chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Pt received vaccine on Monday 3/10/2025, came in today Sunday 3/16 and showed rash to pharmacist. Pt said it started on 3/11 Tuesday and it has improved but the rash was from her injection site all the way down the arm. Pt states her arm is tender and warm. Pt has been taking Benadryl which has helped a little. Pharmacist recommended the pt to go seek medical attention at the ER or Urgent Care to make sure it is not cellulitis. Pt states she will think about it.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Rash, Skin warm, Tenderness
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Pt received vaccine on Monday 3/10/2025, came in today Sunday 3/16 and showed rash to pharmacist. Pt said it started on 3/11 Tuesday and it has improved but the rash was from her injection site all the way down the arm. Pt states her arm is tender and warm. Pt has been taking Benadryl which has helped a little. Pharmacist recommended the pt to go seek medical attention at the ER or Urgent Care to make sure it is not cellulitis. Pt states she will think about it.
Age: 58.0
Sex: M
Vaccine: PNC21
Symptoms: Asthenia, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: muscle pain and bodyweakness-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium
Age: 58.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site pruritus, Injection site swelling, Myalgia, Pain
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: muscle pain and bodyweakness-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Started 3/15/2025 woke up with pain, swelling, and redness at injection site reaching up to the "size of a golfball". no fever, no chills, no heat at the site. Symptoms subsided now to "quarter size" mild redness and mild swelliing. Pt did not take any pain relieve med because "it hasn't got to the point" where she would need to take some for the discomfort.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient says after receiving Moderna booster, she experienced a lasting effect of tingling all over her body. She went to her neurologist and they weren't able to provide a diagnosis. Since then, she's received other vaccines including Flu and COVID (PIZER) and still experiences the tingling feeling all over although it is much less severe than the first time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Hypoaesthesia, Injection site pain
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient states had some injection site pain but that went away and is now reporting weakness, tingling, and pain in shoulder/back area. From an injector standpoint vaccine was administered correctly with no issues.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient states had some injection site pain but that went away and is now reporting weakness, tingling, and pain in shoulder/back area. From an injector standpoint vaccine was administered correctly with no issues.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: Patient reports being very sick and experiencing severe flu like symptoms after receiving RSV + COVID + FLU, Other Vaccines:  VaccineTypeBrand: COVID 2024-2025 12+; Manufacturer: MODERNA; LotNumber: 3042560; Route: IM; BodySite: LEFT ARM; Dose: 1; VaxDate: 09/12/2024, VaccineTypeBrand: RSV (AREXVY VIAL); Manufacturer: GLAXOSMITHKLINE; LotNumber: EY77C; Route: IM; BodySite: RIGHT ARM; Dose: 1; VaxDate: 09/12/2024
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Joint Pain-Medium, Additional Details: PATIENT INDICATED SWELLING, PAIN AND REDNESS NO BOTH FEET. SEEKED MEDICAL ADVISE, DR ATTRIBUTED IT TO REACTION OF VACCINE. PATIENT WAS ADVISED TO TAKE NSAID TO REDUCE INFLAMATION. AWAITING FOR FOLLOWUP
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Joint Pain-Medium, Additional Details: PATIENT INDICATED SWELLING, PAIN AND REDNESS NO BOTH FEET. SEEKED MEDICAL ADVISE, DR ATTRIBUTED IT TO REACTION OF VACCINE. PATIENT WAS ADVISED TO TAKE NSAID TO REDUCE INFLAMATION. AWAITING FOR FOLLOWUP
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, 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
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling of body temperature change, Flushing, Hyperhidrosis, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: felt hold and cold-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: After administration of HPV Gardasil vaccine, the patient felt hot & cold and also sweaty. She also reported feeling light headed. Patient sat down for 10-15 minutes. Patient was offered water. Patient had said she still felt sweaty and shaky. Patient was able to leave / walk out on her own power. Patient's spouse arrived to transport the patient back home. Patient was informed to go the ER if symptoms relapse or worsen. A follow up voicemail was made to check in on the patient.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Hx of fainting; given 2 vax in the R arm per prefrence due to scarring/atrophy in L arm. Tdap given 1st then flu with adequate spacing for co-admin. As bandage was being placed for flu vax pt started to lean forward in chair but I was able to catch her and sit her back in the chair. I noted tense muscle and some shaking/seizing (episode aprox 20 sec). Pt states little food during day. Layed her on her back on bench with feet elevated. Pt got picked up and stated would f/u with provider on 3/19, Other Vaccines:  VaccineTypeBrand: Tdap (Boostrix); Manufacturer: GSK; LotNumber: DY3K7; Route: Intramuscular; BodySite: Right Arm; Dose: 1; VaxDate: 03/18/2025
