chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Screaming, Staring
Clinical narrative: So we drove home about an hour and it was fussy on the way home and he act like he was just annoyed with what happened. Then he started crying as we were going home. We got home i began to rock him and that did not work, I walked and i tried to nurse he was not having it. And i was looking at rocking him and it was like he was looking right passed me and that just really wasnt like him, After that he was just staring i then took him for a walk and the screaming was just getting louder and louder and louder. And it was atleast 8 or 9 when he finally stopped screaming. And when he calmed down i was able to get him to nurse it looked like he was coming back to his senses and you could see the change in his face. His left leg was swollen and irrated. The next day he was very tired and lethagirc like. It took like 2 days of the tiredness and it he was slowly going back to normal, so again it was very odd. It was a slow progression of him getting better,
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: pt says about week after getting the vaccine her left arm broke out with a rash in small bumps from her elbow to her wrists. She has been applying cortisone cream on it. It helps some but it seems to be worse at night. It seems to be getting worse. She sees her provider next month and will ask him to take a look at it.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given before patient was 6 weeks old.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered 12-18y vaccine to 9 yr old. No adverse reaction.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: PATIENT CAME INTO PHARMACY 2 DAYS AFTER VACCINATION AND REPORTED ARM SWELLING AND REDNESS WITH A LUMP AROUND INJECTION SITE ALSO SPREADING ABOUT 6 TO 8 INCHES FROM INJECTION SITE
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TDAP
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: Pt had no adverse effects. No treatment needed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Needle issue, Underdose
Clinical narrative: Patient also received 3 other vaccines that were administered correctly. When the Shingrix was administered, the needle did not properly deliver the vaccination to the patient and the solution sprayed all over the technician and patient when the needle was removed from the arm. The technician reported most of the dose was all over the jacket of the technician and the shirt of the patient so we mixed and administered another dose after discussing with our clinical services manager.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Asthma, Chest X-ray normal, Cough, Depression, Eczema
Clinical narrative: Patient never had any shots. Father took him behind my back to get them. On Father's week patient Had a  fever that started and continued until I got him in my care. Fevers spiked up to 104.8. I took him to emergency 6/22/2019. He had leg pain and cough. I told them what happened and the doctor said no one here will/ can not put down his fever was from the vaccines. They said it was from a virus. Ever since then moving forward patient gets sick every 2 to 3 months with very high fevers, pneumonia,asthma, couldnt breathe at night due to large tonsiles that was removed Nov.10th, 2022.  Strep throat. Ear, Mono- infectious mononucleosis EBV.. Reoccurring rashes on body. Doctor said its eczema. Food sensitities. Depression
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Epstein-Barr virus infection, Food intolerance, Gastrointestinal disorder, Infectious mononucleosis, Influenza A virus test negative
Clinical narrative: Patient never had any shots. Father took him behind my back to get them. On Father's week patient Had a  fever that started and continued until I got him in my care. Fevers spiked up to 104.8. I took him to emergency 6/22/2019. He had leg pain and cough. I told them what happened and the doctor said no one here will/ can not put down his fever was from the vaccines. They said it was from a virus. Ever since then moving forward patient gets sick every 2 to 3 months with very high fevers, pneumonia,asthma, couldnt breathe at night due to large tonsiles that was removed Nov.10th, 2022.  Strep throat. Ear, Mono- infectious mononucleosis EBV.. Reoccurring rashes on body. Doctor said its eczema. Food sensitities. Depression
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Influenza B virus test negative, Pain in extremity, Pharyngitis streptococcal, Pneumonia, Pyrexia
