chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: RAB
Symptoms: Asthma, Chest X-ray, Dyspnoea, Respiratory tract congestion, Wheezing
Clinical narrative: She got her vaccine and shortly afterwards she started wheezing, then she started getting congested and hard time breathing.  She would get better, and then would go back to getting sick.  She wanted to get the ingredients of the vaccine, and asked 3 different doctors including the pulmonologist.  She went to her doctor and they gave her antibiotics Augmentin is too strong, then they put her on Z-pack, then she started on Budesinite and that did not get any better, then was given Albuterol with inhalers and nebulizers which temporarily helps and then she gets wheezy again, short of breath and congested.  The doctors did not know what had caused the symptoms, possibly from the vaccine.  She got diagnosed with mild asthma on 3/1/24 when she went to the pulmonologist.  In a couple of weeks she went back to the pulmonologist and now has now severe asthma.  She is getting sick and getting better, and then back again.  She did not have a history of asthma of any kind prior to the dog bite which was on 12/26/23, and now the asthma.  She got the first vaccine on 12/27/23, the 2nd one on 12/30/23 which she had a headache after that one.  The third one is when she developed the wheeze.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient came to my office on Monday 4/1/24 after receiving a Tdap injection required for employment on 3/29/24 in her "R delt". Unfortunately this injection was not given anywhere near her delt, it was given in the back of the arm in the subcutaneous layer- client has very large near baseball sized indurated redness/hardness/pain.
Age: 17.0
Sex: M
Vaccine: HIBV, MNQ
Symptoms: Wrong product administered
Clinical narrative: no reaction is being reported.  Dr was informed after incorrect vaccine was given.  Dr ordered the meningoccal but the patient was given Hib by accident.  once reported to Dr, he instructed the correct vaccine to be given and documentation in the note was also done
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: A day and a half after the injection I became very, very depressed; even getting out of bed seemed insurmountable. This lasted for four days and then began to lift. After 6 days I felt fine -- totally back to normal.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives, severe itching, rash that began 3/31/24
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Red swollen injection site, fever
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Periarthritis
Clinical narrative: "knot" in muscle as described by patient, diagnosed as frozen shoulder by healthcare provider at orthopedic clinic
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: red swollen injection site, fever
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient received his routine 11 year immunizations at his well visit on 3/28/2024.  Within 24hrs, he developed redness around the site of the Menquadfi and HPV injections on his left shoulder. Over the next 4 days, this area of redness and warmth continued to increase in size. No fevers or other symptoms. Had pain at injection site and in deltoid muscle initially but as of 4/1/24 this had resolved. He was seen by me in office on 4/1/24 for eval, concerning for large localized reaction vs cellulitis however due to continued worsening pt was treated for possible cellulitis with cephalexin PO x1 week.
Age: 30.0
Sex: F
Vaccine: JEV1
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: ***NO PHYSICAL ADVERSE REACTION***                                                                                                                                                                                                                     Vaccine given incorrect route. JEV per package insert is to be given intramuscular. Patient received vaccination Subcutaneous in left arm.                                                                                                                                                                                                                                                                              Notified:  Clinical Nurse Educator   Stated:                                                                                                                                                                                                                                                                                        " In reference to your question about a Japanese Encephalitis vaccine that was administered Subcut instead of IM and does it need to be repeated, the answer is no.  I found the answer in the preventable errors in vaccine administration that I have attached.  It states:  Although vaccines should always be given by the route recommended by the manufacturer, if a vaccine is given by the wrong route (subcutaneously (Subcut) instead of IM, or IM instead of Subcut), it doesn't need to be repeated with the following four exceptions: hepatitis B, rabies, HPV, and inactivated influenza vaccine that is labeled for IM administration given by any route other than IM should not be counted as valid and should be repeated. I contacted my medical director and verified this is accurate.  He agreed so you do not need to repeat the vaccine that was administered Subcut"                                                                                                                                                     Patient notified no need to start series over.
