chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have them now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have them now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the she had them now they had knocked the wind out of her sails.  She had the shingles shots too. 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 Shingrix.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed shingrix 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: Missed shingrix 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 08-MAR-2025 The patient enquired that if he/she got a Shingrix vaccine part 1 but not part 2 what was the recommended course of action. The patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: severe pain in arm that radiated down to hand, loss of full motor control in the hand as of 3/17/25, pain so severe at times can not get comfortable, treated with course of prednisone
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Warmness of the arm
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Pyrexia, Respiratory rate increased
Clinical narrative: High Fever, Elevated heart rate and elevated breathing
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gave the Varicella vaccine before the 28 days live window. Pt had received an MMR vaccine on 02/25/2025.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Syncope
Clinical narrative: patient was sitting on parents lap on bench when recieved vaccine. After the vaccine was given child was upset at parent becuase recieved vaccine. He stood up against the table and syncope episode happened and child fell to the floor and hit hit on childs chair
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure, Visual impairment
Clinical narrative: Suspected vaccination failure; You can get shingles on the inside of your eyes/My eyesight was ruined/still got it; 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) and ophthalmic herpes zoster (Verbatim: You can get shingles on the inside of your eyes/My eyesight was ruined/still got it) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2025 The case was received from the patient via interactive digital media.  The reporter reported that you can get shingles on the inside of your eyes.  The reporter's eyesight was ruined.  The reporter had all shingles vaccines and still got it.  The reporter reported, so just know the vaccine does not prevent all cases of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary 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 Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Other Vaccines:  VaccineTypeBrand: flucelvax; Manufacturer: seqiris; LotNumber: 946636; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: swelling or left arm-Medium, Additional Details: patient's main complaint was swelling and redness of the left arm. went to the urgent care.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Brain scan normal, Cardiac imaging procedure normal, Dizziness, Fatigue
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: After vaccine, pt stayed with wife sitting when he suddenly closed his eyes. 911 was called. Pt was breathing and had heart beat. Pt was weak, tired, and yawning and sweating a lot but would respond. Response team took him to hospital. The day after, I called the wife who stated the hospital did scans of heart and brain and everything came back good. Pt was home doing well and recovering well per wife. Wife states drs told them this was probably due to lack of sleep and overwhelmed over vaccine., Other Vaccines:  VaccineTypeBrand: Capvaxive; Manufacturer: Merck; LotNumber: y019158; Route: IM; BodySite: Left arm; Dose: ; VaxDate: 03/08/2025
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing, Hyperhidrosis, Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: After vaccine, pt stayed with wife sitting when he suddenly closed his eyes. 911 was called. Pt was breathing and had heart beat. Pt was weak, tired, and yawning and sweating a lot but would respond. Response team took him to hospital. The day after, I called the wife who stated the hospital did scans of heart and brain and everything came back good. Pt was home doing well and recovering well per wife. Wife states drs told them this was probably due to lack of sleep and overwhelmed over vaccine., Other Vaccines:  VaccineTypeBrand: Capvaxive; Manufacturer: Merck; LotNumber: y019158; Route: IM; BodySite: Left arm; Dose: ; VaxDate: 03/08/2025
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Yawning
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: After vaccine, pt stayed with wife sitting when he suddenly closed his eyes. 911 was called. Pt was breathing and had heart beat. Pt was weak, tired, and yawning and sweating a lot but would respond. Response team took him to hospital. The day after, I called the wife who stated the hospital did scans of heart and brain and everything came back good. Pt was home doing well and recovering well per wife. Wife states drs told them this was probably due to lack of sleep and overwhelmed over vaccine., Other Vaccines:  VaccineTypeBrand: Capvaxive; Manufacturer: Merck; LotNumber: y019158; Route: IM; BodySite: Left arm; Dose: ; VaxDate: 03/08/2025
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Joint injury
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blood pressure decreased, Fall, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: patient fell over after pfizer vaccine was given immunizer was able to catch pt in catch. She lost consciousness after a few second mom was called into the room, 911 called. pt stated she felt nauseous, became pale and stated she could not see any thing. ems arrived on seen with in a few minutes and took over. I called mom  later on in the day she said pt blood dropped really low and they will follow up with cardiolgist.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Loss of consciousness, Nausea, Pallor, Tremor
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: patient fell over after pfizer vaccine was given immunizer was able to catch pt in catch. She lost consciousness after a few second mom was called into the room, 911 called. pt stated she felt nauseous, became pale and stated she could not see any thing. ems arrived on seen with in a few minutes and took over. I called mom  later on in the day she said pt blood dropped really low and they will follow up with cardiolgist.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: patient fell over after pfizer vaccine was given immunizer was able to catch pt in catch. She lost consciousness after a few second mom was called into the room, 911 called. pt stated she felt nauseous, became pale and stated she could not see any thing. ems arrived on seen with in a few minutes and took over. I called mom  later on in the day she said pt blood dropped really low and they will follow up with cardiolgist.
Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Mouth swelling, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Fever-Medium, Additional Details: The patient is a prescriber so he knows what happened and he reported that he had injection site swelling, fever, redness, and the area hurt so he had to take ibuprofen OTC and we advised to take benadryl (50mg) at bedtime in case it was allergic reaction
Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Fever-Medium, Additional Details: The patient is a prescriber so he knows what happened and he reported that he had injection site swelling, fever, redness, and the area hurt so he had to take ibuprofen OTC and we advised to take benadryl (50mg) at bedtime in case it was allergic reaction
Age: 81.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Chills, Pruritus
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Chills-Medium, Additional Details: Per pt she started to feel Chills at night on 02/10/2025 and start to feel itchy on 02/11/2025. She saw her primary dr. and dermatologist. Dr. have her on benadryl , hydrocortisone topical, and rx topical for itchiness but no improvment. (No epipen no benadryl was given in the pharmacy since symptom on set a day later.)
Age: 81.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Arthralgia, Chills, Pain, Pruritus, Skin ulcer
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Chills-Medium, Additional Details: Per pt she started to feel Chills at night on 02/10/2025 and start to feel itchy on 02/11/2025. She saw her primary dr. and dermatologist. Dr. have her on benadryl , hydrocortisone topical, and rx topical for itchiness but no improvment. (No epipen no benadryl was given in the pharmacy since symptom on set a day later.)
Age: 81.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Sleep disorder
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Chills-Medium, Additional Details: Per pt she started to feel Chills at night on 02/10/2025 and start to feel itchy on 02/11/2025. She saw her primary dr. and dermatologist. Dr. have her on benadryl , hydrocortisone topical, and rx topical for itchiness but no improvment. (No epipen no benadryl was given in the pharmacy since symptom on set a day later.)
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient said it started as mild redness at injection site, but then began to spread downwards. Will be contacting her doctor for evaluation
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Other Vaccines:  VaccineTypeBrand: Flucelvax Trival 2024-2025; Manufacturer: Seqirus; LotNumber: 946637; Route: IM; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Lethargy, Nausea, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Other Vaccines:  VaccineTypeBrand: Flucelvax Trival 2024-2025; Manufacturer: Seqirus; LotNumber: 946637; Route: IM; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Nausea, Palpitations
Clinical narrative: Systemic: racing heart, clammy, felt like going to pass out-Severe, Systemic: Nausea-Medium, Systemic: Tachycardia-Severe, Additional Details: patient stated 1 hour after receiving the vaccine she felt clammy, had a racing heart beat which monitored with her watch, and felt like she was going to pass out. These symptoms lasted on and off for one hour. Patient would like to note that this has never happened with the previous pfizer vaccines she has received
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Systemic: racing heart, clammy, felt like going to pass out-Severe, Systemic: Nausea-Medium, Systemic: Tachycardia-Severe, Additional Details: patient stated 1 hour after receiving the vaccine she felt clammy, had a racing heart beat which monitored with her watch, and felt like she was going to pass out. These symptoms lasted on and off for one hour. Patient would like to note that this has never happened with the previous pfizer vaccines she has received
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Hypertension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Mild
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient's daughter contacted the pharmacy to report patient has been experiencing redness, swelling, soreness at injection site, and fever all starting after receipt of vaccines on 3/10/2025, Other Vaccines:  VaccineTypeBrand: Arexvy (RSV); Manufacturer: ; LotNumber: 24m94; Route: IM; BodySite: Right arm; Dose: unknown; VaxDate: 03/10/2025, VaccineTypeBrand: Boostrix (TdAP); Manufacturer: ; LotNumber: AK334; Route: IM; BodySite: Right arm; Dose: unknown; VaxDate: 03/10/2025
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Medium
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Sleep disorder
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient came in 3 days later with a large red area that is very itchy and keeping patient awake at night.  She is applying hydrocortisone cream and taking zyrtec at bedtime.  she may call her primary md to get something stronger for the itching
