benlysta IV for LUPUS SLE, for 3 to 4 years. Caller reports she received her flu vaccine in Nov 2024 in her left arm. Caller reports in Dec 2024 for left arm and shoulder was very painful and was still persisting to this day. Caller read the Benlysta can cause extremity pain. She was not sure if the Benlysta or the Flu shot maybe what was causing the arm pain. Caller went to Urgent Care in Feb 2025 due to the left arm and shoulder pain. They took an x-ray and nothing was broken. Caller can supply a complete list of other medications she takes.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR207413:same reporter US-GLAXOSMITHKLINE-US2020237640:same Patient/ new case is created because of time gape.
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; pain in limbs; This non-serious case was reported by a physician via call center representative and described the occurrence of fever in a specified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced fever (Verbatim: Fever) and pain in limb (Verbatim: pain in limbs). The outcome of the fever and pain in limb were unknown.   It was unknown if the reporter considered the fever and pain in limb to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever and pain in limb to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-APR-2025 The physician stated that two patients developed fever and pain in limbs after their first dose of Bexsero. The reporter did not have any patient identifiers at that time.; Sender's Comments:  US-GSK-US2025047867:same reporter
Sex: M
Vaccine: RVX, VARZOS
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Hives; Swelling; Itching; Redness/ redness keeps going down the arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 15-APR-2025, the patient received Shingles vaccine (left arm) and RSV vaccine (left arm). On 18-APR-2025, 3 days after receiving Shingles vaccine and RSV vaccine, the patient experienced erythema of extremities (Verbatim: Redness/ redness keeps going down the arm). On an unknown date, the patient experienced hives (Verbatim: Hives), swelling (Verbatim: Swelling) and pruritus (Verbatim: Itching). The outcome of the hives, erythema of extremities, swelling and pruritus were not resolved.   It was unknown if the reporter considered the hives, erythema of extremities, swelling and pruritus to be related to Shingles vaccine and RSV vaccine.     It was unknown if the company considered the hives, erythema of extremities, swelling and pruritus to be related to Shingles vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 21-APR-2025 The patient received the Shingles Vaccine and the RSV Vaccine on Tuesday, 15 April, 2025. Both vaccines were injected in the Left arm.  The patient was unable to provide the manufacturer or brand names of either vaccine. It was not disclosed if the Shingles vaccine was the first or second dose. On Friday, 18 April 2025 the patient began to notice redness. And since this time has been experiencing hives, swelling, and itching. The redness kept going down the arm..
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Shivering; Headache; Sinus pain; Diarrhea; Insomnia; Flu like symptoms; Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first dose of vaccine in 2017).   On 16-APR-2025, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 16-APR-2025, an unknown time after receiving Shingrix, the patient experienced shivering (Verbatim: Shivering), headache (Verbatim: Headache), sinus pain (Verbatim: Sinus pain), diarrhea (Verbatim: Diarrhea), insomnia (Verbatim: Insomnia), influenza-like symptoms (Verbatim: Flu like symptoms) and drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). On 21-APR-2025, the outcome of the shivering, headache, sinus pain, diarrhea, insomnia and influenza-like symptoms were resolved (duration 5 days). The outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the shivering, headache, sinus pain, diarrhea, insomnia and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the shivering, headache, sinus pain, diarrhea, insomnia and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 22-APR-2025 The reporter was the patient who received her first dose of vaccine in 2017 and received the second dose of vaccine on 16th April 2025 in her left arm. Reporter did not had lot number or any information to identify the vaccines. The reporter identified or called the vaccine as Shingrix. The reporter stated after the second dose of vaccine she had shivering, headache, sinus pain, diarrhea, insomnia and flu like symptoms immediately after vaccination. The symptoms lasted 5 days after the second vaccine then resolved.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Sinus pain
Clinical narrative: Shivering; Headache; Sinus pain; Diarrhea; Insomnia; Flu like symptoms; Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first dose of vaccine in 2017).   On 16-APR-2025, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 16-APR-2025, an unknown time after receiving Shingrix, the patient experienced shivering (Verbatim: Shivering), headache (Verbatim: Headache), sinus pain (Verbatim: Sinus pain), diarrhea (Verbatim: Diarrhea), insomnia (Verbatim: Insomnia), influenza-like symptoms (Verbatim: Flu like symptoms) and drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). On 21-APR-2025, the outcome of the shivering, headache, sinus pain, diarrhea, insomnia and influenza-like symptoms were resolved (duration 5 days). The outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the shivering, headache, sinus pain, diarrhea, insomnia and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the shivering, headache, sinus pain, diarrhea, insomnia and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 22-APR-2025 The reporter was the patient who received her first dose of vaccine in 2017 and received the second dose of vaccine on 16th April 2025 in her left arm. Reporter did not had lot number or any information to identify the vaccines. The reporter identified or called the vaccine as Shingrix. The reporter stated after the second dose of vaccine she had shivering, headache, sinus pain, diarrhea, insomnia and flu like symptoms immediately after vaccination. The symptoms lasted 5 days after the second vaccine then resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (Received Zostavax 22 April 2013), Shingrix (The patient received the first dose of shingrix on 15 August 2018, 50mcg, intramuscularly.) and Methotrexate (had a history of taking Methotrexate for arthritis and unclear if arthritis was a preexisting condition, patient had been off of Methotrexate for 3 weeks).   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: has not yet received the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 23-APR-2025 The patient had not yet received the second dose. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not had the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose of Shingrix, intramuscularly injection to deltoid in May 2024).   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: has not had the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 23-APR-2025 The patient reported that she had her first dose of Shingrix in March of 2024.  She did not had the second dose, which was due between May, 2024 and September 2024. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.