Clinical narrative: Patient never had any shots. Father took him behind my back to get them. On Father's week patient Had a  fever that started and continued until I got him in my care. Fevers spiked up to 104.8. I took him to emergency 6/22/2019. He had leg pain and cough. I told them what happened and the doctor said no one here will/ can not put down his fever was from the vaccines. They said it was from a virus. Ever since then moving forward patient gets sick every 2 to 3 months with very high fevers, pneumonia,asthma, couldnt breathe at night due to large tonsiles that was removed Nov.10th, 2022.  Strep throat. Ear, Mono- infectious mononucleosis EBV.. Reoccurring rashes on body. Doctor said its eczema. Food sensitities. Depression
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Rash, Respiratory pathogen panel, Streptococcus test negative, Tonsillar hypertrophy, Tonsillectomy
Clinical narrative: Patient never had any shots. Father took him behind my back to get them. On Father's week patient Had a  fever that started and continued until I got him in my care. Fevers spiked up to 104.8. I took him to emergency 6/22/2019. He had leg pain and cough. I told them what happened and the doctor said no one here will/ can not put down his fever was from the vaccines. They said it was from a virus. Ever since then moving forward patient gets sick every 2 to 3 months with very high fevers, pneumonia,asthma, couldnt breathe at night due to large tonsiles that was removed Nov.10th, 2022.  Strep throat. Ear, Mono- infectious mononucleosis EBV.. Reoccurring rashes on body. Doctor said its eczema. Food sensitities. Depression
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head, Pain, Pain in extremity, Pyrexia
Clinical narrative: About 10 minutes after receiving the shot I had blurred vision in my left eye. About 10 minutes later I cannot eye out of my left eye. This lasted about 30 minutes.  Then my vision started to come back and was fine.  Next day had sore arm no other symptoms. Went to my primary care physician to talk to her about this. She sent me to emergency room for scans and bloodwork. Everything was fine. Next day had fever, achy and sore arm which are the same symptoms I had with the six prior Pfizer Covid vaccines.  This was the first Moderna Covid vaccine I?ve ever gotten. I never had the vision loss with Pfizer shots.  Also received the flu vaccine in the same arm at the same time. Which I had last year also.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: About 10 minutes after receiving the shot I had blurred vision in my left eye. About 10 minutes later I cannot eye out of my left eye. This lasted about 30 minutes.  Then my vision started to come back and was fine.  Next day had sore arm no other symptoms. Went to my primary care physician to talk to her about this. She sent me to emergency room for scans and bloodwork. Everything was fine. Next day had fever, achy and sore arm which are the same symptoms I had with the six prior Pfizer Covid vaccines.  This was the first Moderna Covid vaccine I?ve ever gotten. I never had the vision loss with Pfizer shots.  Also received the flu vaccine in the same arm at the same time. Which I had last year also.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: CMA gave Gardasil to patient. Patient was suppose to receive Tdap.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic shock
Clinical narrative: She  went into anaphylactic shock. She had to be escorted to the urgent care and treated. She took benadryl to help.
Age: 7.0
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Provider ordered PPSV 23 for patient to receive and the MA administered PCV20 in error
Age: 16.0
Sex: F
Vaccine: COVID19, FLU3, MNQ
Symptoms: Wrong product administered
Clinical narrative: Wrong age vaccine was given to patient requiring for patient to come back another time to get revaccinated due to lower dosage administered.
Age: 80.0
Sex: F
Vaccine: COVID19, TD, UNK, UNK, VARZOS
Symptoms: COVID-19, Cough, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Covid 19 started evening of November 10, 2024.  Extreme coughing, fever, nasal congestion, sore muscles.  Took Daytime/Nighttime Cold and Flu medication until Covid diagnosis on 11/14/.2024, then started AZITHROMYCIN 250 MG for 4 days.
Age: 9.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt did not need Td until March 2025.
Age: 43.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Gastroenteritis, Pyrexia
Clinical narrative: Severe gastroenteritis with high fever, lasting 4-5 days
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was under dose received 0.25ml  of Covid vaccine. When he needed 0.5ml  adult dose. Staff have reached out to the patient and he was aware of being under dosed. And at this time he declined to come in for the second half  0.25ml .