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Vaccine made me feel awful for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful 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 feels awful (Verbatim: Vaccine made me feel awful for 2 days). The outcome of the feels awful was resolved (duration 2 days).   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.     It was unknown if the company considered the feels awful to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 13-MAR-2025  This case was reported by a patient via interactive digital media. Vaccine made him/her feel awful for 2 days. Never again.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild, Additional Details: PATIENT EXPRESSED PAIN ON LEFT ARM AROUND THE INJECTION SITE FOR A TOTAL OF 6 DAYS WHEN SHE CAME IN TO REPORT. THE NEXT DAY AFTER GETTING VACCINE SHE HAD A FEVER IN WHICH SHE USED A FEVER REDUCER BUT THE PAIN WOULD NOT RESOLVE WITH OTC PAIN MEDICATION. SHE ALSO HAD REDNESS ALONG THE ARM BUT SHE DID SPECIFY SHE HAD ROSACEA AND THAT WAS A FLARE UP ALONG WITH HER INJECTION SITE PAIN. SHE MAY BE ALLERGIC TO VACCINE BUT WANTED TO DOCUMENT AND TOLD PATIENT TO GO TO URGENT CARE IF PAIN CONSISTS
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rosacea
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild, Additional Details: PATIENT EXPRESSED PAIN ON LEFT ARM AROUND THE INJECTION SITE FOR A TOTAL OF 6 DAYS WHEN SHE CAME IN TO REPORT. THE NEXT DAY AFTER GETTING VACCINE SHE HAD A FEVER IN WHICH SHE USED A FEVER REDUCER BUT THE PAIN WOULD NOT RESOLVE WITH OTC PAIN MEDICATION. SHE ALSO HAD REDNESS ALONG THE ARM BUT SHE DID SPECIFY SHE HAD ROSACEA AND THAT WAS A FLARE UP ALONG WITH HER INJECTION SITE PAIN. SHE MAY BE ALLERGIC TO VACCINE BUT WANTED TO DOCUMENT AND TOLD PATIENT TO GO TO URGENT CARE IF PAIN CONSISTS
Age: 73.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient shows up to pharmacy 3 days post-administration. Injection site is red and swollen. Explained that it's possibly an allergic reaction. Advised to take Benadryl and if that does not work in the next several days or if symptoms worsen to see her primary care physician. Patient was satisfied with advice.
Age: 52.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Muscular weakness, Nervous system disorder, Paraesthesia
Clinical narrative: Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Medium, Additional Details: Guillain-Barré syndrome (severe muscle weakness) was observed after vaccination. Patient reported still having a lot of weakness and still needs assistance walking., Other Vaccines:  VaccineTypeBrand: FLUZONE HIGH-DOSE TRI-VALENT; Manufacturer: SANOFI; LotNumber: UT8419BA; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: 1; VaxDate: 10/23/2024
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Mild
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: pt called pharmacy saying she had itching at injection site as well as itching on the palms of her hands and feet.  she called her doc who informed her to call us.  i told her to take some benadryl and it should go away., Other Vaccines:  VaccineTypeBrand: heplisavb; Manufacturer: dynavax; LotNumber: 945602; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: capvaxive; Manufacturer: merck; LotNumber: y013009; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: shingrix; Manufacturer: glaxcosmith; LotNumber: ts525; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Presyncope
Clinical narrative: near syncope episode, dizziness
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DTaP given, should have been TDaP due to age. Vaccine given on 1/25/2024 - clinic notified of error on 3/13/2025.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient received a Varicella Vaccine on 3/12/25. Vaccine Expired 3/7/25.  No s/sx of adverse reaction was reported.  The writer called Merck National Service Center and spoke with someone on 3/18/25. Verbal statement: While Merck never recommends using an expired vaccine, data supports that it was a valid dose/potent at the time of administration as long as all storage and handling were followed.  However, could not put in writing or email to writer of the statements made.  Writer called the father and spoke with him.  Dad stated he would talk to his wife and was ok with patient getting a third dose if needed.
Age: 56.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Varicella vaccine given prior to the 28 days live window.  Pt received an MMR vaccine on 02/25/2025.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: C-reactive protein normal, Dysuria, Escherichia test positive, Haematuria, Pyelonephritis
Clinical narrative: within 72hrs dysuria and blood in urine, dx'd with pyelonephritis.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: White blood cell count increased
Clinical narrative: within 72hrs dysuria and blood in urine, dx'd with pyelonephritis.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Vomiting
Clinical narrative: child was administered the Gardasil vaccine as ordered by Dr.  no problems in the office.  at 1:30 AM, child started having vomiting, multiple times during the night,  and diarrhea once.
