chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Amnesia, Dyspnoea, Gaze palsy, Headache, Immediate post-injection reaction
Clinical narrative: The patient is here with a seziure-like episode that occurred in the car about 15 minutes after she received her 11 year vaccines at Dr's office.  After receiving the TdaP and Menquadfi vaccines, she immediately did not feel well and had to lay down.  She had not had anything to eat or drink that morning.  She felt beter after 10 minutes and they then left the office.  In the car she reported to mom she did not feel well.  She reports today seeing spots in her vision and then remembers nothing.  Her mom reports she looked back and her head was turned to the left with her eyes rolled back, her right arm was stiff and flexed and her left arm was fully extended and stiff. There were no convulsions.  Mom pulled over and the episode lated about 30 seconds.  Mom then saw her breathing really heavily for about 30 seconds.  She vomited foam and lost bladder control.  She went home and slept for 2 hours after taking tylenol.  She has since had pain at the top of her head and some neck tightness.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Malaise, Musculoskeletal stiffness, Seizure like phenomena, Urinary incontinence, Visual impairment
Clinical narrative: The patient is here with a seziure-like episode that occurred in the car about 15 minutes after she received her 11 year vaccines at Dr's office.  After receiving the TdaP and Menquadfi vaccines, she immediately did not feel well and had to lay down.  She had not had anything to eat or drink that morning.  She felt beter after 10 minutes and they then left the office.  In the car she reported to mom she did not feel well.  She reports today seeing spots in her vision and then remembers nothing.  Her mom reports she looked back and her head was turned to the left with her eyes rolled back, her right arm was stiff and flexed and her left arm was fully extended and stiff. There were no convulsions.  Mom pulled over and the episode lated about 30 seconds.  Mom then saw her breathing really heavily for about 30 seconds.  She vomited foam and lost bladder control.  She went home and slept for 2 hours after taking tylenol.  She has since had pain at the top of her head and some neck tightness.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: The patient is here with a seziure-like episode that occurred in the car about 15 minutes after she received her 11 year vaccines at Dr's office.  After receiving the TdaP and Menquadfi vaccines, she immediately did not feel well and had to lay down.  She had not had anything to eat or drink that morning.  She felt beter after 10 minutes and they then left the office.  In the car she reported to mom she did not feel well.  She reports today seeing spots in her vision and then remembers nothing.  Her mom reports she looked back and her head was turned to the left with her eyes rolled back, her right arm was stiff and flexed and her left arm was fully extended and stiff. There were no convulsions.  Mom pulled over and the episode lated about 30 seconds.  Mom then saw her breathing really heavily for about 30 seconds.  She vomited foam and lost bladder control.  She went home and slept for 2 hours after taking tylenol.  She has since had pain at the top of her head and some neck tightness.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient was given Pentacel mixed with the wrong diluent. Used sterile diluent instead of the diluent included in the box with Pentacel. Therefore not considered active. There is no symptom/signs at this time.
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope within 15 minutes of vaccines while walking out of clinic.  No treatment needed.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Muscle twitching, Screaming, Staring, Tremor
Clinical narrative: Around 11pm 6/25/25 he screamed out like he was in pain and mom picked him up and noticed he was shaking/twitching all over and had a blank stare but he was not crying. This continued for about 5 minutes after which he seemed to be acting normally. He went to the ER and was examined and had a normal exam. He had no fever around that time.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, RV5
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: We believe an error in vaccine administration was made at pt.'s most recent well visit on 6/20/25.  Dr. was the provider who ordered the vaccines at that visit and the baby should have received Vaxelis, PCV15 and Rotavirus vaccines.  After reviewing our vaccine inventory on 6/23/25, it was discovered that most likely the pt received an HPV vaccine instead of the PCV15 vaccine that was ordered.  The MA who administered the vaccines was interviewed and she does not recollect making the error.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Site developed a hard, red lump that became itchy, red, and warm to touch. Subjective fever and abdominal pain approx 36 hours later. Redness surrounding hard lump not receeding after 48 hours. Site remains hard and red.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Site developed a hard, red lump that became itchy, red, and warm to touch. Subjective fever and abdominal pain approx 36 hours later. Redness surrounding hard lump not receeding after 48 hours. Site remains hard and red.