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: Patient given additional dose of IPV not needed.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia, Urticaria
Clinical narrative: #1 of Shringrix was administered on 09/16/2023 without any reactions.  #2 given on 03/22/2024, had couple days fever, myalgias, fatigue, nausea which resolved  then  03/24 evening- had body hives - improved by benadryl and cortizone cream  was improved then today had facial and body hives- took benadryl 12.5 immediately got better unclear if hives r/t vaccine or not. Referred to Allergist
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling, erythema, warmth of thigh
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse reaction this is a report of a vaccine administration error only.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had only received two previous doses of DTaP and given Kinrix.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Alcohol abuse, Cardiac arrest, Hypertension, Metabolic encephalopathy
Clinical narrative: Hospitalization for cardiac arrest on 3/19/2024, acute hypoxic respiratory failure, Sepsis, alcohol abuse, metabolic encephalopathy, nicotine abuse, hypertension, on dates 3/19/2024- 4/1/2024. Treated with Remdesivir.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Tobacco abuse
Clinical narrative: Hospitalization for cardiac arrest on 3/19/2024, acute hypoxic respiratory failure, Sepsis, alcohol abuse, metabolic encephalopathy, nicotine abuse, hypertension, on dates 3/19/2024- 4/1/2024. Treated with Remdesivir.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Death, Dialysis, Fatigue, Hypopnoea
Clinical narrative: Resident received COVID-19 Booster the morning of 3/28/24. Resident displayed mild fatigue symptoms on 3/29/24 (not unusual for him), although went to scheduled dialysis appointment.  No other complications noted.  On Saturday morning 3/30/24 nurses note reads: "At 0535, noticed by staff resident was in bed, laying on his back, unresponsive, appears very pale with shallow breathing. FBS 212 O2 UTO. Supervisor was on unit at this time called to assess res." And "In to see resident who has resp one every 45 sec. Resident unresponsive and blood sugar checked around 200. Calls to both daughters and left message for call back. Back to see resident who has no AP, no pulse nor respirations, pupils fixed and dilated. Resident pronounced at 5:57 am."  Previous vaccinations of resident have been generally well tolerated. On 11/12/21 he received Moderna vaccine with no issues, on 5/06/22 he received Pfizer vaccine with only nausea (not unusual for resident), on 9/27/22 he received Pfizer vaccine with symptoms next day of "malaise, nausea, body aches and chills" and on 9/22/23 he received Moderna vaccine with nausea and low blood sugar the following day, neither unusual for resident.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Mydriasis, Pallor, Pulse absent, Pupil fixed, Respiratory failure
Clinical narrative: Resident received COVID-19 Booster the morning of 3/28/24. Resident displayed mild fatigue symptoms on 3/29/24 (not unusual for him), although went to scheduled dialysis appointment.  No other complications noted.  On Saturday morning 3/30/24 nurses note reads: "At 0535, noticed by staff resident was in bed, laying on his back, unresponsive, appears very pale with shallow breathing. FBS 212 O2 UTO. Supervisor was on unit at this time called to assess res." And "In to see resident who has resp one every 45 sec. Resident unresponsive and blood sugar checked around 200. Calls to both daughters and left message for call back. Back to see resident who has no AP, no pulse nor respirations, pupils fixed and dilated. Resident pronounced at 5:57 am."  Previous vaccinations of resident have been generally well tolerated. On 11/12/21 he received Moderna vaccine with no issues, on 5/06/22 he received Pfizer vaccine with only nausea (not unusual for resident), on 9/27/22 he received Pfizer vaccine with symptoms next day of "malaise, nausea, body aches and chills" and on 9/22/23 he received Moderna vaccine with nausea and low blood sugar the following day, neither unusual for resident.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Resident received COVID-19 Booster the morning of 3/28/24. Resident displayed mild fatigue symptoms on 3/29/24 (not unusual for him), although went to scheduled dialysis appointment.  No other complications noted.  On Saturday morning 3/30/24 nurses note reads: "At 0535, noticed by staff resident was in bed, laying on his back, unresponsive, appears very pale with shallow breathing. FBS 212 O2 UTO. Supervisor was on unit at this time called to assess res." And "In to see resident who has resp one every 45 sec. Resident unresponsive and blood sugar checked around 200. Calls to both daughters and left message for call back. Back to see resident who has no AP, no pulse nor respirations, pupils fixed and dilated. Resident pronounced at 5:57 am."  Previous vaccinations of resident have been generally well tolerated. On 11/12/21 he received Moderna vaccine with no issues, on 5/06/22 he received Pfizer vaccine with only nausea (not unusual for resident), on 9/27/22 he received Pfizer vaccine with symptoms next day of "malaise, nausea, body aches and chills" and on 9/22/23 he received Moderna vaccine with nausea and low blood sugar the following day, neither unusual for resident.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reported increased pain/burning at injection site the evening of 3/27, woke up on 3/28 in am and noted swelling/redness to R arm, redness/swelling increased throughout the day 3/28 and began marking R arm with pen to monitor for progression, redness/swelling continued to spread down R arm 3/29 (not past elbow), notified EH of reaction and reported she had a PA in the office which she works evaluate her and the PA prescribed Cephalexin which she reported she would begin taking at lunch time. Reported pain/redness/swelling improved as of 4/1 but 5 blisters present with no open areas. Reported burning resolved as of 4/1 unless experiences a friction rub.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Peripheral swelling
