chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; Caller reported PROQUAD was administered to a 17 year old; This spontaneous report was received from a medical assistant referring to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 13-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, 0.5 milliliter, administered intramuscularly for prophylaxis (lot #X009731, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 30-SEP-2024; strength was not provided) (Product administered to patient of inappropriate age). No other information was provided. No additional adverse events (AEs) or product quality complaint (PQC) were reported.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient was not given the third dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received second dose of Engerix b on 29th February 2024) and Engerix b (received first dose of Engerix b on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: The patient was not given the third dose). The outcome of the incomplete course of vaccination 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: 11-SEP-2024 and 12-SEP-2024 The other health professional reported that they had a patient (student) present for her third Hepatitis b vaccine and it was noted that when she received the second vaccine that she was given Engenix-B even though she was 19 year at the time.  The patient was not given the third dose and instead instructed to return after their 20th birthday in November. The other health professional asked whether their clinic needs to report this via the Vaccine adverse event reporting system. The other health professional could not find any clear documentation from GlaxoSmithKline in the package insert or online as to whether this would be considered an administration error. No further details available.  Till the time of reporting the patient did not received third dose of Engerix b which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: I received the Spike Vax Covid 24-25 vaccine by Moderna on 9/9/24. I am 67, and have received all previously recommended vaccines, other than the booster this past spring. All my previous vaccines and boosters were Pfizer. About 9 hours after receiving the Spike Vax vaccine I began to feel like my heart was racing, and my lungs felt strange, although I was still breathing ok. My husband checked my pulse and listened to my heart with our at home stethoscope, and said my rates were normal, but I felt the way I have in the past when I have used an albuterol inhaler too close together, or years ago when I used natural ephedra products for my asthma. I saw online that this is a rare possible side effect and could indicate an allergic reaction. As it was late at night, and I was reluctant to go to an emergency room or call 911, I worked on deep breathing. After about half an hour, the feeling subsided, but it was very scary. After that, I had what are typical reactions for me with Covid vaccines- joint and muscle aches, and tiredness. I took acetaminophen for those symptoms. Early the next morning, I woke with a severe headache, which is unusual for me, and more muscle aches, and took more acetaminophen. The tiredness and achiness lasted for about 36 hours. The other symptom I've had that was not typical was that the injection site has stayed large and red and somewhat itchy until today, which is about 96 hours after the injection. Today it is still showing about a 2-inch red area around the injection site but is beginning to fade. It has looked and felt the way it looks after I get my allergy shots for wasp and mixed vespid venom. I have also had a somewhat stiff neck on the left side, which is the side of the injection, and don't know whether that is related. In the past, with the Pfizer vaccines, I always have tiredness, chills, and full body aches for 24-36 hours after an injection. I have never tested positive for Covid, and have tested often over the years, since I do have allergies and asthma, and my husband had a mild case of Covid in 2022. I'm thinking I should probably avoid the Moderna vaccine in the future, and I'm curious what the difference is in the formulation, and why I had a heart related side effect with Moderna, and haven't with Pfizer.
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder, Musculoskeletal stiffness, Myalgia, Pain, Palpitations
Clinical narrative: I received the Spike Vax Covid 24-25 vaccine by Moderna on 9/9/24. I am 67, and have received all previously recommended vaccines, other than the booster this past spring. All my previous vaccines and boosters were Pfizer. About 9 hours after receiving the Spike Vax vaccine I began to feel like my heart was racing, and my lungs felt strange, although I was still breathing ok. My husband checked my pulse and listened to my heart with our at home stethoscope, and said my rates were normal, but I felt the way I have in the past when I have used an albuterol inhaler too close together, or years ago when I used natural ephedra products for my asthma. I saw online that this is a rare possible side effect and could indicate an allergic reaction. As it was late at night, and I was reluctant to go to an emergency room