Age: 57.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Back injury, Dizziness, Fall, Visual impairment
Clinical narrative: Patient had an episode of dizziness that lasted approximately 3-5 minutes and visual disturbances. This event was at 7:45 a.m. It caused him to fall into a piece of equipment and hurt his right-side mid back. At 07:48 BP was 152/88. He denied chest pain, shortness of breath and was not diaphoretic. He did state that he had not had anything to eat this morning. At 07:50 BP was 148/88, RR 16, Oxygen saturation was 99%, heart rate was 88.  Patient was provided a snack and water. 07:55 he says that he is no longer dizzy and just says his back hurts. Ice was provided for his back.
Age: 36.0
Sex: M
Vaccine: HEPA, HPV9, PNC20, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was seen for a provider visit today. During the visit it was recommended that patient receive HPV vaccine. The HPV vaccine was ordered by PA. MA pulled PCV20 vaccine out of the fridge and MA signed off on PCV20 vaccine. MA then administered PCV20 and realized after injecting the vaccine that the wrong vaccine had been pulled/checked off on/administered to patient. Patient was still in clinic, thus, PA and I brought patient back to exam room to explain what happened. We advised patient that he receive PCV20 vaccine instead of the agreed upon HPV9 vaccine. We advised him that there is no true risk to him receiving this vaccine in error as he is of age to receive PCV20, it is just not something that PA recommended due to him not having additional risk factors for vaccination against pneumonia. We than advised patient that he could still receive HPV9 vaccine if he wished to do so before leaving clinic since this is what was intended. Patient was agreeable to receive HPV9 and received vaccine before being discharged home. Patient did not have any medical adverse reaction to PCV20 vaccine.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Heart rate increased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient received Pneumonia vaccine on 6/22/25; came in on 6/26/25, complaining about red itchy area on left arm where vaccination was administered. Patient stated that symptoms (redness, swelling, warmth, pain, itching) started on the day of administration, and have continued since then; patient also claimed she had high heart rate and was having trouble breathing for about 2 days after administration. She had gone to see her doctor on morning of 6/22/25, who told her to take Ibuprofen, and return in 8 days if symptoms continued. I confirmed with patient that she had no fever since vaccine administration. I told her to try taking OTC claritin, benadryl, and/or apply topical cortizone or benadryl cream, and to see her doctor (even before 8 days) if symptoms get worse.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient received Pneumonia vaccine on 6/22/25; came in on 6/26/25, complaining about red itchy area on left arm where vaccination was administered. Patient stated that symptoms (redness, swelling, warmth, pain, itching) started on the day of administration, and have continued since then; patient also claimed she had high heart rate and was having trouble breathing for about 2 days after administration. She had gone to see her doctor on morning of 6/22/25, who told her to take Ibuprofen, and return in 8 days if symptoms continued. I confirmed with patient that she had no fever since vaccine administration. I told her to try taking OTC claritin, benadryl, and/or apply topical cortizone or benadryl cream, and to see her doctor (even before 8 days) if symptoms get worse.
Age: 15.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Cold sweat, Dizziness, Eye movement disorder, Pallor
Clinical narrative: 15 year old male patient presented today for vaccine administration. Received Meningococcal (left deltoid) and varicella (left arm) at 1333 while seated. While sitting in chair after administration, patient became pale. Asked patient how he was feeling, he stated- dizzy. At 1337, His eyes began to roll back and head started to bobble. I helped patient to the floor and called for additional nursing staff. Once on the floor patient began to speak and said he was okay. Patient's aunt (who was in the room and translating) asked patient if he had eaten anything today and he stated no. Patient given cool rags and granola bar to eat along with water.  After 15 mins, patient moved from floor back to chair and allowed to eat a popsicle.  Patient skin returned to normal color. Patient reported no longer feeling dizzy. At 1405, patient allowed to leave with Aunt, who was advised to have patient eat a meal and to take patient to ER and/or follow up with pediatrician should any other events occur. Patient and aunt acknowledged and verbalized understanding.  Vitals:  1337- episode 1342- 110/75, HR 83 Skin clammy, RR 14 1347- 113/80  HR 83, RR 14 1352- 119/82  HR 108 RR 14 1357- 116/69  HR 85  RR 14 1402- 114/67  HR 83  RR 14 Skin warm and dry.