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Contusion, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Came by on 3/19/2025, Her arm is bruised up and said she started having symptoms on 3/18/2025. Gotten the Flu shot and the Capvaxive together together, pt said that she been on flu shot before, first time getting pneuminia shot. We suspect it from the Capvaxive. Called MD and spoken to someone at MD office. Talking to patient on follow up with MD. will schedule with md appointment this week, Other Vaccines:  VaccineTypeBrand: Fluvelvax; Manufacturer: ; LotNumber: 946637; Route: Intramusclar; BodySite: Left Arm; Dose: 1; VaxDate: 03/13/2025
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Came by on 3/19/2025, Her arm is bruised up and said she started having symptoms on 3/18/2025. Gotten the Flu shot and the Capvaxive together together, pt said that she been on flu shot before, first time getting pneuminia shot. We suspect it from the Capvaxive. Called MD and spoken to someone at MD office. Talking to patient on follow up with MD. will schedule with md appointment this week, Other Vaccines:  VaccineTypeBrand: Fluvelvax; Manufacturer: ; LotNumber: 946637; Route: Intramusclar; BodySite: Left Arm; Dose: 1; VaxDate: 03/13/2025
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: Systemic: feeling unwell, breathing-Medium, Additional Details: Patient states felt unwell the night of the vaccines. Today, 3/19/25, pt states still feeling unwell and has heaving breathing. Advised pt to call MD or go to urgent care., Other Vaccines:  VaccineTypeBrand: Pfizer 2024-2025 COVID 12YR+; Manufacturer: Pfizer; LotNumber: LN0590; Route: IM; BodySite: Right Deltoid; Dose: 1; VaxDate: 03/13/2025, VaccineTypeBrand: Priorix MMR; Manufacturer: GSK; LotNumber: 342RC; Route: SC; BodySite: Left upper arm; Dose: 1; VaxDate: 03/13/2025, VaccineTypeBrand: Flucelvax 2024-2025; Manufacturer: Seqirus; LotNumber: 946625; Route: IM; BodySite: Right Deltoid; Dose: 1; VaxDate: 03/13/2025
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Other Vaccines:  VaccineTypeBrand: pfizer 5-11 yr; Manufacturer: pfizer; LotNumber: lm2045; Route: im; BodySite: r arm; Dose: unknown; VaxDate: 11/27/2024
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: patient collapsed and fainted. patient recovered and responsive after fainting. ems called and patient taken by ems
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Joint injury, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: patient had limited movement in arm, could not raise it
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: gsk; LotNumber: dy3k7; Route: IM; BodySite: right arm; Dose: ; VaxDate: 03/18/2025
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Neuralgia
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: Patient still reporting pain post 17 days of vaccination, pain has been averaging 7/10 on scale of 10. Nerve pain radiating from hand to shoulder, Other Vaccines:  VaccineTypeBrand: capvaxine; Manufacturer: merck; LotNumber: xn575; Route: im; BodySite: right deltoid; Dose: 1; VaxDate: 03/03/2025
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: Patient still reporting pain post 17 days of vaccination, pain has been averaging 7/10 on scale of 10. Nerve pain radiating from hand to shoulder, Other Vaccines:  VaccineTypeBrand: capvaxine; Manufacturer: merck; LotNumber: xn575; Route: im; BodySite: right deltoid; Dose: 1; VaxDate: 03/03/2025
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Dizziness, Fatigue, Hypotension, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: 911 was called to further evaluate hypotension and near syncope event. ekg done in clinic, wnl. patient and family refused to be taken to ED. patient monitored in clinic for 30 min returned to baseline, departed home with family. could not clear note without putting a response, there was no redness, swelling, pain, brusing, noted at injection site
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Presyncope, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: 911 was called to further evaluate hypotension and near syncope event. ekg done in clinic, wnl. patient and family refused to be taken to ED. patient monitored in clinic for 30 min returned to baseline, departed home with family. could not clear note without putting a response, there was no redness, swelling, pain, brusing, noted at injection site
Age: 13.0
Vaccine: TDAP
Symptoms: Dizziness, Fall, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient became lightheaded while walking out of pharmacy with his mom. Fell and bumped his head. Came to and mom declined calling 911 and drove him to the clinic nearby right away.  Attempted to call patient but haven't heard back.