Age: 49.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient experienced severe arm pain and red ring on skin around the injection sites.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling to area of injection, red raised spots the size a a quarter from shoulder to elbow. R arm was achy. Lasted from 2/26/25 thru 2/31/25
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Hyperhidrosis, Musculoskeletal stiffness, Pallor, Tinnitus, Vision blurred
Clinical narrative: Possible vasovagal syncope episode lasting about 5 seconds. Brief period of resident becoming pale, diaphoretic, ears ringing, blurry vision. Resident laid back in the chair he was sitting in, legs extended, and was then stiff. Eyes open. He was able to follow commands. He sat up and consumed apple juice and had a snack. Cold pack placed on the back of his neck. Monitored x 15 mins in Nurses station. Reported he was well and feeling better and returned to his pod.
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: used without the active vaccine component; used without the active vaccine component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: used without the active vaccine component) and inappropriate dose of vaccine administered (Verbatim: used without the active vaccine component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 13-MAR-2025 The reporter need to ask about Shingrix vaccine and how to obtain extra diluent for the vaccine. A pharmacy that stocks this vaccine and one was inadvertently used without the active vaccine component. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.33
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Vomiting, Wrong product administered
Clinical narrative: Patient was administered a dose of Trumenba in error, patient was supposed to get a dose of PCV20 instead. Family counseled by provider, patients parent reported today 3/18/2025 patient had a fever and vomited once since administration. No treatment indicated for administration error.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dyspnoea, Pyrexia, Sensitive skin
Clinical narrative: Patient mother reports the patient had a fever and shortness of breathe following the vaccine the next day. She also stated that the patients skin was sensitive.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 3rd does given when not recommended by guidelines since first 2 doses were given prior to age 14. No side effects reported.
Age: 73.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Amnesia, Computerised tomogram normal, Confusional state, Decreased appetite, Fatigue
Clinical narrative: Pt reports receiving a flu shot at the office and an RSV vaccine at pharmacy last Friday. By Saturday, he experienced extreme fatigue and memory loss. As a truck driver, he struggled with a routine delivery. Sleeping excessively at multiple stops and side-swiping a truck due to confusion. He lost track of time, mistakenly believing he would be home Sunday night when it was already Monday. He also did not eat or drink anything during this period.    He suspects a reaction to the vaccines. Additionally, he developed swelling in his right leg and went to ER, where CT scan and US were normal. He was given a Rocephin shot and prescribed cephalexin. He denies current memory issues.
Age: 73.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Peripheral swelling, Road traffic accident, Somnolence, Thirst decreased, Ultrasound Doppler normal
Clinical narrative: Pt reports receiving a flu shot at the office and an RSV vaccine at pharmacy last Friday. By Saturday, he experienced extreme fatigue and memory loss. As a truck driver, he struggled with a routine delivery. Sleeping excessively at multiple stops and side-swiping a truck due to confusion. He lost track of time, mistakenly believing he would be home Sunday night when it was already Monday. He also did not eat or drink anything during this period.    He suspects a reaction to the vaccines. Additionally, he developed swelling in his right leg and went to ER, where CT scan and US were normal. He was given a Rocephin shot and prescribed cephalexin. He denies current memory issues.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPAB
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash developed on stomach, left side of neck, and left wrist. The rash did cause itching. Patient said she applied a cream and the rash cleared on neck and stomach. However, the wrist still has appearance of a rash. Patient stated she thinks the rash is taking a little longer to clear on her wrist due to the watch she is wearing
Age: 68.0
Sex: M
Vaccine: PNC21
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Extreme/uncontrollable chills that resolved after 1.5 hour nap.  Woke up with "soaked" sheets
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: incorrect dilution
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling of body temperature change, Malaise
Clinical narrative: About 1-2 hours after injection I began to feel unwell. I felt cold and hot. It has been difficult to breathe since getting the injection.  It?s taken about 2 months to recover.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Electroneuromyography, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Nerve injury
Clinical narrative: Paralyzed hips on down both sides,  neurological damage in spine and legs especially. Neurological swelling  of spine and neurological death of some leg nerves.  Had to have spinal operation to help with swelling of nerves. Still having nerve damage in penis and anus also legs.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paralysis, Peripheral nerve injury, Spinal cord oedema, Spinal operation
Clinical narrative: Paralyzed hips on down both sides,  neurological damage in spine and legs especially. Neurological swelling  of spine and neurological death of some leg nerves.  Had to have spinal operation to help with swelling of nerves. Still having nerve damage in penis and anus also legs.