Age: 83.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced redness and itchiness at the injection site of her Covid shot the next day on 04/10/2025. It resolved soon after but then again on 04/15/2025 the patient reports that both of her injection sites were bothering her but the left deltoid (PCV21 injection) was red, itchy, and swollen.
Age: 61.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Influenza virus test, Injection site reaction, Migraine, SARS-CoV-2 test, Urine analysis
Clinical narrative: Patient had a swollen right deltoid the next morning when she woke up and a severe migraine that lasted about a week. She eventually went to the emergency room and was treated for her migraine with fluids and medications
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: potentially received only the adjuvant of Shingrix a as a first dose; potentially received only the adjuvant of Shingrix a as a first dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: potentially received only the adjuvant of Shingrix a as a first dose) and inappropriate dose of vaccine administered (Verbatim: potentially received only the adjuvant of Shingrix a as a first dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 18-JUN-2025 The licensed practical nurse called to report that they might had accidentally administered only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was the first dose of Shingrix for all patients involved. There was no immunity screening or titers test available for Shingrix. This was 1 of 7 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pyrexia, Skin warm
Clinical narrative: Patient reported left arm red area is very hard swollen and very warm when I touch it. In addition I had a temperature  for a few days.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: The provider ordered Dtap instead of Tdap, and MA did not catch it.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Night sweats, Sleep study normal
Clinical narrative: After Vaccine I started having night sweats. Had vaccine #2 on May 7, 2024 and the night sweats increased to where I had to change my  night clothes 2-3 times/night and change my sheets at least 3 times a week. This lasted for at least six months and finally subsided. I will do a separate report for the May 7 vaccine.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Contusion, Depressed level of consciousness, Electrocardiogram, Fall
Clinical narrative: Treatment RN were called in to the room for syncope patient.  Patient collapsed after receiving HPV vaccine. Per parent describing the situation, patient had and episode of shaking before falling and hitting the floor head first. CN was already in the room attending to patient with father by patient's side.  Pale color, clammy skin, and sweaty, half awake and nauseous. Legs were elevated on chair.   VS were taken at 10:42 97/54, HR 55, Temp 96.7 100% O2; BSG result at 79   10:45 - DOD attended and examined the patient.  Ordered an EKG.  EKG result were shown to PCP and DOD.   10:55 - Dr. examined and talked to patient (no further instruction given). Patient complains of neck pain (MD's aware) due to impact sustained.  Dr.  reported mild contusion to right forehead and pain of left neck, pale, clammy. FROM of neck. Patient was given water, juice, vitals done.  11:00 - BP retaken 94/52; HR 52, O2 100%   11:25 - BP 105/67 (BP Location: Right arm, Pt Position: Lying, Cuff Size: Medium)  | Pulse (!) 57  | Temp 97 °F (36.1 °C) (Temporal)  | Resp 18  | Ht 1.803 m (5' 11")  | Wt 138 lb 10.7 oz (62.9 kg)  | SpO2 98%  | BMI 19.34 kg/m²    Dr. noted patient recovered after about 20 minutes and was able to walk out.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Hyperhidrosis, Nausea, Pallor, Tremor
Clinical narrative: Treatment RN were called in to the room for syncope patient.  Patient collapsed after receiving HPV vaccine. Per parent describing the situation, patient had and episode of shaking before falling and hitting the floor head first. CN was already in the room attending to patient with father by patient's side.  Pale color, clammy skin, and sweaty, half awake and nauseous. Legs were elevated on chair.   VS were taken at 10:42 97/54, HR 55, Temp 96.7 100% O2; BSG result at 79   10:45 - DOD attended and examined the patient.  Ordered an EKG.  EKG result were shown to PCP and DOD.   10:55 - Dr. examined and talked to patient (no further instruction given). Patient complains of neck pain (MD's aware) due to impact sustained.  Dr.  reported mild contusion to right forehead and pain of left neck, pale, clammy. FROM of neck. Patient was given water, juice, vitals done.  11:00 - BP retaken 94/52; HR 52, O2 100%   11:25 - BP 105/67 (BP Location: Right arm, Pt Position: Lying, Cuff Size: Medium)  | Pulse (!) 57  | Temp 97 °F (36.1 °C) (Temporal)  | Resp 18  | Ht 1.803 m (5' 11")  | Wt 138 lb 10.7 oz (62.9 kg)  | SpO2 98%  | BMI 19.34 kg/m²    Dr. noted patient recovered after about 20 minutes and was able to walk out.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site indentation