Age: 77.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Fever-Mild, Systemic: Swelling, pain,redness, warm to touch.-Mild, Additional Details: Patient  present to the pharmacy on 3/19 at approx.430pm stating she was just seen in the ER for adverse reaction to Capvaxive. Her arm wa visible red, and swollen. The area affected was approxiate 2 to 3 inches below the site of injection. She was given antibx at the ER. I also recommended benadryl which she purchased. The area had the appearance of a covid arm.
Age: 77.0
Sex: F
Vaccine: PNC21
Symptoms: Pruritus, Pyrexia, Skin warm, Swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Fever-Mild, Systemic: Swelling, pain,redness, warm to touch.-Mild, Additional Details: Patient  present to the pharmacy on 3/19 at approx.430pm stating she was just seen in the ER for adverse reaction to Capvaxive. Her arm wa visible red, and swollen. The area affected was approxiate 2 to 3 inches below the site of injection. She was given antibx at the ER. I also recommended benadryl which she purchased. The area had the appearance of a covid arm.
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GSK; LotNumber: 5Y9CA; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Lethargy
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GSK; LotNumber: 5Y9CA; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GSK; LotNumber: 5Y9CA; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: pain,swelling,redness in arm-Severe, Additional Details: patient reported pain,swelling,redness in left arm. visited urgent care. recd cephalexin. then since pain didn't subside, went to hospital
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Lethargy, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: pain,swelling,redness in arm-Severe, Additional Details: patient reported pain,swelling,redness in left arm. visited urgent care. recd cephalexin. then since pain didn't subside, went to hospital
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: see dr for treatment.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Injection site pain, Loss of consciousness, Seizure, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: Patient fainted after receiving 2nd dose of vaccine, she passed out a few seconds and had convulsion. Then she opened her eyes and asked  what happened. Paramedic came and took over., Other Vaccines:  VaccineTypeBrand: vaqta; Manufacturer: merck; LotNumber: y017625; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: Patient fainted after receiving 2nd dose of vaccine, she passed out a few seconds and had convulsion. Then she opened her eyes and asked  what happened. Paramedic came and took over., Other Vaccines:  VaccineTypeBrand: vaqta; Manufacturer: merck; LotNumber: y017625; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Patient felt weird immediately after and could taste the vaccine and feel it move through arm, hand and upper back...she can still taste the vaccine and feels strange.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient was administered three private vaccines on 3/19/2025 including MMR vaccine per recommended schedule by this RN. Prior to preparation of vaccines and after retrieval from cold storage, they were all double checked by RN. Upon documentation of administration, it was discovered lot number of MMR not in database. (But this is an occasional occurrence from purchasing). The lot number was inactive as it expired five days prior on 3/14/2025 but it was still in the freezer in the regular basket. I immediately sequestered the remaining expired vaccine in a brown bag and labeled DO NOT USE, EXPIRED. Dr. informed immediately upon discovery. When going to select the vaccines from the freezer, there was no Proquad in stock. This was not mentioned earlier by any other staff. This caused RN to select individual MMR & Varicella plus the Kinrix. So not only are we out of Proquad but also MMR now. State nurse was informed 3/20/25. The dose will need to be repeated, not less than 28 days.  Mother was called and informed on 3/21/2025 and is agreeable to repeat in future.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swelling, pain, redness and warmth left thigh starting  within 12 hours of shot, progressing until day3 , then resolving
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Pt came in for shots, advised parents that pt did not need vaccines, but that the state vaccine system showed that they were due for covid vaccine. Parents were unsure of what vaccines pt received and consented to receiving dose of Covid vaccine. Upon further review from Supervisor on 3/24/2025, pt had already received 1st dose of covid vaccine on 1/13/2025, but there was an error in system that did not populate vaccine into the state vaccine system.