Age: 13.0
Sex: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Teen was given a high dose flu vaccine instead of a regular dose flu vaccine. Client had no adverse side effects from vaccine.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient age 8 given a Dtap, should not have been given over the age of 6.  No symptoms
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid 19 infection followed by five-day course of Paxlovid.  After symptoms resolved, a rebound of symptoms occurred after three days.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU3, HEPA, HPV9, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pfizer 12+ vaccine was administered to a child 9years old. Client did not have an abnormal side effects noted.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysstasia, Mobility decreased, Vertigo
Clinical narrative: I called Pharmacy to verify that I received a GSK flue shot, but I am not 100% certain if it was Fluarix or FluLaval. About 3-4 hours after I received the vaccine, while I was home, I started to feel dizzy and lightheaded. I felt like I was going to pass out. I had to lay down and was unable to stand up, sit up, or turn my head without feeling like the room was spinning. This lasted about 12 hours and slowly wore off over that time. I have never before had vertigo and have not experienced it since. I have also never had an adverse reaction to a vaccine and never had a vasovagal reaction before. This seemed completely isolated. I do have pre-existing neurological problems (Tourette's), but that has never been a problem with any other vaccines (e.g. I have received multiple covid vaccines, Hep A, HPV, TDAP, etc. without issue). I did not seek treatment because I was not able to get out of my bed.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: started with epistaxis bilateral that was intermittent for 2 -3 days.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: THREE RED SWALLOWED WARM PATCHES ON LEFT ARM, PT THINKS ONE OF THEM IS AT THE SITE OF INJECTION. I LINED AROUND THE PATCHES AND NUMBERED THEM BASED ON HOW RED THEY LOOKED FOR FURTHER CHANGES, AND PROVIDED THE PT WITH DIPHENHYDRAMINE SYRUP WHICH SHE FELT COMFORTABLE WITH. I ASKED HER TO GIVE ME A CALL IF SHE FELT ANY WORSE. DIDN'T SEEM TO BE A SERIOUS CONDITION BUT THE PT STATES HER MON HAD A " BLOOD POISONING" AFTER HAVING AN [ UNKNOWN VACCINE], PLUS SHE HAD SOME " BAD REACTION " AFTER SWINE FLU VACCINE A FEW YEARS AGO.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: My husband and I took my mother-in law to pharmacy for an appointment for her flu shot . Before she was seen they asked her which vaacineshe was there to receive.  She told them the flu vaacine for older adults as she is 95 years old. They repeated this back to her.  When they called her to actually get her injection, she again told them the vaccine she needed.  She received the injuection and sat down to wait briefly.  as we sat there, a pharmacist called her to the counter and told her they had made a mistake and gave her the normal adult, not high dose older adult vaccine. I talked with the store manager and voiced my concerns and disappointment  as an RN. They said they were sorry and please don't report us.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: CLIENT GIVEN REGULAR DOSE INFLUENZA VACCINE.  PER CLIENT AGE OF 72 YEAERS- SHOULD HAVE BEEN HIGH DOSE.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site pain, Nausea, Skin warm, Vomiting
Clinical narrative: Errythema, warmth, nausea, vomiting, pain to site
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Fatigue, Pain in extremity
Clinical narrative: Arm soreness. Fatigue. Fever 99.1. High blood pressure.  159/94. usual medicated bp is around 115/75  taken weekly.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given flublok for ages 18yo and up
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Burning sensation, Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Reported to Urg Care on 11/14/24 at 13:16 with L arm redness/swelling - said they noticed it on Tues 11/13/24. It was itching, pain, burning, swelling and redness. On exam it was Tender/painful erythemic area of left outer extremity. Diagnosed as cellulitis - given  Keflex 500 mg  1 cap q 8 H x 7 days
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Tenderness
Clinical narrative: Reported to Urg Care on 11/14/24 at 13:16 with L arm redness/swelling - said they noticed it on Tues 11/13/24. It was itching, pain, burning, swelling and redness. On exam it was Tender/painful erythemic area of left outer extremity. Diagnosed as cellulitis - given  Keflex 500 mg  1 cap q 8 H x 7 days
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient expired 11/19/2024.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Pain in extremity, Tendonitis
Clinical narrative: pt states when she was injected with the vaccines they stung and burn more than usual. Within several hours both arms were hurting more than usual after having other vaccinations. She feels likes the injections were not placed were they were supposed to be. They were  burning, dull aches and pains. She was not able to raise them all of the way up loosing the range of motion. She was not able to touch them or lay on them. She continued to have pain so was using ibuprofin for about three weeks. She went to speak to the pharmacist at this time to see if maybe there was a vaccination error. She went to Dr. and was diagnosed with tendonitis and bursitis in both shoulders. The right bicep has more busititis and tendonitis than the left does. She was precrebribed meloxicam 15mg. She is applying ice packs and is doing some physical therapy exercises to do at home and her range of motion is better.  She is getting better but has not fully recovered.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Ageusia, Asthenia, Decreased appetite, SARS-CoV-2 test negative, Skin laceration
Clinical narrative: Cut on arm after injection. Severe weakness x 3 weeks. Weight loss of 12 pounds. Loss of appetite, loss of taste. Ongoing at present.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Weight decreased
Clinical narrative: Cut on arm after injection. Severe weakness x 3 weeks. Weight loss of 12 pounds. Loss of appetite, loss of taste. Ongoing at present.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pruritus, Rash
Clinical narrative: about 5 to 6 days after receiving the vaccine Patient started experiencing rash/itching on neck, chest, stomach, feet and back. Had an appointment rheumatologist in october and received a prescription for triamcinolone cream,  that did not seem to work. He has also seen his primary doctor and dermatologist and has received prednisone tablets (which he started taking in november) and he states that it is not working. He is seeing the dermatologist who might run blood samples to see what type of allergic reaction he experienced.