Age: 53.0
Sex: M
Vaccine: PNC21
Symptoms: Diarrhoea, Pain, Vomiting
Clinical narrative: Painful all the body for 3 days. Threw up . Diarrhea all nights are days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site discolouration, Injection site erythema
Clinical narrative: Redness and swelling around injection site, fatigue, chills, headache, arm soreness. On Day 4, the redness around the injection site has now turned black and blue.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Redness and swelling around injection site, fatigue, chills, headache, arm soreness. On Day 4, the redness around the injection site has now turned black and blue.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pruritus, Musculoskeletal stiffness, Pain in extremity, Skin warm
Clinical narrative: Arm became stiff and sore day after vaccination.  Over the following days area became warm to touch and developed redness, itching at site.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Swelling face
Clinical narrative: Facial swelling,  lethargy within 10 mins of administration - Given epinephrine injection and 911 called
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2025  This case was reported by a patient via interactive digital media. The patient got the vaccine, then had shingles a few weeks later.
Age: 21.0
Sex: F
Vaccine: MMRV
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: 21 year old female was administered MMRV (ProQuad Merck) off label - patient notified and did not have any questions.  Registry is accurate.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site, treated with ibuprofen/warm compress
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fibrin D dimer, Haemoptysis, Headache
Clinical narrative: Excruciating pains in all my joints including my jaws,  lungs pain and eliminating fleggms with blood clogs, headache, total weakness; I can't open a bottle of water.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Pulmonary pain
Clinical narrative: Excruciating pains in all my joints including my jaws,  lungs pain and eliminating fleggms with blood clogs, headache, total weakness; I can't open a bottle of water.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Feeling hot, Gout, Joint stiffness, Lacrimation increased
Clinical narrative: Beginning around 3/12/2025, about 13-14 days after receiving the vaccine and expecting its side-effects to be concluded, I developed a mild warm feeling in the skin of my chest, arms, stomach. This all occurred with ZERO flu-like symptoms except for watery eyes. I was not feeling like I was truly ill, just hot and temperature tests revealed my internal temp was normal. Over the course of that day, a measles like rash appeared on my chest with some extending above the neck line but not to the face. I also began to experience arthritis like joint pain. As the days went on, the rash spread downward to my stomach, flank, back, thighs, arms, calves and even to my ankles. The joint pain (mild in nature) continued. After nearly 5 days, the rash on the chest began to fade and has been fading in the order it appeared. Now, on 3/18/2025, a full 6 days after the rash appeared, most of it has disappeared with a little left on the legs and some here and there. However, my left index finger has joint pain in the morning like it has stiffened up (arthritis like) and some gout, both of which have eased over the course of the day today 3/18/2025. Overall, the side-effects appear to be fading today. I am marking "recovered" below because I believe I have recovered.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash morbilliform
Clinical narrative: Beginning around 3/12/2025, about 13-14 days after receiving the vaccine and expecting its side-effects to be concluded, I developed a mild warm feeling in the skin of my chest, arms, stomach. This all occurred with ZERO flu-like symptoms except for watery eyes. I was not feeling like I was truly ill, just hot and temperature tests revealed my internal temp was normal. Over the course of that day, a measles like rash appeared on my chest with some extending above the neck line but not to the face. I also began to experience arthritis like joint pain. As the days went on, the rash spread downward to my stomach, flank, back, thighs, arms, calves and even to my ankles. The joint pain (mild in nature) continued. After nearly 5 days, the rash on the chest began to fade and has been fading in the order it appeared. Now, on 3/18/2025, a full 6 days after the rash appeared, most of it has disappeared with a little left on the legs and some here and there. However, my left index finger has joint pain in the morning like it has stiffened up (arthritis like) and some gout, both of which have eased over the course of the day today 3/18/2025. Overall, the side-effects appear to be fading today. I am marking "recovered" below because I believe I have recovered.