Clinical narrative: Reported increased pain/burning at injection site the evening of 3/27, woke up on 3/28 in am and noted swelling/redness to R arm, redness/swelling increased throughout the day 3/28 and began marking R arm with pen to monitor for progression, redness/swelling continued to spread down R arm 3/29 (not past elbow), notified EH of reaction and reported she had a PA in the office which she works evaluate her and the PA prescribed Cephalexin which she reported she would begin taking at lunch time. Reported pain/redness/swelling improved as of 4/1 but 5 blisters present with no open areas. Reported burning resolved as of 4/1 unless experiences a friction rub.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: COVID vaccine was diluted by the nurse, with sterile water instead of sodium chloride 0.9%. vaccine was administered and it was not realized until after the administration that it was incorrectly diluted. The occurrence was reported to myself, RN Clinical Resource Nurse for Hospital. The patient will be contacted to repeat the vaccine today if possible. No studies showing hard from sterile water but vaccine is not effective when diluted that way.
Age: 5.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Lip erythema, Rash pruritic, Urticaria
Clinical narrative: Itchy rash noticed hives on body and red lips. Rash resolved spontaneously during the same evening.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient developed rash on one side of the body on 3/30/24.  Rash appeared on the left side at the injection site, under arm, armpit, left breast and left hip.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Severe Body Aches, Fever to 101, Headache, Arm Soreness at injection site. Severe first 24-36 hours, subsided to mild next 12-24.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Per client report, she broke out in hives "all over my body." She received the vaccine on Thursday afternoon and on Sunday night she started with hives. Denies any new medication or food introduced. Her only symptom is hives. Denies any itching, throat itching, trouble breathing, etc. She took benadryl.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult Hep A given to 4-year-old.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: March 16 - cellulitis on right shin,; March 17-20 - hospitalized in Hospital, IV vancomycin and cefazoln while in hosppital, Zyvox for 7 days when discharged, still being treated by Hospital Wound Clinic
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Streptococcus test negative
Clinical narrative: Eryethema and vesicles persisting on face and body for 3 days.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Condition aggravated, Oral herpes, PFAPA syndrome, Pyrexia, Stomatitis
Clinical narrative: Client's PFAPA flared up after the second dose resulting in a fever and fever blister/sores to break out. Requiring a prednisone taper to treat PFAPA symptoms. Only vaccine the client has received in the past week.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Infant irritability, Injection site erythema, Injection site inflammation, Pruritus, Rash
Clinical narrative: Pt recvd the above vaccines at 11:52 on 3/29 and at 7:00 pm that night, parent noticed redness, inflammation on rt thigh.  Baby was very fussy, no fever. Over the following two days, baby contd to have increasing rash that covered most of body except for face.  Baby evaluated today by Dr, 'dx hives possibly from vaccinations'.   Plan: Wash skin daily. Topical steroids to help itchiness. Will refer to allergy for evaluation. Call if not improving in 1 week, sooner if symptoms get worse.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: Pt recvd the above vaccines at 11:52 on 3/29 and at 7:00 pm that night, parent noticed redness, inflammation on rt thigh.  Baby was very fussy, no fever. Over the following two days, baby contd to have increasing rash that covered most of body except for face.  Baby evaluated today by Dr, 'dx hives possibly from vaccinations'.   Plan: Wash skin daily. Topical steroids to help itchiness. Will refer to allergy for evaluation. Call if not improving in 1 week, sooner if symptoms get worse.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Computerised tomogram pelvis, Herpes zoster, Magnetic resonance imaging spinal, Muscular weakness
Clinical narrative: Patient received Varicella vaccine 6/20/2005 and 6/10/2008. No history of varicella infection. 3/24/2024 onset of right medial knee pain with vesicular rash, gradually progressed to right quadricep/hip flexor weakness, right quadricep pain- unable to bear weight.  Herpes Zoster peripheral neuropathy and lumbar neuritis.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Myalgia, Neuropathy peripheral, Radiculopathy, Rash vesicular, Ultrasound Doppler