Age: 0.5
Sex: F
Vaccine: ADEN_4_7, HIBV, PNC20, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Hib (ActHib) vaccine given to patient. Vaccine expired on 11/08/2024 and was given 11/12/2024. Patient's parent was called 11/20/2024 when event was caught. At this time, child is doing well. Expired vaccine removed from inventory, nurse educated on medication rights. Appointment scheduled for revaccination of Hib.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain in extremity
Clinical narrative: Patient reports extended arm pain and restricted range of motion immediately after administration and continuing today (30 days after administration)
Age: 61.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Dysstasia, Mobility decreased, Muscular weakness
Clinical narrative: Patient complained of severe leg muscle weakness. He could barely stand up after receiving vaccine but was walking around slow today.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Muscle weakness of hands, arms legs
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Cough, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: pt says she went to bed feeling ok but woke up with such a headache that she thought she had a brain tumor. She had to use a walker to get to get her tylenol. Her left arm was swollen. She had a lump the size of a walnut at the injection site and the a red streak running down from the injection site about 2 to 3 inches long. She went to the clinic because she started caughing. She was given a chest xray that was clear. She was precribed tessalon coughing medication and fluticosone nasal spray. She is still taking medication and is recovering.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site streaking
Clinical narrative: pt says she went to bed feeling ok but woke up with such a headache that she thought she had a brain tumor. She had to use a walker to get to get her tylenol. Her left arm was swollen. She had a lump the size of a walnut at the injection site and the a red streak running down from the injection site about 2 to 3 inches long. She went to the clinic because she started caughing. She was given a chest xray that was clear. She was precribed tessalon coughing medication and fluticosone nasal spray. She is still taking medication and is recovering.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Feeling cold, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness at injection site, soreness, stiffness, swelling, warmth, fever, chills
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Redness at injection site, soreness, stiffness, swelling, warmth, fever, chills
Age: 76.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Cough
Clinical narrative: Dry cough started within week of vaccination and persists  to date.
Age: 44.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blister, Rash
Clinical narrative: Large rash on back of right thigh. Raised vesicles approximately 3mm in diameter. Started behind and above the knee. Applied topical hydrocortisone with no effect. Continued to spread up leg wrapping towards the groin. Only stopped spreading and reversed by using Benadryl 2-3 times/day for the next 5 days.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: limited motion in shoulder/ arm. pain.