Age: 63.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Flushing
Clinical narrative: Pt c.o. heart rate at 130, extremely dizzy, feeling flush and weak.  Sent patient to the ER.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Patient sat down in waiting area after vaccine.  The technician went out to hand the patient a requested copy of administration report and fainted for a few seconds while seated in chair.  Patient refused ambulance and states seated for 20-30 minutes and drank some water and had a friend pick her up.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: inadvertently gave an MMRV instead of MMR, where it is located in fridge I grabbed what i thought was MMR, prepared it for administration and did not verify with second check prior to administering
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: inadvertently gave MMRV instead of MMR, where it is located in the freezer I grabbed what i thought was MMR from the bin, prepared it for administration and did not verify with a second check prior to giving it to child
Age: 64.0
Sex: M
Vaccine: PNC20
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient received PCV20 vaccine on 03/16/2025 at Pharmacy.  went hone and 2-3 hours later was covered in hives. Pt apt on 03/18/25 at Community Health Center for rash from vaccine.  Pt showed picture left arm, back and stomach. positive for pruritic, no lip edema, no tongue edema, Pt applied topical Benadryl. Rash resolved. Called pharmacy unable to get lot number  of PCV20 vaccine
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Crying, Dizziness, Gait disturbance, Nausea
Clinical narrative: dizziness, weakness, hives on arm, nausea, crying, approx 2-3 hours after shot, hives resolved spontaneously within 1 hour, able to ambulate but initially with assistance, no emesis, vital signs at office FU within normal limits,  supportive care treatment only,
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: dizziness, weakness, hives on arm, nausea, crying, approx 2-3 hours after shot, hives resolved spontaneously within 1 hour, able to ambulate but initially with assistance, no emesis, vital signs at office FU within normal limits,  supportive care treatment only,
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Heart rate increased, Hypertension, Loss of consciousness, Postural orthostatic tachycardia syndrome
Clinical narrative: Started having symptoms of POTS that same month. First saw her PCP in September 2023 for POTS. Eventually diagnosed 1 month ago by a cardiologist. High blood pressure problems, high pulse at times, blacking out events. Is on a beta blocker currently for treatment. Patient reported this diagnoses at appointment today and this RN was questioning her about her POTs symptoms and realized they started about the same time. Deferred 3rd dose of HPV and 2nd dose of Bexero today per this RN collaborating with primary care provider.
Age: 23.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: There was no adverse effect.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Got hives, the interesting part is that his brother got the same vaccine, same day, same pharmacy and also got hives, which struck me as uncommon. Was given at Pharmacy
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt was administrated PCV20 vaccine on 03/11/2025 and had blood draw as well, arm was warm slightly swollen and caused achiness after vaccine. On Sunday 03/17/2025 arm was itchy pt noticed some red patchy areas.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose accelerated dosing/ diid not receive; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose accelerated dosing/ diid not receive). The outcome of the incomplete course of vaccination 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: 04-MAR-2025 Pharmacist called and reported that they had a patient who received a Twinrix dose on 10-Feb-2025 from batch number 429JJ with expiry date 01-APR-2026, she was going to be traveling to an area where it was a high or intermedia endemic for hepatitis. And so she had intentionally meant to do the accelerated dosing, however, reporter thought she got confused about when she received the doses, so she got one 10-Feb-2025, which was 22 days ago, today (on the day of reporting) she was going to get the 2nd one but it looks like she should receive the 2nd one about 2 weeks ago, 7 days after the 1st dose, and then she would receive the 3rd one today.  So, reporter was wondering about, she would be traveling in June, so he/she was if it was possible for her, since she got the 1st dose in 10-Feb-2025, if she got her 2nd dose today, could she been getting a 3rd dose in you know 2 weeks to have accelerated dosing or not . During the call the reporter mentioned it seems this was the 1st Twinrix scheme dose for the patient, and, they did not have any records about the patient being immunocompromised. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to an incomplete course of vaccination.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix given intramuscularly, instead subcutaneous; 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 patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix given intramuscularly, instead subcutaneous). 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: 05-MAR-2025 The registered pharmacist reported that a pharmacist stated to them that they had a Priorix given intramuscularly instead of subcutaneous, which led to subcutaneous injection formulation administered by other route  The reporter was just wondering does it need to be readministered or was still effective.
Vaccine: DTAP, FLU4, TDAP
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis and Flu Seasonal QIV Quebec (FluLaval Tetra) for prophylaxis.   On an unknown date, the patient received Boostrix, Infanrix and FluLaval Tetra. On an unknown date, an unknown time after receiving Boostrix, Infanrix and FluLaval Tetra, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug 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: 11-MAR-2025 A licensed practical nurse reported temperature excursions for Boostrix, Infanrix and Flulaval. Healthcare professional mentioned that these excursions occurred since 12th September 2024 until 28th February 2025. During the call, healthcare professional mentioned that probably a couple of these vaccines were used which led to incorrect storage of drug. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023167156:same reporter