or call 911, I worked on deep breathing. After about half an hour, the feeling subsided, but it was very scary. After that, I had what are typical reactions for me with Covid vaccines- joint and muscle aches, and tiredness. I took acetaminophen for those symptoms. Early the next morning, I woke with a severe headache, which is unusual for me, and more muscle aches, and took more acetaminophen. The tiredness and achiness lasted for about 36 hours. The other symptom I've had that was not typical was that the injection site has stayed large and red and somewhat itchy until today, which is about 96 hours after the injection. Today it is still showing about a 2-inch red area around the injection site but is beginning to fade. It has looked and felt the way it looks after I get my allergy shots for wasp and mixed vespid venom. I have also had a somewhat stiff neck on the left side, which is the side of the injection, and don't know whether that is related. In the past, with the Pfizer vaccines, I always have tiredness, chills, and full body aches for 24-36 hours after an injection. I have never tested positive for Covid, and have tested often over the years, since I do have allergies and asthma, and my husband had a mild case of Covid in 2022. I'm thinking I should probably avoid the Moderna vaccine in the future, and I'm curious what the difference is in the formulation, and why I had a heart related side effect with Moderna, and haven't with Pfizer.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Increased severity of tinnitus
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium decreased, Chills, Dehydration, Hyperhidrosis, Impaired work ability
Clinical narrative: STARTING 20 HOURS AFTER VACCINE ON 9/5/24 LETHARGIC, CHILLS, EXCESSIVE SWEATING AT NIGHT,NAUSEUOS, DRY HEAVES 30+ TIMES WITH AT LEAST 3 EPISODES OF VOMITING. PATIENT WENT TO ER ON TUESDAY 9/10/24 AND WAS GIVEN FLUIDS FOR DEHYDRATION ANDTABLETS FOR LOW POTASSIUM. PATIENT OUT OF WORK UNTIL 9/12/24, WENT BACK ON 9/12/24 BUT LEFT EARLY DUE TO CHILLS. PATIENT ONLY RECEIVED ONE VACCINE ON 9/5/24
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Night sweats, Retching, Vomiting
Clinical narrative: STARTING 20 HOURS AFTER VACCINE ON 9/5/24 LETHARGIC, CHILLS, EXCESSIVE SWEATING AT NIGHT,NAUSEUOS, DRY HEAVES 30+ TIMES WITH AT LEAST 3 EPISODES OF VOMITING. PATIENT WENT TO ER ON TUESDAY 9/10/24 AND WAS GIVEN FLUIDS FOR DEHYDRATION ANDTABLETS FOR LOW POTASSIUM. PATIENT OUT OF WORK UNTIL 9/12/24, WENT BACK ON 9/12/24 BUT LEFT EARLY DUE TO CHILLS. PATIENT ONLY RECEIVED ONE VACCINE ON 9/5/24
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram abnormal
Clinical narrative: Describe Event, Problem, or Product Use Error: patient with parox at fib no episodes sine 1/24. Onset at fib 24 hrs after modern covid vaccine. Spontaneously converted 24 hrs later. Last October 2023 patient had at fib same day as covid vaccine. rhythm strip showed at fib with slow vent response
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: During adminisitration of Fluzone vaccination, approximately 1/4 of liquid leaked out of back of syringe while the rest easily injected into deltoid muscle.
Age: 21.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Balance disorder, Blood folate, Blood thyroid stimulating hormone, Dizziness, Full blood count
Clinical narrative: Lightheaded - Balance issues - numbness toes and legs - can walk but unable to run/jog
Age: 21.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Glycosylated haemoglobin, Hypoaesthesia, Laboratory test, Loss of personal independence in daily activities, Metabolic function test
Clinical narrative: Lightheaded - Balance issues - numbness toes and legs - can walk but unable to run/jog
Age: 21.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Vitamin B12
Clinical narrative: Lightheaded - Balance issues - numbness toes and legs - can walk but unable to run/jog
Age: 35.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: No reported signs/symptoms of adverse effects from administration.; pediatric VAQTA was administered instead of adult VAQTA; This spontaneous report was received from register nurse, concerning a 35-year-old patient of unknown gender.   The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 16-SEP-2024, the patient was vaccinated with the first dose of pediatric hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1st dose, (lot #X026666, expiration date: 29-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided). The patient was 35 year old (vaccine underdose). No adverse event reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Immunisation reaction, Lethargy, Pyrexia
Clinical narrative: Severe cough, fever, lethargic, headache
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling face
Clinical narrative: Patient reported facial swelling and body itching, requiring diphenhydramine for relief
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Fever of 99-101 nausea  muscle ache headache stomach ache arm pain. Did not take any treatment .
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 99-101 nausea  muscle ache headache stomach ache arm pain. Did not take any treatment .