Age: 5.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event
Clinical narrative: incorrect Covid formula given for age of child- gave for 12y and older to a 5 yo child.  No adverse reaction noted, pt observed for 10m post vaccination. Parents were notified of error and educated on possible side effects and treatment of them. advised to contact health dept or PCP if any issues arose.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Respiratory tract congestion
Clinical narrative: Patient received 0.3mL of non diluted vaccine (vaccine is multi-dose and should have been diluted with 1.1 mL of 0.9% Sodium Chloride and then given a dose of 0.3 mL). Patient is doing okay per parent, states patient has congestion but is his normal self outside of that.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient ordered FLU Vaccine and COVID Vaccine given.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pruritus, Skin warm, Swelling
Clinical narrative: Client experienced red swelled hot face including neck and a little on chest with itchiness - client tired Benadryl OTC, then, presented to clinic on 11/19/24 at 330 pm and was given an injection of triamcinolone acetonide (kenalog-40) 1 ml/40 mg
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Client experienced red swelled hot face including neck and a little on chest with itchiness - client tired Benadryl OTC, then, presented to clinic on 11/19/24 at 330 pm and was given an injection of triamcinolone acetonide (kenalog-40) 1 ml/40 mg
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave @ 5 Days beyond BUD
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave vaccine 5 days beyond BUD
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient stating his arm is still sore a month later.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered vaccine 5 days beyond BUD
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: pt states that she has experienced numbness and tingling down right arm since receiving shingrix vaccine. Pt went to NP and NP believes a nerve may have been hit.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Breast disorder female, Breast swelling, Mammogram abnormal, Peripheral swelling, Ultrasound breast abnormal
Clinical narrative: swelling under r arm and across r side of breast, mammogram and ultrasound confirmed fatty tissue
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered vaccine 5 days after BUD
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered vaccine 12 days past BUD
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: After getting the COVID19 vaccine, I began experiencing episodes of dermatitis. I have never had dermatitis before this at any point in my life for any reason. To date, my body now reacts in a dermatitis flare up any time I get sick for any reason or my immune system is responding to something (i.e. come into contact with someone who was/is sick with any ailment). The dermatitis flare ups span from my abdomen and up to my neck, sometimes onto the bottom of my chin (minimal), and from my elbow up on both of my arms. The first sign that an episode is occuring comes in the form of a red rash (similar to a fever/heat rash), which now signals to me that I'm either about to get sick or ive come into contact with someone who was and my immune system must be responding. The next stage (within 24 hours) occurs regardless of whether I actively "contract" any illnesses (exhibit and signs or symptoms) or if my immune system fights it off (no sign/symptoms of any illness such as cough, sore throat, runny nose, sick stomach, etc--only left with the dermatitis). The next stage comes in the form of bumps or hives. The resulting "hives" are tiny bumps that appear similar to a pimple with a small white head; however, they are not pimples and there is no pus contained inside. They are both itchy and painful. I have tried hydrocortisone on them as well as a prescription cream for dermatitis. Neither ointments gave relief or helped. The episodes are fairly brief and go away on their own just as quickly if I use any ointments or not. However, they are painful and embarrassing, and significantly bring down my quality of life every time I experience an episode. I am upset that no one seems to care about this reaction that seems to be irreversible.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Atrial fibrillation, Chills, Condition aggravated, Decreased appetite
Clinical narrative: Sore muscles, fever, chills, aches, headache, intense joint pain, loss of appetite, fatigue, atrial fibrillation.  Stayed in bed, shivering for two days. Felt too sick to return to work for four days. This is very unlike me. Also had an enormous bruise at the injection site which took over a week to clear
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Injection site bruising, Malaise
Clinical narrative: Sore muscles, fever, chills, aches, headache, intense joint pain, loss of appetite, fatigue, atrial fibrillation.  Stayed in bed, shivering for two days. Felt too sick to return to work for four days. This is very unlike me. Also had an enormous bruise at the injection site which took over a week to clear
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain, Pyrexia
Clinical narrative: Sore muscles, fever, chills, aches, headache, intense joint pain, loss of appetite, fatigue, atrial fibrillation.  Stayed in bed, shivering for two days. Felt too sick to return to work for four days. This is very unlike me. Also had an enormous bruise at the injection site which took over a week to clear