Clinical narrative: Patient received Varicella vaccine 6/20/2005 and 6/10/2008. No history of varicella infection. 3/24/2024 onset of right medial knee pain with vesicular rash, gradually progressed to right quadricep/hip flexor weakness, right quadricep pain- unable to bear weight.  Herpes Zoster peripheral neuropathy and lumbar neuritis.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Weight bearing difficulty
Clinical narrative: Patient received Varicella vaccine 6/20/2005 and 6/10/2008. No history of varicella infection. 3/24/2024 onset of right medial knee pain with vesicular rash, gradually progressed to right quadricep/hip flexor weakness, right quadricep pain- unable to bear weight.  Herpes Zoster peripheral neuropathy and lumbar neuritis.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Frequent bowel movements, Haematochezia
Clinical narrative: Pt experienced blood in her stool x 2  on 3/25/2024 and again on 3/31/2024 . She has had some increase in stool frequency.  She has otherwise been well appearing and acting her normal self per parents. Not fussy.  No episodic pain.  Feeding well. Well appearing on exam. Normal abdominal exam.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Hypotension
Clinical narrative: Patient's wife reports patient the following day in the evening around 8:00 pm he felt faint. He went to lay down. His wife said she took his blood pressure and it dropped to 99/43. She reports his blood pressure was low for about an hour before it started coming back up. His PCP requested to report to VAERS this hypotensive adverse reaction.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Eye injury, Lumbar puncture
Clinical narrative: weeks after vaccine; lost eye sight
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Injection site pain, Loss of consciousness, Pallor, Tremor
Clinical narrative: Pt received HPV9 in LA and reported pain at the site. He received MCV4O in RA within 1 minute and immediately stated, "I can't see." He appeared pale and began to have mild tremors as he was laid supine with legs elevated. Pt reported he had blacked out and then woke up, but staff did not notice total loss of consciousness. Pt reported he had not eaten all day. Mom reported pt had been feeling nervous leading to injection time. BP 90/50, down from baseline of 119/77. Pt drank water and ate several food items. He was mostly recovered in 10 minutes, still reporting feeling dizzy. He was monitored an additional 20 mins.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Faeces discoloured, Frequent bowel movements, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Approximately 1.5 days after her third dose of live oral Rotavirus vaccine, pt developed frequent bloody stools. The stool was loose yellow with mucous and bright red or pink blood. She had >10 stools in 1 day. The blood resolved after 1 day although she continues to have more frequent stools than normal 3 days after the vaccine. She has no fever, abdominal pain, anorexia, vomiting, or decrease in wet diapers.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Polymerase chain reaction, Rotavirus test positive, Ultrasound abdomen normal
Clinical narrative: Approximately 1.5 days after her third dose of live oral Rotavirus vaccine, pt developed frequent bloody stools. The stool was loose yellow with mucous and bright red or pink blood. She had >10 stools in 1 day. The blood resolved after 1 day although she continues to have more frequent stools than normal 3 days after the vaccine. She has no fever, abdominal pain, anorexia, vomiting, or decrease in wet diapers.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP reported VARIVAX was administered after a temperature excursion to two patients. This AE is for patient two of two.; This spontaneous report was received from a registered nurse (R.N) concerning to a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 15-MAR-2024, the patient was vaccinated with  a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X021930, expiration date: 29-AUG-2025, once, administered for prophylaxis (strength, and route of administration were not provided), that had gone through a temperature excursion of minus 13.2 degrees Celsius for 18 minutes, no further information or adverse events were reported (improper storage of product in use).  This is one of 2 reports received from the same nurse.  ; Sender's Comments:  US-009507513-2403USA006967:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles after vaccination/Suspected vaccination failure; Shingles; Shingle pain; 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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Shingle pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were resolved (duration 4 years).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: This case was reported by a patient via interactive digital media. The patient stated that he/she had shingle pain for 4 years. It was the worst and he/she had the vaccine 2 years before that. Nothing you can do about it. Doctor just shrugged the shoulder. Ice packs helped. 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. The follow-up could not be possible as no contact details were available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: PATIENT STATED THAT HER LEFT SIDE ABOVE HER SHOULDER BLADE IS SWOLLEN.  SHE HAS TRIED TYLENOL BUT DIDN'T HELP MUCH