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In DEC-2020, the patient received the 1st dose of Shingrix. On 16-SEP-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 The patient had first dose in December 2020 and then had the second dose in early 2021. The day before reporting the patient was diagnosed with an early stage of a new shingles outbreak. The patient questioned should he/she get a booster vaccine after this episode had cleared. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine  Shingrix (1st dose)and Shingrix(2nd dose)
Age: 22.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest discomfort
Clinical narrative: Pt. called on 9/25 complaining of chest discomfort and potential irregular heartbeat overnight after vaccination on 9/24. She states that she has a history of irregular heartbeat but these were different symptoms from before. She was advised to follow up with PCP and/or urgent care.
Age: 12.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: She got her vaccine and said that she noticed that she got home and everything that her fingers were swollen and very itchy and red.  No shortness of breath or any other reactions.  She is at the nurse this morning with this complaint and says they are itching really bad and swollen and red, a few fingers on both hands.  She has not had any reactions to previous vaccines.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Heart rate increased
Clinical narrative: Elevated heart rate over 125 bpm while at rest. Was experiencing low-grade fever (99.7deg F) and headache at  time of adverse event. Took (2) Tylenol and placed wet washcloth on forehead to reduce fever. After 30 minutes, fever began to break, and heart rate reduced to between 93-117 bpm at rest.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The provider mistakenly ordered the Fluad HD, thinking that her age  of 64 and 8 months and comorbidities put her at higher risk, thus would benefit from the HD dose.  There was no actual adverse reaction.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 57.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dry mouth, Dysgeusia, Dyspepsia, Erythema, Neck pain
Clinical narrative: MMR vaccination given sub-Q in L posterior lateral upper arm and Hep B vaccination given IM to R deltoid.    2:30 pm - Pt walked to lobby and c/o shakiness, metallic taste in mouth, indigestion, dry mouth, and "achy" L side of neck. VS: T- 97.0, P- 76, R- 18, B/P- 124/74, SpO2- 100% on R.A. Injection sites are clear. Pt evaluated by PCP. LS clear and no signs of swelling to tongue or throat.    2:45 pm - After sitting with pt in room for 15 mins, P- 85, SpO2- 99% on R.A. Pt has no further complaints. Pt took a drink of water without any difficulties swallowing.    3 pm - After sitting an addition 15 minutes, pt c/o itchiness to bilateral ears, chin, R upper arm and upper chest. Skin to mentioned areas is pale red. No c/o breathing or swallowing issues. Pt evaluated by PCP. PCP ordered Benadryl 25 mg/ 10 ml solution x2.   3:10 pm - Pt drank Benadryl 50 mg without any difficulties.   3:25 pm - VS: T- 97.2, P- 67, R- 18, B/P- 120/72, SpO2- 100%. Skin to bilateral ears, chin, R upper arm and upper chest is now dark pink. Pt has no further c/o itchiness. Pt drank water without any difficulties or complaints.    3:45 pm - Pt re-evaluated by PCP and instructed to fill script for prednisone at Pharmacy and to take as prescribed. Pt verbalized understanding and was discharged to home.
Age: 57.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pruritus, Tremor
Clinical narrative: MMR vaccination given sub-Q in L posterior lateral upper arm and Hep B vaccination given IM to R deltoid.    2:30 pm - Pt walked to lobby and c/o shakiness, metallic taste in mouth, indigestion, dry mouth, and "achy" L side of neck. VS: T- 97.0, P- 76, R- 18, B/P- 124/74, SpO2- 100% on R.A. Injection sites are clear. Pt evaluated by PCP. LS clear and no signs of swelling to tongue or throat.    2:45 pm - After sitting with pt in room for 15 mins, P- 85, SpO2- 99% on R.A. Pt has no further complaints. Pt took a drink of water without any difficulties swallowing.    3 pm - After sitting an addition 15 minutes, pt c/o itchiness to bilateral ears, chin, R upper arm and upper chest. Skin to mentioned areas is pale red. No c/o breathing or swallowing issues. Pt evaluated by PCP. PCP ordered Benadryl 25 mg/ 10 ml solution x2.   3:10 pm - Pt drank Benadryl 50 mg without any difficulties.   3:25 pm - VS: T- 97.2, P- 67, R- 18, B/P- 120/72, SpO2- 100%. Skin to bilateral ears, chin, R upper arm and upper chest is now dark pink. Pt has no further c/o itchiness. Pt drank water without any difficulties or complaints.    3:45 pm - Pt re-evaluated by PCP and instructed to fill script for prednisone at Pharmacy and to take as prescribed. Pt verbalized understanding and was discharged to home.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There were no adverse events. Administered wrong vaccine patient should have received TDap instead.