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: patient woke up with fever and a small amount of swelling around the injection site. Through out the day her arm swelled more and is painful to touch, redness around injection site is bigger than baseball size.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: C-reactive protein increased, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: hypersensitivity to Prevnar-20  Left arm pain,redness, swelling, with fever of 102.7 day one and continued fever for 2 more days with no response to abx.  CRP as high as 51.  Seem to be hypersensitivy reaction to Prevnar.  Motrin/ citrazine, benedryl ordered. + steroid cream, referral to derm was placed.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine use by date expired on 11/14/2024
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest discomfort, Chest pain, Computerised tomogram normal, Dizziness
Clinical narrative: Full-body intense ache, Chest ache/tightness with shortness of breath, severe fatigue, short  but frequent lightheaded episodes, Intense muscle ache at base of skull/back of neck. Aches started very early morning after Covid Vaccine injection, lasted two days. Intense chest ache began early morning, after Covid vaccine injection, and on Monday morning (11/18/2024) I had to be referred by an urgent care video call to immediately go to an Emergency Room.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Myalgia, Pain
Clinical narrative: Full-body intense ache, Chest ache/tightness with shortness of breath, severe fatigue, short  but frequent lightheaded episodes, Intense muscle ache at base of skull/back of neck. Aches started very early morning after Covid Vaccine injection, lasted two days. Intense chest ache began early morning, after Covid vaccine injection, and on Monday morning (11/18/2024) I had to be referred by an urgent care video call to immediately go to an Emergency Room.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second flu vaccine on 11/16/2024. Per his chart, he had already received a flu vaccine on 10/31/24. Patient did not have any adverse effects. Only reporting that he received a 2nd flu vaccine.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Deep vein thrombosis, Pneumonia
Clinical narrative: Pneumonia, DVT Blood clots
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Fatigue, Loss of consciousness
Clinical narrative: Loss of consciousness lasting 1 - 2 minutes, semi-conscious for 10 - 15 minutes, extreme fatigue lasting approximately 10 hours.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administereed dose 12 days after BUD
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Decreased appetite, Fatigue, Musculoskeletal disorder, Neck pain
Clinical narrative: Joint Pain, loss of use of her in her hands and severe neck pain, pale skin, fatigue, swelling  in hands, loss of appetite
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Pallor, Peripheral swelling
Clinical narrative: Joint Pain, loss of use of her in her hands and severe neck pain, pale skin, fatigue, swelling  in hands, loss of appetite
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: started having MUSCLE pain, especially in THIGHS, also very fatigued and lack of energy. It's getting better after about 2 weeks .
Age: 38.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Brain fog, Chest discomfort, Chest pain, Fatigue, Headache
Clinical narrative: Chest pain about 36 hours after injection; nausea, headache, brain fog, fatigue 48 hours after injection for one day; chest tightness started 36 hours after injection and is still continuing as of 4 days post injection
Age: 38.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Nausea
Clinical narrative: Chest pain about 36 hours after injection; nausea, headache, brain fog, fatigue 48 hours after injection for one day; chest tightness started 36 hours after injection and is still continuing as of 4 days post injection
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bell's palsy, Cardiac murmur, Computerised tomogram, Full blood count, Urine analysis
Clinical narrative: Bells palsy, heart  murmur
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; revaccinated at provider's office; PROQUAD was reconstituted today and then stored in the fridge and administered 30 minutes after reconstitution.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, administered for prophylaxis (lot #y008788, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 30-OCT-2025; dose not reported, strength, and route of administration were not provided). It was reported that the vaccine was reconstituted and then stored in the fridge and administered 90 minutes after reconstitution (Product storage error). No reported signs/symptoms of adverse effects. Limited information provided. There was no additional adverse event (AE) or product quality complaint (PQC).  Follow up information was received from the medical assistant on 07-NOV-2024 and refers to a 4-year-old female patient. The patient's concomitant medications included influenza vaccine (FLU VACCINE VII) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).   On 08-OCT-2024, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered subcutaneously at left side. This vaccine was administered to patient past 30 mins mark after it's been reconstitution. On 10-OCT-2024, the patient was revaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot#, expiration date and route of administration were not provided) at provider's office (Extra dose administered).