Vaccine: VARZOS
Symptoms: Encephalomyelitis
Clinical narrative: Myleoencephalitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of encephalomyelitis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced encephalomyelitis (Verbatim: Myleoencephalitis) (serious criteria disability and GSK medically significant). The outcome of the encephalomyelitis was not reported.   It was unknown if the reporter considered the encephalomyelitis to be related to Shingles vaccine.     The company considered the encephalomyelitis to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a reporter via  interactive digital media. The reporter reported that he/she knew two people (2 patients) now who have got the Shingles shot and one to two weeks later got myleoencephalitis and now they were disabled.; Sender's Comments: Encephalomyelitis is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sever Pain in Left Arm at injection site 3 months later; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-DEC-2024, the patient received the 1st dose of Shingrix (left arm). On 29-DEC-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Sever Pain in Left Arm at injection site 3 months later). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 14-MAR-2025 Consumer reported that he took the first dose of Shingrix vaccine and experienced severe pain in left arm at injection site 3 months later. Reporter also mentioned that they did not want to get second shot because of ongoing pain from first shot.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue, Tremor
Clinical narrative: right arm shaking; Inappropriate reconstitution technique/gave the patient only sterile water instead of the vaccine; Inappropriate reconstitution technique/gave the patient only sterile water instead of the vaccine; This non-serious case was reported by a pharmacist and described the occurrence of tremor limb in a 53-year-old female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 14-MAR-2025, the patient received Priorix (right deltoid). On 14-MAR-2025, less than a day after receiving Priorix, the patient experienced tremor limb (Verbatim: right arm shaking), inappropriate preparation of medication (Verbatim: Inappropriate reconstitution technique/gave the patient only sterile water instead of the vaccine) and inappropriate dose of vaccine administered (Verbatim: Inappropriate reconstitution technique/gave the patient only sterile water instead of the vaccine). The outcome of the tremor limb was not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   The reporter considered the tremor limb to be related to Priorix and Priorix Pre-Filled Syringe Device.     The company considered the tremor limb to be related to Priorix and Priorix 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: 14-MAR-2025 The reporter stated she gave the patient only sterile water instead of the vaccine Priorix.  The Priorix was not reconstituted, only the sterile water was injected in R deltoid which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The patient's right arm was shaking a little after that. The pharmacist wants to know what else she can do next.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix was given intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 58-year-old female patient who received MMR (Priorix) for prophylaxis.   On 12-MAR-2025, the patient received Priorix (intramuscular). On 12-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was given intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-MAR-2025 The Pharmacist reported that a Priorix vaccine was given intramuscularly instead of subcutaneously which led to, subcutaneous injection formulation administered by other route. The batch number and expiry date was not provided. No other details were available.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got his 2nd dose which is off schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in November 2024).   On 13-MAR-2025, the patient received the 2nd dose of Twinrix adult. On 13-MAR-2025, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: got his 2nd dose which is off schedule). The outcome of the drug dose administration interval too long was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-MAR-2025 The reporter called and stated he got his Twinrix vaccine in November 2024 and received 2nd dose on 13th March 2025 which was off schedule. Doses were supposed to be given 0, 1 and 6 months. The patient received the 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Needle prick feeling all over; This non-serious case was reported by a consumer and described the occurrence of prick pain feeling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism (has hypothyrodism). Concomitant products included levothyroxine sodium (Synthroid).   On 04-FEB-2025, the patient received Shingrix. On 11-MAR-2025, 35 days after receiving Shingrix, the patient experienced prick pain feeling (Verbatim: Needle prick feeling all over). The outcome of the prick pain feeling was not resolved.   It was unknown if the reporter considered the prick pain feeling to be related to Shingrix.     It was unknown if the company considered the prick pain feeling to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAR-2025 A female patient received the Shingrix vaccine and had a needle prick feeling all over. The patient received Synthroid vaccine for hyperthyroidism.