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: At 0200 on 3/29/2024 patient noted chest pressure that woke her up from her sleep. Chest pressure continued along with injection site soreness and noted that she was running a fever of 101.5 with body aches throughout the morning. Severe Chest Pain and shortness of breath began suddenly around 1000 while out running errands. Patient called 911 for assistance and was brought to Emergency Room by ambulance for further evaluation.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia, Sleep disorder
Clinical narrative: At 0200 on 3/29/2024 patient noted chest pressure that woke her up from her sleep. Chest pressure continued along with injection site soreness and noted that she was running a fever of 101.5 with body aches throughout the morning. Severe Chest Pain and shortness of breath began suddenly around 1000 while out running errands. Patient called 911 for assistance and was brought to Emergency Room by ambulance for further evaluation.
Age: 22.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Incorrect vaccine administered to pt. Pt was due for MMR. MMRV was administered to pt instead of MMR.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: Deep muscle pain/ Stiffness in areas other than injection site.  Different type of pain that what I am used to with PsA.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Endotracheal intubation, Erythema, Localised oedema, Swelling, Swelling face
Clinical narrative: Significant swelling, redness, and edema of neck resulting in intubation for airway protection. The patient has been having redness on chest and swelling under right side of jaw for 2 days, per ECF that the patient was at when administered the vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles even after both the shots/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles even after both the shots/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2024 This case was reported by patient's spouse via interactive digital media. The reporter stated that the shot was not a full guarantee that you won't get them again. The doctors won't tell you that. Reporter's wife and others they have heard from, got them even after both shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case had been linked with US2024AMR038942, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR038942:Same reporter, different patient
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Brain fog, Chills, Extra dose administered, Fatigue, Headache
Clinical narrative: Patient came in on 3/29/2024 for their Second HPV shot, it was at that time the patient and their father were alerted they accidentally received a second Flu shot, when they thought they received their first dose of HPV.  Documentation on consent form and in chart confirms this patient received 2 influenza shots. The first flu shot was given on 9/21/2023, in patients right deltoid, the second given on 2/19/2024. Patient was not seen in the office and there were no documented phone calls post injection but the patient and his father reported he was very sick after this. They reported that the patient was very sick for about 1 1/2 weeks. He reported brain fog, fatigue, headaches, body aches, sweats & Chills.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Malaise, Pain
Clinical narrative: Patient came in on 3/29/2024 for their Second HPV shot, it was at that time the patient and their father were alerted they accidentally received a second Flu shot, when they thought they received their first dose of HPV.  Documentation on consent form and in chart confirms this patient received 2 influenza shots. The first flu shot was given on 9/21/2023, in patients right deltoid, the second given on 2/19/2024. Patient was not seen in the office and there were no documented phone calls post injection but the patient and his father reported he was very sick after this. They reported that the patient was very sick for about 1 1/2 weeks. He reported brain fog, fatigue, headaches, body aches, sweats & Chills.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Pt. came in for second dose of Meningococcal Group B vaccine (Bexsero #2). Pt. given expired vaccine. Vaccine expired on 03/31/2024 and it was administered on 04/01/2024. Clinical manager aware and pt.'s PCP aware. I asked if pt. should receive vaccine again, but was told by PCP it was not necessary.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine given to patient was beyond 30 days after thaw date although the original expiration date is May 15,2024 (vaccine thaw date was 2/1/2024) . This was overlooked in the pharmacy workflow  and the error was found out after vaccine administration. I called and emailed  Moderna Help Desk and per their response "Thank you for your patience. Analysis of the vaccine associated with your storage excursion is complete. The vaccine administered on March 12, 2024 from lot number 208F23-3A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." There were no adverse effects reported by patient.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Needle issue, Underdose
Clinical narrative: Dose was not fully administered due to issues with the needle and syringe. needle popped off.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine given to patient was beyond 30 days after thaw date although the original expiration date is May 15,2024 (vaccine thaw date was 2/1/2024) . This was overlooked in the pharmacy workflow  and the error was found out after vaccine administration. I called and emailed  Moderna Help Desk and per their response "Thank you for your patience. Analysis of the vaccine associated with your storage excursion is complete. The vaccine administered on March 12, 2024 from lot number 208F23-3A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." There were no adverse effects reported by patient.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Pain