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP called to report a patient was given two doses of VARIVAX in the same day. Caller states one was given intramuscular, and one was given subcutaneous. No side effects or symptoms reported. Caller verified both doses were the same lot number and ex; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-NOV-2024, the patient was vaccinted with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #Y005922, expiration date reported as and upon internal review confirmed to be: 13-MAR-2026, administered intramuscularlly for prophylaxis; and with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #Y005922, expiration date reported as and upon internal review confirmed to be: 13-MAR-2026, administered subcutaneously for prophylaxis. Therefore, the patient was given two doses of varicella virus vaccine live (oka/merck) (VARIVAX) in the same day (overdose). No side effects or symptoms were reported. No additional information was provided. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Caller stated no patient symptoms have been reported. No additional AE/no PQC reported; the patient had received their 1st dose 30-SEP-2022 and their 2nd dose 04-OCT-2023. Caller stated the patient was then given a 3rd dose on 08-NOV-2024; This spontaneous report has been received from a medical assistant and refers to a 13-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 30-SEP-2022, 04-OCT-2023 and 08-NOV-2024, the patient was vaccinated with the first, second and third doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, respectively, as prophylaxis (lot number of third dose X024727 has been verified to be valid, expiration date 15-MAY-2026; doses, routes of administration and expiration dates of first and second doses were not provided) (inappropriate schedule of product administration).   No additional adverse events were reported.  Lot number of first and second doses are being requested and will be submitted if received.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Contraindication to vaccination, Exposure during pregnancy, No adverse event
Clinical narrative: No adverse side effects were reported.; patient was administered VARIVAX while pregnant; patient was administered VARIVAX while pregnant; This spontaneous prospective pregnancy report was received from Physician and refers to a 30-year-old female patient (also reported as age late 20's to early 30's). The patient's medical history and previous drug reactions or allergies were not reported. Concomitant therapies included ustekinumab (STELARA).  On 12-NOV-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided) while pregnant approximately 27 or 28 weeks (exposure during pregnancy and contraindicated product administered). No adverse side effects were reported.  Based on the patient's gestational age, her last menstrual period (LMP) has been estimated as 30-APR-2024. Based on the estimated LMP, the estimated date of conception has been considered as 14-MAY-2024; and the estimated date of delivery (EDD) as 04-FEB-2025. Information about patient's obstetrical history or any fetal information regarding this pregnancy were not provided.  Lot number is being requested and will be submitted if received.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects or symptoms reported; HCP called to report a patient had received an expired dose of MMR II.; This spontaneous report was received from Certified Medical Assistant referring to a 12 month old patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 18-NOV-2024 , the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter, lot # W029542, expiration date: 15-SEP-2024, albumin status: rHA (expired product administered) (strength, route and anatomical location were not provided) for prophylaxis.  No adverse events reported. It was mentioned that product did not have any temperature excursions.
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain
Clinical narrative: neuropathy in feet and legs; This serious case was reported by a consumer via interactive digital media and described the occurrence of peripheral neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 peripheral neuropathy (Verbatim: neuropathy in feet and legs) (serious criteria GSK medically significant). The outcome of the peripheral neuropathy was not resolved.   The reporter considered the peripheral neuropathy to be possibly related to Shingles vaccine.     The company considered the peripheral neuropathy to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-NOV-2024 This case was reported by a patient via interactive digital media. The patient was reporter. The patient stated that to be careful on shingles shot. The patient got one and it possibly caused him/her to have neuropathy in feet and legs. The patient stated that there was a file against this company for this.  The paient reported  that he/she would gladly take a 3 to 4 months of shingles than to have neuropathy that never goes away and continued to become more painful. The follow-up could not be possible as no contact details were available.; Sender's Comments: Neuropathy peripheral  is an unlisted event which is considered unrelated to GSK  Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Skin ulcer
Clinical narrative: I have an open sore under my right breast and it is painful; open sore under my right breast and it is painful; This non-serious case was reported by a consumer and described the occurrence of skin ulcer in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin ulcer (Verbatim: I have an open sore under my right breast and it is painful) and skin pain (Verbatim: open sore under my right breast and it is painful). The outcome of the skin ulcer and skin pain were not resolved.   It was unknown if the reporter considered the skin ulcer and skin pain to be related to Shingles vaccine.     It was unknown if the company considered the skin ulcer and skin pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-NOV-2024 The patient reported that she had received Shingles vaccine, and she had an open sore under her right breast, and it was painful. The reporter asked questioned was this reaction from the shot or was it shingles. The patient mentioned that she received too many medications used for pulmonary hypertension.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Intervertebral disc protrusion, Nerve compression