Clinical narrative: After getting my second dose I went home was bruised when I went back on September 5, 2024 for my depo shot I told the nurse that I still had a dent in my arm where I got the last gardicil vaccine by them and was told to give it some time that it might be that it was still bruised. Since then I have stated to them it won't go away its been almost a year and my arm still has the dent and won't go away
Age: 77.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site reaction, Vaccination site vesicles
Clinical narrative: Injection site reaction; Injection site vesicles; Injection site induration; Complaining of arm pain; Area was hard, red, induration present and large blister present (size of a quarter); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE VESICLES (Injection site vesicles), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE PAIN (Complaining of arm pain) and VACCINATION SITE ERYTHEMA (Area was hard, red, induration present and large blister present (size of a quarter)) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042648) for COVID-19 prophylaxis.    Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication.    Concurrent medical conditions included Diabetes. Concomitant products included Amlodipine besilate, Benazepril hydrochloride (Lotrel), Atenolol, Insulin aspart (Novolog), Empagliflozin, Metformin hydrochloride (Synjardy), Esomeprazole magnesium (Nexium) and Tirzepatide (Mounjaro) for an unknown indication.   On 18-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 20-Apr-2025, the patient experienced VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE VESICLES (Injection site vesicles), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE PAIN (Complaining of arm pain) and VACCINATION SITE ERYTHEMA (Area was hard, red, induration present and large blister present (size of a quarter)). At the time of the report, VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE VESICLES (Injection site vesicles), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE PAIN (Complaining of arm pain) and VACCINATION SITE ERYTHEMA (Area was hard, red, induration present and large blister present (size of a quarter)) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   On 23-Apr-2025, the patient visited the clinic due to complaints of arm pain after receiving vaccines from the pharmacy. There was no fever, and pain occurred only when the area was palpated. Antibiotics were prescribed by the physician, and a follow-up was scheduled for 28-Apr-2025.
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: My husband had the same batch given and also had an eye bleed; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (My husband had the same batch given and also had an eye bleed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE HAEMORRHAGE (My husband had the same batch given and also had an eye bleed). At the time of the report, EYE HAEMORRHAGE (My husband had the same batch given and also had an eye bleed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided by the reporter. Patient was cleared up with symptom but was of concern for a while. No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2025-787613 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787613:Patient (case for husband)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: she had caught COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she had caught COVID-19) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine. Past adverse reactions to the above products included No adverse effect with Moderna Covid-19 vaccine.    On 19-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (she had caught COVID-19). At the time of the report, COVID-19 (she had caught COVID-19) outcome was unknown.            No concomitant medication was reported. The patient had all the Moderna shots, and at the time of reporting, she was due for another one. She went to four pharmacies, but nobody had the Moderna COVID-19 vaccine. She even went to the facilities listed on website (which state they had the Moderna COVID-19 vaccine), but nobody had it. She was off schedule because she had caught COVID-19, which resulted in her being recommended to wait for 6 months. She had all her Moderna COVID-19 vaccine (5 or 6 shots), the last one before she caught infected with COVID-19.  She took her mask off to go to the dentist and then the dermatologist. One week after, she got COVID. The facility where she got her latest Modena COVID-19 vaccine currently did not have the vaccine, as they said they can't get it. The pharmacy only had Pfizer, but she didn't want to switch if she could get Moderna. She and her husband searched for the vaccine in several pharmacies without any result and believe they will not purchase the vaccine just for her. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: He is still not right and got real sick with fever and "everything"; He is still not right and got real sick with fever and "everything"; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (He is still not right and got real sick with fever and "everything") and PYREXIA (He is still not right and got real sick with fever and "everything") in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (He is still not right and got real sick with fever and "everything") and PYREXIA (He is still not right and got real sick with fever and "everything"). At the time of the report, MALAISE (He is still not right and got real sick with fever and "everything") and PYREXIA (He is still not right and got real sick with fever and "everything") had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       Concomitant medication was not provided.  It was reported that the patient received the moderna vaccine the previous Thursday but did not specify the exact date. He added that he was still not feeling well and had become very sick with fever and other symptoms. He then inquired whether those were side effects of the vaccine and whether it usually took a while to recover from them.  It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported.   Reporter did not allow further contact