Age: 66.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Discomfort, Erythema, Hypersomnia, Pyrexia, Skin discolouration
Clinical narrative: She got her vaccines, her right toe became unbearable to not even applying pressure to it, but when applying pressure it was worse.  She does not have any toe issues or ingrown toenails.  It turned purplish red, and she took 1 Ibuprofen due to fever which is normal for her about 4-5 days.  It did not take a difference on her toe, and she slept more due to discomfort.  She took 400 mg last night and the symptoms of the toe have disappeared.  The purple went to red, and she could not fear the discomfort anymore.  This morning it happened again, but not as severe as the first day, it is still red.  She has never had a toe issue of any kind.  It is hot to touch.  She thought that at the corner there was something oozing from the nail where it meets the toe and put antibiotic ointment and a bandaide on it.  She has not called her doctor yet.  If the symptom becomes worse then she will call her doctor, but believes it it related to the vaccines that she got.
Age: 66.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Skin warm
Clinical narrative: She got her vaccines, her right toe became unbearable to not even applying pressure to it, but when applying pressure it was worse.  She does not have any toe issues or ingrown toenails.  It turned purplish red, and she took 1 Ibuprofen due to fever which is normal for her about 4-5 days.  It did not take a difference on her toe, and she slept more due to discomfort.  She took 400 mg last night and the symptoms of the toe have disappeared.  The purple went to red, and she could not fear the discomfort anymore.  This morning it happened again, but not as severe as the first day, it is still red.  She has never had a toe issue of any kind.  It is hot to touch.  She thought that at the corner there was something oozing from the nail where it meets the toe and put antibiotic ointment and a bandaide on it.  She has not called her doctor yet.  If the symptom becomes worse then she will call her doctor, but believes it it related to the vaccines that she got.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 58 years old and received high dose vaccine indicated for 65 and older
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: General malaise, severe fatigue for a few days
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Injection site warmth
Clinical narrative: 65 year old female signed consent to receive Prevnar 20.  Nurse was putting this in system when she realized Prevnar 20 was already given 3/19/24. Pt was notified in office and was told to contact us if she had any reaction.  I called the patient today (9/26/24) and she said she was fine, but her arm was a little warm to touch at the injection site.  Patient denied any rash, fevers or redness.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: new employee gave menb instead of menveo, she now is having us check all immz given before being administered
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Diarrhoea, Dizziness, Headache, Pruritus
Clinical narrative: Rash all over body, Itching, Dizziness, Chest Pain, Headache, Diarrhea, Possible Partial Seizure
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash all over body, Itching, Dizziness, Chest Pain, Headache, Diarrhea, Possible Partial Seizure
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pruritus
Clinical narrative: area from elbow to wrist itchy on right arm (injection arm)
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Electrocardiogram normal, Fatigue, Headache, Paraesthesia
Clinical narrative: The following day after receiving my COVID and flu vaccines, I experience typical symptoms such as headache and fatigue. However, I started to also develop a tingling sensation in my chest, mostly of the right side. It felt worse that night, and the following morning (9/26) it still feels significant. I have felt this sensation before after receiving Moderna COVID vaccines.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error, Wrong technique in product usage process
Clinical narrative: pt was given just the powder part of the vaccine using a separate sterile diluent. This would be considered and invalid dose.