Clinical narrative: body aches for 24 hours; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number NDC 58160084811) for prophylaxis.   Concurrent medical conditions included hypothyroidism. Concomitant products included levothyroxine.   On 04-MAR-2024, the patient received Arexvy. On 04-MAR-2024, less than a day after receiving Arexvy, the patient experienced general body pain (Verbatim: body aches for 24 hours). On 05-MAR-2024, the outcome of the general body pain was resolved (duration 24 hrs).   It was unknown if the reporter considered the general body pain to be related to Arexvy.     It was unknown if the company considered the general body pain to be related to Arexvy.   Additional Information: GSK receipt date: 17-MAR-2024 The patient had body aches for 24 hours
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccine breakthrough infection
Clinical narrative: Shingles break through; This non-serious case was reported by a pharmacist and described the occurrence of shingles in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-OCT-2023, the patient received the 1st dose of Shingrix (right deltoid). In JAN-2024, 3 months after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles break through). The patient was treated with valacyclovir hydrochloride. The outcome of the shingles was resolving.   The reporter considered the shingles to be related to Shingrix.     The company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAR-2024 The patient received first dose of Shingrix and had shingles breakthrough between 1st and 2nd dose.  The patient was taking antivirals to help resolve. The patient had shingles outbrake on the right side.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: had fever; myalgia; This non-serious case was reported by a consumer via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: had fever) and myalgia (Verbatim: myalgia). The outcome of the fever and myalgia were resolved.   The reporter considered the fever and myalgia to be related to Shingrix.     The company considered the fever and myalgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAR-2024 The medical assistant shared information regarding her mother's adverse events. The patient had fever and myalgia for approximately 2 to 3 days.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: 4th dose of Pediarix was inadvertently administered; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a child patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received the 4th dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: 4th dose of Pediarix was inadvertently administered). The outcome of the extra dose administered was unknown.   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: 13-MAR-2024 A 4th dose of Pediarix was inadvertently administered to the patient as part of the catch-up series which led to extra dose administered. No safety concerns were identified. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Headache, Influenza like illness
Clinical narrative: fever; Chills; crappy headache; Loss of appetite; Diarrhea; fllu like sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness (Verbatim: fllu like sick), fever (Verbatim: fever), chills (Verbatim: Chills), headache (Verbatim: crappy headache), appetite lost (Verbatim: Loss of appetite) and diarrhea (Verbatim: Diarrhea). The outcome of the sickness was resolved (duration 4 days) and the outcome of the fever and chills were not reported and the outcome of the headache, appetite lost and diarrhea were resolved (duration 1 day).   It was unknown if the reporter considered the sickness, fever, chills, headache, appetite lost and diarrhea to be related to Shingles vaccine.     It was unknown if the company considered the sickness, fever, chills, headache, appetite lost and diarrhea to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he or she did not want to discourage anyone but got the first Shingles vaccination about ten days before reporting. The patient was flu like sick for about four days. Fever chills, and stuff. So the last few days the patient had a different symptom each day like a crappy headache one day then loss of appetite one day then diarrhea for a day. It was normal for some of them to had these symptoms that long. So, patient mentioned to not to worry if do. The patient was a bit sensitive to stuff like that. The patient mentioned he or she would probably be pretty sick again the next shot as well, but it was worth it to not get shingles. Most were only sick a few days. Patient was just reassuring in case someone was sick longer that it was normal. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; Chills; crappy headache; Loss of appetite; Diarrhea; fllu like sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness (Verbatim: fllu like sick), fever (Verbatim: fever), chills (Verbatim: Chills), headache (Verbatim: crappy headache), appetite lost (Verbatim: Loss of appetite) and diarrhea (Verbatim: Diarrhea). The outcome of the sickness was resolved (duration 4 days) and the outcome of the fever and chills were not reported and the outcome of the headache, appetite lost and diarrhea were resolved (duration 1 day).   It was unknown if the reporter considered the sickness, fever, chills, headache, appetite lost and diarrhea to be related to Shingles vaccine.     