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: First excursion was at 9.8C for 25 minutes while the second excursion was at 8.7C for minutes due to one of the employees returning vaccines and doing inventory with no reported adverse event; Initial information received on 23-Jun-2025 (with live follow-up information received on 23-Jun-2025)regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered with IPV (VERO) [IPOL] vaccine that had first excursion was at 9.8c for 25 minutes while the second excursion was at 8.7c for minutes due to one of the employees returning vaccines and doing inventory with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5ml dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Immunization that had a temperature excursion was at 9.8c for 25 minutes while the second excursion was at 8.7c for minutes due to one of the employees returning vaccines and doing inventory with no reported adverse event (product storage error).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly- extended stability data does not cover the excursion, human error was involved, The product was administered  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered act-hib that was reconstituted with sterile water instead of sodium chloride with no reported adverse event; Initial information received on 24-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered with HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with sterile water instead of sodium chloride with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Immunization reconstituted with sterile water instead of sodium chloride with no reported adverse event (product preparation error).  Information on the batch number was requested corresponding to the one at time of event occurrence  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: HCP calling to report an AE regarding the GARDASIL 9 vaccine. HCP reported that a 42 year old female patient received two doses of the GARDASIL 9 vaccine three years ago. HCP stated that the patient did not complete the vaccination series for the GAR; No additional AE/PQC reported.; This spontaneous report was received from a pharmacist and refers to a 42-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date (reported as 3 years ago), the patient was vaccinated with the first and second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), administered for prophylaxis (doses, lot #s, expiration dates, route of administration and anatomical site of injection were not reported). The reporter stated that the patient did not complete the vaccination series for the Human Papillomavirus 9-valent Vaccine, Recombinant vaccine (GARDASIL®9) and has not yet received her third dose of the vaccine. The reporter did not provide the reason for the missed dose of the vaccine (Product dose omission issue).  No additional adverse event was provided (no adverse event).
Vaccine: VARZOS
Symptoms: Discomfort, Pain, Pruritus
Clinical narrative: so painful; itching; uncomfortable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis.   On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: so painful), pruritus (Verbatim: itching) and discomfort (Verbatim: uncomfortable). The outcome of the pain, pruritus and discomfort were not reported.   It was unknown if the reporter considered the pain, pruritus and discomfort to be related to Herpes Zoster vaccine.     It was unknown if the company considered the pain, pruritus and discomfort to be related to Herpes Zoster vaccine.   Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had ever had something so painful and uncomfortable and thought he/she had ever been so miserable and then the itch and itching was uncomfortable.  Nighttime was the worst.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Havrix adult dosage at at 18. Patient was monitored and informed about the error and the patient will need to be revaccinated when the patient turns 19 years old. No adverse reactions.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: General physical health deterioration, Night sweats
Clinical narrative: First Shingrix on January 31, 2024 and Second Shingrix on May 7, 2024. After first vaccine I started having night sweats and they got worse after second vaccine. Changed night clothes 2/3 times nightly and sheets at least 3 times a week. Stopped after six months but my general health is poor, and I attribute it to the Shingrix vaccines.