Age: 99.0
Sex: F
Vaccine: PNC20
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: PATIENT HAD PREVIOUSLY RECEIVED A DOSE OVER 1 YEAR AGO (3/2023) - THIS WAS NOT KNOWN AT THE TIME OF ADMINISTRATION AS IT WAS NOT REPORTED IN THE STATE SYSTEM - PATIENT DID NOT REPORT ANY ADVERSE EFFECTS POST-VACCINE ADMINISTRATION, WILL CONTINUE TO BE MONITORED
Age: 73.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT HAD PREVIOUSLY RECEIVED A DOSE 1 YEAR AGO (11/2023) - THIS WAS NOT KNOWN AT THE TIME OF ADMINISTRATION AS IT WAS NOT REPORTED IN THE SYSTEM - PATIENT DID NOT REPORT ANY ADVERSE EFFECTS POST-VACCINE ADMINISTRATION, WILL CONTINUE TO BE MONITORED
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: PEDIATRIC DOSE GIVEN TO PATIENT , NO ADVERSE REACTIONS NOTED
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia
Clinical narrative: Pt reported on 9/22/24 that he had moderate/severe shoulder pain that started a couple days after vaccination.  explained to patient that sometimes the vaccines can cause an inflammatory response that can cause should er pain. Pt reported on 9/25/ that the pain was much better with Motrin and stretching. Encouraged to see PCP if worse or unimproved.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Muscle disorder, Peripheral swelling, Rash
Clinical narrative: On 9/17/2024 patient received her annual Flu vaccine on Left upper arm IM, the next day 9/18/2024 she noticed her left arm was swollen and had a "muscle frozen the area" where she received her shot, she then started having rashes on her neck area spreading through her chest area and left lower arm. Patient is currently using topical cortisone cream w/ relief. Denies mouth, tongue swelling, throat tightness, difficulty breathing at any time since receiving flu vaccine on 9/17. Reports having similar experience w/raised hives approx. 3-4 years ago after receiving a flu shot at Hospital.  Does not recall the brand received. Did not experience any signs of anaphylaxis at that time. Reports being allergic to codeine and  many sensitivities  (non-specific) but does include preservatives.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash
Age: 86.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED A PREVIOUS DOSE 2/2024 AND THEN ANOTHER DOSE ON 9/25/2024 -IT WAS UNKNOWN THAT THE PATIENT RECEIVED A DOSE EARLIER IN THE YEAR UNTIL 1 DAY AFTER VACCINE ADMINISTRATION OF THE SECOND DOSE; THE PATIENT WAS MONITORED WITH NO REPORTED ADVERSE EFFECTS - WILL CONTINUE TO MONITOR
Age: 93.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Balance disorder, Blood glucose normal, Fall, Feeling abnormal
Clinical narrative: He got his vaccine, sometime in the morning in the middle of the night he was prespiring profusely with the blankets, pillows, sheets soaking wet.  He woke up not feeling great, had breakfast, and by mid morning around 10:30 his legs became very weak and he fell to the ground, crumbled to the ground.  His wife could not pick him up, he had no strength at all.  She called 9-1-1 who checked his VS including his glucose reading and everything was in the normal range, no fever, nothing.  Daughters came over, they got dinner and he went to bed.  The next morning his legs were still weak, but not like it was.  He was very unsteady on his feet on Wednesday.  He woke up today and it looks like he is feeling much better.  He is able to walk better.  She did talk to his doctors office and they could not see him until 9/30/24 with the NP in the office.  The 9-1-1 people told him to go to the ER but he did not want to as there were no other symptoms as the complete loss of use of his legs, unsteadiness and the sweating.  He is not sweating anymore.  He is improving, but still not back to 100%, but feels that in a couple more days he will be fine.   Wife states that he will not get another COVID vaccine as he is 93 years old, and due to him being so sick they will not get anymore.
Age: 93.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Gait disturbance, Hyperhidrosis, Illness, Muscular weakness, Musculoskeletal disorder
Clinical narrative: He got his vaccine, sometime in the morning in the middle of the night he was prespiring profusely with the blankets, pillows, sheets soaking wet.  He woke up not feeling great, had breakfast, and by mid morning around 10:30 his legs became very weak and he fell to the ground, crumbled to the ground.  His wife could not pick him up, he had no strength at all.  She called 9-1-1 who checked his VS including his glucose reading and everything was in the normal range, no fever, nothing.  Daughters came over, they got dinner and he went to bed.  The next morning his legs were still weak, but not like it was.  He was very unsteady on his feet on Wednesday.  He woke up today and it looks like he is feeling much better.  He is able to walk better.  She did talk to his doctors office and they could not see him until 9/30/24 with the NP in the office.  The 9-1-1 people told him to go to the ER but he did not want to as there were no other symptoms as the complete loss of use of his legs, unsteadiness and the sweating.  He is not sweating anymore.  He is improving, but still not back to 100%, but feels that in a couple more days he will be fine.   Wife states that he will not get another COVID vaccine as he is 93 years old, and due to him being so sick they will not get anymore.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Eye movement disorder, Trismus
Clinical narrative: Uncontrolled eye and jaw movements.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: 1.5 DIAMETER RED CIRCLE AND SORE
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Irritability
Clinical narrative: Patient was given the 12years and older formulation of Moderna Covid vaccine 2024/2025.  After speaking with the parent she noted patient had been complaining of leg pain at injection site and has been more cranky.  By the following Monday, symptoms had improved.  Mother was recommended to call back if symptoms did not improve or got worse.  To date, parent has not called back or made an appt for the patient.