It was unknown if the company considered the sickness, fever, chills, headache, appetite lost and diarrhea to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he or she did not want to discourage anyone but got the first Shingles vaccination about ten days before reporting. The patient was flu like sick for about four days. Fever chills, and stuff. So the last few days the patient had a different symptom each day like a crappy headache one day then loss of appetite one day then diarrhea for a day. It was normal for some of them to had these symptoms that long. So, patient mentioned to not to worry if do. The patient was a bit sensitive to stuff like that. The patient mentioned he or she would probably be pretty sick again the next shot as well, but it was worth it to not get shingles. Most were only sick a few days. Patient was just reassuring in case someone was sick longer that it was normal. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Headache; chills; tired; sick to stomach; sick for two days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-MAR-2024, the patient received the 1st dose of Shingles vaccine. In MAR-2024, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick for two days), headache (Verbatim: Headache), chills (Verbatim: chills), tiredness (Verbatim: tired) and upset stomach (Verbatim: sick to stomach). The outcome of the sickness was resolving (duration 2 days) and the outcome of the headache, chills, tiredness and upset stomach were not reported.   It was unknown if the reporter considered the sickness, headache, chills, tiredness and upset stomach to be related to Shingles vaccine.     It was unknown if the company considered the sickness, headache, chills, tiredness and upset stomach to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-Mar-2024 This case was reported by a patient via interactive digital media. Patient had just got the first shot two days ago (from the reporting).  Patient had been sick for two days and at the time of reporting starting to feel better.  Patient had headache, chills, tired and sick to stomach.  Patient was told the second shot would be worse.  Patient hoped it would be better than getting the shingles, watched his/her mother suffer at age 82. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Malaise
Clinical narrative: sick for 2 weeks; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick for 2 weeks). The outcome of the sickness was resolved (duration 2 weeks).   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2024 This case was reported by a patient via interactive digital media. The patient reporter that he/she was sick for 2 weeks following that shot but no RSV. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: still having nerve pain in other parts of my body from contracting shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of post herpetic neuralgia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles and pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced post herpetic neuralgia (Verbatim: still having nerve pain in other parts of my body from contracting shingles). The outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2024 This case was reported by a patient via interactive digital media. The patient reported that it was so true, get your shot. The patient did not received the shot but got shingles, very painful, would definitely get the second one in 4 months. At the time of reporting the patient still had nerve pain in other parts of his/her body from contracting shingles. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Lymph node pain, Lymphadenopathy, Pain, Swelling
Clinical narrative: cellulitis; pain; Swelling; swelling with lymph node involvement in her arm; pain with lymph node involvement in her arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of cellulitis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cellulitis (Verbatim: cellulitis), pain (Verbatim: pain), swelling (Verbatim: Swelling), swollen lymph nodes (Verbatim: swelling with lymph node involvement in her arm) and lymph node pain (Verbatim: pain with lymph node involvement in her arm). The outcome of the cellulitis, pain, swelling, swollen lymph nodes and lymph node pain were resolving.   It was unknown if the reporter considered the cellulitis, pain, swelling, swollen lymph nodes and lymph node pain to be related to Shingrix.     It was unknown if the company considered the cellulitis, pain, swelling, swollen lymph nodes and lymph node pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAR-2024 The patient experienced cellulitis, pain, and swelling, with lymph node involvement in her arm. It was resolving.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shingrix, 2 of which were 5 weeks apart; recived 3rd dose of shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix, 2 of which were 5 weeks apart) and extra dose administered (Verbatim: recived 3rd dose of shingrix vaccine). The outcome of the drug dose administration interval too short and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 22-MAR-2024 The patient received 3 doses of Shingrix vaccine, 2 of which were 5 weeks apart and the reporter wanted to know if there was any harm to report to the patient, which led to, extra dose administered with 3rd dose of Shingrix and shortening of the vaccination schedule with 2nd dose of Shingrix. This case had been link with US2024037502, reported by the same reporter.; Sender's Comments:  US-GSK-US2024037502:same reporter ,different patient