Age: 66.0
Sex: M
Vaccine: PNC21
Symptoms: Cellulitis, Injection site pain, Pain in extremity, Serum sickness
Clinical narrative: Patient had significant soreness of the injection site for days afterwards.  He was seen in urgent care 03/31/2025  and was diagnosed with pain in upper arm, cellulitis in left upper limb and other serum reaction due to vaccination.  Patient was given antibiotics and short course of oral steroid.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient came in for vaccinations, when vaccines were reviewed this writer did not realize that the patient had two accounts in database after vaccines were given this writer noticed that there was another account for the same patient with additional vaccines. This writer confirmed name with parent and the two accounts matched the patient's demographics.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, X-ray limb
Clinical narrative: patient was seen in clinic today, 6/26/25, and reports persistent right shoulder pain since receiving the HPV vaccine on 6/9/25. Treatment: treat with NSAIDs and referred to orthopedics and physical therapy
Age: 1.5
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Discomfort, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Onset of unilateral thoracic rash (from just above nipple line to just above groin, small red raised spots (papules), itchy and uncomfortable; 6 week duration; treated with topical colloidal oatmeal and Benadryl cream
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Peripheral swelling
Clinical narrative: Left arm swollen with baseball size  lump in arm at injection site. Have been taking Tylenol and icing with no improvement
Age: 16.0
Sex: F
Vaccine: MNP
Symptoms: Headache, Pain, Pain in extremity, Periorbital swelling, Peripheral swelling
Clinical narrative: Pt c/o left arm pain and body aches about 2 hours after vaccine was given. She woke up next morning with body hives and itching and headache. She called office at 716am and was advised to take Benadryl and Motrin. Mom worried it is an allergic reaction and will get worse. F/u call 3 hrs later. Pt was able to go back to sleep. Mom states the last time she got vaccines her arm was swollen and very painful. This was in 2020 and she received Tdap and Menveo. Mm also states pt has seasonal allergies and some "weird ones". She can not use most face makeup product d/t reactions. Another f/u 3 hors later now Hives have blended together, but body aches and H/a is gone.  No fevers. Hives/rash started on feet and legs. Then arms and neck no facial hives. No difficulty breathing. No vomiting no lip or tongue swelling. Advised to continue Benadryl every 6 hrs. and ER if needed. Now 3 days later mom calls states pt eyes are swollen. Appt made for today. Pt seen no rash or hive present. No acute distress. v/s wnl. arm is not swollen. Eyes are slightly puffy but no redness or drainage. Will continue to monitor can change to Zyrtec if needed and VAERS form filled out on line. Penbraya information package insert given to Dad. F/u as needed
Age: 16.0
Sex: F
Vaccine: MNP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt c/o left arm pain and body aches about 2 hours after vaccine was given. She woke up next morning with body hives and itching and headache. She called office at 716am and was advised to take Benadryl and Motrin. Mom worried it is an allergic reaction and will get worse. F/u call 3 hrs later. Pt was able to go back to sleep. Mom states the last time she got vaccines her arm was swollen and very painful. This was in 2020 and she received Tdap and Menveo. Mm also states pt has seasonal allergies and some "weird ones". She can not use most face makeup product d/t reactions. Another f/u 3 hors later now Hives have blended together, but body aches and H/a is gone.  No fevers. Hives/rash started on feet and legs. Then arms and neck no facial hives. No difficulty breathing. No vomiting no lip or tongue swelling. Advised to continue Benadryl every 6 hrs. and ER if needed. Now 3 days later mom calls states pt eyes are swollen. Appt made for today. Pt seen no rash or hive present. No acute distress. v/s wnl. arm is not swollen. Eyes are slightly puffy but no redness or drainage. Will continue to monitor can change to Zyrtec if needed and VAERS form filled out on line. Penbraya information package insert given to Dad. F/u as needed
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: 8/3/21- Days after first Covid shot in left arm, pain in left shoulder began and has continued unabated ever since. Had second Covid shot on 8/25/21 this time in right arm because of pain on left shoulder. Just a few days later, 9/1, right shoulder exhibited pain very similar to pain in left shoulder following first shot. This pain has continued to this day, most times requiring acetaminophen and naproxen at bedtime to control the pain so I can get to sleep.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Bacterial vaginosis, Injection site rash, Laboratory test abnormal, Rash
Clinical narrative: 6/18 vaccine 6/21 started Flagyl for bacterial vaginosis 6/24 rash began @ injection site 6/26 rash all over body
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder
Clinical narrative: THIS VACCINE HAS PUT ME BACK ONE YEAR. NEVER WILL I GET ANOTHER VACCINE AGAIN NOT EVEN THE FLU IT EFFECTED MY EYES. THATS ALL I HAVE TO SAY.