Age: 68.0
Sex: F
Vaccine: COVID19, HEPAB, PNC20
Symptoms: Induration, Injection site erythema, Pruritus
Clinical narrative: Hard, red area on arm. slight itching. symptoms started the evening of vaccination and were present two days later.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash papular, Swelling
Clinical narrative: raise rash, redness, swelling
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Product administered to patient of inappropriate age
Clinical narrative: Patient received the 12+ years formulation of Covid vaccine.  Per Mom on Monday, patient was just more tired/cranky than usual.  Recommended that mom call back if symptoms did not resolve or worsened.  To date, mom has not called back and patient has not been seen for a visit.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient had appointment to receive Influenza and Covid-19 vaccines in clinic. A interpreter was used during the duration of the appointment. Patient told parent that she received the Influenza vaccine already and this was reflected in the chart and confirmed with the parents that she had received Influenza vaccination on an earlier date. Parents agreed to move forward with the administration of only the Covid-19 vaccine for today's appointment.  Vaccine was administered in the left deltoid with no complications. After patient and family left the clinic, the patient's chart wanted to reconcile an additional vaccine. The vaccine shown was a Covid-19 vaccine that appeared to be received on 9/12/2024.  Dr. was consulted and advised that there will be no harm done to the patient and that she may just experience typical side effects of the Covid-19 vaccine. Family was made aware and they had no concerns or questions.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: Employee was given the flu shot and two minutes after she received it she had a reaction. Two small areas of hive like bumps appeared immediately upon receipt. Pt reported the site as "itchy" and she had a quarter size area of redness.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed the morning after the vaccine there was a very large and pretty bad looking bruise at the injection site. Beyond the injection site, the skin is swollen and red. Over the afternoon it became very itchy. Today, two days after the vaccine being administered, the redness and swollenness had doubled in size and is extremely itchy. I tried OTC benadryl and OTC anti-itch cream to no avail. I contacted the hospital I received the vaccine at and they suggested using ice, to monitor for any other symptoms, and they would call to check in on me tomorrow. They sent me a link to this site to report my adverse reaction. I have never had a reaction to a vaccine previously which is why I was concerned.
Age: 36.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Asthenia, Mobility decreased, Pain, Sleep disorder
Clinical narrative: here for right shoulder pain. He received the flu vaccine on his right side on 9/20 and covid vaccine on the left. Over the weekend, he had body aches and low energy levels, rested all weekend. On Monday, notice some right shoulder pain but it wasn't severe. Yesterday, the pain worsened and now has severe pain and limited range of motion. Pain is worsened when he tries to lift anything with his right hand, cannot find a comfortable position to sleep in. No fevers. No numbness or weakness. No direct trauma. p/w right shoulder pain and decreased ROM after flu vaccination. Concerning for SIRVA.  Discussed the following:  - Ice, alternating with heat - NSAIDs (discussed safe use) - Will refer to Physical therapy
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient received multiple vaccines of Covid19 since 2021 - 2024 and each time patient broke out in hives that lasted for 3 months
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Bell's palsy, Dry eye, Facial paralysis
Clinical narrative: Patient administered seasonal high dose flu as above. Began to develop "dry eye" symptom in right eye on 9/22. Presented to his ophthalmologist on 9/25, was diagnosed with Bell's Palsy. On evaluation today in office, he is displaying cranial nerve 7 palsy. Severity is mild, initial treatment with corticosteroid taper
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Vaccine was diluted with sterile water instead of the appropriate diluent that is included with the vaccine.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested flu shot and Gardasil vaccine at the pharmacy. Patient filled out immunization consent form marking those vaccines. Vaccines were administered 9/25/24. On 9/26/24, pharmacy received email from clinical team that the patient also received flu vaccine at another pharmacy on 7/31/24. Patient received 2 flu shots 1 month apart. Patient contacted and reported feeling well with no adverse reactions.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; have a shingles outbreak; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have a shingles outbreak). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 19-SEP-2024 This case was reported by a patient via interactive digital media. The patient had received the double dose of shingles vaccine (Shingrix) in 2022 and unfortunately, he/she had a shingles outbreak right now (at the time of reporting). This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(1 and 2 dose).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Erythema, Pustule