Vaccine: RSV
Symptoms: Neonatal respiratory distress syndrome
Clinical narrative: respiratory issues in newborn; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of respiratory disorder neonatal in a neonate patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (transplacental). On an unknown date, an unknown time after receiving Arexvy, the patient experienced respiratory disorder neonatal (Verbatim: respiratory issues in newborn). The outcome of the respiratory disorder neonatal was not reported.   It was unknown if the reporter considered the respiratory disorder neonatal to be related to Arexvy.     It was unknown if the company considered the respiratory disorder neonatal to be related to Arexvy.   See case US2025030425 for details regarding the mother case.   Additional Information: GSK Receipt Date: 12-MAR-2025 The pharmacist mentioned that a patient received Arexvy while she was pregnant and now, the newborn had respiratory issues. The pharmacist asked if GlaxoSmithKline had any study showing a correlation of giving Arexvy to pregnant women and respiratory issues in newborns.; Sender's Comments:  US-GSK-US2025030425:Mother case
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by a patient via interactive digital media. The patient self-reported this case for himself/herself. Patient had taken the vaccine a few years ago, and other than a sore arm, he/she had no problems.
Vaccine: RSV
Symptoms: Mobility decreased, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: catching a bad cold; Aching body all over; All extremeties hurt; difficulty moving; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cold (Verbatim: catching a bad cold), general body pain (Verbatim: Aching body all over), pain in extremity (Verbatim: All extremeties hurt) and mobility decreased (Verbatim: difficulty moving). The outcome of the cold and mobility decreased were not reported and the outcome of the general body pain and pain in extremity were resolving.   It was unknown if the reporter considered the cold, general body pain, pain in extremity and mobility decreased to be related to Arexvy.     It was unknown if the company considered the cold, general body pain, pain in extremity and mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date : 14-MAR-2025  This case was reported by a patient via interactive digital media. Physical symptoms were catching a bad cold.  Aching body all over.  All extremities hurt , difficulty moving. However once he/she started moving the soreness dissipated.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingrix 2nd does while having active shingles; shingrix 2nd does while having active shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingrix 2nd does while having active shingles) and drug use for unapproved indication (Verbatim: shingrix 2nd does while having active shingles). The outcome of the shingles was not reported and the outcome of the drug use for unapproved indication was not applicable.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2025 The reporter reported that consequences of receiving the Shingrix 2nd doses while having active shingles, which led to drug use for unapproved indication.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; one has had shingles 5 times, the other two once and two times; 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.   On an unknown date, the specified number of patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: one has had shingles 5 times, the other two once and two times). 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.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a reporter via interactive digital media.  Reporter stated that they had 3 friends (patients) who got the Shingles injection, and one had shingles 5 times, the other two had once and two times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got 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: got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   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: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient got both Shingles shots and got shingles after the last one. The patient had shingles now (at the time of reporting). 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 and 2nd dose).
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain, Scar, Vaccination failure
Clinical narrative: Suspected vaccination failure; right now I am on my 3rd bout with Shingles; leave scars; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: right now I am on my 3rd bout with Shingles) and scar (Verbatim: leave scars). The outcome of the vaccination failure and scar were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and scar to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that, right now he/she was on his/her 3rd bout with shingles.  The patient got the Shingles shots, and it probably help, but he/she really could not tell. The patient stated shingles were very painful, zap you of your energy and leave scars.  The patient felt absolutely useless when he/she had them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I got the vaccine and I got shingles anyway twice; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccine and I got shingles anyway twice). 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.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and he/she got shingles anyway twice. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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.
Vaccine: COVID19, VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Three days of wretched misery ensued.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   The patient's past medical history included shingles (I had shingles in summer 2018).   On an unknown date, the patient received Shingles vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: Three days of wretched misery ensued.). The outcome of the feeling abnormal was resolved (duration 3 days).   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 16-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had shingles in summer 2018, eventually got the vaccine in 2023.  Same day as covid booster. Three days of wretched misery ensued. It was unknown if the reporter considered the feeling abnormal to be related to Covid-19 vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by the reporter via interactive digital media. The reporter stated that he/she had two doses of Shingrix shingles vaccine and low and behold got the shingles.  The reporter further stated that the same thing happened to a coworker (patient). 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. This case was linked with case US2025AMR033210 from the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2). US-GSK-US2025AMR033210:different patient/ same reporter US-GSK-US2025AMR033210:different patient/same reporter