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Nausea, Pelvic pain
Clinical narrative: nausea; pelvic pain; fatigue; This spontaneous report was received from a patient's sister and refers to a currently 51-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (dose, strength, route, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the patient had pelvic pain after getting the vaccine and also experienced fatigue and nausea and she recently received laboratory without provided result. At the reporting time, the outcome of events was unknown. The causal relationship between the events and suspect vaccine was not provided. Operator Of Device: Lay User/Patient.  Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP noted that her appointment was after 12 months.; No additional AE; Information has been received from Business Partner/CRO on 25-Jun-2025.  This spontaneous report was received from a/an Other health professional and refers to a(n) female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot # and expiration date were not reported). The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), for the treatment of Prophylaxis.  On an unknown date, the patient experienced HCP noted that her appointment was after 12 months.. On an unknown date, the patient experienced No additional AE.   At the reporting time, the outcome of HCP noted that her appointment was after 12 months. and No additional AE was unknown.   The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac pacemaker insertion (pacemaker insertion (cardiac)) and covid-19 (had COVID infection four times). Concurrent medical conditions included hypertension, fruit allergy (allergy (hives) with stewed tomatoes) and allergy (has reactions (allergy/sensitivity) to unspecified allergens). Concomitant products included losartan, amlodipine, citalopram and acetylsalicylic acid (Aspirin).   In APR-2025, the patient received the 1st dose of Shingrix (intramuscular use, unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Hives) and pruritus (Verbatim: Itching). The patient was treated with calamine, menthol, zinc oxide (Calamine) and triamcinolone acetonide (Triamcinolone). The outcome of the hives and pruritus were not resolved.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.     It was unknown if the company considered the hives and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUN-2025 The reporter was the patient.  She had her first Shingrix dose and she did not know the exact date.  The pharmacy where she received the vaccination did not provide the lot number and expiry date to her.  About two weeks after vaccination, she developed hives and itching from head to toe in 2025. She treated the hives and itching with calamine lotion.  Her healthcare provider treated the hives and itching with a Z-pack (azithromycin), triamcinolone cream, and an unknown medication that came in a taper pack.  The hives have not resolved.  The itching has worsened. She planned to see a dermatologist.  Nothing else was reported.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: pentacel components were administered separately and that the hib was reconstituted with sterile water with no reported adverse event; Initial information received on 24-Jun-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] components separately and that the hib was reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus vaccine (Rotavirus vaccine) and Pneumococcal vaccine conj 15 V (CRM197) (Vaxneuvance) both for Prophylactic vaccination (Immunisation).  On 24-Jun-2025, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine components separately and that the hib was reconstituted with sterile water (formulation: Suspension for injection) (lot UK196AA, strength: standard, frequency: once and expiry date: 30-Mar-2026) via intramuscular route (one on the left thigh, the other on the right thigh) for Immunization with no reported adverse event (wrong technique in product usage process) (Latency: same day).  Reportedly, Pentacel was administered separately- reporter was unsure which side had the DTaP- IPV and which side had the Hib.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Feeling abnormal, Product dose omission issue
Clinical narrative: feeling badly; missed second dose of pre-exposure imovax therapy due to feeling badly; Initial information received on 24-Jun-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age female patient who had missed second dose of pre-exposure Rabies (Hdc) Vaccine [Imovax Rabies] therapy due to feeling badly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, caller stated that the patient missed second dose of pre exposure suspect Rabies (Hdc) Vaccine, Powder and solvent for suspension for injection, (lot number, expiry date and strength not reported) for Immunization therapy due to feeling badly (routine immunisation schedule incomplete) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence  On an unknown date the patient was feeling badly (feeling abnormal) (unknown latency).  Reportedly,patient missed second dose on day 7, now day 11. Pharmacist stated patient missed second dose of preexposure IMOVAX therapy due to feeling badly. She stated it is now day 11 and pharmacist requested recommendation for schedule of second dose. HCP (health care professional) stated patient has no fever, is under the weather like her children, has a sore throat, and it is not related to Imovax injection.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event Feeling abnormal.  At time of reporting, the outcome was Unknown for the event Feeling abnormal.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product availability issue
Clinical narrative: Consumer called to report his father went in for his 3rd dose of TICE BCG today but was told they did not have a dose for him today due to the shortage of the product.; no AE; This spontaneous report was received from a consumer and refers to a male patient of unknown age.   The patient's medical history, concurrent conditionsand concomitant therapies were not reported.   On an unknown date, the patient started therapy with BCG (TICE BCG LIVE), (once per week), (indication, expiration date, and lot # were not reported).  On an unknown date, the patient went in for his 3rd dose of BCG (TICE BCG LIVE), today but was told they did not have a dose for him today due to the shortage of the product (Product availability issue). No adverse event.  Additional information is not expected.
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported.; HCP calling to report inadvertently administering an expired dose of MMRII to a patient.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 09-Jun-2025, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X022985, expiration date: 08-Jun-2025), dose number 1, that was reconstituted with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (expired product administered). No adverse event was reported.