Clinical narrative: Blister with some pustule in nature, red raised
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Significant arm swelling at site w redness and heat
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fall, Fatigue, Feeling abnormal
Clinical narrative: dizziness, tiredness, not myself, in bed 48 hrs. Bad dreams in which I fell out of bed and couldn't get up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: dizziness, tiredness, not myself, in bed 48 hrs. Bad dreams in which I fell out of bed and couldn't get up.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given two vaccines of Fluzone High-Dose; one in the left deltoid, one in the right deltoid. Patient was called by Dr where she explained the situation.  Management was notified about the incident. Patient has not reported any adverse symptoms, to my knowledge.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Blood alkaline phosphatase increased, Blood bilirubin increased, Blood creatinine decreased, Blood sodium decreased, C-reactive protein increased
Clinical narrative: Started with redness at injection site  1 day after administration, 2 days after administration couldn't move arm, crying hysterical headache, took 15ml motrin later that evening fever 103F, headache, achiness, Tylenol or Motrin would not bring fever down, next morning (sat) 105 fever, headache, sore arm, redness at the injection site spread hot tender to touch and hard, went to Hospital ER  where she was admitted for 3 nights/4days.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Carbon dioxide decreased, Conversion disorder, Crying, Headache, Injection site erythema
Clinical narrative: Started with redness at injection site  1 day after administration, 2 days after administration couldn't move arm, crying hysterical headache, took 15ml motrin later that evening fever 103F, headache, achiness, Tylenol or Motrin would not bring fever down, next morning (sat) 105 fever, headache, sore arm, redness at the injection site spread hot tender to touch and hard, went to Hospital ER  where she was admitted for 3 nights/4days.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Mobility decreased, Pain
Clinical narrative: Started with redness at injection site  1 day after administration, 2 days after administration couldn't move arm, crying hysterical headache, took 15ml motrin later that evening fever 103F, headache, achiness, Tylenol or Motrin would not bring fever down, next morning (sat) 105 fever, headache, sore arm, redness at the injection site spread hot tender to touch and hard, went to Hospital ER  where she was admitted for 3 nights/4days.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Red blood cell sedimentation rate increased, Treatment failure, Urine ketone body present
Clinical narrative: Started with redness at injection site  1 day after administration, 2 days after administration couldn't move arm, crying hysterical headache, took 15ml motrin later that evening fever 103F, headache, achiness, Tylenol or Motrin would not bring fever down, next morning (sat) 105 fever, headache, sore arm, redness at the injection site spread hot tender to touch and hard, went to Hospital ER  where she was admitted for 3 nights/4days.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count
Clinical narrative: Started with redness at injection site  1 day after administration, 2 days after administration couldn't move arm, crying hysterical headache, took 15ml motrin later that evening fever 103F, headache, achiness, Tylenol or Motrin would not bring fever down, next morning (sat) 105 fever, headache, sore arm, redness at the injection site spread hot tender to touch and hard, went to Hospital ER  where she was admitted for 3 nights/4days.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Feeling abnormal, Loss of consciousness, Muscle twitching, Nausea
Clinical narrative: After dose of MCV4 was administered client was complaing of feeling weird. This nurse got up in time and held patient from falling over to the ground, then RN came to assist and was asking if patient to open his eyes, while she was doing that this nurse asked for an ice pack. At this point NP was there helping to take his blood pressure. He started to wake up and open his eyes when all of a sudden he had some muscle twitching to bilateral upper arms.   We then assisted him to the ground and attempted to elevate his legs but he placed them down and turned his body to the side and said he felt nauseated. Vitals signs taken O2 Sats 100% RA, HR118, BP 92/58.  No emesis noted ice pack placed on his neck, bottle water given to client to take small sips. He then stated that he felt a little better.  0825 O2 Sats 98% RA, HR 66, BP 102/66. We then assisted him back onto the chair and client insisted that he felt better. We rechecked his Vital signs , O2 Sats 98% RA, HR 97, BP 110/72. Client stated he felt well enough to leave, client left with mom and went to sit down. Event started @ 0820 monitored until 0840.No other issues noted.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema
Clinical narrative: Angioedema to right side of face noted 10 minutes after administration. Sent to emergency room for treatment and evaluation