Clinical narrative: pain at injection site; redness at injection site; swelling at injection site; pinched nerve; herniated disc; could not put weight on right leg/right leg pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic.   On an unknown date, the patient received Arexvy (left arm). On an unknown date, several hours after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swelling at injection site), pinched nerve (Verbatim: pinched nerve), intervertebral disc protrusion (Verbatim: herniated disc) and leg pain (Verbatim: could not put weight on right leg/right leg pain). The outcome of the injection site pain and injection site erythema were resolved and the outcome of the injection site swelling, intervertebral disc protrusion and leg pain were not resolved and the outcome of the pinched nerve was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, pinched nerve, intervertebral disc protrusion and leg pain to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, pinched nerve, intervertebral disc protrusion and leg pain to be related to Arexvy.   Additional Information: GSK receipt date: 07-AUG-2024 The reporter stated she received Arexvy about a month ago ( did not remember the date) in her left arm.  She stated she wanted to protect herself and her new grandbabies.  She stated that hours later she had pain, redness and swelling at the injection site and had to use an Icepack for 4 days.  The patient had recovered from those symptoms except her HCP stated her arm still looked swollen.  A week after getting the vaccine the patient could not put weight on right leg.  The HCP diagnosed her with a pinched nerve and she mentioned she had a herniated disc in her back.  Her right leg still hurts but she was able to walk on it now (at the time of reporting).
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: pain at injection site; redness at injection site; swelling at injection site; pinched nerve; herniated disc; could not put weight on right leg/right leg pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic.   On an unknown date, the patient received Arexvy (left arm). On an unknown date, several hours after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swelling at injection site), pinched nerve (Verbatim: pinched nerve), intervertebral disc protrusion (Verbatim: herniated disc) and leg pain (Verbatim: could not put weight on right leg/right leg pain). The outcome of the injection site pain and injection site erythema were resolved and the outcome of the injection site swelling, intervertebral disc protrusion and leg pain were not resolved and the outcome of the pinched nerve was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, pinched nerve, intervertebral disc protrusion and leg pain to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, pinched nerve, intervertebral disc protrusion and leg pain to be related to Arexvy.   Additional Information: GSK receipt date: 07-AUG-2024 The reporter stated she received Arexvy about a month ago ( did not remember the date) in her left arm.  She stated she wanted to protect herself and her new grandbabies.  She stated that hours later she had pain, redness and swelling at the injection site and had to use an Icepack for 4 days.  The patient had recovered from those symptoms except her HCP stated her arm still looked swollen.  A week after getting the vaccine the patient could not put weight on right leg.  The HCP diagnosed her with a pinched nerve and she mentioned she had a herniated disc in her back.  Her right leg still hurts but she was able to walk on it now (at the time of reporting).
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: tiredness; fever; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-OCT-2024, the patient received the 2nd dose of Shingrix. In OCT-2024, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: tiredness), fever (Verbatim: fever) and chills (Verbatim: chills). The outcome of the tiredness, fever and chills were not resolved.   The reporter considered the tiredness, fever and chills to be related to Shingrix.     The company considered the tiredness, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-OCT-2024 The patient got the Shingrix vaccine the day before reporting.  The patient had some side effects, fever, chills, tiredness.  The reporter asked how long his adverse events from his Shingrix dose would last.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: blisters associated with the Shingles/ Shingles is vaccine blistering disease; pain was so intense; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blister (Verbatim: blisters associated with the Shingles/ Shingles is vaccine blistering disease) and pain (Verbatim: pain was so intense). The outcome of the blister and pain were not reported.   The reporter considered the blister to be related to Shingrix. It was unknown if the reporter considered the pain to be related to Shingrix.     The company considered the blister to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK receipt date: 31-DEC-2023 Th reporter reported the blisters associated with the Shingles Vaccine. The reporter reported when had shingles, the pain was so intense. At the time of reporting, as her friends and family approach their 50th birthday, she tells them did not forget to ask your physician about the shingles vaccine. This case was linked with case US2024AMR131389 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2024AMR131389:Same reporter/Diffrent patient