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: welt on arm occurred few hours after vaccine. patient said its getting better but itches
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Brain fog, Neck pain, Sleep disorder, Vertigo
Clinical narrative: Severe vertigo, nausea, back and neck pain.  Foggy brain trouble sleeping
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Feeling hot, Pyrexia, Swelling
Clinical narrative: Redness, swelling in the arm that started on Day 2 post vaccination and continued to spread over the next two days. Patient stated that it felt hot to the touch and was reporting a low grade fever as well. Patient presented to pharmacy on day 4 post vaccine - stated that they had not taken any OTC medications for it.  Recommended a dose of benadryl and if it didn't resolve to reach out to their PCP to rule out an infection.  So the answer to the below question is currently none of the above, however it could end up in a office visit.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3, HEP, HEPA
Symptoms: Chest X-ray normal, Electrocardiogram normal, Erythema, Metabolic function test, SARS-CoV-2 antibody test
Clinical narrative: Skin rash (presenting with redness, warmth, and localized swelling), beginning the day after administration (09/10/24). Much improved after urgent care visit 09/12/24. Asymptomatic today (09/26/24)
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3, HEP, HEPA
Symptoms: Skin reaction, Skin warm, Swelling
Clinical narrative: Skin rash (presenting with redness, warmth, and localized swelling), beginning the day after administration (09/10/24). Much improved after urgent care visit 09/12/24. Asymptomatic today (09/26/24)
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: She got her vaccine, it was just a slight pinch, and no bid deal.  About 2 days later she had a very rash, round, red circle around the area of the injection, about 6-8".  It has stayed that way, pharmacist told her to use hydrocortisone cream.  Today is 7 days later, it is still there, not as bad but it has not disappeared.  She has not taken anything else for the symptoms other than the coritisone cream.  She told a dermatologist about her condition, and he said that she was probably allergic to the manufacturer, advised to not use them again, ice and the hydrocortisone cream.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Seizure, Syncope
Clinical narrative: Mother stated patient collapsed and was admitted in the hospital for a seizure.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash erythematous, Rash pruritic, Treatment failure
Clinical narrative: (No issues with all the previous COVID vaccines - all Pfizer.  This is first Moderna)  Got vaccine ~3:30 pm Thurs 9/19.  Had really sore arm next day.  Tues morning had a rash on back & sides - very itchy.  Benadryl Gel didn't help, Cortisone-10 cream didn't help, Zyrtec (10 mg) didn't help.  Kept getting worse.  Went to Urgent Care (between PCPs - new one Oct - haven't seen yet) & was seen by NP.  Thought it was allergic reaction - could be to Spikevax or maybe iron (iron makes itchy, but never a rash & last 7 mg Fe was 9/22 - taking 3x/wk).  Rx triamcinolone acetate oint & Benadryl.  Did that night (last night) - rash is spreading.  Now on legs, arms, neck.  Benadryl didn't work.  (Had taken one ~6:00 pm - no hlep.  Oint ~9:30 pm - minor help.  Another Benadryl ~1:30 am - no help.)  Triamcinolone barely helps.  BP seems to be getting higher - reaction to Benadryl (hypertension)?  Will be calling UC back.  Morning BP had been running 120s but was 142/79 @ 10:36 am & 143/77 @ 10:30 pm on Wed 9/25 (was 175 at UC ~1:30 pm 9/25).  Today (9/26) 10:15 am 158/73.  To me (dau w/ lifelong allergies), doesn't look like hives.  Hot pink/orange spots (some raised), but some look more like broken skin (but where she can't reach to have screatched).  She doesn't go out, so I'm pretty sure no mosquito bites or anything.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED A PEDIATRIC DOSE NO ADVERSE OUTCOME
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Feeling hot, Muscle swelling, Myosclerosis, Pruritus
Clinical narrative: Per patient next day: Hard bump extended up and down muscles - elongated hardness in the muscle was 3" long. "lumpy", " a little red", "itchy - got very itchy as the hardness shrank even more", never took temperature, but feels he was feverish and hot two days later.  Coworkers said he looked feverish.
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Pyrexia
Clinical narrative: Per patient next day: Hard bump extended up and down muscles - elongated hardness in the muscle was 3" long. "lumpy", " a little red", "itchy - got very itchy as the hardness shrank even more", never took temperature, but feels he was feverish and hot two days later.  Coworkers said he looked feverish.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discolouration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Large (approximately 4 inch diameter) red, warm, tender circle around the injection site apparent no later than two days after the injection that blanches upon pressing the skin; soreness in arm immediately after injection continuing for at least the next two days